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acetaminophen

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Description

Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID1983
CHEMBL ID112
CHEBI ID46195
SCHEMBL ID3480
SCHEMBL ID19474893
MeSH IDM0000115

Synonyms (1405)

Synonym
BIDD:GT0005
MLS002154041
phenol derivative, 11
smr000112065
MLS001331684
bdbm26197
chembl112 ,
MLS001146925
HMS3268A10
nsc-3991
nsc3991
KBIO1_000660
DIVK1C_000660
pcm paracetamol lichtenstein
paracetamol raffo
viclor richet
malgis
algomol
tylex
n-(4-hydroxyphenyl)acetanilide
paraspen
paracetamol pb
paracetamol dr. schmidgall
paralyoc
labamol
paceco
treupel mon
neuridon
atralidon
minoset
finiweh
panadeine co
treupel n
migraleve yellow
schmerzex
doliprane
paracin
panado-co
paracetamol rosch
paranox
acertol
paracetamol italfarmaco
st joseph aspirin-free
dolefin
minafen
ccris 3
salzone
predimol
toximer p
paracetamol al
plicet
infants' feverall
panex
rhinex d-lay tablets
paracetamol von ct
verpol
duracetamol
neopap
zolben
pantalgin
pinex
parake
dolorstop
tazamol
pacimol
actifed plus
febrin
neo-fepramol
pe-tam
afebryl
anadin dla dzieci
mexalen
setamol
perdolan mono
ecosetol
paracetamol nycomed
paralief
midol teen formula
liquigesic co
febrex
paracetamol winthrop
helon n
mono praecimed
sinaspril
dymadon forte
paracetamol ratiopharm
abenol
percocet-demi
custodial
sanicet
neodol
aspirin-free anacin
paracetamol genericon
demilets
doloreduct
causalon
piramin
fanalgic
kinder finimal
reliv
momentum
neodolito
vips
anacin-3
paralen
nsc 109028
drixoral cold & flu
rubophen
intensin
maxadol
melabon infantil
acetofen
lemgrip
febricet
prodol
panadiene
geralgine-p
malidens
fever all
midol pm night time formula
codabrol
para-suppo
codral pain relief
pamol
cod-acamol forte
pyrigesic
percogesic with codeine
dolegrippin
darocet
eu-med
enelfa
asetam
sinedol
sanicopyrine
para-tabs
veralgina
calmanticold
acenol (pharmaceutical)
paracetamol saar
a-per
dolorfug
theraflu
prontina
empracet
apacet
democyl
parasin
benmyo
curpol
paracetamol fecofar
claradol codeine
paracetamol harkley
rubiemol
codicet
termalgine
parador
upsanol
paldesic
phenaphen w/codeine
pyromed
duaneo
algina
sunetheton
anti-algos
malex n
pyregesic-c
phenipirin
infadrops
paracetamol smithkline beecham
rockamol plus
parogal
fepanil
coricidin sinus
tiffy
asomal
sifenol
dristan cold no drowsiness
4-hydroxyanilid kyseliny octove [czech]
triaminic sore throat formula
spalt n
parakapton
dolko
paramol
fluparmol
asplin
paracemol
oxycocet
sedalito
paracodol
naldegesic
abrol
banesin
bayer select head cold
febrectol
suppap
hsdb 3001
termacet
dresan
exdol
captin
acetominophen
sudafed sinus
panofen
children's acetaminophen elixir drops
dafalgan
rounox
tylex cd
nilnocen
supofen
deminofen
panado-co caplets
antidol
remedol
oltyl
bayer select allergy-sinus
dafalgan codeine
tymol
nodolex
paracetamol hanseler
codoliprane
influbene n
termofren
puernol
panacete
lupocet
no-febril
paedialgon
pulmofen
durapan
vermidon
alpinyl
coricidin d
geluprane
children's tylenol chewable
inalgex
babikan
calapol
kratofin simplex
spalt fur die nacht
pediapirin
lekadol
dolprone
polmofen
medocodene
utragin
dolofugin
parcetol
dol-stop
panadeine
supadol mono
phogoglandin
contra-schmerz p
pirinasol
paracod
bacetamol
cuponol
a.f. anacin
scentalgyl
st joseph aspirin-free for children
analter
magnidol
dymadon co
zatinol
paracenol
duorol
paracetamol antipanin p
paracetamolo [italian]
panodil
parasedol
bayer select sinus pain relief
paracetamol stada
codisal forte
paracetamolum [inn-latin]
setol
cadafen
daygrip
dolcor
junior disprol
excipain
einecs 203-157-5
paradrops
biocetamol
bayer select menstrual multi-symptom
panamax
freka-cetamol
aferadol
percocet-5
lemsip
ortensan
midol regular strength
apitrelal
lonarid mono
scherzatabletten rezeptur 534
cefalex
paracetamolo
codisal
dolotec
titralgan
st. joseph cold tablets for children
codapane
jin gang
farmadol
grippostad
pacet
miralgin
gattaphen t
curadon
sine-off sinus medicine caplets
codalgin
paracetamol hexal
cofamol
volpan
222 af
disprol
demogripal
tylol
predualito
oralgan
desfebre
semolacin
paracetamol basics
tavist allergy/sinus/headache
tachiprina
ildamol
paralink
dhamol
tylenol allergy sinus
seskamol
abrolet
acetaco
medinol paediatric
treuphadol
paracetamol [inn:ban]
pediatrix
paedol
aspac
panaleve
gynospasmine
quiet world
cosutone
paracetol
new cortal for children
croix blanche
paroma
drixoral sinus
paramolan
tricoton
pacemol
setakop
viruflu
nina
stanback
dolorol forte
paracetamol bc
neocitran
fortalidon p
gripin bebe
termalgin
paracetamol heumann
endecon
algesidal
afebrin
kataprin
stopain
panasorbe
scanol
acetamol
dorocoff
dristancito
sinmol
vivimed
supramol-m
rupemol
andox
acephen
febrectal
calonal
SGCUT00014
iv-apap
ofirmev
dds-06a
fensum
perfalgan
efferalgan
dolgesic
acetavance
inchi=1/c8h9no2/c1-6(10)9-7-2-4-8(11)5-3-7/h2-5,11h,1h3,(h,9,10
wygesic
anexsia 10/660
propacet
roxicet 5/500
febranine
paracetamol (inn)
acetaminophen (jp17/usp)
tylenol (tn)
D00217
bayer select headache pain
SPECTRUM_000016
BSPBIO_001786
SPECTRUM5_000736
PRESTWICK_13 ,
NCGC00016361-01
cas-103-90-2
NCGC00025267-01
tocris-1706
BSPBIO_000915
PRESTWICK3_000868
IDI1_000660
PRESTWICK2_000868
BPBIO1_001007
pedric
panadol
abensanil
anhiba
homoolan
injectapap
anapap
nsc-109028
st. joseph fever reducer
paracet
paracetanol
painex
anaflon
paracetamol
febrolin
tabalgin
multin
dirox
phenol, p-acetamido-
nebs
febrinol
datril
acetanilide, 4'-hydroxy-
korum
pyrinazine
lonarid
4-hydroxyacetanilide
alpiny
prompt
tapar
lyteca
component of endecon
nobedon
lestemp
dimindol
naprinol
tempanal
liquagesic
tempra
103-90-2
paracetamole
phendon
napafen
accu-tap
component of hycomine compound
servigesic
calpol
dularin
cetadol
tralgon
component of dilone
acetagesic
acetaminofen
n-acetyl-4-aminophenol
nci-c55801
gelocatil
component of percocet
dial-a-gesic
hedex
wln: qr dmv1
p-acetamidophenol
parmol
janupap
acamol
amadil
acetaminophen
paracetamol dc
tylenol
component of dialog
panets
fevor
4'-hydroxyacetanilide
acetamide, n-(4-hydroxyphenyl)-
pacemo
febro-gesic
component of percogesic
febridol
parapan
nealgyl
dypap
acetalgin
napap
febrilix
n-(4-hydroxyphenyl)acetamide
tussapap
acetamide, n-(p-hydroxyphenyl)-
rivalgyl
finimal
anelix
clixodyne
algotropyl
bickie-mol
valadol
alvedon
component of phenaphen
elixodyne
apadon
p-hydroxyacetanilide
valgesic
eneril
4-acetaminophenol
n-acetyl-p-aminophenol
apamid
ben-u-ron
sk-apap
dymadon
apamide
p-acetaminophenol
temlo
neotrend
apap
p-hydroxyphenolacetamide
p-(acetylamino)phenol
4-acetamidophenol
fendon
nsc109028
conacetol
phenaphen
acetaminophen (4-hydroxyacetanilide)
NCGC00025267-02
AB00051905
C06804
n-(4-hydroxyphenyl)acetamide (tylenol)
TYL ,
acetaminophen, bioxtra, >=99.0%
4-acetamidophenol, 98%
acetaminophen, meets usp testing specifications, 98.0-102.0%, powder
acetaminophen, analytical standard
TO_000023
acetaminophene
paracetamolum
p-acetylaminophenol
4-(acetylamino)phenol
CHEBI:46195 ,
acenol
DB00316
p-hydroxy-acetanilid
NCGC00025267-05
NCGC00025267-04
NCGC00025267-03
hy-phen
anexsia
vicodin
KBIOGR_000560
KBIOSS_000356
KBIO2_002924
KBIO3_001286
KBIO2_000356
KBIO2_005492
SPBIO_000010
NINDS_000660
SPECTRUM4_000140
SPECTRUM2_000085
PRESTWICK0_000868
SPBIO_002836
PRESTWICK1_000868
SPECTRUM3_000283
SPECTRUM1500101
NCGC00016361-02
n-acetyl-para-aminophenol
L024125
HMS2091G03
F48B493F-B1FD-410C-AA0A-F40EC71A0689
HMS502A22
FT-0661041
FT-0661042
FT-0658035
H0190
HMS1570N17
HMS1920A03
NCGC00016361-07
AKOS000121004
STL140694
HMS2097N17
4-13-00-01091 (beilstein handbook reference)
tylenol (caplet)
4-hydroxyanilid kyseliny octove
resfenol
tylenol (geltab)
acetaminophen [usp:jan]
tylenol 8-hour
ec 203-157-5
362o9itl9d ,
flexsure
unii-362o9itl9d
atasol
tox21_201930
NCGC00259479-01
NCGC00253912-01
tox21_300100
BBL005229
BCP9000225
nsc-755853
nsc755853
pharmakon1600-01500101
dtxcid606
dtxsid2020006 ,
tox21_110397
aminofen
valorin
actamin
parelan
pasolind n
redutemp
valorin extra
aceta tablets
pasolind
phenaphen caplets
robigesic
oraphen-pd
dapa x-s
snaplets-fr
panasorb
aceta elixir
HMS2269G20
CCG-38901
NCGC00016361-05
NCGC00016361-04
NCGC00016361-03
NCGC00016361-10
NCGC00016361-06
NCGC00016361-08
NCGC00016361-09
BCPP000441
BCP0726000305
NCGC00016361-13
anexsia component acetaminophen
acetaminophen component of tencon
butapap component acetaminophen
paracetamolum [who-ip latin]
acetaminophen [orange book]
acetaminophen component of tycolet
acetaminophen component of fioricet
8055-08-1
acetaminophen [usp monograph]
acetaminophen [usp-rs]
acetaminophen component of percocet
triaprin component acetaminophen
acetaminophen component of sedapap
paracetamol [iarc]
bancap hc component acetaminophen
lorcet-hd component acetaminophen
acetaminophen [jan]
acetaminophen component of lorcet-hd
paracetamol [mart.]
acetaminophen component of anexsia
roxicet component acetaminophen
acetaminophen component of codrix
ultracet component acetaminophen
acetaminophen component of lortab
acetaminophen component of dhc plus
bucet component acetaminophen
acetaminophen component of darvocet
tylox component acetaminophen
excedrin component acetaminophen
acetaminophen component of vicodin
dhc plus component acetaminophen
dolene ap-65 component acetaminophen
acetaminophen component of ultracet
hy-phen component acetaminophen
acetaminophen component of allay
tencon component acetaminophen
acetaminophen component of combogesic
darvocet component acetaminophen
paracetamol [who-ip]
acetaminophen component of talacen
acetaminophen component of oxycet
acetaminophen component of phrenilin
allay component acetaminophen
acetaminophen component of wygesic
lortab component acetaminophen
medigesic plus component acetaminophen
wygesic component acetaminophen
bancap component acetaminophen
combogesic component acetaminophen
acetaminophen component of norco
phrenilin component acetaminophen
zydone component acetaminophen
acetaminophen component of medigesic plus
acetaminophen component of butapap
fioricet component acetaminophen
acetaminophen component of co-gesic
xartemis component acetaminophen
acetaminophen component of esgic
drixoral plus component acetaminophen
acetaminophen component of triad
acetaminophen component of tylox
acetaminophen component of zydone
acetaminophen [inci]
acetaminophen component of roxilox
acetaminophen component of norcet
anoquan component acetaminophen
roxilox component acetaminophen
acetaminophen component of triaprin
acetaminophen component of synalgos-dc-a
triad component acetaminophen
co-gesic component acetaminophen
percocet component acetaminophen
esgic component acetaminophen
acetaminophen [vandf]
synalgos-dc-a component acetaminophen
acetaminophen [hsdb]
paracetamol [who-dd]
paracetamol [inn]
acetaminophen component of femcet
acetaminophen component of bancap hc
acetaminophen component of anoquan
acetaminophen [usp impurity]
acetaminophen component of bancap
acetaminophen component of bucet
norco component acetaminophen
acetaminophen [mi]
oxycet component acetaminophen
acetaminophen component of xartemis
acetaminophen component of dolene ap-65
codrix component acetaminophen
norcet component acetaminophen
acetaminophen component of hy-phen
acetaminophen component of roxicet
tycolet component acetaminophen
femcet component acetaminophen
duradyne dhc component acetaminophen
acetaminophen component of duradyne dhc
acetaminophen component of excedrin
sedapap component acetaminophen
trezix component acetaminophen
paracetamol [ep monograph]
vicodin component acetaminophen
talacen component acetaminophen
acetaminophen component of drixoral plus
EPITOPE ID:117710
gtpl5239
HY-66005
4-acetamido-phenol
para-acetylaminophenol
4-acetamido phenol
4-(n-acetylamino)phenol
4-acetylaminophenol
acetominophene
n-(4-hydroxyphenyl)ethanamide
p-hydroxyacetoanilide
4-acetominophenol
n-(4-hydroxyphenyl)-acetamide
n-acetyl para aminophenol
SCHEMBL3480
tox21_110397_1
NCGC00016361-12
AB00051905-09
F3096-1731
STR00901
paracetamol, british pharmacopoeia (bp) reference standard
n-(4-hydroxyphenyl-2,3,5,6-d4)acetamide-2,2,2-d3
coricidin d (salt/mix)
darvocet-n (salt/mix)
naldegesic (salt/mix)
resprin
aspirin-free anacin (salt/mix)
tylenol allergy sinus (salt/mix)
p-acetoaminophen
bayer select sinus pain relief (salt/mix)
bayer select menstrual multi-symptom (salt/mix)
sinubid (salt/mix)
propacet (salt/mix)
drixoral cold & flu (salt/mix)
drixoral sinus (salt/mix)
midol teen formula (salt/mix)
zydone (salt/mix)
supac (salt/mix)
liquiprin (salt/mix)
midol regular strength (salt/mix)
coricidin sinus (salt/mix)
sudafed sinus (salt/mix)
theraflu (salt/mix)
sine-aid, maximum strength (salt/mix)
sudafed severe cold formula (salt/mix)
endecon (salt/mix)
bayer select allergy-sinus (salt/mix)
sine-off sinus medicine caplets (salt/mix)
robitussin night relief (salt/mix)
n-acetyl-4-hydroxyaniline
daphalgan
claratal
hy-phen (salt/mix)
citramon p
actifed plus (salt/mix)
coricidin (salt/mix)
tylox (salt/mix)
st. joseph cold tablets for children (salt/mix)
ornex severe cold formula (salt/mix)
demilets (salt/mix)
talacen (salt/mix)
anexsia (salt/mix)
bayer select head cold (salt/mix)
contac cough & sore throat formula (salt/mix)
intensin (salt/mix)
quiet world (salt/mix)
wygesic (salt/mix)
triaminic sore throat formula (salt/mix)
empracet (salt/mix)
vicodin (salt/mix)
midol pm night time formula (salt/mix)
AC-23969
AB00051905_10
SCHEMBL19474893
4-hydroxyphenyl acetamide
mfcd00002328
J-001064
J-514275
SR-01000597517-1
SR-01000597517-4
sr-01000597517
SR-01000597517-2
acetaminophen, united states pharmacopeia (usp) reference standard
liquiprin children's elixir
actimol chewable tablets
datril extra-strength
tylenol infants suspension drops
feverall sprinkle caps junior strength
atasol tablets
suppap-120
apacet extra strength tablets
actamin super
excedrin extra strength caplets
tylenol elixir
tylenol gelcaps
tylenol children's chewable tablets
apacet capsules
actimol children's suspension
tapanol extra strength tablets
panadol extra strength
genebs regular strength tablets
atasol forte caplets
anacin-3 extra strength
genebs extra strength caplets
genapap regular strength tablets
aspirin-free excedrin caplets
atasol drops
tylenol tablets
dial-alpha-gesic
tylenol arthritis extended relief
actamin extra
tylenol caplets
tempra chewable tablets
tylenol children's suspension liquid
excedrin caplets
suppap-325
panadol maximum strength caplets
genapap children's tablets
aspirin free anacin maximum strength caplets
bayer select maximum strength headache pain relief formula
aspirin free anacin maximum strength gel caplets
acetaminophen uniserts
atasol caplets
tempra caplets
panadol junior strength caplets
genapap children's elixir
atasol forte tablets
tylenol regular strength caplets
apo-acetaminophen
liquiprin infants drops
suppap-650
tylenol junior strength chewable tablets
genapap extra strength caplets
genebs x-tra
tylenol extra strength tablets
alpha-per
actimol junior strength caplets
tylenol infants drops
exdol strong
feverall junior strength
panadol maximum strength tablets
apacet regular strength tablets
actimol infants' suspension
tylenol extra strength gelcaps
aspirin free anacin maximum strength tablets
aminofen max
apacet elixir
tylenol drops
tylenol extra strength caplets
apacet extra strength caplets
tylenol extra strength adult liquid pain reliever
genapap extra strength tablets
tylenol children's elixir
AC8790
acetaminophen, pharmaceutical secondary standard; certified reference material
paracetamol for equipment qualification, europepharmacopoeia (ep) reference standard
paracetamol, european pharmacopoeia (ep) reference standard
paracetamol (acetaminophen) 1.0 mg/ml in methanol
SBI-0051269.P003
HMS3714N17
paracetamol;tylenol
SY001162
HMS3676D16
tapanol extra strength caplets
tylenol regular strength tablets
tempra drops
tempra d.s
tylenol junior strength caplets
BCP23431
nsc 3991
HMS3412D16
Q57055
BRD-K41524689-001-08-6
EN300-17510
AMY39958
NCGC00016361-20
n-(4-hydroxyfenyl)ethanamid
acetaminophenol 4-acetamino phenol paracetamol somedon
acetaminophen-13c2,15n1
HY-66005R
acetaminophen (standard)
CS-0694811
care one pain relief8 hour
acetaminophenpain reliever,fever reducer
health mart infants pain and fever
topcare childrens pain and fever
extra strength mapap
aphen
health mart pain and fever
eight hour pain relief
bactimicina childrens pain and fever
acetaminophenregular strength
powerful pain medicine
only for first aid medicine
careone childrens acetaminophen
extra strength acetaminohpen
adwe childrens pain fever
harris teeter pain and feverinfants
pain relief acetaminophen
acetaminophenextra strength
up and up acetaminophenextra strength
careall acetaminophenextra strength
infants fever reducer and pain reliever
circle k pain reliever
pain reliefchildrens
good neighbor pharmacy childrens pain and fever
only for fever
childrens dye free pain and fever
health mart arthritis pain relief
acetaminophenfor children
arthritis pain relieverextended release
acteaminophen
good neighbor pharmacy pain and feverchildrens
berkley and jensen acetaminophen
sunmark pain and feverchildrens
easy care first aid acetaminophen
acetaminophen es
premier value arthritis pain reliever
childrens pain and fever cherry flavor
good neighbor pharmacy pain reliefextra strength
mapap arthritis pain
pain reliefextra strength
childrens tukol acetaminophen fever reducer pain reducer
8 hr arthritis pain relief
tylenol acetaminophen extra strength
members mark acetaminophen
arthritis 8 hour
core values pain and fever
only forfever
tylo arthritis (acetaminophen)
childrens nortemp
mapap
harris teeter arthritis pain
childrens acetaminophen liquid
infants pain relief
compresso pap 90 cpf
m-pap
premier value childrens acetaminophen melts
sunmark arthritis 8 hour
equate 8hr arthritis pain relief
temp x
acetaminophen tablets 500 mg
acetaminophen rapid release
robitussin direct sore throat pain
headache manno more pills, one shot, headache pain relief
pain relief acetaminophenextra strength
pain relief rapid release gelcaps
rapid release pain relief
childrens acetaminophen oral suspension
fever reducingchildrens
acetaminophen gelcaps
ac fast
junior acetaminophenages 6-11
childrens pain relief
certi-cet plusextra strength
acetaminophen (usp-rs)
walgreenchildrens pain fever
headache man
compresso pap 90 f
childrens acetaminophen
acetaminophen caplets, 500 mgextra strength
childrens silapap
genexa acetaminophenextra strength
dolofin infantil
good sense pain and fever
rugby acetaminophen
health mart pain relief
tylo extra
ringl
duralgina
children pain relief
compresso pap 90 cpu
acetaminophenpain reliever/fever reducer
acetaminophen (usp impurity)
childrens mapap acetaminophen
aurophen extra strength for adults
tylenolextra strength
leader extra strength acetaminophen
tylo extra (acetaminophen)
pediacare childrens fever reducer pain reliever cherry
dolex
lil drug store childrens pain and fever
acetaminophen (usp monograph)
acetaminophen 80mg/piece
dg health childrens pain relief
acetaminophen 325 mground
right remedies pain relief caplet
cvs childrens pain plus fever relief
nortemp
arthritis pain acetaminophen
leader 8 hour pain reliever
little remedies infant fever/pain reliever
childrens pain and fever, grape flavor
pain reliever and fever reducer
mejoralito
berley and jensen pain relief
8hr arthritis pain
dg health pain relieverextra strength
equaline acetaminopheninfants
acetaminophen extended-release tablets, 650 mg
acetaminophenextended release
children pain and fever reliever
childrens chewable mapap
acetaminophen 325mg
adwe feverx acetaminophen caplets, 500 mgextra strength
acetaminophen 500mg, film-coated caplet
topcare pain and feverchildrens
acetamax
dolo-neurobion acetaminophen maxextended-release 650 mg
acetaminophen 160mg
acetaminophen extended-release
medline acetaminophen
handy solutions acetaminophen
sohmed extra strength
pain relief rapid release gelcapsextra strength
kids pain and fever
pain reliefextra strengthextra strength
childrens accudialpain reliever/ fever reducer
acetaminophen (usp:jan)
children acetaminophen oral solution
leader arthritis pain reliever
goodysback and body
good neighbor pharmacy pain relief
good neighbor pharmacy infants pain and fever
infants pain relief oral suspension grape flavor
mapapinfants concentrated
pluspharma extra strength pain reliever,fever reducer 500 mg
365 everyday value acetaminophen
dg health 8 hour pain relief
healthy mamashake that ache
leader childrens pain and fever
topcare pain relief
pain and fever reliefchildren
mckesson acetaminophen 325
clear choice extra strength pain reliever
good sense pain and feverinfants
childrens mapap
fortolin
regular strength pain reliever
acetaminophen tablet extended release
tylenol extra strengthcaplet
careall acetaminophen
feveralljr. strength
infants pain and fever
feverallchildrens
extra strenghth acetaminophen
infants silapap
pain reliefadult extra strength
acetaminophen 500mg
cetafen extra
rapid release acetaminophenextra strength
wal-nadol
max relief junior
non-aspirinchildrens
acetaminophen 500 mg
good sense pain reliefextra strength
novalgina acetaminophen pain and fever for childrens
chewable acetaminophenchildrens
harris teeter pain and fever
topcare infants pain and fever
welly childrens travel medicine
pain reliefes
pain reliefinfants
fast acting
pain and fever reliefchildrens
acetaminophen caplet, 500 mg extra strength
childrens pain reliever
sound body pain relief
acetaminophen-apap 8 hour
qaulity choice pain relief regular strength
acetaminophen 500 mg, film-coated caplet
clear choice regular strength pain reliever
careall non aspirinextra strength
up and up childrens acetaminophen
8hr pain relief
feveralladults
pain relieverregular strength
ofirmev (acetaminophen)
signature care infants pain relief
basic care infants pain and fever
notts-muscle aches and pain
pain and fever reliefinfants
careone infants acetaminophen
good sense childrens pain and fever
extra strength acetaminohpenadult rapid burst cherry
fast actingpedia crae
acetaminophen caplets
family wellness pain relief
dover aminophen
tyloextra strength
health mart childrens pain and fever
arthritispain relief
dye free childrens acetaminophen
basic care childrens pain and fever
sunmark infants pain and fever
acetaminophen tablet, extra strength
harris teeter childrens pain and fever
infants pain reliever
dg health infants pain and fever
acetaminophencaplet
leader acetaminophen
infants tylenol
dg health childrens pain and fever
topcare pain and fever
sunmark childrens pain and fever
little fevers by little remedies
dg health 8 hr arthritis pain relief
medique extra strength apap
acetaminophenrapid release
core values pain reliever
meijer childrenspain and fever reducer
equate acetaminophen
excinol extra (acetaminophen)
cvs health extra strength acetaminophen softgels
pharbetolregular strength
equate pain and feverchildrens
acetaminophenpain reliever fever reducer
acetaminophenpain reliever,fever reducer 500 mg
good sense pain relief
infants pain reliefdye free
lil drug store pain reliever
right remedies pain relief extra strength caplet
health sense tactinal regular strength
berkley and jensen pain relief
relorn
conrx extra strength
acetaminophen 500mg es
8 hr pain relief
assured regular strength acetaminophen
compresso pap 90 cpp
sunmark arthritis pain reliever
acetaminophen easy tabsextra strength
tylenolregular strength
acetaminophen 500mges
children pain and fever reliver
xl-dol
junior strength pain relief
up and up acetaminophen
acetaminophen (red)
gericare liquid pain relief
acetaminophen 80 mg
pain and feverchildrens
excinol arthritis (acetaminophen)
curist pain relief
pain reliever, caseys 4good
major acetaminophen
pain relief fever reducer
childrens pain relief dye-free
counteractpain
members mark arthritis pain
pain reliever rapid release
temperal-ito
equate childrens pain and fever
acetaminophen 160mg/5ml
xpect acetaminophen
paracetamol (iarc)
plus pharmapain reliever,fever reducer
medique apap extra strength
muscle aches and pains acetaminophen extended release
topco arthritis 8 hour
acetaminophen caplets, 500 mg
childrens pain relief oral suspension
up and up acetaminopheninfants
rugby regular strength acetaminophen
acetaminophen easy tabs
up and up juniors acetaminophen
tylenol 8hr
acetaminophen-apap arthritis
apap elixer (acetaminophen)
pluspharma extra strength
dg health arthritis pain relief
harris teeter infants pain and fever
compresso pap 90 cpc
pain and feverinfants
panadolextra strength
dg health pain relief
acetaminophen directly compressible granules 90%
8hr arthritis pain relief
childrens pain and feverdissolve packs
n-(4-hydroxyphenyl) acetamide
pain reliever fever reducerextra strength
physicianscare non aspirinextra strength
mapapextra strength
extra strength acetaminophen
pain relief 8 hr
pediacare childrens grape
model aa-1218ce rev 1
medique apap
genexa infants pain and fever
pediacare infants fever reducer grape
walgreen childrens pain plus fever
ed apap
kosher meds childrens pain and fever
quality choice extra strength pain relief
easy care first aid kit-comprehensive
careone acetaminophen
valumeds extra strength pain relief
wal-nadolextra strength
medicine shoppe arthritis pain reliever
aurophen regular strength
acetaminophen tablets, 500 mg extra strength
dye free infants pain and fever
easyfast
good sense pain reliefchildrenschildrens
pluspharma extra strengthpain reliever,fever reducer 500 mg
rexall pain relief
basic care acetaminophen
model 6240-35-001cs
careone 8 hour pain relief
rugby childrens acetaminophen
pain reliefregular strength
apinophenextra strength
childrens chewables
dolex acetaminophen 500mgextra strength
infants pain relief dye-free
acetaminophen 500 mground
counteractchildrens pain reliever
up and up infants acetaminophen
pain and fever
acetaminophen 325 mg
8 hour arthritis pain
parents choice infants pain and fever
dolex acetaminophen 500mg
equate pain and fever
atamel forte
infants dye free pain and fever
extra strength no-pain
acetaminophen 160mg per 5ml
fever reducing
leader 8hr arthritis pain
regular strength pain relief
acetaminophen rapid releaseextra strength
acetaminophen extra strength
health mart pain and feverchildrens
equaline childrens acetaminophen
pain relieverchildrens dye free
help i have a headache
childrens tylenol
topcare 8 hour pain relief
pain relief regular strength
caring mill childrens acetaminophen
good neighbor pharmacy pain and fever
childrens chewable
medique at home apap
flaxendol extra strength acetaminophen
acetaminophen caplet, 500 mg
midol long lasting relief
dg health pain reliever
meijer childrens
acetaminophen 8 hour
sunmark pain relieverextra strength
adwe feverx
kirkland signature acetaminophen
pain relief fever reducerchildren
kirkland signature acetaminophenadult extra strength
liquid acetaminophen
acetaminophenfor adults
pain reliefextra strength easy to swallow
uline acetaminophen extra strength
assured extra strength acetaminophen
equate pain and feverinfants
extra strength pain releif
regular strength acetaminophen
signature care pain relief
sunmark pain and fever
topcare 8 hr arthritis pain relief
tylenol for children plus adults
8 hour pain relief
tylenol extra strength
pain reliever fever reducerchildrens
childrens acetaminophen oral suspensiongrape flavor
dye freeinfants pain and fever
little fevers infant berry fever/pain reliever
sound body pain reliever
dolexchildren pain and fever
junior acetaminophen
harmon core values infants pain and fever
pain reliefchildrens dye free
acetaminophen gelcapsextra strength
neo-lubrina
compresso pap 90 cpl
good sense pain reliefarthritis pain
fridababy children pain and fever acetaminophen 160mg per 5ml vial 10ct
acetaminophen 500 mg, tablet
kidgets infants pain reliever plus fever reducer
chewable acetaminophen
berkley and jensen arthritis pain relief
sp pharma
genexa childrens acetaminophen
genexa acetaminophen
paracetamolum (inn-latin)
infants pain relief oral suspension cherry flavor
8hr muscle aches and pain
fever and pain
circle k pain relieverextra strength
plus pharma
compresso pap 90cpf
signature care childrens pain relief
feverallinfants
acetaminopheninfants
aramark extra strength acetaminophen
premier value arthritis 8 hour
pediacare single dose fever reducer
family wellness acetaminophen
pain relieverchildrens
zee unaspirines
pediacare childrens acetaminophen grape
notts-extra strength 500 mg
dye free pain and feverchildrens
sunmark junior rapid melts
extra strength pain reliever, caseys 4good
rapid release acetaminophen
sunmark pain reliever
pain reliever
berkley and jensen pain reliefextra strength
acetaminophen 325mgrs
better living brands childrens fever and pain reliver
childrens pain reliefreadyincase
qaulity choice pain relief extra strength
leader 8 hr muscle aches and pain
lil drug store pain relieverextra strength
acetaminophen tablet
safetynadol
muscle pain relief
childrens acetaminophendye free grape
harris teeter pain and feverchildrens
acetaminophener
pediacare infants fever reducer dye free
dye free pain reliever
childrens fever reducer and pain reliever
infants nanomol dye-free cherry
dye free pain relieverchildrens
equaline acetaminophen
paracetamol (ep monograph)
pediacare infants fever reducer cherry
dolo-neurobion acetaminophen max
care one arthritis pain relieftemporary minor
little remedies childrens fever pain reliever
paracetamol (mart.)
n02be01
henry schein acetaminophen
averex
pharbetol
gesteira
childrens nanomol dye-free cherry
pain relief extra strength
leader infants pain and fever
tylenol 8 hr arthritis pain
care one arthritis pain relief
drkids childrens pain and fever
acetaminophen regular strength
24 / 7 life extra strength pain reliever
acetaminophen extended release
dye free pain and fever
childrens pain and fever
caring mill acetaminophen
sound body childrens pain and fever
acetaminophen 500 mg, film-coated tablet
care one pain relief
acetamiophen
childrens chewable acetaminophen
excinol extra
medique at home apap extra strength
Z56946051
paracetamol, 1mg/ml in methanol

Research Excerpts

Overview

Acetaminophen (ApAP) is an electron donor capable of reducing radicals generated by redox cycling of hemeproteins. It is a widely used analgesic, but also a main cause of acute liver injury in the United States and many western countries. Acetaminphen overdose is a leading cause of liver failure, and a Leading cause of pediatric poisoning requiring hospital admission.

ExcerptReferenceRelevance
"Acetaminophen (APAP) is a popular analgesic. "( Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
Aoyama, T; Aoyama, Y; Matsumoto, Y; Ohe, Y; Shinoda, S; Tomioka, S, 2007
)
2.06
"Acetaminophen (ApAP) is an electron donor capable of reducing radicals generated by redox cycling of hemeproteins. "( Rational Design of Novel Pyridinol-Fused Ring Acetaminophen Analogues.
Amin, T; Boutaud, O; Jeong, BS; Liu, W; Oates, JA; Porter, NA; Roberts, LJ; Shchepin, RV; Yin, H; Zagol-Ikapitte, I, 2013
)
2.09
"Acetaminophen (APAP) is a widely used analgesic, but also a main cause of acute liver injury in the United States and many western countries. "( Kupffer cells regulate liver recovery through induction of chemokine receptor CXCR2 on hepatocytes after acetaminophen overdose in mice.
Jaeschke, H; Nguyen, NT; Ramachandran, A; Sanchez-Guerrero, G; Umbaugh, DS, 2022
)
2.38
"Acetaminophen is a frequently used over-the-counter or prescribed medication in the United States. "( Prognostic factors of acetaminophen exposure in the United States: An analysis of 39,000 patients.
Hadianfar, A; Hoyte, C; Mégarbane, B; Mehrpour, O; Saeedi, F, 2021
)
2.38
"Acetaminophen is a widely clinically used analgesic. "( Comparison of intravenous and oral administration of acetaminophen in adults undergoing general anesthesia.
Cao, Q; Dong, H; Fan, C; Meng, H; Yuan, R; Zhang, S, 2022
)
2.41
"Acetaminophen (APAP) is a widely consumed drug for pain management and treatment of pyrexia. "( Ameliorative effect of Spatoglossum asperum and its solvent fractions against acetaminophen-induced liver dysfunction in rats.
Ara, J; Azam, M; Ehteshamul-Haque, S; Khan, H; Qureshi, SA; Tariq, A, 2022
)
2.39
"Acetaminophen (APAP) is a worldwide antipyretic as well as an analgesic medication. "( Diacerein ameliorates acetaminophen hepatotoxicity in rats via inhibiting HMGB1/TLR4/NF-κB and upregulating PPAR-γ signal.
Harahsheh, E; Hussein, S; Mohamed Kamel, GA, 2022
)
2.48
"Acetaminophen (APAP) is a common drug causing DILI."( Study on the Protective Effect of Schizandrin B against Acetaminophen-Induced Cytotoxicity in Human Hepatocyte.
Cao, Y; Cheng, L; Gao, Z; Wang, L; Wang, T; Wu, W; Zhang, Q, 2022
)
1.69
"Acetaminophen (APAP) is a widely used antipyretic and analgesic. "( Anti-TLR4 IgG2 Prevents Acetaminophen-induced Acute Liver Injury through the Toll-like Receptor 4/MAPKs Signaling Pathway in Mice.
Feng, T; Gong, D; Wang, C; Wang, M; Wang, Y; Yao, C; Zhang, Y; Zhu, J, 2023
)
2.66
"Acetaminophen overdose is a leading cause of liver failure, and a leading cause of pediatric poisoning requiring hospital admission. "( Comparison of Two-Bag Versus Three-Bag N-Acetylcysteine Regimens for Pediatric Acetaminophen Toxicity.
Camarena-Michel, A; Hoyte, C; Leonard, J; Pennington, S; Sudanagunta, S; Wang, GS, 2023
)
2.58
"Acetaminophen is a popular, universally used, over-the-counter pain medication contained in more than 600 different products and available in a plethora of dosage forms. "( Acetaminophen: Is Too Much of a Good Thing Too Much?
Donaldson, M; Goodchild, JH, 2022
)
3.61
"Acetaminophen (APAP) is a relatively safe analgesic drug, but overdosing can cause acute liver failure. "( The concerted elevation of conjugation reactions is associated with the aggravation of acetaminophen toxicity in Akr1a-knockout mice with an ascorbate insufficiency.
Fujii, J; Homma, T; Itoh, H; Kawamae, K; Kimura, S; Kobayashi, S; Miyata, S; Nakane, M; Osaki, T, 2022
)
2.39
"Acetaminophen (paracetamol) is a widely used drug worldwide and one of the most frequently detected pharmaceuticals in freshwater ecosystems."( Metabolomic analysis predicted changes in growth rate in Daphnia magna exposed to acetaminophen.
Jeong, TY; Labine, LM; Lari, E; Simpson, MJ, 2022
)
1.67
"Acetaminophen is a widely used analgesic throughout the world. "( A bibliometric analysis of graphene in acetaminophen detection: Current status, development, and future directions.
Chen, F; Fu, L; Karimi, F; Mao, S; Su, W; Xiang, S; Zare, N; Zhao, S, 2022
)
2.43
"Acetaminophen (APAP) is a widely used antipyretic analgesic which can lead to acute liver failure after overdoses. "( Caveolin-1 Alleviates Acetaminophen-Induced Hepatotoxicity in Alcoholic Fatty Liver Disease by Regulating the Ang II/EGFR/ERK Axis.
Feng, X; Fu, D; Hu, C; Huang, Y; Jiang, W; Jiang, X; Wang, J; Wen, J; Xin, J; You, T, 2022
)
2.48
"Acetaminophen (APAP) is a frequently used painkiller, and hepatotoxic side effects limit its use."( Exploration of the Protective Mechanism of Naringin in the Acetaminophen-Induced Hepatic Injury by Metabolomics.
Cai, Y; Chen, B; Gu, W; Li, M; Lin, Z; Liu, W; Shen, Z; Wan, CC; Wang, G; Yan, T; Zhao, S; Zheng, G, 2022
)
1.69
"And acetaminophen (APAP) is a promising therapeutic medicine for SAE treatment."( Acetaminophen alleviates ferroptosis in mice with sepsis-associated encephalopathy via the GPX4 pathway.
Chu, J; Jiang, Y; Li, H; Yu, Y; Zhang, J; Zhou, W,
)
2.05
"Acetaminophen (APAP) is a well-known anti-allergic, anti-pyretic, non-steroidal anti-inflammatory drug (NSAID), which upon overdose leads to hepatotoxicity, the major adverse event of this over-the-counter drug."( Acetaminophen induced hepatotoxicity: An overview of the promising protective effects of natural products and herbal formulations.
Anchi, P; Bansod, S; Chilvery, S; Godugu, C; Khurana, A; Saifi, MA; Yelne, A, 2023
)
3.07
"Acetaminophen (AAP) is an analgesic and non-steroidal anti-inflammatory drug and a micropollutant that has been detected in waterbodies worldwide. "( Acetaminophen adsorption to spherical carbons hydrothermally synthesized from sucrose: experimental, molecular, and mathematical modeling studies.
Kim, SB; Lee, SC; Yoo, SH, 2023
)
3.8
"Acetaminophen is an option for antipyresis in clinical cases, particularly when administration of traditional NSAIDs is contraindicated."( Pharmacokinetics and efficacy of orally administered acetaminophen (paracetamol) in adult horses with experimentally induced endotoxemia.
Council-Troche, RM; Davis, JL; McKenzie, HC; Mercer, MA; Messenger, KM; Schaefer, E; Werre, SR, 2023
)
1.88
"Acetaminophen (APAP) is a widely used analgesic drug, but its over-dose is associated with acute liver failure where the clinical approved antidote treatment is limited."( Pien Tze Huang attenuated acetaminophen-induced liver injury by autophagy mediated-NLRP3 inflammasome inhibition.
Chang, D; He, Y; Huang, M; Li, S; Lin, Y; Liu, W; Xu, W; Zhang, Q; Zhao, R; Zheng, Y; Zhou, X, 2023
)
1.93
"Acetaminophen is a frequently used analgesic for pain and fever. "( In utero acetaminophen exposure and child neurodevelopmental outcomes: Systematic review and meta-analysis.
Albanese, CM; Barrett, K; Brown, HK; Fatima, M; Levis, B; Li, J; Pablo, LA; Ricci, C, 2023
)
2.77
"Acetaminophen (APAP) is an over-the-counter antipyretic analgesic that exhibits high hepatotoxicity when used for long-term or in overdoses."( Protection of taraxasterol against acetaminophen-induced liver injury elucidated through network pharmacology and in vitro and in vivo experiments.
Ge, B; Kong, L; Liu, X; Sang, R; Wang, W; Yan, K; Yu, M; Yu, Y; Zhang, X, 2023
)
1.91
"Acetaminophen is a drug widely used in the world and easily accessible due to its antipyretic, analgesics characteristics, among others (1); however, exposure to toxic doses causes organic damage and even death. "( [Use of the Scottish and Newcastle Anti-Emetic Pretreatment (SNAP) scheme in recovery from massive overdose of acetaminophen poisoning with acute liver failure - Case report].
Bellido-Caparó, Á; Gamarra-L Ázaro, A; García-Encinas, C; Tapia-Ib Áñez, EX; Torres-Maure, M,
)
1.79
"Acetaminophen is a pharmaceutical synthesized non-opioid analgesic that belongs to the "aniline analgesics" class of medicine. "( Hepatoprotective Effect of Vitamin B12 in Acetaminophen Induce Hepatotoxicity in Male Rats.
Ahmed Mohammed, R; Fadheel, QJ, 2023
)
2.62
"Acetaminophen (paracetamol) is a ubiquitously administered drug in critically ill patients. "( Population Pharmacokinetic Modeling and Dose Optimization of Acetaminophen and its Metabolites Following Intravenous Infusion in Critically ill Adults.
Mulubwa, M; Qader, AM; Sridharan, K, 2023
)
2.59
"Acetaminophen is a commonly used medication by pregnant women and is known to cross the placenta. "( Association between acetaminophen metabolites and CYP2E1 DNA methylation level in neonate cord blood in the Boston Birth Cohort.
Hong, X; Ladd-Acosta, C; Li, Y; Liang, L; Wang, X, 2023
)
2.68
"Acetaminophen is a common analgesic and fever reduction medicine for pregnant women. "( Course-, dose-, and stage-dependent toxic effects of prenatal acetaminophen exposure on fetal long bone development.
Chen, L; Gu, H; Guo, Y; Li, B; Li, X; Ma, C; Wang, H; Wen, Y; Xiao, H, 2023
)
2.59
"Acetaminophen (APAP) is a common antipyretic and analgesic drug that can cause long-term liver damage after an overdose. "( Caveolin-1 protects against liver damage exacerbated by acetaminophen in non-alcoholic fatty liver disease by inhibiting the ERK/HIF-1α pathway.
Fu, D; Hu, C; Huang, Y; Jiang, X; Jin, L; Li, B; Li, Y; Wu, S; Xin, J; You, T, 2023
)
2.6
"Acetaminophen (APAP) is a double-edged sword, mainly depending on the dosage. "( LPCAT3/LPLAT12 deficiency in the liver ameliorates acetaminophen-induced acute liver injury.
Inagaki, NF; Nakanishi, H; Ohto, T; Shimizu, T; Shindou, H, 2024
)
3.14
"IV acetaminophen is an integral and effective part of our opioid-sparing multimodal pain regimen in TKA."( Evolution of an Opioid Sparse Pain Management Program for Total Knee Arthroplasty With the Addition of Intravenous Acetaminophen.
Bosco, JA; Eftekhary, N; Iorio, R; Long, WJ; Schwarzkopf, R; Wiznia, D; Yu, S, 2020
)
1.28
"Acetaminophen is a widely available analgesic and antipyretic medication. "( [Acetaminophen poisonings hospitalized at the Pomeranian Center of Toxicology in 2010-2015].
Garczewski, B; Sein Anand, J; Waldman, W; Wiśniewski, M, 2019
)
2.87
"Acetaminophen (APAP) is a worldwide commonly used painkiller drug. "( PGC-1β Induces Susceptibility To Acetaminophen-Driven Acute Liver Failure.
Arconzo, M; Bellafante, E; Ducheix, S; Ferretta, A; Moschetta, A; Peres, C; Piccinin, E; Vegliante, MC; Villani, G, 2019
)
2.24
"Acetaminophen is a common analgesic-antipyretic agent, which is safe in therapeutic doses but in higher doses can produce hepatic necrosis. "( Hepatoprotective effect of artichoke leaf extracts in comparison with silymarin on acetaminophen-induced hepatotoxicity in mice.
Abdou, AG; Elsayed Elgarawany, G; Maher Taie, D; Motawea, SM, 2020
)
2.23
"Acetaminophen (APAP), which is an active ingredient of many analgesic drugs, is one of the contaminants of emerging concern in the environment. "( Biotransformation of Acetaminophen by intact cells and crude enzymes of bacteria: A comparative study and modelling.
Akay, C; Tezel, U, 2020
)
2.32
"Acetaminophen (APAP) is a proven lethal oral toxicant in reptiles but the physiological mechanism is unknown."( Lethal methemoglobinemia in the invasive brown treesnake after acetaminophen ingestion.
Mathies, T; Mauldin, RE, 2020
)
1.52
"Acetaminophen (APAP) is a commonly used over-the-counter drug for its analgesic and antipyretic effects. "( Knockdown of Long Noncoding RNAs Hepatocyte Nuclear Factor 1
Chen, L; Manautou, JE; Wang, P; Zhong, XB, 2020
)
2
"Acetaminophen (APAP) is a widely used analgesic drug, which can cause severe liver injury after an overdose. "( Mechanisms and pathophysiological significance of sterile inflammation during acetaminophen hepatotoxicity.
Jaeschke, H; Ramachandran, A, 2020
)
2.23
"Acetaminophen (APAP) is a common antipyretic and analgesic drug, but its overdose can induce acute liver failure with lack of effective therapies. "( Hesperetin attenuated acetaminophen-induced hepatotoxicity by inhibiting hepatocyte necrosis and apoptosis, oxidative stress and inflammatory response via upregulation of heme oxygenase-1 expression.
Chen, Y; He, Z; Jiang, R; Kuang, G; Wan, J; Ye, D; Zhang, L, 2020
)
2.32
"Acetaminophen (APAP) is a well-known antipyretic and analgesic medicine. "( Role of cinnamon oil against acetaminophen overdose induced neurological aberrations through brain stress and cytokine upregulation in rat brain.
Alam, MI; Alshahrani, S; Ashafaq, M; Hussain, S; Islam, F; Khuwaja, G; Madkhali, O; Siddiqui, R, 2022
)
2.46
"Acetaminophen is a widely used analgesic for pain management, especially useful in chronic diseases, such as rheumatoid arthritis. "( Acetaminophen Oxidation and Inflammatory Markers - A Review of Hepatic Molecular Mechanisms and Preclinical Studies.
Barcelos, RP; de Carvalho, NR; Reis, SB; Soares, FAA; Stefanello, ST, 2020
)
3.44
"Acetaminophen (APAP) is a commonly used analgesic."( Hepatoprotective Activity of Yellow Chinese Chive against Acetaminophen-Induced Acute Liver Injury via Nrf2 Signaling Pathway.
Hatanaka, T; Kawakami, K; Moritani, C; Suzaki, E; Tsuboi, S, 2020
)
1.52
"Acetaminophen (APAP) is a well-known analgesic and antipyretic drug."( Tetrahydroxy stilbene glycoside attenuates acetaminophen-induced hepatotoxicity by UHPLC-Q-TOF/MS-based metabolomics and multivariate data analysis.
Chen, NH; Gao, Y; Li, JT; Li, L; Li, X; Yang, SW; Zhang, L, 2021
)
1.61
"Acetaminophen is a widely used analgesic that has been detected in many water bodies with few reports concerning its potential toxicity to fish. "( Acute effects of acetaminophen on the developmental, swimming performance and cardiovascular activities of the African catfish embryos/larvae (Clarias gariepinus).
Erhunmwunse, NO; Ezemonye, LI; Tongo, I, 2021
)
2.4
"Acetaminophen (APAP) is a known hepatotoxin predictably causing intrinsic DILI."( Boldine treatment protects acetaminophen-induced liver inflammation and acute hepatic necrosis in mice.
Ezhilarasan, D; Raghunandhakumar, S, 2021
)
1.64
"Acetaminophen (APAP) is a commonly used pain and fever reliever but is also the most frequent cause of drug-induced liver injury. "( A Potential Role for SerpinA3N in Acetaminophen-Induced Hepatotoxicity.
Shin, DJ; Tran, M; Wang, L; Wu, J, 2021
)
2.34
"Acetaminophen (APAP) is a widely used analgesic and is safe at therapeutic doses. "( Impaired protein adduct removal following repeat administration of subtoxic doses of acetaminophen enhances liver injury in fed mice.
Akakpo, JY; Ding, WX; Jaeschke, H; Nguyen, NT; Ramachandran, A; Weemhoff, JL, 2021
)
2.29
"Acetaminophen is a non-opioid analgesic commonly utilized for pain control after several types of surgical procedures."( Review of Intravenous Acetaminophen for Analgesia in the Postoperative Setting.
Cohn, SM; DiPasquale, A; Segovia, M; Tompkins, DM, 2021
)
2.38
"Acetaminophen (APAP) is a first choice for relieving mild-to-moderate pain."( Chronic treatment with acetaminophen protects against liver aging by targeting inflammation and oxidative stress.
Alen, R; Boscá, L; Brea, R; Casado, M; Fuertes-Agudo, M; García-Monzón, C; Martín-Sanz, P; Rada, P; Valdecantos, P; Valverde, ÁM, 2021
)
1.65
"Acetaminophen is a commonly used analgesic and antipyretic, with the potential to cause significant injury when ingested in toxic amounts. "( Evaluation of Dosing Strategies of N-acetylcysteine for Acetaminophen Toxicity in Patients Greater than 100 Kilograms: Should the Dosage Cap Be Used?
Akpunonu, P; Bailey, AM; Baum, RA; Geraghty, L; Howell, MM; Mohan, S; Su, MK; Weant, KA; Webb, AN; Woolum, JA, 2021
)
2.31
"Acetaminophen is a common cause of intentional and inadvertent overdoses among children and adolescents worldwide. "( Clinical Characteristics, Outcomes, Disposition, and Acute Care of Children and Adolescents Treated for Acetaminophen Toxicity.
Bostwick, JM; Lewis, CP; Romanowicz, M; Shekunov, J; Vande Voort, JL, 2021
)
2.28
"Acetaminophen (APAP) is a widely used antipyretic and analgesic drug that is safe and effective in the therapeutic doses, but overdose may cause hepatotoxicity and even acute liver failure (ALF). "( [Research progress on hepatotoxicity of acetaminophen].
Hu, T; Huang, WQ; Sun, H, 2021
)
2.33
"Acetaminophen (APAP) is a widely applied drug for the alleviation of pain and fever, which is also a dose-depedent toxin. "( The complex roles of neutrophils in APAP-induced liver injury.
Chen, S; Guo, H; Xie, M; Zheng, M; Zhou, C, 2021
)
2.06
"Acetaminophen is a common medication taken in deliberate self-poisoning and unintentional overdose. "( Acetaminophen Poisoning.
Buckley, NA; Chiew, AL, 2021
)
3.51
"Acetaminophen (paracetamol) is a widely used analgesic and antipyretic. "( A review of published cases of Stevens-Johnson syndrome and toxic epidermal necrolysis associated with the use of acetaminophen.
Milosavljević, JZ; Milosavljević, MN; Pejčić, AV, 2021
)
2.27
"Acetaminophen is a common cause of poisoning and liver injury worldwide; however, patient stratification is suboptimal. "( Plasma procalcitonin may be an early predictor of liver injury in acetaminophen poisoning: A prospective cohort study.
Deye, N; Diallo, A; Gourlain, H; Goury, A; Malissin, I; Mégarbane, B; Nuzzo, A; Péron, N; Salem, S; Vicaut, E; Voicu, S, 2021
)
2.3
"Acetaminophen (APAP) is a commonly used painkiller, but it can aggravate lipid deposition in the liver and cause liver injury when used in fatty liver disease."( Caveolin-1 attenuates acetaminophen aggravated lipid accumulation in alcoholic fatty liver by activating mitophagy via the Pink-1/Parkin pathway.
Feng, X; Hu, C; Huang, Y; Jiang, W; Shi, C; Wang, J; Wen, J; Xin, J; Xue, W, 2021
)
1.66
"Acetaminophen (APAP) is a widely self-prescribed analgesic for mild to moderate pain, but overdose or repeat doses can lead to liver injury and death. "( Evaluation of KP-1199: a novel acetaminophen analog for hemostatic function and antinociceptive effects.
Bunker, KD; Bynum, JA; Cap, AP; Cheppudira, BP; Christy, RJ; Garza, T; Hopkins, CD; Reddoch-Cardenas, KM; Slee, DH, 2021
)
2.35
"Acetaminophen is a frequently used adjunct analgesic in pediatric patients undergoing tonsillectomy and adenoidectomy. "( Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial.
Aizenberg, DA; Applegate, RL; Funamura, JL; Hall, B; Kriss, RS; Lammers, CR; Nittur, V; Schwinghammer, AJ; Senders, CW, 2021
)
2.32
"Oral acetaminophen is a much cheaper and safe option but has not been studied as an adjunct to labor analgesia till date."( Oral acetaminophen as an adjunct to continuous epidural infusion and patient-controlled epidural analgesia in laboring parturients: a randomized controlled trial.
Goel, B; Mitra, S; Panghal, R; Sarna, R; Singh, J, 2021
)
1.59
"Acetaminophen is a common antipyretic drug but at overdose can cause severe hepatotoxicity that may further develop into liver failure and hepatic centrilobular necrosis in experimental animals and humans. "( PROTECTIVE EFFECT OF
Abdelrahem, MT; Azim, SAA; Khattab, A; Said, MM, 2017
)
1.9
"Acetaminophen (APAP) is a common medication that induces hepatocellular damage in a time- or dose-dependent manner. "( FGF21 functions as a sensitive biomarker of APAP-treated patients and mice.
Chen, J; Guo, C; Huang, Z; Li, R; Wu, X, 2017
)
1.9
"Acetaminophen (APAP) is a widely used antipyretic and analgesic drug, which is safe and effective at the therapeutic dose. "( Glycyrrhetinic acid prevents acetaminophen-induced acute liver injury via the inhibition of CYP2E1 expression and HMGB1-TLR4 signal activation in mice.
Chen, X; Gong, X; Jiang, R; Kuang, G; Li, K; Ma, L; Tie, H; Wan, J; Wang, B; Xie, T; Yang, G; Zhang, L, 2017
)
2.19
"Acetaminophen (APAP) is a widely available antipyretic and analgesic; however, overdose of the drug inflicts severe damage to the liver. "( Glutathione peroxidase 3 is a protective factor against acetaminophen‑induced hepatotoxicity in vivo and in vitro.
Hara, A; Kanno, SI; Tomizawa, A; Yomogida, S, 2017
)
2.14
"Acetaminophen is an over-the-counter drug used to treat pain and fever, but it has also been shown to reduce core temperature (T "( Acetaminophen (Paracetamol) Induces Hypothermia During Acute Cold Stress.
Foster, J; Govus, A; Hewson, D; Mauger, AR; Taylor, L, 2017
)
3.34
"Acetaminophen (paracetamol) is a first-line treatment for mild and moderate pain. "( Evaluation of a 12-Hour Sustained-Release Acetaminophen (Paracetamol) Formulation: A Randomized, 3-Way Crossover Pharmacokinetic and Safety Study in Healthy Volunteers.
Collaku, A; Liu, DJ; Yue, Y, 2018
)
2.19
"Acetaminophen (APAP) is a commonly used analgesic and antipyretic that can cause hepatotoxicity due to production of toxic metabolites via cytochrome P450 (Cyp) 1a2 and Cyp2e1. "( Fructose diet alleviates acetaminophen-induced hepatotoxicity in mice.
Chang, EB; Chlipala, G; Cho, S; Green, S; Jeong, H; Lee, H; Tripathi, A, 2017
)
2.2
"Acetaminophen toxicity is a leading cause of acute liver failure (ALF). "( miRNA-122 Protects Mice and Human Hepatocytes from Acetaminophen Toxicity by Regulating Cytochrome P450 Family 1 Subfamily A Member 2 and Family 2 Subfamily E Member 1 Expression.
Brüschweiler, R; Bruschweiler-Li, L; Chowdhary, V; Ghoshal, K; James, L; Junge, N; Lee, WM; Lin, CH; Teng, KY; Thakral, S; Wani, N; Yang, D; Zhang, B; Zhang, X, 2017
)
2.15
"Acetaminophen is an over-the-counter drug used worldwide to treat pain and reduce fever."( Is acetaminophen associated with a risk of Stevens-Johnson syndrome and toxic epidermal necrolysis? Analysis of the French Pharmacovigilance Database.
Gras-Champel, V; Guy, C; Jean-Pastor, MJ; Lebrun-Vignes, B; Zenut, M, 2018
)
1.82
"Acetaminophen, which is a para-aminophenol derivative, can lead to fatal hepatic necrosis with direct hepatotoxic effects at high doses."( The effect of sulforaphane on oxidative stress and inflammation in rats with toxic hepatitis induced by acetaminophene.
Aktas, MS; Dokumacioglu, A; Dokumacioglu, E; Hanedan, B; Iskender, H; Musmul, A; Sen, TM, 2017
)
1.39
"Acetaminophen (APAP) is a readily available and safe painkiller. "( Fast food diet-induced non-alcoholic fatty liver disease exerts early protective effect against acetaminophen intoxication in mice.
Choi, D; Kim, JY; Kim, TH; Koo, SH; Lee, JH, 2017
)
2.12
"Acetaminophen (paracetamol) is a widely used analgesic and antipyretic drug that is safe at therapeutic doses. "( Kaurenoic acid extracted from Sphagneticola trilobata reduces acetaminophen-induced hepatotoxicity through inhibition of oxidative stress and pro-inflammatory cytokine production in mice.
Arakawa, NS; Borghi, SM; Bussmann, AJC; Casagrande, R; Fattori, V; Hirooka, EY; Lourenco-Gonzalez, Y; Marcondes-Alves, L; Verri, WA, 2019
)
2.2
"Acetaminophen is a commonly used medicine for pain relief and emerging evidence suggests that it may improve endurance exercise performance. "( Acute acetaminophen ingestion improves performance and muscle activation during maximal intermittent knee extensor exercise.
Bailey, SJ; Bowtell, JL; Jones, AM; Morgan, PT; Vanhatalo, A, 2018
)
2.4
"Acetaminophen (APAP) is an analgesic and antipyretic agent primarily used in the clinical setting. "( Extracts from guava fruit protect renal tubular endothelial cells against acetaminophen‑induced cytotoxicity.
Lin, SY; Liu, HC; Wei, CW; Wu, TK; Yu, YL, 2018
)
2.15
"Acetaminophen seems to be a reasonable first-line option for patients with acute LBP in Japan."( Randomized open-label [corrected] non-inferiority trial of acetaminophen or loxoprofen for patients with acute low back pain.
Arai, YC; Hayashi, K; Ikemoto, T; Miki, K; Sekiguchi, M; Shi, K; Ushida, T, 2018
)
1.45
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug. "( Autophagy and acetaminophen-induced hepatotoxicity.
Shan, S; Shen, Z; Song, F, 2018
)
2.28
"Acetaminophen (APAP) is a well-known analgesic, deemed a very safe over-the-counter medication. "( Absolute quantitation of acetaminophen-modified human serum albumin in acute liver failure patients by liquid chromatography/tandem mass spectrometry.
Geib, T; Karvellas, CJ; LeBlanc, A; Leslie, EM; Roy, R; Shiao, TC; Sleno, L, 2018
)
2.23
"Acetaminophen (APAP) is a worldwide used drug for treating fever and pain. "( Ginsenoside Rg1 protects against acetaminophen-induced liver injury via activating Nrf2 signaling pathway in vivo and in vitro.
Gao, X; Huo, X; Kong, Y; Liu, K; Liu, Z; Ma, X; Meng, Q; Ning, C; Sun, H; Sun, P; Wang, C, 2018
)
2.2
"Acetaminophen is a common cause of acute liver failure in pediatrics. "( A case report of full recovery from severe cerebral edema secondary to acetaminophen-induced hepatotoxicity in a 13 year old girl.
Austin, EB; Crouse, BA; Hobbs, H; Lobos, AT, 2018
)
2.16
"Acetaminophen (APAP) is a well-known antipyretic and analgesic drug. "( Astragaloside IV Attenuates Acetaminophen-Induced Liver Injuries in Mice by Activating the Nrf2 Signaling Pathway.
Ding, Y; Huang, W; Ji, L; Li, L; Liu, C; Sun, K; Tumen, B; Wang, S; Zhang, L; Zhang, W, 2018
)
2.22
"Acetaminophen is a mild analgesic and antipyretic agent, which can cause centrilobular hepatic necrosis in toxic doses, whereas alcohol causes death due to liver diseases."( Pharmacokinetic changes of tramadol in rats with hepatotoxicity induced by ethanol and acetaminophen in perfused rat liver model.
Ardakani, YH; Esmaeili, Z; Ghazi-Khansari, M; Hassanzadeh, G; Lavasani, H; Mohammadi, S; Nezami, A; Rouini, MR, 2019
)
1.46
"Acetaminophen is a safe antipyretic against FSs and has the potential to prevent FS recurrence during the same fever episode."( Acetaminophen and Febrile Seizure Recurrences During the Same Fever Episode.
Inoue, K; Kashiwagi, M; Murata, S; Nomura, S; Oba, C; Ogino, M; Okasora, K; Shirasu, A; Syabana, K; Tamai, H; Tanabe, T; Yamazaki, S, 2018
)
3.37
"Acetaminophen, APAP, is a common over-the-counter drug with antipyretic-analgesic action. "( Protective effect of cinnamon against acetaminophen-mediated cellular damage and apoptosis in renal tissue.
Abdeen, A; Abdel-Daim, M; Abdelkader, A; Abdo, M; Aboubakr, M; Aleya, L; Wareth, G, 2019
)
2.23
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug that leads to severe hepatotoxicity at excessive doses. "( Fucoidan Alleviates Acetaminophen-Induced Hepatotoxicity via Oxidative Stress Inhibition and Nrf2 Translocation.
Gu, JG; Tu, MJ; Wang, YQ; Wei, JG; Zhang, W, 2018
)
2.25
"Acetaminophen is a widely used medication for fever and pain management during pregnancy. "( Association of maternal prenatal acetaminophen use with the risk of attention deficit/hyperactivity disorder in offspring: A meta-analysis.
Gou, X; Mu, D; Qu, Y; Shi, J; Tang, J; Tang, Y; Wang, Y; Xiao, D, 2019
)
2.24
"Acetaminophen (APAP) is a commonly used analgesic responsible for more than half of acute liver failure cases. "( Identification of Novel Regulatory Genes in APAP Induced Hepatocyte Toxicity by a Genome-Wide CRISPR-Cas9 Screen.
Friesen, CA; Heruth, DP; Li, DY; Qi, LS; Shortt, K; Singh, S; Wu, W; Wyckoff, GJ; Ye, SQ; Zhang, LQ; Zhang, N, 2019
)
1.96
"Acetaminophen co-exposure is a novel independent risk factor for the occurrence of MALA that deserves further investigation."( Incidence and risk factors for hyperlactatemia in ED patients with acute metformin overdose.
Hoffman, RS; Manini, AF; Taub, ES, 2019
)
1.24
"Acetaminophen (paracetamol) is a widely used analgesic-antipyretic drug that causes hepatotoxicity at higher than the effective doses."( Marine macro-algae attenuates nephrotoxicity and hepatotoxicity induced by cisplatin and acetaminophen in rats.
Ehteshamul-Haque, S; Hira, K; Sohail, N; Sultana, V; Tariq, A, 2019
)
1.46
"Acetaminophen (APAP) is a widely used over-the-counter drug for antipyretic and analgesic, but an overdose will induce acute liver injury. "( Geniposide protected hepatocytes from acetaminophen hepatotoxicity by down-regulating CYP 2E1 expression and inhibiting TLR 4/NF-κB signaling pathway.
Gong, X; Jiang, R; Kuang, G; Wan, J; Wang, Y; Wu, S; Xiong, L; Xu, F; Yang, S; Zeng, T, 2019
)
2.23
"Acetaminophen (APAP) is a highly effective analgesic, which is safe at therapeutic doses. "( Acetaminophen hepatotoxicity: A mitochondrial perspective.
Jaeschke, H; Ramachandran, A, 2019
)
3.4
"Acetaminophen (APAP) is a clinically popular analgesic and antipyretic drug, but excessive APAP can cause fatal hepatotoxicity. "( Effects of Photoperiod on Acetaminophen-Induced Hepatotoxicity in Mice.
Cai, J; Cheng, Y; Fan, C; Gao, H; Lin, T; Lu, J; Pu, D; Sun, Y; Wan, Z; Wang, H; Zhang, R, 2020
)
2.3
"Acetaminophen (APAP) is an antipyretic and analgesic, which is commonly associated with drug-induced hepatic injury. "( Acetaminophen-induced hepatocyte injury: C2-ceramide and oltipraz intervention, hepatocyte nuclear factor 1 and glutathione S-transferase A1 changes.
Chang, Y; Hao, B; Li, C; Li, R; Li, Y; Liu, F; Ma, X; Muhammad, I; Shi, C; Wang, F; Yang, Y; Zhang, Y, 2019
)
3.4
"Acetaminophen overdose is a major concern among the pediatric population. "( Validation of ICD-9-CM codes for identification of acetaminophen-related emergency department visits in a large pediatric hospital.
de Achaval, S; Feudtner, C; Palla, S; Suarez-Almazor, ME, 2013
)
2.08
"Acetaminophen is a frequently prescribed over-the-counter drug to reduce fever and pain in the event of inflammatory process. "( Acetaminophen prevents oxidative burst and delays apoptosis in human neutrophils.
Carvalho, F; Costa, VM; Couto, D; Fernandes, E; Freitas, M; Porto, G; Ribeiro, D, 2013
)
3.28
"Acetaminophen (APAP) is an analgesic and antipyretic agent. "( The effects of N-acetylcysteine and ozone therapy on oxidative stress and inflammation in acetaminophen-induced nephrotoxicity model.
Agilli, M; Alp, BF; Aydin, FN; Aydin, I; Cayci, T; Macit, E; Ozcan, A; Ozkan, E; Oztosun, M; Taslipinar, MY; Toygar, M; Ucar, F, 2013
)
2.05
"Acetaminophen (APAP) is an antipyretic analgesic drug that when taken in overdose causes depletion of glutathione (GSH) and hepatotoxicity. "( Therapeutic effect of liposomal-N-acetylcysteine against acetaminophen-induced hepatotoxicity.
Alipour, M; Buonocore, C; Omri, A; Pucaj, K; Suntres, ZE; Szabo, M, 2013
)
2.08
"Acetaminophen toxicity is a common cause of AFHF; this combination has a strong association with cerebral edema. "( Acute fulminant hepatic failure, encephalopathy and early CT changes.
Al-Amri, A; Das, S; Gulka, I; Thayapararajah, SW; Young, GB, 2013
)
1.83
"Acetaminophen intoxication is a leading cause of acute liver failure. "( Efficacy of adipose tissue-mesenchymal stem cell transplantation in rats with acetaminophen liver injury.
Barbagallo, I; Li Volti, G; Piazza, C; Puzzo, L; Salomone, F, 2013
)
2.06
"Acetaminophen (APAP) is a widely used analgesic. "( Circulating acylcarnitines as biomarkers of mitochondrial dysfunction after acetaminophen overdose in mice and humans.
Curry, SC; Jaeschke, H; Li, F; Ma, X; McGill, MR; Sharpe, MR; Williams, CD, 2014
)
2.07
"Acetaminophen (paracetamol) is a commonly used over-the-counter analgesic and antipyretic and has previously been shown to improve exercise performance through a reduction in perceived pain. "( Acute acetaminophen (paracetamol) ingestion improves time to exhaustion during exercise in the heat.
Castle, PC; Foster, J; Harding, C; Mauger, AR; Taylor, L; Wright, B, 2014
)
2.33
"Acetaminophen (APAP) is a widely used analgesic drug that can cause acute liver injury in overdose situations."( Metabolomics evaluation of the effects of green tea extract on acetaminophen-induced hepatotoxicity in mice.
Beger, RD; Greenhaw, J; Lu, Y; Petrova, K; Salminen, WF; Schnackenberg, LK; Sun, J; Yang, X, 2013
)
1.35
"Acetaminophen is a leading cause of acute liver failure (ALF). "( Candidate gene polymorphisms in patients with acetaminophen-induced acute liver failure.
Court, MH; Greenblatt, DJ; Hazarika, S; Lee, WM; Peter, I; Vasiadi, M, 2014
)
2.1
"Acetaminophen (APAP) is a substance that harms human health by stimulating free radical production. "( Abrogation by Trifolium alexandrinum root extract on hepatotoxicity induced by acetaminophen in rats.
Aziz, AT; Rehman, H; Saggu, S; Sakeran, MI; Zidan, N, 2014
)
2.07
"Acetaminophen is a common analgesic and antipyretic compound which, when administered in high doses, has been associated with significant morbidity and mortality, secondary to hepatic toxicity. "( Baccharis trimera improves the antioxidant defense system and inhibits iNOS and NADPH oxidase expression in a rat model of inflammation.
Araujo, CM; Bianco de Souza, GH; Chaves, MM; Costa, DC; Cruz Padua, Bd; de Brito Magalhaes, CL; Pedrosa, ML; Rossoni Junior, JV; Seiberf, JB; Silva, ME, 2013
)
1.83
"Acetaminophen is a commonly used over-the-counter analgesic and overdose of acetaminophen was the most frequent cause of acute liver failure."( Inhibitory effects of Schisandra chinensis on acetaminophen-induced hepatotoxicity.
Bai, Y; Wang, J; Wang, KP; Zhang, JZ, 2014
)
1.38
"Acetaminophen is a commonly-used analgesic in the US and, at doses of more than 4 g/day, can lead to serious hepatotoxicity. "( A perspective on the epidemiology of acetaminophen exposure and toxicity in the United States.
Ben-Joseph, R; Blieden, M; Paramore, LC; Shah, D, 2014
)
2.12
"Acetaminophen (APAP), is a safe analgesic and antipyretic drug at therapeutic dose, and is widely used in the clinic. "( Dual role of acetaminophen in promoting hepatoma cell apoptosis and kidney fibroblast proliferation.
Chang, WJ; Chou, PL; Hung, YT; Lin, PS; Lin, SY; Liu, HC; Tseng, HH; Wei, CW; Wu, TK; Yiang, GT; Yu, YL, 2014
)
2.21
"Acetaminophen is a commonly used antipyretic agent, which in high doses, causes uremia and used for experimentally induction of kidney disease."( Therapeutic potential of different commercially available synbiotic on acetaminophen-induced uremic rats.
Das, K; Mahapatra, SD; Mahapatra, TD; Mandal, A; Mandal, S; Mondal, KC; Nandi, DK; Patra, A; Paul, T; Roy, S, 2015
)
1.37
"Acetaminophen Psi Nomogram is a sensitive and specific tool for prediction of hepatotoxicity secondary to acute acetaminophen overdose. "( Acetaminophen Psi Nomogram: a sensitive and specific clinical tool to predict hepatotoxicity secondary to acute acetaminophen overdose.
Chomchai, C; Chomchai, S; Lawattanatrakul, N, 2014
)
3.29
"Acetaminophen is an old drug that is now available in an intravenous formulation."( OFIRMEV: an old drug becomes new again.
Nishimoto, RN, 2014
)
1.12
"Oral acetaminophen is an alternative to PDA therapy in preterm infants when indomethacin/ibuprofen is not effective or is contraindicated, and it may be considered before surgical ligation."( Acetaminophen for patent ductus arteriosus.
Gales, BJ; Gales, MA; Le, J, 2015
)
2.37
"Acetaminophen (APAP) is a commonly used analgesic and antipyretic. "( Protective effect of Baccharis trimera extract on acute hepatic injury in a model of inflammation induced by acetaminophen.
Brandão, GC; Chaves, MM; Costa, DC; de Souza, GH; Lima, WG; Magalhães, CL; Pádua, Bda C; Pedrosa, ML; Rodrigues, IV; Rossoni Júnior, JV; Silva, ME, 2014
)
2.06
"Acetaminophen is a commonly prescribed and over-the-count used drug, and is considered to be the preferred treatment choice for anticoagulated patients requiring analgesic drug therapy. "( How safe is acetaminophen use in patients treated with vitamin K antagonists? A systematic review and meta-analysis.
Barra, M; Caldeira, D; Costa, J; Ferreira, JJ; Pinto, FJ, 2015
)
2.24
"Acetaminophen (APAP) is a widely used antipyretic and analgesic, but an acute or cumulative overdose of acetaminophen can cause severe hepatic failure."( Bee venom phospholipase A2 protects against acetaminophen-induced acute liver injury by modulating regulatory T cells and IL-10 in mice.
Bae, H; Chung, HS; Keum, DJ; Kim, H; Kwak, Jw, 2014
)
1.38
"Acetaminophen is an accelerator of the reaction in the glucose oxidase peroxidase method and does not displace bilirubin from human serum albumin."( Evaluation of bilirubin displacement effect by acetaminophen in vitro.
Itoh, S; Kusaka, T; Okada, H; Sugino, M, 2015
)
2.12
"Acetaminophen is a commonly used medication to manage fever and pain in children and the drug is generally considered to be safe when used at appropriate therapeutic dosages. "( Severe intrinsic acute kidney injury associated with therapeutic doses of acetaminophen.
Aizawa, T; Hirono, K; Ito, E; Ito, T; Joh, K; Tanaka, H; Tsuruga, K; Watanabe, S, 2015
)
2.09
"Acetaminophen (APAP) is a commonly used and effective analgesic/antipyretic agent and relatively safe drug even in long-term treatment."( [Investigation of Predisposition Biomarkers to Identify Risk Factors for Drug-induced Liver Injury in Humans: Analyses of Endogenous Metabolites in an Animal Model Mimicking Human Responders to APAP-induced Hepatotoxicity].
Kobayashi, A; Kondo, K; Sugai, S, 2015
)
1.14
"Acetaminophen (APAP) is a widely used analgesic drug that can cause acute liver injury in overdose situations."( Apocynum venetum Attenuates Acetaminophen-Induced Liver Injury in Mice.
Chen, C; Jiang, Z; Melzig, MF; Wang, J; Xie, W; Zhang, X, 2015
)
1.43
"Acetaminophen (APAP) is a commonly used analgesic drug that can cause liver injury, liver necrosis and liver failure. "( Translational biomarkers of acetaminophen-induced acute liver injury.
Beger, RD; Bhattacharyya, S; Gill, PS; James, LP; Schnackenberg, LK; Sun, J; Yang, X, 2015
)
2.15
"Acetaminophen is a nonsteroidal, nonsalicylate analgesic and antipyretic that is, today, the most common medication ingredient found in oral and rectal over-the-counter and prescription drugs. "( Acetaminophen by infusion.
Turkoski, BB,
)
3.02
"Acetaminophen (paracetamol) is a widely used nonopioid, non-NSAID analgesic that is effective against a variety of pain types, but the consequences of overdose can be severe. "( Acetaminophen (paracetamol) oral absorption and clinical influences.
Decker, JF; Patrick, JT; Pergolizzi, JV; Raffa, RB; Taylor, R, 2014
)
3.29
"Acetaminophen is a commonly used pediatric medication that has recently been approved for intravenous use in the United States. "( Intravenous acetaminophen use in pediatrics.
Shastri, N, 2015
)
2.24
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug. "( Acetaminophen induces JNK/p38 signaling and activates the caspase-9-3-dependent cell death pathway in human mesenchymal stem cells.
Chang, WJ; Chen, JN; Lin, KT; Wei, CW; Yiang, GT; Yu, YL, 2015
)
3.3
"Acetaminophen (APAP) is a readily available over-the-counter drug and is one of the most commonly used analgesics/antipyretics worldwide. "( Interindividual variation in gene expression responses and metabolite formation in acetaminophen-exposed primary human hepatocytes.
Claessen, SM; Coonen, ML; Jetten, MJ; Kleinjans, JC; Lommen, A; Peijnenburg, AA; Ruiz-Aracama, A; van Delft, JH; van Herwijnen, MH, 2016
)
2.1
"Acetaminophen (paracetamol) is a well-tolerated analgesic and antipyretic drug when used at therapeutic doses. "( Alpha-lipoic acid treatment of acetaminophen-induced rat liver damage.
Mahmoud, AA; Mahmoud, YI; Nassar, G, 2015
)
2.15
"Acetaminophen is a safe alternative in children with hypersensitivity to NSAIDs."( [Hypersensitivity reactions to non-steroidal anti-inflammatory drugs and tolerance to alternative drugs].
Calvo Campoverde, K; Giner-Muñoz, MT; Lozano Blasco, J; Machinena, A; Martínez Valdez, L; Plaza, AM; Rojas Volquez, M, 2016
)
1.16
"Acetaminophen (APAP) is an effective antipyretic and one of the most commonly used analgesic drugs. "( TRPA1 mediates the hypothermic action of acetaminophen.
Andersson, DA; Bevan, S; Gentry, C, 2015
)
2.13
"Acetaminophen is a widespread and commonly used painkiller all over the world. "( Timescale analysis of a mathematical model of acetaminophen metabolism and toxicity.
Reddyhoff, D; Regan, S; Ward, J; Webb, S; Williams, D, 2015
)
2.12
"Acetaminophen is a preferred option for pain management during pregnancy when compared with other medications such as nonsteroidal anti-inflammatory drugs or opioids for pyretic or pain relief."( Association Between Prenatal Acetaminophen Exposure and Future Risk of Attention Deficit/Hyperactivity Disorder in Children.
Erramouspe, J; Hayes, VA; Hoover, RM, 2015
)
1.43
"Acetaminophen is a common therapy for fever in patients in the intensive care unit (ICU) who have probable infection, but its effects are unknown."( Acetaminophen for Fever in Critically Ill Patients with Suspected Infection.
Beasley, R; Bellomo, R; Freebairn, R; Hammond, N; Henderson, S; Holliday, M; Mackle, D; McArthur, C; McGuinness, S; Myburgh, J; Saxena, M; van Haren, F; Weatherall, M; Webb, S; Young, P, 2015
)
3.3
"Acetaminophen is a commonly used drug that induces serious hepatotoxicity when overdosed, leading to increased levels of serum aminotransferases. "( Acetaminophen-induced liver injury: Implications for temporal homeostasis of lipid metabolism and eicosanoid signaling pathway.
Azghadi, SM; Gruia, AT; Mic, AA; Mic, FA; Nica, DV; Suciu, M, 2015
)
3.3
"Acetaminophen is a commonly used analgesic that can cause severe hepatotoxicity in overdose. "( Acetaminophen hepatotoxicity in mice: Effect of age, frailty and exposure type.
Cogger, V; de Cabo, R; Hilmer, SN; Huizer-Pajkos, A; Jones, B; Kane, AE; Le Couteur, DG; Mach, J; McKenzie, C; Mitchell, SJ, 2016
)
3.32
"Acetaminophen is a commonly used analgesic/antipyretic; overdoses can lead to liver damage. "( Relation of Health Literacy to Exceeding the Labeled Maximum Daily Dose of Acetaminophen.
Battista, DR; Kaufman, DW; Kelly, JP; Malone, MK; Shiffman, S; Weinstein, RB, 2016
)
2.11
"Acetaminophen (APAP) elixir is a widely used pediatric antipyretic medication. "( Are Recommended Doses of Acetaminophen Effective for Children Aged 2 to 3 Years? A Pharmacokinetic Modeling Answer.
Abourbih, DA; Gosselin, S; Kazim, S; Villeneuve, E, 2016
)
2.18
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug. "( Detecting mRNA Predictors of Acetaminophen-Induced Hepatotoxicity in Mouse Blood Using Quantitative Real-Time PCR.
Kanno, S; Tomizawa, A; Yomogida, S, 2016
)
2.17
"Acetaminophen (APAP) is a mainstay for pain management worldwide. "( The Use of Intravenous Acetaminophen for Acute Pain in the Emergency Department.
Motov, SM; Sin, B; Tatunchak, T; Wai, M, 2016
)
2.19
"Acetaminophen is known to be a relatively weak analgesic with fewer side effects than nonsteroidal anti-inflammatory drugs (NSAIDs). "( Comparison of the analgesic effect of intravenous acetaminophen with that of flurbiprofen axetil on post-breast surgery pain: a randomized controlled trial.
Hara, M; Miyamoto, C; Nonaka, T; Sugita, M; Yamamoto, T, 2016
)
2.13
"Acetaminophen (APAP) is a well-known analgesic and antipyretic drug. "( Acetaminophen from liver to brain: New insights into drug pharmacological action and toxicity.
Ghanem, CI; Manautou, JE; Mottino, AD; Pérez, MJ, 2016
)
3.32
"Acetaminophen is a pharmaceutical, frequently found in surface water as a contaminant. "( LC-MS/MS method development for quantitative analysis of acetaminophen uptake by the aquatic fungus Mucor hiemalis.
Balsano, E; Esterhuizen-Londt, M; Kühn, S; Pflugmacher, S; Schwartz, K, 2016
)
2.12
"Acetaminophen (APAP) is an analgesic and antipyretic agent commonly known agent to cause hepatic and renal toxicity at a higher dose. "( Ameliorative effect of naringin in acetaminophen-induced hepatic and renal toxicity in laboratory rats: role of FXR and KIM-1.
Adil, M; Bodhankar, SL; Ghosh, P; Kandhare, AD; Raygude, KS; Venkata, S, 2016
)
2.15
"Acetaminophen (ACT) is a mild analgesic commonly used for relief of fever, headache and some minor pains. "( Degradations of acetaminophen via a K2S2O8-doped TiO2 photocatalyst under visible light irradiation.
Aranzamendez, GL; de Luna, MDG; Lin, JC; Lu, MC, 2016
)
2.22
"Acetaminophen is a widely used analgesic and antipyretic agent, which is safe at therapeutic doses. "( Role of nicotinamide (vitamin B3) in acetaminophen-induced changes in rat liver: Nicotinamide effect in acetaminophen-damged liver.
Mahmoud, AA; Mahmoud, YI, 2016
)
2.15
"Acetaminophen (paracetamol) is a widely used analgesic and antipyretic drug. "( Acetaminophen Increases Aldosterone Secretion While Suppressing Cortisol and Androgens: A Possible Link to Increased Risk of Hypertension.
Ohlsson Andersson, Å; Oskarsson, A; Ullerås, E, 2016
)
3.32
"Acetaminophen is a medication commonly used in multiple different drug formulations, many of which are available without a prescription."( Acetaminophen Use: An Unusual Cause of Drug-Induced Pulmonary Eosinophilia.
Moran-Mendoza, O; Saint-Pierre, MD, 2016
)
2.6
"Acetaminophen overdose is a leading cause of drug-induced liver failure in the United States. "( Detection of Acetaminophen-Protein Adducts in Decedents with Suspected Opioid-Acetaminophen Combination Product Overdose.
Andrenyak, DM; Curry, SC; Grey, TC; McGill, LD; Rollins, DE; Thomas, KC; Wilkins, DG, 2016
)
2.25
"Acetaminophen is a non-steroidal anti-inflammatory drug used as an antipyretic agent for the alternative to aspirin. "( Electrochemical properties of the acetaminophen on the screen printed carbon electrode towards the high performance practical sensor applications.
Chen, SM; Karikalan, N; Karthik, R; Karuppiah, C; Velmurugan, M, 2016
)
2.16
"Acetaminophen toxicity is a common cause of pediatric liver failure. "( Serum Acetaminophen Protein Adduct Concentrations in Pediatric Emergency Department Patients.
Anderson, V; Dart, RC; Green, JL; Heard, K; Kile, D; Lavonas, EJ, 2017
)
2.38
"Acetaminophen (APAP) is an antipyretic and analgesic drug that, in high doses, leads to severe liver injury and potentially death. "( Lycopene pretreatment improves hepatotoxicity induced by acetaminophen in C57BL/6 mice.
Bandeira, ACB; Bezerra, FS; Cangussú, SD; Costa, DC; da Silva, RC; Figueiredo, VP; Rossoni, JV; Talvani, A, 2017
)
2.14
"Acetaminophen (APAP) is a widely used analgesic drug that is frequently co-administered with caffeine (CAF) in the treatment of pain. "( Multiscale modeling reveals inhibitory and stimulatory effects of caffeine on acetaminophen-induced toxicity in humans.
Baier, V; Blank, LM; Cordes, H; Kuepfer, L; Thiel, C, 2017
)
2.13
"Acetaminophen (APAP) is a conventional drug widely used in the clinic because of its antipyretic-analgesic effects. "( Astaxanthin pretreatment attenuates acetaminophen-induced liver injury in mice.
Bi, J; Deng, Y; Gu, J; Liu, C; Zhang, J; Zhang, S, 2017
)
2.17
"Acetaminophen (APAP) is a leading cause of fatal overdose. "( Evaluation of a urine screen for acetaminophen.
Bosse, GN; Ingram, DN; Jortani, S; Womack, EP, 2008
)
2.07
"Acetaminophen is an analgesic and antipyretic drug believed to exert its effect through interruption of nociceptive processing. "( Acetaminophen prevents hyperalgesia in central pain cascade.
Crawley, B; Fitzsimmons, B; Hua, XY; Malkmus, S; Saito, O; Yaksh, TL, 2008
)
3.23
"Acetaminophen is an OTC medication and amongst the most used pain relievers. "( [Accidental acetaminophen overdose].
Hamwi, I; Picksak, G; Stichtenoth, DO, 2008
)
2.17
"Acetaminophen (AAP) is a commonly used analgesic and antipyretic drug; however, when used in high doses, it causes fulminant hepatic necrosis in both humans and experimental animals. "( Synergistic action of sodium selenite and N-acetylcysteine in acetaminophen-induced liver damage.
Bilgili, A; Eraslan, G; Onbasilar, I; Ozdemir, M; Yalçin, S, 2008
)
2.03
"Acetaminophen is a widely used analgesic antipyretic agent. "( Acetaminophen bioactivation by human cytochrome P450 enzymes and animal microsomes.
Auriola, S; Juvonen, RO; Laine, JE; Pasanen, M, 2009
)
3.24
"Acetaminophen (AA) is a widely used antipyretic drug that causes hepatotoxicity at high doses. "( Altered disposition of acetaminophen in Nrf2-null and Keap1-knockdown mice.
Aleksunes, LM; Csanaky, IL; Klaassen, CD; Reisman, SA, 2009
)
2.11
"Acetaminophen is a commonly used drug for the treatment of patients with common cold and influenza. "( Phyllanthus urinaria extract attenuates acetaminophen induced hepatotoxicity: involvement of cytochrome P450 CYP2E1.
Chan, AK; Chan, AS; Cheng, CH; Cheng, GY; Chui, CH; Fong, DW; Gambari, R; Hau, DK; Kan, CW; Kok, SH; Lai, PB; Lau, FY; Leung, AK; Tang, JC; Tong, CS; Wong, RS; Wong, WY; Yuen, MC; Zhu, GY, 2009
)
2.06
"Acetaminophen is a dose dependent hepatotoxin which is frequently associated with intentional self-harm. "( Acetaminophen overdose in Jamaica.
Lee, MG; Mills, MO, 2008
)
3.23
"Acetaminophen is an analgesic drug that is frequently used in suicide attempts. "( Severe acetaminophen poisoning treated with a fractionated plasma separation and absorption system: A case report.
Güvenç, B; Murt, M; Rana Alpay, N; Satar, S; Sebe, A, 2009
)
2.25
"Acetaminophen (APAP) is a widely used analgesic drug, and is mainly biotransformed and eliminated as nontoxic conjugates with glucuronic acid and sulfuric acid."( [Dosing time based on molecular mechanism of biological clock of hepatic drug metabolic enzyme].
Matsunaga, N, 2009
)
1.07
"Acetaminophen (APAP) is a widely used over the counter therapeutic that is known to be effective and safe at therapeutic doses."( The role of damage associated molecular pattern molecules in acetaminophen-induced liver injury in mice.
Holt, MP; Ju, C; Martin-Murphy, BV, 2010
)
1.32
"Acetaminophen (AP) is a widely used, cheap, and over-the-counter nonsteroidal anti-inflammatory drug. "( Repeated preexposure or coexposure to arsenic differentially alters acetaminophen-induced oxidative stress in rat kidney.
Manimaran, A; Sankar, P; Sarkar, SN, 2011
)
2.05
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug and is safe at therapeutic doses but its overdose frequently causes liver injury. "( Arjunolic acid, a triterpenoid saponin, prevents acetaminophen (APAP)-induced liver and hepatocyte injury via the inhibition of APAP bioactivation and JNK-mediated mitochondrial protection.
Das, J; Ghosh, J; Manna, P; Sil, PC, 2010
)
2.06
"Acetaminophen is a widely used analgesic that can cause acute liver failure when consumed above a maximum daily dose. "( Acetaminophen toxicity with concomitant use of carbamazepine.
Ahmed, SN; Heino, A; Jickling, G, 2009
)
3.24
"Acetaminophen (APAP) is a widely used antipyretic and analgesic agent. "( Gap junction dysfunction reduces acetaminophen hepatotoxicity with impact on apoptotic signaling and connexin 43 protein induction in rat.
Asamoto, M; Naiki, T; Naiki-Ito, A; Ogawa, K; Sato, S; Shirai, T; Takahashi, S, 2010
)
2.08
"Acetaminophen is an old and comfortable friend. "( Acetaminophen: old friend--new rules.
Turkoski, BB,
)
3.02
"Acetaminophen is a dose-dependent toxin. "( Acetaminophen dose does not predict outcome in acetaminophen-induced acute liver failure.
Gregory, B; Larson, AM; Lee, WM; Reisch, J, 2010
)
3.25
"Acetaminophen is a commonly used analgesic and has been shown to be a main cause of drug-induced liver failure. "( Late extensive intravenous administration of N-acetylcysteine can reverse hepatic failure in acetaminophen overdose.
Mehrpour, O; Sanaei-Zadeh, H; Shadnia, S, 2011
)
2.03
"Acetaminophen poisoning is a common clinical problem, and early identification of patients with more severe poisoning is key to improving outcomes."( Association between gastrointestinal manifestations following acetaminophen poisoning and outcome in 291 acetaminophen poisoning patients.
Al-Jabi, SW; Awang, R; Sulaiman, SA; Zyoud, SH, 2010
)
2.04
"Acetaminophen (APAP) is an analgesic-antipyretic drug widely used in children. "( Heat shock protein 70 induction and its urinary excretion in a model of acetaminophen nephrotoxicity.
Molinas, SM; Monasterolo, LA; Pagotto, MA; Pisani, GB; Rosso, M; Trumper, L; Wayllace, NZ, 2010
)
2.04
"Acetaminophen overdose is a well known cause of liver function disorder and even hepatic failure. "( [Severe metabolic acidosis as a result of 5-oxoproline in acetaminophen use].
Holman, M; ter Maaten, JC, 2010
)
2.05
"Acetaminophen (APAP) is a safe and effective analgesic and antipyretic when used at therapeutic levels. "( Effects of sesame oil against after the onset of acetaminophen-induced acute hepatic injury in rats.
Chandrasekaran, VR; Chang, YC; Chien, SP; Hsu, DZ; Liu, MY,
)
1.83
"Acetaminophen (paracetamol) is a widely used drug and known as a safety antipyretic and analgesic drug in childhood. "( A case of acetaminophen (paracetamol) causing renal failure without liver damage in a child and review of literature.
Bek, K; Genc, G; Ozkaya, O; Sullu, Y, 2010
)
2.21
"Acetaminophen is a leading cause of overdose-related hepatotoxicity. "( Intravenous acetylcysteine for the treatment of acetaminophen overdose.
Doyon, S; Klein-Schwartz, W, 2011
)
2.07
"Acetaminophen (paracetamol) is a familiar agent for treating many types of pain, including postsurgical pain."( Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations.
Labhsetwar, SA; Pergolizzi, JV; Raffa, RB; Tallarida, R; Taylor, R, 2012
)
1.32
"Acetaminophen is a commonly used analgesic and antipyretic agent which, at high doses, causes liver and kidney necrosis in man and animals."( Evaluation of phytoconstituents and anti-nephrotoxic and antioxidant activities of Monochoria vaginalis.
Kumar, BS; Kumar, RP; Palani, S; Raja, S; Selvaraj, R, 2011
)
1.09
"Acetaminophen is a commonly used analgesic and antipyretic drug, and is frequently used to study gastric emptying. "( The effect of the once-daily human glucagon-like peptide 1 analog liraglutide on the pharmacokinetics of acetaminophen.
Flint, A; Hindsberger, C; Kapitza, C; Zdravkovic, M, 2011
)
2.03
"Acetaminophen injection is an antipyretic and analgesic agent recently marketed in the United States as Ofirmev. "( Acetaminophen injection: a review of clinical information.
Jones, VM, 2011
)
3.25
"Acetaminophen (paracetamol) is a widely used over-the-counter drug, but concerns of genotoxic effects have been raised. "( Cancer risk associated with long-term use of acetaminophen in the prospective VITamins and lifestyle (VITAL) study.
Brasky, TM; Walter, RB; White, E, 2011
)
2.07
"As acetaminophen (APAP) is a well-known hepatotoxin, we investigated the effect of the aqueous extract of the T. "( Tournefortia sarmentosa extract attenuates acetaminophen-induced hepatotoxicity.
Hsu, WH; Huang, HI; Kuo, WH; Lai, YL; Teng, CY; Yang, CC, 2012
)
1.26
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug, but at high dose it leads to undesirable side effects, such as hepatotoxicity and nephrotoxicity. "( Hesperidin alleviates acetaminophen induced toxicity in Wistar rats by abrogation of oxidative stress, apoptosis and inflammation.
Ahmad, ST; Ali, N; Arjumand, W; Nafees, S; Rashid, S; Seth, A; Sultana, S, 2012
)
2.14
"Acetaminophen (APAP) is a widely used medication in pregnancy and is considered safe. "( Unintentional chronic acetaminophen poisoning during pregnancy resulting in liver transplantation.
Minns, AB; Thornton, SL, 2012
)
2.14
"Acetaminophen is a widely used drug worldwide and is one of the most frequently detected in bodies of water making it a high priority trace pollutant. "( Acetaminophen degradation by electro-Fenton and photoelectro-Fenton using a double cathode electrochemical cell.
de Luna, MD; Lu, MC; Su, CC; Veciana, ML, 2012
)
3.26
"Acetaminophen injection is an antipyretic and analgesic agent recently marketed in the United States as Ofirmev. "( Acetaminophen injection: a review of clinical information including forms not available in the United States.
Beckwith, MC; Fox, ER; Jones, VM, 2012
)
3.26
"Acetaminophen (APAP) is a safe analgesic and antipyretic drug. "( Chemokines and mitochondrial products activate neutrophils to amplify organ injury during mouse acute liver failure.
Amaral, SS; Avila, TV; Cara, DC; De Paula, AM; Leite, MF; Lima, BH; Lima, CX; Lopes, GA; Marques, PE; Melgaço, JG; Menezes, GB; Nogueira, LL; Oliveira, AG; Pinto, MA; Pires, DA; Russo, RC; Soriani, FM; Teixeira, MM, 2012
)
1.82
"Acetaminophen (APAP) is a commonly used nonsteroidal analgesic because it is considered safe. "( [Study of the serum concentrations of acetaminophen overdose].
Hosoya, J; Iseki, K; Shiraishi, T; Suzuki, T; Takahashi, N; Tominaga, A; Toyoguchi, T, 2012
)
2.09
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug. "( Quantitative analysis of acetaminophen and its six metabolites in rat plasma using liquid chromatography/tandem mass spectrometry.
An, JH; Jung, BH; Lee, HJ, 2012
)
2.13
"Acetaminophen is a commonly used antipyretic agent which, at high doses, causes renal tubular damage and uremia. "( In vivo assessment of bacteriotherapy on acetaminophen-induced uremic rats.
Das, K; Mandal, A; Mondal, KCh; Nandi, DK; Roy, S,
)
1.84
"Acetaminophen is an analgesic drug that is used safely in therapeutic doses. "( The effect of different doses of flumazenil on acetaminophen toxicity in rats.
Aksu, R; Bicer, C; Boyaci, A; Bozogluer, E; Madenoglu, H; Yazici, C, 2012
)
2.08
"Acetaminophen is a commonly used analgesic; excessive doses can lead to liver damage. "( Prevalence and correlates of exceeding the labeled maximum dose of acetaminophen among adults in a U.S.-based internet survey.
Kaufman, DW; Kelly, JP; Malone, MK; Rohay, JM; Shiffman, S; Weinstein, RB, 2012
)
2.06
"Acetaminophen is a widely prescribed drug used to relieve pain and fever; however, it is a leading cause of drug-induced liver injury and a burden on public healthcare. "( Identification of early biomarkers during acetaminophen-induced hepatotoxicity by fourier transform infrared microspectroscopy.
Chandrasekar, B; Deobagkar-Lele, M; Gautam, R; Kumar B N, V; Nandi, D; Rakshit, S; Umapathy, S, 2012
)
2.09
"Acetaminophen (APAP) is a commonly used and effective analgesic and antipyretic agent. "( Enhancement of acetaminophen-induced chronic hepatotoxicity in restricted fed rats: a nonclinical approach to acetaminophen-induced chronic hepatotoxicity in susceptible patients.
Hashimoto, T; Kobayashi, A; Kondo, K; Kuno, H; Shoda, T; Sugai, S; Suzuki, Y; Takahashi, A; Toyoda, K; Yamada, N, 2012
)
2.17
"Acetaminophen is a safe antipyretic and analgesic drug within the clinically recommended dosage range, but overdose can cause fatal liver and or kidney damage. "( Effect of acetaminophen on the progression of renal damage in adenine induced renal failure model rats.
Arimizu, K; Chuang, VT; Hirata, S; Irie, T; Ishitsuka, Y; Kadowaki, D; Kitamura, K; Maruyama, T; Narita, Y; Otagiri, M; Sumikawa, S; Taguchi, K, 2012
)
2.22
"Acetaminophen (paracetamol) is a widely used analgesic, but its sites and mechanisms of action remain incompletely understood. "( Antinociception by systemically-administered acetaminophen (paracetamol) involves spinal serotonin 5-HT7 and adenosine A1 receptors, as well as peripheral adenosine A1 receptors.
Liu, J; Reid, AR; Sawynok, J, 2013
)
2.09
"Acetaminophen is a widely used medication for the treatment of pain and fever in children and pregnant women. "( Acetaminophen and asthma.
Henderson, AJ; Shaheen, SO, 2013
)
3.28
"Acetaminophen overdose is a common reason for hospital admission and the most frequent cause of hepatotoxicity in the Western world. "( Mechanistic biomarkers provide early and sensitive detection of acetaminophen-induced acute liver injury at first presentation to hospital.
Antoine, DJ; Bateman, DN; Coyle, J; Dear, JW; Goldring, CE; Gray, AJ; Lewis, PS; Masson, M; Moggs, JG; Park, BK; Platt, V; Thanacoody, RH; Webb, DJ, 2013
)
2.07
"Acetaminophen (paracetamol) is a widely prescribed analgesic-antipyretic drug. "( Acetaminophen (paracetamol)-induced anaphylactic shock.
Bachmeyer, C; Blay, F; Habki, R; Leynadier, F; Vermeulen, C, 2002
)
3.2
"Acetaminophen is a common antipyretic-analgesic drug usually administered orally any time of the day. "( Chronopharmacokinetics of acetaminophen in healthy human volunteers.
Chuhwak, PD; Kolawole, JA; Okeniyi, SO,
)
1.87
"Acetaminophen (AA) is a commonly used analgesic and antipyretic drug; however, when used in high doses, it causes fulminant hepatic necrosis and nephrotoxic effects in both humans and experimental animals. "( Protective effects of melatonin, vitamin E and N-acetylcysteine against acetaminophen toxicity in mice: a comparative study.
Ayanoğlu-Dülger, G; Sehirli, AO; Sener, G, 2003
)
1.99
"Acetaminophen is a weak inhibitor of cyclooxygenase (COX), and its combination with an NSAID may augment COX inhibition-related side effects."( Propacetamol augments inhibition of platelet function by diclofenac in volunteers.
Munsterhjelm, E; Niemi, TT; Rosenberg, PH; Syrjälä, MT; Ylikorkala, O, 2003
)
1.04
"Acetaminophen is an over-the-counter analgesic/antipyretic agent widely used in primary dysmenorrhoea as monotherapy or in combination."( Is acetaminophen, and its combination with pamabrom, an effective therapeutic option in primary dysmenorrhoea?
De Los Santos, AR; Di Girolamo, G; González, CD; Sánchez, AJ, 2004
)
1.67
"Acetaminophen is a widely used analgesic, and recent studies have shown that it has some benefits in the ischemic heart. "( Acetaminophen and experimental acute myocardial infarction.
Hale, SL; Kloner, RA, 2004
)
3.21
"Acetaminophen acts as a competitive inhibitor at 27 degrees C (Ki = 126 microM) and an uncompetitive inhibitor at 37 degrees C (Ki = 214 microM)."( Kinetic and structural analysis of the inhibition of adenosine deaminase by acetaminophen.
Ataie, G; Cristalli, G; Divsalar, A; Mardanian, S; Moosavi-Movahedi, AA; Ranjbar, B; Saboury, AA; Safarian, S, 2004
)
1.27
"Acetaminophen is a widely used antipyretic analgesic, reducing fever caused by bacterial and viral infections and by clinical trauma such as cancer or stroke. "( Acetaminophen-induced hypothermia in mice is mediated by a prostaglandin endoperoxide synthase 1 gene-derived protein.
Ayoub, SS; Ballou, LR; Botting, RM; Colville-Nash, PR; Goorha, S; Willoughby, DA, 2004
)
3.21
"Acetaminophen (paracetamol) is an analgesic-antipyretic drug virtually devoid of typical anti-inflammatory activity and hence free of some of the side-effects of aspirin and related agents (e.g. "( Long-term acetaminophen (paracetamol) treatment causes liver and kidney ultra-structural changes during rat pregnancy.
Kulay, L; Neto, JA; Oliveira-Filho, RM; Simões, MJ; Soares, JM, 2004
)
2.17
"Acetaminophen is a widely used antipyretic and analgesic drug whose mechanism of action has recently been suggested to involve inhibitory effects on prostaglandin synthesis via a newly discovered cyclooxygenase variant (COX-3). "( Acetaminophen-sensitive prostaglandin production in rat cerebral endothelial cells.
Busija, DW; Kis, B; Simandle, SA; Snipes, JA, 2005
)
3.21
"Acetaminophen (ACE) is a common over-the-counter analgesic."( Multi-residue determination of anti-inflammatory analgesics in sera by liquid chromatography--mass spectrometry.
Cummings, MR; Miksa, IR; Poppenga, RH, 2005
)
1.05
"Acetaminophen is a widely used antipyretic drug. "( Churg-Strauss syndrome associated with hypersensitivity to acetaminophen.
Kawakami, M; Masuzawa, A; Moriguchi, M; Otsuka, M; Sugawara, H; Tabei, K; Tsuda, T; Yamada, S, 2005
)
2.01
"Acetaminophen (paracetamol) is a popular domestic analgesic and antipyretic agent with a weak anti-inflammatory action and a low incidence of adverse effects as compared with aspirin and other non-steroidal anti-inflammatory drugs. "( Conversion of acetaminophen to the bioactive N-acylphenolamine AM404 via fatty acid amide hydrolase-dependent arachidonic acid conjugation in the nervous system.
Alexander, JP; Andersson, DA; Basbaum, AI; Björk, H; Cravatt, BF; Ermund, A; Högestätt, ED; Jönsson, BA; Zygmunt, PM, 2005
)
2.13
"Acetaminophen, which is a weak inhibitor of platelet cyclooxygenase 1, has a dose-dependent antiaggregatory effect. "( Dose-dependent inhibition of platelet function by acetaminophen in healthy volunteers.
Munsterhjelm, E; Munsterhjelm, NM; Neuvonen, PJ; Niemi, TT; Rosenberg, PH; Ylikorkala, O, 2005
)
2.02
"Acetaminophen is a commonly used alternative to nonsteroidal anti-inflammatory drugs, which have recently been demonstrated to increase mortality after acute myocardial infarction (AMI)."( Role of acetaminophen in acute myocardial infarction.
Gorman, JH; Gorman, RC; Hinmon, R; Jackson, BM; Leshnower, BG; Parish, LM; Plappert, T; Sakamoto, H; Zeeshan, A, 2006
)
1.49
"Acetaminophen (APAP) is a pharmaceutical that has similar metabolic and toxic responses in rodents and humans."( Phenotypic anchoring of acetaminophen-induced oxidative stress with gene expression profiles in rat liver.
Boorman, GA; Boysen, G; Cunningham, ML; Heinloth, AN; Kosyk, O; Paules, RS; Powell, CL; Ross, PK; Rusyn, I; Schoonhoven, R; Swenberg, JA, 2006
)
1.36
"Acetaminophen overdose is a leading cause of drug-related acute liver failure in the United States. "( Acetaminophen-induced liver injury is attenuated in male glutamate-cysteine ligase transgenic mice.
Botta, D; Dabrowski, MJ; Farin, FM; Fausto, N; Kavanagh, TJ; Keener, CL; Ladiges, WC; Pierce, RH; Shi, S; Srinouanprachanh, SL; Ware, CB; White, CC, 2006
)
3.22
"Acetaminophen overdose is a frequent cause of acute liver failure. "( Severe hepatotoxicity after therapeutic doses of acetaminophen.
Cairon, E; Mian, P; Moling, O; Pristerá, R; Rimenti, G; Rizza, F, 2006
)
2.03
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug that is safe at therapeutic doses but which can precipitate liver injury at high doses. "( Mitochondrial protection by the JNK inhibitor leflunomide rescues mice from acetaminophen-induced liver injury.
Boelsterli, UA; Goh, CW; Latchoumycandane, C; Ong, MM, 2007
)
2.01
"Acetaminophen (APAP) is a widely-used analgesic and a known hepatotoxic agent. "( VEGF isoforms and receptors expression throughout acute acetaminophen-induced liver injury and regeneration.
Bartsocas, CS; Bozas, E; Garyfallidis, S; Grypioti, A; Mykoniatis, MG; Nicolopoulou-Stamati, P; Papastefanou, VP, 2007
)
2.03
"Acetaminophen is a common ingestant that is routinely screened for, with serum testing, after overdoses. "( Comparison of urine and serum testing for early detection of acetaminophen ingestion.
Bebarta, VS; MacDaniel, J; Martin, JF; Schwertner, HA, 2007
)
2.02
"Acetaminophen is a commonly used antipyretic and analgesic agent. "( Acetaminophen hepatotoxicity.
Larson, AM, 2007
)
3.23
"Acetaminophen is a safe medication that should be considered first-line therapy."( Approach to managing musculoskeletal pain: acetaminophen, cyclooxygenase-2 inhibitors, or traditional NSAIDs?
Choquette, D; Craig, BN; Davis, P; De Angelis, C; Fulthorpe, G; Habal, F; Hunt, RH; Stewart, JI; Turpie, AG, 2007
)
1.32
"Acetaminophen/hydrocodone is a common non-opioid/opioid analgesic indicated for the treatment of moderate to severe pain. "( Resolution of an oral ulcer secondary to acetaminophen/hydrocodone withdrawal.
Balasubramaniam, R; Lin, PC; White, DK; Yepes, JF,
)
1.84
"Acetaminophen is a widely prescribed analgesic/antipyretic metabolized by hepatic glucuronide and sulfate conjugation. "( Reduced distribution and clearance of acetaminophen in patients with congestive heart failure.
Abernethy, DR; Greenblatt, DJ; Ochs, HR; Schuppan, U,
)
1.85
"Acetaminophen is a remarkably safe agent when used in therapeutic doses. "( Acetaminophen overdose.
Rumack, BH, 1983
)
3.15
"Acetaminophen is an effective antipyretic and analgesic with few side effects that is toxic only in massive overdose."( Use of antipyretic analgesics in the pediatric patient.
Gladtke, E, 1983
)
0.99
"Acetaminophen is an effective analgesic and antipyretic agent with few adverse effects when used in recommended dosages. "( Acetaminophen: a practical pharmacologic overview.
Cornett, JW; Jackson, CH; MacDonald, NC, 1984
)
3.15
"Acetaminophen appears to be an adequate, although not completely, innocuous ASA substitute."( Adverse pulmonary responses to aspirin and acetaminophen in chronic childhood asthma.
Fischer, TJ; Gartside, PS; Guilfoile, TD; Kearns, GL; Kesarwala, HH; Moomaw, CJ; Winant, JG, 1983
)
1.25
"Acetaminophen is a substrate for both the TS and TL forms of PST."( Platelet phenol sulfotransferase activity: correlation with sulfate conjugation of acetaminophen.
Reiter, C; Weinshilboum, R, 1982
)
1.21
"Acetaminophen is an analgesic that is frequently used in Canada, and the occurrence of overdoses with this drug seems to be increasing. "( Treatment of acetaminophen poisoning.
Freedman, F; Sellers, EM, 1981
)
2.07
"Acetaminophen (APAP) is a widely used analgesic and antipyretic, but its disposition in human milk has not yet been reported. "( Disposition of acetaminophen in milk, saliva, and plasma of lactating women.
Berlin, CM; Ragni, M; Yaffe, SJ, 1980
)
2.06
"Acetaminophen is a widely available and frequently recommended over-the-counter analgesic and antipyretic. "( Acetaminophen hepatotoxicity and overdose.
Bailey, BO, 1980
)
3.15
"Acetaminophen is a mild analgesic and antipyretic agent that is safe and effective when taken in therapeutic doses. "( Modulation of macrophage functioning abrogates the acute hepatotoxicity of acetaminophen.
Gardner, CR; Jollow, DJ; Laskin, DL; Price, VF, 1995
)
1.96
"Acetaminophen is a suitable substitute for aspirin for its analgesic or antipyretic uses in patients in whom aspirin is contraindicated (e.g., prepartum patients, children with febrile conditions, patients with asthma, peptic ulcer, gouty arthritis, hyperuricemia, hemophilia or other bleeding disorders, and those taking anticoagulants)."( Acetylsalicylic acid and acetaminophen.
Kacso, G; Terézhalmy, GT, 1994
)
1.31
"Acetaminophen (APAP) is a widely used analgesic and antipyretic drug that causes massive centrilobular hepatic necrosis at high doses, leading to death. "( Stimulated hepatic tissue repair underlies heteroprotection by thioacetamide against acetaminophen-induced lethality.
Bucci, TJ; Chanda, S; Mangipudy, RS; Mehendale, HM; Warbritton, A, 1995
)
1.96
"Acetaminophen (APAP) is a commonly used analgesic and antipyretic agent which, in high doses, causes liver and kidney necrosis in man and animals. "( Gender-related differences in susceptibility to acetaminophen-induced protein arylation and nephrotoxicity in the CD-1 mouse.
Cohen, SD; Hart, SG; Hoivik, DJ; Khairallah, EA; Manautou, JE; Tveit, A, 1995
)
1.99
"Acetaminophen is a safe antipyretic therapy prescribed in children. "( [Paracetamol and other antipyretic analgesics: optimal doses in pediatrics].
Stamm, D, 1994
)
1.73
"Acetaminophen poisoning is a significant medical problem in the United States and is frequently managed by family physicians. "( Management of acetaminophen toxicity.
Fuller, SH; Larsen, LC, 1996
)
2.1
"Acetaminophen is a metabolite of phenacetin, a drug that has been implicated as a causal agent in the development of renal and bladder cancer. "( Acetaminophen and renal and bladder cancer.
Derby, LE; Jick, H, 1996
)
3.18
"Acetaminophen is an analgesic and antipyretic which causes liver toxicity in humans and experimental animals with overdose. "( Evidence suggesting the 58-kDa acetaminophen binding protein is a preferential target for acetaminophen electrophile.
Cohen, SD; Hoivik, DJ; Khairallah, EA; Manautou, JE; Mankowski, DC; Tveit, A, 1996
)
2.02
"Acetaminophen (APAP) is an analgesic and antipyretic agent which may cause hepatotoxicity and nephrotoxicity with overdose in man and laboratory animals. "( Protein arylation precedes acetaminophen toxicity in a dynamic organ slice culture of mouse kidney.
Brendel, K; Cohen, SD; Fisher, RL; Gandolfi, AJ; Hoivik, DJ; Khairallah, EA, 1996
)
2.03
"Acetaminophen poisoning is a major cause of hospital admission and has been extensively reviewed. "( Acetaminophen poisoning in late pregnancy. A case report.
Chao, HT; Hung, JH; Lee, WL; Wang, PH; Yang, MJ; Yang, ML, 1997
)
3.18
"Acetaminophen is a mild analgesic and antipyretic agent known to cause centrilobular hepatic necrosis at toxic doses. "( Role of nitric oxide in acetaminophen-induced hepatotoxicity in the rat.
DeGeorge, GL; Gardner, CR; Heck, DE; Laskin, DL; Laskin, JD; Thomas, PE; Yang, CS; Zhang, XJ, 1998
)
2.05
"Acetaminophen (AP) is a widely-used analgesic agent that has been linked to human liver and kidney disease with prolonged or high-dose usage. "( Role of CYP2A5 and 2G1 in acetaminophen metabolism and toxicity in the olfactory mucosa of the Cyp1a2(-/-) mouse.
Ding, X; Genter, MB; Gu, J; Liang, HC; McKinnon, RA; Nebert, DW; Negishi, M, 1998
)
2.04
"Acetaminophen (APAP) is a common analgesic and antipyretic compound which, when administered in high doses, has been associated with significant morbidity and mortality, secondary to hepatic toxicity. "( Role of neutrophils in hepatotoxicity induced by oral acetaminophen administration in rats.
Kokoska, ER; Miller, TA; Nadig, DE; Smith, GS; Solomon, H; Tiniakos, DG, 1998
)
1.99
"Acetaminophen is a phenolic compound which produces a clear inhibitory dose-response curve with peroxynitrite in its range of clinical effectiveness."( A new screening method to detect water-soluble antioxidants: acetaminophen (Tylenol) and other phenols react as antioxidants and destroy peroxynitrite-based luminol-dependent chemiluminescence.
Qazi, N; Sacks, M; Van Dyke, K,
)
1.09
"Acetaminophen is a commonly used analgesic/antipyretic that also contains a p-phenol."( Acetaminophen alters estrogenic responses in vitro: stimulation of DNA synthesis in estrogen-responsive human breast cancer cells.
Harnagea-Theophilus, E; Miller, MR, 1998
)
2.46
"Acetaminophen (APAP) is a widely used analgesic and antipyretic that can lead to severe liver damage when taken at excessive doses. "( Modulation of serum growth factor signal transduction in Hepa 1-6 cells by acetaminophen: an inhibition of c-myc expression, NF-kappaB activation, and Raf-1 kinase activity.
Boulares, HA; Cohen, SD; Giardina, C; Khairallah, EA; Navarro, CL, 1999
)
1.98
"Acetaminophen overdose is a common intoxication in daily practice the standard treatment is N-acetylcysteine (NAC) antidotal therapy for possible poisoning. "( Hemodialysis as adjunctive therapy for severe acetaminophen poisoning: a case report.
Deng, JF; Tsai, WJ; Wu, ML; Yang, CC, 1999
)
2
"Acetaminophen is a widely used analgesic and anti-inflammatory drug that is considered a good alternative to salicylates for individuals who cannot tolerate salicylates. "( Acetaminophen inhibits iNOS gene expression in RAW 264.7 macrophages: differential regulation of NF-kappaB by acetaminophen and salicylates.
Hong, JH; Hur, GM; Kim, YM; Lee, JH; Lee, YS; Lim, JH; Ryu, YS; Seok, JH, 2000
)
3.19
"Acetaminophen is a widely used nonprescription analgesic and antipyretic agent. "( Acetaminophen hepatotoxicity: An update.
Barve, S; Devalarja, R; McClain, CJ; Price, S; Shedlofsky, S,
)
3.02
"Acetaminophen (paracetamol) is an analgesic antipyretic drug with no antiinflammatory effects and is widely used worldwide. "( Paracetamol (acetaminophen) hypersensitivity.
Camo, IP; Cosmes, EL; Cuevas, M; de Paramo, BJ; Gancedo, SQ; Martin, JA, 2000
)
2.12
"Acetaminophen is a phenol with antioxidant properties, but little is known about its actions on the mammalian myocardium and coronary circulation. "( Coronary and myocardial effects of acetaminophen: protection during ischemia-reperfusion.
McConnell, P; Merrill, G; Powell, S; Vandyke, K, 2001
)
2.03
"Acetaminophen was found to be a good reducing agent of both oCOX-1 and hCOX-2."( Mechanism of acetaminophen inhibition of cyclooxygenase isoforms.
Ouellet, M; Percival, MD, 2001
)
1.4
"Acetaminophen is a widely used analgesic, which has exhibited evidence of estrogenic activity in estrogen-receptor positive human breast cancer cells. "( Acetaminophen elicits anti-estrogenic but not estrogenic responses in the immature mouse.
Patel, R; Rosengren, RJ, 2001
)
3.2
"Acetaminophen is a common cause of poisoning in children. "( Is chronic poisoning with acetaminophen in children a frequent occurrence in Toronto?
Bailey, B; Kapur, BM; Koren, G; Lalkin, A, 2001
)
2.05
"Acetaminophen is a widely used over-the-counter drug that causes severe hepatic damage upon overdose. "( Reduction of toxic metabolite formation of acetaminophen.
Hazai, E; Monostory, K; Vereczkey, L, 2002
)
2.02
"Acetaminophen is a widely used analgesic and antipyretic drug that exhibits toxicity at high doses to the liver and kidneys. "( Acetaminophen induces a caspase-dependent and Bcl-XL sensitive apoptosis in human hepatoma cells and lymphocytes.
Boulares, AH; Cuvillier, O; Smulson, ME; Stoica, BA; Zoltoski, AJ, 2002
)
3.2
"Acetaminophen (APAP) is a common overdosed medication. "( Utility of acetaminophen screening in unsuspected suicidal ingestions.
Chiang, WK; Lucanie, R; Reilly, R, 2002
)
2.15
"Acetaminophen is an effective mild analgesic and antipyretic agent. "( Acetaminophen.
Ameer, B; Greenblatt, DJ, 1977
)
3.14
"Acetaminophen is a readily available, widely used drug which has been thought safer than aspirin. "( Acute acetaminophen intoxication.
Austin, F; Carloss, H; Forrester, J; Fuson, T, 1978
)
2.18
"Acetaminophen is a safe drug when used properly, but overdosage can cause severe toxicity."( Acetaminophen poisoning.
Calvert, LJ; Linder, CW, 1978
)
2.42
"Acetaminophen (AA) is a drug whose biotransformation by sulfation is easily saturated. "( Homeostasis of sulfate and 3'-phosphoadenosine 5'-phosphosulfate in rats after acetaminophen administration.
Kim, HJ; Klaassen, CD; Madhu, C; Rozman, P, 1992
)
1.95
"Acetaminophen is a popular nonprescription analgesic that is often taken in overdose by adolescents during suicidal gestures. "( Acetaminophen overdose as a suicidal gesture: a survey of adolescents' knowledge of its potential for toxicity.
Diaco, D; Harris, E; Moreno, A; Myers, WC; Otto, TA, 1992
)
3.17
"Acetaminophen is an antipyretic and analgesic drug frequently prescribed in children. "( [Optimal dose of acetaminophen in children].
Badoual, J; Olive, G; Pons, G,
)
1.91
"Acetaminophen is an exception to the recalcitrance of arylamides to such bioactivation processes because it also possesses the phenolic functional group, which, like the arylamine group, is oxidized by certain reactive oxygen species."( Metabolic activation and nucleic acid binding of acetaminophen and related arylamine substrates by the respiratory burst of human granulocytes.
Corbett, BR; Corbett, MD; Hannothiaux, MH; Quintana, SJ,
)
1.11
"Acetaminophen appears to be an uncommon cause of fixed drug eruption, with a tendency for lesions to appear at the same or at different sites in flares, perhaps because of a prolonged refractory period and the tendency to become completely refractory in some locations."( Wandering fixed drug eruption: a mucocutaneous reaction to acetaminophen.
Baker, GF; Guin, JD; Haynie, LS; Jackson, D, 1987
)
1.24
"Acetaminophen is a common drug used in pregnancy. "( Maternal acetaminophen overdose at 15 weeks of gestation.
Gabbe, SG; Landon, MB; Ludmir, J; Main, DM, 1986
)
2.13
"Acetaminophen (Tylenol) is a widely used analgesic/antipyretic drug which is enzymatically bioactivated, or toxified, by the cytochromes P-450 to a hepatotoxic reactive intermediary metabolite. "( Delayed enhancement of acetaminophen hepatotoxicity by general anesthesia using diethyl ether or halothane.
Ku, MS; Ramji, P; Wells, PG, 1986
)
2.02
"Acetaminophen is a popular analgesic and antipyretic medication that has few side effects and little toxicity when used in recommended doses. "( Management of acute acetaminophen overdose.
Hall, AH; Rumack, BH, 1986
)
2.04
"Acetaminophen is a widely used, nonprescription analgesic and antipyretic drug which can cause severe hepatic and renal cellular necrosis. "( Repetitive microvolumetric sampling and analysis of acetaminophen and its toxicologically relevant metabolites in murine plasma and urine using high performance liquid chromatography.
To, EC; Wells, PG,
)
1.82

Effects

Acetaminophen has a remarkable safety profile when prescribed in proper therapeutic doses. International consensus panels recommend its use as first-line therapy in dosages of up to 4 g/day.

Acetaminophen (APAP) has recently been found to target COX-3, a newly identified COX isozyme. The mechanism is not well understood. It has been associated with asthma in cross-sectional studies and a birth cohort.

ExcerptReferenceRelevance
"Acetaminophen has a remarkable safety profile when prescribed in proper therapeutic doses, but hepatotoxicity can occur when misused or after an overdose. "( Late Diagnosis of Paracetamol Poisoning is Always Lethal in Young Adult.
Aamir, M; Fatima, S; Naz, S, 2020
)
2
"Acetaminophen has a reasonable safety profile when consumed in therapeutic doses. "( Protective effect of pioglitazone, a PPARγ agonist against acetaminophen-induced hepatotoxicity in rats.
Candasamy, M; Chellappan, DK; Dua, K; Gubbiyappa, KS; Gupta, G; Krishna, G, 2014
)
2.09
"Acetaminophen has a good risk/benefit ratio that has prompted international consensus panels to recommend its use as first-line therapy in dosages of up to 4 g/day."( Acetaminophen as symptomatic treatment of pain from osteoarthritis.
Bertin, P; Jolivet-Landreau, I; Keddad, K, 2004
)
2.49
"Acetaminophen has been shown to reduce postoperative opiate burden, and may provide similar efficacy for closure of the patent ductus arteriosus (PDA) as nonsteroidal anti-inflammatory drugs (NSAIDs)."( Racing against time: leveraging preclinical models to understand pulmonary susceptibility to perinatal acetaminophen exposures.
Dobrinskikh, E; Jensen, EA; McCulley, DJ; McKenna, S; Sherlock, LG; Sucre, JMS; Wright, CJ, 2022
)
1.66
"Acetaminophen (APAP) use has been associated with blunted vaccine immune responses. "( Impact of acetaminophen on the efficacy of immunotherapy in cancer patients.
Bessede, A; Cabart, M; Chaibi, A; Chaput, N; Cousin, S; Danlos, FX; Guégan, JP; Italiano, A; Khettab, M; Mahon, FX; Marabelle, A; Nafia, I; Peyraud, F; Rey, C; Roubaud, G; Soria, JC; Spalato, M, 2022
)
2.57
"Acetaminophen intoxication has become the leading cause of acute liver failure (ALF) in Europe and the USA."( Early biomarkers predicting outcome in a porcine model of acetaminophen intoxication: A pilot study.
Königsrainer, A; Lischner, U; Morgalla, M; Peter, A; Schenk, M; Thiel, C; Thiel, K, 2022
)
2.41
"Acetaminophen has been evaluated in horses for treatment of musculoskeletal pain but not as an antipyretic."( Pharmacokinetics and efficacy of orally administered acetaminophen (paracetamol) in adult horses with experimentally induced endotoxemia.
Council-Troche, RM; Davis, JL; McKenzie, HC; Mercer, MA; Messenger, KM; Schaefer, E; Werre, SR, 2023
)
2.6
"Acetaminophen toxicity has been associated with elevation of microRNAs. "( Circulating microRNA Profiles in Acetaminophen Toxicity.
Ambros, V; Carreiro, S; Chapman, B; Lee, R; Marvel-Coen, J, 2020
)
2.28
"Acetaminophen has been increasingly used for the treatment of cancer-related pain in Japan since the revision of the package insert on January 21, 2011. "( Risk Factors for Acetaminophen-induced Liver Injury: A Single-center Study from Japan.
Hidaka, N; Kaji, Y; Matsuoka, I; Takatori, S; Tanaka, A; Tanaka, M, 2020
)
2.34
"Acetaminophen has shown a gradual increase in detection in surface waters. "( Activated hydrochar produced from brewer's spent grain and its application in the removal of acetaminophen.
Bergamasco, R; de Araújo, TP; de Barros, MASD; Quesada, HB; Vareschini, DT, 2020
)
2.22
"Acetaminophen (APAP) has hepatotoxic potential when overdosed. "( Hepatic Adaptation to Therapeutic Doses of Acetaminophen: An Exploratory Study in Healthy Individuals.
Arakawa, N; Aso, M; Kumagai, Y; Maeda, M; Maekawa, K; Ochiai, M; Ohno, Y; Saito, Y; Sakamoto, Y; Song, I; Tanaka, R, 2020
)
2.26
"Acetaminophen has a remarkable safety profile when prescribed in proper therapeutic doses, but hepatotoxicity can occur when misused or after an overdose. "( Late Diagnosis of Paracetamol Poisoning is Always Lethal in Young Adult.
Aamir, M; Fatima, S; Naz, S, 2020
)
2
"Acetaminophen has been widely used as an analgesic agent after various types of surgery. "( The feasibility and safety in using acetaminophen with fentanyl for pain control after liver resection with regards to liver function: A prospective single-center pilot study in Japan.
Adachi, T; Eguchi, S; Hara, T; Hidaka, M; Ichinomiya, T; Kamada, N; Nakashima, M; Ohyama, K; Soyama, A, 2021
)
2.34
"Acetaminophen has become a novel treatment option for patent ductus arteriosus closure in premature infants. "( Acetaminophen in late pregnancy and potential for in utero closure of the ductus arteriosus-a pharmacokinetic evaluation and critical review of the literature.
de Vrijer, B; Eastabrook, G; Garcia-Bournissen, F; Hutson, JR; Lurie, A, 2021
)
3.51
"Acetaminophen (APAP) has been associated with the development of atopic diseases. "( Prenatal exposure to acetaminophen increases the risk of atopic dermatitis in children: A nationwide nested case-control study in Taiwan.
Bai, YM; Chang, YT; Chen, MH; Chen, TJ; Dai, YX; Li, CY; Tsai, SJ, 2021
)
2.38
"Acetaminophen has been increasingly used in treating patent ductus arteriosus (PDA) in preterm neonates. "( Intravenous acetaminophen (at 15 mg/kg/dose every 6 hours) in critically ill preterm neonates with patent ductus arteriosus: A prospective study.
Al Ansari, E; Al Jufairi, M; Al Madhoob, A; Al Marzooq, R; Hasan, SJR; Hubail, Z; Sridharan, K, 2021
)
2.44
"Acetaminophen use has been reported to be associated with an increased risk of ASD."( Endocannabinoid System Dysregulation from Acetaminophen Use May Lead to Autism Spectrum Disorder: Could Cannabinoid Treatment Be Efficacious?
Antonucci, N; Brigida, AL; Gould, GG; Schultz, S; Siniscalco, D, 2021
)
1.61
"Acetaminophen (AP) has been frequently detected in different environments due to its wide usage as a common analgesic and antipyretic pharmaceutical. "( Two transformation pathways of Acetaminophen with Fe
Gao, J; Sun, Z; Tong, Y; Wang, X, 2021
)
2.35
"Acetaminophen has emerged as an alternative to indomethacin and ibuprofen with less significant adverse effects, but there is no consensus regarding its use."( Acetaminophen Therapy for Persistent Patent Ductus Arteriosus.
Amin, S; Manalastas, M; Nicoski, P; Weiss, MG; Zaheer, F, 2021
)
2.79
"Acetaminophen (APAP) has been shown to inhibit lipid peroxidation and, thus, may be renal protective in patients with sepsis."( Effect of Acetaminophen on the Prevention of Acute Kidney Injury in Patients With Sepsis.
Aljuhani, O; Bakhsh, H; Erstad, BL; Patanwala, AE, 2018
)
1.6
"As acetaminophen has few side effects of gastrointestinal and renal systems, its use is recommended for the control of long term pain man- agement The side effects of acetaminophen and their management are discussed."( [Side Effects of Acetaminophen and their Management].
Saeki, S, 2016
)
1.29
"Acetaminophen has been shown to influence cognitive and affective behavior possibly via alterations in serotonin function. "( Acetaminophen enhances the reflective learning process.
Beevers, CG; Carver, CS; Hamilton, B; Koslov, S; Pearson, R; Shumake, J, 2018
)
3.37
"Acetaminophen has long been assumed to selectively alleviate physical pain, but recent research has started to reveal its broader psychological effects. "( Acetaminophen influences social and economic trust.
Krajbich, I; Roberts, ID; Way, BM, 2019
)
3.4
"Acetaminophen has been commonly used as the fi rst-line treatment for OA pain and cLBP, but its long-term use is not recommended based on recent evidence."( Evidence-Based Recommendations on the Pharmacological Management of Osteoarthritis and Chronic Low Back Pain: An Asian Consensus
Ip, AKK; Murakami, T; Shin, HK; Sun, WZ; Tam, CK; Ushida, T; Wang, JH; Williamson, OD; Yabuki, S, 2019
)
1.24
"Acetaminophen has been suggested as the analgesic of choice during orthodontic treatment as it showed no effect on orthodontic tooth movement in previous animal studies."( Comparison of the effects of ibuprofen and acetaminophen on PGE2 levels in the GCF during orthodontic tooth movement: a human study.
Ganeshkar, SV; Hegde, S; Patil, AK; Shetty, N, 2013
)
1.37
"Acetaminophen (APAP) has been used as a probe drug to investigate drug-induced liver injury (DILI). "( Use of a systems model of drug-induced liver injury (DILIsym(®)) to elucidate the mechanistic differences between acetaminophen and its less-toxic isomer, AMAP, in mice.
Howell, BA; Siler, SQ; Watkins, PB, 2014
)
2.06
"Acetaminophen has a reasonable safety profile when consumed in therapeutic doses. "( Protective effect of pioglitazone, a PPARγ agonist against acetaminophen-induced hepatotoxicity in rats.
Candasamy, M; Chellappan, DK; Dua, K; Gubbiyappa, KS; Gupta, G; Krishna, G, 2014
)
2.09
"Acetaminophen overdose has become the leading cause of acute liver failure in the US."( Transcriptomic studies on liver toxicity of acetaminophen.
Cheng, F; Figler, B; Toska, E; Zagorsky, R, 2014
)
1.38
"Oral acetaminophen has gained increasing attention as an alternative pharmaceutical agent for PDA closure in premature infants, although safety concerns remain."( What is new for patent ductus arteriosus management in premature infants in 2015?
Laughon, MM; Perez, KM, 2015
)
0.87
"Acetaminophen has been used as a tool for clinical and nonclinical experimental designs that evaluate gastric emptying because acetaminophen is not absorbed in stomach but efficiently absorbed from the small intestine. "( Acetaminophen absorption kinetics in altered gastric emptying: establishing a relevant pharmacokinetic surrogate using published data.
Srinivas, NR, 2015
)
3.3
"Acetaminophen overuse has been linked to liver injury."( Patterns of acetaminophen medication use associated with exceeding the recommended maximum daily dose.
Battista, D; Kaufman, DW; Kelly, JP; Malone, MK; Rohay, JM; Shiffman, S; Weinstein, RB, 2015
)
2.24
"Acetaminophen has recently been recognized as having impacts that extend into the affective domain. "( Acetaminophen attenuates error evaluation in cortex.
Handy, TC; Heine, SJ; Inzlicht, M; Kam, JW; Randles, D, 2016
)
3.32
"IV acetaminophen has also been shown to be effective in alleviating pain for surgical procedures."( A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty.
Abubaker, H; Ahrendtsen, L; Demas, E; Gupta, A, 2016
)
1.16
"Acetaminophen has several pharmacologic properties that suggest it could be carcinogenic in human beings. "( Use of acetaminophen in relation to the occurrence of cancer: a review of epidemiologic studies.
Weiss, NS, 2016
)
2.33
"Acetaminophen has been studied for acute migraine treatment."( Efficacy and tolerability of coadministration of rizatriptan and acetaminophen vs rizatriptan or acetaminophen alone for acute migraine treatment.
Diamond, M; Diamond, S; Freitag, F; Janssen, I; Rodgers, A; Skobieranda, F, 2008
)
1.31
"Acetaminophen has pro-survival effects on neurons in culture. "( Acetaminophen inhibits neuronal inflammation and protects neurons from oxidative stress.
Grammas, P; Tripathy, D, 2009
)
3.24
"Acetaminophen has been associated with asthma and is in part metabolised via the glutathione pathway. "( Prenatal acetaminophen exposure and risk of wheeze at age 5 years in an urban low-income cohort.
Ali, D; Barr, RG; Chew, GL; Garfinkel, RS; Goldstein, IF; Miller, RL; Perera, FP; Perzanowski, MS; Tang, D, 2010
)
2.22
"Acetaminophen has been tried in stroke patients to produce hypothermia so that injury following cerebral ischemia can be reduced."( Endothelin-A receptor antagonist BQ123 potentiates acetaminophen induced hypothermia and reduces infarction following focal cerebral ischemia in rats.
Briyal, S; Gulati, A, 2010
)
1.33
"Acetaminophen has significant fentanyl-sparing effects and reduces side effects when combined with fentanyl in intravenous parent-/nurse-controlled analgesia for postoperative pediatric pain management."( Fentanyl-sparing effect of acetaminophen as a mixture of fentanyl in intravenous parent-/nurse-controlled analgesia after pediatric ureteroneocystostomy.
Cho, JS; Hong, JY; Kil, HK; Kim, WO; Koo, BN; Suk, EH, 2010
)
2.1
"Acetaminophen has neuroprotective properties in animal models."( Randomized, double-blind, placebo-controlled trial of acetaminophen for preventing mood and memory effects of prednisone bursts.
Brown, ES; Denniston, D; Desai, S; Gabrielson, B; Khan, DA; Khanani, S,
)
1.1
"Acetaminophen has been hypothesized to increase the risk of asthma and allergic disease, and geohelminth infection to reduce the risk, but evidence from longitudinal cohort studies is lacking."( The role of acetaminophen and geohelminth infection on the incidence of wheeze and eczema: a longitudinal birth-cohort study.
Alem, A; Amberbir, A; Britton, J; Davey, G; Medhin, G; Venn, A, 2011
)
2.19
"Acetaminophen has unique analgesic and antipyretic properties. "( Intravenous acetaminophen.
Jahr, JS; Lee, VK, 2010
)
2.18
"Oral acetaminophen has been shown to be safe and effective in a variety of acute pain models."( Continuous multimechanistic postoperative analgesia: a rationale for transitioning from intravenous acetaminophen and opioids to oral formulations.
Labhsetwar, SA; Pergolizzi, JV; Raffa, RB; Tallarida, R; Taylor, R, 2012
)
1.05
"Acetaminophen has been used as an analgesic for more than a hundred years, but its mechanism of action has remained elusive. "( Effects of the analgesic acetaminophen (Paracetamol) and its para-aminophenol metabolite on viability of mouse-cultured cortical neurons.
DeSilva, M; Gu, TT; Qiang, M; Schultz, S; Whang, K, 2012
)
2.13
"Acetaminophen has no effect on the progression of renal damage in adenine-induced renal failure model rats. "( Effect of acetaminophen on the progression of renal damage in adenine induced renal failure model rats.
Arimizu, K; Chuang, VT; Hirata, S; Irie, T; Ishitsuka, Y; Kadowaki, D; Kitamura, K; Maruyama, T; Narita, Y; Otagiri, M; Sumikawa, S; Taguchi, K, 2012
)
2.22
"Acetaminophen has recently been identified as a promising snake toxicant."( Risk assessment of an acetaminophen baiting program for chemical control of brown tree snakes on Guam: evaluation of baits, snake residues, and potential primary and secondary hazards.
Eisemann, JD; Hurley, JC; Johnston, JJ; Kohler, DJ; Primus, TM; Savarie, PJ, 2002
)
1.35
"Acetaminophen may have been blunted some adverse effects."( Adverse effects of superactivated charcoal administered to healthy volunteers.
Sato, RL; Sumida, SM; Wong, JJ; Yamamoto, LG, 2002
)
1.04
"Acetaminophen (APAP) has recently been found to target COX-3, a newly identified COX isozyme. "( Acetaminophen modifies hippocampal synaptic plasticity via a presynaptic 5-HT2 receptor.
Bazan, NG; Chen, C, 2003
)
3.2
"Acetaminophen use has been associated with asthma in cross-sectional studies and a birth cohort."( Prospective study of acetaminophen use and newly diagnosed asthma among women.
Barr, RG; Camargo, CA; Curhan, GC; Schwartz, J; Somers, SC; Speizer, FE; Stampfer, MJ; Wentowski, CC, 2004
)
1.36
"Acetaminophen metabolites have been shown to affect rat liver microsomal Ca2+ stores, but the mechanism is not well understood."( Acetaminophen alters microsomal ryanodine Ca2+ channel in HepG2 cells overexpressing CYP2E1.
Braszko, JJ; Holownia, A, 2004
)
2.49
"Acetaminophen has a good risk/benefit ratio that has prompted international consensus panels to recommend its use as first-line therapy in dosages of up to 4 g/day."( Acetaminophen as symptomatic treatment of pain from osteoarthritis.
Bertin, P; Jolivet-Landreau, I; Keddad, K, 2004
)
2.49
"Acetaminophen has been used safely and effectively for many years to manage pain and/or fever in patients of all ages. "( The therapeutic use of acetaminophen in patients with liver disease.
Benson, GD; Koff, RS; Tolman, KG,
)
1.88
"Acetaminophen granules have been formed by a melt granulation process with the objective of retarding drug release for prolonged action formulations. "( Modification of drug release from acetaminophen granules by melt granulation technique - consideration of release kinetics.
Okor, RS; Uhumwangho, MU, 2006
)
2.06
"Acetaminophen has been widely used for > 50 years in the treatment of pain and fever and provides for the safe and effective relief of these symptoms. "( Acetaminophen safety and hepatotoxicity--where do we go from here?
Amar, PJ; Schiff, ER, 2007
)
3.23
"Acetaminophen has become a very popular over-the-counter analgesic in some countries and as a result it is used increasingly as an agent for self-poisoning. "( The treatment of acetaminophen poisoning.
Critchley, JA; Prescott, LF, 1983
)
2.05
"Acetaminophen has been in use since the 1890s."( History of antipyretic analgesic therapy.
Haas, H, 1983
)
0.99
"Acetaminophen has variable effects on prostaglandin synthesis depending on the tissue preparation used. "( Tissue selectivity and variability of effects of acetaminophen on arachidonic acid metabolism.
Capetola, RJ; Fuller, BL; Levinson, SL; Marinan, BA; Rosenthale, ME; Tolman, EL, 1983
)
1.96
"Acetaminophen has been one of the most serious electrochemical interferences to oxidase-based amperometric biosensors that measure H2O2. "( Elimination of the acetaminophen interference in an implantable glucose sensor.
Hu, Y; Moatti-Sirat, D; Poitout, V; Reach, G; Wilson, GS; Zhang, Y, 1994
)
2.06
"Acetaminophen has no effect on the rate of tooth movement in rabbits undergoing orthodontic treatment."( The effect of acetaminophen on tooth movement in rabbits.
Acs, G; Cisneros, GJ; Roche, JJ, 1997
)
1.38
"Acetaminophen has no antiestrogenic/estrogenic activity in mice or rats uteri."( Acetaminophen-induced proliferation of breast cancer cells involves estrogen receptors.
DeGeorge, GL; Gadd, SL; Harnagea-Theophilus, E; Knight-Trent, AH; Miller, MR, 1999
)
2.47
"Acetaminophen has similar analgesic and antipyretic properties to nonsteroidal antiinflammatory drugs (NSAIDs), which act via inhibition of cyclooxygenase enzymes. "( Mechanism of acetaminophen inhibition of cyclooxygenase isoforms.
Ouellet, M; Percival, MD, 2001
)
2.12
"Acetaminophen half-life has not been studied in patients receiving the antidote N -acetylcysteine."( The value of plasma acetaminophen half-life in antidote-treated acetaminophen overdosage.
Bondesen, S; Christensen, E; Ott, P; Schiødt, FV, 2002
)
1.36
"Acetaminophen has antipyretic and analgesic properties yet differs from the nonsteroidal antiinflammatory drugs and inhibitors of prostaglandin H synthase (PGHS)-2 by exhibiting little effect on platelets or inflammation. "( Determinants of the cellular specificity of acetaminophen as an inhibitor of prostaglandin H(2) synthases.
Aronoff, DM; Boutaud, O; Marnett, LJ; Oates, JA; Richardson, JH, 2002
)
2.02
"Acetaminophen has recently been reported to protect against drug damage to gastric mucosa in vivo. "( Cytoprotective effect of acetaminophen against taurocholate-induced damage to rat gastric monolayer cultures.
Hiraishi, H; Ivey, KJ; Ota, S; Razandi, M; Sekhon, S; Terano, A, 1988
)
2.02
"Acetaminophen has been shown to be cataractogenic in mice and rabbits. "( Metabolic evidence for the involvement of enzymatic bioactivation in the cataractogenicity of acetaminophen in genetically susceptible (C57BL/6) and resistant (DBA/2) murine strains.
Basu, PK; Lubek, BM; Wells, PG, 1988
)
1.94
"Acetaminophen has been reported either to prolong or not to affect the clearance of chloramphenicol. "( Interaction between chloramphenicol and acetaminophen.
Aranda, JV; Beharry, K; Davis, DJ; Martin, SR; Rex, J; Spika, JS, 1986
)
1.98
"Acetaminophen has been proposed as an agent which protects the gastric mucosa against damage induced by aspirin and other non-steroidal anti-inflammatory agents. "( Effect of acetaminophen on human gastric mucosal injury caused by ibuprofen.
Lanza, FL; Nelson, RS; Rack, MF; Royer, GL; Schwartz, JH; Seckman, CE, 1986
)
2.12

Actions

Acetaminophen (APAP) can cause life-threatening renal damages and there is no specific treatment for APAP-induced renal damage. In excess of 25 billion doses are used annually as a nonprescription medication in the U.S.

ExcerptReferenceRelevance
"Acetaminophen (APAP) can cause acute liver failure, but treatment options are still limited. "( Kahweol Protects against Acetaminophen-Induced Hepatotoxicity in Mice through Inhibiting Oxidative Stress, Hepatocyte Death, and Inflammation.
Kim, GM; Kim, JY; Leem, J, 2022
)
2.47
"Acetaminophen overdoses cause cell injury in the liver. "( Intracellular Quantum Sensing of Free-Radical Generation Induced by Acetaminophen (APAP) in the Cytosol, in Mitochondria and the Nucleus of Macrophages.
Elias Llumbet, A; Mzyk, A; Nie, L; Nusantara, AC; Schirhagl, R; Sharmin, R; Woudstra, W; Wu, K, 2022
)
2.4
"Acetaminophen plays a key role in first-line Covid-19 cure as a supportive therapy of fever and pain. "( Sensitive electrochemical assay of acetaminophen based on 3D-hierarchical mesoporous carbon nanosheets.
Caddeo, F; Chen, J; Huang, Q; Huang, S; Jin, M; Liu, X; Liu, Z; Shui, L; Xie, P; Yan, Y, 2023
)
2.63
"Acetaminophen (APAP) may cause acute liver injury with therapeutic doses in high-risk conditions such as chronic alcohol consumption or malnutrition. "( Association between adverse outcomes of hepatitis A and acetaminophen use: A population-based cohort study.
Chung, JW; Jang, ES; Kim, JW; Park, GC, 2023
)
2.6
"Acetaminophen was found to increase the AUB with an estimated median difference of 15 (95% CI, 5-25) mm Hg × minutes (P = .003)."( Effect of Intravenous Acetaminophen on Mean Arterial Blood Pressure: A Post Hoc Analysis of the EFfect of Intravenous ACetaminophen on PosToperative HypOxemia After Abdominal SurgeRy Trial.
AlGharrash, A; Bakal, O; Bravo, M; Essber, H; Mascha, EJ; Mosteller, L; Pu, X; Rivas, E; Rodriguez-Patarroyo, F; Turan, A, 2021
)
1.66
"Acetaminophen is a common cause of intentional and inadvertent overdoses among children and adolescents worldwide. "( Clinical Characteristics, Outcomes, Disposition, and Acute Care of Children and Adolescents Treated for Acetaminophen Toxicity.
Bostwick, JM; Lewis, CP; Romanowicz, M; Shekunov, J; Vande Voort, JL, 2021
)
2.28
"Acetaminophen is a common cause of poisoning and liver injury worldwide; however, patient stratification is suboptimal. "( Plasma procalcitonin may be an early predictor of liver injury in acetaminophen poisoning: A prospective cohort study.
Deye, N; Diallo, A; Gourlain, H; Goury, A; Malissin, I; Mégarbane, B; Nuzzo, A; Péron, N; Salem, S; Vicaut, E; Voicu, S, 2021
)
2.3
"Acetaminophen does not inhibit this synthesis at the inflammatory site."( Pharmacology of Acetaminophen, Nonsteroidal Antiinflammatory Drugs, and Steroid Medications: Implications for Anesthesia or Unique Associated Risks.
Candido, KD; Knezevic, NN; Perozo, OJ, 2017
)
1.52
"Acetaminophen (APAP) can cause erroneously high readings in real-time continuous glucose monitoring (rtCGM) systems. "( Resistance to Acetaminophen Interference in a Novel Continuous Glucose Monitoring System.
Balo, AK; Calhoun, P; Hughes, J; Johnson, TK; Price, D, 2018
)
2.28
"The acetaminophen-mediated increase in NF-κB was significantly reversed by lophirones B and C."( Lophirones B and C halt acetaminophen hepatotoxicity by upregulating redox transcription factor Nrf-2 through Akt, PI3K, and PKC pathways.
Ajala-Lawal, RA; Ajiboye, TO; Aliyu, NO, 2018
)
1.27
"Acetaminophen is a common cause of acute liver failure in pediatrics. "( A case report of full recovery from severe cerebral edema secondary to acetaminophen-induced hepatotoxicity in a 13 year old girl.
Austin, EB; Crouse, BA; Hobbs, H; Lobos, AT, 2018
)
2.16
"Acetaminophen is a leading cause of acute liver failure (ALF). "( Candidate gene polymorphisms in patients with acetaminophen-induced acute liver failure.
Court, MH; Greenblatt, DJ; Hazarika, S; Lee, WM; Peter, I; Vasiadi, M, 2014
)
2.1
"Acetaminophen is known to cause hepatoxicity via the formation of a reactive metabolite, N-acetyl p-benzoquinone imine (NAPQI), as a result of covalent binding to liver proteins. "( Absolute quantitation of NAPQI-modified rat serum albumin by LC-MS/MS: monitoring acetaminophen covalent binding in vivo.
LeBlanc, A; Roy, R; Shiao, TC; Sleno, L, 2014
)
2.07
"Acetaminophen did not increase erythrocyte-bound bilirubin, and the addition of tert-butyl-p-hydroxyanisole lowered its displacement factor. "( Evaluation of bilirubin displacement effect by acetaminophen in vitro.
Itoh, S; Kusaka, T; Okada, H; Sugino, M, 2015
)
2.12
"Acetaminophen may cause liver damage with dose-dependent manner."( [A Case of Acetaminophen Poisoning Associated with Tramcet Overdose].
Egashira, T; Fukusaki, M; Goto, S; Terao, Y; Tuji, T; Urabe, S, 2016
)
1.55
"Acetaminophen can increase the risk of arsenic-mediated hepatic oxidative damage; therefore, the decontamination of water polluted with coexisting acetaminophen and arsenic gives rise to new challenges for the purification of drinking water. "( Fenton-Like Catalysis and Oxidation/Adsorption Performances of Acetaminophen and Arsenic Pollutants in Water on a Multimetal Cu-Zn-Fe-LDH.
Küppers, S; Lu, H; Qiu, Y; Zhang, H; Zhu, J; Zhu, L; Zhu, Z, 2016
)
2.12
"Acetaminophen DILI yielded lower risks of mortality (HR 0.24, 95 % CI: 0.13-0.42)."( The incidence, presentation, outcomes, risk of mortality and economic data of drug-induced liver injury from a national database in Thailand: a population-base study.
Pan-Ngum, W; Phaosawasdi, K; Poovorawan, K; Sobhonslidsuk, A; Soonthornworasiri, N, 2016
)
1.16
"Acetaminophen (APAP) can cause life-threatening renal damages and there is no specific treatment for APAP-induced renal damage. "( Curcumin prevents oxidative renal damage induced by acetaminophen in rats.
Cekmen, M; Ersoz, C; Ilbey, YO; Ozbek, E; Simsek, A; Somay, A, 2009
)
2.05
"Acetaminophen is a leading cause of overdose-related hepatotoxicity. "( Intravenous acetylcysteine for the treatment of acetaminophen overdose.
Doyon, S; Klein-Schwartz, W, 2011
)
2.07
"Acetaminophen appears to cause a concentration-dependent reduction of potassium concentrations and an elevation of creatinine concentrations of short duration (<24 h) after overdose."( Impact of serum acetaminophen concentration on changes in serum potassium, creatinine and urea concentrations among patients with acetaminophen overdose.
Al-Jabi, SW; Awang, R; Sulaiman, SA; Zyoud, SH, 2011
)
2.16
"Acetaminophen (paracetamol) plays a vital role in American health care, with in excess of 25 billion doses being used annually as a nonprescription medication. "( Confusion: acetaminophen dosing changes based on NO evidence in adults.
Krenzelok, EP; Royal, MA, 2012
)
2.21
"Acetaminophen did not cause hepatic lipid peroxidation in wild-type mice but did cause lipid peroxidation in iNOS knockout mice."( Acetaminophen-induced hepatotoxicity.
Hinson, JA; James, LP; Mayeux, PR, 2003
)
2.48
"Acetaminophen displays good gastrointestinal tolerance without any effect on haemostasis."( Is acetaminophen, and its combination with pamabrom, an effective therapeutic option in primary dysmenorrhoea?
De Los Santos, AR; Di Girolamo, G; González, CD; Sánchez, AJ, 2004
)
1.67
"For acetaminophen, a small increase in overall fracture risk was observed with use within the last year (odds ratio [OR] = 1.45, 95% confidence interval [CI] 1.41-1.49)."( Fracture risk associated with use of nonsteroidal anti-inflammatory drugs, acetylsalicylic acid, and acetaminophen and the effects of rheumatoid arthritis and osteoarthritis.
Mosekilde, L; Rejnmark, L; Vestergaard, P, 2006
)
1.03
"Acetaminophen appears to cause concentration-dependent hypokalaemia after overdose, and the pharmacological basis requires further consideration."( Acute acetaminophen overdose is associated with dose-dependent hypokalaemia: a prospective study of 331 patients.
Malkowska, AM; Robinson, OD; Stephen, AF; Waring, WS, 2008
)
1.55
"Acetaminophen poisoning may cause the serum transaminase level to increase during the 24 hours after ingestion."( The temporal profile of increased transaminase levels in patients with acetaminophen-induced liver dysfunction.
Carracio, TR; Mofenson, HC; Singer, AJ, 1995
)
1.97
"Acetaminophen use may increase the acceptance of influenza vaccine by health care workers in whom concern about side effects is an impediment to vaccination."( Effects of acetaminophen on adverse effects of influenza vaccination in health care workers.
Aoki, FY; Cheang, M; Hammond, GW; Murdzak, C; Seklà, LH; Wright, B; Yassi, A, 1993
)
1.4
"Acetaminophen overdose can cause significant morbidity in children and adolescents."( Acetaminophen overdose in children and adolescents.
Chao, HC; Hsieh, KH; Huang, JL; Lin, SJ; Lin, TY,
)
2.3
"The acetaminophen group had lower pain scores on Day 1 (2.1 vs 3.3; P = 0.03) and a shorter average duration of PCA use (35.8 vs 45.5 h; P = 0.03)."( Acetaminophen as an adjunct to morphine by patient-controlled analgesia in the management of acute postoperative pain.
Fox, L; McGuinnety, M; Schug, SA; Sidebotham, DA; Thomas, J, 1998
)
2.22
"Acetaminophen (Tylenol) can inhibit fever and some types of pain without being a particularly effective anti-inflammatory."( A new screening method to detect water-soluble antioxidants: acetaminophen (Tylenol) and other phenols react as antioxidants and destroy peroxynitrite-based luminol-dependent chemiluminescence.
Qazi, N; Sacks, M; Van Dyke, K,
)
1.09
"Acetaminophen may increase International Normalized Ratio (INR) in patients taking anticoagulation medication, and in patients with acetaminophen poisoning without hepatic injury. "( Acetaminophen causes an increased International Normalized Ratio by reducing functional factor VII.
Buckley, NA; Dawson, AH; Goodhew, I; Reith, DM; Seldon, M; Whyte, IM, 2000
)
3.19
"Acetaminophen is a common cause of poisoning in children. "( Is chronic poisoning with acetaminophen in children a frequent occurrence in Toronto?
Bailey, B; Kapur, BM; Koren, G; Lalkin, A, 2001
)
2.05

Treatment

Acetaminophen (APAP) pretreatment was significantly associated with a 14%-16% lower risk of severe and any-stage acute kidney injury but similar risks of kidney replacement therapy and in-hospital mortality. The drug increased levels of ALT and AST, changed hepatic histopathology, promoted oxidative stress and decreased antioxidant enzyme activities.

ExcerptReferenceRelevance
"Acetaminophen treatment obviously increased the levels of ALT and AST, changed hepatic histopathology, promoted oxidative stress, decreased antioxidant enzyme activities, and elevated the pro-inflammatory cytokines."( Echinacoside alleviates acetaminophen-induced liver injury by attenuating oxidative stress and inflammatory cytokines in mice.
Chen, C; Li, B; Thida, M; Zhang, X, 2021
)
1.65
"Acetaminophen treatment was significantly associated with a 14%-16% lower risk of severe and any-stage acute kidney injury but similar risks of kidney replacement therapy and in-hospital mortality."( Early Postoperative Acetaminophen Administration and Severe Acute Kidney Injury After Cardiac Surgery.
Jia, Y; Sessler, DI; Wu, X; Xiong, C; Yan, F; Yuan, S; Zhao, Y, 2023
)
1.96
"Acetaminophen pretreatment did not add analgesia any more than that of placebo. "( Can Acetaminophen Pretreatment Decrease the Pain Associated With Closed Nasal Bone Reduction? A Triple-Blind Randomized Clinical Trial.
Aghazadeh, K; Firouzifar, M; Mousavi-Asl, B; Safaeyan, M; Sohrabpour, S, 2021
)
2.62
"Acetaminophen (APAP)-treated wild-type and FXR knockout mice were used to investigate the functional dependence of the effects of the selected DHPs on FXR."( Structural basis for the hepatoprotective effects of antihypertensive 1,4-dihydropyridine drugs.
Guo, F; Jin, L; Li, Y; Lu, Y; Wang, Y; Wei, Y; Xu, S; Yao, B; Zheng, W; Zhu, Y, 2018
)
1.2
"In acetaminophen-treated mice we detected flow reduction localized to pericentral regions."( A simple automated method for continuous fieldwise measurement of microvascular hemodynamics.
Clendenon, JL; Clendenon, SG; Dunn, KW; Filson, AJ; Fu, X; Glazier, JA; Klaunig, JE; Mang, H; Martinez, M; Sluka, JP; Von Hoene, RA; Winfree, S, 2019
)
1.03
"Acetaminophen treatment was found to trigger an oxidative stress in liver, leading to an increase of serum marker enzymes."( Antioxidant and hepatoprotective potential of Pouteria campechiana on acetaminophen-induced hepatic toxicity in rats.
Ananth, DA; Aseervatham, GS; Christabel, PH; Jeyadevi, R; Sasikumar, JM; Sivasudha, T, 2014
)
1.36
"Acetaminophen treatment decreased renal lipid deposition, ER-stress related signaling, apoptosis and albuminuria."( Acetaminophen attenuates obesity-related renal injury through ER-mediated stress mechanisms.
Arvapalli, R; Blough, E; Dai, X; Driscoll, H; Mahmood, M; Rice, KM; Wang, C; Wu, M, 2014
)
2.57
"Acetaminophen (APAP) pretreatment with a hepatotoxic dose (400 mg/kg) in mice results in resistance to a second, higher dose (600 mg/kg) of APAP (APAP autoprotection). "( Tolerance to acetaminophen hepatotoxicity in the mouse model of autoprotection is associated with induction of flavin-containing monooxygenase-3 (FMO3) in hepatocytes.
Goedken, MJ; Gurevich, I; Hines, RN; Manautou, JE; Rasmussen, T; Rohrer, PR; Rudraiah, S, 2014
)
2.21
"Acetaminophen treatment significantly elevated both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities; however, the pre-intake of G."( Preventive effect of Ganoderma amboinense on acetaminophen-induced acute liver injury.
Hsu, CC; Lin, KY; Lin, WL; Wang, ZH; Yin, MC, 2008
)
1.33
"Acetaminophen-treated dogs regained a significantly greater fraction of baseline function after high concentrations of H(2)O(2) than vehicle-treated dogs."( Acetaminophen is cardioprotective against H2O2-induced injury in vivo.
Baliga, SS; Golfetti, R; Hadzimichalis, NM; Jaques-Robinson, KM; Merrill, GF, 2008
)
2.51
"Acetaminophen treatment significantly depleted hepatic GSH and ascorbic acid levels, increased hepatic level of malonyldialdehyde (MDA), reactive oxygen species (ROS), and oxidized glutathione (GSSG), as well as decreased hepatic activity of glutathione peroxidase (GPX), catalase, and superoxide dismutase (SOD) (P < 0.05)."( Protective effects from carnosine and histidine on acetaminophen-induced liver injury.
Chen, HC; Chen, HT; Wu, ST; Yan, SL; Yin, MC, 2009
)
1.33
"Acetaminophen treatment had a positive inotropic effect on cardiac function."( Acetaminophen combinations protect against iron-induced cardiac damage in gerbils.
Blough, ER; Dornon, L; Laurino, JP; Morrison, RG; Rice, KM; Studeny, M; Walker, EM; Walker, SM; Wehner, PS; Wu, M, 2009
)
2.52
"Acetaminophen treatment increased both the cytosolic and mitochondria-associated P-JNK levels, but the c-jun-N-terminal kinase (JNK) signaling inhibitor SP600125 was hepatoprotective in wildtype mice only, indicating that the JNK pathway may not be critically involved in the absence of CypD."( Acetaminophen overdose-induced liver injury in mice is mediated by peroxynitrite independently of the cyclophilin D-regulated permeability transition.
Boelsterli, UA; LoGuidice, A, 2011
)
2.53
"Acetaminophen treatment upregulates VEGF, PEDF and PACAP in brain endothelial cells exposed to oxidative stress."( Age-related decrease in cerebrovascular-derived neuroprotective proteins: effect of acetaminophen.
Grammas, P; Martinez, J; Sanchez, A; Tripathy, D; Yin, X, 2012
)
1.32
"In acetaminophen-treated group, levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total oxidant status (TOS) in the blood, prothrombin time (PT) and international normalized ratio (INR) were significantly increased when compared with controls. "( N-Acetyl cysteine and erdosteine treatment in acetaminophen-induced liver damage.
Baltaci, D; Colakoglu, S; Kandis, H; Kara, IH; Karakus, A; Kaya, H; Memisogullari, R; Saritas, A; Yildirim, U, 2014
)
1.28
"Acetaminophen-treated mice consistently displayed signs characteristic of FHF, including elevated plasma aminotransferase activity."( Decreased factor VIII levels during acetaminophen-induced murine fulminant hepatic failure.
Doering, CB; Lollar, P; Nichols, CE; Parker, ET, 2003
)
1.32
"Acetaminophen treatment of HepG2 cells caused oxidative damage and apoptosis."( N-acetylcysteine does not protect HepG2 cells against acetaminophen-induced apoptosis.
Hirsh, M; Iancu, TC; Manov, I, 2004
)
1.29
"Acetaminophen treatment caused a significant (P < 0.05-0.001) decrease in GSH levels whereas MDA levels and MPO activity were increased in both tissues."( Protective effects of MESNA (2-mercaptoethane sulphonate) against acetaminophen-induced hepatorenal oxidative damage in mice.
Ayanoğlu-Dülger, G; Cetinel, S; Gedik, N; Sehirli, O; Sener, G; Yeğen, BG,
)
1.09
"Acetaminophen treatment significantly depleted glutathione content, increased oxidation stress and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities (P < 0.05); however, the intake of SAC or SPC significantly alleviated glutathione depletion and the elevation of ALT and AST, enhanced glutathione peroxidase activity, and lowered malondialdehyde formation (P < 0.05)."( Protective effect of s-allyl cysteine and s-propyl cysteine on acetaminophen-induced hepatotoxicity in mice.
Hsu, CC; Liao, TS; Lin, CC; Yin, MC, 2006
)
1.29
"The acetaminophen group was treated with antibiotics (amoxicillin-clavulonic acid), acetaminophen and placebo, acetaminophen-plus-honey group was treated with antibiotics (amoxicillin-clavulonic acid), acetaminophen, and honey. "( Can postoperative pains following tonsillectomy be relieved by honey? A prospective, randomized, placebo controlled preliminary study.
Elhan, AH; Genc, S; Ozlugedik, S; Tezer, M; Titiz, A; Unal, A, 2006
)
0.89
"Acetaminophen-treated hearts showed a significant decrease in late stage apoptotic myocytes compared with vehicle-treated hearts following injury (58 +/- 1 vs."( Acetaminophen-mediated cardioprotection via inhibition of the mitochondrial permeability transition pore-induced apoptotic pathway.
Baliga, SS; Firestein, BL; Golfetti, R; Hadzimichalis, NM; Jaques, KM; Merrill, GF, 2007
)
2.5
"acetaminophen pretreatment on the propofol injection pain."( Efficacy of intravenous acetaminophen and lidocaine on propofol injection pain.
Arun, O; Canbay, O; Celebi, N; Karagöz, AH; Ozgen, S; Saricaoğlu, F, 2008
)
1.37
"Acetaminophen pretreatment decreases the sulfate availability, but results in many side effects that complicate the analysis of the results."( Sulfation and glucuronidation as competing pathways in the metabolism of hydroxamic acids: the role of N,O-sulfonation in chemical carcinogenesis of aromatic amines.
Meerman, JH; Mulder, GJ, 1983
)
0.99
"Acetaminophen plus FeSO4 treatment of mice significantly increased serum alanine aminotransferase levels at 2, 4, and 6 h compared to controls."( Mechanism of acetaminophen-induced hepatotoxicity: covalent binding versus oxidative stress.
Gibson, JD; Hinson, JA; Pumford, NR; Samokyszyn, VM,
)
1.22
"Some acetaminophen-treated male mice showed a significant elevation in serum levels of the hepatic enzyme alanine aminotransferase at a normally non-hepatotoxic oral dose."( Increased basal expression of hepatic Cyp1a1 and Cyp1a2 genes in inbred mice selected for susceptibility to acetaminophen-induced hepatotoxicity.
Casley, WL; Girard, M; Menzies, JA; Moon, TW; Mousseau, N; Whitehouse, LW, 1997
)
0.96
"In acetaminophen-treated mice serum alanine aminotransferase (ALT) was 779 +/- 271 at 2 h, 7421 +/- 552 IU/l at 4 h, 5732 +/- 523 IU/l at 8 h, and 5984 +/- 497 IU/l at 24 h."( Deferoxamine delays the development of the hepatotoxicity of acetaminophen in mice.
Bucci, TJ; Hinson, JA; Kusewitt, DF; Pumford, NR; Schnellmann, JG, 1999
)
1.06
"Acetaminophen was the treatment of choice for 96% and dipyrone for 4%."( Parental knowledge of the treatment of fever in children.
Barzilai, A; Davidovitch, N; Eisen, I; Kaplan, G; Linder, N; Sirota, L; Snapir, A, 1999
)
1.02
"Acetaminophen treatment increased the plasma levels of aspartate transaminase, alanine aminotransferase, and alkaline phosphatase and caused hepatic DNA fragmentation and hepatocyte necrosis."( Role of taurine in preventing acetaminophen-induced hepatic injury in the rat.
Bouchier-Hayes, D; Kay, E; Redmond, HP; Wang, JH; Waters, E; Wu, QD, 2001
)
1.32
"Acetaminophen-treated hearts regained a significantly greater fraction of baseline, preischemia control function during reperfusion than vehicle-treated hearts."( Acetaminophen and low-flow myocardial ischemia: efficacy and antioxidant mechanisms.
Merrill, GF, 2002
)
2.48
"Acetaminophen treatment alone caused mitochondrial cytochrome c release, depletion of the hepatic ATP content by 55%, and a 10-fold increase in mitochondrial glutathione disulfide levels."( Acetaminophen-induced inhibition of Fas receptor-mediated liver cell apoptosis: mitochondrial dysfunction versus glutathione depletion.
Jaeschke, H; Knight, TR, 2002
)
2.48
"of acetaminophen, was treated with oral N-acetylcysteine."( Acetaminophen hepatotoxicity and malnutrition.
Bargman, GJ; Newman, TJ, 1979
)
2.22
"Acetaminophen pretreatment did not decrease the threshold dose of toxicity for thioacetamide but did accentuate hepatotoxic doses."( Potentiation of the toxicity of model hepatotoxicants by acetaminophen.
Moore, L; Wright, PB, 1991
)
1.25
"Acetaminophen treatment significantly increased antipyrine half-life by 29% and reduced its clearance by 24%, without affecting its volume of distribution."( Influence of acetaminophen on antipyrine kinetics in rats.
Descotes, J; Sauveur, C; Vial, T, 1990
)
1.37
"Acetaminophen treatment resulted in a twofold increase in macrophage yields from the liver compared with controls."( Potential role of activated macrophages in acetaminophen hepatotoxicity. I. Isolation and characterization of activated macrophages from rat liver.
Laskin, DL; Pilaro, AM, 1986
)
1.26
"Acetaminophen pretreatment caused a threefold increase in phenytoin-induced fetal cleft palates without increasing resorptions."( Pharmacological studies on the potentiation of phenytoin teratogenicity by acetaminophen.
Lum, JT; Wells, PG, 1986
)
1.22
"Pigs treated with acetaminophen survived with no obvious hemodynamic instability during the 50-min observation period."( ACETAMINOPHEN ATTENUATES PULMONARY VASCULAR RESISTANCE AND PULMONARY ARTERIAL PRESSURE AND INHIBITS CARDIOVASCULAR COLLAPSE IN A PORCINE MODEL OF ENDOTOXEMIA.
Bergström, A; Chew, MS; Elander, L; Engblom, D; Larsson, A; Lipcsey, M; Yang, B, 2023
)
2.68
"Late treatment with acetaminophen to avoid surgery for pPDA is associated with reduced ligation but no difference in death/NDI, supporting the safety and effectiveness of this approach."( Is late treatment with acetaminophen safe and effective in avoiding surgical ligation among extremely preterm neonates with persistent patent ductus arteriosus?
Banihani, R; Jain, A; Jasani, B; Martins, FF; Mashally, S; Nield, LE; Weisz, DE, 2021
)
1.26
"Treatment with acetaminophen significantly elevated the levels of inflammatory cytokines by hES-HLCs."( Prediction of drug-induced immune-mediated hepatotoxicity using hepatocyte-like cells derived from human embryonic stem cells.
Cho, EB; Han, YM; Jang, MJ; Jeong, WI; Kim, DE; Kim, E; Kim, MY; Kim, S; Kim, Y; Kim, YR; Lee, JY; Lee, SH, 2017
)
0.79
"Pain treatment with acetaminophen was not inferior to that with diclofenac or the combination of acetaminophen and diclofenac in acute minor musculoskeletal extremity trauma, both in rest and with movement."( Acetaminophen or Nonsteroidal Anti-Inflammatory Drugs in Acute Musculoskeletal Trauma: A Multicenter, Double-Blind, Randomized, Clinical Trial.
Goddijn, H; Goslings, JC; Hollmann, MW; Kemper, EM; Lirk, P; Ridderikhof, ML; Schinkel, E; Van Dieren, S; Vandewalle, E, 2018
)
2.25
"Treatment with acetaminophen (15 μg/ml), a specific hemoprotein reductant, prevented CFH-dependent permeability in human lungs (P = 0.046) and hPMVECs (P = 0.037)."( Cell-free hemoglobin promotes primary graft dysfunction through oxidative lung endothelial injury.
Bastarache, JA; Cantu, E; Christie, JD; Crespo, MM; Dhillon, G; Diamond, JM; Hage, CA; Kawut, SM; Kuck, JL; Lama, VN; Landstreet, SR; Lederer, DJ; McDyer, J; McNeil, JB; Miller, A; Nagata, H; Orens, JB; Palmer, SM; Porteous, MK; Shah, PD; Shaver, CM; Ware, LB; Weinacker, A; Wickersham, N; Wille, KM, 2018
)
0.82
"The treatment with acetaminophen must be interrupted and acetylcysteine should be administered."( [Metabolic Acidosis under Acetaminophen Intake - an Unordinary Side Effect].
Böttcher, A; Hitzing, S; Laube, M, 2018
)
1.1
"Treatment of acetaminophen (APAP) in overdose can cause a potentially serious and fatal liver injury. "( Fine-tuning the expression of microRNA-155 controls acetaminophen-induced liver inflammation.
Liang, W; Lv, L; Wang, P; Yuan, K; Zhang, J; Zhang, X, 2016
)
1.05
"Treatment with acetaminophen resulted in a significant increase in mean systolic (from 122.4±11.9 to 125.3±12.0 mm Hg P=0.02 versus placebo) and diastolic (from 73.2±6.9 to 75.4±7.9 mm Hg P=0.02 versus placebo) ambulatory blood pressures."( Acetaminophen increases blood pressure in patients with coronary artery disease.
Corti, R; Enseleit, F; Flammer, AJ; Gay, S; Haile, SR; Hermann, M; Hirt, A; Holzmeister, J; Hurlimann, D; Kaiser, P; Landmesser, U; Lüscher, TF; Mocharla, P; Neidhart, M; Noll, G; Nussberger, J; Périat, D; Ruschitzka, F; Sudano, I; Vanhoutte, PM; Wolfrum, M, 2010
)
2.14
"Treatment with acetaminophen significantly elevated levels of plasma GOT and GPT as well as hepatic TBARS but reduced hepatic GSH levels in CO compared to OO and BT groups. "( Dietary saturated and monounsaturated fats protect against acute acetaminophen hepatotoxicity by altering fatty acid composition of liver microsomal membrane in rats.
Chang, YH; Chung, H; Hwang, HJ; Hwang, J; Kim, SY; Park, JH; Shim, E, 2011
)
0.96
"Treatment with acetaminophen induced formation of autophagosomes in hepatocytes from wild-type mice, but not in Atg7-deficient mice. "( Loss of autophagy promotes murine acetaminophen hepatotoxicity.
Fukada, H; Igusa, Y; Ikejima, K; Inami, Y; Izumi, K; Komatsu, M; Tanaka, K; Watanabe, S; Yamashina, S, 2012
)
1.01
"Pretreatment with acetaminophen induced growth response, weaker than that of growth factors, but pretreatment and growth factors reduced cell damage equally effectively."( Autoprotection against acetaminophen toxicity in cultured rat hepatocytes: the effect of pretreatment and growth factors.
Dich, J; Grunnet, N; Tygstrup, N, 2003
)
0.95
"Treatment with acetaminophen did not impact maternal temperature curves."( Prophylactic acetaminophen does not prevent epidural fever in nulliparous women: a double-blind placebo-controlled trial.
Citron, DR; Evans, T; Goetzl, L; Lieberman, E; Richardson, BE; Rivers, J; Suresh, MS, 2004
)
1.03
"Treatment of acetaminophen poisoning consists of preventing gastrointestinal absorption of the drug, use of the antidote N-acetylcysteine and supportive care."( Management of acetaminophen toxicity.
Fuller, SH; Larsen, LC, 1996
)
1.01
"Mice treated with acetaminophen plus gadolinium chloride, or acetaminophen plus dextran sulfate, had significantly less evidence of hepatotoxicity as evidenced by lower serum alanine transaminase (ALT) levels (28 +/- 1 IU/L and 770 +/- 240 IU/L, respectively) at 8 hours compared with acetaminophen (6,380 +/- 408 IU/L)."( Pretreatment of mice with macrophage inactivators decreases acetaminophen hepatotoxicity and the formation of reactive oxygen and nitrogen species.
Hinson, JA; Mayeux, PR; Michael, SL; Niesman, MR; Pumford, NR, 1999
)
0.87
"Treatment with acetaminophen ameliorates subjective symptoms induced by endotoxemia without compromising the humoral response of a subject to endotoxin."( Acetaminophen has greater antipyretic efficacy than aspirin in endotoxemia: a randomized, double-blind, placebo-controlled trial.
Bieglmayer, C; Eichler, HG; Jilma, B; Kapiotis, S; Pernerstorfer, T; Schmid, R, 1999
)
2.09
"Treatment with acetaminophen 2.5 h before Jo inhibited the increase in hepatic caspase-3 activity by preventing the processing of the proenzyme."( Acetaminophen-induced inhibition of Fas receptor-mediated liver cell apoptosis: mitochondrial dysfunction versus glutathione depletion.
Jaeschke, H; Knight, TR, 2002
)
2.1
"Mice treated with acetaminophen exhibited decreased glutathione peroxidase activity, decreased thioltransferase activity, and decreased adenine nucleotide concentrations in the liver."( Acetaminophen-induced oxidation of protein thiols. Contribution of impaired thiol-metabolizing enzymes and the breakdown of adenine nucleotides.
Nelson, SD; Tirmenstein, MA, 1990
)
2.05
"The treatment with acetaminophen and Cd lasted 2 and 10 months, respectively."( Potentiation of cadmium nephrotoxicity by acetaminophen.
Amor, AO; Bernard, AM; de Russis, R; Lauwerys, RR, 1988
)
0.86

Toxicity

Acetaminophen-induced liver injury is a type of injury in which the initial toxic injury is followed by innate immune activation. nitrotyrosine protein adducts (3-NT), a hallmark of peroxynitrite production, were colocalized with necrotic hepatic centrilobular regions.

ExcerptReferenceRelevance
" This indicates less conjugation of the toxic metabolites of paracetamol and bromobenzene to liver glutathione (G-SH) in the presence of DMSO."( Antidotal effects of dimethyl sulphoxide against paracetamol-, bromobenzene-, and thioacetamide-induced hepatotoxicity.
Siegers, CP, 1978
)
0.26
"The toxic and carcinogenic effects of many compounds depend on their activation to reactive molecules in the cytochrome P-450 system of the endoplasmic reticulum of cells."( Diet, DDT, and the toxicity of drugs and chemicals.
McLean, AE, 1977
)
0.26
" To be effective, antidotal therapy must be given early after acetaminophen ingestion when the patient, despite the toxic injury occurring in his liver, may appear quite well."( Liver toxicity after acetaminophen ingestion. Inadequacy of the dose estimate as an index of risk.
Alexander, M; Ambre, J, 1977
)
0.82
" Toxicity is likely to occur after a minimum ingestion of 140 mg/kg, but the toxic dose may vary as a function of individual glutathione levels."( Toxicity of acetaminophen overdose.
Peterson, RG; Rumack, BH, 1978
)
0.64
" It is concluded that haemoperfusion through this column is a safe and simple procedure, which merits evaluation in the treatment of severe drug overdose in man."( The safety assessment in the dog of a charcoal haemoperfusion column.
Fennimore, J; Kolthammer, JC; Lang, S; Watson, PA, 1976
)
0.26
" In this model low concentrations (10(-8) to 10(-14) M) of iloprost, a stable analogue of prostacyclin, offered protection against the toxic effects of paracetamol."( Paracetamol toxicity and its prevention by cytoprotection with iloprost.
Boobis, AR; Davies, DS; Fawthrop, DJ; Hardwick, SJ; Nasseri-Sina, P; Wilson, JW, 1992
)
0.28
"1 The ability of iloprost (ZK36374) to protect hamster isolated hepatocytes from the toxic effects of paracetamol and its reactive metabolite N-acetyl-p-benzoquinoneimine (NABQI) was investigated."( Cytoprotection by iloprost against paracetamol-induced toxicity in hamster isolated hepatocytes.
Boobis, AR; Davies, DS; Fawthrop, DJ; Nasseri-Sina, P; Wilson, J, 1992
)
0.28
" Liver slices from rats fed butter diets were significantly more sensitive to the toxic effects of paracetamol than those from margarine fed rats."( Effect of dietary fat on the in vitro hepatotoxicity of paracetamol.
Beales, D; Henderson, L; McDanell, RE; Sethi, JK, 1992
)
0.28
" We conclude that single doses of nonprescription ibuprofen are well tolerated and demonstrate a side effect profile indistinguishable from that of acetaminophen and placebo."( Nonprescription ibuprofen: side effect profile.
Dash, BH; Furey, SA; Waksman, JA, 1992
)
0.48
"Acetaminophen is eliminated primarily by glucuronidation, thereby avoiding cytochrome P450-catalyzed bioactivation to a toxic reactive intermediate."( Biotransformation and toxicity of acetaminophen in congenic RHA rats with or without a hereditary deficiency in bilirubin UDP-glucuronosyltransferase.
Chow, SY; de Morais, SM; Wells, PG, 1992
)
2.01
" One of the mechanisms for this protection appears to be the decreased AA toxic activation via P-450, as well as increased detoxication via glucuronidation of AA."( Protective effects of fulvotomentosides on acetaminophen-induced hepatotoxicity.
Jia, XS; Klaassen, CD; Liu, J; Liu, YP; Madhu, C; Mao, Q, 1992
)
0.55
" Fifty-five patients (18%) had toxic paracetamol levels, 51% received treatment with NAC, including 40% of those with non-toxic levels, and 11% of those treated with NAC experienced side effects."( Hepatotoxicity from paracetamol self-poisoning in western Sydney: a continuing challenge.
Batey, RG; Brotodihardjo, AE; Byth, K; Farrell, GC, 1992
)
0.28
"0 mmol/kg) alone were toxic to mice induced with benzo(a)pyrene but not to control or phenobarbitone-induced mice."( Cysteine isopropylester protects against paracetamol-induced toxicity.
Butterworth, M; Cohen, GM; Smith, LL; Upshall, DG, 1992
)
0.28
" The present study has examined the effect of a toxic concentration of acetaminophen on cytosolic free calcium in single mouse hepatocytes, using the dye fura-2 and video imaging fluorescence microscopy."( Level of cytosolic free calcium during acetaminophen toxicity in mouse hepatocytes.
Burcham, PC; Harman, AW; Madsen, BW; Mahar, SO, 1992
)
0.79
"N-Acetylcysteine (NAC) is protective against acetaminophen-induced hepatotoxicity primarily by providing precursor for the glutathione synthetase pathway, while cysteamine has been demonstrated to alter the cytochrome P-450 dependent formation of toxic acetaminophen metabolite."( Cysteamine in combination with N-acetylcysteine prevents acetaminophen-induced hepatotoxicity.
Brown, IR; Peterson, TC, 1992
)
0.79
" In both patients starvation, due to abdominal pain, nausea and vomiting or diarrhoea, was probably contributing to the toxic effect of the drug."( Hepatotoxicity due to repeated intake of low doses of paracetamol.
Broomé, U; Eriksson, LS; Kalin, M; Lindholm, M, 1992
)
0.28
" Additionally, due to malnutrition and/or to human immunodeficiency virus infection per se, our patient may have had decreased hepatic reserves of glutathione with which to conjugate the toxic acetaminophen product of the P450 system."( Severe hepatotoxicity in a patient receiving both acetaminophen and zidovudine.
Goetz, MB; Shriner, K, 1992
)
0.73
" The authors hypothesized that most adolescents are naive about the toxic and lethal potential of acetaminophen in overdose."( Acetaminophen overdose as a suicidal gesture: a survey of adolescents' knowledge of its potential for toxicity.
Diaco, D; Harris, E; Moreno, A; Myers, WC; Otto, TA, 1992
)
1.94
" This suggests that DEDC acts as a trap for the toxic quinoneimines, thus preventing alkylation of essential macromolecules."( Molecular mechanism for prevention of N-acetyl-p-benzoquinoneimine cytotoxicity by the permeable thiol drugs diethyldithiocarbamate and dithiothreitol.
Lauriault, VV; O'Brien, PJ, 1991
)
0.28
" Following clinical observations that this drug combination induces significant adverse effects, its gastric toxicity was investigated in rats."( Potentiation of gastric toxicity of ibuprofen by paracetamol in the rat.
Bhattacharya, SK; Goel, RK; Tandon, R, 1991
)
0.28
" These studies indicate that glutathione conjugation of PAP generates a metabolite that is more toxic to the kidney than the parent compound."( Nephrotoxicity of 4-aminophenol glutathione conjugate.
Foster, JR; Fowler, LM; Lock, EA; Moore, RB, 1991
)
0.28
" Under conditions of vitamin A deficiency formation of acetanilide toxic metabolites was increased as a result of which excretion of mercapturic acids with urine was elevated but excess of vitamin A and its hyperdose inhibited these reactions."( [Biotransformation and toxicity of xenobiotics in various routes of administration of vitamin A into the rat body].
Bogdanov, NG; Gutsol, VI; Pentiuk, AA,
)
0.13
" N-Acetyl-m-aminophenol (AMAP) was approximately 10-fold less toxic than APAP, despite the fact that it bound covalently to a greater extent to hepatocyte macromolecules."( Comparative cytotoxic effects of acetaminophen (N-acetyl-p-aminophenol), a non-hepatotoxic regioisomer acetyl-m-aminophenol and their postulated reactive hydroquinone and quinone metabolites in monolayer cultures of mouse hepatocytes.
Bjørge, C; Holme, JA; Hongslo, JK; Nelson, SD, 1991
)
0.56
" The percentage of APAP-glutathione conjugate was very low in all species, indicating that either very little of the toxic APAP metabolite, N-acetylbenzoquinoneimine, was formed, or in the species susceptible to N-acetylbenzoquinoneimine-induced cytotoxicity, the glutathione S-transferase activity or the amount of glutathione was low."( Metabolism and cytotoxicity of acetaminophen in hepatocyte cultures from rat, rabbit, dog, and monkey.
Amacher, DE; Higgins, CV; Smolarek, TA,
)
0.42
" Sera from both rats and monkeys following gavage with acetaminophen were also toxic to cultured embryos."( Acetaminophen toxicity to cultured rat embryos.
Bruno, M; Gamache, P; Hinson, JA; Khairallah, E; Klein, NW; Weeks, BS, 1990
)
1.97
" For BB, both the toxic effect and the protective influence of zinc were apparent 24 h following administration."( Protective effect of zinc in the hepatotoxicity of bromobenzene and acetaminophen.
Piotrowski, JK; Swietlicka, EA; Szymańska, JA, 1991
)
0.52
"Exposure of isolated mouse hepatocytes to a toxic concentration of acetaminophen (5 mM) resulted in damage to the mitochondrial respiratory apparatus."( Acetaminophen toxicity results in site-specific mitochondrial damage in isolated mouse hepatocytes.
Burcham, PC; Harman, AW, 1991
)
1.96
" The basic mechanism through which PEX reduces the liver toxicity of AAP is assumed to be the decrease in the amount of toxic metabolite formed."( Effect of potassium ethylxanthogenate on the acetaminophen hepatotoxicity in mice.
Dimova, S; Stoytchev, T, 1990
)
0.54
"A potential side effect of paracetamol is its hepatotoxicity."( [Paracetamol hepatotoxicity].
Lubec, G, 1990
)
0.28
" Inhibition of cellular respiration as well as a lowering of cellular ATP contents and ATP/ADP ratios was associated with exposure to toxic concentrations of paracetamol."( Mitochondrial dysfunction in paracetamol hepatotoxicity: in vitro studies in isolated mouse hepatocytes.
Burcham, PC; Harman, AW, 1990
)
0.28
"The hepatotoxicity of acetaminophen (APAP) overdose depends on metabolic activation to a toxic reactive metabolite via hepatic mixed function oxidase."( Acetaminophen hepatotoxicity: is there a role for prostaglandin synthesis?
Ben-Zvi, Z; Danon, A; Katz, S; Weissman-Teitellman, B, 1990
)
2.04
" On the other hand, sodium valproate and isoniazid was, respectively, seven and 100 times more toxic for embryos than adults, thus indicating that these pharmaceuticals might pose developmental hazards to mammalian development."( In vitro testing for developmental toxicity using the Hydra attenuata assay.
Støttum, A; Wiger, R, 1985
)
0.27
" Centrilobular hepatic necrosis and elevation in transaminase activity following a toxic dose of acetaminophen were prevented by treatment with cysteamine."( The role of heme oxygenase and aryl hydrocarbon hydroxylase in the protection by cysteamine from acetaminophen hepatotoxicity.
Peterson, MR; Peterson, TC; Williams, CN, 1989
)
0.71
" PEX in a dose of 80 mg/kg body weight, administered subcutaneously or orally one hour before AAP, or simultaneously with it, induces prolongation of the survival of the experimental animals and increases LD50 of AAP."( Effect of potassium ethylxanthogenate on the toxicity and analgesic effect of acetaminophen.
Dimova, S; Stoytchev, T, 1989
)
0.51
" Analysis of the actually reported and the computer-assisted predicted data has shown that the computer-assisted predictive formula may be clinically helpful in determining if the plasma acetaminophen level is in the toxic or nontoxic range."( Computer-assisted predictive mathematical relationship among plasma acetaminophen concentration and time and hepatotoxicity in man.
Chung, SJ, 1989
)
0.7
"A comparison was made among phenylpropanolamine, aspirin, acetaminophen and ibuprofen in terms of their relative safety, as measured by adverse reaction reports published since 1980, the five semiannual reports published by the Drug Abuse Warning Network during 1984-1986 and annual reports from Poison Control Centers from 1983-1986."( A comparison of the relative safety of phenylpropanolamine, acetaminophen, ibuprofen and aspirin as measured by three compendia.
Winick, C, 1989
)
0.76
"142) were found to protect mice against the hepatotoxicity of paracetamol, which is due to cytochrome P-450 dependent formation of toxic metabolites and radicals."( In vivo effects of immunostimulating lipopeptides on mouse liver microsomal cytochromes P-450 and on paracetamol-induced toxicity.
Delaforge, M; Jaouen, M; Jollès, P; Mansuy, D; Migliore-Samour, D, 1989
)
0.28
" However, they also increased the susceptibility of hepatocytes to paracetamol toxicity, indicating that a component of paracetamol's toxic effect involves formation of species that are detoxified by the GSH-Px/GSSG-Rd enzymes."( A role for the glutathione peroxidase/reductase enzyme system in the protection from paracetamol toxicity in isolated mouse hepatocytes.
Adamson, GM; Harman, AW, 1989
)
0.28
" Collectively, the data suggest that the protective effect of cobalt chloride treatment on acetaminophen hepatotoxicity results from a combination of the suppression of the toxic pathway of cytochrome P-450 oxidation, an increase in the protective capacity of glutathione, and an enhancement of the nontoxic pathway of glucuronidation."( The mechanisms of cobalt chloride-induced protection against acetaminophen hepatotoxicity.
Jollow, DJ; Price, VF; Roberts, SA,
)
0.59
" While the glutathione conjugating system is enhanced by selenium treatment, amelioration of acetaminophen toxicity is most likely the result of enhanced glucuronidation which effectively diverts the amount of acetaminophen to be converted by the cytochrome P-450 system to the toxic metabolite."( Protective effects of selenium on acetaminophen-induced hepatotoxicity in the rat.
Davies, MH; Merrick, BA; Park, KS; Schnell, RC; Weir, SW, 1988
)
0.77
"The effects of acetaminophen and its major toxic metabolite, N-acetyl-p-benzoquinone imine (NAPQI), have been investigated in hepatocytes isolated from 3-methylcholanthrene-pretreated and -untreated rats, respectively."( The toxicity of acetaminophen and N-acetyl-p-benzoquinone imine in isolated hepatocytes is associated with thiol depletion and increased cytosolic Ca2+.
Moldéus, P; Moore, G; Moore, M; Nelson, S; Orrenius, S; Thor, H, 1985
)
0.97
"N-acetyl-p-benzoquinone imine (NAPQI), a reactive metabolite of acetaminophen, has previously been shown to be toxic to hepatocytes freshly isolated from rat liver [Mol."( Comparative cytotoxic effects of N-acetyl-p-benzoquinone imine and two dimethylated analogues.
Cotgreave, IA; Harvison, PJ; Moldéus, P; Nelson, SD; Porubek, DJ; Rundgren, M, 1988
)
0.51
"The effect of toxic doses of acetaminophen on hepatic intracellular calcium compartmentation were studied in mice."( Effect of acetaminophen hepatotoxicity on hepatic mitochondrial and microsomal calcium contents in mice.
Burcham, PC; Harman, AW, 1988
)
0.97
" This could be due to an increased activation of the drug to a toxic metabolite or to a decreased capacity to detoxify the toxic metabolite by conjugation with glutathione (GSH)."( Glutathione deficiency in alcoholics: risk factor for paracetamol hepatotoxicity.
Lauterburg, BH; Velez, ME, 1988
)
0.27
" In contrast, only DEHP and BBS induced toxic renal lesions."( The chronic hepatic or renal toxicity of di(2-ethylhexyl) phthalate, acetaminophen, sodium barbital, and phenobarbital in male B6C3F1 mice: autoradiographic, immunohistochemical, and biochemical evidence for levels of DNA synthesis not associated with car
Anderson, LM; Diwan, BA; Hagiwara, A; Lindsey, K; Ward, JM, 1988
)
0.51
" FS 205-397 will offer potent analgesic and antipyretic therapy in man based on an innovative biochemical principle which eliminates the undesirable toxic effects associated with most other non-narcotic analgesics."( FS 205-397: a new antipyretic analgesic with a paracetamol-like profile of activity but lack of acute hepatotoxicity in mice.
Achini, R; Foote, RW; Römer, D, 1988
)
0.27
" The toxic electrophile produced by cytochrome P-450 oxidation of acetaminophen, N-acetyl-p-benzoquinoneimine, is reduced rapidly by NADH in aqueous solution."( Mechanism by which ethanol diminishes the hepatotoxicity of acetaminophen.
Nelson, SD; Slattery, JT; Thummel, KE, 1988
)
0.75
" An improved method is described in which toxic APAP metabolites are generated by a purified and reconstituted cytochrome P-450 system, minimizing the amount of exogenous detoxification enzymes in the assay."( Drug metabolite toxicity assessed in human lymphocytes with a purified, reconstituted cytochrome P-450 system.
Cannon, M; Leeder, JS; Nakhooda, A; Spielberg, SP, 1988
)
0.27
" This allowed potentially toxic elevations in calcium concentration to be detected as early as 2 hr after acetaminophen overdose."( Early sustained rise in total liver calcium during acetaminophen hepatotoxicity in mice.
Corcoran, GB; Neese, BL; Wong, BK, 1987
)
0.74
" The possible causes for the injury from ostensibly nontoxic drug levels appear to be either the induction by chronic alcohol intake of the cytochrome P-450 system responsible for converting acetaminophen to a toxic metabolite, or the effect of alcoholism and the associated malnutrition in reducing the glutathione concentration, responsible normally for preventing hepatotoxicity by conjugation with the toxic metabolite."( Acetaminophen hepatotoxicity in alcoholics. A therapeutic misadventure.
Adler, E; Benjamin, SB; Cuccherini, BA; Seeff, LB; Zimmerman, HJ, 1986
)
1.9
"The cytotoxicity of paracetamol and of its putative toxic metabolite, N-acetyl-p-benzo-quinoneimine (NABQI) have been investigated in hepatocytes from hamster, mouse, rat and human liver."( Species differences in the hepatotoxicity of paracetamol are due to differences in the rate of conversion to its cytotoxic metabolite.
Boobis, AR; Davies, DS; Seddon, CE; Tee, LB, 1987
)
0.27
" Also, the effect of food deprivation of both the euthyroid and PTU-induced hypothyroid rats for 24 h, as well as forced feeding of the euthyroid rats after a toxic dose of APAP, was determined."( Effect of nutritional status on propylthiouracil-induced protection against acetaminophen hepatotoxicity in the rat.
Cho, CD; Hirose, N; Raheja, KL, 1987
)
0.5
" The operative status of the hepatic GSH conjugative system has an important influence on the rate of elimination of toxic APAP doses."( Time development of distribution and toxicity following single toxic APAP doses in male BOM:NMRI mice.
Ingebrigtsen, K; Jansen, JH; Nafstad, I; Skoglund, LA, 1987
)
0.27
" Treatment consisted of N-acetylcysteine, ascorbic acid and DL-methionine to decrease toxic effects of the paracetamol and intravenous fluids, blood transfusion and amoxycillin as supportive treatment."( Paracetamol toxicity in a cat.
Ilkiw, JE; Ratcliffe, RC, 1987
)
0.27
" Pretreatment of the mice by inducers of drug-metabolizing enzymes, such as 3-methylcholanthrene and Aroclor 1254, lowered the concentration threshold for the toxic responses."( Species differences in cytotoxic and genotoxic effects of phenacetin and paracetamol in primary monolayer cultures of hepatocytes.
Holme, JA; Søderlund, E, 1986
)
0.27
" Elevated glutathione may be responsible for inhibiting covalent binding but above-normal concentrations have never been demonstrated in vivo after N-acetyl-L-cysteine treatment or separated adequately from other possible hepatoprotective actions including direct reduction of the toxic acetaminophen metabolite by the antidote."( Role of glutathione in prevention of acetaminophen-induced hepatotoxicity by N-acetyl-L-cysteine in vivo: studies with N-acetyl-D-cysteine in mice.
Corcoran, GB; Wong, BK, 1986
)
0.72
" As well as its effect in reducing the formation of the reactive metabolite, DTT has a potent protective effect against the toxic processes initiated by the APAP reactive metabolite."( Comparison of the protective effects of N-acetylcysteine, 2-mercaptopropionylglycine and dithiothreitol against acetaminophen toxicity in mouse hepatocytes.
Harman, AW; Self, G, 1986
)
0.48
" Since the major nontoxic pathway (glucuronide) and the toxic pathway (as measured by mercapturate) decreased to a similar extent, the data indicate that the anomalous lack of protection cannot be explained on the basis of altered metabolic disposition of the drug."( Anomalous susceptibility of the fasted hamster to acetaminophen hepatotoxicity.
Jollow, DJ; Miller, MG; Price, VF, 1986
)
0.52
" PAR and the 3-monoalkyl derivatives were found to deplete cellular GSH to about the same extent and to be equally toxic in freshly isolated hepatocytes from 3-methylcholanthrene treated rats."( Paracetamol, 3-monoalkyl- and 3,5-dialkyl derivatives. Comparison of their microsomal cytochrome P-450 dependent oxidation and toxicity in freshly isolated hepatocytes.
De Vries, J; Debets, AJ; Kulkens, T; Van De Straat, R; Vermeulen, NP, 1986
)
0.27
" Species differences in sensitivity to paracetamol toxicity were shown to be due to differences in the rate of oxidation of the drug to its toxic metabolite."( Freshly isolated hepatocytes as a model for studying the toxicity of paracetamol.
Boobis, AR; Davies, DS; Hampden, CE; Tee, LB,
)
0.13
" The depression of the nontoxic glucuronidation and sulfation pathways resulted in an increased proportion of the dose converted to the toxic metabolite and, hence, contributed to the potentiation of liver injury in fasted rats."( Mechanisms of fasting-induced potentiation of acetaminophen hepatotoxicity in the rat.
Jollow, DJ; Miller, MG; Price, VF, 1987
)
0.53
" APAP at 7 mM was significantly more toxic to these hepatocytes and had a similar but more marked effect on glutathione concentrations."( Acetaminophen metabolism, cytotoxicity, and genotoxicity in rat primary hepatocyte cultures.
Byard, JL; Milam, KM, 1985
)
1.71
" Since cysteamine decreased both beta and the apparent rate constant for mercapturate formation (K'MA), the proportion of the dose of acetaminophen which is converted to the toxic metabolite (K'MA/beta) was not significantly decreased in the presence of cysteamine."( Acetaminophen hepatotoxicity: studies on the mechanism of cysteamine protection.
Jollow, DJ; Miller, MG, 1986
)
1.92
" These data cannot support the concept that induction of cytochrome P-450 leads to greater formation of the hypothetical toxic metabolite of acetaminophen, or that induction enhances its hepatotoxicity, in the rat."( Phenobarbital induction does not potentiate hepatotoxicity but accelerates liver cell necrosis from acetaminophen overdose in the rat.
Lerche, A; Pedersen, NT; Poulsen, HE, 1985
)
0.69
" Ranitidine administration (50 mg per kg) enhanced acetaminophen hepatotoxicity throughout the toxic dose range of acetaminophen (600 to 1,000 mg per kg) and potentiation of acetaminophen hepatotoxicity by ranitidine was dose-dependent."( Ranitidine-acetaminophen interaction: effects on acetaminophen-induced hepatotoxicity in Fischer 344 rats.
Dent, JG; Leonard, TB; Morgan, DG,
)
0.77
" The results showed that the combination was no more toxic than paracetamol alone and, on the basis of the LD50:ED50 ratio, was less toxic by the oral than by the rectal route."( Acute toxicity and analgesic action of a combination of buclizine, codeine and paracetamol ('Migraleve') in tablet and suppository form in rats.
Behrendt, WA; Cserepes, J, 1985
)
0.27
"Several xenobiotics undergo biotransformation reactions which yield reactive and potentially toxic compounds."( The role of metabolic activation in drug toxicity.
Moldéus, P; Ormstad, K, 1985
)
0.27
" Whereas a toxic dose of acetaminophen administration did not effect SGOT and SGPT levels after 30 hr in PTU pretreated rats given either a single or multiple injections of DEM, the same dose of acetaminophen in the control rats raised these transaminases to a very high level."( Prevention of acetaminophen hepatotoxicity by propylthiouracil in the glutathione depleted rat.
Cho, C; Linscheer, WG; Raheja, KL, 1983
)
0.93
" In a double-blind, two-week, cross-over study, no clinical or laboratory evidence of adverse effects was found."( Hepatotoxicity following the therapeutic use of antipyretic analgesics.
Benson, GD, 1983
)
0.27
" Since acetaminophen hepatotoxicity is increased in rats fed alcohol chronically and acute ethanol has been shown to inhibit the biotransformation of acetaminophen to reactive metabolite(s) by mixed function oxidation, we postulate that acute ethanol administration decreases acetaminophen-induced hepatotoxicity in rats fed alcohol chronically by inhibiting the enhanced production of toxic metabolites."( Interaction of acute ethanol administration with acetaminophen metabolism and toxicity in rats fed alcohol chronically.
Altomare, E; Leo, MA; Lieber, CS,
)
0.84
" The development of type B lactic acidosis with hypoglycemia might have been caused by a deficit in gluconeogenesis secondary to severe hepatic failure and/or a toxic metabolite of acetaminophen."( Anion gap acidosis with hypoglycemia in acetaminophen toxicity.
Schnurr, LP; Zabrodski, RM, 1984
)
0.73
"Acetaminophen LD50 was two fold lower in female than male mice, the greater sensitivity of female mice for acetaminophen was also reflected in the serum enzyme levels of glutamic oxaloacetic and pyruvic transaminases (SGOT/SGPT), where the enhancement of both enzymes was higher in female than male mice."( Sex related differences in acetaminophen toxicity in the mouse.
Fearon, Z; Guerrero Munoz, F, 1984
)
2.01
"Administration of tert-butyl-4-hydroxyanisole or of two dithiolthiones to female CD-1 mice protected against the acute toxic effects of two hepatotoxic agents, acetaminophen and carbon tetrachloride."( Chemoprotective effects of two dithiolthiones and of butylhydroxyanisole against carbon tetrachloride and acetaminophen toxicity.
Ansher, SS; Bueding, E; Dolan, P,
)
0.54
" We suggest that the enhancement of acetaminophen toxicity by ethanol is the result of an effect of ethanol on hepatocyte membranes which renders the cells more susceptible to toxic injury."( Increased acetaminophen-induced hepatotoxicity after chronic ethanol consumption in mice.
Massey, TE; McElligott, TF; Power, EM; Racz, WJ; Walker, RM, 1983
)
0.94
" The mechanism of acetaminophen induced hepatotoxicity has been extensively investigated, and the hepatotoxicity seems to be related to the toxic metabolites generated by biotransformation process (Gillette et al."( The target portion of acetaminophen induced hepatotoxicity in rats: modification by thiol compounds.
Aoto, Y; Hirayama, C; Ikeda, F; Murawaki, Y; Yamada, S, 1983
)
0.91
" After riboflavin deficiency was established by determining erythrocyte glutathione reductase activity coefficient, rats in all groups were administered a toxic dose of acetaminophen (1 g/kg body weight) orally."( Effect of riboflavin status on acetaminophen toxicity in the rat.
Cho, C; Linscheer, WG; Raheja, KL; Turkki, PR, 1983
)
0.75
"Using weanling mice of two different genetic strains we demonstrated a potentiation of the toxic effects of acetaminophen by prior infection with influenza B virus."( Potentiation of the toxic effects of acetaminophen in mice by concurrent infection with influenza B virus: a possible mechanism for human Reye's syndrome?
Hudak, G; MacDonald, MG; McGrath, PP; McMartin, DN; Washington, GC, 1984
)
0.75
"2 ml per animal of 19% alcohol, given at 3 - 4 hours after an LD50 dose of acetaminophen, produced a 24 hour survival of 92%."( The effect of alcohol on the toxicity of acetaminophen in mice.
Banda, PW; Quart, BD, 1984
)
0.76
" In contrast, no toxic effects of pHAA (less than or equal to 20 mM) could be demonstrated."( Cytotoxic effects of N-acetyl-p-benzoquinone imine, a common arylating intermediate of paracetamol and N-hydroxyparacetamol.
Dahlin, DC; Dybing, E; Holme, JA; Nelson, SD, 1984
)
0.27
" Acetaminophen appeared to be less toxic to selenium-deficient hepatocytes than to controls."( Toxicity studies in isolated hepatocytes from selenium-deficient rats and vitamin E-deficient rats.
Burk, RF; Hill, KE, 1984
)
1.18
" rC) depresses the cytochrome P-450 species responsible for the formation of the toxic metabolite and less reactive species are available for binding to cell macromolecules."( The prevention of acetaminophen-induced hepatotoxicity by the interferon inducer poly(rI . rC).
Dickson, G; Renton, KW, 1984
)
0.6
" A toxic dose of the drug ( LD20 ) produced elevated serum glutamate-pyruvate transaminase and lactate dehydrogenase activities 20-24 hr after drug administration only in 19- and 33-day-old animals."( Hepatotoxicity of acetaminophen in neonatal and young rats. I. Age-related changes in susceptibility.
Fischer, LJ; Green, MD; Shires, TK, 1984
)
0.6
" In an animal model used to assess the effect of cimetidine on acetaminophen toxicity, the LD50 of acetaminophen alone in Charles River CD-1 mice was 480 mg/kg (95% confidence interval: 436-528 mg/kg)."( Differential effect of cimetidine on drug oxidation (antipyrine and diazepam) vs. conjugation (acetaminophen and lorazepam): prevention of acetaminophen toxicity by cimetidine.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ; Shader, RI, 1983
)
0.72
" In conclusion, the L-1210 leukaemia seems to modify the acetaminophen hepatotoxicity and this effect might be explained by decreased acetaminophen biotransformation into toxic metabolites or intermediates."( Influence of leukaemia on acetaminophen-induced hepatotoxicity in mice.
d'Auteuil, C; Lavigne, JG; Lavoie, JM, 1982
)
0.81
"A high proportion of toxic and carcinogenic effects of chemicals develop through the pathway of lethal synthesis."( The influence of nutrition and inducers on mechanisms of toxicity in humans and animals.
McLean, AE; Tame, D; Witts, DJ, 1980
)
0.26
" 6 Following overdosage of paracetamol, a toxic intermediate metabolite causes acute hepatic necrosis which may be fatal."( Hepatotoxicity of mild analgesics.
Prescott, LF, 1980
)
0.26
" The rate of formation of acetaminophen sulfate was also modestly increased in diabetic animals, whereas the apparent rate of the toxic pathway was approximately equal in both normal and diabetic animals."( Increased resistance of diabetic rats to acetaminophen-induced hepatotoxicity.
Jollow, DJ; Price, VF, 1982
)
0.83
" The decrease in acetaminophen induced hepatotoxicity was therefore attributed to an inhibitory effect of ethanol on the biotransformation of acetaminophen to the toxic intermediate."( Effect of a concomitant single dose of ethanol on the hepatotoxicity and metabolism of acetaminophen in mice.
Paul, CJ; Solomonraj, G; Whitehouse, LW; Wong, LT, 1980
)
0.82
" A significant reduction in the LD50 was seen in the alcohol-pretreated mice, and correlations were noted between histological findings in the liver and the LD50 data."( Potentiation of acetaminophen hepatotoxicity by alcohol.
Holtzman, JL; Kromhout, JP; McClain, CJ; Peterson, FJ, 1980
)
0.61
" The LD50 was 1025 mg/kg when given intraperitoneally (i."( The pharmacology and toxicology of meta-substituted acetanilide I: acute toxicity of 3-hydroxyacetanilide in mice.
Nelson, EB, 1980
)
0.26
" These cases plus similar reports in the literature suggest that isoniazid or rifampin, or both, may potentiate the hepatotoxicity of acetaminophen, perhaps by induction of cytochrome P450 isozymes that oxidize acetaminophen to its toxic metabolites."( Hepatotoxicity associated with acetaminophen usage in patients receiving multiple drug therapy for tuberculosis.
Nelson, SD; Nolan, CM; Sandblom, RE; Slattery, JT; Thummel, KE, 1994
)
0.78
" stocksianum did not produce any lethality or adverse effects in the livers of treated mice."( Effect of Teucrium stocksianum on paracetamol-induced hepatotoxicity in mice.
Ali, BH; Bashir, AK; Rasheed, RA, 1995
)
0.29
"Acetaminophen is a mild analgesic and antipyretic agent that is safe and effective when taken in therapeutic doses."( Modulation of macrophage functioning abrogates the acute hepatotoxicity of acetaminophen.
Gardner, CR; Jollow, DJ; Laskin, DL; Price, VF, 1995
)
1.96
" PSP did not reverse the depletion of total glutathione (GSH+GSSG) by the toxic dose of paracetamol."( Effect of polysaccharide peptide (PSP) on glutathione and protection against paracetamol-induced hepatotoxicity in the rat.
Chiu, LC; Ooi, VE; Yeung, JH, 1994
)
0.29
" Nimesulide 50 mg and 100 mg were generally well-tolerated but at the highest dose level, nimesulide 200 mg, the incidence of adverse events was greater although not significantly."( Multi-centre double-blind study to define the most favourable dose of nimesulide in terms of efficacy/safety ratio in the treatment of osteoarthritis.
Bourgeois, P; Dreiser, RL; Lequesne, MG; Macciocchi, A; Monti, T, 1994
)
0.29
" These studies in part led to a more thorough description of possible adverse effects or even restrictions for use."( OTC pharmaceuticals and genotoxicity testing: the paracetamol, anthraquinone, and griseofulvin cases.
Kasper, P; Müller, L, 1995
)
0.29
" These data suggest that APAP has a dual toxic effect on MVh2E1-9 cells: a P450-independent antiproliferative effect and the CYP2E1-dependent cytotoxic effect."( Cytotoxicity of acetaminophen in human cytochrome P4502E1-transfected HepG2 cells.
Cederbaum, AI; Dai, Y, 1995
)
0.64
"Infusion-related adverse events (IRAEs) such as nausea, vomiting, fever, chills, and thrombophlebitis that are associated with amphotericin B therapy often lead clinicians to prescribe a number of adjunctive pretreatment medications in an attempt to reduce the incidence and severity of these events."( Pretreatment regimens for adverse events related to infusion of amphotericin B.
Cleary, JD; Goodwin, SD; Grasela, TH; Taylor, JW; Walawander, CA, 1995
)
0.29
" This further suggests that renal, rather than hepatic, biotransformation of APAP to a toxic electrophile is central to APAP-induced nephrotoxicity in the mouse."( Gender-related differences in susceptibility to acetaminophen-induced protein arylation and nephrotoxicity in the CD-1 mouse.
Cohen, SD; Hart, SG; Hoivik, DJ; Khairallah, EA; Manautou, JE; Tveit, A, 1995
)
0.55
" Valproate caused a dose-dependent increase in leakage of lactic acid dehydrogenase (LDH), and glycine prevented this toxic response."( Effect of glycine on valproate toxicity in rat hepatocytes.
Gray, PD; Tolman, KG; Vance, MA,
)
0.13
" Results of qualitative and quantitative covalent binding of tienilic acid metabolite(s) to human liver microsomes were then compared to those obtained with two drugs leading to direct toxic hepatitis, namely, acetaminophen and chloroform."( Specificity of in vitro covalent binding of tienilic acid metabolites to human liver microsomes in relationship to the type of hepatotoxicity: comparison with two directly hepatotoxic drugs.
Ballet, F; Beaune, PH; Bonierbale, E; Catinot, R; Challine, D; Dansette, PM; Gautier, JC; Lecoeur, S; Mansuy, D; Valadon, P,
)
0.32
"When administered four hours after a toxic dose of acetaminophen, 4-methylpyrazole significantly inhibits hepatotoxicity in the rat, as reflected by lower levels of serum transaminases and lesser degrees of hepatic necrosis."( 4-Methylpyrazole blocks acetaminophen hepatotoxicity in the rat.
Baevsky, RH; Brennan, RJ; DelVecchio, JA; Lefevre, R; Mankes, RF; Raccio-Robak, N; Zink, BJ, 1994
)
0.85
"To evaluate the effects of acetaminophen on the incidence of adverse effects to, and the immunogenicity of, whole-virus influenza vaccine in health care workers."( Effects of acetaminophen on adverse effects of influenza vaccination in health care workers.
Aoki, FY; Cheang, M; Hammond, GW; Murdzak, C; Seklà, LH; Wright, B; Yassi, A, 1993
)
0.97
" Prednisolone pretreatment resulted in decreased covalent binding of the toxic metabolite in vivo and an increased urinary excretion of glutathione-derived conjugates of acetaminophen, indicating an enhanced detoxification of the reactive metabolite by glutathione."( Prednisolone stimulates hepatic glutathione synthesis in mice. Protection by prednisolone against acetaminophen hepatotoxicity in vivo.
Lauterburg, BH; Schranz, C; Speck, RF, 1993
)
0.7
" Formation of the acetaminophen toxic metabolite, as measured by glutathione conjugate formation, was much lower in rat slices compared with hamster slices."( Predictive value of liver slices for metabolism and toxicity in vivo: use of acetaminophen as a model hepatotoxicant.
Adams, PE; Beyer, J; deGraffenried, LA; Hall, GL; Miller, MG, 1993
)
0.85
" Isoniazid induces the cytochrome P-450 system, resulting in increased metabolism of acetaminophen, formation of toxic metabolites, depletion of glutathione stores, and subsequent hepatocellular injury."( Acetaminophen hepatotoxicity: potentiation by isoniazid.
Crippin, JS, 1993
)
1.95
" In addition, immunohistochemical studies indicated that toxic concentrations of acetaminophen which altered the endoplasmic reticulum helped maintain cytochrome P450 1A1 in liver cells from beta-naphthoflavone-induced trout."( Acetaminophen toxicity in cultured trout liver cells. I. Morphological alterations and effects on cytochrome P450 1A1.
Blair, JB; Hinton, DE; Miller, MR; Pack, D; Wentz, E, 1993
)
1.95
" Hepatocellular damage is probably caused by accumulation of the toxic intermediate metabolite N-acetyl-p-benzoquinoneimine when hepatic glutathione stores are depleted."( Management of acetaminophen toxicity.
Fuller, SH; Larsen, LC, 1996
)
0.65
" Across all 48 studies, 83% of both the NAP- and placebo-treated patients reported no adverse events."( Safety profile of over-the-counter naproxen sodium.
Bartziek, RD; DeArmond, B; Francisco, CA; Halladay, S; Huang, FY; Lin, JS; Skare, KL,
)
0.13
" Thinking that biliary tract obstructions hould increases drugs toxicity because interferes toxic substances excretion or it modify the activity of P-450 we decided to study acetaminophen toxicity in rats with biliary tract obstruction."( [Effects of cholestasis on hepatotoxicity of acetaminophen in rats].
Fernández, L; Mago, A; Morales de Martínez, A; Salas Coll, CA; Torrealba de Ron, AT,
)
0.58
" Studies of the relationship between genotoxicity and toxic effects in the rat (induction of micronuclei in rat bone marrow including dose-response relationship, biotransformation of paracetamol at different dosages, concomitant toxicity and biochemical markers) have recently been completed."( Series: current issues in mutagenesis and carcinogenesis, No. 65. The genotoxicity and carcinogenicity of paracetamol: a regulatory (re)view.
Bergman, K; Müller, L; Teigen, SW, 1996
)
0.29
"The aim of this study was an experimental assessment of the influence of caffeine on the symptoms of the toxic action of paracentamol in mice as well as a detailed analysis if paracetamol pharmacokinetics in men receiving caffeine at the same time."( [Influence of caffeine on toxicity and pharmacokinetics of paracetamol].
Raińska-Giezek, T, 1995
)
0.29
" While AAP caused a 117-fold elevation of serum transaminase activities in mice kept on a standard laboratory diet, which was significantly exacerbated by ethanol and inhibited by nicotinic acid amide (NAA), adverse effects were noted in animals fed a diet free of precursors of NAD."( Influence of diet free of NAD-precursors on acetaminophen hepatotoxicity in mice.
Altrichter, S; Dietrich, A; Ehrlich, W; Grätz, R; Klewer, M; Kröger, H; Kurpisz, M; Miesel, R, 1996
)
0.56
"The sum pain intensity difference (efficacy analysis) and the proportion of patients reporting a side effect (safety analysis)."( Analgesic efficacy and safety of paracetamol-codeine combinations versus paracetamol alone: a systematic review.
de Craen, AJ; Di Giulio, G; Kessels, AG; Kleijnen, J; Lampe-Schoenmaeckers, JE, 1996
)
0.29
" In the multidose studies the proportion of patients reporting a side effect was significantly higher with paracetamol-codeine combinations."( Analgesic efficacy and safety of paracetamol-codeine combinations versus paracetamol alone: a systematic review.
de Craen, AJ; Di Giulio, G; Kessels, AG; Kleijnen, J; Lampe-Schoenmaeckers, JE, 1996
)
0.29
"The hepatotoxicity of acetaminophen overdose depends on the metabolic activation to a toxic reactive metabolite by the hepatic mixed function oxidases."( Effect of nifedipine, verapamil, diltiazem and trifluoperazine on acetaminophen toxicity in mice.
Dimova, S; Koleva, M; Rangelova, D; Stoythchev, T, 1995
)
0.84
" When administered 1 hour prior to, immediately after, or 20 minutes after a toxic dose of APAP, DASO2 at a dose of 25 mg/kg completely protected mice from development of hepatotoxicity, as indicated by liver histopathology and serum lactate dehydrogenase levels."( Protective effect of diallyl sulfone against acetaminophen-induced hepatotoxicity in mice.
Lee, MJ; Lin, MC; Patten, C; Reuhl, KR; Wang, EJ; Xiao, F; Yang, CS, 1996
)
0.55
" This profile of hematologic adverse effects associated with acetaminophen toxicity has not been reported previously."( Agranulocytosis, plasmacytosis, and thrombocytosis followed by a leukemoid reaction due to acute acetaminophen toxicity.
Celik, I; Dündar, SV; Gürsoy, M; Haznedaroğlu, IC; Ozcebe, OI; Sayinalp, N,
)
0.59
"Acetaminophen is toxic in overdose and even at routine therapeutic doses in glutathione-deficient populations such as alcoholics and AIDS patients."( Acetaminophen toxicity is substantially reduced by beta-carotene in mice.
Baranowitz, SA; Maderson, PF, 1995
)
3.18
"Research into the pathogenesis of acetaminophen (paracetamol)-induced hepatotoxicity has concentrated on the generation of toxic metabolites by the hepatocytes."( Role of macrophages in acetaminophen (paracetamol)-induced hepatotoxicity.
Breach, CS; Brown, IN; Goldin, RD; Ratnayaka, ID; Wickramasinghe, SN, 1996
)
0.88
" In rat liver slices a concentration of 5 mM 4-HPA killed approximately 50% of hepatocytes after 6 hr of incubation, whereas acetaminophen was not toxic at concentrations up to 50 mM."( Metabolism and toxicity of 4-hydroxyphenylacetone in rat liver slices: comparison with acetaminophen.
London, R; Perera, K; Thompson, DC, 1996
)
0.72
" Analysis of protein adducts indicated that after toxic doses, acetaminophen covalently bound at high levels to cysteine residues on a relatively small number of hepatic proteins."( Acetaminophen-induced hepatotoxicity. Analysis of total covalent binding vs. specific binding to cysteine.
Hinson, JA; Matthews, AM; Pumford, NR; Roberts, DW, 1996
)
1.98
" Twenty-eight patients (39%) had severe liver toxic effects, and six of them underwent liver transplantation."( Outcome of acetaminophen overdose in pediatric patients and factors contributing to hepatotoxicity.
Ament, ME; Berquist, W; Davis, J; Gugig, R; Heyman, MB; McDiarmid, S; Rivera-Penera, T; Rosenthal, P; Vargas, J, 1997
)
0.69
" The results of these studies demonstrated that CS-mediated protection is not selective for a particular species, organ system or toxic chemical."( Cholesteryl hemisuccinate treatment protects rodents from the toxic effects of acetaminophen, adriamycin, carbon tetrachloride, chloroform and galactosamine.
Fariss, MW; Lippman, HR; Mumaw, VR; Ray, SD, 1997
)
0.52
" Furthermore, paracetamol hepatotoxicity is induced in rats and the activity of specific cytochrome P450 forms, involved in the metabolic activation of paracetamol to the toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI) is examined, after the administration of guaiazulene, using diagnostic cytochrome P450 substrates."( Effect of guaiazulene on some cytochrome P450 activities. Implication in the metabolic activation and hepatotoxicity of paracetamol.
Kourounakis, AP; Kourounakis, PN; Rekka, EA,
)
0.13
" These data together with histopathological results, clearly showed that the inducible GSH system in weanling rat liver act as a safe guard against APAP toxicity."( Role of glutathione conjugation in protection of weanling rat liver against acetaminophen-induced hepatotoxicity.
Allameh, A; Vansoun, EY; Zarghi, A, 1997
)
0.53
" Serum ALT levels were measured at 24 hours after a toxic but nonlethal dose of ACP that insured 48 hour survival of the animals."( Protection against acetaminophen-induced hepatotoxicity by L-CySSME and its N-acetyl and ethyl ester derivatives.
Cohen, JF; Nagasawa, HT; Rathbun, WB; Shoeman, DW, 1996
)
0.62
" Understanding the former provides explanations for the toxic interactions which may occur with alcohol or other xenobiotics, while understanding of the latter led to the development of antidotes for the treatment of acute poisoning."( Selective protein arylation and acetaminophen-induced hepatotoxicity.
Cohen, SD; Khairallah, EA,
)
0.41
" When PEITC (19-150 micromol/kg) was given to mice intragastrically 1 hr before or immediately prior to a toxic dose of APAP, the APAP-induced hepatotoxicity was significantly decreased or was completely prevented."( Effects of phenethyl isothiocyanate on acetaminophen metabolism and hepatotoxicity in mice.
Chen, L; Li, Y; Reuhl, KR; Stein, AP; Wang, EJ; Yang, CS, 1997
)
0.57
" There were no adverse reactions in either group."( [Comparative, randomized, parallel clinical study of the effectiveness and safety of aceclofenac vs. paracetamol in the treatment of viral pharyngoamygdalitis].
Conti, M, 1997
)
0.3
" This study examines whether acetaminophen is toxic to sinusoidal endothelial cells (SEC), which might lead to microcirculatory disruption."( Sinusoidal endothelial cells as a target for acetaminophen toxicity. Direct action versus requirement for hepatocyte activation in different mouse strains.
Bart, JA; DeLeve, LD; Kaplowitz, N; Shulman, HM; van der Hoek, A; Wang, X, 1997
)
0.85
" No adverse sequelae developed in the three viable infants."( Placental transfer of N-acetylcysteine following human maternal acetaminophen toxicity.
Bearer, CF; Dart, RC; Gupta, U; Horowitz, RS; Jarvie, DR, 1997
)
0.54
" Fischer-344 rats, which are susceptible to APAP nephrotoxicity, have two toxic metabolic pathways involving cytochrome P450-dependent oxidation of APAP to N-acetyl-p-benzoquinone imine (NAPQI) and P450-independent deacetylation of APAP to p-aminophenol (PAP)."( Enhanced nephrotoxicity of acetaminophen in fructose-induced hypertriglyceridemic rats: contribution of oxidation and deacetylation of acetaminophen to an enhancement of nephrotoxicity.
Doi, K; Ikegami, H; Ishida, K, 1997
)
0.59
" Serum acetaminophen levels for which an estimate of time from last dose could be calculated were available for 30 patients, of which 22 levels were greater than the toxic range described for acute ingestion."( Therapeutic misadventures with acetaminophen: hepatoxicity after multiple doses in children.
Barbacci, MB; Heubi, JE; Zimmerman, HJ, 1998
)
1.04
"Acetaminophen is a mild analgesic and antipyretic agent known to cause centrilobular hepatic necrosis at toxic doses."( Role of nitric oxide in acetaminophen-induced hepatotoxicity in the rat.
DeGeorge, GL; Gardner, CR; Heck, DE; Laskin, DL; Laskin, JD; Thomas, PE; Yang, CS; Zhang, XJ, 1998
)
2.05
" There were no serious adverse events observed in this study, with the overall incidence of side effects being somewhat less in the (R)- ketoprofen groups than in the acetaminophen 1,000 mg group."( Analgesic efficacy and safety of (R)- ketoprofen in postoperative dental pain.
Cooper, SA; Hersh, EV; Reynolds, B; Reynolds, DC, 1998
)
0.5
" No significant differences in adverse event rates were observed between lots of CPDT-IPV//PRP-T or between separate or combined injections of CPDT-IPV and PRP-T."( Safety and immunogenicity of a combined five-component pertussis-diphtheria-tetanus-inactivated poliomyelitis-Haemophilus B conjugate vaccine administered to infants at two, four and six months of age.
Barreto, L; Boyd, M; Cunning, L; Gold, R; Guasparini, R; Harrison, D; Meekison, W; Mills, E; Russell, M; Thipphawong, J; Xie, F, 1998
)
0.3
" Incubation of the cells with CP (2 mM and 10 mM) drastically attenuated the GSH and cysteine depletion caused by toxic concentrations of paracetamol (1 mM and 5 mM)."( 2-Methyl-thiazolidine-2,4-dicarboxylic acid protects against paracetamol induced toxicity in human liver derived HepG2 cells.
Rommelspacher, H; Włodek, L, 1997
)
0.3
" The PTU-induced elevated baseline levels of this inhibitor protein inactivated m-ATPase, and prevented hepatotoxicity by a toxic dose of acetaminophen (AAP) (paracetamol), by maintaining hepatic adenosine 5'-triphosphate (ATP) levels."( Induction of an ATPase inhibitor protein by propylthiouracil and protection against paracetamol (acetaminophen) hepatotoxicity in the rat.
Banerjee, A; Chan, SH; Chiji, H; Cho, C; Linscheer, WG; Murthy, UK; Nandi, J, 1998
)
0.72
" Adverse events were minor and similar between treatments."( Coadministration of acetaminophen and troglitazone: pharmacokinetics and safety.
Eastmond, R; Lettis, S; Young, MA, 1998
)
0.62
" Thus, the protection against APAP toxicity afforded by deletion of both CYP2E1 and CYP1A2 likely reflects greatly diminished production of the toxic electrophile, NAPQI."( Protection against acetaminophen toxicity in CYP1A2 and CYP2E1 double-null mice.
Bruno, MK; Buters, JT; Cohen, SD; Gonzalez, FJ; Lucas, AM; Stern, ST; Ward, JM; Zaher, H, 1998
)
0.63
" We examined the generality of this pattern in livers of rats given a minimally toxic dose of an hepatotoxin and in liver biopsy samples from patients who had taken overdoses of acetaminophen."( Zonal location of compensatory hepatocyte proliferation following chemically induced hepatotoxicity in rats and humans.
Archer, MC; Cameron, RG; Lee, VM,
)
0.32
" The prodrugs were designed to release L-cysteine, which is then available to support glutathione (GSH) biosynthesis and provide cytoprotection against a variety of toxic insults."( Differential chemoprotection against acetaminophen-induced hepatotoxicity by latentiated L-cysteines.
Franklin, MR; Lamb, JG; Phaneuf, HL; Roberts, JC; Szakacs, JG; Zera, RT, 1998
)
0.57
" Selection of pharmacologic therapy for the management of chronic pain must take into consideration the increased potential for adverse effects in this population."( Safety issues in the pharmacologic management of chronic pain in the elderly.
Shimp, LA,
)
0.13
" We studied the effects of acarbose on the hepatotoxicity of carbon tetrachloride (CCl4) and acetaminophen (AP) in rats, both of which exert their toxic effects through bioactivation associated with cytochrome P450 2E1 (CYP2E1)."( Acarbose alone or in combination with ethanol potentiates the hepatotoxicity of carbon tetrachloride and acetaminophen in rats.
Kaneko, T; Sato, A; Wang, PY; Wang, Y, 1999
)
0.74
" In humans, polymorphisms have been associated with adverse drug reactions but have not been shown to cause any serious developmental or physiological defects thus suggesting that in mammals, xenobiotic-metabolizing enzymes may only be required for metabolism of foreign chemicals and have no other critical role."( The study of xenobiotic-metabolizing enzymes and their role in toxicity in vivo using targeted gene disruption.
Gonzalez, FJ, 1998
)
0.3
"We report a case fatality from chronic acetaminophen (APAP) toxicity in an 18-month-old toddler, born 14 weeks premature, who had been receiving less than the standard toxic threshold of the pediatric suspension of APAP for 4 days prior to presentation."( "The silent killer": chronic acetaminophen toxicity in a toddler.
King, W; Nichols, M; Pershad, J, 1999
)
0.86
" We identified epidemiologic studies, published from January 1970 to December 1995, that investigated the association of serious adverse effects with aspirin, diclofenac, acetaminophen, and dipyrone to determine and compare the excess mortality associated with short-term drug use."( Comparative safety evaluation of non-narcotic analgesics.
Andrade, SE; Martinez, C; Walker, AM, 1998
)
0.49
" Administration of deferoxamine (75 mg/kg) 1 h after a toxic dose of acetaminophen (300 mg/kg) significantly delayed the development of the toxicity without altering covalent binding."( Deferoxamine delays the development of the hepatotoxicity of acetaminophen in mice.
Bucci, TJ; Hinson, JA; Kusewitt, DF; Pumford, NR; Schnellmann, JG, 1999
)
0.78
" Results from this work demonstrate that, in the absence of CYP1A2, phenacetin is more toxic than in controls."( Role of CYP1A2 in the toxicity of long-term phenacetin feeding in mice.
Coakley, CJ; Gonzalez, FJ; Kimura, S; Morishima, H; Peters, JM; Ward, JM, 1999
)
0.3
" We have developed a mouse model to demonstrate the toxic effects of methotrexate: mice were given 50 mg/kg acetaminophen, which itself has no effect on the liver."( Nicotinamide and methionine reduce the liver toxic effect of methotrexate.
Bache, K; Hauschild, A; Kröger, H; Krüger, D; Ohde, M; Thefeldt, W; Voigt, WP, 1999
)
0.52
"To compare the incidence of serious adverse clinical events among children <2 years old given ibuprofen and acetaminophen to control fever."( The safety of acetaminophen and ibuprofen among children younger than two years old.
Lesko, SM; Mitchell, AA, 1999
)
0.88
"The risk of serious adverse clinical events among children <2 years old receiving short-term treatment with either acetaminophen or ibuprofen suspension was small and did not vary by choice of medication."( The safety of acetaminophen and ibuprofen among children younger than two years old.
Lesko, SM; Mitchell, AA, 1999
)
0.87
" These results suggest that ethanol inhibited not only the microsomal (CYP2E1 mediated) formation of a toxic quinone metabolite from APAP, but also accelerated the conversion of the toxic quinone metabolite produced back to APAP by stimulating cytoplasmic QR activity."( Protective effect of ethanol against acetaminophen-induced hepatotoxicity in mice: role of NADH:quinone reductase.
Cha, YN; Cho, TS; Kim, DJ; Lee, SM, 1999
)
0.58
"Acetaminophen toxicity in hepatocytes is attributed to generation of the toxic metabolite N-acetyl-p-benzoquinoneimine, leading to depletion of intracellular glutathione, alteration of redox potential and ultimately, cellular necrosis."( Resistance of three immortalized human hepatocyte cell lines to acetaminophen and N-acetyl-p-benzoquinoneimine toxicity.
Edwards, RJ; Hodgson, HJ; McCloskey, P; Roberts, E; Selden, C; Tootle, R, 1999
)
1.98
"We demonstrated that HH25, HH29 and HHY41 are resistant to the toxic effects of acetaminophen under conditions that induce cytotoxicity in rat primary hepatocytes, as indicated by maintenance of glutathione levels and basal LDH release."( Resistance of three immortalized human hepatocyte cell lines to acetaminophen and N-acetyl-p-benzoquinoneimine toxicity.
Edwards, RJ; Hodgson, HJ; McCloskey, P; Roberts, E; Selden, C; Tootle, R, 1999
)
0.77
"We assessed the quality of assessment and reporting of adverse effects in randomized, double-blind clinical trials of single-dose acetaminophen or ibuprofen compared with placebo in moderate to severe postoperative pain."( Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain.
Collins, SL; Edwards, JE; McQuay, HJ; Moore, RA, 1999
)
0.51
"To determine whether the use of diclofenac ophthalmic solution is a safe and effective analgesic in the treatment of traumatic corneal abrasions in the emergency department."( Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions.
Allegra, JR; Eskin, B; Nashed, AH; Szucs, PA, 2000
)
0.31
" The outcome measurements were improvement in NPIS score 2 hours after treatment, use of oxycodone-acetaminophen, and occurrence of any adverse effects."( Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions.
Allegra, JR; Eskin, B; Nashed, AH; Szucs, PA, 2000
)
0.52
"Diclofenac ophthalmic solution appears to be a safe and effective analgesic in the treatment of traumatic corneal abrasions in the ED."( Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions.
Allegra, JR; Eskin, B; Nashed, AH; Szucs, PA, 2000
)
0.31
" Increased caution and awareness of the toxic effects of acetaminophen are needed, and it should be dispensed with appropriate package-label warnings."( [Acetaminophen toxicity in children as a "therapeutic misadventure"].
Granot, E; Ohali, M; Shahroor, S; Shvil, Y, 2000
)
1.46
" Both active treatments had a side effect profile similar to placebo."( Solubilized ibuprofen: evaluation of onset, relief, and safety of a novel formulation in the treatment of episodic tension-type headache.
Ashraf, E; Cooper, S; Doyle, G; Jayawardena, S; Koronkiewicz, K; Packman, B; Packman, E,
)
0.13
" This liver injury is due not to the drug itself but to the formation of the toxic metabolite N-acetyl-p-benzoquinine imine generated through the cytochrome P-450 drug-metabolizing system."( Acetaminophen hepatotoxicity: An update.
Barve, S; Devalarja, R; McClain, CJ; Price, S; Shedlofsky, S,
)
1.57
" We concluded that management of acetaminophen toxicity can be optimized by early identification, obtaining a complete drug screen, starting N-acetylcysteine early or whenever toxic acetaminophen levels or elevated transaminases are identified, and referring patients with acetaminophen toxicity to a liver center."( Acetaminophen hepatoxicity.
Broughan, TA; Soloway, RD, 2000
)
2.03
" This toxic reaction is associated with metabolic activation by the P450 system to form a quinoneimine metabolite, N-acetyl-p-benzoquinoneimine (NAPQI), which covalently binds to proteins and other macromolecules to cause cellular damage."( Increased resistance to acetaminophen hepatotoxicity in mice lacking glutathione S-transferase Pi.
Henderson, CJ; Kitteringham, N; Otto, D; Park, BK; Powell, H; Wolf, CR, 2000
)
0.61
" However, these drugs are associated with an increased risk for the development of adverse sequelae, including serious upper gastrointestinal side effects such as symptomatic ulcers, perforation, obstruction, and gastrointestinal bleeding."( Treatment of osteoarthritis with acetaminophen: efficacy, safety, and comparison with nonsteroidal anti-inflammatory drugs.
Hochberg, MC; Shamoon, M, 2000
)
0.59
" Adverse effects were comparable in the three groups, except for significantly more nausea in the control group (39% vs."( Analgesic efficacy and safety of nefopam vs. propacetamol following hepatic resection.
Fletcher, D; Gillon, MC; Incagnoli, P; Josse, C; Kuhlman, L; Mimoz, O; Mirand, A; Soilleux, H, 2001
)
0.31
" Although the risk of developing toxic reactions to acetaminophen appears to be lower in children than in adults, such reactions occur in pediatric patients from intentional overdoses."( Acetaminophen toxicity in children.
, 2001
)
2
"We recently reported that nitrotyrosine and acetaminophen (APAP)-cysteine protein adducts colocalize in the hepatic centrilobular cells following a toxic dose of APAP to mice."( Acetaminophen-induced hepatotoxicity in mice lacking inducible nitric oxide synthase activity.
Bucci, TJ; Hinson, JA; Irwin, LK; Mayeux, PR; Michael, SL; Pumford, NR; Warbritton, AR, 2001
)
2.01
" Here, to explore its mechanism, we administered APAP at subtoxic (150 mg/kg ip) and toxic (500 mg/kg ip) doses to overnight fasted mice."( Genomics and proteomics analysis of acetaminophen toxicity in mouse liver.
Pognan, F; Ruepp, SU; Shaw, J; Tonge, RP; Wallis, N, 2002
)
0.59
"In order to investigate gene expression changes associated with cytotoxicity, we used cDNA arrays to monitor the expression of over 5,000 genes in response to toxic stress in the HepG2 liver cell line."( Gene expression changes associated with cytotoxicity identified using cDNA arrays.
Gore, MA; Morshedi, MM; Reidhaar-Olson, JF, 2000
)
0.31
" Immediately after this, a toxic dose of acetaminophen (500 mg/kg orally) was administered followed by another administration one hour later (500 mg/kg orally)."( The protective effect of garlic oil on hepatotoxicity induced by acetaminophen in mice and comparison with N-acetylcysteine.
Kalantari, H; Salehi, M, 2001
)
0.81
" Therefore it protects the liver from toxic doses of acetaminophen."( The protective effect of garlic oil on hepatotoxicity induced by acetaminophen in mice and comparison with N-acetylcysteine.
Kalantari, H; Salehi, M, 2001
)
0.8
" Key search terms included acetaminophen, paracetamol, toxic hepatitis, hepatotoxicity, liver dysfunction, overdose, drug toxicity, and poisoning."( Hepatotoxicity associated with chronic acetaminophen administration in patients without risk factors.
Bolesta, S; Haber, SL, 2002
)
0.88
" An evaluation of the literature regarding the toxic potential of acetaminophen when given at doses < or = 4 g/d chronically (> or = 4 d) to adult patients without risk factors was conducted."( Hepatotoxicity associated with chronic acetaminophen administration in patients without risk factors.
Bolesta, S; Haber, SL, 2002
)
0.82
"We recently reported that following a toxic dose of acetaminophen to mice, tyrosine nitration occurs in the protein of cells that become necrotic."( Effect of inhibitors of nitric oxide synthase on acetaminophen-induced hepatotoxicity in mice.
Bucci, TJ; Hinson, JA; Irwin, LK; Mayeux, PR; Michael, SL, 2002
)
0.82
" Several inflammatory cytokines, such as interleukins, transforming growth factor beta1, human hepatocyte growth factor, and lymphotoxin, downregulate gene expression of major cytochrome P-450 enzymes with the specific effects on mRNA levels, protein expression, and enzyme activity observed with a given cytokine varying for each P-450 studied, thus eventually leading to metabolite-mediated adverse drug reactions and immunometallic diseases which sometimes result in tissue injury beyond the site(s) where metabolic bioactivation takes place."( Important role of prodromal viral infections responsible for inhibition of xenobiotic metabolizing enzymes in the pathomechanism of idiopathic Reye's syndrome, Stevens-Johnson syndrome, autoimmune hepatitis, and hepatotoxicity of the therapeutic doses of
Prandota, J,
)
0.13
"The aim of the study was to evaluate the toxic effect of acetaminophen on rat fetuses."( Embryofetotoxicity of acetaminophen (paracetamol) in experimental in vivo model.
Blicharski, T; Burdan, F; Kiś, G; Siezieniewska, Z, 2001
)
0.87
" Studies performed in both experimental animals and humans indicate that chronic alcohol use leads to a short-term, two- to threefold increase in hepatic content of cytochrome P4502E1, the major isoform responsible for the generation of the toxic metabolite from paracetamol, although increased oxidative metabolism of paracetamol at recommended doses has not been demonstrated clinically."( Alcohol exposure and paracetamol-induced hepatotoxicity.
Riordan, SM; Williams, R, 2002
)
0.31
" In conclusion, the administration of 4-MP and/or NAC after 4 h of administering toxic dose of acetaminophen, inhibits hepatotoxicity in rats."( Comparison of the therapeutic efficacy of 4-methylpyrazole and N-acetylcysteine on acetaminophen (paracetamol) hepatotoxicity in rats.
Acar, HV; Cankir, Z; Cermik, H; Cinan, U; Danaci, M; Küçükardali, Y; Nalbant, S; Ozkan, S; Top, C, 2002
)
0.76
" We studied the effects of TRZ on the hepatotoxicity of carbon tetrachloride (CCl(4)) and acetaminophen (APAP) in rats, both of which exert their toxic effects through bioactivation associated with cytochrome P450 3A (CYP3A) and 2E1 (CYP2E1)."( Troglitazone enhances the hepatotoxicity of acetaminophen by inducing CYP3A in rats.
Kaneko, T; Li, J; Qin, LQ; Sato, A; Wang, PY; Wang, Y, 2002
)
0.8
" These results suggest an innovative therapeutic approach for treating the adverse effects of acetaminophen and potentially other hepatotoxic agents."( Modulation of acetaminophen-induced hepatotoxicity by the xenobiotic receptor CAR.
Chua, SS; Huang, W; Moore, DD; Wei, P; Zhang, J, 2002
)
0.89
" Tolerability was assessed by recording adverse events (AEs)."( Comparison of the efficacy and safety of nonprescription doses of naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies.
Akin, MD; Dawood, MY; Milsom, I; Minic, M; Niland, NF; Spann, J; Squire, RA, 2002
)
0.53
" There was no significant difference among the treatment groups in the incidence of adverse events (P=0."( Efficacy and safety of acetaminophen and naproxen in the treatment of tension-type headache. A randomized, double-blind, placebo-controlled trial.
Bowen, DL; Cooper, KM; May, LG; Prior, MJ, 2002
)
0.63
" We describe a case of toxic hepatitis free of the aforementioned risk factors associated with chronic ingestion of moderately excessive doses of acetaminophen."( Chronic acetaminophen toxicity: a case report and review of the literature.
Belson, MG; Brown, DK; Lane, JE; Scheetz, A, 2002
)
0.95
" This protection was associated with decreased formation of the toxic metabolite of APAP."( Effect of caffeine on acetaminophen hepatotoxicity in cultured hepatocytes treated with ethanol and isopentanol.
Bement, J; Chatfield, K; DiPetrillo, K; Jeffery, E; Kostrubsky, V; Sinclair, J; Sinclair, P; Wood, S; Wrighton, S, 2002
)
0.63
" The purpose of this study is to report the frequency of adverse effects from oral superactivated charcoal (SAC) given to healthy volunteers."( Adverse effects of superactivated charcoal administered to healthy volunteers.
Sato, RL; Sumida, SM; Wong, JJ; Yamamoto, LG, 2002
)
0.31
" The adverse effects of both groups were recorded and compared."( Adverse effects of superactivated charcoal administered to healthy volunteers.
Sato, RL; Sumida, SM; Wong, JJ; Yamamoto, LG, 2002
)
0.31
"Superactivated charcoal consumption is associated with significant adverse effects in some healthy volunteers, which may impede a drug overdose patient's ability to willingly drink charcoal slurry in a reasonable period of time."( Adverse effects of superactivated charcoal administered to healthy volunteers.
Sato, RL; Sumida, SM; Wong, JJ; Yamamoto, LG, 2002
)
0.31
" All main flavonolignans of silymarin tested displayed concentration-dependent cytoprotection against the toxic effects of both allyl alcohol and carbon tetrachloride but neither paracetamol nor galactosamine."( Primary cultures of human hepatocytes as a tool in cytotoxicity studies: cell protection against model toxins by flavonolignans obtained from Silybum marianum.
Bachleda, P; Dvorák, Z; Kosina, P; Simánek, V; Ulrichová, J; Walterová, D, 2003
)
0.32
" The protection afforded by V-PYRRO/NO does not appear to be caused by a decrease in the formation of toxic acetaminophen metabolites, which consumes glutathione (GSH), because V-PYRRO/NO did not alter acetaminophen-induced hepatic GSH depletion."( The nitric oxide donor, V-PYRRO/NO, protects against acetaminophen-induced hepatotoxicity in mice.
Clark, J; Keefer, LK; Li, C; Liu, J; Myers, P; Saavedra, JE; Waalkes, MP, 2003
)
0.78
" Somnolence, fatigue, and nausea were the most common volunteered adverse events; only somnolence was significantly greater after CPA than after either PA or placebo."( Efficacy and safety of clemastine-pseudoephedrine-acetaminophen versus pseudoephedrine-acetaminophen in the treatment of seasonal allergic rhinitis in a 1-day, placebo-controlled park study.
Casale, TB; del Rio, E; Gold, MS; Meltzer, EO; O'Connor, R; Reitberg, D; Weiler, JM; Weiler, K, 2003
)
0.57
"Treatment with CPA was safe and highly effective in reducing symptoms associated with SAR."( Efficacy and safety of clemastine-pseudoephedrine-acetaminophen versus pseudoephedrine-acetaminophen in the treatment of seasonal allergic rhinitis in a 1-day, placebo-controlled park study.
Casale, TB; del Rio, E; Gold, MS; Meltzer, EO; O'Connor, R; Reitberg, D; Weiler, JM; Weiler, K, 2003
)
0.57
" The effect of these drugs was also examined in mice challenged with toxic doses of acetaminophen."( Selective blockade of mGlu5 metabotropic glutamate receptors is protective against acetaminophen hepatotoxicity in mice.
Battaglia, G; Freitas, I; Griffini, P; Ngomba, RT; Nicoletti, F; Richelmi, P; Storto, M; Vairetti, M, 2003
)
0.77
") substantially reduced liver necrosis and the production of ROS, although it did not affect the conversion of acetaminophen into the toxic metabolite, N-acetylbenzoquinoneimine."( Selective blockade of mGlu5 metabotropic glutamate receptors is protective against acetaminophen hepatotoxicity in mice.
Battaglia, G; Freitas, I; Griffini, P; Ngomba, RT; Nicoletti, F; Richelmi, P; Storto, M; Vairetti, M, 2003
)
0.76
" It decreases morphine requirements but its effect on the incidence of morphine-related adverse effects remains unknown."( Adjunctive analgesia with intravenous propacetamol does not reduce morphine-related adverse effects.
Aubrun, F; Bellanger, A; Coriat, P; Kalfon, F; Langeron, O; Mottet, P; Riou, B, 2003
)
0.32
" The primary end-point was the incidence of morphine-related adverse effects."( Adjunctive analgesia with intravenous propacetamol does not reduce morphine-related adverse effects.
Aubrun, F; Bellanger, A; Coriat, P; Kalfon, F; Langeron, O; Mottet, P; Riou, B, 2003
)
0.32
"001) but the incidence of morphine-related adverse effects did not differ between groups (42 vs 46%, not significant)."( Adjunctive analgesia with intravenous propacetamol does not reduce morphine-related adverse effects.
Aubrun, F; Bellanger, A; Coriat, P; Kalfon, F; Langeron, O; Mottet, P; Riou, B, 2003
)
0.32
"Although propacetamol induced a small morphine-sparing effect, it did not change the incidence of morphine-related adverse effects in the postoperative period."( Adjunctive analgesia with intravenous propacetamol does not reduce morphine-related adverse effects.
Aubrun, F; Bellanger, A; Coriat, P; Kalfon, F; Langeron, O; Mottet, P; Riou, B, 2003
)
0.32
" We conclude that these drugs are toxic to renal inner medullary collecting duct cells under the conditions of high osmolality normally present in the inner medulla, that combinations of the drugs are more toxic than are the drugs individually, and that the toxicity includes induction of proliferation of these cells that are otherwise quiescent in the presence of high osmolality."( Toxicity of acetaminophen, salicylic acid, and caffeine for first-passage rat renal inner medullary collecting duct cells.
Burg, MB; Cai, Q; Dmitrieva, NI; Ferguson, D; Michea, LF; Rocha, G, 2003
)
0.7
" The Boston University Fever Study aimed to assess the risk of rare but serious adverse events in febrile children."( The safety of ibuprofen suspension in children.
Lesko, SM, 2003
)
0.32
" It has been reported that the toxic effects of AA are the result of oxidative reactions that take place during its metabolism."( Protective effects of melatonin, vitamin E and N-acetylcysteine against acetaminophen toxicity in mice: a comparative study.
Ayanoğlu-Dülger, G; Sehirli, AO; Sener, G, 2003
)
0.55
"In all, 28 of 33 patients (85%) completed the study; discontinuations were for adverse events (N=3), patient choice (N=1), and lack of effectiveness (N =1)."( Effectiveness and safety of new oxycodone/acetaminophen formulations with reduced acetaminophen for the treatment of low back pain.
Domingos, J; Galer, BS; Gammaitoni, AR; Lacouture, P; Schlagheck, T, 2003
)
0.58
" To determine the importance of reversible versus toxic events, N-acetylcysteine (NAC) was administered to mice either before APAP or 1, 2, or 4 h after APAP."( Effect of N-acetylcysteine on acetaminophen toxicity in mice: relationship to reactive nitrogen and cytokine formation.
Hinson, JA; James, LP; Lamps, LW; McCullough, SS, 2003
)
0.61
" The risk of ulcer complications can however be reduced, and perhaps completely removed, by using the lowest dose of the least toxic member of the class."( Adverse effects of conventional non-steroidal anti-inflammatory drugs on the upper gastrointestinal tract.
Langman, MJ, 2003
)
0.32
"Acetaminophen, a safe analgesic when dosed properly but hepatotoxic at overdoses, has been reported to induce DNA strand breaks but it is unclear whether this event preceeds hepatocyte toxicity or is only obvious in case of overt cytotoxicity."( Antioxidants protect primary rat hepatocyte cultures against acetaminophen-induced DNA strand breaks but not against acetaminophen-induced cytotoxicity.
El-Bahay, C; Hanelt, S; Kahl, R; Lewerenz, V; Nastevska, C; Röhrdanz, E, 2003
)
2
" The protection offered by arabic gum does not appear to be caused by a decrease in the formation of toxic acetaminophen metabolites, which consumes glutathione, because arabic gum did not alter acetaminophen-induced hepatic glutathione depletion."( Protective effect of arabic gum against acetaminophen-induced hepatotoxicity in mice.
Al-Bekairi, AM; Al-Shabanah, OA; Gamal el-din, AM; Mostafa, AM; Nagi, MN, 2003
)
0.8
"The hepatic toxic response to acetaminophen (APAP) is characterized by centrilobular (CL) necrosis preceded by hepatic microvascular injury and congestion."( Early hepatic microvascular injury in response to acetaminophen toxicity.
Abril, ER; Bethea, NW; Ito, Y; McCuskey, RS, 2003
)
0.86
"The relative influence of various risk factors for adverse events (AE) in analgesics users have never been precisely quantified."( Risk factors for adverse events in analgesic drug users: results from the PAIN study.
Charlesworth, A; Jones, JK; LeParc, JM; Moore, N; Schneid, H; Van Ganse, E; Verrière, F; Wall, R,
)
0.13
" Recent data have shown that nitrated tyrosine residues as well as acetaminophen adducts occur in the necrotic cells following toxic doses of acetaminophen."( Acetaminophen-induced hepatotoxicity.
Hinson, JA; James, LP; Mayeux, PR, 2003
)
2
"The effects of toxic and nontoxic compound treatments were investigated by high resolution custom developed 2-11 pH gradient NEPHGE (non equilibrium pH gradient electrophoresis) two-dimensional electrophoresis."( Toward the identification of liver toxicity markers: a proteome study in human cell culture and rats.
Bonk, I; Bryant, S; Klatt, M; Köpke, A; Nebrich, G; Taufmann, M; Thome-Kromer, B; Wacker, U, 2003
)
0.32
"We conduct a study to determine the rate of adverse events (anaphylactoid and cardiorespiratory) associated with the use of oral N-acetylcysteine by the intravenous route for the treatment of suspected acetaminophen poisoning and to examine specific variables that may be associated with adverse events."( What is the rate of adverse events after oral N-acetylcysteine administered by the intravenous route to patients with suspected acetaminophen poisoning?
Brizendine, EJ; Furbee, RB; Kao, LW; Kirk, MA; Mehta, NH; Skinner, JR, 2003
)
0.71
" Adverse events were divided into categories of cutaneous, systemic, or life threatening."( What is the rate of adverse events after oral N-acetylcysteine administered by the intravenous route to patients with suspected acetaminophen poisoning?
Brizendine, EJ; Furbee, RB; Kao, LW; Kirk, MA; Mehta, NH; Skinner, JR, 2003
)
0.52
"There were 7 adverse events identified in 187 patients (3."( What is the rate of adverse events after oral N-acetylcysteine administered by the intravenous route to patients with suspected acetaminophen poisoning?
Brizendine, EJ; Furbee, RB; Kao, LW; Kirk, MA; Mehta, NH; Skinner, JR, 2003
)
0.52
"Intravenous administration of an oral solution of N-acetylcysteine is associated with a low rate of adverse events and should be considered for selected patients with suspected acetaminophen poisoning."( What is the rate of adverse events after oral N-acetylcysteine administered by the intravenous route to patients with suspected acetaminophen poisoning?
Brizendine, EJ; Furbee, RB; Kao, LW; Kirk, MA; Mehta, NH; Skinner, JR, 2003
)
0.72
" The most common treatment-related adverse events for tramadol/APAP were somnolence (6."( Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial.
Emkey, R; Jordan, D; Kamin, M; Rosenthal, N; Wu, SC, 2004
)
0.61
"5 mg/APAP 325 mg combination tablets were effective and safe as add-on therapy with COX-2 NSAID for treatment of OA pain."( Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial.
Emkey, R; Jordan, D; Kamin, M; Rosenthal, N; Wu, SC, 2004
)
0.61
"Paracetamol has always been regarded as a useful and safe drug."( Hepatotoxicity and persistent renal insufficiency after repeated supratherapeutic paracetamol ingestion in a Chinese boy.
Fu, YM; Kwok, KL; Ng, DK, 2004
)
0.32
"To assess the effectiveness of pretreatment with ibuprofen or acetaminophen compared with no pretreatment in decreasing adverse events in children and adolescents receiving the first and second series of pamidronate therapy; and to compare the effectiveness of ibuprofen versus acetaminophen for prevention of adverse events associated with pamidronate infusion."( Effectiveness of pretreatment in decreasing adverse events associated with pamidronate in children and adolescents.
Bates, CM; Batisky, DL; Hayes, JR; Mahan, JD; Nahata, MC; Robinson, RE, 2004
)
0.56
" Adverse drug events secondary to pamidronate infusion and subsequent drug therapies received were documented."( Effectiveness of pretreatment in decreasing adverse events associated with pamidronate in children and adolescents.
Bates, CM; Batisky, DL; Hayes, JR; Mahan, JD; Nahata, MC; Robinson, RE, 2004
)
0.32
"Pretreatment with ibuprofen or acetaminophen appears to decrease the occurrence of adverse events from pamidronate therapy."( Effectiveness of pretreatment in decreasing adverse events associated with pamidronate in children and adolescents.
Bates, CM; Batisky, DL; Hayes, JR; Mahan, JD; Nahata, MC; Robinson, RE, 2004
)
0.61
" Thereafter, two groups of 15 male Sprague-Dawley rats each were treated with the toxic dose of paracetamol intraperitoneally to induce severe hepatotoxicity."( The role of cytochrome-P450 inhibitors in the prevention of hepatotoxicity after paracetamol overdose in rats.
Abraham, AM; Barr, S; Coetsee, C; Walubo, A, 2004
)
0.32
" The results show that these two technology platforms together offer a complementary view into cellular responses to toxic processes, providing new insight into the toxic consequences, even for well-studied therapeutic agents such as acetaminophen."( Integrated application of transcriptomics and metabonomics yields new insight into the toxicity due to paracetamol in the mouse.
Coen, M; Lenz, EM; Lindon, JC; Nicholson, JK; Pognan, F; Ruepp, SU; Wilson, ID, 2004
)
0.51
" In conclusion, this study provides evidence that supports the hypothesis that gene expression profiling may be a sensitive means of identifying indicators of potential adverse effects in the absence of the occurrence of overt toxicity."( Gene expression profiling of rat livers reveals indicators of potential adverse effects.
Blackshear, PE; Boorman, GA; Cunningham, ML; Fannin, RD; Heinloth, AN; Irwin, RD; Li, L; Nettesheim, P; Paules, RS; Sieber, SO; Snell, ML; Tennant, RW; Travlos, GS; Tucker, CJ; Vansant, G, 2004
)
0.32
"Paracetamol is classically considered as a very safe analgesic/antipyretic compound and, more specifically, as being virtually devoid of any gastrointestinal (GI) ulcerogenic potential."( Gastrointestinal safety of paracetamol: is there any cause for concern?
Bannwarth, B, 2004
)
0.32
"A double null mouse line (2XENKO) lacking the xenobiotic receptors CAR (constitutive androstane receptor) (NR1I3) and PXR (pregnane X receptor) (NR1I2) was generated to study their functions in response to potentially toxic xenobiotic and endobiotic stimuli."( The constitutive androstane receptor and pregnane X receptor function coordinately to prevent bile acid-induced hepatotoxicity.
Evans, RM; Huang, W; Moore, DD; Qatanani, M; Zhang, J, 2004
)
0.32
" Activation of PXR represents an important mechanism for the induction of cytochrome P450 3A (CYP3A) enzymes that can convert acetaminophen (APAP) to its toxic intermediate metabolite, N-acetyl-p-benzoquinone imine (NAPQI)."( Enhanced acetaminophen toxicity by activation of the pregnane X receptor.
Aleksunes, LA; Gonzalez, FJ; Guo, GL; Kliewer, SA; Manautou, JE; Moffit, JS; Nicol, CJ; Slitt, AL; Ward, JM, 2004
)
0.95
" A standardized form was used to abstract all data, including outcome measures of pain at rest, walking pain, and dropouts due to adverse effects."( A comparison of the efficacy and safety of nonsteroidal antiinflammatory agents versus acetaminophen in the treatment of osteoarthritis: a meta-analysis.
Balshaw, R; Barlas, S; Lee, C; Schnitzer, TJ; Straus, WL; Vogel, S, 2004
)
0.55
" Safety, measured by discontinuation due to adverse events, was not statistically different between NSAID- and acetaminophen-treated groups."( A comparison of the efficacy and safety of nonsteroidal antiinflammatory agents versus acetaminophen in the treatment of osteoarthritis: a meta-analysis.
Balshaw, R; Barlas, S; Lee, C; Schnitzer, TJ; Straus, WL; Vogel, S, 2004
)
0.76
" Moreover, our data suggest that the toxic mechanism of AAP differs from that of NAPQI."( Enhancement of acetaminophen cytotoxicity in selenium-binding protein-overexpressed COS-1 cells.
Abe, M; Ishida, T; Oguri, K; Yamada, H, 2004
)
0.68
" This species is normally detoxified by GSH, but following a toxic dose GSH is depleted and the metabolite covalently binds to a number of different proteins."( Acetaminophen-induced hepatotoxicity: role of metabolic activation, reactive oxygen/nitrogen species, and mitochondrial permeability transition.
Hinson, JA; James, LP; McCullough, SS; Reid, AB, 2004
)
1.77
" The most common treatment related adverse events with tramadol/APAP were nausea (12."( Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial.
Beaulieu, A; Fortin, L; Kamin, M; Peloso, PM; Rosenthal, N, 2004
)
0.59
"C57BL/6 mice were administered a toxic dose of APAP intraperitoneally to cause liver injury with or without depletion of NK and NKT cells by anti-NK1."( Innate immune system plays a critical role in determining the progression and severity of acetaminophen hepatotoxicity.
Govindarajan, S; Kaplowitz, N; Liu, ZX, 2004
)
0.54
" It is highly likely that critical, limiting steps in any given mechanistic pathway may become overwhelmed with increasing exposures, signaling the emergence of new modalities of toxic tissue injury at these higher doses."( Dose-dependent transitions in mechanisms of toxicity: case studies.
Andersen, ME; Bogdanffy, MS; Bus, JS; Cohen, SD; Conolly, RB; David, RM; Doerrer, NG; Dorman, DC; Gaylor, DW; Hattis, D; Rogers, JM; Setzer, RW; Slikker, W; Swenberg, JA; Wallace, K, 2004
)
0.32
" In particular, hepatocyte subpopulations are distributed along the sinusoid in zones 1 to 3, leading to prototypical "periportal" and "centrilobular" patterns of cell death in response to a toxic insult."( In vitro zonation and toxicity in a hepatocyte bioreactor.
Allen, JW; Bhatia, SN; Khetani, SR, 2005
)
0.33
" Indeed, pretreatment of male CD-1 mice with APAP-CYS before challenge with a threshold toxic dose of APAP resulted in significant enhancement of APAP-induced nephrotoxicity."( Contribution of acetaminophen-cysteine to acetaminophen nephrotoxicity in CD-1 mice: I. Enhancement of acetaminophen nephrotoxicity by acetaminophen-cysteine.
Bruno, MK; Cohen, SD; Hennig, GE; Horton, RA; Roberts, JC; Stern, ST, 2005
)
0.67
" This APAP-CYS-induced renal GSH depletion could interfere with intrarenal detoxification of APAP or its toxic metabolite N-acetyl-p-benzoquinoneimine (NAPQI) and may be the mechanism responsible for the potentiation of APAP nephrotoxicity."( Contribution of acetaminophen-cysteine to acetaminophen nephrotoxicity II. Possible involvement of the gamma-glutamyl cycle.
Bruno, MK; Cohen, SD; Hill, DW; Horton, RA; Roberts, JC; Stern, ST, 2005
)
0.67
"Acetaminophen (paracetamol), one of the most widely used analgesics, is toxic under conditions of overdose or in certain disease conditions, but the mechanism of acetaminophen toxicity is still not entirely understood."( Acetaminophen toxicity and resistance in the yeast Saccharomyces cerevisiae.
Bachhawat, AK; Chakraborti, AK; Srikanth, CV, 2005
)
3.21
" Safety was monitored through adverse event reporting, clinical examination, and laboratory testing."( Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery.
Groudine, SB; Jahr, JS; Payen-Champenois, C; Reynolds, LW; Sinatra, RS; Viscusi, ER, 2005
)
0.56
"Acetaminophen poisoning accounts for a disproportionate percentage of all toxic ingestions, and can be life-threatening."( An update of N-acetylcysteine treatment for acute acetaminophen toxicity in children.
Marzullo, L, 2005
)
2.02
" This review summarizes this controversy, and offers a framework to develop a safe treatment plan that has the optimal outcome for the patient, as well as reflecting knowledge of the potential caveats at work."( An update of N-acetylcysteine treatment for acute acetaminophen toxicity in children.
Marzullo, L, 2005
)
0.58
" The rate of adverse hypersensitivity reactions to these agents is generally low."( Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and nimesulide associated or not with common non-steroidal anti-inflammatory drugs.
D'Amato, G; D'Amato, M; Liccardi, G; Piccolo, A; Piscitelli, E; Salzillo, A; Senna, G, 2005
)
0.57
"We evaluated the tolerability of CE in a group of patients with documented history of adverse cutaneous reactions to P and N associated or not to classic NSAIDs."( Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and nimesulide associated or not with common non-steroidal anti-inflammatory drugs.
D'Amato, G; D'Amato, M; Liccardi, G; Piccolo, A; Piscitelli, E; Salzillo, A; Senna, G, 2005
)
0.57
" Each side effect was recoded into a dichotomous response (i."( Time-contingent dosing of an opioid analgesic after tonsillectomy does not increase moderate-to-severe side effects in children.
Holdridge-Zeuner, D; Lanier, B; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2005
)
0.33
"In the field of gene expression analysis, DNA microarray technology has a major impact on many different areas including toxicogenomics, such as in predicting the adverse effects of new drug candidates and improving the process of risk assessment and safety evaluation."( Relationship between hepatic gene expression profiles and hepatotoxicity in five typical hepatotoxicant-administered rats.
Kato, H; Katoh, M; Minami, K; Nakajima, M; Narahara, M; Saito, T; Sugiyama, H; Tomita, H; Yokoi, T, 2005
)
0.33
" The administration of a toxic dose of acetaminophen (3."( Platelet-activating factor (PAF) involvement in acetaminophen-induced liver toxicity and regeneration.
Basayiannis, AC; Demopoulos, CA; Grypioti, AD; Mykoniatis, MG; Papadimas, GK; Papadopoulou-Daifoti, Z; Theocharis, SE, 2005
)
0.85
" We demonstrate that this non-negative area estimates the cellular burden of toxic adducts formed following overdose."( A new predictor of toxicity following acetaminophen overdose based on pretreatment exposure.
Good, AM; Johnson, DW; Juurlink, DN; Sivilotti, ML; Yarema, MC, 2005
)
0.6
" Adverse events occurred with the same frequency in the 3 treatment groups."( Analgesic efficacy and safety of intravenous paracetamol (acetaminophen) administered as a 2 g starting dose following third molar surgery.
Hiesse-Provost, O; Jensen, TS; Juhl, GI; Norholt, SE; Tonnesen, E, 2006
)
0.58
"Administration of the non-metabolizable organic anion indocyanine green (ICG) prior to a toxic dose of acetaminophen (4-acetamidophenol; APAP) reduces liver injury 24h after dosing."( Cholestasis induced by model organic anions protects from acetaminophen hepatotoxicity in male CD-1 mice.
Hennig, GE; Manautou, JE; Silva, VM, 2006
)
0.79
"APAP is likely to remain a common toxic exposure and continue to cause significant morbidity and mortality."( Updates on acetaminophen toxicity.
Eldridge, DL; Kirk, MA; Norvell, J; Rowden, AK, 2005
)
0.72
" In addition, the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers (AAPCC) database was searched for human exposure cases."( The safety profile of sustained release paracetamol during therapeutic use and following overdose.
Bogdan, GM; Dart, RC; Green, JL, 2005
)
0.33
" The strongest predictor of severe hepatotoxicity was delayed or no N-acetyl cysteine treatment in patients consuming greater than 10 g of paracetamol or with toxic serum paracetamol levels."( Paracetamol overdose and hepatotoxicity at a regional Australian hospital: a 4-year experience.
Ayonrinde, OA; Ayonrinde, OT; Hurley, JC; Phelps, GJ, 2005
)
0.33
" Mrp2 expression not only is important in biliary excretion, but also influences the toxic potential of reactive intermediates by controlling intrahepatic GSH and possibly drug metabolism."( Transport deficient (TR-) hyperbilirubinemic rats are resistant to acetaminophen hepatotoxicity.
Chen, C; Manautou, JE; Silva, VM; Thibodeau, MS, 2005
)
0.56
" The difference in toxic response to APAP between knockout and control strain mice could not be attributed to differences in APAP bioactivation, assessed by measurement of CYP2E1 and glutathione S-transferase activities, hepatic nonprotein sulfhydryl content, or covalent binding of reactive APAP metabolites to proteins."( Increased hepatotoxicity of acetaminophen in Hsp70i knockout mice.
Dix, DJ; Roberts, SM; Tolson, JK; Voellmy, RW, 2006
)
0.63
"Acetaminophen (paracetamol-P) is a widely used analgesic-antipyretic drug with no anti inflammatory effects and its rate of adverse hypersensitivity reactions is very low."( Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and other non-steroidal anti-inflammatory drugs.
Cazzola, M; D'Amato, G; D'Amato, M; De Giglio, C; Liccardi, G; Manfredi, D; Piscitelli, E, 2005
)
2.01
"We evaluated the tolerability of CE in a group of patients with documented history of adverse cutaneous reactions to P and to classic NSAIDs."( Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and other non-steroidal anti-inflammatory drugs.
Cazzola, M; D'Amato, G; D'Amato, M; De Giglio, C; Liccardi, G; Manfredi, D; Piscitelli, E, 2005
)
0.57
" It was reported that these toxic effects of AAP are due to oxidative reactions that take place during its metabolism."( Protective effects of ginkgo biloba against acetaminophen-induced toxicity in mice.
Ercan, F; Gedik, N; Omurtag, GZ; Sehirli, O; Sener, G; Tozan, A; Yüksel, M, 2006
)
0.59
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
"Accidental or incidental paracetamol overdose in children may be associated with toxic liver damage leading to fulminant liver failure."( Paracetamol induced hepatotoxicity.
Davies, P; Kelly, DA; Mahadevan, SB; McKiernan, PJ, 2006
)
0.33
" Expression of platelet endothelial cell adhesion molecule, a measure of small vessel density, and endothelial nitric oxide synthase (NOS), a downstream target of VEGFR2, were increased at 48 and 72 h following toxic doses of APAP, and treatment with SU5416 decreased their expression."( Vascular endothelial growth factor and hepatocyte regeneration in acetaminophen toxicity.
Donahower, B; Hinson, JA; James, LP; Kurten, R; Lamps, LW; McCullough, SS; Simpson, P, 2006
)
0.57
" Male and female mice were injected with a toxic dose of APAP (500 mg/kg, ip)."( Acetaminophen metabolism does not contribute to gender difference in its hepatotoxicity in mouse.
Chou, N; Dai, G; He, L; Wan, YJ, 2006
)
1.78
"This study was conducted to determine the impact of knockout of selenium (Se)-dependent glutathione peroxidase-1 (GPX1-/-) or double knockout of GPX1 and copper, zinc (Cu,Zn)-super-oxide dismutase (SOD1) on cell death induced by acetaminophen (APAP) and its major toxic metabolite N-acetyl-P-benzoquinoneimine (NAPQI)."( Double null of selenium-glutathione peroxidase-1 and copper, zinc-superoxide dismutase enhances resistance of mouse primary hepatocytes to acetaminophen toxicity.
Lei, XG; Zhu, JH, 2006
)
0.72
"Severe injury to the liver, such as that induced by toxic doses of acetaminophen, triggers a cascade of events leading to hepatocyte death."( Blockade of the receptor for advanced glycation end products attenuates acetaminophen-induced hepatotoxicity in mice.
Dun, H; Ekong, U; Emond, JC; Feirt, N; Guarrera, JV; Guo, J; Ippagunta, N; Lu, Y; Qu, W; Ramasamy, R; Schmidt, AM; Weinberg, A; Zeng, S, 2006
)
0.8
"A model was employed in which toxic doses of acetaminophen (1125 mg/kg) were administered to C57BL/6 mice."( Blockade of the receptor for advanced glycation end products attenuates acetaminophen-induced hepatotoxicity in mice.
Dun, H; Ekong, U; Emond, JC; Feirt, N; Guarrera, JV; Guo, J; Ippagunta, N; Lu, Y; Qu, W; Ramasamy, R; Schmidt, AM; Weinberg, A; Zeng, S, 2006
)
0.83
" Tolerability evaluations consisted of determinations of hepatic (aminotransferase activities) and renal (serum creatinine) function, adverse events, and physical examinations."( Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6-12 months) safety of acetaminophen in adult patients with osteoarthritis.
Benson, GD; Schweinle, JE; Temple, AR; Zinsenheim, JR, 2006
)
0.54
" No statistically significant differences were observed between the 2 treatment groups in the proportion of patients who reported > or = 1 adverse event (206 [71."( Multicenter, randomized, double-blind, active-controlled, parallel-group trial of the long-term (6-12 months) safety of acetaminophen in adult patients with osteoarthritis.
Benson, GD; Schweinle, JE; Temple, AR; Zinsenheim, JR, 2006
)
0.54
" In SH-SY5Y cells amitriptyline was severely toxic, while selegiline and paracetamol failed to show any toxic effect, and carbamazepine was only slightly toxic at the highest concentration."( The combined use of human neural and liver cell lines and mouse hepatocytes improves the predictability of the neurotoxicity of selected drugs.
Mannerström, M; Tähti, H; Toimela, T; Ylikomi, T, 2006
)
0.33
" C57BL/6 mice were given an intraperitoneal toxic dose of APAP (500 mg/kg), which caused severe acute liver injury characterized by significant elevation of serum ALT, centrilobular hepatic necrosis, and increased hepatic inflammatory cell accumulation."( Neutrophil depletion protects against murine acetaminophen hepatotoxicity.
Gunawan, B; Han, D; Kaplowitz, N; Liu, ZX, 2006
)
0.59
"Mouse hepatocytes and C57BL/6 mice were administered a toxic dose of APAP with or without SP600125, a chemical c-jun N-terminal kinase (JNK) inhibitor."( c-Jun N-terminal kinase plays a major role in murine acetaminophen hepatotoxicity.
Gaarde, WA; Gunawan, BK; Han, D; Hanawa, N; Kaplowitz, N; Liu, ZX, 2006
)
0.58
" The toxic response to APAP is triggered by a highly reactive metabolite N-acetyl-p-benzoquinone-imine."( Role of innate immunity in acetaminophen-induced hepatotoxicity.
Kaplowitz, N; Liu, ZX, 2006
)
0.63
" The review establishes that aspirin, paracetamol and ibuprofen are safe in OTC doses and that there is no evidence for any difference between the medicines as regards efficacy and safety for treatment of colds and flu (except in certain cases such as the use of aspirin in feverish children)."( Efficacy and safety of over-the-counter analgesics in the treatment of common cold and flu.
Eccles, R, 2006
)
0.33
"Despite the lack of clinical data on the safety and efficacy of analgesics for the treatment of colds and flu symptoms a case can be made that these medicines are safe and effective for treatment of these common illnesses."( Efficacy and safety of over-the-counter analgesics in the treatment of common cold and flu.
Eccles, R, 2006
)
0.33
" Because NSAIDs are associated with adverse renal effects, they should be used cautiously in patients with advanced renal disease."( Safe pharmacologic treatment strategies for osteoarthritis pain in African Americans with hypertension, and renal and cardiac disease.
Johnson, J; Weinryb, J, 2006
)
0.33
"Paracetamol is regarded as a relatively safe drug in the gastro-duodenal region of humans but recent epidemiological investigations have suggested that at high doses there may be an increased risk of ulcers and bleeding."( Paracetamol [acetaminophen]-induced gastrotoxicity: revealed by induced hyperacidity in combination with acute or chronic inflammation.
Rainsford, KD; Whitehouse, MW, 2006
)
0.7
" Safety assessments included monitoring vital signs, adverse events, study joint assessments, and clinical laboratory results at each study visit."( Three-month efficacy and safety of acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double-blind, placebo-controlled study.
Altman, RD; Schweinle, JE; Temple, AR; Zinsenheim, JR, 2007
)
0.62
" Study treatments were generally well tolerated, and there was no significant difference among the groups in the overall number of adverse events."( Three-month efficacy and safety of acetaminophen extended-release for osteoarthritis pain of the hip or knee: a randomized, double-blind, placebo-controlled study.
Altman, RD; Schweinle, JE; Temple, AR; Zinsenheim, JR, 2007
)
0.62
" Male rats were treated with acetaminophen (APAP), carbon tetrachloride (CCL), amiodarone (AD) or tetracycline (TC) at toxic doses."( Genomic cluster and network analysis for predictive screening for hepatotoxicity.
Fukushima, T; Hamada, Y; Horii, I; Kikkawa, R, 2006
)
0.63
" Their detection in the environment and their bioactivity have resulted in concern for potential adverse effects on non-target species."( Aquatic toxicity of acetaminophen, carbamazepine, cimetidine, diltiazem and six major sulfonamides, and their potential ecological risks in Korea.
Choi, K; Jung, J; Kim, PG; Kim, Y; Park, J; Park, S, 2007
)
0.66
"3 mug/ml (trough plasma concentration (C(min)) measured just before the next infusion) without any C(max) in the toxic range for any subject."( Safety and pharmacokinetics of paracetamol following intravenous administration of 5 g during the first 24 h with a 2-g starting dose.
Dufour, G; Evene, E; Gendron, A; Gregoire, N; Gualano, V; Hovsepian, L, 2007
)
0.34
"This study was used to test the effect on planned safe use of over-the-counter (OTC) analgesics of adding information about the potential for nonsteroidal anti-inflammatory drug (NSAID) interaction with antihypertensive medications, the potential for interaction of alcohol and acetaminophen, and NSAID ceiling effects to the Federal Drug Administration's (FDA's) OTC analgesics pamphlet."( Effect of reading additional safety information on planned use of over-the-counter analgesics.
Amendola, MG; Interlandi, E; Inthavong, S; Lewchik, B; Li, L; McDonald, DD; Pace, N; Polouse, L; Wall, K,
)
0.31
" Using the power of prospective multilaboratory investigations, seven centers individually conducted a common toxicogenomics experiment designed to advance understanding of molecular pathways perturbed in liver by an acute toxic dose of N-acetyl-p-aminophenol (APAP) and to uncover reproducible genomic signatures of APAP-induced toxicity."( Multicenter study of acetaminophen hepatotoxicity reveals the importance of biological endpoints in genomic analyses.
Bammler, TK; Beyer, RP; Bradford, BU; Cranson, AB; Cunningham, ML; Fannin, RD; Freedman, JH; Fry, RC; Higgins, GM; Hurban, P; Kaufmann, WK; Kavanagh, TJ; Kayton, RJ; Kerr, KF; Kosyk, O; Lasarev, MR; Linney, E; Lobenhofer, EK; McConnachie, LA; Meira, LB; Palmer, VS; Paules, RS; Powell, CL; Ross, PK; Rusyn, I; Samson, LD; Sieber, SO; Spencer, PS; Suk, W; Tennant, RJ; Vliet, PA; Weis, BK; Wolfinger, R; Woods, CG; Zarbl, H, 2007
)
0.66
" Detailed clinical analysis of patients after intake of toxic doses of paracetamol revealed, apart from hepatotoxicity, cases of acute renal failure."( [Selected biochemical parameters of urine in the evaluation of paracetamol nephrotoxicity].
Długosz, A; Kochman, K; Lepka, M; Marchewka, Z; Przewłocki, M, 2006
)
0.33
" On the basis of performed investigations it may be assumed that the determination of these parameters in urine will enable early detection of changes in the kidneys occurring under the influence of toxic doses of paracetamol and prevent their further development due to appropriate therapeutic management."( [Selected biochemical parameters of urine in the evaluation of paracetamol nephrotoxicity].
Długosz, A; Kochman, K; Lepka, M; Marchewka, Z; Przewłocki, M, 2006
)
0.33
"Acetaminophen has been widely used for > 50 years in the treatment of pain and fever and provides for the safe and effective relief of these symptoms."( Acetaminophen safety and hepatotoxicity--where do we go from here?
Amar, PJ; Schiff, ER, 2007
)
3.23
" Primary safety/tolerability endpoints included the mortality rate and incidence of adverse drug reactions, while efficacy endpoints included alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels."( Safety and efficacy of intravenous N-acetylcysteine for acetaminophen overdose: analysis of the Hunter Area Toxicology Service (HATS) database.
Dawson, AH; Francis, B; Whyte, IM, 2007
)
0.59
"3%) had an adverse drug reaction to IV-NAC, of which seven (1."( Safety and efficacy of intravenous N-acetylcysteine for acetaminophen overdose: analysis of the Hunter Area Toxicology Service (HATS) database.
Dawson, AH; Francis, B; Whyte, IM, 2007
)
0.59
" It is safe when taken at therapeutic doses; however, overdose can lead to serious and even fatal hepatotoxicity."( Acetaminophen hepatotoxicity.
Larson, AM, 2007
)
1.78
" In this situation, newborns might be exposed to toxic levels of morphine when breastfeeding."( Safety of codeine during breastfeeding: fatal morphine poisoning in the breastfed neonate of a mother prescribed codeine.
Aleksa, K; Cairns, J; Chitayat, D; Gaedigk, A; Karaskov, T; Koren, G; Leeder, JS; Madadi, P; Teitelbaum, R, 2007
)
0.34
" Simultaneous treatment with flutamide and acetaminophen (APAP) resulted in additive to synergistic toxic effects."( Transport, metabolism, and hepatotoxicity of flutamide, drug-drug interaction with acetaminophen involving phase I and phase II metabolites.
Ellis, E; Kostrubsky, SE; Mutlib, AE; Nelson, SD; Strom, SC, 2007
)
0.83
" Previous studies demonstrated differential expression of hepatobiliary transporter mRNA in mice treated with a toxic dose of APAP dissolved in 50% propylene glycol."( Influence of acetaminophen vehicle on regulation of transporter gene expression during hepatotoxicity.
Aleksunes, LM; Augustine, LM; Cherrington, NJ; Manautou, JE, 2007
)
0.71
" Administration of toxic APAP doses to C57BL/6J mice generates electrophilic stress and subsequently increases levels of hepatic Nqo1, Gclc and the efflux multidrug resistance-associated protein transporters 1-4 (Mrp1-4)."( Induction of Mrp3 and Mrp4 transporters during acetaminophen hepatotoxicity is dependent on Nrf2.
Aleksunes, LM; Augustine, LM; Chan, JY; Cherrington, NJ; Goedken, MJ; Klaassen, CD; Maher, JM; Manautou, JE; Slitt, AL, 2008
)
0.6
"Although used widely and recognized as a safe drug at therapeutic dose, acetaminophen has a narrow therapeutic margin."( [Acetaminophen: hepatotoxicity at therapeutic doses and risk factors].
Hadengue, A; Iten, A; Seirafi, M, 2007
)
1.48
" Prazosin prevented hepatotoxicity when administered 1 h before a toxic paracetamol insult and importantly, when administered up to 1 h post paracetamol injection."( alpha(1)-Adrenoceptor antagonists prevent paracetamol-induced hepatotoxicity in mice.
Kitteringham, NR; Macdonald, I; Park, BK; Randle, LE; Sathish, JG; Williams, DP, 2008
)
0.35
" Hemodynamic data, sedation scores, and renal and hepatic function were assessed for control of adverse events."( Clinical analgesic efficacy and side effects of dexmedetomidine in the early postoperative period after arthroscopic knee surgery.
Gómez-Vázquez, ME; Hernández-Jiménez, A; Hernández-Salazar, E; Pérez-Sánchez, A; Salazar-Páramo, M; Zepeda-López, VA, 2007
)
0.34
" The most frequent adverse events with dexmedetomidine were bradycardia and hypertension."( Clinical analgesic efficacy and side effects of dexmedetomidine in the early postoperative period after arthroscopic knee surgery.
Gómez-Vázquez, ME; Hernández-Jiménez, A; Hernández-Salazar, E; Pérez-Sánchez, A; Salazar-Páramo, M; Zepeda-López, VA, 2007
)
0.34
" In conclusion, NAC is safe in non-acetaminophen-induced ALF."( Safety and efficacy of N-acetylcysteine in children with non-acetaminophen-induced acute liver failure.
Bansal, S; Cheeseman, P; Dhawan, A; Kortsalioudaki, C; Mieli-Vergani, G; Taylor, RM, 2008
)
0.86
"In summary, scientific evidence demonstrates that the rate of serious GI adverse events associated with the use of NSAIDs is comparatively low depending on the definition used, serious GI adverse events occur in 1% of patients each year and occurs in the use of high doses with long-term treatment in chronic conditions."( Ibuprofen and gastrointestinal safety: a dose-duration-dependent phenomenon.
Bjarnason, I, 2007
)
0.34
" As model toxic compounds lipopolysaccharide (LPS, inducing inflammation), paracetamol (necrosis), carbon tetrachloride (CCl(4), fibrosis and necrosis) and gliotoxin (apoptosis) were used."( Microarray analysis in rat liver slices correctly predicts in vivo hepatotoxicity.
Bauerschmidt, S; Draaisma, AL; Elferink, MG; Groothuis, GM; Merema, MT; Olinga, P; Polman, J; Schoonen, WG, 2008
)
0.35
" Mice were administered a diet supplemented with GrTP or vehicle for 5 consecutive days followed by intraperitoneal (IP) injection of a toxic dose of APAP or sham."( Green-tea polyphenols downregulate cyclooxygenase and Bcl-2 activity in acetaminophen-induced hepatotoxicity.
Chen, TS; Oz, HS, 2008
)
0.58
" On the 32nd day, a marginally toxic dose of APAP (360 mg/kg, ip) yielded 70% mortality in steatohepatitic mice, while all non steatohepatitic mice receiving the same dose survived."( Nonalcoholic steatohepatitic (NASH) mice are protected from higher hepatotoxicity of acetaminophen upon induction of PPARalpha with clofibrate.
Bhave, VS; Donthamsetty, S; Latendresse, JR; Mehendale, HM; Mitra, MS, 2008
)
0.57
"Acetaminophen (APAP) is safe at therapeutic levels but causes liver injury via N-acetyl-p-benzoquinone imine (NAPQI)-induced oxidative stress when overdose."( Prevention of acetaminophen (APAP)-induced hepatotoxicity by leflunomide via inhibition of APAP biotransformation to N-acetyl-p-benzoquinone imine.
Chan, EC; New, LS; Tan, SC, 2008
)
2.15
"In patients with massive acetaminophen ingestion, erratic absorption may occur, and toxic serum concentrations may persist beyond a standard 21-hour course of intravenous NAC therapy."( Acetaminophen overdose with altered acetaminophen pharmacokinetics and hepatotoxicity associated with premature cessation of intravenous N-acetylcysteine therapy.
Hoffman, RS; Howland, MA; Nelson, LS; Smith, SW, 2008
)
2.09
" Erdosteine prevented APAP-induced liver injury and toxic side effects probably through the antioxidant and radical scavenging effects of erdosteine."( Effects of erdosteine on acetaminophen-induced hepatotoxicity in rats.
Duru, M; Helvaci, R; Kaya, H; Koc, A; Kozlu, T; Kuvandik, G; Nacar, A; Sogüt, S; Yonden, Z, 2008
)
0.65
" Safety was evaluated by retrieving information about the nature and incidence of adverse events (AE), whether they were related to the study compound, and the percentage considered being serious."( High dose transdermal buprenorphine for moderate to severe pain in spanish pain centres--a retrospective multicenter safety and efficacy study.
Barutell, C; Camba, A; González-Escalada, JR; Rodríguez, M,
)
0.13
"Transdermal buprenorphine was an effective and considerably safe drug for relieving chronic moderate to severe pain."( High dose transdermal buprenorphine for moderate to severe pain in spanish pain centres--a retrospective multicenter safety and efficacy study.
Barutell, C; Camba, A; González-Escalada, JR; Rodríguez, M,
)
0.13
" A toxic dose of acetaminophen (800 mg/kg body weight intraperitoneally) induced severe abnormality in all basic parameters with apparent toxicity in liver (enlargement of hepatocytes, loss of cytoplasmic content with disruption in the hepatic plates and sinusoidal dilation) and renal tissue (glomerular damage with congestion of tubules)."( Effect of crude sulphated polysaccharide from brown algae against acetaminophen-induced toxicity in rats.
Raghavendran, HR; Srinivasan, P, 2008
)
0.92
" Patients were assessed for pain control and adverse events."( Morphine infusions after pediatric cranial surgery: a retrospective analysis of safety and efficacy.
Bowen-Roberts, T; Hammond, AM; Kent, SK; Ou, CH; Steinbok, P; Warren, DT, 2008
)
0.35
"These findings suggest that CMI is as safe a treatment option as acetaminophen and codeine."( Morphine infusions after pediatric cranial surgery: a retrospective analysis of safety and efficacy.
Bowen-Roberts, T; Hammond, AM; Kent, SK; Ou, CH; Steinbok, P; Warren, DT, 2008
)
0.58
"Intravenous acetylcysteine seemed to be a safe and effective formulation of N-acetylcysteine."( Safety and effectiveness of acetadote for acetaminophen toxicity.
Brooks, DE; Katz, KD; Kehrl, T; Sokolowski, D; Whyte, AJ, 2010
)
0.62
" These results suggest that the expression of these enzymes, which are involved in the antioxidant system, may not be altered after AAP toxicity, although classical toxic changes such as depletion of GSH, hepatocellular necrosis, and increased immunostaining for iNOS and nitrotyrosine were detected."( The effects of acute acetaminophen toxicity on hepatic mRNA expression of SOD, CAT, GSH-Px, and levels of peroxynitrite, nitric oxide, reduced glutathione, and malondialdehyde in rabbit.
Adiguzel, K; Akgoz, M; Cigremis, Y; Karaman, M; Kart, A; Ozen, H; Turel, H, 2009
)
0.67
" One important example of this type of injury is acetaminophen-induced liver injury, in which the initial toxic injury is followed by innate immune activation."( Acetaminophen-induced hepatotoxicity in mice is dependent on Tlr9 and the Nalp3 inflammasome.
Flavell, RA; Imaeda, AB; Mahmood, S; Mehal, WZ; Mohamadnejad, M; Sohail, MA; Sutterwala, FS; Watanabe, A, 2009
)
2.05
" Mild-to-moderate adverse effects were reported."( A randomized, double-blind, placebo-controlled study comparing the efficacy and safety of paracetamol, serratiopeptidase, ibuprofen and betamethasone using the dental impaction pain model.
Chopra, D; Kakkar, AK; Mehra, P; Rehan, HS, 2009
)
0.35
" Furthermore, the use of antidotes that reduced the toxic insult was also recorded using this technique."( Acute liver acetaminophen toxicity in rabbits and the use of antidotes: a metabonomic approach in serum.
Galanopoulou, P; Giannioti, K; Liapi, C; Mikros, E; Papalois, A; Theocharis, S; Zira, A, 2009
)
0.73
" The paracetamol test with Wagner-Nelson analysis can be a safe and accurate method for measuring gastric emptying in women of childbearing age."( Paracetamol absorption test with Wagner-Nelson analysis for safe and accurate measurements of gastric emptying in women.
Nakada, K; Sanaka, M, 2008
)
0.35
" Liver regeneration is a vital process for survival after a toxic insult, it occurs at a relative late time point after the injurious phase."( Prolonged treatment with N-acetylcystine delays liver recovery from acetaminophen hepatotoxicity.
Fink, MP; He, X; Killeen, ME; Miki, K; Yang, R, 2009
)
0.59
" The incidence of adverse events (AEs) was comparable in the 2 treatment groups: 226 AEs were reported in 61 patients (88."( Efficacy and safety of low-dose transdermal buprenorphine patches (5, 10, and 20 microg/h) versus prolonged-release tramadol tablets (75, 100, 150, and 200 mg) in patients with chronic osteoarthritis pain: a 12-week, randomized, open-label, controlled, pa
Berggren, AC; Karlsson, M, 2009
)
0.35
"Toxicogenomic studies are increasingly used to uncover potential biomarkers of adverse health events, enrich chemical risk assessment, and to facilitate proper identification and treatment of persons susceptible to toxicity."( Population-based discovery of toxicogenomics biomarkers for hepatotoxicity using a laboratory strain diversity panel.
Gatti, DM; Harrill, AH; Ross, PK; Rusyn, I; Threadgill, DW, 2009
)
0.35
"Acetaminophen (APAP) is safe at therapeutic levels but causes hepatotoxicity via N-acetyl-p-benzoquinone imine-induced oxidative stress upon overdose."( Rifampicin-activated human pregnane X receptor and CYP3A4 induction enhance acetaminophen-induced toxicity.
Cheng, J; Gonzalez, FJ; Idle, JR; Krausz, KW; Ma, X, 2009
)
2.03
"Ibuprofen, paracetamol and placebo have similar tolerability and safety profiles in terms of gastrointestinal symptoms, asthma and renal adverse effects."( Systematic review and meta-analysis of the clinical safety and tolerability of ibuprofen compared with paracetamol in paediatric pain and fever.
Kleijnen, J; Soares-Weiser, K; Southey, ER, 2009
)
0.35
" The histopathological examination on toxic models revealed centrizonal necrosis and fatty changes."( Hepatoprotective activity of picroliv, curcumin and ellagic acid compared to silymarin on paracetamol induced liver toxicity in mice.
Girish, C; Jayanthi, S; Koner, BC; Pradhan, SC; Rajesh, B; Ramachandra Rao, K, 2009
)
0.35
"It is well established that following a toxic dose of acetaminophen (APAP), nitrotyrosine protein adducts (3-NT), a hallmark of peroxynitrite production, were colocalized with necrotic hepatic centrilobular regions where cytochrome P450 2E1 (CYP2E1) is highly expressed, suggesting that 3-NT formation may be essential in APAP-mediated toxicity."( Role of cytochrome P450 2E1 in protein nitration and ubiquitin-mediated degradation during acetaminophen toxicity.
Abdelmegeed, MA; Chen, C; Gonzalez, FJ; Moon, KH; Song, BJ, 2010
)
0.83
"Acetaminophen overdose causes hepatotoxicity mediated by toxic metabolites generated through the cytochrome P450 enzyme."( Using acetaminophen's toxicity mechanism to enhance cisplatin efficacy in hepatocarcinoma and hepatoblastoma cell lines.
Czauderna, P; Fuchs, J; Knap, N; Losin, M; Neuwelt, AJ; Neuwelt, EA; Pagel, MA; Warmann, S; Wozniak, M; Wu, YJ, 2009
)
2.28
"Our results suggest that a chemotherapeutic regimen containing both AAP and CDDP with delayed NAC rescue has the potential to enhance chemotherapeutic efficacy while decreasing adverse effects."( Using acetaminophen's toxicity mechanism to enhance cisplatin efficacy in hepatocarcinoma and hepatoblastoma cell lines.
Czauderna, P; Fuchs, J; Knap, N; Losin, M; Neuwelt, AJ; Neuwelt, EA; Pagel, MA; Warmann, S; Wozniak, M; Wu, YJ, 2009
)
0.83
" A control group was treated by mineral water (0+0) mg/kg and a second group was treated with only a toxic dose of 100 mg/kg of PARA (100+0)."( [Protective effect of diclofenac towards the oxidative stress induced by paracetamol toxicity in rats].
Aouacheri, W; Djafer, R; Lefranc, G; Saka, S,
)
0.13
" According to the Uppsala Monitoring Centre, WHO Collaborating Centre for International Drug Monitoring, the number of adverse effects registered in the years 1978-2009 (March) was 14441 for metamizol and 67581 for paracetamol."( [Safety of metamizole and paracetamol for acute pain treatment].
Kotfis, K; Zukowski, M,
)
0.13
"Acetaminophen (APAP) hepatotoxicity results from cytochrome P450 metabolism of APAP to the toxic metabolite, n-acetyl-benzoquinone imine (NAPQI), which reacts with cysteinyl residues to form APAP adducts and initiates cell injury."( Susceptibility to acetaminophen (APAP) toxicity unexpectedly is decreased during acute viral hepatitis in mice.
Getachew, Y; James, L; Lee, WM; Miller, BC; Thiele, DL, 2010
)
2.14
" The aim of this study was to determine whether PGI2 is playing a role in host defense to toxic effect of acetaminophen (APAP)."( The role of prostacyclin in modifying acute hepatotoxicity of acetaminophen in mice.
Cavar, I; Culo, F; Heinzel, R; Kelava, T, 2009
)
0.81
" Adoption of these two recommendations may lead to the increased use of NSAIDs with the potential of increasing incidence of NSAIDs-related adverse reactions."( FDA proposals to limit the hepatotoxicity of paracetamol (acetaminophen): are they reasonable?
Day, RO; Graham, GG; Graudins, A; Mohamudally, A, 2010
)
0.6
"To determine which class of non-opioid analgesics - paracetamol (acetaminophen), NSAIDs or COX-2 inhibitors - is the most effective at reducing morphine consumption and associated adverse effects when used as part of multimodal analgesia following major surgery."( Paracetamol and selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs) for the reduction of morphine-related side effects after major surgery: a systematic review.
Jenkins, B; Maund, E; McDaid, C; Rice, S; Woolacott, N; Wright, K, 2010
)
0.6
" Other outcomes of interest were morphine-related adverse effects and adverse effects related to the non-opioids."( Paracetamol and selective and non-selective non-steroidal anti-inflammatory drugs (NSAIDs) for the reduction of morphine-related side effects after major surgery: a systematic review.
Jenkins, B; Maund, E; McDaid, C; Rice, S; Woolacott, N; Wright, K, 2010
)
0.36
" We analyzed whether toxic doses of APAP could induce heat shock protein 70 (HSP70) in the kidney and whether HSP70 could be detected in urine."( Heat shock protein 70 induction and its urinary excretion in a model of acetaminophen nephrotoxicity.
Molinas, SM; Monasterolo, LA; Pagotto, MA; Pisani, GB; Rosso, M; Trumper, L; Wayllace, NZ, 2010
)
0.59
" Several reports have shown that inflammation induced by the endotoxin, lipopolysaccharide (LPS) augments the toxic response to hepatotoxicants in vivo."( Role of c-Jun N-terminal kinase (JNK) in regulating tumor necrosis factor-alpha (TNF-alpha) mediated increase of acetaminophen (APAP) and chlorpromazine (CPZ) toxicity in murine hepatocytes.
Gandhi, A; Ghose, R; Guo, T, 2010
)
0.57
"Acetaminophen (APAP), also known as paracetamol, is the commonest cause of toxic ingestion in the world."( Effects of medical ozone therapy on acetaminophen-induced nephrotoxicity in rats.
Cayci, T; Demirbag, S; Guven, A; Kaldirim, U; Korkmaz, A; Ozcan, A; Ozler, M; Surer, I; Uysal, B, 2010
)
2.08
" The FDA advisory committee reviewed numerous observational studies and adverse event reporting data."( Removal of opioid/acetaminophen combination prescription pain medications: assessing the evidence for hepatotoxicity and consequences of removal of these medications.
Dahl, JL; Duh, MS; Korves, C; Michna, E, 2010
)
0.69
" The expression of the CYP2E1 enzyme, which is reported to transform AP to its toxic metabolites, was higher in L-02 than in Hep3B cells."( Acetaminophen-induced cytotoxicity on human normal liver L-02 cells and the protection of antioxidants.
Ji, L; Liang, Q; Min, Y; Sheng, Y; Wang, Z; Xia, Y, 2010
)
1.8
" This study was aimed at identifying the specific agent responsible for hearing loss from toxic killing of cochlear sensory cells."( Acetaminophen ototoxicity after acetaminophen/hydrocodone abuse: evidence from two parallel in vitro mouse models.
Kalinec, F; Kalinec, GM; Luxford, WM; Warren, FM; Yorgason, JG, 2010
)
1.8
" These observations prompted us to investigate whether PGE2 plays a role in host defence to toxic effect of APAP."( The role of prostaglandin E2 in acute acetaminophen hepatotoxicity in mice.
Cavar, I; Culo, F; Kelava, T; Saraga-Babić, M; Vukojević, K, 2010
)
0.63
" The primary safety outcome was the percentage of patients with NAC-related adverse events."( A multicenter comparison of the safety of oral versus intravenous acetylcysteine for treatment of acetaminophen overdose.
Aguilera, E; Al-Helial, M; Arnold, T; Bebarta, VS; Bogdan, G; Buchanan, J; Clark, RF; Dart, R; Delgado, J; Froberg, B; Haur, W; Heard, K; Hoppe, J; Kao, L; Kokko, J; Lares, C; Lavonas, E; McDonagh, J; Mendoza, C; Mlynarchek, S; O'Malley, G; Odujebe, O; Qi, M; Rhyee, S; Stanford, C; Tan, HH; Tran, NN; Varney, S; Zosel, A, 2010
)
0.58
" There were no serious adverse events related to NAC for either route."( A multicenter comparison of the safety of oral versus intravenous acetylcysteine for treatment of acetaminophen overdose.
Aguilera, E; Al-Helial, M; Arnold, T; Bebarta, VS; Bogdan, G; Buchanan, J; Clark, RF; Dart, R; Delgado, J; Froberg, B; Haur, W; Heard, K; Hoppe, J; Kao, L; Kokko, J; Lares, C; Lavonas, E; McDonagh, J; Mendoza, C; Mlynarchek, S; O'Malley, G; Odujebe, O; Qi, M; Rhyee, S; Stanford, C; Tan, HH; Tran, NN; Varney, S; Zosel, A, 2010
)
0.58
"IV and oral NAC are generally mild adverse drug reactions."( A multicenter comparison of the safety of oral versus intravenous acetylcysteine for treatment of acetaminophen overdose.
Aguilera, E; Al-Helial, M; Arnold, T; Bebarta, VS; Bogdan, G; Buchanan, J; Clark, RF; Dart, R; Delgado, J; Froberg, B; Haur, W; Heard, K; Hoppe, J; Kao, L; Kokko, J; Lares, C; Lavonas, E; McDonagh, J; Mendoza, C; Mlynarchek, S; O'Malley, G; Odujebe, O; Qi, M; Rhyee, S; Stanford, C; Tan, HH; Tran, NN; Varney, S; Zosel, A, 2010
)
0.58
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" Both treatments were well tolerated and safe in patients with OA flare-up."( Efficacy and safety of etodolac-paracetamol fixed dose combination in patients with knee osteoarthritis flare-up: a randomized, double-blind comparative evaluation.
Ambade, R; Bartakke, G; Chandanwale, A; Chandurkar, N; Pareek, A, 2010
)
0.36
" Although both classes of drug are generally well tolerated, they can lead to well-characterized adverse effects."( Concomitant use of ibuprofen and paracetamol and the risk of major clinical safety outcomes.
de Vries, F; Setakis, E; van Staa, TP, 2010
)
0.36
" Acetaminophen was more toxic to the CD45 dim and negative populations than to the CD45 bright population."( Isolation of periportal, midlobular, and centrilobular rat liver sinusoidal endothelial cells enables study of zonated drug toxicity.
DeLeve, LD; Wang, L; Wang, X; Xie, G, 2010
)
1.27
"The aim of the study was to analyze factors predicting pain relief and adverse events in patients receiving opioids for acute pain in a prehospital setting."( Predictors of pain relief and adverse events in patients receiving opioids in a prehospital setting.
Barniol, C; Bounes, V; Ducassé, JL; Houze-Cerfon, CH; Minville, V, 2011
)
0.37
" Univariable and multivariable analyses were performed to identify predictive factors of pain relief and adverse effects."( Predictors of pain relief and adverse events in patients receiving opioids in a prehospital setting.
Barniol, C; Bounes, V; Ducassé, JL; Houze-Cerfon, CH; Minville, V, 2011
)
0.37
"0%) presented one adverse effect, all mild to moderate in severity, with no significant predictive factors."( Predictors of pain relief and adverse events in patients receiving opioids in a prehospital setting.
Barniol, C; Bounes, V; Ducassé, JL; Houze-Cerfon, CH; Minville, V, 2011
)
0.37
" Therefore, toxic responses to the reactive metabolites have been expected to be expressed more strongly in a glutathione-depleted condition."( In vitro cytotoxicity assay to evaluate the toxicity of an electrophilic reactive metabolite using glutathione-depleted rat primary cultured hepatocytes.
Fujimoto, K; Kishino, H; Manabe, S; Sanbuissho, A; Yamoto, T, 2010
)
0.36
" pentaphylla is able to alter the toxic condition of the hepatocytes so as to protect the membrane integrity against paracetamol-induced leakage of marker enzymes."( Hepatoprotective activity of Glycosmis pentaphylla against paracetamol-induced hepatotoxicity in Swiss albino mice.
Jain, R; Nayak, SS; Sahoo, AK, 2011
)
0.37
"It is now widely appreciated that drug metabolites, in addition to the parent drugs themselves, can mediate the serious adverse effects exhibited by some new therapeutic agents, and as a result, there has been heightened interest in the field of drug metabolism from researchers in academia, the pharmaceutical industry, and regulatory agencies."( Role of biotransformation in drug-induced toxicity: influence of intra- and inter-species differences in drug metabolism.
Baillie, TA; Rettie, AE, 2011
)
0.37
" Safety was assessed according to spontaneous reports of adverse events (AEs) and clinically meaningful changes from baseline laboratory parameters."( Safety of multiple-dose intravenous acetaminophen in adult inpatients.
Bergese, SD; Candiotti, KA; Royal, MA; Singla, NK; Singla, SK; Viscusi, ER, 2010
)
0.64
"Overall, IV acetaminophen was shown to be safe and well tolerated in adult inpatients when given as repeated doses for up to 5 days."( Safety of multiple-dose intravenous acetaminophen in adult inpatients.
Bergese, SD; Candiotti, KA; Royal, MA; Singla, NK; Singla, SK; Viscusi, ER, 2010
)
1.01
" The findings from this trial support the use of IV acetaminophen as a safe therapy in adult patients."( Safety of multiple-dose intravenous acetaminophen in adult inpatients.
Bergese, SD; Candiotti, KA; Royal, MA; Singla, NK; Singla, SK; Viscusi, ER, 2010
)
0.89
" The efficacy measures included VAS scores and adverse effect assessment 10, 30, and 60 minutes after the administration of tramadol/acetaminophen."( Efficacy and safety of tramadol/acetaminophen in the treatment of breakthrough pain in cancer patients.
Chang, CS; Chung, CY; Ho, ML; Hsu, NC; Lin, HY; Wang, CC, 2010
)
0.85
"Tramadol/acetaminophen might be efficacious and safe in the treatment of breakthrough pain in cancer."( Efficacy and safety of tramadol/acetaminophen in the treatment of breakthrough pain in cancer patients.
Chang, CS; Chung, CY; Ho, ML; Hsu, NC; Lin, HY; Wang, CC, 2010
)
1.06
" Safety was assessed through incidence of adverse events and subject's assessment of tolerability."( Efficacy and safety of E-OA-07 in moderate to severe symptoms of osteoarthritis: a double-blind randomized placebo-controlled study.
Kulkarni, MP; Rosenbloom, RA; Shakeel, A; Shinde, BS,
)
0.13
" In the US, the FDA has issued warnings about the potential adverse effects of kava, but kava dietary supplements are still available to consumers."( Kava extract, an herbal alternative for anxiety relief, potentiates acetaminophen-induced cytotoxicity in rat hepatic cells.
Salminen, WF; Yang, X, 2011
)
0.6
"5%) reported at least one adverse event (AE)."( Epidemiological data, efficacy and safety of a paracetamol-tramadol fixed combination in the treatment of moderate-to-severe pain. SALZA: a post-marketing study in general practice.
Ganry, H; Mejjad, O; Serrie, A, 2011
)
0.37
" This down-regulation results in suppression of downstream cytochrome P450 enzymes involved in conversion of APAP to its toxic metabolite."( Polyinosinic-polycytidylic acid suppresses acetaminophen-induced hepatotoxicity independent of type I interferons and toll-like receptor 3.
Cheng, G; Chow, EK; Deng, JC; Ghaffari, AA; Iyer, SS, 2011
)
0.63
" Safety evaluations included adverse event (AE), physical exam, and laboratory assessments."( A randomized study of the efficacy and safety of intravenous acetaminophen compared to oral acetaminophen for the treatment of fever.
Breitmeyer, JB; Pan, C; Peacock, WF; Royal, MA; Smith, WB, 2011
)
0.61
"A single dose of IV acetaminophen is as safe and effective in reducing endotoxin-induced fever as PO acetaminophen."( A randomized study of the efficacy and safety of intravenous acetaminophen compared to oral acetaminophen for the treatment of fever.
Breitmeyer, JB; Pan, C; Peacock, WF; Royal, MA; Smith, WB, 2011
)
0.93
"Acetaminophen (APAP) overdose is one of the most frequent causes of acute liver failure in the United States and is primarily mediated by toxic metabolites that accumulate in the liver upon depletion of glutathione stores."( Dendritic cell depletion exacerbates acetaminophen hepatotoxicity.
Ayo, D; Bedrosian, AS; Cieza-Rubio, NE; Connolly, MK; Dorvil-Castro, M; Hackman, M; Henning, JR; Ibrahim, J; Malhotra, A; Miller, G; Nguyen, AH; Pachter, HL, 2011
)
2.08
" No adverse outcomes were associated with medication errors."( Evaluation of a simplified N-acetylcysteine dosing regimen for the treatment of acetaminophen toxicity.
Halcomb, SE; Johnson, MT; McCammon, CA; Mullins, ME, 2011
)
0.6
" Some animal studies indicate that such nanomaterials may have some toxicity, but their synergistic actions on the adverse effects of drugs are not well understood."( Effect of 70-nm silica particles on the toxicity of acetaminophen, tetracycline, trazodone, and 5-aminosalicylic acid in mice.
Hasezaki, T; Isoda, K; Kondoh, M; Li, X; Tsutsumi, Y; Watari, A; Yagi, K, 2011
)
0.62
" The aim was to assess whether non-alcoholic steatosis sensitizes rat liver to acute toxic effect of acetaminophen."( Susceptibility of rat non-alcoholic fatty liver to the acute toxic effect of acetaminophen.
Cervinková, Z; Haňáčková, L; Kučera, O; Lotková, H; Podhola, M; Roušar, T; Staňková, P, 2012
)
0.82
"Liver from rats fed HFGD is more susceptible to acute toxic effect of acetaminophen, compared to non-steatotic liver."( Susceptibility of rat non-alcoholic fatty liver to the acute toxic effect of acetaminophen.
Cervinková, Z; Haňáčková, L; Kučera, O; Lotková, H; Podhola, M; Roušar, T; Staňková, P, 2012
)
0.84
" For studies of toxic processes, 1H NMR spectroscopy of biofluids allows monitoring of endogenous metabolite profiles that alter characteristically in response to changes in physiological status."( A 1H NMR-based metabolomics approach for mechanistic insight into acetaminophen-induced hepatotoxicity.
Ando, Y; Fukuhara, K; Ohno, A; Okuda, H; Yamoto, T, 2011
)
0.61
" As fasting promotes SIRT3-mediated mitochondrial-protein deacetylation and acetaminophen metabolites bind to lysine residues, we investigated whether deacetylation predisposes mice to toxic metabolite-mediated disruption of mitochondrial proteins."( SIRT3-dependent deacetylation exacerbates acetaminophen hepatotoxicity.
Aponte, AM; Bourdi, M; Chen, Y; Gucek, M; Li, JH; Lombard, DB; Lu, Z; Pohl, LR; Sack, MN, 2011
)
0.86
" The objective was to assess side effect frequency, degree of bother, and impact on health-related quality of life (HRQoL)."( Oxycodone-related side effects: impact on degree of bother, adherence, pain relief, satisfaction, and quality of life.
Ackerman, SJ; Anastassopoulos, KP; Benson, C; Chow, W; Kim, MS; Tapia, C,
)
0.13
" This raises a question about the unmet need for pain medications with improved side effect profiles."( Oxycodone-related side effects: impact on degree of bother, adherence, pain relief, satisfaction, and quality of life.
Ackerman, SJ; Anastassopoulos, KP; Benson, C; Chow, W; Kim, MS; Tapia, C,
)
0.13
" Thus, we observed 50% growth inhibition of cell proliferation at 1 mM in the biochip, which appeared similar to human plasmatic toxic concentrations reported at 2 mM."( Integrated proteomic and transcriptomic investigation of the acetaminophen toxicity in liver microfluidic biochip.
Briffaut, AS; Chafey, P; Grandvalet, Y; Leclerc, E; Legallais, C; Letourneur, F; Merlier, F; Prot, JM, 2011
)
0.61
" No serious adverse effects associated with bowel stimulation were reported."( Safety and efficacy of immediate postoperative feeding and bowel stimulation to prevent ileus after major gynecologic surgical procedures.
Fanning, J; Hojat, R, 2011
)
0.37
"Immediate postoperative feeding and bowel stimulation is a safe and effective approach to preventing ileus in patients who undergo major gynecologic surgical procedures."( Safety and efficacy of immediate postoperative feeding and bowel stimulation to prevent ileus after major gynecologic surgical procedures.
Fanning, J; Hojat, R, 2011
)
0.37
" The increased APAP resistance in LXR Tg mice was associated with increased APAP clearance, increased APAP sulfation, and decreased formation of toxic APAP metabolites."( Activation of liver X receptor increases acetaminophen clearance and prevents its toxicity in mice.
Gao, J; Hoon Lee, J; Jiang, M; Niu, Y; Poloyac, SM; Qin, W; Saini, SP; Tian, H; Tortorici, MA; Uppal, H; Venkataramanan, R; Xie, W; Zhai, Y; Zhang, B, 2011
)
0.64
" The primary endpoints were patient-reported gastrointestinal (GI) adverse events (AEs); the secondary endpoints were the incidence of patient-reported non-GI AEs."( Short-term acetylsalicylic acid (aspirin) use for pain, fever, or colds - gastrointestinal adverse effects: a meta-analysis of randomized clinical trials.
Baron, JA; Brueckner, A; Lanas, A; McCarthy, D; Senn, S; Voelker, M, 2011
)
0.37
" We also handsearched the conference proceedings for the American College of Rheumatology (ACR) and European League against Rheumatism (EULAR) (2008 to 2009) and checked the websites of regulatory agencies for reported adverse events, labels and warnings."( Safety of non-steroidal anti-inflammatory drugs, including aspirin and paracetamol (acetaminophen) in people receiving methotrexate for inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, other spondyloarthritis).
Colebatch, AN; Edwards, CJ; Marks, JL, 2011
)
0.59
" Two of these studies reported no evidence for increased risk of methotrexate-induced pulmonary disease; one study assessed the effect of concurrent NSAIDs on renal function and found no adverse effect; one study identified no adverse effect on liver function; three studies demonstrated no increase in methotrexate withdrawal; and one study showed no increase in all adverse events, including major toxic reactions."( Safety of non-steroidal anti-inflammatory drugs, including aspirin and paracetamol (acetaminophen) in people receiving methotrexate for inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, other spondyloarthritis).
Colebatch, AN; Edwards, CJ; Marks, JL, 2011
)
0.59
"In the management of rheumatoid arthritis, the concurrent use of NSAIDs with methotrexate appears to be safe provided appropriate monitoring is performed."( Safety of non-steroidal anti-inflammatory drugs, including aspirin and paracetamol (acetaminophen) in people receiving methotrexate for inflammatory arthritis (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, other spondyloarthritis).
Colebatch, AN; Edwards, CJ; Marks, JL, 2011
)
0.59
" Liver regeneration is a vital process for survival after a toxic insult."( Ringer's lactate improves liver recovery in a murine model of acetaminophen toxicity.
Kajander, H; Koskinen, ML; Tenhunen, J; Yang, R; Zhang, S; Zhu, S, 2011
)
0.61
"Both delayed presentation and staggered overdose pattern are associated with adverse outcomes following paracetamol overdose."( Staggered overdose pattern and delay to hospital presentation are associated with adverse outcomes following paracetamol-induced hepatotoxicity.
Bates, CM; Craig, DG; Davidson, JS; Hayes, PC; Martin, KG; Simpson, KJ, 2012
)
0.38
" In conclusion, we discovered metabolite biomarkers belonging to three different metabolic pathways to check for liver toxicity with mass spectrometry from a metabolomics study that could be used to evaluate hepatotoxicity induced by drugs or other toxic compounds."( Discovery of common urinary biomarkers for hepatotoxicity induced by carbon tetrachloride, acetaminophen and methotrexate by mass spectrometry-based metabolomics.
Chung, BC; Jung, BH; Kumar, BS; Kwon, OS, 2012
)
0.6
" Regarding safety, there were no statistically significant differences between treatment groups in the incidence of adverse events in the dental pain and tension-type headache studies."( Assessment of the efficacy and safety profiles of aspirin and acetaminophen with codeine: results from 2 randomized, controlled trials in individuals with tension-type headache and postoperative dental pain.
Fisher, M; Gatoulis, SC; Voelker, M, 2012
)
0.62
" We reviewed US Poison Center data, peer-reviewed literature, US Food and Drug Administration Adverse Event Reports, and US Manufacturer Safety Reports describing adverse effects after acetaminophen administration."( Toxicity from repeated doses of acetaminophen in children: assessment of causality and dose in reported cases.
Bond, GR; Bui, A; Clark, RF; Dart, RC; Green, JL; Heard, K; Koff, RS; Kozer, E; Mlynarchek, SL,
)
0.61
" In addition, it was found that the microsomal Ca(2+)-ATPase activity was not directly related to acetaminophen toxic species generated in the P450 enzyme system in vitro."( Effects and mechanisms of rifampin on hepatotoxicity of acetaminophen in mice.
Chen, C; Chen, Z; He, M; Huang, J; Huang, R; Jiao, Y; Lin, X; Zhang, S, 2012
)
0.84
" Drug-related adverse events were noted in 8 patients with 1,000 mg paracetamol, in 9 patients with 400 mg etodolac and in 9 patients for 800 mg etodolac during the study."( Efficacy and safety of 400 and 800 mg etodolac vs. 1,000 mg paracetamol in acute treatment of migraine: a randomized, double-blind, crossover, multicenter, phase III clinical trial.
Baykan, B; Ertaş, M; Özge, A; Öztürk, V; Sirin, H, 2013
)
0.39
"Our study showed that etodolac is a safe and effective alternative in acute migraine treatment and showed comparable efficacy to paracetamol 1,000 mg."( Efficacy and safety of 400 and 800 mg etodolac vs. 1,000 mg paracetamol in acute treatment of migraine: a randomized, double-blind, crossover, multicenter, phase III clinical trial.
Baykan, B; Ertaş, M; Özge, A; Öztürk, V; Sirin, H, 2013
)
0.39
" Data obtained with the prophylactic protocol of treatment might indicate that individuals under treatment with ACE inhibitors are less susceptible to the toxic effects of APAP."( Effects of treatment with enalapril on hepatotoxicity induced by acetaminophen in mice.
Betto, MR; Campos, MM; Driemeier, D; Lazarotto, LF; Leite, CE; Watanabe, TT, 2012
)
0.62
" (MO) extracts and its curative role in acetaminophen (APAP)-induced toxic liver injury in rats caused by oxidative damage."( Moringa oleifera hydroethanolic extracts effectively alleviate acetaminophen-induced hepatotoxicity in experimental rats through their antioxidant nature.
Arulselvan, P; Fakurazi, S; Sharifudin, SA, 2012
)
0.89
" The considerable decrease of the sample toxicity during photo-Fenton treatment using FeSO(4) indicates a safe application of the process for the removal of this pharmaceutical."( Paracetamol degradation intermediates and toxicity during photo-Fenton treatment using different iron species.
Agüera, A; Fernandez-Alba, AR; Malato, S; Pupo Nogueira, RF; Trovó, AG, 2012
)
0.38
" While the hepatotoxic effects of the drug have been well recognized in cases of acute overdose and chronic supratherapeutic doses, the toxic effects of acetaminophen are rarely documented in cases where therapeutic guidelines are followed."( Acute liver failure following cleft palate repair: a case of therapeutic acetaminophen toxicity.
Boyajian, M; Cheerharan, M; Iorio, ML; Kaufman, SS; Reece-Stremtan, S, 2013
)
0.82
" The search aimed to identify studies describing adverse events (AE) with the concurrent use of paracetamol and/or NSAID in people taking MTX for IA."( Safety of nonsteroidal antiinflammatory drugs and/or paracetamol in people receiving methotrexate for inflammatory arthritis: a Cochrane systematic review.
Colebatch, AN; Edwards, CJ; Marks, JL; van der Heijde, DM, 2012
)
0.38
" Of the studies examining concurrent use of MTX and NSAID, there were no reported adverse effects on lung, liver, or renal function, and no increase in MTX withdrawal or in major toxic reactions."( Safety of nonsteroidal antiinflammatory drugs and/or paracetamol in people receiving methotrexate for inflammatory arthritis: a Cochrane systematic review.
Colebatch, AN; Edwards, CJ; Marks, JL; van der Heijde, DM, 2012
)
0.38
"The purpose of this study was to determine whether flumazenil antagonized the toxic effects of acetaminophen overdose in rats."( The effect of different doses of flumazenil on acetaminophen toxicity in rats.
Aksu, R; Bicer, C; Boyaci, A; Bozogluer, E; Madenoglu, H; Yazici, C, 2012
)
0.85
"Osteoarthritis (OA) is the most common cause of disability in older adults, and although analgesic use can be helpful, it can also result in adverse drug events."( Adverse effects of analgesics commonly used by older adults with osteoarthritis: focus on non-opioid and opioid analgesics.
Hanlon, JT; Marcum, ZA; O'Neil, CK, 2012
)
0.38
"To review the recent literature to describe potential adverse drug events associated with analgesics commonly used by older adults with OA."( Adverse effects of analgesics commonly used by older adults with osteoarthritis: focus on non-opioid and opioid analgesics.
Hanlon, JT; Marcum, ZA; O'Neil, CK, 2012
)
0.38
" This drug is, however, effective and safe if notes of caution are applied."( [Paracetamol. Efficacious and safe for all ages].
Wehling, M, 2013
)
0.39
" Another class of non-opioid analgesic with confirmed efficacy for the treatment of chronic mild to moderate pain are non-steroidal anti-inflammatory drugs (NSAIDs), although this efficacy is offset by the potential of adverse gastrointestinal events."( Adverse effects associated with non-opioid and opioid treatment in patients with chronic pain.
Cherubino, P; Fornasari, D; Labianca, R; Sarzi-Puttini, P; Vellucci, R; Zuccaro, SM, 2012
)
0.38
" Though safe at therapeutic doses, overdose causes mitochondrial dysfunction and centrilobular necrosis in the liver."( Metabolism and disposition of acetaminophen: recent advances in relation to hepatotoxicity and diagnosis.
Jaeschke, H; McGill, MR, 2013
)
0.68
" Moderate to severe gastrointestinal adverse events occurred in 50% of patients in the oxycodone/acetaminophen group compared with 15% of the equianalgesic morphine/oxycodone group."( Comparison of the efficacy and safety of dual-opioid treatment with morphine plus oxycodone versus oxycodone/acetaminophen for moderate to severe acute pain after total knee arthroplasty.
Gimbel, JS; Kelen, R; Minkowitz, HS; Richards, P; Stern, W, 2013
)
0.82
" was given as toxic dose for inducing hepatotoxicity."( Investigation of hepatoprotective activity of Cyathea gigantea (Wall. ex. Hook.) leaves against paracetamol-induced hepatotoxicity in rats.
Kiran, PM; Raju, AV; Rao, BG, 2012
)
0.38
" APAP toxicity is initiated by its toxic metabolite NAPQI."( CHOP is a critical regulator of acetaminophen-induced hepatotoxicity.
Barda, L; Chung, RT; Gonzalez-Rodriguez, A; Iwawaki, T; Mills, M; Mueller, T; Nahmias, Y; Scaiewicz, V; Shibolet, O; Tirosh, B; Uzi, D; Valverde, AM; Xavier, R, 2013
)
0.67
"A toxic dose of APAP was orally administered to wild type (wt) and CHOP knockout (KO) mice and damage mechanisms were assessed."( CHOP is a critical regulator of acetaminophen-induced hepatotoxicity.
Barda, L; Chung, RT; Gonzalez-Rodriguez, A; Iwawaki, T; Mills, M; Mueller, T; Nahmias, Y; Scaiewicz, V; Shibolet, O; Tirosh, B; Uzi, D; Valverde, AM; Xavier, R, 2013
)
0.67
" Consequently, several drug toxicities observed in vivo cannot be reproduced in 2D in vitro models, for example, the toxic effects of acetaminophen."( Hepatic 3D cultures but not 2D cultures preserve specific transporter activity for acetaminophen-induced hepatotoxicity.
Bachmann, A; Burkhardt, B; Damm, G; Müller-Vieira, U; Nadalin, S; Nussler, AK; Sánchez, JJ; Schyschka, L; Wang, Z; Zeilinger, K, 2013
)
0.82
"High doses of KRG reduced mortality at the LD50 of APAP."( Korean red ginseng extract prevents APAP-induced hepatotoxicity through metabolic enzyme regulation: the role of ginsenoside Rg3, a protopanaxadiol.
Cho, MK; Gum, SI, 2013
)
0.39
"We investigated the effect of aging on hepatic pharmacokinetics and the degree of hepatotoxicity following a toxic dose of acetaminophen."( The effect of aging on acetaminophen pharmacokinetics, toxicity and Nrf2 in Fischer 344 rats.
Cogger, VC; de Cabo, R; Hilmer, SN; Huizer-Pajkos, A; Jones, BE; Le Couteur, DG; Mach, J; McKenzie, C, 2014
)
0.92
" Among the patients who took opioids, at least one side effect of moderate or severe intensity (score ≥ 4) was reported by 62%."( Side effects from oral opioids in older adults during the first week of treatment for acute musculoskeletal pain.
Dickey, RM; Esserman, DA; Fillingim, RB; Hunold, KM; Isaacs, CG; McLean, SA; Pereira, GF; Platts-Mills, TF; Sloane, PD, 2013
)
0.39
" Secondary end points included quality of life (Korean Short Form-36), functionality (Korean Oswestry Disability Index), and adverse events."( A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain.
Lee, CS; Lee, JH, 2013
)
0.59
" Adverse events were reported more frequently with TA-ER than with placebo; the most common adverse events reported were nausea, dizziness, constipation, and vomiting."( A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablet for the treatment of chronic low back pain.
Lee, CS; Lee, JH, 2013
)
0.59
" Our observation suggested that silymarin ameliorated the toxic effects of APAP-induced hepatotoxicity and nephrotoxicity in mice."( Protective effects of silymarin against acetaminophen-induced hepatotoxicity and nephrotoxicity in mice.
Baycu, C; Bektur, NE; Sahin, E; Unver, G, 2016
)
0.7
"Gap junctional intercellular communication (GJIC), by which glutathione (GSH) and inorganic ions are transmitted to neighboring cells, is recognized as being largely involved in toxic processes of chemicals."( Role of connexin 32 in acetaminophen toxicity in a knockout mice model.
Arakawa, S; Igarashi, I; Kai, K; Maejima, T; Sanbuissho, A; Teranishi, M, 2014
)
0.71
" No adverse drug effects were noted in either group."( Hepatotoxicity in Obese Versus Nonobese Patients With Acetaminophen Poisoning Who Are Treated With Intravenous N-Acetylcysteine.
Erstad, BL; Patanwala, AE; Radosevich, JJ,
)
0.38
" It is treated with intravenous acetylcysteine, but the standard regimen is complex and associated with frequent adverse effects related to concentration, which can cause treatment interruption."( Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning: a randomised controlled trial.
Bateman, DN; Butcher, I; Cooper, JG; Coyle, J; Dear, JW; Eddleston, M; Gray, A; Lewis, SC; Rodriguez, A; Sandilands, EA; Thanacoody, HK; Thomas, SH; Veiraiah, A; Vliegenthart, AD; Webb, DJ, 2014
)
0.4
" Specific and sensitive detection of liver injury is important for the prompt and safe treatment of patients with the antidote N-acetylcysteine (NAC) and for the determination of NAC efficacy."( Stratification of paracetamol overdose patients using new toxicity biomarkers: current candidates and future challenges.
Antoine, DJ; Dear, JW, 2014
)
0.4
" The NCP-cultured HepG2 cells showed higher expression of mRNA and protein levels of cytochrome P450 2E1, which metabolizes APAP to a toxic metabolite, APAP-cysteine adduct formation, and higher sensitivity against APAP-induced cell injury compared with conventionally cultured cells."( Evaluation of three-dimensional cultured HepG2 cells in a nano culture plate system: an in vitro human model of acetaminophen hepatotoxicity.
Abe, N; Aritomi, K; Irie, T; Irikura, M; Ishitsuka, Y; Kai, H; Shimizu, D; Shuto, T; Tomishima, Y, 2014
)
0.61
" In the following study, the relationship of acylcarnitines with other known indicators of APAP toxicity was examined in children receiving low-dose (therapeutic) and high-dose ('overdose' or toxic ingestion) exposure to APAP."( Targeted liquid chromatography-mass spectrometry analysis of serum acylcarnitines in acetaminophen toxicity in children.
Beger, RD; Bhattacharyya, S; Gill, P; James, LP; Kearns, GL; Letzig, LG; Marshall, JD; Pence, L; Reed, MD; Simpson, PM; Sullivan, JE; Van Den Anker, JN; Yan, K, 2014
)
0.63
" A variety of adverse events (AEs) of varying severity have been noted during HPC infusions."( Infusion technique of hematopoietic progenitor cells and related adverse events (CME).
Bryant, SC; Gastineau, DA; Greiner, CW; Hogan, WJ; Jacob, EK; Lingineni, RK; Mohr, A; Mulay, SB; Padley, D, 2014
)
0.4
"Acetaminophen (APAP) is the most commonly reported toxic ingestion in the world."( Protective effect of chitosan treatment against acetaminophen-induced hepatotoxicity.
Erkasap, N; Karimi, H; Ozcelik, E; Uslu, S, 2014
)
2.1
" This study demonstrated that different mixtures of IBU and APAP were associated with different toxic effects in green neon shrimp."( Acute toxicity of mixture of acetaminophen and ibuprofen to Green Neon Shrimp, Neocaridina denticulate.
Chen, CM; Chiu, YW; Huang, DJ; Sung, HH; Wang, SY, 2014
)
0.69
" However, it is highly toxic when the dosage surpasses the detoxification capability of an exposed organism, with involvement of an already described oxidative stress pathway."( Biochemical and standard toxic effects of acetaminophen on the macrophyte species Lemna minor and Lemna gibba.
Antunes, SC; Gonçalves, F; Martins, L; Nunes, B; Pinto, G, 2014
)
0.67
"Drug-induced hepatotoxicity is a serious adverse effect with high morbidity and mortality rates but substantial individual to individual variation is observed in its severity."( Highly expressed protein kinase A inhibitor α and suppression of protein kinase A may potentiate acetaminophen-induced hepatotoxicity.
Bae, ON; Cho, SD; Kim, M; Lee, JY; Lim, KM; Yun, JW, 2014
)
0.62
" Next, the hiPSC-Hep, primary cryopreserved human hepatocytes (cryo-hHep) and the hepatic cell lines HepaRG and Huh7 were treated with staurosporine and acetaminophen, and the toxic responses were compared."( Critical differences in toxicity mechanisms in induced pluripotent stem cell-derived hepatocytes, hepatic cell lines and primary hepatocytes.
Andersson, TB; Brolén, G; Cotgreave, I; Glinghammar, B; Jonebring, A; Li, XQ; Liljevald, M; Sagemark, J; Sjogren, AK, 2014
)
0.6
" Some authors do not recommend treatment with N-acetylcysteine at low paracetamol plasma concentrations since unnecessary adverse effects may be induced."( Recommendations for the paracetamol treatment nomogram and side effects of N-acetylcysteine.
de Vries, I; Koppen, A; Meulenbelt, J; van Riel, A, 2014
)
0.4
"5 grams (the permissible safe dose is 4 grams) due to the viral infection."( [Hepatotoxicity of acetaminophen in a patient treated with capecitabine due to breast cancer].
Drzymała, M; Golon, K; Karczmarek-Borowska, B, 2014
)
0.73
" Overall adverse events in the 2 treatment groups were also compared."( Efficacy and safety of transdermal fentanyl in the control of postoperative pain after photorefractive keratectomy.
Bae, JH; Choi, CY; Kim, JM; Kim, YJ; Lee, YW, 2014
)
0.4
" Total number of patients who reported adverse events was significantly higher in the fentanyl group (P=0."( Efficacy and safety of transdermal fentanyl in the control of postoperative pain after photorefractive keratectomy.
Bae, JH; Choi, CY; Kim, JM; Kim, YJ; Lee, YW, 2014
)
0.4
"TDF was more effective in the control of postoperative pain after PRK than tramadol/acetaminophen and no irreversible or severe adverse effect was reported with 12 μg/h concentration."( Efficacy and safety of transdermal fentanyl in the control of postoperative pain after photorefractive keratectomy.
Bae, JH; Choi, CY; Kim, JM; Kim, YJ; Lee, YW, 2014
)
0.63
" The aim of this review was to provide an update of current knowledge of adverse events (AE) associated with the most common perioperative non-opioid analgesics: paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids (GCCs), gabapentinoids and their combinations."( Adverse effects of perioperative paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review.
Dahl, JB; Hamunen, K; Hansen, MS; Kjer, JJ; Kontinen, VK; Mathiesen, O; Nikolajsen, L; Pommergaard, HC; Rosenberg, J; Wetterslev, J, 2014
)
0.4
"Treatment-emergent adverse events, physical examinations, vital sign measurements, and clinical laboratory testing were assessed throughout the study."( Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery.
Barrett, T; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.64
" Adverse events occurred during the OLE in 64 patients (43."( Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery.
Barrett, T; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.64
" This adverse potential has never been captured in animal models, and the responsible compound(s) remains to be determined."( Flavokawains a and B in kava, not dihydromethysticin, potentiate acetaminophen-induced hepatotoxicity in C57BL/6 mice.
Leitzman, P; Narayanapillai, SC; O'Sullivan, MG; Xing, C, 2014
)
0.64
" The toxic chemicals tested were acetaminophen (APAP), 5-aminosalicylic acid (5-ASA), tetracycline (TC), and sodium valproate (VPA)."( Toxicity of 50-nm polystyrene particles co-administered to mice with acetaminophen, 5-aminosalicylic acid or tetracycline.
Ishida, I; Isoda, K; Nozawa, T; Tezuka, M, 2014
)
0.92
" Secondary endpoints included SPID at additional time points, total pain relief at all on-therapy time points (TOTPAR), sum of SPID and TOTPAR at all on-therapy time points (SPID + TOTPAR), use of rescue medication, subjective pain assessment (PGIC, Patient Global Impression of Change), and adverse events (AEs)."( A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement.
Bin, SI; Chang, N; Cho, SD; Choi, CH; Ha, CW; Kang, SB; Kyung, HS; Lee, JH; Lee, MC; Park, YB; Rhim, HY; Seo, SS, 2015
)
0.63
"This study demonstrated that the analgesic effect of TA-ER is non-inferior to TA-IR, and supports TA-ER as an effective and safe treatment for moderate to severe acute pain post total knee replacement."( A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement.
Bin, SI; Chang, N; Cho, SD; Choi, CH; Ha, CW; Kang, SB; Kyung, HS; Lee, JH; Lee, MC; Park, YB; Rhim, HY; Seo, SS, 2015
)
0.63
" On the other hand, several adverse effects have been reported with such medications, including peripheral vasoconstriction, gastrointestinal bleeding and perforation, weakened platelet aggregation, hyperbilirubinemia and renal failure."( Safety of therapeutics used in management of patent ductus arteriosus in preterm infants.
Erdeve, O; Oncel, MY, 2015
)
0.42
" No adverse effects were observed for doses of up to 900 mg/kg/d for 14 d."( Metabolism by conjugation appears to confer resistance to paracetamol (acetaminophen) hepatotoxicity in the cynomolgus monkey.
Barrass, N; Bi, L; Gales, S; Hutchison, M; Lenz, E; Parry, T; Powell, H; Qiao, J; Qin, Q; Ren, J; Thurman, D; Wilson, ID; Yu, H, 2015
)
0.65
" Adverse events in both trials were typical of those associated with opioid analgesics."( Efficacy and safety of once-daily, extended-release hydrocodone in individuals previously receiving hydrocodone/acetaminophen combination therapy for chronic pain.
Bartoli, A; He, E; Michna, E; Wen, W, 2015
)
0.63
" The toxic effect of acetaminophen was studied in mice on 1) maternal liver; mirrored by biomarkers of liver injury, centrilobular necrosis, and infiltration of granulocytes; 2) fetal liver; reflected by the frequency of hematopoietic stem cells, and 3) postnatal health; evaluated by the severity of allergic airway inflammation among offspring."( Prenatal acetaminophen induces liver toxicity in dams, reduces fetal liver stem cells, and increases airway inflammation in adult offspring.
Arck, P; Barikbin, R; Erhardt, A; Huebener, P; Karimi, K; Keßler, T; Ramisch, K; Thiele, K; Tiegs, G, 2015
)
1.15
"Acetaminophen (APAP, paracetamol, N-acetyl-p-aminophenol) is a widely used analgesic that is safe at therapeutic doses but is a major cause of acute liver failure (ALF) following overdose."( Metabolic phenotyping applied to pre-clinical and clinical studies of acetaminophen metabolism and hepatotoxicity.
Coen, M, 2015
)
2.09
" No adverse events were observed with respect to DDN."( Deep dry needling of trigger points located in the lateral pterygoid muscle: Efficacy and safety of treatment for management of myofascial pain and temporomandibular dysfunction.
Gonzalez-Perez, LM; Granados-Nunez, M; Infante-Cossio, P; Lopez-Martos, R; Ruiz-Canela-Mendez, P; Urresti-Lopez, FJ, 2015
)
0.42
" The objective of this study was to evaluate the effect of a dual-modality (written and spoken) literacy-appropriate educational strategy on patients' knowledge of and safe use of opioid analgesics."( Improving patient knowledge and safe use of opioids: a randomized controlled trial.
Adams, JG; Ahlstrom, E; Cameron, KA; Chevrier, A; Courtney, DM; Engel, KG; McCarthy, DM; McConnell, R; Sears, J; Wolf, MS, 2015
)
0.42
"We conducted a systematic literature review to assess the adverse event (AE) profile of paracetamol."( Paracetamol: not as safe as we thought? A systematic literature review of observational studies.
Bernstein, I; Birrell, F; Buckner, S; Conaghan, PG; Constanti, M; Delgado Nunes, V; Doherty, M; Dziedzic, K; Latchem, S; Miller, P; Porcheret, M; Roberts, E; Wise, E; Zhang, W, 2016
)
0.43
"NAC is safe for NAI-ALF."( Efficacy and safety of acetylcysteine in "non-acetaminophen" acute liver failure: A meta-analysis of prospective clinical trials.
Hu, J; Quan, Q; Ren, X; Sun, Z; Zhang, Q, 2015
)
0.68
" Secondary outcomes were adverse effects, patient adherence, and use of rescue medication."( Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials.
Day, RO; Ferreira, ML; Ferreira, PH; Lin, CW; Machado, GC; Maher, CG; McLachlan, AJ; Pinheiro, MB, 2015
)
0.42
"This article provides an overview on the Institute for Safe Medication Practices (ISMP), the only independent nonprofit organization in the USA devoted to the prevention of medication errors."( The Institute for Safe Medication Practices and Poison Control Centers: Collaborating to Prevent Medication Errors and Unintentional Poisonings.
Vaida, AJ, 2015
)
0.42
" Microarray data of rat PCLS exposed to APAP andCCl4was generated using a toxic dose based on decrease in ATP levels."( Acute toxicity of CCl4 but not of paracetamol induces a transcriptomic signature of fibrosis in precision-cut liver slices.
Elferink, ML; Groothuis, GM; Olinga, P; Schoonen, WG; Vatakuti, S, 2015
)
0.42
"To determine whether metamizole is clinically safe compared to placebo and other analgesics."( Metamizole-associated adverse events: a systematic review and meta-analysis.
Blozik, E; da Costa, BR; Fässler, M; Jüni, P; Kötter, T; Linde, K; Reichenbach, S; Scherer, M, 2015
)
0.42
" Adverse events (AEs), serious adverse events (SAEs), and dropouts were assessed."( Metamizole-associated adverse events: a systematic review and meta-analysis.
Blozik, E; da Costa, BR; Fässler, M; Jüni, P; Kötter, T; Linde, K; Reichenbach, S; Scherer, M, 2015
)
0.42
"For short-term use in the hospital setting, metamizole seems to be a safe choice when compared to other widely used analgesics."( Metamizole-associated adverse events: a systematic review and meta-analysis.
Blozik, E; da Costa, BR; Fässler, M; Jüni, P; Kötter, T; Linde, K; Reichenbach, S; Scherer, M, 2015
)
0.42
" To determine the developmental toxic effect of arsanilic acid (Ars) and acetaminophen (AAP) on the hepatic development, the differentiating cells were treated with the test chemicals (below IC12."( Hepatic differentiation of human adipose tissue-derived mesenchymal stem cells and adverse effects of arsanilic acid and acetaminophen during in vitro hepatic developmental stage.
Bang, SI; Cho, MH; Kang, HG; Kang, SJ; Kwon, MJ; Park, YH; Park, YI; So, B; Yang, YH, 2015
)
0.86
" Acetaminophen (APAP) is a commonly used and effective analgesic/antipyretic agent and relatively safe drug even in long-term treatment."( [Investigation of Predisposition Biomarkers to Identify Risk Factors for Drug-induced Liver Injury in Humans: Analyses of Endogenous Metabolites in an Animal Model Mimicking Human Responders to APAP-induced Hepatotoxicity].
Kobayashi, A; Kondo, K; Sugai, S, 2015
)
1.33
"14%) with acute poisoning at toxic doses showed hepatotoxicity signs, 4 (57."( Hepatotoxicity induced by acute and chronic paracetamol overdose in adults. Where do we stand?
Borobia, AM; Carcas, AJ; Frías, J; García, S; Martín, J; Martínez, AM; Medrano, N; Quintana, M; Ramírez, E; Ruiz, JA; Tong, HY, 2015
)
0.42
" Such formulations could increase phenylephrine-related cardiovascular adverse events particularly in susceptible individuals."( Potential cardiovascular adverse events when phenylephrine is combined with paracetamol: simulation and narrative review.
Anderson, BJ; Atkinson, HC; Potts, AL, 2015
)
0.42
"MEDLINE and EMBASE databases were searched for papers discussing or describing any adverse effect, hypersensitivity or safety concerns related to phenylephrine alone or in combination with other drugs."( Potential cardiovascular adverse events when phenylephrine is combined with paracetamol: simulation and narrative review.
Anderson, BJ; Atkinson, HC; Potts, AL, 2015
)
0.42
" Safety was monitored through adverse event reporting."( Comparison of the efficacy and safety of different doses of propacetamol for postoperative pain control after breast surgery.
Kang, JE; Kim, HS; Kim, JT; Lee, JH; Park, SK; Song, IK, 2015
)
0.42
"Registered nurses (RNs) play a pivotal role in treating pain and preventing and recognizing the adverse effects (AEs) of analgesics in patients with dementia."( Registered Nurses' Knowledge about Adverse Effects of Analgesics when Treating Postoperative Pain in Patients with Dementia.
Hartikainen, S; Kankkunen, P; Kvist, T; Rantala, M, 2015
)
0.42
" A good knowledge of the different strategies to decrease the gastrointestinal and cardiovascular toxic effects of NSAIDs is key to the management of OA."( Safety and efficacy of paracetamol and NSAIDs in osteoarthritis: which drug to recommend?
Frazier, A; Latourte, A; Richette, P, 2015
)
0.42
" One notable exception is acetaminophen (APAP, paracetamol), which is a safe drug at therapeutic doses but can cause severe liver injury and acute liver failure after intentional and unintentional overdoses."( Acetaminophen: Dose-Dependent Drug Hepatotoxicity and Acute Liver Failure in Patients.
Jaeschke, H, 2015
)
2.16
" Thus, toxic oral APAP doses sufficient to cause severe widespread liver damage do not cause significant damage when administered concurrently with equal amounts of NAC, that is, in the NAC-APAP treated animals, hepatic transaminases increase only marginally and liver architecture remains fully intact."( Co-administration of N-Acetylcysteine and Acetaminophen Efficiently Blocks Acetaminophen Toxicity.
Andrus, JP; Herzenberg, LA; Owumi, SE, 2015
)
0.68
" Using this approach we determined, in terms of the model parameters, the critical dose between safe and overdose cases, timescales for exhaustion and regeneration of important cofactors for acetaminophen metabolism and total toxin accumulation as a fraction of initial dose."( Timescale analysis of a mathematical model of acetaminophen metabolism and toxicity.
Reddyhoff, D; Regan, S; Ward, J; Webb, S; Williams, D, 2015
)
0.87
" Collected data included socio-demographics, treatment information, incidence of adverse drug reactions (ADRs), numerical rating scale for intensity of pain, EuroQol-5D (EQ-5D) scale, and physician's global impression (PGI) during the 12 week observation period."( Overall safety profile and effectiveness of tramadol hydrochloride/acetaminophen in patients with chronic noncancer pain in Japanese real-world practice.
Fujie, M; Kawai, K; Ogawa, Y; Suzuki, J; Yajima, T; Yokomori, J; Yoshizawa, K, 2015
)
0.65
" Potential links to adverse short- and long-term infant outcomes for these products are reviewed, and the strengths and limitations of data to support these."( Over-the-counter medications: Risk and safety in pregnancy.
Chambers, C, 2015
)
0.42
"Nonsteroidal anti-inflammatory drugs (NSAIDs) such as meloxicam are commonly used to treat osteoarthritis (OA) but are associated with potentially serious dose-related adverse events (AEs)."( Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study.
Altman, R; Gibofsky, A; Hochberg, M; Jaros, M; Young, C, 2015
)
0.42
" Considering its toxic effect and the loss of protection in PHH, BA is not a clinically useful treatment option for APAP overdose patient."( Benzyl alcohol protects against acetaminophen hepatotoxicity by inhibiting cytochrome P450 enzymes but causes mitochondrial dysfunction and cell death at higher doses.
Du, K; Jaeschke, H; McGill, MR; Xie, Y, 2015
)
0.7
"The goal of this study is to summarize trends in rates of adverse events attributable to acetaminophen use, including hepatotoxicity and mortality."( Trends in rates of acetaminophen-related adverse events in the United States.
Ding, Y; Iyasu, S; Major, JM; Mehta, H; Pham, TM; Staffa, JA; Trinidad, JP; Wang, C; Willy, ME; Wong, HL; Zhou, EH, 2016
)
0.98
" Rates of emergency department visits for unintentional acetaminophen-related adverse events decreased from 58."( Trends in rates of acetaminophen-related adverse events in the United States.
Ding, Y; Iyasu, S; Major, JM; Mehta, H; Pham, TM; Staffa, JA; Trinidad, JP; Wang, C; Willy, ME; Wong, HL; Zhou, EH, 2016
)
1.01
"Acetaminophen-related adverse events continue to be a public health burden."( Trends in rates of acetaminophen-related adverse events in the United States.
Ding, Y; Iyasu, S; Major, JM; Mehta, H; Pham, TM; Staffa, JA; Trinidad, JP; Wang, C; Willy, ME; Wong, HL; Zhou, EH, 2016
)
2.21
" It is safe at therapeutic doses, but its overdose can result in severe hepatotoxicity, a leading cause of drug-induced acute liver failure in the USA."( N-acetylcysteine amide, a promising antidote for acetaminophen toxicity.
Ercal, N; Hart, M; Khayyat, A; Tobwala, S, 2016
)
0.69
" Despite old age and frailty being associated with extensive and long-term utilization of acetaminophen and a high prevalence of adverse drug reactions, there is limited information on the risks of toxicity from acetaminophen in old age and frailty."( Acetaminophen hepatotoxicity in mice: Effect of age, frailty and exposure type.
Cogger, V; de Cabo, R; Hilmer, SN; Huizer-Pajkos, A; Jones, B; Kane, AE; Le Couteur, DG; Mach, J; McKenzie, C; Mitchell, SJ, 2016
)
2.1
" In agreement with in vivo studies, acetaminophen (APAP) toxicity was most profound in HUVEC mono-cultures; whilst in C3A:HUVEC co-culture, cells were less susceptible to the toxic effects of APAP, including parameters of oxidative stress and ATP depletion, altered redox homeostasis, and impaired respiration."( Acetaminophen cytotoxicity is ameliorated in a human liver organotypic co-culture model.
Hayes, PC; Morley, SD; Navarro, M; Nelson, LJ; Plevris, JN; Samuel, K; Treskes, P; Tura-Ceide, O, 2015
)
2.13
" Moreover, cell lines used in the present study were more sensitive to toxic effects of troglitazone than previously reported."( Development of an optimized cytotoxicity assay system for CYP3A4-mediated metabolic activation via modified piggyBac transposition.
Dai, R; Dai, T; Deng, J; Huang, L; Jia, Y; Jiang, J; Xie, S; Zou, S, 2016
)
0.43
" Standard mechanistic studies in animals for examining the toxic and pathological changes associated with the chemical exposure have often been limited to the single end point or pathways."( Acetaminophen Induced Hepatotoxicity in Wistar Rats--A Proteomic Approach.
Agastian, P; Al-Dhabi, NA; Baru, R; Choi, KC; Ilavenil, S; Ock Kim, Y; Srigopalram, S; Valan Arasu, M, 2016
)
1.88
" These approaches can also be used to reveal potential biomarkers of exposure or toxic response."( Identification of protein adduction using mass spectrometry: Protein adducts as biomarkers and predictors of toxicity mechanisms.
Bartlett, MG; Yang, X, 2016
)
0.43
"These results indicate that mice lacking Vnn1 have deficiencies in compensatory repair and immune responses following toxic APAP exposure and that these mechanisms may contribute to the enhanced hepatotoxicity seen."( Enhanced hepatotoxicity by acetaminophen in Vanin-1 knockout mice is associated with deficient proliferative and immune responses.
Chasson, L; Ferreira, DW; Galland, F; Goedken, MJ; Manautou, JE; Naquet, P; Rommelaere, S, 2016
)
0.73
" The effect of a commercial polysaccharide thickener, designed to be added to fluids to promote safe swallowing by dysphagic patients, on rheology and acetaminophen dissolution was tested using crushed immediate-release tablets in water, effervescent tablets in water, elixir and suspension."( Oral medication delivery in impaired swallowing: thickening liquid medications for safe swallowing alters dissolution characteristics.
Cichero, JA; Manrique, YJ; Nissen, LM; Sparkes, AM; Steadman, KJ; Stokes, JR, 2016
)
0.63
" It is considered to be safe when administered within its therapeutic range, but in cases of acute intoxication, hepatotoxicity can occur."( Acetaminophen from liver to brain: New insights into drug pharmacological action and toxicity.
Ghanem, CI; Manautou, JE; Mottino, AD; Pérez, MJ, 2016
)
1.88
"Drug-induced liver injury (DILI) represents a serious medical challenge and a potentially fatal adverse event."( Recent advances in biomarkers and therapeutic interventions for hepatic drug safety - false dawn or new horizon?
Antoine, DJ; Clarke, JI; Dear, JW, 2016
)
0.43
" The hepatotoxic compounds induced the expected zebrafish liver degeneration or changes in size, whereas saccharin did not have any phenotypic adverse effect."( Phenotypic and biomarker evaluation of zebrafish larvae as an alternative model to predict mammalian hepatotoxicity.
Berckmans, P; Covaci, A; Hollanders, K; Maho, W; Peers, B; Remy, S; Verstraelen, S; Witters, H, 2016
)
0.43
" It is safe and effective at recommended doses but has the potential for causing hepatotoxicity and acute liver failure (ALF) with overdose."( Role of food-derived antioxidant agents against acetaminophen-induced hepatotoxicity.
Eugenio-Pérez, D; Montes de Oca-Solano, HA; Pedraza-Chaverri, J, 2016
)
0.69
" Acute adverse events in the morphine group occurred in 19 (3%) participants."( Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial.
Afzal, MS; Al Hilli, SA; Al Rumaihi, K; Anjum, S; Cameron, PA; Mitra, B; Morley, K; Pathan, SA; Shukla, D; Straney, LD; Thomas, SH, 2016
)
0.43
" Although ibuprofen represents the first choice for the closure of PDA, this treatment can cause severe gastrointestinal and adverse renal effects and worsen platelet function."( Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial.
Comandini, A; Dani, C; Lipone, P; Lista, G; Mosca, F; Poggi, C; Ramenghi, L; Romagnoli, C; Rosignoli, MT; Salvatori, E; Schena, F, 2016
)
0.43
" The secondary endpoints include the closure rate of PDA after the second course of treatment with ibuprofen, the re-opening rate of the PDA, the incidence of surgical ligation, and the occurrence of adverse effects."( Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial.
Comandini, A; Dani, C; Lipone, P; Lista, G; Mosca, F; Poggi, C; Ramenghi, L; Romagnoli, C; Rosignoli, MT; Salvatori, E; Schena, F, 2016
)
0.43
" Paracetamol could offer several important therapeutic advantages over current treatment options, and it could become the treatment of choice for the management of PDA, mainly due to its more favorable side effect profile."( Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial.
Comandini, A; Dani, C; Lipone, P; Lista, G; Mosca, F; Poggi, C; Ramenghi, L; Romagnoli, C; Rosignoli, MT; Salvatori, E; Schena, F, 2016
)
0.43
" The findings of this study suggest that RNP(N) possesses effective hepatoprotective properties and does not exhibit the notable adverse effects associated with NAC treatment."( Redox Nanoparticle Therapeutics for Acetaminophen-Induced Hepatotoxicity in Mice.
Boonruamkaew, P; Chonpathompikunlert, P; Nagasaki, Y, 2016
)
0.71
" The aim of this study was to evaluate the toxic effects of three typical NSAIDs, diclofenac (DFC), acetaminophen (APAP) and ibuprofen (IBP), toward the water flea Daphnia magna."( Toxicity Thresholds for Diclofenac, Acetaminophen and Ibuprofen in the Water Flea Daphnia magna.
Du, J; Mei, CF; Xu, MY; Ying, GG, 2016
)
0.93
" Exposure of healthy male Swiss mice to a toxic overdose of APAP (350 mg/kg, ip) significantly increased serum hepatocellular enzyme activities, decreased hepatocellular glutathione (GSH) levels, and induced severe centrilobular hepatocellular necrosis."( Elucidation of the hepatoprotective moiety of 5β-scymnol that suppresses paracetamol toxicity in mice.
Carter, F; Hodges, LD; Kalafatis, N; Macrides, TA; Wright, PF, 2016
)
0.43
" In this research, we have explored the feasibility of retrospectively mapping population-level adverse events from the FDA Adverse Event Reporting System (FAERS) to chemical and biological databases to identify drug safety signals and the underlying molecular mechanisms."( Improving drug safety with a systems pharmacology approach.
Bojunga, N; Lesko, LJ; Schotland, P; Trame, MN; Zien, A, 2016
)
0.43
" Secondary endpoints included opioid requirements, quality of recovery scale (QoR), length of post-anesthesia care unit (PACU) stay, antiemetic consumption, opioid consumption, and opioid related adverse events."( A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty.
Abubaker, H; Ahrendtsen, L; Demas, E; Gupta, A, 2016
)
0.65
" Opioid requirements and adverse events were significantly less in Group 2 which was also statistically significant."( A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty.
Abubaker, H; Ahrendtsen, L; Demas, E; Gupta, A, 2016
)
0.65
"IV ibuprofen combined with IV acetaminophen demonstrated additional benefit in terms of improved pain scores on post-operative day 3 only, fewer potential adverse events related to opioid use, and decreased use of opioids when compared to IV ibuprofen alone."( A Randomized Trial Comparing the Safety and Efficacy of Intravenous Ibuprofen versus Ibuprofen and Acetaminophen in Knee or Hip Arthroplasty.
Abubaker, H; Ahrendtsen, L; Demas, E; Gupta, A, 2016
)
0.94
"A reagentless glutamate biosensor was applied to the determination of glutamate released from liver hepatocellular carcinoma cells (HepG2) in response to toxic challenge from various concentrations of paracetamol."( A novel reagentless glutamate microband biosensor for real-time cell toxicity monitoring.
Fielden, PR; Hart, JP; Hughes, G; Pemberton, RM, 2016
)
0.43
" The secondary outcomes included 48-hour postoperative opioid consumption, incisional pain scores, opioid-related adverse effects, length of mechanical ventilation, length of intensive care unit stay, and the extent of wound hyperalgesia assessed at 24 and 48 hours postoperatively."( Intravenous Acetaminophen as an Adjunct Analgesic in Cardiac Surgery Reduces Opioid Consumption But Not Opioid-Related Adverse Effects: A Randomized Controlled Trial.
Bollag, L; Bowdle, A; Cain, KC; Jelacic, S; Richebe, P; Rivat, C, 2016
)
0.81
"Study selectionAll Cochrane reviews of RCTs between 1999 to 2015, conducted in adults examining the adverse events associated with single dose oral analgesics used for acute post-operative pain were considered."( Single dose oral analgesics for postoperative pain have few adverse events.
Wong, YJ, 2016
)
0.43
" Studies were pooled for post hoc analyses of efficacy and adverse event end points."( Antipyretic Efficacy and Safety of Ibuprofen Versus Acetaminophen Suspension in Febrile Children: Results of 2 Randomized, Double-Blind, Single-Dose Studies.
Jayawardena, S; Kellstein, D, 2017
)
0.71
" We found a change in cell viability after 24h incubation with all tested toxic compounds."( Neutrophil gelatinase-associated lipocalin production negatively correlates with HK-2 cell impairment: Evaluation of NGAL as a marker of toxicity in HK-2 cells.
Čapek, J; Flídr, P; Hauschke, M; Libra, A; Roušar, T; Roušarová, E, 2017
)
0.46
"Acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) are antipyretic analgesics with established adverse effects (AEs); however, only a few studies have compared their AEs simultaneously."( Characterization of the Adverse Effects Induced by Acetaminophen and Nonsteroidal Anti-Inflammatory Drugs Based on the Analysis of the Japanese Adverse Drug Event Report Database.
Kagaya, H; Nagai, J; Shimamura, R; Uesawa, Y, 2017
)
2.15
"We used a high-quality database for spontaneous adverse drug event reporting in Japan."( Characterization of the Adverse Effects Induced by Acetaminophen and Nonsteroidal Anti-Inflammatory Drugs Based on the Analysis of the Japanese Adverse Drug Event Report Database.
Kagaya, H; Nagai, J; Shimamura, R; Uesawa, Y, 2017
)
0.71
" Mouse hepatocytes in primary culture however had approximately three-fold higher susceptibility to the toxic effect of APAP when compared to rat hepatocytes."( Acetaminophen toxicity in rat and mouse hepatocytes in vitro.
Červinková, Z; Endlicher, R; Kučera, O; Lotková, H; Rychtrmoc, D; Sobotka, O, 2017
)
1.9
" We discovered that variants of the merged mechanism provide plausible quantitative explanations for the considerable variation in 24-hour necrosis scores among 37 genetically diverse mouse strains following a single toxic acetaminophen dose."( Competing Mechanistic Hypotheses of Acetaminophen-Induced Hepatotoxicity Challenged by Virtual Experiments.
Hunt, CA; Kaplowitz, N; Kennedy, RC; Ookhtens, M; Petersen, BK; Ropella, GE; Smith, AK, 2016
)
0.89
" Our findings indicate that replacing the current APAP with a safe and functional APAP/5'-AMP formulation could prevent APAP-induced hepatotoxicity."( Adenosine 5'-monophosphate blocks acetaminophen toxicity by increasing ubiquitination-mediated ASK1 degradation.
Kong, Y; Sun, Q; Xu, X; Yang, X; Zhan, Y; Zhang, J, 2017
)
0.73
" In vitro cytotoxicity assays confirmed that HLCs from patients with clinically identified hepatotoxicity were more sensitive to PZ-induced toxicity than other individuals, while a prototype hepatotoxin acetaminophen was similarly toxic to all HLCs studied."( Patient-specific hepatocyte-like cells derived from induced pluripotent stem cells model pazopanib-mediated hepatotoxicity.
Choudhury, Y; Kanesvaran, R; Li, H; Poh, J; Qu, Y; Tan, HS; Tan, MH; Toh, YC; Xing, J; Yu, H, 2017
)
0.64
" There were no differences in safety parameters or serious adverse events."( A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients.
Chumpitazi, CE; Hahn, BJ; Kaelin, BA; Khalil, SN; Macias, CG; Rock, AD, 2017
)
0.46
" Finally, the pharmacodynamic mimicry of GSH by ψ-GSH is illustrated through the isolation and chemical characterization of an entity that can arise only through direct encounter of ψ-GSH with N-acetyl-p-benzoquinoneimine, the primary toxic metabolite of APAP."( Hepatoprotective Effect of ψ-Glutathione in a Murine Model of Acetaminophen-Induced Liver Toxicity.
More, SS; Nugent, J; Nye, SM; Vartak, AP; Vince, R, 2017
)
0.7
" Hepatotoxicity induced by toxic dose of paracetamol was revealed also by notable histopathological alterations, which were not observed in the group treated with paracetamol together with apigenin."( Antioxidative and Protective Actions of Apigenin in a Paracetamol-Induced Hepatotoxicity Rat Model.
Čapo, I; Gigov, S; Kojić-Damjanov, S; Martić, N; Milijašević, B; Paut Kusturica, M; Rašković, A, 2017
)
0.46
" Very few responders knew about the toxic doses of the medicines they used."( Non-steroidal anti-inflammatory drugs vs. Paracetamol: drug availability, patients' preference and knowledge of toxicity.
Nadeem, A; Zamir, Q,
)
0.13
" A priority list of toxic agents for which improved analytical techniques could offer a more widespread availability and rapid access to clinically important test results is presented."( [Access to rapid laboratory analytical services in cases of acute poisoning provides better and safer patient care].
Beck, O; Elmgren, A; Hansson, T; Helander, A; Olsson, E, 2017
)
0.46
" Moreover, those compounds incompletely removed by treatment have the chance to form toxic disinfection byproducts (DBPs) during subsequent disinfection."( Formation and estimated toxicity of trihalomethanes, haloacetonitriles, and haloacetamides from the chlor(am)ination of acetaminophen.
Bond, T; Chu, W; Ding, S; Du, E; Gao, N; Wang, Q; Xu, B, 2018
)
0.69
" To investigate this, mice were treated with toxic doses of APAP and euthanized between 0 and 96 h."( Induction of mitochondrial biogenesis protects against acetaminophen hepatotoxicity.
Asselah, T; Ding, WX; Du, K; Farhood, A; Jaeschke, H; Mansouri, A; McGill, MR; Ramachandran, A; Woolbright, BL, 2017
)
0.7
"Acetaminophen (APAP) is a commonly used analgesic and antipyretic that can cause hepatotoxicity due to production of toxic metabolites via cytochrome P450 (Cyp) 1a2 and Cyp2e1."( Fructose diet alleviates acetaminophen-induced hepatotoxicity in mice.
Chang, EB; Chlipala, G; Cho, S; Green, S; Jeong, H; Lee, H; Tripathi, A, 2017
)
2.2
" The present study aimed to survey the components of OTC drug package inserts for analgesic and antipyretic drugs and to evaluate the adverse event profiles using the Japanese Adverse Drug Event Report database (JADER)."( Adverse Event Trends Associated with OTC Analgesic and Antipyretic Drug: Data Mining of the Japanese Adverse Drug Event Report Database.
Abe, J; Fukuda, A; Hasegawa, S; Hatahira, H; Iguchi, K; Kato, Y; Motooka, Y; Naganuma, M; Nakamura, M; Nakao, S; Ohmori, T; Sasaoka, S; Shimauchi, A, 2017
)
0.46
" Each article has poor power to show risks of acetaminophen, however, the integration of the articles that showed adverse effects of acetaminophen may have power to show them."( Is acetaminophen safe in pregnancy?
Toda, K, 2017
)
1.33
" Adverse nasal effects were more frequent for intranasal benzhydrocodone/APAP vs intranasal HB/APAP."( Relative Bioavailability, Intranasal Abuse Potential, and Safety of Benzhydrocodone/Acetaminophen Compared with Hydrocodone Bitartrate/Acetaminophen in Recreational Drug Abusers.
Barrett, AC; Guenther, SM; Lam, V; Mickle, TC; Roupe, KA; Zhou, J, 2018
)
0.71
"Reduced hydrocodone exposure and drug liking at early time intervals, coupled with adverse nasal effects, can be expected to provide a level of deterrence to the intranasal route of abuse for benzhydrocodone/APAP."( Relative Bioavailability, Intranasal Abuse Potential, and Safety of Benzhydrocodone/Acetaminophen Compared with Hydrocodone Bitartrate/Acetaminophen in Recreational Drug Abusers.
Barrett, AC; Guenther, SM; Lam, V; Mickle, TC; Roupe, KA; Zhou, J, 2018
)
0.71
" Consistent with the toxic effects of APAP in the liver and cisplatin in the kidney, immunohistochemical analysis revealed the elevated expression of luciferase and Hmox1 in centrilobular hepatocytes and in tubular epithelial cells, respectively."( Real-time in vivo imaging reveals localised Nrf2 stress responses associated with direct and metabolism-dependent drug toxicity.
Copple, IM; Forootan, SS; Francis, B; Goldring, CE; Iwawaki, T; Kipar, A; Mutter, FE; Park, BK, 2017
)
0.46
"Acetylcysteine (NAC), an effective antidote for paracetamol poisoning, is commonly associated with adverse reactions."( Fewer adverse effects with a modified two-bag acetylcysteine protocol in paracetamol overdose.
Chandru, P; Gunja, N; Lim, JME; McNulty, R, 2018
)
0.48
" We compared adverse reactions in patients receiving the modified two-bag protocol with a historical control (traditional three-bag regimen with initial bolus of 150 mg/kg/h)."( Fewer adverse effects with a modified two-bag acetylcysteine protocol in paracetamol overdose.
Chandru, P; Gunja, N; Lim, JME; McNulty, R, 2018
)
0.48
" These results add to the accumulating evidence that reducing the initial NAC infusion rate reduces the risk of adverse reactions."( Fewer adverse effects with a modified two-bag acetylcysteine protocol in paracetamol overdose.
Chandru, P; Gunja, N; Lim, JME; McNulty, R, 2018
)
0.48
"Acetaminophen (paracetamol) is a widely used analgesic and antipyretic drug that is safe at therapeutic doses."( Kaurenoic acid extracted from Sphagneticola trilobata reduces acetaminophen-induced hepatotoxicity through inhibition of oxidative stress and pro-inflammatory cytokine production in mice.
Arakawa, NS; Borghi, SM; Bussmann, AJC; Casagrande, R; Fattori, V; Hirooka, EY; Lourenco-Gonzalez, Y; Marcondes-Alves, L; Verri, WA, 2019
)
2.2
" In the present study, we aimed to evaluate the adverse event profiles of OTC combination cold remedy based on the components using the Japanese Adverse Drug Event Report (JADER) database."( [Adverse Event Trends Associated with Over-the-counter Combination Cold Remedy: Data Mining of the Japanese Adverse Drug Event Report Database].
Fukuda, A; Hasegawa, S; Hatahira, H; Hirade, K; Iguchi, K; Motooka, Y; Naganuma, M; Nakamura, M; Nakao, S; Sasaoka, S; Shimauchi, A; Ueda, N; Umetsu, R, 2018
)
0.48
" Although effective, these agents can be associated with adverse effects that may limit their use in some people."( Cardiorenal Safety of OTC Analgesics.
Angiolillo, DJ; Davidson, MH; Kloner, RA; White, WB, 2018
)
0.48
"We could not show that perioperative ivAPAP reduces inpatient opioid prescription with subsequent reduced odds for adverse outcomes."( Intravenous Acetaminophen Does Not Reduce Inpatient Opioid Prescription or Opioid-Related Adverse Events Among Patients Undergoing Spine Surgery.
Cozowicz, C; Mazumdar, M; Memtsoudis, SG; Mörwald, EE; Poeran, J; Zubizarreta, N, 2018
)
0.86
"To assess the risk of significant adverse events in premature infants receiving the novel 4-component group B meningococcal vaccine (4CMenB) with their routine immunisations at 2 months of age."( Safety of meningococcal group B vaccination in hospitalised premature infants.
Beebeejaun, K; Braccio, S; Clarke, P; Heath, PT; Kadambari, S; Kent, A; Ladhani, S, 2019
)
0.51
"4CMenB does not increase the risk of serious adverse events in hospitalised premature infants."( Safety of meningococcal group B vaccination in hospitalised premature infants.
Beebeejaun, K; Braccio, S; Clarke, P; Heath, PT; Kadambari, S; Kent, A; Ladhani, S, 2019
)
0.51
" Secondary outcomes were to assess whether any change in depression was secondary to change in pain (Mobilisation-Observation-Behaviour-Intensity-Dementia-2 Pain Scale) and adverse events."( Efficacy and Safety of Analgesic Treatment for Depression in People with Advanced Dementia: Randomised, Multicentre, Double-Blind, Placebo-Controlled Trial (DEP.PAIN.DEM).
Aarsland, D; Ballard, C; Erdal, A; Flo, E; Husebo, BS; Slettebo, DD, 2018
)
0.48
" Thirty-five patients were withdrawn from the study because of adverse reactions, deterioration or death: 25 (31."( Efficacy and Safety of Analgesic Treatment for Depression in People with Advanced Dementia: Randomised, Multicentre, Double-Blind, Placebo-Controlled Trial (DEP.PAIN.DEM).
Aarsland, D; Ballard, C; Erdal, A; Flo, E; Husebo, BS; Slettebo, DD, 2018
)
0.48
"Analgesic treatment did not reduce depression while placebo appeared to improve depressive symptoms significantly by comparison, possibly owing to the adverse effects of active buprenorphine."( Efficacy and Safety of Analgesic Treatment for Depression in People with Advanced Dementia: Randomised, Multicentre, Double-Blind, Placebo-Controlled Trial (DEP.PAIN.DEM).
Aarsland, D; Ballard, C; Erdal, A; Flo, E; Husebo, BS; Slettebo, DD, 2018
)
0.48
" Functional experiments showed that OPN deficiency protected against the APAP-induced liver injury by inhibiting the toxic APAP metabolism via reducing the expression of the cytochrome P450 family 2 subfamily E member 1 (CYP2E1)."( Metabolic modulation of acetaminophen-induced hepatotoxicity by osteopontin.
Gu, J; Kong, X; Sun, X; Sun, Y; Tong, Y; Wang, C; Wang, K; Wen, Y; Wu, H; Xia, Q; Yu, C, 2019
)
0.82
"High-throughput screening (HTS) of liver toxicants can bridge the gap in understanding adverse effects of chemicals on humans."( High-throughput toxicity testing of chemicals and mixtures in organotypic multi-cellular cultures of primary human hepatic cells.
Ehrich, MF; Orbach, SM; Rajagopalan, P, 2018
)
0.48
" Over the same period, concerns over the long-term adverse effects of paracetamol use have increased, initially in the field of hypertension, but more recently in other areas as well."( Long-term adverse effects of paracetamol - a review.
Dear, JW; MacIntyre, IM; McCrae, JC; Morrison, EE; Webb, DJ, 2018
)
0.48
"Acetaminophen (APAP) hepatotoxicity remains the leading cause of drug-induced liver injury due to the lack of safe and effective therapeutic agents."( Hepatoprotective effects of berberine on acetaminophen-induced hepatotoxicity in mice.
Hua, W; Liu, X; Liu, Y; Wei, Q; Zhao, Z; Zhu, Y, 2018
)
2.19
" Autophagy is a catabolic machinery aimed at recycling cellular components and damaged organelles in response to a variety of stimuli, such as nutrient deprivation and toxic stress."( Autophagy and acetaminophen-induced hepatotoxicity.
Shan, S; Shen, Z; Song, F, 2018
)
0.84
" We consider that mifamurtide therapy is a safe and well-tolerated agent in childhood OS."( The Efficiency and Toxicity of Mifamurtide in Childhood Osteosarcoma.
Berber, M; Dincaslan, H; Incesoy Ozdemir, S; Tacyildiz, N; Unal, E; Yavuz, G, 2018
)
0.48
" Since long-term adverse effects of these xenobiotics and their biological and pharmacokinetic activity especially at environmentally relevant concentrations are better understood, degradation of such contaminants has become a major concern."( Organic micropollutants paracetamol and ibuprofen-toxicity, biodegradation, and genetic background of their utilization by bacteria.
Guzik, U; Hupert-Kocurek, K; Marchlewicz, A; Piński, A; Wojcieszyńska, D; Żur, J, 2018
)
0.48
"0 °C), the mean time when first normalization of body temperature, and the development of adverse events including gastrointestinal problem, elevated liver enzyme, and thrombocytopenia."( The antipyretic efficacy and safety of propacetamol compared with dexibuprofen in febrile children: a multicenter, randomized, double-blind, comparative, phase 3 clinical trial.
Choi, SJ; Choi, UY; Chun, YH; Jeong, DC; Kim, HM; Lee, J; Lee, JH; Moon, S; Rhim, JW, 2018
)
0.48
"Intravenous propacetamol may be a safe and effective choice for pediatric URTI patients presenting with fever who are not able to take oral medications or need faster fever control."( The antipyretic efficacy and safety of propacetamol compared with dexibuprofen in febrile children: a multicenter, randomized, double-blind, comparative, phase 3 clinical trial.
Choi, SJ; Choi, UY; Chun, YH; Jeong, DC; Kim, HM; Lee, J; Lee, JH; Moon, S; Rhim, JW, 2018
)
0.48
" Despite being safe at therapeutic doses, acetaminophen overdose is a leading cause of acute liver failure."( Essential oils of green cumin and chamomile partially protect against acute acetaminophen hepatotoxicity in rats.
Ebada, ME, 2018
)
0.97
"We hypothesized (1) that gastrointestinal (GI) and renal adverse events (AE) would occur more often in infants first prescribed ibuprofen before rather than after six months of age and (2) that ibuprofen would be associated with more adverse effects than acetaminophen in infants younger than six months."( Safety of ibuprofen in infants younger than six months: A retrospective cohort study.
Bang, H; Rothenberg, SJ; Walsh, P, 2018
)
0.66
" This was performed by comparison of mean pain intensity difference, total pain relief at 2 h, onset of pain relief, decrease in number of pain episodes, global improvement, and adverse effects."( Efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80 mg) and paracetamol (500 mg) in amelioration of abdominal pain in acute infectious gastroenteritis: A randomized controlled trial.
Koli, J; Narang, S, 2018
)
0.48
"Fixed-dose combination of drotaverine hydrochloride (80 mg) and PCM (500 mg) is an effective and safe antispasmodic agent in abdominal pain associated with acute infectious gastroenteritis."( Efficacy and safety of fixed-dose combination of drotaverine hydrochloride (80 mg) and paracetamol (500 mg) in amelioration of abdominal pain in acute infectious gastroenteritis: A randomized controlled trial.
Koli, J; Narang, S, 2018
)
0.48
" In the present study, we performed a 13-week toxicity study for acetaminophen (APAP), a well-known drug that exhibits hepatotoxicity as an adverse effect, using an obese rat model to investigate the differences in susceptibility between obese and normal individuals."( A 13-week subchronic toxicity study of acetaminophen using an obese rat model.
Akagi, JI; Cho, YM; Imaida, K; Matsushita, K; Mizuta, Y; Nishikawa, A; Ogawa, K; Toyoda, T, 2018
)
0.99
"As an analgesic and antipyretic drug, acetaminophen (APAP) is commonly used and known to be safe at therapeutic doses."( GADD45α alleviates acetaminophen-induced hepatotoxicity by promoting AMPK activation.
Lei, X; Li, C; Li, X; Mao, Y; Ming, Y; Tang, Y; Wang, Z; Xu, D; Xu, Q; Yao, L, 2019
)
1.11
" However, recent findings in both humans and rodents suggest a link between developmental exposure to AAP and adverse neurobehavioral effects later in life."( A Cannabinoid Receptor Type 1 (CB1R) Agonist Enhances the Developmental Neurotoxicity of Acetaminophen (Paracetamol).
Fredriksson, A; Fredriksson, R; Gordh, T; Hallgren, S; Philippot, G; Viberg, H, 2018
)
0.7
"To investigate the adverse effect of two widely used pharmaceuticals, paracetamol (acetaminophen [APAP]) and oxytetracycline (OTC) on the marine rotifer Brachionus rotundiformis (B."( Adverse effects of two pharmaceuticals acetaminophen and oxytetracycline on life cycle parameters, oxidative stress, and defensome system in the marine rotifer Brachionus rotundiformis.
Byeon, E; Han, J; Hwang, UK; Lee, JS; Park, JC; Seo, JS; Yoon, DS, 2018
)
0.98
" Acetaminophen is a mild analgesic and antipyretic agent, which can cause centrilobular hepatic necrosis in toxic doses, whereas alcohol causes death due to liver diseases."( Pharmacokinetic changes of tramadol in rats with hepatotoxicity induced by ethanol and acetaminophen in perfused rat liver model.
Ardakani, YH; Esmaeili, Z; Ghazi-Khansari, M; Hassanzadeh, G; Lavasani, H; Mohammadi, S; Nezami, A; Rouini, MR, 2019
)
1.65
" Generation of GSH, its conjugation with the toxic NAPQI and the spatial distribution of CYP450 combined together determine the toxicity of APAP."( A spatial-temporal model for zonal hepatotoxicity of acetaminophen.
Ho, H; Means, SA, 2019
)
0.76
" The present study showed strong cytotoxic potential for the NPS 5F-PB-22 and MDAI, moderate effects for MDMA, MDPV, methylone, cathinone, 4-MEC, and mephedrone, and no toxic effects for methamphetamine."( Cytotoxicity of new psychoactive substances and other drugs of abuse studied in human HepG2 cells using an adopted high content screening assay.
Beck, A; Flockerzi, V; Maurer, HH; Meyer, MR; Richter, LHJ, 2019
)
0.51
" Because of the limited clinical experience with the four-component meningococcal B vaccine (4CMenB), active surveillance for adverse events following immunization (AEFI) was conducted."( Short-term safety of 4CMenB vaccine during a mass meningococcal B vaccination campaign in Quebec, Canada.
Billard, MN; Boulianne, N; De Serres, G; Deceuninck, G; Gagné, H; Gariépy, MC; Gilca, V; Landry, M; Ouakki, M; Rouleau, I; Skowronski, DM; Toth, E, 2018
)
0.48
" Seven-day pretreatment with PYC suppressed elevation of CYP2E1 protein expression induced by administration of toxic dose of acetaminophen."( Hepatoprotective and antioxidant potential of Pycnogenol® in acetaminophen-induced hepatotoxicity in rats.
Borišev, I; Bukumirović, N; Čabarkapa, V; Čapo, I; Mikov, M; Milić, N; Miljković, D; Paut Kusturica, M; Rašković, A; Stilinović, N, 2019
)
0.96
"Use of a failure mode effects analysis assisted the team in understanding the failures of the process of safe medication administration."( Increasing compliance of safe medication administration in pediatric anesthesia by use of a standardized checklist.
Adler, AC; Buck, D; Kanjia, MK; Varughese, AM, 2019
)
0.51
"The percentage of compliance with the safe administration checklist for acetaminophen in the preoperative period increased to 97%."( Increasing compliance of safe medication administration in pediatric anesthesia by use of a standardized checklist.
Adler, AC; Buck, D; Kanjia, MK; Varughese, AM, 2019
)
0.75
"Application of quality improvement methods, specifically a safety checklist, were utilized to improve the safe administration of acetaminophen during the perioperative period."( Increasing compliance of safe medication administration in pediatric anesthesia by use of a standardized checklist.
Adler, AC; Buck, D; Kanjia, MK; Varughese, AM, 2019
)
0.72
" This regimen was introduced in the 1970s and has remained largely unchanged even though the initial NAC infusion is frequently associated with adverse reactions, in particular nausea, vomiting, and anaphylactoid reactions."( Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomi
Dear, J, 2019
)
0.51
" This study will provide valuable data regarding the incidence of adverse events caused by the 12-h NAC plus PP100-01 regimen and may provide evidence of PP100-01 efficacy in the treatment of paracetamol-induced liver injury."( Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomi
Dear, J, 2019
)
0.51
"Dihydrocodeine and tramadol are particularly toxic in overdose and codeine is also relatively toxic."( Relative toxicity of analgesics commonly used for intentional self-poisoning: A study of case fatality based on fatal and non-fatal overdoses.
Bankhead, C; Casey, D; Clements, C; Ferrey, A; Fuller, A; Geulayov, G; Gunnell, D; Hawton, K; Kapur, N; Ness, J; Wells, C, 2019
)
0.51
" Thus, the aim of this study was to analyze the toxic effects of pharmaceuticals in non-standard endpoints on two macrophyte species, Lemna minor and Lemna gibba."( Evaluation of pharmaceutical toxic effects of non-standard endpoints on the macrophyte species Lemna minor and Lemna gibba.
Alkimin, GD; Barata, C; Daniel, D; Frankenbach, S; Nunes, B; Serôdio, J; Soares, AMVM, 2019
)
0.51
" Acetaminophen (also known as paracetamol) is known to be toxic in high dosages, namely, by triggering oxidative effects."( Effects of acetaminophen in oxidative stress and neurotoxicity biomarkers of the gastropod Phorcus lineatus.
Almeida, F; Nunes, B, 2019
)
1.81
"Acetaminophen (APAP) is one of the most popular and safe pain medications worldwide."( Acetaminophen Hepatotoxicity.
Jaeschke, H; Ramachandran, A, 2019
)
3.4
" A recent systematic review found increased adverse events and mortality at therapeutic dosage."( Acetaminophen Safety: Risk of Mortality and Cardiovascular Events in Nursing Home Residents, a Prospective Study.
Cantet, C; de Souto Barreto, P; Girard, P; Rolland, Y; Sourdet, S, 2019
)
1.96
"] CONCLUSION: Despite old age, polypharmacy, and polymorbidity, acetaminophen was found safe for most, but not all, of our NH study population."( Acetaminophen Safety: Risk of Mortality and Cardiovascular Events in Nursing Home Residents, a Prospective Study.
Cantet, C; de Souto Barreto, P; Girard, P; Rolland, Y; Sourdet, S, 2019
)
2.2
" No protocol-related adverse events occurred."( Feasibility and Safety of Transnasal High Flow Air to Reduce Core Body Temperature in Febrile Neurocritical Care Patients: A Pilot Study.
Assis, FR; Geocadin, RG; Shah, D; Tandri, H; Ziai, WC, 2019
)
0.51
" No adverse events were seen, and the process showed no signs of shivering or any other serious side effects during short-term exposure."( Feasibility and Safety of Transnasal High Flow Air to Reduce Core Body Temperature in Febrile Neurocritical Care Patients: A Pilot Study.
Assis, FR; Geocadin, RG; Shah, D; Tandri, H; Ziai, WC, 2019
)
0.51
" The relationship between alanine aminotransferase (ALT) activity and APAP-CYS concentration might assist in distinguishing between toxic and non-toxic APAP doses in patients suspected of drug overdose."( The Relationship Between Circulating Acetaminophen-Protein Adduct Concentrations and Alanine Aminotransferase Activities in Patients With and Without Acetaminophen Overdose and Toxicity.
Curry, SC; Gerkin, RD; Jaeschke, H; Kang, AM; O'Connor, AD; Padilla-Jones, A; Ruha, AM; Wilhelms, K; Wilkins, DG, 2019
)
0.79
" Germination tests are important to evaluate the quality of soil and the toxic effects that contaminants can pose to plants."( Individual and mixture toxicity evaluation of three pharmaceuticals to the germination and growth of Lactuca sativa seeds.
Antão, C; Delerue-Matos, C; Oliva-Teles, F; Ramos, S; Rede, D; Santos, LHMLM; Sousa, SR, 2019
)
0.51
" Furthermore, there have been recent concerns over the safety profile of paracetamol, with reports of gastrointestinal, cardiovascular, hepatic and renal adverse events."( Safety of Paracetamol in Osteoarthritis: What Does the Literature Say?
Arden, N; Avouac, B; Conaghan, PG; Migliore, A; Rizzoli, R, 2019
)
0.51
"Drug-induced nephrotoxicity is a frequent serious adverse effect, contributing to morbidity and increased healthcare utilization."( Efficacy of curcumin on prevention of drug-induced nephrotoxicity: A review of animal studies.
Barreto, GE; Beiraghdar, F; Motaharinia, J; Panahi, Y; Sahebkar, A, 2019
)
0.51
"Cisplatin is considered one of the best anticancer medications often used for the treatment of various cancers even with its adverse effects."( Marine macro-algae attenuates nephrotoxicity and hepatotoxicity induced by cisplatin and acetaminophen in rats.
Ehteshamul-Haque, S; Hira, K; Sohail, N; Sultana, V; Tariq, A, 2019
)
0.74
"Both SL and CUR pretreatment prevented the toxic effects of PCM, but CUR is more effective than SL in ameliorating acute PCM induced hepatotoxicity."( Protective effects of curcumin and silymarin against paracetamol induced hepatotoxicity in adult male albino rats.
Ahmad, MM; Fawzy, A; Rezk, NA; Sabry, M, 2019
)
0.51
"Acetaminophen (APAP) is a highly effective analgesic, which is safe at therapeutic doses."( Acetaminophen hepatotoxicity: A mitochondrial perspective.
Jaeschke, H; Ramachandran, A, 2019
)
3.4
" The aim of this study was to evaluate the possible toxic effects of environmentally relevant concentrations (0."( Integrated biomarker response index to assess toxic effects of environmentally relevant concentrations of paracetamol in a neotropical catfish (Rhamdia quelen).
Acco, A; Bozza, DC; Cestari, MM; Corso, CR; Fockink, DH; Guiloski, IC; Lirola, JR; Mela, M; Perussolo, MC; Prodocimo, V; Ramos, LP; Silva de Assis, HC, 2019
)
0.51
" Primary endpoints: all participants experienced ≥1 adverse event (AE), most commonly gastrointestinal."( Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial).
Black, P; Dear, JW; Gallagher, B; Grahamslaw, J; Henriksen, D; Lee, RJ; Morrison, EE; O'Brien, R; Oatey, K; Oosthuyzen, W; Weir, CJ, 2019
)
0.51
" The reductions in CYP-mediated acetaminophen bioactivation and uptake transporter, as well as enhanced antioxidant enzyme activity, may limit the accumulation of toxic products in the liver and thus lower hepatotoxicity."( Epigallocatechin-3-Gallate Reduces Hepatic Oxidative Stress and Lowers CYP-Mediated Bioactivation and Toxicity of Acetaminophen in Rats.
Chang, CH; Li, CC; Yao, HT, 2019
)
1.01
" When compared with placebo, total rescue opioid consumption was similar and significantly fewer intravenous acetaminophen patients prematurely discontinued because of treatment-emergent adverse events (P < ."( Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants.
Cooper, DS; Devarakonda, K; Gosselin, NH; Hammer, GB; Lu, J; Maxwell, LG; Pheng, LH; Szmuk, P; Taicher, BM; Visoiu, M, 2020
)
1
" AAP is generally considered safe for humans, but its effects on aquatic organisms are not well known."( Temperature-dependent toxicity of acetaminophen in Japanese medaka larvae.
Kagami, Y; Kashiwada, S; Kataoka, C; Kitagawa, H; Sugiyama, T; Takeshima, A; Tatsuta, H, 2019
)
0.79
" The aim of this study was to characterize the direct toxic effects of APAP in different regions of the brain and on behavior in rats where the magnitude of hepatotoxicity produced is not associated with ALF."( Acute acetaminophen intoxication induces direct neurotoxicity in rats manifested as astrogliosis and decreased dopaminergic markers in brain areas associated with locomotor regulation.
Bisagno, V; De Fino, F; Di Carlo, MB; Ghanem, CI; Gómez, G; Manautou, JE; Martínez, SA; Pérez, MJ; Scazziota, A; Vigo, MB, 2019
)
0.99
" Adverse events (all non-serious) were reported by 17% of methoxyflurane-treated patients and 3% of SAT-treated patients."( Analgesic Efficacy, Practicality and Safety of Inhaled Methoxyflurane Versus Standard Analgesic Treatment for Acute Trauma Pain in the Emergency Setting: A Randomised, Open-Label, Active-Controlled, Multicentre Trial in Italy (MEDITA).
Bonafede, E; Carpinteri, G; Fabbri, A; Farina, A; Gangitano, G; Intelligente, F; Mercadante, S; Ruggiano, G; Sblendido, A; Serra, S; Soldi, A; Voza, A, 2019
)
0.51
" Primary safety outcomes will be the number of patients experiencing any (serious) adverse event, the number of patients withdrawn due to adverse events and the number of patients with gastrointestinal and hepatic adverse events."( Efficacy and safety of modified-release paracetamol for acute and chronic pain: a systematic review protocol.
Dosenovic, S; Margan Koletic, Z; Puljak, L, 2019
)
0.51
"When taken in the recommended dosage, acetaminophen is a safe and effective analgesic and antipyretic agent."( Acute acetaminophen toxicity in adults.
Saccomano, SJ, 2019
)
1.27
"Drug-induced nephrotoxicity is a frequent adverse event that can lead to acute or chronic kidney disease and increase the healthcare expenditure."( Melatonin ameliorates the drug induced nephrotoxicity: Molecular insights.
Naureen, Z; Raza, Z,
)
0.13
"Acetaminophen is a common analgesic-antipyretic agent, which is safe in therapeutic doses but in higher doses can produce hepatic necrosis."( Hepatoprotective effect of artichoke leaf extracts in comparison with silymarin on acetaminophen-induced hepatotoxicity in mice.
Abdou, AG; Elsayed Elgarawany, G; Maher Taie, D; Motawea, SM, 2020
)
2.23
"Acetaminophen-protein adducts are specific biomarkers of toxic acetaminophen (paracetamol) metabolite exposure."( Early acetaminophen-protein adducts predict hepatotoxicity following overdose (ATOM-5).
Buckley, NA; Chan, BSH; Chiew, AL; Isbister, GK; James, LP; McArdle, K; Pickering, JW, 2020
)
2.48
" This study examined a new biomarker of acetaminophen toxicity, which measures the amount of toxic metabolite exposure called acetaminophen-protein adduct."( Early acetaminophen-protein adducts predict hepatotoxicity following overdose (ATOM-5).
Buckley, NA; Chan, BSH; Chiew, AL; Isbister, GK; James, LP; McArdle, K; Pickering, JW, 2020
)
1.31
" In this article, we review recent pharmacological and toxicological findings about APAP from basic, clinical, and epidemiological studies, including spontaneous drug adverse events reporting system, especially focusing on drug-induced asthma and pre-and post-natal closure of ductus arteriosus."( Toxicological Property of Acetaminophen: The Dark Side of a Safe Antipyretic/Analgesic Drug?
Ishitsuka, Y; Kadowaki, D; Kondo, Y, 2020
)
0.86
"Acute renal failure induced by a toxic dose of acetaminophen (also known as paracetamol, or APAP) is common in both humans and experimental animal models."( Suppression of glomerular damage and apoptosis and biomarkers of acute kidney injury induced by acetaminophen toxicity using a combination of resveratrol and quercetin.
Abdel Kader, DH; Al-Ani, B; Dallak, M; Dawood, AF; Eid, RA; Haidara, MA; Kamar, SS; Shams Eldeen, AM, 2022
)
1.2
" HMGB1 acts as a danger-associated molecular patterns during this toxic process but the mechanisms of action and targeted cells are incompletely defined."( New insights in acetaminophen toxicity: HMGB1 contributes by itself to amplify hepatocyte necrosis in vitro through the TLR4-TRIF-RIPK3 axis.
Devière, J; Dressen, C; Gustot, T; Leclercq, I; Lemmers, A; Liefferinckx, C; Minsart, C; Moreau, R; Quertinmont, E, 2020
)
0.9
"The presence of anthropogenic drugs in the aquatic ecosystems is a reality nowadays, and a large number of studies have been reporting their putative toxic effects on wildlife."( Antioxidative and neurotoxicity effects of acute and chronic exposure of the estuarine polychaete Hediste diversicolor to paracetamol.
Barbosa, I; Freitas, R; Nunes, B; Pizarro, I, 2020
)
0.56
" The incidence of adverse events (AEs) was significantly higher in the AC group compared to NS and PBO."( Efficacy and safety of naproxen sodium 440 mg versus acetaminophen 600 mg/codeine phosphate 60 mg in the treatment of postoperative dental pain.
Cattry, E; Paredes-Diaz, A; Troullos, E, 2020
)
0.81
" Time to meaningful pain relief and duration of pain relief were assessed; tolerability was evaluated by adverse events."( Efficacy and Safety of Single and Multiple Doses of a Fixed-dose Combination of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: Results From 2 Phase 3, Randomized, Parallel-group, Double-blind, Placebo-controlled Studies.
Cruz-Rivera, M; DePadova, E; Kellstein, D; Leyva, R; Muse, D; Paluch, E; Searle, S, 2020
)
0.78
" Adverse event rates were lowest with the FDC."( Efficacy and Safety of Single and Multiple Doses of a Fixed-dose Combination of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: Results From 2 Phase 3, Randomized, Parallel-group, Double-blind, Placebo-controlled Studies.
Cruz-Rivera, M; DePadova, E; Kellstein, D; Leyva, R; Muse, D; Paluch, E; Searle, S, 2020
)
0.78
" Drug-induced toxicity can be relieved by several natural products, which are preferred due to their dietary nature and less adverse reactions."( Omega-3 fatty acids protect against acetaminophen-induced hepatic and renal toxicity in rats through HO-1-Nrf2-BACH1 pathway.
Abo El-Magd, NF; Eraky, SM, 2020
)
0.83
" First and second groups served as normal and toxic control were given distilled water 6 ml/ kg while third, fourth and fifth experimental groups were given N-acetylcysteine (300 mg/ kg), prazosin (0."( Hepatoprotective Effect Of Prazosin Is Comparable To N-Acetylcysteine In Acetaminophen Induced Hepatotoxicity In Mice.
Chiragh, S; Hussain, M; Shad, MN; Sulaiman, S,
)
0.36
" Intraperitoneal or po administration of the new chemical entities (NCEs), 3b and 3r, in concentrations equal to a toxic dose of ApAP did not result in the formation of NAPQI."( A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
Abet, V; Alvarez-Builla, J; Bazan, HA; Bazan, NG; Bhattacharjee, S; Burgos, C; Edwards, S; Gordon, WC; Heap, J; Jun, B; Ledet, AJ; Pahng, AR; Paul, D; Recio, J, 2020
)
0.56
" As herbal preparations may interact with pharmaceutical drugs the following in vitro study was undertaken to determine whether the toxic effects of paracetamol on liver cell growth in culture would be exacerbated by the addition of psoralen, a furanocoumarin compound that is present in Psoralea corylifolia, a common Chinese herb."( Paracetamol (acetaminophen) hepatotoxicity increases in the presence of an added herbal compound.
Britza, SM; Byard, RW; Musgrave, IF, 2020
)
0.93
" There were no serious adverse events related to ChAdOx1 nCoV-19."( Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.
Aley, PK; Angus, B; Becker, S; Belij-Rammerstorfer, S; Bellamy, D; Bibi, S; Bittaye, M; Clutterbuck, EA; Dold, C; Douglas, AD; Ewer, KJ; Faust, SN; Finn, A; Flaxman, AL; Folegatti, PM; Gilbert, SC; Green, C; Hallis, B; Heath, P; Hill, AVS; Jenkin, D; Lambe, T; Lazarus, R; Makinson, R; Minassian, AM; Pollard, AJ; Pollock, KM; Ramasamy, M; Robinson, H; Snape, M; Tarrant, R; Voysey, M, 2020
)
0.56
" It is adequately comprehended that the metabolism of high-dose APAP by cytochrome P450 enzymes generates N-acetyl-p-benzoquinone imine (NAPQI), a toxic metabolite, which leads to glutathione (GSH) depletion, oxidative stress, and activation of various complex molecular pathways that initiate liver injury and downstream hepatic necrosis."( Current etiological comprehension and therapeutic targets of acetaminophen-induced hepatotoxicity.
Adelusi Temitope, I; Chowdhury, A; Nabila, J; Wang, S, 2020
)
0.8
"This study sought to determine whether a brief intervention at the time of emergency department (ED) discharge can improve safe dosing of liquid acetaminophen and ibuprofen by parents or guardians."( Medication Education for Dosing Safety: A Randomized Controlled Trial.
Camargo, CA; Cohen, A; Espinola, JA; Faridi, M; Hayes, BD; Naureckas Li, C; Porter, S; Samuels-Kalow, M, 2020
)
0.76
" The primary outcome was defined as parent or guardian report of safe dosing at the time of first follow-up call."( Medication Education for Dosing Safety: A Randomized Controlled Trial.
Camargo, CA; Cohen, A; Espinola, JA; Faridi, M; Hayes, BD; Naureckas Li, C; Porter, S; Samuels-Kalow, M, 2020
)
0.56
" Among those participants receiving the intervention, 25 of 35 (71%) were able to identify a safe dose for their child at the time of the first call compared with 28 of 62 (45%) of those in the control arm."( Medication Education for Dosing Safety: A Randomized Controlled Trial.
Camargo, CA; Cohen, A; Espinola, JA; Faridi, M; Hayes, BD; Naureckas Li, C; Porter, S; Samuels-Kalow, M, 2020
)
0.56
"A multifaceted intervention at the time of ED discharge-consisting of a simplified dosing handout, a teaching session, teach-back, and provision of a standardized dosing device-can improve parents' knowledge of safe dosing of liquid medications at 48 to 72 hours."( Medication Education for Dosing Safety: A Randomized Controlled Trial.
Camargo, CA; Cohen, A; Espinola, JA; Faridi, M; Hayes, BD; Naureckas Li, C; Porter, S; Samuels-Kalow, M, 2020
)
0.56
"Anaphylactoid reactions are well-documented adverse events associated with the intravenous administration of N-acetylcysteine (NAC) in patients with acetaminophen overdose."( A Case Report of a Severe, Unusually Delayed Anaphylactoid Reaction to Intravenous N-Acetylcysteine During Treatment of Acute Acetaminophen Toxicity in an Adolescent.
Cao, DJ; Epperson, LC; Weiss, ST, 2021
)
1.03
" Secondary outcomes included morphine consumption at 24, 48, and 72 hours after surgery, length of hospital stay, range of motion, daily ambulation distance, and adverse events occurrence."( Effect and safety of intravenous versus oral acetaminophen after unicompartmental knee replacement: A protocol of randomized controlled study.
Guo, D; Li, X; Wang, H; Zhou, T, 2020
)
0.82
"Fomepizole (4-methylpyrazole) is safe and has shown efficacy in preclinical models, human hepatocytes and in volunteers against APAP overdose."( Novel strategies for the treatment of acetaminophen hepatotoxicity.
Akakpo, JY; Jaeschke, H; Ramachandran, A, 2020
)
0.83
"IV tramadol is superior to IV paracetamol in relieving acute pain of primary dysmenorrhea with a comparable side effect profile."( Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial.
Abbas, AM; Alalfy, M; AlAmodi, AA; Ali, AS; Fadlalmola, HA; Ghamry, NK; Hamza, M; Islam, Y; Mahmoud, AO; Shareef, MA, 2020
)
0.56
" It is considered to be safe within a therapeutic range, in case of acute intoxication hepatotoxicity occurs."( Tetrahydroxy stilbene glycoside attenuates acetaminophen-induced hepatotoxicity by UHPLC-Q-TOF/MS-based metabolomics and multivariate data analysis.
Chen, NH; Gao, Y; Li, JT; Li, L; Li, X; Yang, SW; Zhang, L, 2021
)
0.88
" Evidence for safety or associations with adverse health outcomes is conflicting, limiting definitive decision-making for healthcare professionals."( Over-the-counter analgesics during pregnancy: a comprehensive review of global prevalence and offspring safety.
Fowler, PA; Hay, DC; Mitchell, RT; Zafeiri, A, 2021
)
0.62
" We illustrate that insufficient sulfation leads to a shift in biotransformation of paracetamol to toxic oxidation pathways and patients with low sulfate reserves are at higher risk of paracetamol toxicity."( Sulfate conjugation may be the key to hepatotoxicity in paracetamol overdose.
Chiew, AL; Duffull, SB; Isbister, GK; Li, J, 2021
)
0.62
" After drug administration, the children were admitted and observed in the hospital for six hours during which period a half-hourly temperature measurement and monitoring for adverse events were done."( Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety.
Akande, PA; Alaje, EO; Meremikwu, MM; Odey, FA; Udoh, EE, 2020
)
0.56
" The adverse events of both drugs were mild and quite comparable with vomiting being the commonest."( Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety.
Akande, PA; Alaje, EO; Meremikwu, MM; Odey, FA; Udoh, EE, 2020
)
0.56
" The adverse events of both drugs were mild and comparable."( Ibuprofen versus paracetamol for treating fever in preschool children in Nigeria: a randomized clinical trial of effectiveness and safety.
Akande, PA; Alaje, EO; Meremikwu, MM; Odey, FA; Udoh, EE, 2020
)
0.56
" At therapeutic recommended doses, acetaminophen forms limited amounts of N-acetyl-p-benzoquinone-imine (NAPQI) without adverse cellular effects."( Assessment of the biochemical pathways for acetaminophen toxicity: Implications for its carcinogenic hazard potential.
Atillasoy, E; Bandara, SB; Chappell, GA; Cohen, SM; Deore, M; Eichenbaum, G; Hardisty, JF; Hermanowski-Vosatka, A; Jacobson-Kram, D; Jaeschke, H; Kuffner, E; Monnot, AD; Murray, FJ; Pitchaiyan, SK; Wikoff, D, 2021
)
1.16
" The outcome measures of interest in the meta-analysis were ≥ 50% pain relief , need for rescue medications, and occurrence of adverse drug events."( Efficacy and Safety of Ibuprofen Plus Paracetamol in a Fixed-Dose Combination for Acute Postoperative Pain in Adults: Meta-Analysis and a Trial Sequential Analysis.
Abushanab, D; Al-Badriyeh, D, 2021
)
0.62
" While inconclusive based on TSA, the FDC was at the highest doses at least as well tolerated as placebo regarding the occurrence of adverse events, including severe, common, and treatment-related adverse events, as well as those that lead to discontinuation, but it was also significantly associated with lower rates of headache and nausea."( Efficacy and Safety of Ibuprofen Plus Paracetamol in a Fixed-Dose Combination for Acute Postoperative Pain in Adults: Meta-Analysis and a Trial Sequential Analysis.
Abushanab, D; Al-Badriyeh, D, 2021
)
0.62
" Thus, from the overall result of this study reveals that Phoscoliv can be effectively used as a potent and safe hepatoprotective medicine."( Hepatoprotective effect of essential phospholipids enriched with virgin coconut oil (Phoscoliv) on paracetamol-induced liver toxicity.
Jagmag, T; Jose, SP; Kulkarni, A; Mohanan, R; Sreevallabhan, S; Sukumaran, S; Tilwani, J, 2021
)
0.62
" Our results showed that toll-like receptor 5 (TLR5) was abundantly expressed in hepatocytes and dramatically downregulated in the toxic mouse livers."( Exogenous activation of toll-like receptor 5 signaling mitigates acetaminophen-induced hepatotoxicity in mice.
Jeong, H; Kim, B; Kim, JW; Lim, CW; Qi, J; Yang, D; Yang, MS; Zhou, Z, 2021
)
0.86
" In reliable, well-controlled test systems, clastogenic effects were only observed in unstable, p53-deficient cell systems or at toxic and/or excessively high concentrations that adversely affect cellular processes (e."( A comprehensive weight of evidence assessment of published acetaminophen genotoxicity data: Implications for its carcinogenic hazard potential.
Deore, M; Eichenbaum, G; Jacobson-Kram, D; Jaeschke, H; Kirkland, D; Kovochich, M; Miller, JV; Monnot, AD; More, SL; Murray, FJ; Pitchaiyan, SK; Unice, K, 2021
)
0.86
" Our results clarified that Paracetamol toxicity caused significant adverse effects on hematological, serum biochemical parameters, and oxidant -antioxidant status as well as histopathological picture of heart, liver, and kidney."( Protective role of Chlorella vulgaris with Thiamine against Paracetamol induced toxic effects on haematological, biochemical, oxidative stress parameters and histopathological changes in Wistar rats.
Alkhalifah, DHM; Assar, DH; Elkaw, EM; Hamouda, RA; Hamza, HA; Hozzein, WN; Latif, AAE, 2021
)
0.62
"8) against the toxic group (51."( Hepatoprotective and antioxidant activity of Dicliptera bupleuroides Nees. extracts on paracetamol induced hepatotoxicity in rats.
Akbar, S; Bushra, R; Ghayas, S; Hussain, K; Ishtiaq, S, 2020
)
0.56
" These results reveal an FXR-DCA-TNF-α axis that potentiates APAP hepatotoxicity, which could guide the clinical safe use of APAP."( FXR-Deoxycholic Acid-TNF-α Axis Modulates Acetaminophen-Induced Hepatotoxicity.
Gonzalez, FJ; Hao, H; Krausz, KW; Luo, Y; Takahashi, S; Wang, G; Wang, H; Yagai, T; Yan, N; Yan, T; Zhao, M, 2021
)
0.89
"We extracted pain and adverse events outcomes from 36 systematic reviews that assessed the efficacy of paracetamol in 44 painful conditions."( The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews.
Abdel Shaheed, C; Ahedi, H; Day, RO; Dmitritchenko, A; Ferreira, GE; Kamper, S; Langendyk, V; Latimer, J; Lin, C; Maher, CG; McLachlan, AJ; McLachlan, H; Saragiotto, B; Stanaway, F, 2021
)
0.62
" Safety and tolerability of the FDC were assessed by adverse events (AEs) for the total group and subgroups (age, sex, race)."( Safety and tolerability of fixed-dose combinations of ibuprofen and acetaminophen: pooled analysis of phase 1-3 clinical trials.
Cruz-Rivera, M; Kellstein, D; Leyva, R; Meeves, S; Su, J, 2021
)
0.86
"Acetaminophen is a commonly used analgesic and antipyretic, with the potential to cause significant injury when ingested in toxic amounts."( Evaluation of Dosing Strategies of N-acetylcysteine for Acetaminophen Toxicity in Patients Greater than 100 Kilograms: Should the Dosage Cap Be Used?
Akpunonu, P; Bailey, AM; Baum, RA; Geraghty, L; Howell, MM; Mohan, S; Su, MK; Weant, KA; Webb, AN; Woolum, JA, 2021
)
2.31
" Secondary endpoints included number of drug-related adverse events, occurrence of hepatotoxicity, cumulative NAC dose, regimen cost, length of hospital and intensive care unit stays, and in-hospital mortality."( Evaluation of Dosing Strategies of N-acetylcysteine for Acetaminophen Toxicity in Patients Greater than 100 Kilograms: Should the Dosage Cap Be Used?
Akpunonu, P; Bailey, AM; Baum, RA; Geraghty, L; Howell, MM; Mohan, S; Su, MK; Weant, KA; Webb, AN; Woolum, JA, 2021
)
0.87
"Acetaminophen (APAP) is a widely used antipyretic and analgesic drug that is safe and effective in the therapeutic doses, but overdose may cause hepatotoxicity and even acute liver failure (ALF)."( [Research progress on hepatotoxicity of acetaminophen].
Hu, T; Huang, WQ; Sun, H, 2021
)
2.33
"Preterm infants are at greater risk for adverse drug effects due to hepatic immaturity."( Caffeine disrupts ataxia telangiectasia mutated gene-related pathways and exacerbates acetaminophen toxicity in human fetal immortalized hepatocytes.
Bandi, S; Gupta, P; Gupta, S; Maisuradze, L; Sharma, Y; Viswanathan, P, 2021
)
0.84
"APAP toxicity model was implemented by administering a toxic dose of APAP."( The effects of mitochondrial transplantation in acetaminophen-induced liver toxicity in rats.
Atalay, O; Celik, E; Cicek, Z; Kubat, GB; Ozler, M; Suvay, S; Ulger, O, 2021
)
0.88
"It has been evaluated that mitochondrial transplantation can be used as an important alternative or adjunctive treatment method in liver damage caused by toxic dose APAP intake."( The effects of mitochondrial transplantation in acetaminophen-induced liver toxicity in rats.
Atalay, O; Celik, E; Cicek, Z; Kubat, GB; Ozler, M; Suvay, S; Ulger, O, 2021
)
0.88
" Current analgesics have adverse effects."( Results of two Phase 1, Randomized, Double-blind, Placebo-controlled, Studies (Ascending Single-dose and Multiple-dose Studies) to Determine the Safety, Tolerability, and Pharmacokinetics of Orally Administered LX9211 in Healthy Participants.
Banks, P; Boehm, KA; Bundrant, L; Gopinathan, S; Hunt, TL; Kassler-Taub, K; Tyle, P; Warner, C; Wason, S; Wilson, A, 2021
)
0.62
" No deaths or serious adverse events occurred."( Results of two Phase 1, Randomized, Double-blind, Placebo-controlled, Studies (Ascending Single-dose and Multiple-dose Studies) to Determine the Safety, Tolerability, and Pharmacokinetics of Orally Administered LX9211 in Healthy Participants.
Banks, P; Boehm, KA; Bundrant, L; Gopinathan, S; Hunt, TL; Kassler-Taub, K; Tyle, P; Warner, C; Wason, S; Wilson, A, 2021
)
0.62
"These studies found that LX9211 was safe and well tolerated in healthy participants."( Results of two Phase 1, Randomized, Double-blind, Placebo-controlled, Studies (Ascending Single-dose and Multiple-dose Studies) to Determine the Safety, Tolerability, and Pharmacokinetics of Orally Administered LX9211 in Healthy Participants.
Banks, P; Boehm, KA; Bundrant, L; Gopinathan, S; Hunt, TL; Kassler-Taub, K; Tyle, P; Warner, C; Wason, S; Wilson, A, 2021
)
0.62
" It had lower risk of gastrointestinal adverse effects (AEs) than acetaminophen (risk ratio [RR] = 0."( Comparative efficacy and safety of acetaminophen, topical and oral non-steroidal anti-inflammatory drugs for knee osteoarthritis: evidence from a network meta-analysis of randomized controlled trials and real-world data.
Doherty, M; Kaur, J; Lei, G; Li, X; Persson, MSM; Sarmanova, A; Wei, J; Yang, Z; Zeng, C; Zhang, W; Zhang, Y, 2021
)
1.14
" Pain at rest/motion (based on pain visual analog scale (VAS) score), rescue analgesia consumption, satisfaction level and adverse events were assessed after AKS."( Oxycodone-paracetamol tablet exhibits increased analgesic efficacy for acute postoperative pain, higher satisfaction and comparable safety profiles compared with celecoxib in patients underwent arthroscopic knee surgery.
Di, J; Liu, J; Xing, E; Zhang, Y, 2021
)
0.62
" Adverse event data was collected throughout the study, in addition to scheduled vital sign assessments, laboratory tests and electrocardiograms."( Extending the safety profile of the post-operative administration of an intravenous acetaminophen/ibuprofen fixed dose combination: An open-label, multi-center, single arm, multiple dose study.
Atkinson, H; Carson, S; Gilchrist, N; Gottlieb, IJ; Stanescu, I, 2021
)
0.85
" The FDC was safe when used for 48 h to 5 days."( Extending the safety profile of the post-operative administration of an intravenous acetaminophen/ibuprofen fixed dose combination: An open-label, multi-center, single arm, multiple dose study.
Atkinson, H; Carson, S; Gilchrist, N; Gottlieb, IJ; Stanescu, I, 2021
)
0.85
" The results of this study suggest a new toxic mechanism of acetaminophen-induced liver injury in patients with acatalasemia."( Compromised glutathione synthesis results in high susceptibility to acetaminophen hepatotoxicity in acatalasemic mice.
Eitoku, M; Matsuura-Harada, Y; Nagaoka, K; Ogino, K; Ogino, N; Suganuma, N; Tomizuka, K, 2021
)
1.1
"Objectives We aimed to investigate the safety of zoledronic acid (ZOL) combined with acetaminophen (APAP) regarding both the adverse events and the efficacy of ZOL combined with an eldecalcitol (ELD) in a randomized clinical trial conducted in patients with primary osteoporosis."( Safety and Efficacy of Zoledronic Acid Treatment with and without Acetaminophen and Eldecalcitol for Osteoporosis.
Ikari, K; Mochizuki, T; Okazaki, K; Yano, K, 2021
)
1.08
" Administration of acetaminophen plus morphine versus morphine alone did not increase adverse events and a morphine sparing effect of acetaminophen was demonstrated in two studies."( The efficacy and safety of acetaminophen use following liver resection: a systematic review.
Koea, J; Murphy, V; Srinivasa, S, 2022
)
1.35
"Use of acetaminophen for adult patients undergoing liver resection surgery as post-operative analgesia at a standard dosage is safe for baseline analgesia."( The efficacy and safety of acetaminophen use following liver resection: a systematic review.
Koea, J; Murphy, V; Srinivasa, S, 2022
)
1.47
" Prior studies focused on pharmacokinetics (PK) of APAP in cirrhosis but did not rigorously examine clinical outcomes, sensitive biomarkers of liver damage, or serum APAP-protein adducts, which are a specific marker of toxic bioactivation."( Short-Term Safety of Repeated Acetaminophen Use in Patients With Compensated Cirrhosis.
Dranoff, JA; Fleming, DP; James, LP; Kennon-McGill, S; Mathews, SE; McCullough, SS; McGill, MR; Moran, JH; Peterson, EC; Spencer, HJ; Tripod, ME; Vazquez, JH, 2022
)
1.01
" APAP is safe at therapeutic levels, however, an overdose can cause severe liver injury."( Potential benefits of using hydrogen sulfide, vitamin E and necrostatin-1 to counteract acetaminophen‑induced hepatotoxicity in rats.
Abdel-Hakeem, EA; El-Tahawy, NF; Elbassuoni, EA; Saad, AH; Saleh, NEH, 2021
)
0.84
"To assess the effectiveness and safety of different preparations and doses of non-steroidal anti-inflammatory drugs (NSAIDs), opioids, and paracetamol for knee and hip osteoarthritis pain and physical function to enable effective and safe use of these drugs at their lowest possible dose."( Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis.
Almeida, MO; Bobos, P; Bodmer, NS; Cheng, PS; da Costa, BR; Gao, L; Hari, R; Hawker, GA; Hincapié, CA; Iskander, SM; Jüni, P; Kiyomoto, HD; Montezuma, T; Pereira, TV; Rudnicki, M; Saadat, P; Sutton, AJ; Tugwell, P, 2021
)
0.62
"3% of the oral NSAIDs, topical NSAIDs, and opioids, respectively, had an increased risk of dropouts due to adverse events."( Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis.
Almeida, MO; Bobos, P; Bodmer, NS; Cheng, PS; da Costa, BR; Gao, L; Hari, R; Hawker, GA; Hincapié, CA; Iskander, SM; Jüni, P; Kiyomoto, HD; Montezuma, T; Pereira, TV; Rudnicki, M; Saadat, P; Sutton, AJ; Tugwell, P, 2021
)
0.62
" However, these treatments are probably not appropriate for patients with comorbidities or for long term use because of the slight increase in the risk of adverse events."( Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis.
Almeida, MO; Bobos, P; Bodmer, NS; Cheng, PS; da Costa, BR; Gao, L; Hari, R; Hawker, GA; Hincapié, CA; Iskander, SM; Jüni, P; Kiyomoto, HD; Montezuma, T; Pereira, TV; Rudnicki, M; Saadat, P; Sutton, AJ; Tugwell, P, 2021
)
0.62
" RNA-sequencing analysis suggested that Utx deficiency in female mice upregulated antitoxic phase II conjugating enzymes, including sulfotransferase family 2 A member 1 (Sult2a1), thus reduces the amount of toxic APAP metabolites in injured liver; while Utx deficiency also alleviated ER stress through downregulating transcription of ER stress genes including Atf4, Atf3, and Chop."( Histone demethylase UTX aggravates acetaminophen overdose induced hepatotoxicity through dual mechanisms.
Chen, H; Chen, X; Huang, K; Huang, Y; Wang, Q; Wu, D; Xie, Y; Xiong, M; Yang, D; Zheng, L, 2022
)
1
"The study aimed at exploring the adverse events following immunization (AEFI) and their incidences among health workers in three different districts of central and western Nepal following the first dose of Covishield vaccine,."( Adverse events following the first dose of Covishield (ChAdOx1 nCoV-19) vaccination among health workers in selected districts of central and western Nepal: A cross-sectional study.
Paudel, B; Pyakurel, P; Regmi, A; Subedi, P; Yadav, GK, 2021
)
0.62
" Incidence of adverse events was calculated in percentage while Chi-square Test was used to check the association of AEFI with independent variables."( Adverse events following the first dose of Covishield (ChAdOx1 nCoV-19) vaccination among health workers in selected districts of central and western Nepal: A cross-sectional study.
Paudel, B; Pyakurel, P; Regmi, A; Subedi, P; Yadav, GK, 2021
)
0.62
"More than two-third of the vaccinees developed one or more forms of adverse events, but most events were self-limiting."( Adverse events following the first dose of Covishield (ChAdOx1 nCoV-19) vaccination among health workers in selected districts of central and western Nepal: A cross-sectional study.
Paudel, B; Pyakurel, P; Regmi, A; Subedi, P; Yadav, GK, 2021
)
0.62
"Acetaminophen (APAP) is one of the popular and safe pain medications worldwide."( Acetaminophen-Induced Nephrotoxicity: Suppression of Apoptosis and Endoplasmic Reticulum Stress Using Boric Acid.
Aytuğ, H; Çoban, FK; Demirel, HH; İnce, S; İslam, İ, 2023
)
3.8
" Despite its effectiveness, CDDP might cause severe toxic adverse effects on multiple body organs during cancer chemotherapy, including the kidneys, heart, liver, gastrointestinal tract, and auditory system, as well as peripheral nerves causing severely painful neuropathy."( Interactions of Analgesics with Cisplatin: Modulation of Anticancer Efficacy and Potential Organ Toxicity.
El-Sheikh, A; Khired, Z, 2021
)
0.62
"Paracetamol is a popular and safe drug preferred by victims of pain or pyrexia; however, its overdose or abuse is a growing concern worldwide."( Drynaria quercifolia suppresses paracetamol‑induced hepatotoxicity in mice by inducing Nrf-2.
Bhattacharjee, S; Bhattacharya, S; Chatterjee, S; Choudhury, PR; Mandal, DP; Rahaman, A; Sarkar, A; Talukdar, AD, 2022
)
0.72
" Although it is well known that APAP-induced liver injury (AILI) is caused by toxic mechanism, recently it is also reported to be immune related."( Role of caspase-8 and/or -9 as biomarkers that can distinguish the potential to cause toxic- and immune related-adverse event, for the progress of acetaminophen-induced liver injury.
Furukawa, Y; Hattori, T; Ijiri, Y; Kato, R; Noda, T; Tanaka, K, 2022
)
0.92
" Thereby, in case of N-acetylcysteine refractory, additional administration of steroid hormones should be effective and recommended as a novel strategy for AILI with immune related adverse event (irAE)."( Role of caspase-8 and/or -9 as biomarkers that can distinguish the potential to cause toxic- and immune related-adverse event, for the progress of acetaminophen-induced liver injury.
Furukawa, Y; Hattori, T; Ijiri, Y; Kato, R; Noda, T; Tanaka, K, 2022
)
0.92
" We identified a mechanism by which acetaminophen overdose causes an increase in bile acid concentrations (to above toxic thresholds) in hepatocytes."( Interruption of bile acid uptake by hepatocytes after acetaminophen overdose ameliorates hepatotoxicity.
Akakpo, JY; Begher-Tibbe, B; Brackhagen, L; Brecklinghaus, T; Canbay, A; Copple, IM; Curry, SC; Friebel, A; Ghallab, A; Goldring, C; González, D; Hassan, R; Hengstler, JG; Hobloss, Z; Hoehme, S; Hofmann, U; Jaeschke, H; Kappenberg, F; Longerich, T; Luedde, T; Marchan, R; Murad, W; Myllys, M; Olyaee, M; Overbeck, N; Rahnenführer, J; Reinders, J; Schreiter, T; Seddek, AL; Sezgin, S; Sowa, JP; Trauner, M; Urban, S; Vucur, M; Zühlke, S, 2022
)
1.24
"Although widely believed by pediatricians and parents to be safe for use in infants and children when used as directed, increasing evidence indicates that early life exposure to paracetamol (acetaminophen) may cause long-term neurodevelopmental problems."( Paracetamol (acetaminophen) use in infants and children was never shown to be safe for neurodevelopment: a systematic review with citation tracking.
Anderson, LG; Cendejas-Hernandez, J; Larivière, V; Lawton, VG; Palkar, A; Parker, W; Sarafian, JT, 2022
)
1.28
" However, paracetamol caused fewer adverse effects."( Comparative safety and efficacy of paracetamol versus non-steroidal anti-inflammatory agents in neonates with patent ductus arteriosus: A systematic review and meta-analysis of randomized controlled trials.
Chatziravdeli, VI; Dardiotis, E; Doxani, C; Katsaras, DN; Katsaras, GN; Mitsiakos, G; Papavasileiou, GN; Stefanidis, I; Touloupaki, M, 2022
)
0.72
"We conducted a systematic search of the electronic databases Ovid Medline, Ovid Embase and Web of Science from inception to August 2021 for original research studies of any design that described the use of paracetamol in the prenatal or neonatal (within the first four weeks of life) periods and examined the occurrence of neurodevelopmental, atopic or reproductive adverse outcomes at or beyond birth."( Long-Term Safety of Prenatal and Neonatal Exposure to Paracetamol: A Systematic Review.
Patel, R; Samiee-Zafarghandy, S; Sushko, K; van den Anker, J, 2022
)
0.72
" Eleven (100%), 11 (100%), and three (27%) studies on prenatal exposure reported adverse neurodevelopmental, atopic and reproductive outcomes."( Long-Term Safety of Prenatal and Neonatal Exposure to Paracetamol: A Systematic Review.
Patel, R; Samiee-Zafarghandy, S; Sushko, K; van den Anker, J, 2022
)
0.72
"The available evidence, although limited, suggests a possible association between prenatal paracetamol exposure and an increased risk of neurodevelopmental, atopic and reproductive adverse outcomes."( Long-Term Safety of Prenatal and Neonatal Exposure to Paracetamol: A Systematic Review.
Patel, R; Samiee-Zafarghandy, S; Sushko, K; van den Anker, J, 2022
)
0.72
" The secondary outcomes included the incidence of central nervous system (CNS) pathologies, adverse events, and medical costs."( Efficacy, safety, and economic impact of diazepam suppositories with as-needed acetaminophen for prevention of seizure recurrence during the same fever episode in children with suspected simple febrile seizures.
Fujita, S; Hataya, H; Kishibe, S; Miyama, S; Morikawa, EK; Morikawa, Y; Narita, K; Sammori, H; Suzuki, S; Takehira, K; Tanaka, M; Tsukamoto, J; Wang, Q; Yano, M, 2022
)
0.95
" No severe adverse events occurred, although mild ataxia was observed significantly more often in the patients receiving diazepam and as-needed acetaminophen (29."( Efficacy, safety, and economic impact of diazepam suppositories with as-needed acetaminophen for prevention of seizure recurrence during the same fever episode in children with suspected simple febrile seizures.
Fujita, S; Hataya, H; Kishibe, S; Miyama, S; Morikawa, EK; Morikawa, Y; Narita, K; Sammori, H; Suzuki, S; Takehira, K; Tanaka, M; Tsukamoto, J; Wang, Q; Yano, M, 2022
)
1.15
"Compared with as-needed acetaminophen alone, diazepam with as-needed acetaminophen may reduce seizure recurrence more during the same fever episode without severe adverse events or additional costs in children with suspected SFS."( Efficacy, safety, and economic impact of diazepam suppositories with as-needed acetaminophen for prevention of seizure recurrence during the same fever episode in children with suspected simple febrile seizures.
Fujita, S; Hataya, H; Kishibe, S; Miyama, S; Morikawa, EK; Morikawa, Y; Narita, K; Sammori, H; Suzuki, S; Takehira, K; Tanaka, M; Tsukamoto, J; Wang, Q; Yano, M, 2022
)
1.26
" The control group received neither acetaminophen nor the extract while the last group received only a toxic dose of acetaminophen."( Protective Effect of the Hydroalcoholic Extract of Pelargonium Graveolens L. on Rats with Acetaminophen- Induced Nephrotoxicity.
Akbarpour, B; Asmarian, S; Gholyaf, M; Mohammadi, F, 2022
)
1.22
"The results showed that by strengthening cell protection mechanisms against oxidative stress, geranium extract reduces the toxic effects of acetaminophen on mice's kidney function and thus ameliorates the damage."( Protective Effect of the Hydroalcoholic Extract of Pelargonium Graveolens L. on Rats with Acetaminophen- Induced Nephrotoxicity.
Akbarpour, B; Asmarian, S; Gholyaf, M; Mohammadi, F, 2022
)
1.14
" Therefore, there is an urgent need to provide safe and effective treatment for patients."( Study on the Protective Effect of Schizandrin B against Acetaminophen-Induced Cytotoxicity in Human Hepatocyte.
Cao, Y; Cheng, L; Gao, Z; Wang, L; Wang, T; Wu, W; Zhang, Q, 2022
)
0.97
"As a consequence of the altered hepatic architecture in advanced liver disease, drug metabolism is modified by changes in pharmacokinetic and pharmacodynamic properties, leading to the appearance of adverse effects and drug interactions and increasing the risk of over- or underdosing of medications."( Management of Pharmacologic Adverse Effects in Advanced Liver Disease.
García-Cortés, M; García-García, A, 2022
)
0.72
" Like every other drug(s), APAP also undergo metabolism by oxidation or conjugation by glucuronate and sulphate to form the toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI)."( Protective effect of probiotics against acetaminophen induced nephrotoxicity.
Dua, TK; Palai, S; Paul, P; Roy, A, 2022
)
0.99
" An adverse effect on the hematological system arising out of xenobiotic exposure causes impaired hemostasis and coagulation leading to disease."( Hematotoxicity of Co-Administration of Bisphenol A and Acetaminophen in Rats and its Amelioration by Melatonin.
Akhter, MS; Alshahrani, S; Dobie, G; Hamali, HA; Madkhali, AM; Mobarki, AA; Qadri, M; Rashid, H, 2023
)
1.16
"Acetaminophen (APAP) is a relatively safe analgesic drug, but overdosing can cause acute liver failure."( The concerted elevation of conjugation reactions is associated with the aggravation of acetaminophen toxicity in Akr1a-knockout mice with an ascorbate insufficiency.
Fujii, J; Homma, T; Itoh, H; Kawamae, K; Kimura, S; Kobayashi, S; Miyata, S; Nakane, M; Osaki, T, 2022
)
2.39
" We studied whether the use of paracetamol had an adverse influence on neonatal adaptation and the outcomes of infants during the first hospitalization."( Paracetamol preceding very preterm birth: Is it safe?
Aikio, O; Hallman, M; Laitala, A; Saarela, T; Vääräsmäki, M, 2022
)
0.72
" No perinatal adverse reactions were detected."( Paracetamol preceding very preterm birth: Is it safe?
Aikio, O; Hallman, M; Laitala, A; Saarela, T; Vääräsmäki, M, 2022
)
0.72
"Antenatal paracetamol given within 24 h before birth had no adverse effects on extremely or very preterm infants."( Paracetamol preceding very preterm birth: Is it safe?
Aikio, O; Hallman, M; Laitala, A; Saarela, T; Vääräsmäki, M, 2022
)
0.72
" Unsolicited adverse events (UAEs) were reported through phone calls or visits, and serious adverse events (SAEs) were recorded per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines."( Monitoring of Adverse Events in Recipients of the 2-Dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in the UMURINZI Ebola Vaccination Campaign.
Allen, S; Hammoud, N; Ingabire, R; Karita, E; Katwere, M; Magod, B; Mazarati, JB; Mazzei, A; Noben, J; Nsanzimana, S; Nyombayire, J; Parker, R; Priddy, F; Robinson, C; Sayinzoga, F; Tichacek, A; Wall, KM, 2023
)
0.91
" The regimen was otherwise safe and well-tolerated."( Monitoring of Adverse Events in Recipients of the 2-Dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed by MVA-BN-Filo in the UMURINZI Ebola Vaccination Campaign.
Allen, S; Hammoud, N; Ingabire, R; Karita, E; Katwere, M; Magod, B; Mazarati, JB; Mazzei, A; Noben, J; Nsanzimana, S; Nyombayire, J; Parker, R; Priddy, F; Robinson, C; Sayinzoga, F; Tichacek, A; Wall, KM, 2023
)
0.91
"Paracetamol (acetaminophen) use during pregnancy and early childhood was accepted as safe in the 1970s, but is now a subject of considerable concern."( The safety of pediatric use of paracetamol (acetaminophen): a narrative review of direct and indirect evidence.
Anderson, LG; Bono-Lunn, D; Cendejas Hernandez, J; Jones Iii, JP; Konsoula, Z; Kuchibhatla, M; Lawton, VG; Palkar, A; Parker, W; Patel, E; Reissner, KJ; Sarafian, JT, 2022
)
1.35
"ESPB was an efficient and safe procedure for postoperative pain management in PCNL."( Efficiency and Safety of Erector Spinae Plane Block in Percutaneous Nephrolithotomy: A Meta-Analysis Based on Randomized Controlled Trials.
Jin, T; Lin, L; Luo, Z; Ma, Y; Xiao, K, 2022
)
0.72
"Therapeutic experiments are commonly performed on laboratory animals to investigate the possible mechanism(s) of action of toxic agents as well as drugs or substances under consideration."( A review: Systematic research approach on toxicity model of liver and kidney in laboratory animals.
Abbasnezhad, A; Mohebbati, R; Salami, F, 2022
)
0.72
"Drug-induced liver injury (DILI) is a rare but serious adverse event that can progress to acute liver failure (ALF)."( Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review.
Aithal, GP; Alvarez-Alvarez, I; Andrade, RJ; Arikan, C; Atallah, E; Lucena, MI; Medina-Caliz, I; Niu, H, 2022
)
0.96
" tuberculata at the doses of (1 ml/kg, 2 ml/kg and 3 ml/kg body weight) were significantly lower when compared to toxic control mice group (P<0."( Hepatoprotective effects of walnut oil and Caralluma tuberculata against paracetamol in experimentally induced liver toxicity in mice.
Alharbi, M; Ali, W; Alshammari, A; Aziz, T; Iqbal, Z; Jamil, S; Khan, AA; Khan, FF; Shahzad, M; Ur Rahman, S; Zahid, M, 2022
)
0.72
"The liver plays an important role in regulating the metabolic processes and is the most frequently targeted organ by toxic chemicals."( Acetaminophen induced hepatotoxicity: An overview of the promising protective effects of natural products and herbal formulations.
Anchi, P; Bansod, S; Chilvery, S; Godugu, C; Khurana, A; Saifi, MA; Yelne, A, 2023
)
2.35
" So, it was felt that there is a need for the novel therapeutic approach for the treatment of liver diseases with less adverse effects."( Acetaminophen induced hepatotoxicity: An overview of the promising protective effects of natural products and herbal formulations.
Anchi, P; Bansod, S; Chilvery, S; Godugu, C; Khurana, A; Saifi, MA; Yelne, A, 2023
)
2.35
"Selective COX-2 inhibitor NSAIDs are safe in patients with N-ERD."( Which non-steroidal anti-inflammatory drug (NSAID) is safer in patients with Non-steroids Exacerbated Respiratory Disease (N-ERD)? A single-center retrospective study.
Çakmak, ME, 2022
)
0.72
"Acetaminophen (APAP), a widely used antipyretic and analgesic drug in clinics, is relatively safe at therapeutic doses; however, APAP overdose may lead to fatal acute liver injury."( The molecular mechanisms of acetaminophen-induced hepatotoxicity and its potential therapeutic targets.
Huang, L; Luo, G; Zhang, Z, 2023
)
2.65
" We investigate the role of the US FDA Adverse Event Reporting System (FAERS), a consolidated pharmacovigilance database, in outlining DSP habits and toxidromes."( Deliberate Self-Poisoning: Real-Time Characterization of Suicidal Habits and Toxidromes in the Food and Drug Administration Adverse Event Reporting System.
Bartolucci, M; De Ponti, F; Fusaroli, M; Giunchi, V; Necibi, EN; Pelletti, G; Pelotti, S; Poluzzi, E; Pugliese, C; Raschi, E, 2023
)
0.91
"Data from the first quarter (Q1) of 2015 to the fourth quarter (Q4) of 2021 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were retrieved for disproportionality and Bayesian analysis."( Hepatic failure associated with immune checkpoint inhibitors: An analysis of the Food and Drug Administration Adverse Event Reporting System database.
Cui, X; Guo, M; Li, D; Xu, Y; Yan, C; Zhao, Y, 2023
)
0.91
"Primary outcomes were low back pain intensity (0-100 scale) at end of treatment and safety (number of participants who reported any adverse event during treatment)."( Comparative effectiveness and safety of analgesic medicines for adults with acute non-specific low back pain: systematic review and network meta-analysis.
Bagg, MK; Cashin, AG; Day, R; Ferraro, MC; Gustin, SM; Hagstrom, AD; Jones, MD; Leake, HB; Maher, CG; McAuley, JH; McLachlan, AJ; Nikolakopolou, A; O'Connell, NE; Rizzo, RR; Schabrun, S; Sharma, S; Wand, BM; Wewege, MA, 2023
)
0.91
" Although the use of indomethacin is the standard therapy for PDA, it is sometimes not applicable because of its adverse effects, such as renal and platelet dysfunctions."( iPAPP: study protocol for a multicentre randomised controlled trial comparing safety and efficacy of intravenous paracetamol and indomethacin for the treatment of patent ductus arteriosus in preterm infants.
Fukuoka, N; Honda, M; Kawada, K; Kikuchi, K; Mikami, M; Motojima, Y; Namba, F; Ogawa, K; Sakatani, S; Sako, M; Ueda, K, 2023
)
0.91
" These findings have led some to suggest that acetaminophen is a safe and effective therapy for PDA closure."( Acetaminophen for the patent ductus arteriosus: has safety been adequately demonstrated?
Jensen, EA; McCulley, DJ; Mitra, S; Wright, CJ, 2023
)
2.61
"IP-ZA along with standing multiple-doses-per-day acetaminophen, administered to patients in the immediate postfracture period, is not associated with significant acute adverse effects."( Safety of Inpatient Zoledronic Acid in the Immediate Postfracture Setting.
Bolster, MB; Fan, W; Franco-Garcia, E; Leder, BZ; Ly, TV; Mannstadt, M, 2023
)
1.16
" As an over-the-counter pain reliever and antipyretic, Acetaminophen is the active metabolite of phenacetin and acetanilide, but it is less toxic than either precursor."( Hepatoprotective Effect of Vitamin B12 in Acetaminophen Induce Hepatotoxicity in Male Rats.
Ahmed Mohammed, R; Fadheel, QJ, 2023
)
1.42
"Acetaminophen (APAP) is one of the world's popular and safe painkillers, and overdose can cause severe liver damage and even acute liver failure."( Xanthohumol protect against acetaminophen-induced hepatotoxicity via Nrf2 activation through the AMPK/Akt/GSK3β pathway.
Cao, C; Ci, X; Fan, X; Hou, W; Li, K; Zhu, L, 2023
)
2.65
" In this study, using a mouse model of acetaminophen (APAP)-induced hepatotoxicity, we identified a gut bacterial metabolite that controls the hepatic expression of CYP2E1 that catalyzes the conversion of APAP to a reactive, toxic metabolite."( Phenylpropionic acid produced by gut microbiota alleviates acetaminophen-induced hepatotoxicity.
Bae, ON; Chang, EB; Cho, S; Guzman, G; Jeong, H; Ko, Y; Lee, H; Leone, VA; Won, KJ; Yang, X,
)
0.64
"Paracetamol is widely available and yet is substantially more toxic than other analgesics available without prescription."( Paracetamol (acetaminophen) overdose and hepatotoxicity: mechanism, treatment, prevention measures, and estimates of burden of disease.
Buckley, NA; Cairns, R; Chidiac, AS; Noghrehchi, F,
)
0.5
"6%) and responded that not all over-the-counter medications are safe during pregnancy (95."( The use, perceptions and knowledge of safety of over-the-counter medications during pregnancy in a Canadian population.
Brogly, SB; Casey, E; Gaudet, L; Velez, MP,
)
0.13
" Further research on the risk of over-the-counter medications and combinations in pregnancy is needed to help women to make safe choices during pregnancy."( The use, perceptions and knowledge of safety of over-the-counter medications during pregnancy in a Canadian population.
Brogly, SB; Casey, E; Gaudet, L; Velez, MP,
)
0.13
" Due to the strong evidence of increased risk of fever after administration, surveillance of adverse events following immunization (AEFIs) is a priority for 4CMenB."( Adverse events following immunization (AEFIs) with anti-meningococcus type B vaccine (4CMenB): Data of post-marketing active surveillance program. Apulia Region (Italy), 2019-2023.
Ancona, D; Di Lorenzo, A; Martinelli, A; Moscara, L; Stefanizzi, P; Stella, P; Tafuri, S, 2023
)
0.91

Pharmacokinetics

Microdialysis may provide a minimally invasive method to monitor the free concentrations of drugs, such as acetaminophen, in different compartments.

ExcerptReferenceRelevance
" Using a "simplex" non-linear optimization procedure, the pharmacokinetic parameters were found to be influenced considerably by the choice of the weighting factors (W1) attributed to individual data points."( Data point weighting in pharmacokinetic analysis: intravenous paracetamol in man.
Clements, JA; Prescott, LF, 1976
)
0.26
" The average biological half-life after oral administration of 1 g paracetamol was significantly prolonged in patients with hepatic cirrhosis compared to the controls (3."( Paracetamol (acetaminophen) clearance in patients with cirrhosis of the liver.
Andreasen, PB; Hutters, L, 1979
)
0.63
" The overall plasma elimination of acetaminophen is somewhat slow in the neonate, but is comparable to that of adults in both children and adolescents, as judged by half-life determinations."( Pharmacokinetics of acetaminophen in children.
Peterson, RG; Rumack, BH, 1978
)
0.86
" The administration of papaverine did not change the AUC and Cmax, but tmax was significantly longer."( Effect of papaverine and atropine on pharmacokinetics of paracetamol administered orally.
Gawrońska-Szklarz, B; Kaźmierczyk, J; Samochowiec, L; Wójcicki, J,
)
0.13
" The time to reach the peak concentration was shorter by 8% in follicular phase than in males."( Comparative pharmacokinetics of paracetamol in men and women considering follicular and luteal phases.
Baskiewicz, Z; Gawrońska-Szklarz, B; Kazimierczyk, J; Raczyński, A; Wójcicki, J, 1979
)
0.26
"The pharmacokinetic behaviour of N-acetyl-p-aminophenol (paracetamol) after single dose applications of 500 mg and 1000 mg dosages in the form of liquids, tablets and suppositories was compared."( [Comparative pharmacokinetics of paracetamol in humans following single oral and rectal administration (author's transl)].
Berner, G; Haase, W; Liedtke, R; Nicolai, W; Staab, R; Wagener, HH, 1979
)
0.26
" Significant changes were observed after 40% ethanol, an increase of AUC, beta, k12, k21, V2 and t1/2 alpha, decrease of Cmax and prolongation of tmax."( The effect of a single dose of ethanol on pharmacokinetics of paracetamol.
Baśkiewicz, Z; Gawrońska-Szklarz, B; Kazimierczyk, J; Kałucki, K; Wójcicki, J,
)
0.13
"The pharmacokinetic characteristics of the analgesic phenacetin have been determined in six healthy adults."( On the pharmacokinetics of phenacetin in man.
Dubach, UC; Raaflaub, J, 1975
)
0.25
" There was no significant difference in the biologic half-life and no apparent difference in the volume of distribution of acetaminophen between the three groups of subjects but the anephrics, unlike the normal subjects, showed pronounced accumulation of acetaminophen glucuronide and sulfate in plasma."( Pharmacokinetics of acetaminophen elimination by anephric patients.
Briggs, WA; Levy, G; Lowenthal, DT; Oie, S; Van Stone, JC, 1976
)
0.79
" Reported pharmacodynamic data were used with pharmacokinetic curves to identify effective therapeutic drug concentrations for optimum therapy for a drug with a "deep tissue" effective compartment."( Pharmacokinetics and pharmacodynamics in the design of controlled-release beads with acetaminophen as model drug.
Ayres, JW; Hossain, M, 1992
)
0.51
" The results demonstrate the importance of defining the precise posture in studies in which pharmacokinetic and pharmacodynamic measurements are made on drugs which are absorbed rapidly and are subject to presystemic elimination."( The influence of posture on the pharmacokinetics of orally administered nifedipine.
Ahsan, CH; Challenor, VF; Daniels, R; George, CF; Macklin, BS; Renwick, AG; Waller, DG, 1992
)
0.28
" Pharmacokinetic and pharmacodynamic analyses were performed with temperature as the effect parameter and mean acetaminophen, total ibuprofen, and ibuprofen stereoisomer concentrations over time."( Pharmacokinetics and pharmacodynamics of ibuprofen isomers and acetaminophen in febrile children.
Cox, S; Edge, JH; Kelley, MT; Mortensen, ME; Walson, PD, 1992
)
0.73
" Both steady-state volume of distribution and elimination half-life of acetaminophen were decreased in diabetic rats by 23 and 25%, respectively."( Long-term diabetes alters the hepatobiliary clearance of acetaminophen, bilirubin and digoxin.
Sherman, SE; Watkins, JB, 1992
)
0.76
" Cmax occurred about 2 1/2 hours before maximum antipyresis, when plasma acetaminophen or ibuprofen was 25 to 50% less than Cmax."( Single-dose pharmacokinetics of ibuprofen and acetaminophen in febrile children.
Bertrand, KM; Brown, RD; Eichler, VF; Johnson, VA; Kearns, GL; Wilson, JT, 1992
)
0.77
" Pirenzepine had no significant effect on plasma paracetamol Cmax (17."( The effect of pirenzepine on gastric emptying and salivary flow rate: constraints on the use of saliva paracetamol concentrations for the determination of paracetamol pharmacokinetics.
Edwards, C; Kamali, F; Rawlins, MD, 1992
)
0.28
" The half-life of amantadine after 42 days ingestion was 15."( Effects of chronic amantadine hydrochloride ingestion on its and acetaminophen pharmacokinetics in young adults.
Aoki, FY; Sitar, DS, 1992
)
0.52
" Noncompartmental pharmacokinetic parameters were calculated and compared to determine whether acetaminophen exhibited linear or dose-dependent pharmacokinetics."( Multiple-dose acetaminophen pharmacokinetics.
Ayres, JW; Sahajwalla, CG, 1991
)
0.86
" The mean area under the indomethacin plasma concentration curve AUC 0-alpha was 10."( Lack of effect of paracetamol on the pharmacokinetics of indomethacin and paracetamol in humans.
Seideman, P, 1991
)
0.28
" The surface area under the curve of paracetamol concentration changes was found to diminish after the bilateral removal of ovaries; there was a shortening of the half-life period for the elimination phase, and also an increase of the total clearance."( [Effect of estrogens on pharmacokinetics of phenazone and N-acetyl-p-aminophenol].
Kwiatkowski, A, 1991
)
0.28
" Therefore, caffeine is maximally effective in potentiating the effect of analgesics at a dose of 10 mg/kg and this potentiation is not due to a pharmacokinetic interaction with the analgesic, and also not due to phosphodiesterase (PDE) inhibition."( Determination of the optimal analgesia-potentiating dose of caffeine and a study of its effect on the pharmacokinetics of aspirin in mice.
Gayawali, K; Pandhi, P; Sharma, PL, 1991
)
0.28
" An analytical method was developed, which detects parent drugs and active metabolites, in order to compare the pharmacokinetic and metabolic behaviour of the two products."( High-pressure liquid chromatographic evaluation of cyclic paracetamol-acetylsalicylate and its active metabolites with results of a comparative pharmacokinetic investigation in the rat.
Lucarelli, C; Marzo, A; Meroni, G; Quadro, G; Ripamonti, M; Treffner, E, 1990
)
0.28
"Because serum concentrations of zidovudine decrease after the coadministration of acetaminophen, a pharmacokinetic interaction between zidovudine and acetaminophen is unlikely to increase the risk for hematologic toxicity associated with zidovudine."( Acetaminophen does not impair clearance of zidovudine.
Antoniskis, D; Cohen, J; Ko, R; Koda, R; Leedom, J; Nicoloff, J; Sattler, FR; Shields, M, 1991
)
1.95
" The mean residence times for paracetamol or its metabolites were significantly altered by change in posture or by sleep, whereas other pharmacokinetic parameters were unchanged."( Effects of posture and sleep on the pharmacokinetics of paracetamol (acetaminophen) and its metabolites.
Denton, MJ; Roberts, MS; Rumble, RH, 1991
)
0.52
" The pharmacokinetic results obtained with microdialysis sampling were the same as those obtained from blood collection."( In vivo microdialysis sampling for pharmacokinetic investigations.
Lunte, CE; Puckett, DL; Scott, DO; Sorenson, LR; Steele, KL, 1991
)
0.28
"In order to investigate the in vivo first-pass metabolism of acetaminophen (AAP) following the oral and intraduodenal administration in rats, a pharmacokinetic compartment model including absorption process was developed."( Dose-dependent pharmacokinetics and first-pass metabolism of acetaminophen in rats.
Higashi, Y; Kawamata, K; Murakami, T; Tone, Y; Yata, N, 1990
)
0.76
" The pharmacokinetic parameters of paracetamol remained unaltered in the presence of the CMRs as compared with those observed after paracetamol without additives, in spite of nearly twenty-fold differences in the dissolution rate between the products."( Effect of central muscle relaxants on single-dose pharmacokinetics of peroral paracetamol in man.
Elo, HA; Paronen, P; Saano, V, 1990
)
0.28
" Although acetaminophen elimination half-life can be estimated with reasonable precision using a two-point blood-sampling procedure, clearance and volume of distribution values using the two-point method overestimate the actual values."( Validity of a two-point acetaminophen pharmacokinetic study.
Blyden, GT; Greenblatt, DJ; Harmatz, JS; Luna, BG; Scavone, JM, 1990
)
0.99
" No significant alteration of half-life, area under the concentration-time curve or peak concentration of chloramphenicol was observed."( Lack of effect of paracetamol on the pharmacokinetics of chloramphenicol.
Neill, P; Nyazema, NZ; Stein, CM; Thornhill, DP, 1989
)
0.28
" There were no overall differences observed in the elimination half-life of antipyrine, nor were there significant differences between trials in cumulative urinary excretion or fractional recovery of intact antipyrine, 4-hydroxyantipyrine, norantipyrine, or 3-hydroxymethyl antipyrine."( Lack of effect of influenza vaccine on the pharmacokinetics of antipyrine, alprazolam, paracetamol (acetaminophen) and lorazepam.
Blyden, GT; Greenblatt, DJ; Scavone, JM, 1989
)
0.49
" Although total clearance, elimination half-life and steady-state volume of distribution were not altered, biliary clearance of acetaminophen was decreased by 39 to 50%."( Exposure of rats to inhalational anesthetics alters the hepatobiliary clearance of cholephilic xenobiotics.
Watkins, JB, 1989
)
0.48
" The pharmacokinetics of acetaminophen in plasma from a subject who had orally ingested 975 mg of the drug in tablet form is conducted using this method, and various pharmacokinetic parameters are determined."( Determination of acetaminophen in human plasma by ion-pair reversed-phase high-performance liquid chromatography. Application to a single-dose pharmacokinetic study.
Rustum, AM, 1989
)
0.92
"The present work studies the characterization of the pharmacokinetic profile of paracetamol following oral administration of DUOROL tablets containing 500 mg of the active compound."( Choice of optimum pharmacokinetic model of orally administered paracetamol.
Calvo, MB; Dominguez-Gil, A; Lanao, JM; Pedraz, JL,
)
0.13
" The pharmacokinetic parameters were calculated using an Odra-1305 computer under George-3 operation system."( Pharmacokinetics of paracetamol in patients with stomach cancer.
Gabriel, J; Gawrońska-Szklarz, B; Wójcicki, J,
)
0.13
" Some pharmacokinetic parameters (tmax, Cmax, V2) were changed to a greater extent after 6 than after 2 weeks following the stroke."( Pharmacokinetics of paracetamol in ischemic cerebral apoplexy.
Gawrońska-Szklarz, B; Stańkowska-Chomicz, A,
)
0.13
" The transplacental clearances from both sides of the placental membrane and the nontransplacental clearances in both the mother and the fetus were then determined using an indirect method, a two-compartment open pharmacokinetic body model."( Pharmacokinetic studies of the disposition of acetaminophen in the sheep maternal-placental-fetal unit.
Benet, LZ; Rudolph, AM; Wang, LH, 1986
)
0.53
" The purposes of this investigation were to determine the pharmacokinetics of acetaminophen in rats when endogenous sulfate depletion is prevented by administration of inorganic sulfate and to develop a simple, physiologically based pharmacokinetic model for the elimination of acetaminophen under these conditions."( Effect of prevention of inorganic sulfate depletion on the pharmacokinetics of acetaminophen in rats.
Levy, G; Lin, JH, 1986
)
0.73
"A retrospective study was undertaken to determine the accuracy of predicting acetaminophen levels using the pharmacokinetic equation for first-order absorption and elimination of a single oral ingestion, (Formula: see text) Forty-four acute adult acetaminophen overdoses were studied during a 22-month period."( Prediction of acetaminophen level from clinical history of overdose using a pharmacokinetic model.
Edwards, DA; Fish, SF; Lamson, MJ; Lovejoy, FH, 1986
)
0.86
" The mean half-life of acetaminophen during pregnancy (3."( Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women.
Piehl, E; Rayburn, W; Shukla, U; Stetson, P, 1986
)
2.02
" Diethylmaleate pretreatment decreased the total clearance and increased the half-life of acetaminophen."( Role of glutathione turnover in drug sulfation: differential effects of diethylmaleate and buthionine sulfoximine on the pharmacokinetics of acetaminophen in the rat.
Galinsky, RE, 1986
)
0.69
" Thus a pharmacokinetic interaction between CAP and APAP was not demonstrated in acutely ill febrile children during concomitant therapy."( Absence of a pharmacokinetic interaction between chloramphenicol and acetaminophen in children.
Bocchini, JA; Brown, RD; Cotter, DL; Kearns, GL; Wilson, JT, 1985
)
0.5
" The total area under the plasma concentration curve and the absorption and elimination half-lives did not, however, differ significantly."( Impact of dilution on the pharmacokinetic behavior of acetaminophen in rabbits after oral administration.
De Beer, JO; Jacobs, GA; Janssens, G; Martens, MA, 1985
)
0.52
" Pharmacokinetic parameters compared were t1/2,alpha, t1/2,Z, tmax, Cmax and AUCpo."( Chronopharmacokinetics of paracetamol in normal subjects.
Bosch, E; Malan, J; Moncrieff, J, 1985
)
0.27
" The plasma half-life of the unchanged drug was significantly prolonged, and the ratio of the plasma concentrations of unchanged to conjugated paracetamol was significantly higher than in the patients without liver damage."( The effects of hepatic and renal damage on paracetamol metabolism and excretion following overdosage. A pharmacokinetic study.
Prescott, LF; Wright, N, 1973
)
0.25
" Pharmacokinetic variables were determined from multiple plasma acetaminophen concentrations measured by liquid chromatography during 12 h after the dose."( Reduced distribution and clearance of acetaminophen in patients with congestive heart failure.
Abernethy, DR; Greenblatt, DJ; Ochs, HR; Schuppan, U,
)
0.64
" Measurement by radioimmunoassay of plasma levonorgestrel has been used to compare the pharmacokinetic parameters of the drug after oral and intravenous administration in both control and liver-affected animals."( Influence of acetaminophen-induced hepatic necrosis on the pharmacokinetics of levonorgestrel.
Gommaa, AA; Osman, FH, 1983
)
0.64
" In addition, ibuprofen can be combined with acetaminophen without altering the pharmacokinetic profile."( Pharmacokinetics of ibuprofen.
Albert, KS; Gernaat, CM, 1984
)
0.53
"The effects of N-acetylcysteine (NAC) on the pharmacokinetic parameters of acetaminophen (AP) in adult female beagles were studied."( Effect of antidotal N-acetylcysteine on the pharmacokinetics of acetaminophen in dogs.
Mohammad, FK; St Omer, VE, 1984
)
0.74
"A pharmacokinetic model of the enterohepatic circulation of acetaminophen glucuronide was investigated in rats with particular attention to a lag time between biliary excretion and reabsorption."( Pharmacokinetic study of the enterohepatic circulation of acetaminophen glucuronide in rats.
Hanawa, M; Iwai, M; Kaneniwa, N; Watari, N, 1984
)
0.75
" The main pharmacokinetic parameters and the relative bioavailability were calculated."( [Comparative pharmacokinetics and biologic availability of paracetamol as suppositories].
Degen, J; Maier-Lenz, H, 1984
)
0.27
" Elimination of salicylate involves two saturable (nonlinear) major pathways and three apparently first-order (linear) minor pathways; these mixed order kinetics lead to somewhat complex mathematics affecting elimination half-life which, in turn, can have implications for anticipating side effects and toxicity."( Pharmacokinetic considerations of common analgesics and antipyretics.
Hartwig-Otto, H, 1983
)
0.27
" There were no significant differences in the biological half-life (T1/2), the apparent volume of distribution (Vd), and the clearance (C) of antipyrine and paracetamol."( Pharmacokinetics of antipyrine, paracetamol, and morphine in rat at 71 ATA.
Aanderud, L; Bakke, OM, 1983
)
0.27
" It was used in a pharmacokinetic study in twelve volunteers."( [Plasma determination of paracetamol using high performance liquid chromatography. Application to a pharmacokinetic study].
Albin, H; Demotes-Mainard, F; Jarry, C; Vinçon, G, 1984
)
0.27
" Oral contraceptive steroid subjects had a lower elimination half-life of acetaminophen (2."( Increased metabolic clearance of acetaminophen with oral contraceptive use.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ; Ochs, HR, 1982
)
0.78
" Plasma concentrations of paracetamol were measured and pharmacokinetic variables were determined."( Pharmacokinetics of parenteral paracetamol and its analgesic effects in post-operative dental pain.
Rawlins, MD; Seymour, RA, 1981
)
0.26
" Paracetamol, the only metabolised drug which is conjugated for which pharmacokinetic parameters have been accurately determined in obesity, undergoes increased clearance in obese subjects."( Pharmacokinetics of drugs in obesity.
Abernethy, DR; Greenblatt, DJ,
)
0.13
"The pharmacokinetic behaviour of paracetamol (300 mg) and salicylamide (200 mg) in the course of combined repetitive (three times tau = 4 h) administration of suppositories was investigated in 10 healthy, male volunteers."( [Multiple-dose pharmacokinetics of paracetamol and salicylamide in man after combined rectal application (author's transl)].
Ebel, S; Haase, W; Liedtke, R; Missler, B; Stein, L, 1980
)
0.26
" The half-life was the same in the obese patients (2."( The effect of obesity on acetaminophen pharmacokinetics in man.
Granville, GE; Kramer, WG; Lee, WH, 1981
)
0.57
"To study the pharmacokinetic interactions between aspirin (250 mg/kg) and simultaneously administered oral acetaminophen (125 mg/kg) or caffeine (50 mg/kg) in male rats, noninterfering GLC assays for these drugs were developed."( Interactions of aspirin with acetaminophen and caffeine in rat stomach: pharmacokinetics of absorption and accumulation in gastric mucosa.
Jager, LP; Olling, M; Seegers, JM; Van Noordwijk, J, 1980
)
0.77
" The results obtained are in reasonably good agreement with predictions of acetaminophen disposition based upon a previously developed pharmacokinetic model of capacity-limited acetaminophen elimination, but additional studies are needed to refine that model."( Acetaminophen pharmacokinetics after overdose.
Koup, JR; Levy, G; Slattery, JT, 1981
)
1.94
"The pharmacokinetic profile and efficacy of nimesulide were assessed in 2 separate studies that recruited children with hypoglycaemia or upper respiratory tract infection and fever, respectively."( Clinical and pharmacokinetic study of nimesulide in children.
Berardi, M; Guarnaccia, S; Renzetti, I; Ugazio, AG, 1993
)
0.29
"The influence of caffeine (60 mg) was studied on the pharmacokinetic characteristics of acetaminophen (500 mg single dose) in ten healthy male human volunteers in a complete cross-over design."( The effect of caffeine on the pharmacokinetics of acetaminophen in man.
Ahmad, B; Gilani, AU; Iqbal, N; Janbaz, KH; Niazi, SK, 1995
)
0.77
" There was no effect of ASA, ibuprofen or paracetamol on the single-dose kinetics of ethanol, but concurrent intake of ethanol reduced the peak concentration of ASA by 25%."( Pharmacokinetic interactions of alcohol and acetylsalicylic acid.
Lidén, A; Melander, A; Melander, O, 1995
)
0.29
"Measurement of drug concentrations in tissues would be useful for clinical pharmacokinetic studies, but appropriate experimental methods are not available at present."( Application of microdialysis to clinical pharmacokinetics in humans.
Buxbaum, A; Eichler, HG; Georgopoulos, A; Müller, M; Schmid, R; Wasicek, C, 1995
)
0.29
" Major pharmacokinetic parameters (absorption half-life, elimination half-life, maximum concentration, time to reach maximum concentration, area under the curve, and area under the inhibitory curve) were calculated for tissues; tissue/plasma concentration ratios could be derived."( Application of microdialysis to clinical pharmacokinetics in humans.
Buxbaum, A; Eichler, HG; Georgopoulos, A; Müller, M; Schmid, R; Wasicek, C, 1995
)
0.29
" This technique may become a valuable addition for pharmacokinetic characterization of selected drugs."( Application of microdialysis to clinical pharmacokinetics in humans.
Buxbaum, A; Eichler, HG; Georgopoulos, A; Müller, M; Schmid, R; Wasicek, C, 1995
)
0.29
" The Cmax in oral drop and tablet were 11."( [Pharmacokinetics and bioavailability study on acetaminophen oral drop in healthy volunteers].
Hong, Z; Li, L; Li, Z; Qiang, W; Wang, M; Wang, Y; Zou, J, 1994
)
0.55
"The pharmacokinetic parameters of paracetamol were studied after 15 min intravenous infusion of 15 mg/kg of propacetamol (Prodafalgan) in 5 neonates aged less than 10 days and 7 infants aged between 1 and 12 months."( Pharmacokinetics of paracetamol in the neonate and infant after administration of propacetamol chlorhydrate.
Autret, E; Breteau, M; Dutertre, JP; Furet, Y; Jonville, AP; Laugier, J, 1993
)
0.29
" These results demonstrate that microdialysis may provide a minimally invasive method to monitor the free concentrations of drugs, such as acetaminophen, in different compartments, and allow a multitude of pharmacokinetic data to be obtained from freely moving animals."( Application of microdialysis to the pharmacokinetics of analgesics: problems with reduction of dialysis efficiency in vivo.
Brune, K; Geisslinger, G; Sauernheimer, C; Williams, KM, 1994
)
0.49
" The study revealed an increase in AUC and paracetamol half-life as well as decrease in the total body clearance."( Effect of mestranol on pharmacokinetics of paracetamol.
Droździk, M; Gawrońska-Szklarz, B; Kwiatkowski, A; Wójcicki, J, 1994
)
0.29
"To evaluate an animal model of multiple-dose activated charcoal (MDAC) therapy and correlate the pharmacokinetic properties of four drugs with the efficacy of MDAC."( Correlation of drug pharmacokinetics and effectiveness of multiple-dose activated charcoal therapy.
Chyka, PA; Holley, JE; Mandrell, TD; Sugathan, P, 1995
)
0.29
" Acute intraperitoneal doses of ethanol (1 ml kg-1) are shown to increase the relative bioavailability, measured as AUC, by 40%, elimination half-life by 24%, and changes in CL and Vd were also observed."( Pharmacokinetic studies using microdialysis probes in subcutaneous tissue: effects of the co-administration of ethanol and acetaminophen.
Kissinger, PT; Linhares, MC, 1994
)
0.5
" In contrast, there were no observed differences in pharmacokinetic parameters, serum elimination, or biliary excretion for the clinically important cardiac glycoside digoxin (dose of 100 nmol/kg)."( Chronic voluntary exercise may alter hepatobiliary clearance of endogenous and exogenous chemicals in rats.
Crawford, ST; Sanders, RA; Watkins, JB,
)
0.13
" The mean half-life was significantly lower and oral clearance was significantly higher in the first trimester group compared to the control group."( Paracetamol pharmacokinetics during the first trimester of human pregnancy.
Beaulac-Baillargeon, L; Rocheleau, S, 1994
)
0.29
"To investigate a possible pharmacokinetic interaction between zidovudine and paracetamol."( Short-term, combined use of paracetamol and zidovudine does not alter the pharmacokinetics of either drug.
Beijnen, JH; Burger, DM; Koks, CH; Meenhorst, PL; Underberg, WJ; van der Heijde, JF, 1994
)
0.29
" Pharmacokinetic monitoring was performed on day 0 (AZT alone) and after 7 days of combined use of paracetamol and AZT."( Short-term, combined use of paracetamol and zidovudine does not alter the pharmacokinetics of either drug.
Beijnen, JH; Burger, DM; Koks, CH; Meenhorst, PL; Underberg, WJ; van der Heijde, JF, 1994
)
0.29
"Combined use of paracetamol and AZT did not result in a significant change in any of the calculated pharmacokinetic parameters of AZT or its primary metabolite AZT-glucuronide."( Short-term, combined use of paracetamol and zidovudine does not alter the pharmacokinetics of either drug.
Beijnen, JH; Burger, DM; Koks, CH; Meenhorst, PL; Underberg, WJ; van der Heijde, JF, 1994
)
0.29
" Pharmacokinetic experiments were carried out in all the animals before the operation, 1 month after, and 2 months after ovariectomy."( [Pharmacokinetics of paracetamol after removal of ovaries in rabbits].
Droździk, M; Gawrońska-Szklarz, B; Kwiatkowski, A; Wójcicki, J, 1993
)
0.29
" The pharmacokinetic interactions between paracetamol (PA) and antipyrine (AP) were studied in pigs in order to investigate the usefulness of this combination for the simultaneous assessment of oxidative and conjugative metabolism."( Dose-dependent pharmacokinetic interaction between antipyrine and paracetamol in vivo and in vitro when administered as a cocktail in pig.
Monshouwer, M; Pijpers, A; van Miert, AS; Verheijden, JH; Witkamp, RF, 1994
)
0.29
"Exposure to weightlessness induces physiologic changes that may lead to pharmacokinetic and pharmacodynamic alterations of drugs administered to crew members in flight."( Application of physiologically based pharmacokinetic models for assessing drug disposition in space.
Bourne, DW; Putcha, L; Srinivasan, RS, 1994
)
0.29
" A two-compartment open model for extravascular administration was used for calculation of pharmacokinetic parameters."( [Pharmacokinetics of acetaminophen in individuals occupationally exposed to polyvinyl chloride modified with plasticizers].
Droździk, M; Gawrońska-Szklarz, B; Górnik, W; Smilgin, Z; Tustanowski, S; Wójcicki, J, 1993
)
0.6
" No influence on other pharmacokinetic parameters of either drug could be detected."( Pharmacokinetics of zidovudine and acetaminophen in a patient on chronic acetaminophen therapy.
Beijnen, JH; Burger, DM; Koks, CH; Meenhorst, PL, 1994
)
0.57
"The observed pharmacokinetic profiles of both drugs are discussed and compared with two studies dealing with zidovudine therapy in combination with short-term use of acetaminophen and with a case report of acetaminophen-induced hepatotoxicity during concomitant use of zidovudine."( Pharmacokinetics of zidovudine and acetaminophen in a patient on chronic acetaminophen therapy.
Beijnen, JH; Burger, DM; Koks, CH; Meenhorst, PL, 1994
)
0.76
" Although other causes cannot be ruled out, there was no influence on other pharmacokinetic parameters of zidovudine."( Pharmacokinetics of zidovudine and acetaminophen in a patient on chronic acetaminophen therapy.
Beijnen, JH; Burger, DM; Koks, CH; Meenhorst, PL, 1994
)
0.57
"A pharmacokinetic program using population-based parameter estimates and a Bayesian forecasting model was retrospectively evaluated for predicting acetaminophen serum concentrations in overdose patients."( Prediction of acetaminophen concentrations in overdose patients using a Bayesian pharmacokinetic model.
Gentry, CA; Paloucek, FP; Rodvold, KA, 1994
)
0.85
"Successful pharmacokinetic modeling often requires the ability of a simple model to describe a complex series of physiological processes."( Hepatic disposition of acetaminophen and metabolites. Pharmacokinetic modeling, protein binding and subcellular distribution.
Brouwer, KL; Studenberg, SD, 1993
)
0.6
"A pharmacokinetic study has been performed on a new non-steroidal anti-inflammatory drug, AU-8001 (4'-acetamidophenyl-2-(5'-p-toluyl-1'-methylpyrrole)acetate, CAS 82239-77-8) in the rat, following intravenous (10 mg/kg) and oral (50 mg/kg) administrations."( Pharmacokinetic study of 4'-acetamidophenyl-2-(5'-p-toluyl-1'-methylpyrrole)acetate in the rat.
Domenéch, J; Obach, R; Sabater, J, 1993
)
0.29
"3 min of half-life of hepatic uptake) when compared with the control group (15."( Plasma-kallikrein clearance by the liver of acetaminophen-intoxicated rats.
Borges, DR; de Toledo, CF, 1993
)
0.55
"To evaluate intrapleural analgesia with bupivacaine following partial pulmonary resection and to determine pharmacokinetic parameters of bupivacaine with epinephrine."( Interpleural analgesia with bupivacaine following thoracotomy: ineffective results of a controlled study and pharmacokinetics.
Debaene, B; Elman, A; Magny-Metrot, C; Murciano, G,
)
0.13
" Maximum peak concentration (C Max) and maximum time to reach the peak concentration (T Max) were assessed after the first and last injections."( Interpleural analgesia with bupivacaine following thoracotomy: ineffective results of a controlled study and pharmacokinetics.
Debaene, B; Elman, A; Magny-Metrot, C; Murciano, G,
)
0.13
" The half-life for acetaminophen was determined to be 20."( Pharmacokinetic monitoring in subcutaneous tissue using in vivo capillary ultrafiltration probes.
Kissinger, PT; Linhares, MC, 1993
)
0.61
" A pharmacokinetic study was conducted to quantitate changes in the formation clearance (Cl(f)) of NAPQI to assess in vivo the activation and inhibition of NAPQI formation by methylxanthines."( Effects of caffeine and theophylline on acetaminophen pharmacokinetics: P450 inhibition and activation.
Lee, CA; Lillibridge, JH; Nelson, SD; Slattery, JT, 1996
)
0.56
" The pharmacokinetic calculations in men demonstrated an interaction between paracetamol and caffeine which was indicated by a decrease in plasma paracetamol levels, by a smaller surface under the curve of changes of paracetamol levels indicating faster elimination of the drug after simultaneous administration with caffeine."( [Influence of caffeine on toxicity and pharmacokinetics of paracetamol].
Raińska-Giezek, T, 1995
)
0.29
" Pharmacokinetic parameters were estimated by a non-linear least squares program, MULTI(FILT), based on the fast inverse Laplace transform algorithm."( Pharmacokinetics of acetaminophen sulfate after oral administration in rats: analysis of plasma profiles exhibiting a non-linear second peak.
Kimura, T; Kurosaki, Y; Nakayama, T; Sawamoto, T, 1996
)
0.62
"The pharmacodynamic properties of meloxicam, a new nonsteroidal antiinflammatory drug (NSAID), that go beyond those typical of an NSAID were examined."( General pharmacology of meloxicam--Part II: Effects on blood pressure, blood flow, heart rate, ECG, respiratory minute volume and interactions with paracetamol, pirenzepine, chlorthalidone, phenprocoumon and tolbutamide.
Engelhardt, G; Homma, D; Schlegel, K; Schnitzler, C; Utzmann, R, 1996
)
0.29
" Both the AUC and the Cmax were less after ER APAP than after IR APAP; otherwise, there was no evident difference in any measure."( A pharmacokinetic comparison of acetaminophen products (Tylenol Extended Relief vs regular Tylenol)
Douglas, DR; Sholar, JB; Smilkstein, MJ, 1996
)
0.58
"In this model involving a single supratherapeutic dose, ER APAP evidenced no pharmacokinetic features that would suggest the need for an alternate poisoning screening strategy."( A pharmacokinetic comparison of acetaminophen products (Tylenol Extended Relief vs regular Tylenol)
Douglas, DR; Sholar, JB; Smilkstein, MJ, 1996
)
0.58
"Two strains of rats, Sprague-Dawley and Wistar, were assayed in order to determine which strain is the more suitable experimental model for the study of pharmacokinetic alterations induced by spinal cord injury."( Comparison between Sprague-Dawley and Wistar rats as an experimental model of pharmacokinetic alterations induced by spinal cord injury.
Castañeda-Hernández, G; Flores-Murrieta, F; García-López, P; Grijalva, I; Guízar-Sahagún, G; Ibarra, A; Madrazo, I; Pérez-Urizar, J, 1996
)
0.29
" In present study, in order to evaluate whether there is some alteration of the phase II metabolism including glucuronide and sulfate conjugations in 16-week-old SHRs and the age-matched Wistar rats, the pharmacokinetic parameters of acetaminophen (A), A-sulfate, and A-glucuronide were investigated after intravenous (iv) and oral 100 mg/kg administration of A to 16-week-old SHRs and the age-matched Wistar rats."( Pharmacokinetics of acetaminophen after intravenous and oral administration to spontaneously hypertensive rats and normotensive Wistar rats.
Jang, SH; Lee, MG; Lee, MH, 1994
)
0.8
"05) were observed between efficacy measures and the various pharmacokinetic parameters (AUC0-300, Cmax and Tmax) for ibuprofen after the soluble dose."( Are the pharmacokinetics of ibuprofen important determinants for the drug's efficacy in postoperative pain after third molar surgery?
Hawkesford, JE; Jones, K; Seymour, RA, 1997
)
0.3
" However, the area under the plasma concentration time curve and the elimination half-life of paracetamol metabolites increased significantly with worsening renal insufficiency."( Single-dose pharmacokinetics of paracetamol and its conjugates in Chinese non-insulin-dependent diabetic patients with renal impairment.
Anderson, PJ; Chan, JC; Chan, MT; Critchley, JA; Lau, GS, 1997
)
0.3
" Pharmacokinetic models suggest that absorption of acetaminophen is a function of zero-order dissolution of suppositories and first-order absorption from the rectum."( Twenty-four-hour pharmacokinetics of rectal acetaminophen in children: an old drug with new recommendations.
Berkelhamer, MC; Birmingham, PK; Coté, CJ; Fanta, KB; Fisher, DM; Henthorn, TK; Smith, FA; Tobin, MJ, 1997
)
0.81
" We present a model based on experimental studies of chemical induction of CYP2E1 by ligand stabilization through which this mechanism of induction can be translated into its pharmacokinetic consequence with regard to clearance of substrate."( Pharmacokinetic consequences of induction of CYP2E1 by ligand stabilization.
Chien, JY; Slattery, JT; Thummel, KE, 1997
)
0.3
"To know the influences of a Chinese traditional medicine (KAKKONTO) on the metabolism of acetaminophen (APAP), we have carried out pharmacokinetic studies on APAP under KAKKONTO coadministration in humans and rats."( Pharmacokinetic study on acetaminophen: interaction with a Chinese medicine.
Honda, Y; Mineshita, S; Qi, J; Toyoshima, A, 1997
)
0.82
" The plasma level-time curves were fitted according to one compartment open pharmacokinetic model."( [The effect of exercise on the pharmacokinetics of acetaminophen and acetylsalicylic acid].
Sawrymowicz, M, 1997
)
0.55
" No statistically or clinically relevant differences were observed in maximum concentration (Cmax), time to Cmax (tmax), or elimination half-life of troglitazone, its two main metabolites, and acetaminophen or in acetaminophen urinary sulfate excretion, although there was a slight decrease in acetaminophen glucuronide excretion during administration with troglitazone."( Coadministration of acetaminophen and troglitazone: pharmacokinetics and safety.
Eastmond, R; Lettis, S; Young, MA, 1998
)
0.81
" Estimation of population pharmacokinetic parameters was made using both a standard two-stage population approach (MKMODEL) and a nonlinear mixed effect model (NONMEM)."( Paracetamol plasma and cerebrospinal fluid pharmacokinetics in children.
Anderson, BJ; Chan, PL; Holford, NH; Woollard, GA, 1998
)
0.3
" Pharmacokinetic interactions between these two classes of drugs have been described in experimental models, and exceptionally in humans."( Pharmacokinetic parameters and killing rates in serum of volunteers receiving amoxicillin, cefadroxil or cefixime alone or associated with niflumic acid or paracetamol.
Bernard, E; Carsenti-Etesse, H; De Salvador, F; Dellamonica, P; Durant, J; Farinotti, R; Roger, PM; Rouveix, B,
)
0.13
"There are no adequate pharmacodynamic data relating concentrations of acetaminophen in serum to analgesia."( Perioperative pharmacodynamics of acetaminophen analgesia in children.
Anderson, BJ; Holford, NH; Kanagasundaram, S; Mahadevan, M; Woollard, GA, 1999
)
0.82
"Mean (% CV) estimates of population pharmacokinetic parameters with percent coefficient of variation, standardized to a 70-kg person, for a one-compartment model with first-order input, lag time, and first order-elimination were a volume of distribution of 60 (21) 1 and a clearance of 13."( Perioperative pharmacodynamics of acetaminophen analgesia in children.
Anderson, BJ; Holford, NH; Kanagasundaram, S; Mahadevan, M; Woollard, GA, 1999
)
0.58
" The (R)- and (S)-enantiomers of warfarin exhibited significantly different pharmacokinetic properties."( The effects of acetaminophen on pharmacokinetics and pharmacodynamics of warfarin.
Bartle, WR; Kwan, D; Walker, SE, 1999
)
0.66
" Thus, not only drug monitoring but also pharmacokinetic investigations from blood plasma have become possible without further sample pretreatment."( Pharmacokinetic investigations with direct injection of plasma samples: possible savings using capillary electrophoresis (CE).
Kunkel, A; Wätzig, H, 1999
)
0.3
" Neither the elimination half-life nor the area under the curve was significantly different between the two sessions."( Pharmacokinetic interaction between acetaminophen and lansoprazole.
Enatsu, I; Hanada, Y; Kuyama, Y; Makino, H; Mineshita, S; Qi, J; Sanaka, M; Tanaka, H; Yamanaka, M, 1999
)
0.58
"Despite widespread use in children pharmacokinetic data about paracetamol are relatively scarce, not the least in the youngest age groups."( Plasma paracetamol concentrations and pharmacokinetics following rectal administration in neonates and young infants.
Hansen, TG; Morton, NS; O'Brien, K; Rasmussen, SN, 1999
)
0.3
" the mean Tmax was 102."( Plasma paracetamol concentrations and pharmacokinetics following rectal administration in neonates and young infants.
Hansen, TG; Morton, NS; O'Brien, K; Rasmussen, SN, 1999
)
0.3
"The use of marker compounds for estimating drug metabolic capacity or pharmacokinetic parameters is common in the biological sciences."( Simple and rapid assay for acetaminophen and conjugated metabolites in low-volume serum samples.
Bai, S; Brunner, LJ, 1999
)
0.6
" Serum concentrations were determined serially with an HPLC method, and pharmacokinetic analysis was performed."( Multiple-dose pharmacokinetics of rectally administered acetaminophen in term infants.
Deinum, HT; Okken, A; Quak, CM; Tibboel, D; van Lingen, RA, 1999
)
0.55
"A small but statistically significant increase in Cmax occurred after treatment with cisapride owing to faster gastric emptying rate as shown by the paracetamol absorption test."( Impact of gastric emptying on the pharmacokinetics of ethanol as influenced by cisapride.
Jones, AW; Jönsson, KA; Kechagias, S, 1999
)
0.3
" The time-concentration profiles for each individual were used to estimate pharmacokinetic parameters using a non-linear mixed effects model (NONMEM)."( Pharmacokinetics of paracetamol in adults after cardiac surgery.
Anderson, BJ; Holford, NH; Schuitmaker, M; Woollard, GA, 1999
)
0.3
" Applicability of the method was demonstrated by a pharmacokinetic study in normal volunteers who received 2 mg propacetamol."( Rapid liquid chromatographic assay for the determination of acetaminophen in plasma after propacetamol administration: application to pharmacokinetic studies.
Calahorra, B; Campanero, MA; García-Quétglas, E; Honorato, J; López-Ocáriz, A, 1999
)
0.55
" An open, randomised, crossover study design was used to compare the pharmacokinetic parameters of soluble aspirin and solid paracetamol tablets in 16 healthy, male volunteers from the University of the Witwatersrand, South Africa, in both fed and fasted states."( Comparison of the pharmacokinetic profiles of soluble aspirin and solid paracetamol tablets in fed and fasted volunteers.
Chetty, M; Clinton, C; Havlik, I; Little, S; Moodley, I; Muir, N; Schall, R; Stillings, M, 2000
)
0.31
" These neonatal and infant data were then included with data from four published studies of paracetamol pharmacokinetics (n = 221) and age-related pharmacokinetic changes investigated."( A model for size and age changes in the pharmacokinetics of paracetamol in neonates, infants and children.
Anderson, BJ; Holford, NH; Woollard, GA, 2000
)
0.31
"Population pharmacokinetic parameter estimates and their coefficients of variation (CV%) for a one compartment model with first order input, lag time and first order elimination were volume of distribution 69."( A model for size and age changes in the pharmacokinetics of paracetamol in neonates, infants and children.
Anderson, BJ; Holford, NH; Woollard, GA, 2000
)
0.31
"Two open-label, two-way, crossover studies were performed to assess any pharmacokinetic interaction of telmisartan with either acetaminophen or ibuprofen."( Pharmacokinetics of acetaminophen and ibuprofen when coadministered with telmisartan in healthy volunteers.
Fraunhofer, A; Stangier, J; Su, CA; Tetzloff, W, 2000
)
0.84
"The plasma pharmacokinetic profile of acetaminophen did not change significantly at D7 compared to D1."( Single and multiple dose pharmacokinetics of acetaminophen (paracetamol) in polymedicated very old patients with rheumatic pain.
Bannwarth, B; Lagrange, F; Le Bars, M; Matoga, M; Maury, S; Palisson, M; Pehourcq, F, 2001
)
0.84
" On the basis of pharmacokinetic data alone, a dose regimen of acetaminophen 1 g tid seems to be appropriate in such patients."( Single and multiple dose pharmacokinetics of acetaminophen (paracetamol) in polymedicated very old patients with rheumatic pain.
Bannwarth, B; Lagrange, F; Le Bars, M; Matoga, M; Maury, S; Palisson, M; Pehourcq, F, 2001
)
0.81
" Plasma concentration profiles and pharmacokinetic parameters of acetaminophen in rabbits were investigated after oral administration of the prepared tablets."( Pharmacokinetics of acetaminophen from rapidly disintegrating compressed tablet prepared using microcrystalline cellulose (PH-M-06) and spherical sugar granules.
Endo, H; Fujii, M; Ishikawa, T; Koizumi, N; Matsumoto, M; Mukai, B; Shirotake, S; Utoguchi, N; Watanabe, Y, 2001
)
0.87
" Based on the authors' previous pharmacokinetic data, they examined whether a 40-mg/kg loading dose followed by 20-mg/kg doses at 6-h intervals maintain serum concentrations within the target range of 10-20 microg/ml, without evidence of accumulation."( Initial and subsequent dosing of rectal acetaminophen in children: a 24-hour pharmacokinetic study of new dose recommendations.
Birmingham, PK; Coté, CJ; Fisher, DM; Hall, SC; Henthorn, TK; Tobin, MJ, 2001
)
0.58
" The authors assessed whether their published pharmacokinetic parameters predicted the acetaminophen concentrations in the present study."( Initial and subsequent dosing of rectal acetaminophen in children: a 24-hour pharmacokinetic study of new dose recommendations.
Birmingham, PK; Coté, CJ; Fisher, DM; Hall, SC; Henthorn, TK; Tobin, MJ, 2001
)
0.8
" Pharmacokinetic parameters from the earlier study predicted the serum concentrations observed for both initial and subsequent doses."( Initial and subsequent dosing of rectal acetaminophen in children: a 24-hour pharmacokinetic study of new dose recommendations.
Birmingham, PK; Coté, CJ; Fisher, DM; Hall, SC; Henthorn, TK; Tobin, MJ, 2001
)
0.58
" There was large interindividual variability in pharmacokinetic characteristics."( Initial and subsequent dosing of rectal acetaminophen in children: a 24-hour pharmacokinetic study of new dose recommendations.
Birmingham, PK; Coté, CJ; Fisher, DM; Hall, SC; Henthorn, TK; Tobin, MJ, 2001
)
0.58
" Plasma acetaminophen concentrations were determined using HPLC, and its main pharmacokinetic parameters were generated."( Pharmacokinetics of acetaminophen in Hong Kong Chinese subjects.
Chow, AH; Chow, MS; Tomlinson, B; Yin, OQ, 2001
)
1.07
" Characterization of the pharmacokinetic and/or pharmacodynamic behavior of operationally critical medications is crucial for their effective use in flight; as a first step, we sought to determine whether drugs administered in space actually reach the site of action at concentrations sufficient to elicit the therapeutic response."( Pharmacokinetic consequences of spaceflight.
Cintrón, NM; Putcha, L, 1991
)
0.28
" Oxycodone AUC(0-t), AUC(0-infinity), and Cmax were dose dependent, whereas tma and t(1/2) were not."( Comparison of the pharmacokinetics of oxycodone administered in three Percocet formulations.
Davis, MW; Gammaitoni, AR, 2002
)
0.31
"A population pharmacokinetic analysis of acetaminophen time-concentration profiles in 283 children (124 aged < or = 6 months) reported in six studies was undertaken using nonlinear mixed-effects models."( Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis.
Anderson, BJ; Hansen, TG; Holford, NH; Lin, YC; van Lingen, RA, 2002
)
2.02
"Population pharmacokinetic parameter estimates and their variability (percent) for a one-compartment model with first-order input, lag time, and first-order elimination were as follows: volume of distribution, 66."( Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis.
Anderson, BJ; Hansen, TG; Holford, NH; Lin, YC; van Lingen, RA, 2002
)
1.76
"The contribution of an entero-salivary recirculation (salivary secretion-swallowed-reabsorption of drug from the gastrointestinal tract) to the values of the pharmacokinetic parameters of paracetamol was studied in a two-way crossover design."( Importance of entero-salivary recirculation in paracetamol pharmacokinetics.
Niselman, A; Rubio, M; Schaiquevich, P, 2002
)
0.31
"The reliability of the serum acetaminophen (APAP) concentration at 45 min (C45) as a measure of gastric emptying (GE) has been evaluated using a pharmacokinetic simulation work."( [The validity of serum acetaminophen concentration at 45 min as an index of gastric emptying rate: a study based on pharmacokinetic theories].
Anjiki, H; Hattori, K; Ishii, T; Kuyama, Y; Obara, M; Saitoh, M; Sanaka, M; Takikawa, H; Yamamoto, T, 2002
)
0.92
" CL(int,in vivo) was calculated from in vivo pharmacokinetic data using two frequently used mathematical models (the well stirred and dispersion models)."( Utility of hepatocytes in predicting drug metabolism: comparison of hepatic intrinsic clearance in rats and humans in vivo and in vitro.
Kagayama, A; Naritomi, Y; Sugiyama, Y; Terashita, S, 2003
)
0.32
" In the control group there were no significant differences in pharmacokinetic parameters for paracetamol in 24-25 and 28-29-day-old calves."( The effect of food or water deprivation on paracetamol pharmacokinetics in calves.
Antoszek, J; Grochowina, B; Janus, K; Muszczynski, Z; Suszycki, S, 2003
)
0.32
" The plasma Cmax showed a significant increase (10."( Influence of simulated weightlessness on the oral pharmacokinetics of acetaminophen as a gastric emptying probe in man: a plasma and a saliva study.
Bareille, MP; Gandia, P; Guell, A; Houin, G; Lavit, M; Le-Traon, AP; Saivin, S, 2003
)
0.55
" Since space experiments are infrequent and difficult to perform, in order to evaluate pharmacokinetic modifications, simulation experiments of weightlessness have to be carried out on earth, using animal-models such as the Morey-Holton model."( Influence of simulated weightlessness on the pharmacokinetics of acetaminophen administered by the oral route: a study in the rat.
Gandia, P; Houin, G; Lavit, M; Saivin, S, 2004
)
0.56
" A comparison is also presented between several methods based on animal pharmacokinetic data, using the same set of proprietary compounds, and it lends further support for the use of this method, as opposed to methods that require the gathering of pharmacokinetic data in laboratory animals."( Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
Gao, F; Lombardo, F; Obach, RS; Shalaeva, MY, 2004
)
0.32
" A population pharmacokinetic analysis of paracetamol (acetaminophen) time-concentration profiles in 48 neonates was undertaken using non-linear mixed-effects models."( Intravenous paracetamol (propacetamol) pharmacokinetics in term and preterm neonates.
Allegaert, K; Anderson, BJ; de Hoon, J; Debeer, A; Devlieger, H; Naulaers, G; Tibboel, D; Verbesselt, R, 2004
)
0.57
" Pharmacokinetic values obtained were found to be in similar ranges as those previously reported."( Effect of zobo drink (Hibiscus sabdariffa water extract) on the pharmacokinetics of acetaminophen in human volunteers.
Kolawole, JA; Maduenyi, A,
)
0.36
"A preliminary pharmacokinetic study of paracetamol was carried out in Nigerians for whom it is normal to consume paracetamol or its combination during almost any type of symptoms."( Pharmacokinetics and saliva secretion of paracetamol in healthy male Nigerians.
Babalola, CP; Femi-Oyewo, MN; Oladimeji, FA,
)
0.13
"To study the pharmacokinetic and metabolism profiles of a single dose of acetaminophen in patients with cirrhosis."( Pharmacokinetic variations of acetaminophen according to liver dysfunction and portal hypertension status.
Carnicer, F; Esteban, A; Frances, R; Horga, JF; Lasso de la Vega, MC; Palazòn, JM; Pascual, S; Pérez-Mateo, M; Such, J; Zapater, P, 2004
)
0.84
"01) and higher elimination half-life (3."( Pharmacokinetic variations of acetaminophen according to liver dysfunction and portal hypertension status.
Carnicer, F; Esteban, A; Frances, R; Horga, JF; Lasso de la Vega, MC; Palazòn, JM; Pascual, S; Pérez-Mateo, M; Such, J; Zapater, P, 2004
)
0.61
"The chimpanzee (CHP) was evaluated as a pharmacokinetic model for humans (HUMs) using propranolol, verapamil, theophylline, and 12 proprietary compounds."( The chimpanzee (Pan troglodytes) as a pharmacokinetic model for selection of drug candidates: model characterization and application.
Bai, SA; Christ, DD; Diamond, S; Grace, JE; Grossman, SJ; He, K; Qian, M; Wong, H; Wright, MR; Yeleswaram, K, 2004
)
0.32
" The pharmacokinetic parameters were calculated from the semi-logarithmic plots of concentration-time data for PCM."( Alteration of oral salivary pharmacokinetics of paracetamol by an investigational anti-malarial phytomedicine, in healthy human volunteers.
Inyang, U; Mustapha, K; Obodozie, O,
)
0.13
"Surgery, with all its potential influencing factors, together with chemotherapy given about 4 weeks previously do not seem to have a major impact on the pharmacokinetic behavior and the between-subject variability of paracetamol after intravenous administration."( Pharmacokinetics of intravenous paracetamol in children and adolescents under major surgery.
Boos, J; Hempel, G; Koling, S; Pinheiro, PV; Reich, A; Schulze-Westhoff, P; Würthwein, G, 2005
)
0.33
" Serum APAP concentrations (APAPs) were measured hourly from zero through eight hours and again at 24 hours, and basic noncompartmental pharmacokinetic parameters were compared."( Pharmacokinetic effects of diphenhydramine or oxycodone in simulated acetaminophen overdose.
Goklaney, A; Halcomb, SE; Mullins, ME; Sivilotti, ML, 2005
)
0.56
"A population pharmacokinetic analysis of paracetamol time-concentration profiles (846 observations) from 144 children [postconception age (PCA) 27 weeks-14 years] was undertaken using nonlinear mixed effects models (NONMEM)."( Pediatric intravenous paracetamol (propacetamol) pharmacokinetics: a population analysis.
Allegaert, K; Anderson, BJ; Autret-Leca, E; Boccard, E; Pons, G, 2005
)
0.33
" Pharmacokinetic model fits showed that about half of the oral talinolol dose given with and without meal is drained from the intestine via a presystemic storage compartment."( The talinolol double-peak phenomenon is likely caused by presystemic processing after uptake from gut lumen.
Bernsdorf, A; Giessmann, T; Hartmann, V; Modess, C; Mrazek, C; Nagel, S; Siegmund, W; Wegner, D; Weitschies, W; Zschiesche, M, 2005
)
0.33
" Large patient-to-patient variations in pharmacokinetic parameters occurred, although intraindividual variability was limited."( Inter- and intraindividual variabilities in pharmacokinetics of fentanyl after repeated 72-hour transdermal applications in cancer pain patients.
Bressolle, F; Caumette, L; Culine, S; Garcia, F; Pinguet, F; Poujol, S; Solassol, I, 2005
)
0.33
"The mean Cmax of 11."( The pharmacokinetics of a single rectal dose of paracetamol (40 mg x kg(-1)) in children with liver disease.
Addison, R; Ashley, EM; Cormack, CR; Howell, T; Keating, J; Sherwood, RA; Sudan, S, 2006
)
0.33
" Maximal paracetamol concentration (Cmax), time to Cmax (Tmax), area under the curve (AUC) and elimination half-life (t(1/2)) were compared."( Comparative pharmacokinetics of Panadol Extend and immediate-release paracetamol in a simulated overdose model.
Graudins, A; Tan, C, 2006
)
0.33
" Panadol Extend produced lower Cmax (0."( Comparative pharmacokinetics of Panadol Extend and immediate-release paracetamol in a simulated overdose model.
Graudins, A; Tan, C, 2006
)
0.33
"Reductions in Panadol Extend Cmax and AUC(0-12 h) might be related to elimination occurring during the absorption phase."( Comparative pharmacokinetics of Panadol Extend and immediate-release paracetamol in a simulated overdose model.
Graudins, A; Tan, C, 2006
)
0.33
" However, a significantly shorter elimination half-life of PCM was observed in the thalassemic subjects (p<0."( A pharmacokinetic study of paracetamol in Thai beta-thalassemia/HbE patients.
Chantharaksri, U; Fucharoen, P; Fucharoen, S; Howard, TA; Morales, NP; Sanvarinda, Y; Sirankapracha, P; Tankanitlert, J; Temsakulphong, A; Ware, RE, 2006
)
0.33
" Our pharmacokinetic data provide additional evidence that plasma PCM-G is higher in thalassemic patients with hyperbilirubinemia, which could be a casual relationship in regulating the UDP-glucuronosyltransferase expression."( A pharmacokinetic study of paracetamol in Thai beta-thalassemia/HbE patients.
Chantharaksri, U; Fucharoen, P; Fucharoen, S; Howard, TA; Morales, NP; Sanvarinda, Y; Sirankapracha, P; Tankanitlert, J; Temsakulphong, A; Ware, RE, 2006
)
0.33
" The objective of this pharmacokinetic study was to compare the rate of absorption of PS versus P at a 500 mg dose."( A pharmacokinetic study investigating the rate of absorption of a 500 mg dose of a rapidly absorbed paracetamol tablet and a standard paracetamol tablet.
Burnett, I; Grattan, TJ; Ibáñez, Y; Luján, M; Martin, AJ; Rodríguez, JM, 2006
)
0.33
" Pharmacokinetic parameters were measured in salivary samples using a colorimetric method."( Oral ciprofloxacin affects the pharmacokinetics of paracetamol in saliva.
El-Abadla, NS; Issa, MM; Nejem, RM, 2006
)
0.33
"05) and paracetamol half-life was prolonged (1."( Oral ciprofloxacin affects the pharmacokinetics of paracetamol in saliva.
El-Abadla, NS; Issa, MM; Nejem, RM, 2006
)
0.33
" A sigmoid Emax model was used as the pharmacodynamic model."( Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
Aoyama, T; Aoyama, Y; Matsumoto, Y; Ohe, Y; Shinoda, S; Tomioka, S, 2007
)
0.61
" The paracetamol pharmacokinetic profile was assessed in 26 subjects after both the 2-g starting dose and the 1-g doses."( Safety and pharmacokinetics of paracetamol following intravenous administration of 5 g during the first 24 h with a 2-g starting dose.
Dufour, G; Evene, E; Gendron, A; Gregoire, N; Gualano, V; Hovsepian, L, 2007
)
0.34
" Pharmacokinetic parameters were measured in plasma samples using a microbiological assay."( Effects of paracetamol on the pharmacokinetics of ciprofloxacin in plasma using a microbiological assay.
El-Abadla, NS; El-Naby, MK; Issa, MM; Kheiralla, ZA; Nejem, RM; Roshdy, AA, 2007
)
0.34
"No significant differences were found as a result of concomitant administration of paracetamol in the ciprofloxacin pharmacokinetic parameters oral clearance (CL/F) and apparent volume of distribution (Vd/F)."( Effects of paracetamol on the pharmacokinetics of ciprofloxacin in plasma using a microbiological assay.
El-Abadla, NS; El-Naby, MK; Issa, MM; Kheiralla, ZA; Nejem, RM; Roshdy, AA, 2007
)
0.34
" We believe that a pharmacokinetic interaction may have occurred."( Effects of paracetamol on the pharmacokinetics of ciprofloxacin in plasma using a microbiological assay.
El-Abadla, NS; El-Naby, MK; Issa, MM; Kheiralla, ZA; Nejem, RM; Roshdy, AA, 2007
)
0.34
" This pharmacokinetic feature could prove crucial from the therapeutic point of view as it would allow a lower latency in the action time of paracetamol in producing its analgesic and antithermal effect."( Relative bioavailability of new formulation of paracetamol effervescent powder containing sodium bicarbonate versus paracetamol tablets: a comparative pharmacokinetic study in fed subjects.
de los Santos, MC; Di Girolamo, G; Gonzalez, CD; Keller, G; Lopez, MI; Massa, JM; Opezzo, JA; Schere, D, 2007
)
0.34
" These results suggest that rutaecarpine might cause changes in the pharmacokinetic parameters of APAP in rats."( The effects of rutaecarpine on the pharmacokinetics of acetaminophen in rats.
Bista, SR; Jahng, Y; Jeong, H; Jeong, TC; Kang, MJ; Kim, DH; Lee, SK, 2007
)
0.59
" The paracetamol's absorption phase and elimination half-life appeared prolonged, with peak blood concentration occurring at 20 hours post-ingestion, requiring an extended course of intravenous N-acetylcysteine."( Prolonged absorption and delayed peak paracetamol concentration following poisoning with extended-release formulation.
Buckley, NA; Roberts, DM, 2008
)
0.35
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" A population pharmacokinetic analysis of the paracetamol plasma concentration time-profiles was undertaken using nonlinear mixed effects models."( Pharmacokinetics and analgesic effects of intravenous propacetamol vs rectal paracetamol in children after major craniofacial surgery.
Anderson, BJ; Mathot, RA; Prins, SA; Searle, S; Tibboel, D; Van Dijk, M; Van Leeuwen, P, 2008
)
0.35
" Pharmacokinetic parameters were standardized to a 70 kg person using allometric '1/4 power' models."( Pharmacokinetics and analgesic effects of intravenous propacetamol vs rectal paracetamol in children after major craniofacial surgery.
Anderson, BJ; Mathot, RA; Prins, SA; Searle, S; Tibboel, D; Van Dijk, M; Van Leeuwen, P, 2008
)
0.35
" Pharmacokinetic analysis revealed significantly prolonged acetaminophen absorption and a second peak acetaminophen concentration of 228 microg/mL approximately 48 hours postingestion."( Acetaminophen overdose with altered acetaminophen pharmacokinetics and hepatotoxicity associated with premature cessation of intravenous N-acetylcysteine therapy.
Hoffman, RS; Howland, MA; Nelson, LS; Smith, SW, 2008
)
2.03
" As pharmacokinetic studies in this population are hampered by limitations in the number and volume of plasma samples, we developed an LC-MS/MS assay for the simultaneous determination of these medications in small volume human plasma specimens for pharmacokinetic evaluations in neonates."( A tandem mass spectrometry assay for the simultaneous determination of acetaminophen, caffeine, phenytoin, ranitidine, and theophylline in small volume pediatric plasma specimens.
Budha, NR; Christensen, ML; Mehrotra, N; Meibohm, B; Zhang, Y, 2008
)
0.58
" Size is the primary covariate and although lean body weight is argued as a better measure than total body weight, the use of different fractions of fat mass to explain how pharmacokinetic parameters vary with body composition has been proposed."( Mechanistic basis of using body size and maturation to predict clearance in humans.
Anderson, BJ; Holford, NH, 2009
)
0.35
" Finally, this procedure was successfully applied to a pharmacokinetic study."( Two-dimensional liquid chromatography-ion trap mass spectrometry for the simultaneous determination of ketorolac enantiomers and paracetamol in human plasma: application to a pharmacokinetic study.
Besson, M; Daali, Y; Dayer, P; Desmeules, JA; Ing-Lorenzini, KR; Veuthey, JL, 2009
)
0.35
" The following study examined the pharmacokinetic profile and clinical associations of adducts in 53 adults with acute APAP overdose resulting in acute liver failure."( Pharmacokinetics of acetaminophen-protein adducts in adults with acetaminophen overdose and acute liver failure.
Capparelli, E; Davern, TJ; Hinson, JA; James, LP; Lee, WM; Letzig, L; Roberts, DW; Simpson, PM, 2009
)
0.68
" Various pharmacokinetic parameters were calculated by non compartmental model."( Pharmacokinetic-interaction of Vitex negundo Linn. & paracetamol.
Mishra, B; Nagwani, S; Tiwari, OP; Tripathi, YB, 2009
)
0.35
"No clinically relevant changes were noted in the serum concentrations of tapentadol, and accordingly, no dosage adjustments with respect to the investigated pharmacokinetic mechanism of interaction are warranted for the administration of tapentadol given concomitantly with acetaminophen, naproxen, or acetylsalicylic acid."( Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: results of two randomized, open-label, crossover, drug-drug interaction studies.
Mangold, B; Oh, C; Ravenstijn, PG; Rengelshausen, J; Smit, JW; Terlinden, R; Upmalis, D; Wang, SS, 2010
)
0.93
"Overall, pharmacokinetic data were roughly comparable with earlier publications, but differences were noted in the subgroup ICU patients."( Paracetamol for intravenous use in medium--and intensive care patients: pharmacokinetics and tolerance.
Brüggemann, RJ; de Maat, MM; Ponssen, HH; Tijssen, TA, 2010
)
0.36
" Alterations in these pharmacokinetic principles have been rarely reported."( Bactrian ("double hump") acetaminophen pharmacokinetics: a case series and review of the literature.
Burke, CR; Hendrickson, RG; McKeown, NJ; West, PL, 2010
)
0.66
" Reported here are the results of two studies on the pharmacokinetic properties of a novel ibuprofen (200 mg) and paracetamol (500 mg) fixed-dose combination tablet."( The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol.
Aspley, S; Munn, A; Tanner, T; Thomas, T, 2010
)
0.36
"Administration of ibuprofen and paracetamol in a fixed-dose combination tablet does not significantly alter the pharmacokinetic profiles of either drug, except for enhancing the rate of paracetamol absorption, offering potential therapeutic benefits in relation to the onset of analgesia."( The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol.
Aspley, S; Munn, A; Tanner, T; Thomas, T, 2010
)
0.36
" Finger-prick and venous blood samples will result in equivalent pharmacokinetic parameters of oral paracetamol only after distribution equilibrium is attained."( Can finger-prick sampling replace venous sampling to determine the pharmacokinetic profile of oral paracetamol?
Cameron, GA; Cameron, L; Hawksworth, GH; Helms, PJ; McLay, JS; Mohammed, BS, 2010
)
0.36
" Serum specimens of rats in each group were obtained at different time points to determine the concentrations of Paracetamol by RP-HPLC after oral administration of Paracetamol at different dosage, and the pharmacokinetic parameters were calculated by software 3P87, so as to observe the influence of electroacupuncture on absorption and metabolism of Paracetamol."( [Effects of electroacupuncture at "Zusanli" (ST 36) on Pharmacokinetics of paracetamol in rates].
Chen, SH; Meng, GY; Wang, LP; Yan, M; Yang, B, 2010
)
0.36
"To develop a semi-mechanistic population pharmacokinetic model based on gastric emptying function for acetaminophen plasma concentration in critically ill patients tolerant and intolerant to enteral nutrition before and after prokinetic therapy."( A semi-mechanistic gastric emptying model for the population pharmacokinetic analysis of orally administered acetaminophen in critically ill patients.
Aarons, L; Dukes, G; Maclaren, R; Ogungbenro, K; Vasist, L; Young, M, 2011
)
0.8
" Population pharmacokinetic modelling was carried out in a nonlinear mixed effects analysis software, NONMEM."( A semi-mechanistic gastric emptying model for the population pharmacokinetic analysis of orally administered acetaminophen in critically ill patients.
Aarons, L; Dukes, G; Maclaren, R; Ogungbenro, K; Vasist, L; Young, M, 2011
)
0.58
"The four-compartment semi-mechanistic population pharmacokinetic model adequately described the data."( A semi-mechanistic gastric emptying model for the population pharmacokinetic analysis of orally administered acetaminophen in critically ill patients.
Aarons, L; Dukes, G; Maclaren, R; Ogungbenro, K; Vasist, L; Young, M, 2011
)
0.58
"The method was successfully applied to the pharmacokinetic study of chiisanogenin in rat after oral administration of chiisanogenin and the extract of Acanthopanax sessiliflorus fruits."( Determination and pharmacokinetic study of chiisanogenin in rat plasma by ultra performance liquid chromatography-tandem mass spectrometry.
Li, F; Qin, F; Song, Y; Yang, C; Yu, K,
)
0.13
" Microdosing of (14)C-labeled drug followed by AMS is a powerful tool that can be used in the early phase of drug development for pharmacokinetic analysis of drugs and their metabolites and for detecting the formation of active metabolites in humans."( Microdose study of 14C-acetaminophen with accelerator mass spectrometry to examine pharmacokinetics of parent drug and metabolites in healthy subjects.
Hamabe, Y; Ikeda, T; Ikushima, I; Kusuhara, H; Nozawa, K; Sugiyama, Y; Tozuka, Z, 2010
)
0.67
" Peak plasma concentration (Cmax), AUC((0-∞),) time to peak concentration (Tmax) and elimination half-life (t(1/2) ) were compared."( The comparative pharmacokinetics of modified-release and immediate-release paracetamol in a simulated overdose model.
Chiew, A; Day, P; Graudins, A; Naidoo, D; Salonikas, C; Thomas, R, 2010
)
0.36
"PEx exhibited significantly lower paracetamol Cmax (252."( The comparative pharmacokinetics of modified-release and immediate-release paracetamol in a simulated overdose model.
Chiew, A; Day, P; Graudins, A; Naidoo, D; Salonikas, C; Thomas, R, 2010
)
0.36
" Pharmacokinetic analysis of ICG demonstrated that the total body clearance (Cl(T)) of ICG was significantly decreased and the mean residence time (MRT) was significantly increased in the APAP mice compared to the saline mice."( Indocyanine green clearance varies as a function of N-acetylcysteine treatment in a murine model of acetaminophen toxicity.
Abdel-Rahman, SM; Brown, A; Hinson, JA; James, LP; Letzig, L; McCullough, SS; Milesi-Hallé, A, 2011
)
0.59
" The pharmacokinetics of paracetamol and imatinib in Korean patients with CML were similar to previous pharmacokinetic results in white patients with CML."( Effects of imatinib mesylate on the pharmacokinetics of paracetamol (acetaminophen) in Korean patients with chronic myelogenous leukaemia.
Demirhan, E; Hayes, M; Jin, Y; Kim, DW; Park, S; Schran, H; Tan, EY; Wang, Y, 2011
)
0.6
" Paracetamol clearance showed a statistically significant dependence on age group, whereas volume of distribution during elimination and elimination half-life were associated with age group and sex, respectively."( Pharmacokinetics of intravenous paracetamol in elderly patients.
Aantaa, R; Kuusniemi, K; Liukas, A; Neuvonen, PJ; Niemi, M; Olkkola, KT; Virolainen, P, 2011
)
0.37
"To assess the disintegration and dissolution of a new fast-dissolving acetaminophen tablet formulation (FD-APAP) and the impact on pharmacokinetic and pharmacodynamic parameters."( Comparison of a novel fast-dissolving acetaminophen tablet formulation (FD-APAP) and standard acetaminophen tablets using gamma scintigraphy and pharmacokinetic studies.
Clarke, CP; Clarke, GD; Starkey, YY; Wilson, CG, 2011
)
0.87
"A population pharmacokinetic analysis of 943 paracetamol observations from 158 neonates (27-45 weeks' postmenstrual age (PMA)) was undertaken using non-linear mixed effects models."( The pharmacokinetics of intravenous paracetamol in neonates: size matters most.
Allegaert, K; Anderson, BJ; Palmer, GM, 2011
)
0.37
" This study aimed to investigate the feasibility of population pharmacokinetic modeling to quantify the rate of gastric emptying (GE) and small intestinal transit time (SITT) in response to drugs that affect GI motility in fed and fasted dogs."( Using pharmacokinetic modeling to determine the effect of drug and food on gastrointestinal transit in dogs.
Al-Saffar, A; Sjödin, L; Visser, S,
)
0.13
" Population pharmacokinetic analysis of paracetamol and sulfapyridine in plasma was used to determine the rate of GE and SITT."( Using pharmacokinetic modeling to determine the effect of drug and food on gastrointestinal transit in dogs.
Al-Saffar, A; Sjödin, L; Visser, S,
)
0.13
"Population pharmacokinetic modeling of paracetamol and sulfapyridine provides a suitable preclinical non-invasive experimental method for quantification of drug- and food-induced changes in the rate of GE and SITT in conscious beagle dogs for use in safety evaluations to predict changes in GI transit and/or to explain the pharmacokinetic profile of drugs under development."( Using pharmacokinetic modeling to determine the effect of drug and food on gastrointestinal transit in dogs.
Al-Saffar, A; Sjödin, L; Visser, S,
)
0.13
"The aim of this study was to explore the pharmacokinetic profiles of the new ER tramadol/acetaminophen fixed-dose combination and compare them with those of a conventional immediate-release (IR) formulation after multiple dosing as a Phase I clinical exploratory trial."( Pharmacokinetics of extended-release versus conventional tramadol/acetaminophen fixed-dose combination tablets: an open-label, 2-treatment, multiple-dose, randomized-sequence crossover study in healthy korean male volunteers.
Cho, JY; Chung, YJ; Jang, IJ; Kim, TE; Shin, HS; Shin, SG; Yi, S; Yoon, SH; Yu, KS, 2011
)
0.83
" Tramadol and acetaminophen concentrations in plasma were determined simultaneously using LC-MS/MS, and the pharmacokinetic properties were analyzed by noncompartmental method."( Pharmacokinetics of extended-release versus conventional tramadol/acetaminophen fixed-dose combination tablets: an open-label, 2-treatment, multiple-dose, randomized-sequence crossover study in healthy korean male volunteers.
Cho, JY; Chung, YJ; Jang, IJ; Kim, TE; Shin, HS; Shin, SG; Yi, S; Yoon, SH; Yu, KS, 2011
)
0.97
" The pharmacokinetic parameters of allindicated active components exhibited no detectable distinctions, except for the time to attaining maximum concentration ofparacetamol and the value of the maximum concentration of loratadine."( [Comparative pharmacokinetics of antigrippin-maximum administered in capsules and powder for preparing solutions].
Belolipetskaia, VG; Belolipetskiĭ, NA; Blagodatskikh, SV; Guranda, DF; Kibalchich, DA; Rudenko, LI; Zhabina, EA, 2011
)
0.37
" However, we have to be aware that such dosing suggestions are - at present - without any validated pharmacodynamic correlates since the applicability of a fixed acetaminophen target concentration (10 mg·l(-1)) in neonates of different subpopulations remains to be documented."( Pharmacokinetics and pharmacodynamics of intravenous acetaminophen in neonates.
Allegaert, K; van den Anker, J, 2011
)
0.81
"A sensitive and selective liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of salbutamol in human plasma and urine, and successfully applied to the pharmacokinetic study of salbutamol in Chinese healthy volunteers after inhalation of salbutamol sulfate aerosol."( Determination of salbutamol in human plasma and urine using liquid chromatography coupled to tandem mass spectrometry and its pharmacokinetic study.
Chen, K; Guo, R; Liu, S; Liu, X; Teng, Y; Wang, B; Wei, C; Yuan, G; Zhang, D; Zhang, R, 2012
)
0.38
" Commonly used approaches are physiologically-based pharmacokinetic modeling (PBPK) and allometric scaling (AS) in combination with maturation of clearance for early life."( First dose in children: physiological insights into pharmacokinetic scaling approaches and their implications in paediatric drug development.
Danhof, M; Eissing, T; Freijer, J; Strougo, A; Willmann, S; Yassen, A, 2012
)
0.38
"Gastrectomy leads to pathophysiological changes within the alimentary tract, which may affect drug absorption and pharmacokinetic parameters (PK)."( Comparison of the pharmacokinetics of paracetamol from two generic products in patients after total gastric resection.
Grabowski, T; Grześkowiak, E; Kamińska, A; Kokot, ZJ; Murawa, D; Murawa, P; Połom, K; Sobiech, M; Szałek, E; Urbaniak, B; Wolc, A, 2011
)
0.37
"A pharmacokinetic model was developed for PG co-administered with paracetamol or phenobarbital in neonates."( Developmental pharmacokinetics of propylene glycol in preterm and term neonates.
Allegaert, K; Danhof, M; De Cock, RF; de Hoon, J; Knibbe, CA; Kulo, A; Verbesselt, R, 2013
)
0.39
" The physiologically based pharmacokinetic modeling approach is important, as it allowed the prediction of human brain ECF exposure on the basis of human CSF concentrations."( Physiologically based pharmacokinetic modeling to investigate regional brain distribution kinetics in rats.
Danhof, M; de Lange, EC; Ploeger, B; Smeets, J; Westerhout, J, 2012
)
0.38
" This suggests that postpartum is another specific status in young women that merits focused, compound-specific pharmacokinetic evaluation."( The impact of Caesarean delivery on paracetamol and ketorolac pharmacokinetics: a paired analysis.
Allegaert, K; de Hoon, J; Devlieger, R; Kulo, A; Smits, A; van Calsteren, K; Verbesselt, R, 2012
)
0.38
" The aim of this study was to determine whether a commercially available curcuminoid/piperine extract alters the pharmacokinetic disposition of probe drugs for these enzymes in human volunteers."( Effect of a herbal extract containing curcumin and piperine on midazolam, flurbiprofen and paracetamol (acetaminophen) pharmacokinetics in healthy volunteers.
Badmaev, V; Court, MH; Greenblatt, DJ; Hanley, MJ; Harmatz, JS; Hazarika, S; Majeed, M; Masse, G; Volak, LP, 2013
)
0.6
" A non-compartment model estimated the pharmacokinetic parameters of APAP and its metabolites, and the ratios of the area under curve (AUC; AUC(metabolite) /AUC(APAP) ) were also observed to evaluate the change of APAP metabolism."( Evaluation of pharmacokinetic differences of acetaminophen in pseudo germ-free rats.
An, JH; Jung, BH; Lee, HJ; Lee, SH, 2012
)
0.64
" Individual pharmacokinetic profiles were calculated assuming a linear one-compartment model with instantaneous input, first-order output."( The pharmacokinetics of a high intravenous dose of paracetamol after caesarean delivery: the effect of gestational age.
Allegaert, K; de Hoon, J; Deprest, J; Devlieger, R; Hopchet, L; Kulo, A; van de Velde, M; Verbesselt, R, 2012
)
0.38
"037], resulting in the absence of differences in median elimination half-life [112 (28) vs."( The pharmacokinetics of a high intravenous dose of paracetamol after caesarean delivery: the effect of gestational age.
Allegaert, K; de Hoon, J; Deprest, J; Devlieger, R; Hopchet, L; Kulo, A; van de Velde, M; Verbesselt, R, 2012
)
0.38
" These pharmacokinetic differences illustrate the relevance of performing pharmacokinetic studies at delivery."( The pharmacokinetics of a high intravenous dose of paracetamol after caesarean delivery: the effect of gestational age.
Allegaert, K; de Hoon, J; Deprest, J; Devlieger, R; Hopchet, L; Kulo, A; van de Velde, M; Verbesselt, R, 2012
)
0.38
" The mean hydrocodone CMAX was 11."( Pharmacokinetics of hydrocodone and hydromorphone after oral hydrocodone in healthy Greyhound dogs.
KuKanich, B; Spade, J, 2013
)
0.39
" Pharmacokinetic parameters were analysed using non-compartmental methods."( Effects of etravirine on the pharmacokinetics and pharmacodynamics of warfarin in rats.
Abobo, CV; Hsiao, C; John, J; John, M; Liang, D; Wu, L, 2013
)
0.39
" Despite these differences, even commonly administered drugs have not undergone pharmacokinetic evaluation in pregnant women or at delivery."( Paracetamol and ketorolac pharmacokinetics and metabolism at delivery and during postpartum.
Allegaert, K; Hendrickx, S; Kelchtermans, J; Kulo, A; Smits, A; van Calsteren, K; van de Velde, M, 2012
)
0.38
" The pharmacokinetic changes described may decrease susceptibility to acetaminophen-induced hepatotoxicity but may increase risk of nephrotoxicity in old age."( The effect of aging on acetaminophen pharmacokinetics, toxicity and Nrf2 in Fischer 344 rats.
Cogger, VC; de Cabo, R; Hilmer, SN; Huizer-Pajkos, A; Jones, BE; Le Couteur, DG; Mach, J; McKenzie, C, 2014
)
0.95
" The present study was to investigate the effects of giving N-acetylcysteine (NAC) alone and in combination with either glycyrrhizin (GL), silibinin (SIB) or spironolactone (SL) on the plasma pharmacokinetic (PK) profiles, hepatic exposure, biliary excretion and urinary excretion of acetaminophen (APAP) and its major metabolite, acetaminophen glucuronide (AG)."( Changes in pharmacokinetic profiles of acetaminophen and its glucuronide after pretreatment with combinations of N-acetylcysteine and either glycyrrhizin, silibinin or spironolactone in rat.
Liu, X; Wang, Q; Xu, R; Yang, J; Zang, M; Zhang, J, 2014
)
0.85
" The aim of this work was to develop and validate a new sensitive and reproducible isocratic reversed phase HPLC-UV detection method for simultaneous determination of MET and PAR in human plasma for the routine use in a therapeutic drug monitoring and pharmacokinetic laboratories."( Simultaneous determination of paracetamol and methocarbamol in human plasma By HPLC using UV detection with time programming: application to pharmacokinetic study.
El-Bedaiwy, HM; Helmy, SA, 2014
)
0.4
"In order to characterize the variation in pharmacokinetics of paracetamol across the human age span, we performed a population pharmacokinetic analysis from preterm neonates to adults with specific focus on clearance."( Population pharmacokinetics of paracetamol across the human age-range from (pre)term neonates, infants, children to adults.
Allegaert, K; Danhof, M; Knibbe, CA; Mathot, RA; Tibboel, D; van der Marel, CD; Wang, C, 2014
)
0.4
"04) and Cmax from 18."( Effects of iron on the pharmacokinetics of paracetamol in saliva.
Issa, MM; Nejem, RM; Shanab, AA, 2013
)
0.39
"In the present study, the pharmacokinetic and drug interaction evaluation of two drugs pefloxacin and paracetamol was carried out by a single-dose, two-treatment and two-sequence crossover design."( Report: pharmacokinetic and drug interaction studies of pefloxacin with paracetamol (NNAID) in healthy volunteers in Pakistan.
Ali, SA; Gauhar, S; Naqvi, SB; Shoaib, MH, 2014
)
0.4
" However, pharmacokinetic data from prolonged administration of intravenous paracetamol in neonates are limited."( Multiple intravenous doses of paracetamol result in a predictable pharmacokinetic profile in very preterm infants.
Anand, KJ; Andriessen, P; Derijks, L; Kramer, BW; Neef, C; van Ganzewinkel, C; van Lingen, RA, 2014
)
0.4
"A two-compartment pharmacokinetic model gave the best fit for all individual patients and resulted in a predictable pharmacokinetic profile."( Multiple intravenous doses of paracetamol result in a predictable pharmacokinetic profile in very preterm infants.
Anand, KJ; Andriessen, P; Derijks, L; Kramer, BW; Neef, C; van Ganzewinkel, C; van Lingen, RA, 2014
)
0.4
"Our study found that multiple doses of intravenous paracetamol resulted in a predictable pharmacokinetic profile in very preterm infants."( Multiple intravenous doses of paracetamol result in a predictable pharmacokinetic profile in very preterm infants.
Anand, KJ; Andriessen, P; Derijks, L; Kramer, BW; Neef, C; van Ganzewinkel, C; van Lingen, RA, 2014
)
0.4
" A model based on pharmacokinetic parameters was developed to predict 4-h acetaminophen concentration for this and other ingested doses."( Four-hour acetaminophen concentration estimation after ingested dose based on pharmacokinetic models.
Gosselin, S; Villeneuve, E; Whyte, I, 2014
)
1.04
"A pharmacokinetic crossover study using different dosage forms of paracetamol (intravenous and oral solution, capsule and tablet) was conducted in four male and four female Göttingen minipigs after an overnight fast."( Pharmacokinetics of paracetamol in Göttingen minipigs: in vivo studies and modeling to elucidate physiological determinants of absorption.
Flament, C; Grimm, HP; Lorentsen, H; Parrott, N; Suenderhauf, C; Tuffin, G, 2014
)
0.4
" The aims of this study were to determine the population pharmacokinetic profile of intravenous acetaminophen and its metabolites in adult surgical patients and to identify patient characteristics associated with acetaminophen metabolism in the postoperative period."( Population pharmacokinetics of intravenous acetaminophen and its metabolites in major surgical patients.
Curran, N; Kennedy, J; Medlicott, NJ; Murphy, PG; Owens, KH; Reith, DM; Sreebhavan, S; Thompson-Fawcett, M; Zacharias, M, 2014
)
0.88
" Despite this approval, pediatric pharmacokinetic data using this product have not been previously published."( Pharmacokinetics of hydrocodone/acetaminophen combination product in children ages 6-17 with moderate to moderately severe postoperative pain.
Awni, W; Dutta, S; Kearns, G; Liu, W; Neville, KA, 2015
)
0.7
" A population pharmacokinetic-pharmacodynamic model describing the pharmacodynamic effects of paracetamol and NAC on the INR was developed in Phoenix NLME."( Population pharmacokinetic-pharmacodynamic modelling to describe the effects of paracetamol and N-acetylcysteine on the international normalized ratio.
Buckley, NA; Medlicott, NJ; Owens, KH; Reith, DM; Whyte, IM; Zacharias, M, 2015
)
0.42
" The present study was intended to understand the pharmacodynamic interaction between paracetamol and ondansetron in postoperative patients."( Randomized, double-blind, placebo-controlled study to investigate the pharmacodynamic interaction of 5-HT3 antagonist ondansetron and paracetamol in postoperative patients operated in an ENT department under local anesthesia.
Bhosale, UA; Kale, J; Khobragade, R; Naik, C; Yegnanarayan, R, 2015
)
0.42
"The pharmacodynamic interaction between paracetamol and ondansetron coadministration does not block but instead increase paracetamol analgesia, reduce the postoperative analgesic requirement, and improve the postoperative comfort level."( Randomized, double-blind, placebo-controlled study to investigate the pharmacodynamic interaction of 5-HT3 antagonist ondansetron and paracetamol in postoperative patients operated in an ENT department under local anesthesia.
Bhosale, UA; Kale, J; Khobragade, R; Naik, C; Yegnanarayan, R, 2015
)
0.42
" In order to assess covariate effects of intravenous paracetamol disposition in adults, pharmacokinetic data on discrete studies were pooled."( Covariates of intravenous paracetamol pharmacokinetics in adults.
Allegaert, K; Anderson, BJ; de Maat, MM; Olkkola, KT; Owens, KH; Van de Velde, M, 2014
)
0.4
" This study evaluated the pharmacokinetics of three hydrocodone ER tablet prototypes with varying levels of polymer coating to identify the prototype expected to have the greatest abuse deterrence potential based on pharmacokinetic characteristics that maintain systemic exposure to hydrocodone comparable to that of a commercially available hydrocodone immediate-release (IR) product."( Pharmacokinetics of hydrocodone extended-release tablets formulated with different levels of coating to achieve abuse deterrence compared with a hydrocodone immediate-release/acetaminophen tablet in healthy subjects.
Bond, M; Darwish, M; Robertson, P; Tracewell, W; Yang, R, 2015
)
0.61
" Blood samples for pharmacokinetic assessments were collected predose and through 72 h postdose."( Pharmacokinetics of hydrocodone extended-release tablets formulated with different levels of coating to achieve abuse deterrence compared with a hydrocodone immediate-release/acetaminophen tablet in healthy subjects.
Bond, M; Darwish, M; Robertson, P; Tracewell, W; Yang, R, 2015
)
0.61
"All three hydrocodone ER tablet prototypes (low-, intermediate-, and high-level polymer coating) demonstrated ER pharmacokinetic characteristics."( Pharmacokinetics of hydrocodone extended-release tablets formulated with different levels of coating to achieve abuse deterrence compared with a hydrocodone immediate-release/acetaminophen tablet in healthy subjects.
Bond, M; Darwish, M; Robertson, P; Tracewell, W; Yang, R, 2015
)
0.61
" In the presence of levodopa, gastric emptying is interrupted at times associated with double-peaks in pharmacokinetic profiles."( Empirical and semi-mechanistic modelling of double-peaked pharmacokinetic profile phenomenon due to gastric emptying.
Aarons, L; Ogungbenro, K; Pertinez, H, 2015
)
0.42
" We aimed to investigate pharmacokinetic interactions between acetaminophen and phenylephrine."( Increased bioavailability of phenylephrine by co-administration of acetaminophen: results of four open-label, crossover pharmacokinetic trials in healthy volunteers.
Anderson, BJ; Atkinson, HC; Potts, AL; Salem, II; Stanescu, I, 2015
)
0.89
" This research aimed to evaluate bioavailability and compare pharmacokinetic (PK) properties of the new SR paracetamol formulation (2x1,000 mg) with those of immediate-release (IR) paracetamol (2x500 mg) and existing extended-release (ER) paracetamol (2x665 mg)."( Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation.
Collaku, A; Liu, DJ; Youngberg, SP, 2015
)
0.42
" Food significantly increased Cmax of SR formulation, with ratios fast vs."( Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation.
Collaku, A; Liu, DJ; Youngberg, SP, 2015
)
0.42
" This study aimed to evaluate the pharmacokinetic profiles of an SR 75-mg tramadol/650-mg acetaminophen formulation after a single dose compared with an immediate release (IR) 37."( An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects.
Chae, SW; Im, YJ; Jeon, JY; Kim, EY; Kim, MG; Kim, Y; Oh, DJ; Shin, DH; Yoo, JS, 2015
)
0.86
"Two clinical trials were conducted: (1) an open-label, randomized, 3-period, 3-treatment, crossover study to assess the pharmacokinetic SR (one 75-mg tramadol/650-mg acetaminophen combination tablet) formulation profiles after a single dose and IR (one 37."( An assessment of the pharmacokinetics of a sustained-release formulation of a tramadol/acetaminophen combination in healthy subjects.
Chae, SW; Im, YJ; Jeon, JY; Kim, EY; Kim, MG; Kim, Y; Oh, DJ; Shin, DH; Yoo, JS, 2015
)
0.83
" [(14)C]-PARA pharmacokinetic parameters were within a two-fold range after a therapeutic dose or a microdose."( Observational infant exploratory [(14)C]-paracetamol pharmacokinetic microdose/therapeutic dose study with accelerator mass spectrometry bioanalysis.
Byrne, L; Crawley, FP; deLigt, R; Earnshaw, C; French, NS; Garner, CR; Grynkiewicz, G; Lass, J; Maruszak, W; Park, KB; Schipani, A; Selby, AM; Siner, S; Turner, MA; Vaes, WH; van Duijn, E; Varendi, H, 2015
)
0.42
"The principal aim of this study was to develop, validate, and demonstrate a physiologically based pharmacokinetic (PBPK) model to predict and characterize the absorption, distribution, metabolism, and excretion of acetaminophen (APAP) in humans."( Physiologically based modeling of the pharmacokinetics of acetaminophen and its major metabolites in humans using a Bayesian population approach.
Reisfeld, B; Zurlinden, TJ, 2016
)
0.86
"The geometric mean ratio and 90% confidence interval of Cmax and AUC of acetaminophen were within 80-125% suggesting that the rate ad extent of acetaminophen were not affected when given at various time points with respect to pradigastat/meal timing."( Assessment of pharmacokinetic drug-drug interaction between pradigastat and acetaminophen in healthy subjects.
Ayalasomayajula, S; Chen, J; Koo, P; Majumdar, T; Meyers, D; Rebello, S; Salunke, A; Sunkara, G, 2015
)
0.88
" However, when given 1 h after a meal, the Tmax of acetaminophen was delayed by ∼1."( Assessment of pharmacokinetic drug-drug interaction between pradigastat and acetaminophen in healthy subjects.
Ayalasomayajula, S; Chen, J; Koo, P; Majumdar, T; Meyers, D; Rebello, S; Salunke, A; Sunkara, G, 2015
)
0.9
" This review sought evidence from single dose pharmacokinetic studies on the extent and timing of peak plasma concentrations of analgesic drugs in the fed and fasting states."( Effects of food on pharmacokinetics of immediate release oral formulations of aspirin, dipyrone, paracetamol and NSAIDs - a systematic review.
Derry, S; Moore, RA; Straube, S; Wiffen, PJ, 2015
)
0.42
" Food typically delayed absorption for all drugs where the fasting tmax was less than 4 h."( Effects of food on pharmacokinetics of immediate release oral formulations of aspirin, dipyrone, paracetamol and NSAIDs - a systematic review.
Derry, S; Moore, RA; Straube, S; Wiffen, PJ, 2015
)
0.42
" The present study evaluated the possiblility of a pharmacokinetic interaction between favipiravir and acetaminophen, in vitro and in vivo."( Favipiravir inhibits acetaminophen sulfate formation but minimally affects systemic pharmacokinetics of acetaminophen.
Court, MH; Epstein, CR; Giesing, D; Greenblatt, DJ; Harmatz, JS; Kadota, T; Kurosaki, C; Nakagawa, Y; Nakamura, T; Zhao, Y, 2015
)
0.95
" In human volunteers, both acute (1 day) and extended (6 days) administration of favipiravir slightly but significantly increased (by about 20 %) systemic exposure to acetaminophen (total AUC), whereas Cmax was not significantly changed."( Favipiravir inhibits acetaminophen sulfate formation but minimally affects systemic pharmacokinetics of acetaminophen.
Court, MH; Epstein, CR; Giesing, D; Greenblatt, DJ; Harmatz, JS; Kadota, T; Kurosaki, C; Nakagawa, Y; Nakamura, T; Zhao, Y, 2015
)
0.93
" The developed and validated method was successfully applied to a pharmacokinetic study of AAP (500mg) with DHC (20mg) capsule in Chinese healthy volunteers (N=20)."( Simultaneous determination of acetaminophen and dihydrocodeine in human plasma by UPLC-MS/MS: Its pharmacokinetic application.
Gao, P; Liu, Z; Lou, D; Qiu, X; Su, D; Zhang, NS, 2015
)
0.71
" The mean absorption time and absorption half-life were unexpectedly short (4."( Oral pharmacokinetics of acetaminophen to evaluate gastric emptying profiles of Shiba goats.
Aboubakr, M; Elbadawy, M; Khalil, WF; Miyazaki, Y; Sasaki, K; Shimoda, M, 2015
)
0.72
" Published pharmacokinetic data of acetaminophen in subjects with normal gastric emptying vs."( Acetaminophen absorption kinetics in altered gastric emptying: establishing a relevant pharmacokinetic surrogate using published data.
Srinivas, NR, 2015
)
2.14
"The aims of this study were to develop a population pharmacokinetic model for intravenous paracetamol in preterm and term neonates and to assess the generalizability of the model by testing its predictive performance in an external dataset."( Population Pharmacokinetics of Intravenous Paracetamol (Acetaminophen) in Preterm and Term Neonates: Model Development and External Evaluation.
Allegaert, K; Cook, SF; Deutsch, N; King, AD; Roberts, JK; Samiee-Zafarghandy, S; Sherwin, CM; Stockmann, C; van den Anker, JN; Wilkins, DG; Williams, EF, 2016
)
0.68
" Blood samples were collected for pharmacokinetic analysis of study drugs and their metabolites over an 8-hour period beginning after the second dose of the study medication."( Pharmacokinetics of hydrocodone and tramadol administered for control of postoperative pain in dogs following tibial plateau leveling osteotomy.
Benitez, ME; KuKanich, B; McMurphy, R; Roush, JK, 2015
)
0.42
" The terminal half-life for hydrocodone was 15."( Pharmacokinetics of hydrocodone and tramadol administered for control of postoperative pain in dogs following tibial plateau leveling osteotomy.
Benitez, ME; KuKanich, B; McMurphy, R; Roush, JK, 2015
)
0.42
"Previously published studies have suggested the lack of a pharmacokinetic interaction between ibuprofen and paracetamol when they are delivered as a fixed-dose oral combination."( Pharmacokinetics and Bioavailability of a Fixed-Dose Combination of Ibuprofen and Paracetamol after Intravenous and Oral Administration.
Atkinson, HC; Beasley, CP; Frampton, C; Robson, R; Salem, II; Stanescu, I, 2015
)
0.42
"A single-dose, open-label, randomized, five-period cross-over sequence pharmacokinetic study was undertaken in 30 healthy volunteers."( Pharmacokinetics and Bioavailability of a Fixed-Dose Combination of Ibuprofen and Paracetamol after Intravenous and Oral Administration.
Atkinson, HC; Beasley, CP; Frampton, C; Robson, R; Salem, II; Stanescu, I, 2015
)
0.42
"The pharmacokinetic parameters of ibuprofen and paracetamol were very similar for the combination and monotherapy IV preparations; the ratios of the C max, AUC t and AUC∞ values fell within the 80-125% acceptable bioequivalence range."( Pharmacokinetics and Bioavailability of a Fixed-Dose Combination of Ibuprofen and Paracetamol after Intravenous and Oral Administration.
Atkinson, HC; Beasley, CP; Frampton, C; Robson, R; Salem, II; Stanescu, I, 2015
)
0.42
"Concomitant administration of 3 mg/mL ibuprofen and 10 mg/mL paracetamol in a fixed-dose IV combination does not alter the pharmacokinetic profiles of either drug."( Pharmacokinetics and Bioavailability of a Fixed-Dose Combination of Ibuprofen and Paracetamol after Intravenous and Oral Administration.
Atkinson, HC; Beasley, CP; Frampton, C; Robson, R; Salem, II; Stanescu, I, 2015
)
0.42
" Although antidote, acetylcysteine, is potentially extracted by renal replacement therapies, pharmacokinetic data are lacking to guide potential dosing alterations."( The pharmacokinetics and extracorporeal removal of N-acetylcysteine during renal replacement therapies.
Hernandez, SH; Hoffman, RS; Howland, M; Schiano, TD, 2015
)
0.42
" Alterations in pharmacokinetics were determined by applying standard pharmacokinetic equations."( The pharmacokinetics and extracorporeal removal of N-acetylcysteine during renal replacement therapies.
Hernandez, SH; Hoffman, RS; Howland, M; Schiano, TD, 2015
)
0.42
" In this pooled study, we focused on the population pharmacokinetic profile of intravenous paracetamol metabolism and its covariates in young women."( Paracetamol pharmacokinetics and metabolism in young women.
Allegaert, K; Beleyn, B; de Hoon, J; Deprest, J; Knibbe, CA; Kulo, A; Peeters, MY; Smits, A; van Calsteren, K, 2015
)
0.42
" In both studies, a high-fat meal did not affect the Cmax for hydrocodone."( Single-dose pharmacokinetics of 2 or 3 tablets of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) under fed and fasted conditions: two randomized open-label trials.
Devarakonda, K; Giuliani, MJ; Kostenbader, K; Young, JL, 2015
)
0.63
" Because there are some data about the impact of aniseed EO on drug effects, this survey aimed to assess the potential of pharmacokinetic herb-drug interaction between aniseed EO and acetaminophen and caffeine in mice."( Pharmacokinetic Herb-Drug Interaction between Essential Oil of Aniseed (Pimpinella anisum L., Apiaceae) and Acetaminophen and Caffeine: A Potential Risk for Clinical Practice.
Božin, B; Mijatović, V; Petković, S; Samojlik, I; Stilinović, N; Vukmirović, S, 2016
)
0.84
" Parental education material in the form of weight-based dosing guides has been proposed; however, validation of current recommended APAP dosages using pharmacokinetic models is needed."( Are Recommended Doses of Acetaminophen Effective for Children Aged 2 to 3 Years? A Pharmacokinetic Modeling Answer.
Abourbih, DA; Gosselin, S; Kazim, S; Villeneuve, E, 2016
)
0.74
"The purpose of this study was to determine the pharmacokinetic and antinociceptive effects of an acetaminophen/codeine combination administered orally to six healthy greyhounds."( Pharmacokinetics and pharmacodynamics of oral acetaminophen in combination with codeine in healthy Greyhound dogs.
KuKanich, B, 2016
)
0.91
" Comparing pharmacokinetic data with MRI data it was observed that maximal blood levels occurred before the solvent and the dispersion agent were removed from the muscle tissue."( Simultaneous magnetic resonance imaging and pharmacokinetic analysis of intramuscular depots.
Evert, K; Hadlich, S; Kühn, JP; Oswald, S; Probst, M; Scheuch, E; Seidlitz, A; Siegmund, W; Weitschies, W, 2016
)
0.43
" The objective of this research was to develop subpopulation-specific physiologically based pharmacokinetic (PBPK) models for two genetically different groups (Western Europeans and East Asians) and then use the models to quantify the difference in absorption, distribution, metabolism, and excretion (ADME) of APAP between these groups."( Characterizing the Effects of Race/Ethnicity on Acetaminophen Pharmacokinetics Using Physiologically Based Pharmacokinetic Modeling.
Reisfeld, B; Zurlinden, TJ, 2017
)
0.71
"A comprehensive set of human pharmacokinetic data mined from the literature was divided into two groups based on ethnicity as an indicator of the expected abundance of phenol-metabolizing alleles."( Characterizing the Effects of Race/Ethnicity on Acetaminophen Pharmacokinetics Using Physiologically Based Pharmacokinetic Modeling.
Reisfeld, B; Zurlinden, TJ, 2017
)
0.71
"Model simulations were in good agreement with experimental data for both time-dependent parent and metabolite concentrations and summary pharmacokinetic parameters."( Characterizing the Effects of Race/Ethnicity on Acetaminophen Pharmacokinetics Using Physiologically Based Pharmacokinetic Modeling.
Reisfeld, B; Zurlinden, TJ, 2017
)
0.71
"A randomized, open-label, two-treatment, crossover, pharmacokinetic study of paracetamol dosed orally and intramuscularly was conducted."( Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria.
Chierakul, W; Chotivanich, K; Dondorp, AM; Newton, PN; Plewes, K; Ruengweerayut, R; Silamut, K; Tarning, J; Teerapong, P; Wattanakul, T; White, NJ, 2016
)
0.43
"The population pharmacokinetic properties of paracetamol were best described by a two-compartment disposition model, with zero-order and first-order absorption for intramuscular and oral syrup administration, respectively."( Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria.
Chierakul, W; Chotivanich, K; Dondorp, AM; Newton, PN; Plewes, K; Ruengweerayut, R; Silamut, K; Tarning, J; Teerapong, P; Wattanakul, T; White, NJ, 2016
)
0.43
"The main pharmacokinetic parameters for paracetamol after iv and po administration to patients with CP were as follows: Cmax, 19."( Pharmacokinetics of paracetamol in patients with chronic pancreatitis.
Adrych, K; Grabowski, T; Grześkowiak, E; Karbownik, A; Mziray, M; Siepsiak, M; Szałek, E, 2016
)
0.43
"There was no chronobiological effect on the pharmacokinetic parameters of paracetamol."( Influence of the Time of Intravenous Administration of Paracetamol on its Pharmacokinetics and Ocular Disposition in Rabbits.
Bienert, A; Cerbin-Koczorowska, M; Grabowski, T; Grześkowiak, E; Karbownik, A; Płotek, W; Wolc, A, 2017
)
0.46
" The median plasma Cmax in the 1 g IV group was significantly greater than the oral groups."( Comparative Plasma and Cerebrospinal Fluid Pharmacokinetics of Paracetamol After Intravenous and Oral Administration.
Bjorksten, AR; Hogg, M; Jamsen, K; Kirkpatrick, C; Langford, RA; Leslie, K; Williams, DL, 2016
)
0.43
" Evidence for differences in CSF Cmax and Tmax was lacking because of the small size of this study."( Comparative Plasma and Cerebrospinal Fluid Pharmacokinetics of Paracetamol After Intravenous and Oral Administration.
Bjorksten, AR; Hogg, M; Jamsen, K; Kirkpatrick, C; Langford, RA; Leslie, K; Williams, DL, 2016
)
0.43
"Blood samples were taken from 21 male and five female individuals, during a 24-h period, to characterize the pharmacokinetic profile of acetaminophen."( Bioequivalence and Pharmacokinetic Evaluation Study of Acetaminophen vs. Acetaminophen Plus Caffeine Tablets in Healthy Mexican Volunteers.
Abarca, JE; Guzmán, NA; Molina, DR; Núñez, BF; Soto-Sosa, JC, 2016
)
0.88
" Sunitinib concentration in plasma, brain, kidney and liver were determined and non-compartmental pharmacokinetic analysis performed."( Sunitinib-paracetamol sex-divergent pharmacokinetics and tissue distribution drug-drug interaction in mice.
Chee, EL; Chee, YL; Chew, CC; Fernández, C; Koo, TW; Liew, MH; Mariño, EL; Modamio, P; Ng, S; Segarra, I, 2017
)
0.46
"The pharmacokinetic profile of intravenous acetaminophen administered to critically ill multiple-trauma patients was studied after 4 consecutive doses of 1 g every 6 hours."( Pharmacokinetic Study of Intravenous Acetaminophen Administered to Critically Ill Multiple-Trauma Patients at the Usual Dosage and a New Proposal for Administration.
Fuster-Lluch, O; Gerónimo-Pardo, M; Zapater-Hernández, P, 2017
)
0.99
" The predictive performance of three published pharmacokinetic models was evaluated."( Population pharmacokinetics of intravenous acetaminophen in Japanese patients undergoing elective surgery.
Hasegawa, M; Imaizumi, T; Iseki, Y; Mogami, M; Murakawa, M; Obara, S, 2017
)
0.72
" Bariatric surgery resulted in faster absorption and normalized pharmacokinetic parameters, prompting an increase in paracetamol bioavailability."( Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques on Paracetamol and Caffeine Metabolism.
Boix, DB; Civit, E; de la Torre, R; Farré, M; Goday Arno, A; Grande, L; Langohr, K; Le Roux, JAF; Lí Carbó, M; Nino, OC; Papaseit, E; Pera, M; Pérez-Mañá, C; Ramon, JM; Rodríguez-Morató, J, 2017
)
0.46
"This pharmacokinetic simulation study is an important step in determining plasma acetylcysteine concentrations that are likely to be achieved using various modified treatment regimens."( Pharmacokinetic modelling of modified acetylcysteine infusion regimens used in the treatment of paracetamol poisoning.
Graudins, A; Landersdorfer, C; Wong, A, 2017
)
0.46
" Graphical analysis, descriptive statistics and population pharmacokinetic modelling were used to describe data."( The standard treatment protocol for paracetamol poisoning may be inadequate following overdose with modified release formulation: a pharmacokinetic and clinical analysis of 53 cases.
Brogren, J; Salmonson, H; Sjöberg, G, 2018
)
0.48
" The pharmacokinetic analysis showed a complex, dose dependent serum versus time profile with prolonged absorption and delayed serum peak concentrations with increasing dose."( The standard treatment protocol for paracetamol poisoning may be inadequate following overdose with modified release formulation: a pharmacokinetic and clinical analysis of 53 cases.
Brogren, J; Salmonson, H; Sjöberg, G, 2018
)
0.48
"The pharmacokinetic and clinical analysis showed that the standard treatment protocol, including risk assessment and NAC regimen, used for IR paracetamol poisoning not appear suitable for MR formulation."( The standard treatment protocol for paracetamol poisoning may be inadequate following overdose with modified release formulation: a pharmacokinetic and clinical analysis of 53 cases.
Brogren, J; Salmonson, H; Sjöberg, G, 2018
)
0.48
" Median Tmax of hydrocodone following benzhydrocodone API was delayed by more than one hour compared with HB."( Pharmacokinetics and Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone, After Intranasal Administration in Recreational Drug Users.
Barrett, AC; Dickerson, D; Guenther, SM; Mickle, TC; Roupe, KA; Webster, LR; Zhou, J, 2018
)
0.48
" Our aim was to translate a recently published comprehensive CNS physiologically-based pharmacokinetic (PBPK) model from rat to human, and to predict drug concentration-time profiles in multiple CNS compartments on available human data of four drugs (acetaminophen, oxycodone, morphine and phenytoin)."( Prediction of human CNS pharmacokinetics using a physiologically-based pharmacokinetic modeling approach.
Beukers, MW; Danhof, M; de Lange, ECM; Huntjens, DR; Kokki, H; Kokki, M; Krauwinkel, W; Proost, JH; Välitalo, PA; van Hasselt, JGC; Vermeulen, A; Wong, YC; Yamamoto, Y, 2018
)
0.66
" Thus, coadministration of probiotics with drugs may lead to changes in the pharmacokinetic parameters of the drugs."( Effect of Probiotics on Pharmacokinetics of Orally Administered Acetaminophen in Mice.
Choi, MS; Jeong, JJ; Kim, DH; Kim, IS; Kim, JK; Lim, SM; Yoo, HH, 2018
)
0.72
" The main pharmacokinetic parameters of paracetamol in the TN vs."( THE EFFECT OF TOTAL AND PARTIAL NEPHRECTOMY ON THE PHARMACOKINETICS OF INTRAVENOUS PARACETAMOL IN HUMANS.
Grabowski, T; Grzesowiak, E; Karbownik, A; Polom, W; Porazka, J; Szalek, E; Wolc, A, 2017
)
0.46
"The current investigation utilized a previously published parent-metabolite population pharmacokinetic model describing acetaminophen glucuronidation, sulfation, and oxidation to examine the potential role of genetic variability on the relevant metabolic pathways."( Polymorphic Expression of UGT1A9 is Associated with Variable Acetaminophen Glucuronidation in Neonates: A Population Pharmacokinetic and Pharmacogenetic Study.
Cook, SF; Gaedigk, A; Gaedigk, R; Kumar, SS; Linakis, MW; Liu, X; Sherwin, CMT; van den Anker, JN; Wilkins, DG, 2018
)
0.93
"A clinical pharmacokinetic study in adult patients with TBI was performed as a sub-study to a prospective, phase 2B, randomized placebo-controlled study (PARITY)."( Population pharmacokinetics of intravenous paracetamol in critically ill patients with traumatic brain injury.
Gowardman, J; Lipman, J; Myburgh, J; Parker, SL; Roberts, JA; Saxena, M, 2018
)
0.48
"All patients were included in the pharmacokinetic sub-study."( Population pharmacokinetics of intravenous paracetamol in critically ill patients with traumatic brain injury.
Gowardman, J; Lipman, J; Myburgh, J; Parker, SL; Roberts, JA; Saxena, M, 2018
)
0.48
" An increase in the elimination half-life and reduced clearance rate of tramadol were seen in the acetaminophen and ethanol groups, in comparison to the control group."( Pharmacokinetic changes of tramadol in rats with hepatotoxicity induced by ethanol and acetaminophen in perfused rat liver model.
Ardakani, YH; Esmaeili, Z; Ghazi-Khansari, M; Hassanzadeh, G; Lavasani, H; Mohammadi, S; Nezami, A; Rouini, MR, 2019
)
0.95
" Blood samples were collected for pharmacokinetic analysis for up to 6 hours after the loading dose."( Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial.
Anderson, BJ; Atkinson, HC; Frampton, C; Playne, R; Stanescu, I, 2018
)
0.48
"Intravenous acetaminophen is commonly administered as an adjunctive to opioids during major surgical procedures, but neither the correct pharmacokinetic size descriptor nor the dose is certain in severely obese adolescents undergoing bariatric surgery."( Acetaminophen pharmacokinetics in severely obese adolescents and young adults.
Anderson, BJ; Hakim, M; Michalsky, MP; Syed, A; Tobias, JD; Tumin, D; Walia, H, 2019
)
2.34
" Moreover, as the zebrafish larva is a developing organism, continuous physiological changes impact pharmacokinetic or toxicokinetic processes like the absorption and elimination of exogenous compounds, influencing the interpretation of observations and conclusions drawn from experiments at different larval ages."( Impact of post-hatching maturation on the pharmacokinetics of paracetamol in zebrafish larvae.
Hankemeier, T; Harms, AC; Kantae, V; Krekels, EHJ; Spaink, HP; van der Graaf, PH; van Wijk, RC, 2019
)
0.51
" Pharmacokinetic study was successfully applied and proved the possibility of co-administration of SOF with PAR and MET."( Determination of sofosbuvir with two co-administered drugs; paracetamol and DL-methionine by two chromatographic methods. Application to a pharmacokinetic study.
Abdel-Rahman, HM; Abdelrahman, MM; Abdelwahab, NS; Fares, MY, 2019
)
0.51
" The objective of this study is to determine if missing body weights in preterm and term neonates affect estimates of model parameters and which methods can be used to improve performance of a population pharmacokinetic model of paracetamol."( Population Pharmacokinetic Modeling in the Presence of Missing Time-Dependent Covariates: Impact of Body Weight on Pharmacokinetics of Paracetamol in Neonates.
Allegaert, K; Cook, SF; Krzyzanski, W; Sherwin, CMT; van den Anker, JN; Vermeulen, A; Wilbaux, M, 2019
)
0.51
"Different pediatric physiologically-based pharmacokinetic (PBPK) models have been described incorporating developmental changes that influence plasma drug concentrations."( Development of a physiologically-based pharmacokinetic pediatric brain model for prediction of cerebrospinal fluid drug concentrations and the influence of meningitis.
de Wildt, SN; Koenderink, JB; Russel, FGM; Verscheijden, LFM, 2019
)
0.51
" So the present study was designed to evaluate the effect of vitamin C and omega-3 on the pharmacokinetic property of paracetamol."( Vitamin C, omega-3 and paracetamol pharmacokinetic interactions using saliva specimens as determiners.
Ahmed, ZH; Aljasani, BM; Jaccob, AA, 2019
)
0.51
" Terminal elimination half-life was prolonged in neonates and younger infants and in intermediate and older infants similar to values in adults."( Randomized Population Pharmacokinetic Analysis and Safety of Intravenous Acetaminophen for Acute Postoperative Pain in Neonates and Infants.
Cooper, DS; Devarakonda, K; Gosselin, NH; Hammer, GB; Lu, J; Maxwell, LG; Pheng, LH; Szmuk, P; Taicher, BM; Visoiu, M, 2020
)
0.79
" This trial aims to compare the pharmacokinetic (PK) parameters of paracetomol between the IV and SC routes in PC patients."( Intravenous versus subcutaneous route pharmacokinetics of paracetamol (acetaminophen) in palliative care patients: study protocol for a randomized trial (ParaSCIVPallia).
Alix, A; Creveuil, C; Gourio, C; Guillaumé, C; Lelong-Boulouard, V; Lepoupet, M; Peyro-Saint-Paul, L; Vernant, M, 2020
)
0.79
" We aimed to develop a fetal-maternal physiologically based pharmacokinetic (PBPK) model (f-m PBPK) to quantitatively predict placental acetaminophen transfer, characterize fetal acetaminophen exposure, and quantify the contributions of specific clearance pathways in the term fetus."( Integration of Placental Transfer in a Fetal-Maternal Physiologically Based Pharmacokinetic Model to Characterize Acetaminophen Exposure and Metabolic Clearance in the Fetus.
Allegaert, K; Annaert, P; Conings, S; Dallmann, A; Mian, P; Pfister, M; Tibboel, D; van Calsteren, K; van den Anker, JN, 2020
)
0.97
" Herein, we summarized the pharmacokinetic characteristics of favipiravir and possible drug-drug interactions from the view of drug metabolism."( Favipiravir: Pharmacokinetics and Concerns About Clinical Trials for 2019-nCoV Infection.
Chen, XP; Du, YX, 2020
)
0.56
"Physiological and drug-specific parameters need to be adjusted when extrapolating a pharmacokinetic (PK) model from adults to neonates, so as to reproduce the time profiles of the studied drug(s) consistent with clinical, in vivo data or in vitro cell line measurements."( Extrapolation for a pharmacokinetic model for acetaminophen from adults to neonates: A Latin Hypercube Sampling analysis.
Ho, H; Zhang, E; Zhang, S, 2020
)
0.82
" The present study evaluated the feasibility of integrating in vitro data from three-dimensionally (3D)-cultured HepaRG cells and physiologically based pharmacokinetic (PBPK) modeling to predict chemical-induced liver toxicity."( Integration of in vitro data from three dimensionally cultured HepaRG cells and physiologically based pharmacokinetic modeling for assessment of acetaminophen hepatotoxicity.
Carmichael, PL; Guo, J; Li, F; Li, J; Li, W; Li, Y; Peng, H; Peng, S; Wang, Y; Yu, L; Zhang, C; Zhang, Q; Zhao, J, 2020
)
0.76
" The pharmacokinetic analysis was performed using a noncompartmental model."( Pharmacokinetics of acetaminophen after intravenous and oral administration in fasted and fed Labrador Retriever dogs.
Cuniberti, B; Giorgi, M; Lisowski, A; Poapolathep, A; Sartini, I; Łebkowska-Wieruszewska, B, 2021
)
0.94
"A full Bayesian statistical treatment of complex pharmacokinetic or pharmacodynamic models, in particular in a population context, gives access to powerful inference, including on model structure."( Well-tempered MCMC simulations for population pharmacokinetic models.
Bois, FY; Chiu, WA; Gao, W; Hsieh, NH; Reisfeld, B, 2020
)
0.56
" However, few data have been provided to clinicians about the pharmacokinetic drug-drug interactions of cannabinoids with other concomitant administered medications."( Potential Pharmacokinetic Drug-Drug Interactions between Cannabinoids and Drugs Used for Chronic Pain.
Guevara, N; Guido, PC; Maldonado, C; Schaiquevich, P; Vázquez, M, 2020
)
0.56
"Plasma concentrations of acetaminophen, its glucuronide and sulfate conjugates, and cysteinyl acetaminophen were experimentally determined after oral administrations of 10 mg/kg in humanised-liver mice, control mice, rats, common marmosets, cynomolgus monkeys, and minipigs; the results were compared with reported human pharmacokinetic data."( Plasma and hepatic concentrations of acetaminophen and its primary conjugates after oral administrations determined in experimental animals and humans and extrapolated by pharmacokinetic modeling.
Miura, T; Mogi, M; Sasaki, T; Shimizu, M; Suemizu, H; Toda, A; Uehara, S; Utoh, M; Yamazaki, H, 2021
)
1.2
" In this study, the human intestinal barrier (emulated by a co-culture of Caco-2 and HT-29 cells) and the liver equivalent (emulated by spheroids made of differentiated HepaRG cells and human hepatic stellate cells) were integrated into a two-organ chip (2-OC) microfluidic device to assess some acetaminophen (APAP) pharmacokinetic (PK) and toxicological properties."( An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment.
Bortot, LO; de Carvalho, M; Dias, MM; Indolfo, NC; Lorencini, M; Marin, TM; Pagani, E; Rocco, SA; Schuck, DC; Vasconcelos Bento, GI, 2020
)
0.73
" This article critically evaluated the literature reporting an association between acetaminophen use and in utero ductus arteriosus closure and provided a comparative pharmacokinetic analysis of fetal acetaminophen exposure in pregnancy vs drug levels in neonates, with the goal of making an expert recommendation regarding its safety."( Acetaminophen in late pregnancy and potential for in utero closure of the ductus arteriosus-a pharmacokinetic evaluation and critical review of the literature.
de Vrijer, B; Eastabrook, G; Garcia-Bournissen, F; Hutson, JR; Lurie, A, 2021
)
2.29
" We aimed to develop a population pharmacokinetic (PK) model for immediate-release (IR) and MR paracetamol and its major metabolism, and quantitatively understand the formulation difference in toxicity assessment based on the nomogram line."( Population pharmacokinetics of immediate-release and modified-release paracetamol and its major metabolites in a supratherapeutic dosing study.
Chiew, AL; Duffull, SB; Isbister, GK; Li, J, 2022
)
0.72
" Plasma concentrations for paracetamol and its metabolites glucuronide (APAPG) and sulfate conjugate (APAPS) for both formulations were measured and analysed with population pharmacokinetic (PK) method using NONMEM."( Population pharmacokinetics of immediate-release and modified-release paracetamol and its major metabolites in a supratherapeutic dosing study.
Chiew, AL; Duffull, SB; Isbister, GK; Li, J, 2022
)
0.72
"Both randomized, placebo-controlled studies' primary objectives evaluated the tolerability and pharmacokinetic properties of oral LX9211."( Results of two Phase 1, Randomized, Double-blind, Placebo-controlled, Studies (Ascending Single-dose and Multiple-dose Studies) to Determine the Safety, Tolerability, and Pharmacokinetics of Orally Administered LX9211 in Healthy Participants.
Banks, P; Boehm, KA; Bundrant, L; Gopinathan, S; Hunt, TL; Kassler-Taub, K; Tyle, P; Warner, C; Wason, S; Wilson, A, 2021
)
0.62
" The objective of this study was to apply physiologically based pharmacokinetic (PBPK) models in pediatric patients to investigate the absorption and pharmacokinetics of 4 drugs belonging to the Biopharmaceutics Classification System (BCS) class I administered as oral liquid formulations."( Evaluation of Physiologically Based Pharmacokinetic Models to Predict the Absorption of BCS Class I Drugs in Different Pediatric Age Groups.
Burckart, GJ; Dallmann, A; Liu, XI; van den Anker, JN, 2021
)
0.62
"In preterm neonates, physiologically based pharmacokinetic (PBPK) models are suited for studying the effects of maturational and non-maturational factors on the pharmacokinetics of drugs with complex age-dependent metabolic pathways like acetaminophen (APAP)."( Physiologically based pharmacokinetic modelling of acetaminophen in preterm neonates-The impact of metabolising enzyme ontogeny and reduced cardiac output.
Abbasi, MY; Allegaert, K; Olafuyi, O, 2021
)
1.06
" To investigate differences in APAP metabolism in specific patient populations and to optimize dosing regimens, quantification of metabolites from the different metabolic pathways is needed to perform pharmacokinetic (PK) studies."( Determination of paracetamol and its metabolites via LC-MS/MS in dried blood volumetric absorptive microsamples: A tool for pharmacokinetic studies.
Baerdemaeker, L; Delahaye, L; Stove, CP, 2021
)
0.62
" Pharmacokinetic analysis of urine and plasma paracetamol clearance profiles was carried out, which enabled the calculation of possible screening limits (SL) that can regulate for a detection time of 120 h."( Pharmacokinetics of paracetamol in the Thoroughbred horse following an oral multi-dose administration.
Fenwick, S; Gray, B; Habershon-Butcher, J; Hincks, P; Muir, T; Paine, S; Pesko, B; Scarth, J; Taylor, P, 2022
)
0.72
" The integrated UPLC-Q-TOF/MS, pharmacodynamic study, histopathological combination with network pharmacology and molecular docking technology were used to explore the potential mechanisms."( Network pharmacology, molecular docking technology integrated with pharmacodynamic study to reveal the potential targets of Schisandrol A in drug-induced liver injury by acetaminophen.
Deng, S; Ge, J; Li, J; Li, M; Li, X; Ma, L; Ma, Y; Zhang, J; Zheng, Y, 2022
)
0.92
" Additionally, the role of nutrition status on the pharmacokinetic profile of acetaminophen (APAP) at toxic doses is either scanty or not available."( The effect of nutritional status on the pharmacokinetic profile of acetaminophen.
Badanthadka, M; Mamatha, BS; Shetty, M; Souza, VD; Vijayanarayana, K, 2022
)
1.19
" Groups I and II were used for the pharmacokinetic assessment, and group III was used for the residue analysis and histopathologic evaluation."( Acetaminophen pharmacokinetics in geese.
Gajda, A; Gbylik-Sikorska, M; Giorgi, M; Krawczyk, A; Lisowski, A; Pietruk, K; Poapolathep, A; Sartini, I; Łebkowska-Wieruszewska, B, 2022
)
2.16
" A two-compartment pharmacokinetic model with first-order elimination described disposition for both drugs."( Population Pharmacokinetic Modelling of Acetaminophen and Ibuprofen: the Influence of Body Composition, Formulation and Feeding in Healthy Adult Volunteers.
Anderson, BJ; Atkinson, HC; Morse, JD; Stanescu, I, 2022
)
0.99
" The objective of the current analysis was to evaluate the effects on the gastric emptying rate caused by semaglutide on pharmacokinetic model parameters of paracetamol and atorvastatin in healthy subjects."( Population pharmacokinetic of paracetamol and atorvastatin with co-administration of semaglutide.
Kristensen, K; Langeskov, EK, 2022
)
0.72
" We examined the APAP overdose pharmacokinetic (PK) profiles to assess the role of dose, coingestants and formulation: immediate release (IR), extended release (ER), and modified release (MR) on APAP pharmacokinetic measures."( Population pharmacokinetic analysis of acetaminophen overdose with immediate release, extended release and modified release formulations.
Brittain, S; Dart, RC; Reynolds, K; Spyker, DA; Yarema, M; Yip, L, 2022
)
0.99
" There are few estimates of acetaminophen pharmacokinetic parameters in children with congenital heart disease, especially those with cyanotic heart disease."( Acetaminophen pharmacokinetics in infants and children with congenital heart disease.
Anderson, BJ; Holladay, J; McKee, CT; Morse, J; Rice-Weimer, J; Tobias, JD; Winch, P, 2023
)
2.65
" Pharmacokinetic parameter estimates were scaled using allometry and standardized to a 70 kg person."( Acetaminophen pharmacokinetics in infants and children with congenital heart disease.
Anderson, BJ; Holladay, J; McKee, CT; Morse, J; Rice-Weimer, J; Tobias, JD; Winch, P, 2023
)
2.35
" Population pharmacokinetic parameter estimates were similar to other studies in children."( Acetaminophen pharmacokinetics in infants and children with congenital heart disease.
Anderson, BJ; Holladay, J; McKee, CT; Morse, J; Rice-Weimer, J; Tobias, JD; Winch, P, 2023
)
2.35
" Plasma samples were collected, concentrations of drug and metabolites determined via liquid chromatography-mass spectrometry, and pharmacokinetic analyses were performed."( Pharmacokinetics and effects of codeine in combination with acetaminophen on thermal nociception in horses.
Kanarr, K; Kass, PH; Knych, HK; McKemie, DS; Tueshaus, T, 2023
)
1.15
"Physiologically based pharmacokinetic modeling could be used to predict changes in exposure during pregnancy and possibly inform medicine use in pregnancy in situations in which there is currently limited or no available clinical PK data."( Use of Physiologically Based Pharmacokinetic Modeling for Hepatically Cleared Drugs in Pregnancy: Regulatory Perspective.
Cole, S; Coppola, P; Kerwash, E, 2023
)
0.91
" Pharmacokinetic parameters for the parent compound were estimated with a nonlinear mixed-effects model."( Pharmacokinetics and safety of prolonged paracetamol treatment in neonates: An interventional cohort study.
Avachat, C; Barry, JM; Birnbaum, AK; Brink Henriksen, T; Christensen, U; Dalhoff, K; Haslund-Krog, S; Holst, H; Poulsen, S; Remmel, RP; Sherwin, CMT; van den Anker, JN; Wilkins, D, 2023
)
0.91
" We used nonlinear mixed-effect modeling for estimating the primary pharmacokinetic parameters of acetaminophen and its metabolites."( Population Pharmacokinetic Modeling and Dose Optimization of Acetaminophen and its Metabolites Following Intravenous Infusion in Critically ill Adults.
Mulubwa, M; Qader, AM; Sridharan, K, 2023
)
1.37
" A joint two-compartment acetaminophen pharmacokinetic model linked to glucuronide and sulfate metabolite compartments was used."( Population Pharmacokinetic Modeling and Dose Optimization of Acetaminophen and its Metabolites Following Intravenous Infusion in Critically ill Adults.
Mulubwa, M; Qader, AM; Sridharan, K, 2023
)
1.46
"A joint pharmacokinetic model for intravenous acetaminophen and its principal metabolites in a critically ill patient population has been developed."( Population Pharmacokinetic Modeling and Dose Optimization of Acetaminophen and its Metabolites Following Intravenous Infusion in Critically ill Adults.
Mulubwa, M; Qader, AM; Sridharan, K, 2023
)
1.41

Compound-Compound Interactions

The current study investigated the immune effects induced in healthy mice by repeated administration of tramadol alone or in combination with acetaminophen or dexketoprofen. The aim of the study was to determine which non-narcotic analgesic provides better post-operative pain control.

ExcerptReferenceRelevance
"Continuous Reaction Time (CRT) was measured in cancer patients receiving peripherally acting analgesics either alone (n = 16) or in combination with opioids (n = 16)."( Reaction time in cancer patients receiving peripherally acting analgesics alone or in combination with opioids.
Banning, A; Kaiser, F; Sjøgren, P, 1992
)
0.28
" Neither decrease in plasma acetaminophen levels nor depression of cytochrome P-450 enzyme activity appears to be the mechanism of protection when these doses of NAC, cysteamine, or both drugs together are administered with a toxic dose of acetaminophen in mice."( Cysteamine in combination with N-acetylcysteine prevents acetaminophen-induced hepatotoxicity.
Brown, IR; Peterson, TC, 1992
)
0.82
"In a double-blind, placebo-controlled study in 125 patients undergoing a cholecystectomy, a comparison was made of the quality of post-operative pain relief during 'patient-controlled' intake of sublingual buprenorphine in combination with either rectally administered naproxen 1000 mg/24 h, paracetamol 4000 mg/24 h or a placebo."( Application of sublingual buprenorphine in combination with naproxen or paracetamol for post-operative pain relief in cholecystectomy patients in a double-blind study.
Crul, BJ; Joosten, HJ; Vollaard, EJ; von Egmond, J; Witjes, WP, 1992
)
0.28
" Data on the efficacy of orphenadrine alone and in combination with paracetamol for painful conditions are evaluated in the present review."( Clinical and pharmacological review of the efficacy of orphenadrine and its combination with paracetamol in painful conditions.
Donnell, D; Hunskaar, S,
)
0.13
"The respiratory and psychomotor effects of a single oral dose of meptazinol (200 mg) and dextropropoxyphene (65 mg)/paracetamol (650 mg) mixture, was compared alone and in combination with ethanol (0."( Comparison of the effects of therapeutic doses of meptazinol and a dextropropoxyphene/paracetamol mixture alone and in combination with ethanol on ventilatory function and saccadic eye movements.
Ali, NA; Allen, EM; Graham, DF; Marshall, RW; Richens, A, 1985
)
0.27
" These effects, combined with the common use of cimetidine in clinical practice, make the risk of adverse drug interactions a relatively frequent risk in the clinical setting."( Drug interactions involving cimetidine--mechanisms, documentation, implications.
Greene, W, 1984
)
0.27
" Brief information on the following reports of drug-drug interactions is given in this article with the intention of giving these reports wider publicity and, possibly, encouraging further observation and research to establish or disprove their validity in a larger and wider range of patients or volunteer subjects."( Early reports on drug interactions.
D'Arcy, PF, 1983
)
0.27
"Only drug-drug interactions that are believed clinically important and that are primarily pharmacokinetic in nature are discussed in this article."( Therapeutic implications of drug interactions with acetaminophen and aspirin.
Hayes, AH, 1981
)
0.51
" The population was divided into two groups: group 1 received 20 mg of nalbuphine hydrochloride and group 2 received 2 g of propacetamol combined with 10 mg of nalbuphine hydrochloride."( [Comparison of the analgesic efficacy of nalbuphine and its combination with propacetamol during the immediate postoperative period in gynecologic-obstetric surgery].
Granry, JC; Jacob, JP; Monrigal, C, 1994
)
0.29
" After a dose of 100 mg/kg of caffeine given alone and in combination with 50 mg/kg of theophylline, hepatic GSH levels were decreased by 22."( Hepatic glutathione and lipid peroxidation in rats treated with theophylline. Effect of dose and combination with caffeine and acetaminophen.
Abdel-Meguid, EM; Farag, MM, 1994
)
0.49
"At 2 months of age, 145 infants were randomized to receive either a two-component acellular pertussis vaccine [lymphocytosis-promoting factor (LPF)/filamentous hemagglutinin (FHA)] or standard whole-cell pertussis vaccine, each combined with diphtheria-tetanus toxoids, as their primary immunization series."( Primary immunization series for infants: comparison of two-component acellular and standard whole-cell pertussis vaccines combined with diphtheria-tetanus toxoids.
Andrew, M; Feldman, S; Jones, L; Lamb, D; Meschievitz, C; Moffitt, JE; Perry, CS, 1993
)
0.29
"The analgesic drug combination Thomapyrin consisting of acetylsalicylic acid (CAS 50-78-2, ASA), paracetamol (CAS 103-90-2, NAPAP) and caffeine (CAS 58-08-2) in the ratio 5:4:1 was investigated for its chronic toxicity in rats."( Studies on the chronic oral toxicity of an analgesic drug combination consisting of acetylsalicylic acid, paracetamol and caffeine in rats including an electron microscopical evaluation of kidneys.
Bauer, E; Bauer, M; Greischel, A; Hirsch, U; Lehmann, H; Schmid, J; Schneider, P, 1996
)
0.29
"The objective of this study was to quantify the analgesic efficacy of paracetamol and its combination with codeine or caffeine through a systematic overview and meta-analysis of relevant randomized controlled trials (RCTs)."( Analgesic efficacy of paracetamol and its combination with codeine and caffeine in surgical pain--a meta-analysis.
Li Wan Po, A; Zhang, WY, 1996
)
0.29
" When the 40- or 80-mg/100 g acarbose diet was combined with ethanol, the ethanol-induced potentiation of CCl4 and AP hepatotoxicity was augmented."( Acarbose alone or in combination with ethanol potentiates the hepatotoxicity of carbon tetrachloride and acetaminophen in rats.
Kaneko, T; Sato, A; Wang, PY; Wang, Y, 1999
)
0.52
"Propacetamol and ketorolac, combined with patient-controlled analgesia morphine, show similar analgesic efficacy after gynecologic surgery."( A double-blinded evaluation of propacetamol versus ketorolac in combination with patient-controlled analgesia morphine: analgesic efficacy and tolerability after gynecologic surgery.
Agrò, F; Aloe, L; Ballabio, M; De Cillis, P; De Nicola, A; Giunta, F; Ischia, S; Marinangeli, F; Stefanini, S; Varrassi, G, 1999
)
0.3
" Opioids should not be combined with alcohol, and meperidine must be avoided in the patient who has taken monoamine oxidase inhibitors in the previous 14 days."( Adverse drug interactions in dental practice: interactions associated with analgesics, Part III in a series.
Haas, DA, 1999
)
0.3
"To evaluate the efficacy of N-acetylcysteine (N-AC) alone or combined with multiple-dose activated charcoal (AC) in the treatment of acetaminophen (ACT) overdose."( [Evaluation of the efficacy of N-acetylcysteine administered alone or in combination with activated charcoal in the treatment of acetaminophen overdoses].
Escalante-Galindo, P; Montoya-Cabrera, MA; Nava-Juárez, A; Terán-Hernández, JA; Terroba-Larios, VM,
)
0.54
" Group A (n = 7) were treated only with N-AC and group B (n = 7) with N-AC combined with AC."( [Evaluation of the efficacy of N-acetylcysteine administered alone or in combination with activated charcoal in the treatment of acetaminophen overdoses].
Escalante-Galindo, P; Montoya-Cabrera, MA; Nava-Juárez, A; Terán-Hernández, JA; Terroba-Larios, VM,
)
0.34
" With the high degree of interpatient variability and the unpredictability of various drug-drug interactions with warfarin, close and frequent monitoring of international normalized ratios is the key for safe oral anticoagulation therapy."( Warfarin-acetaminophen drug interaction revisited.
Chan, LN; Nutescu, E; Shek, KL, 1999
)
0.72
" Another drug whose mechanism of action is unknown is caffeine, which is often used in combination with other analgesics, augmenting their effect."( Effects of caffeine and paracetamol alone or in combination with acetylsalicylic acid on prostaglandin E(2) synthesis in rat microglial cells.
Aicher, B; Engelhardt, G; Fiebich, BL; Hüll, M; Lieb, K; Pairet, M; van Ryn, J, 2000
)
0.31
" Its combination with pamabrom, a mild diuretic agent, (Women s Tylenol Menstrual Relief Caplets, Midol Teen) was approved by the FDA for use in this indication."( Is acetaminophen, and its combination with pamabrom, an effective therapeutic option in primary dysmenorrhoea?
De Los Santos, AR; Di Girolamo, G; González, CD; Sánchez, AJ, 2004
)
0.94
"NSAIDs are widely applied to treat cancer pain and are frequently combined with opioids in combination preparations for this purpose."( NSAIDS or paracetamol, alone or combined with opioids, for cancer pain.
Carr, DB; Goudas, L; Lau, J; McNicol, E; Strassels, SA, 2005
)
0.33
"To assess the effects of NSAIDs, alone or combined with opioids, for the treatment of cancer pain."( NSAIDS or paracetamol, alone or combined with opioids, for cancer pain.
Carr, DB; Goudas, L; Lau, J; McNicol, E; Strassels, SA, 2005
)
0.33
" When a levodopa or droxidopa preparation, judged as grade 3 in screening, was concomitantly administered with an iron preparation, a significant reduction in bioavailability of the test drug was observed, indicating possible drug interaction between the test drug and oral iron."( [Simple method for precognition of drug interaction between oral iron and phenolic hydroxyl group-containing drugs].
Kamimura, N; Murayama, N; Sunagane, N; Terawaki, Y; Uruno, T; Yoshinobu, E, 2005
)
0.33
" Drug eruption due to a drug combination appears to be very rare."( Multiple fixed drug eruption due to drug combination.
Hara, H; Yokoyama, A, 2005
)
0.33
" The present prospective, placebo-controlled and double-blind study aimed to evaluate the analgesic efficacy of diclofenac, a non-steroid anti-inflammatory drug (NSAID), in combination with paracetamol and opioids."( Analgesic efficacy of diclofenac in combination with morphine and paracetamol after mastectomy and immediate breast reconstruction.
Legeby, M; Olofsson, C; Sandelin, K; Wickman, M, 2005
)
0.33
" In this work, thermodynamic constraints on non-equilibrium metabolite concentrations are used to reveal the biochemical interactions between the metabolic pathways of ethanol and acetaminophen (N-acetyl-p-aminophenol), two drugs known to interact unfavorably."( Thermodynamically based profiling of drug metabolism and drug-drug metabolic interactions: a case study of acetaminophen and ethanol toxic interaction.
Beard, DA; Yang, F, 2006
)
0.74
" The results therefore indicate that TTS-F offers more effective pain relief than codeine/paracetamol, in combination with R/T, in patients with metastatic bone pain, obtaining complete treatment satisfaction matched by improvements in their QoL."( Comparison of transdermal fentanyl with codeine/paracetamol, in combination with radiotherapy, for the management of metastatic bone pain.
Katsouda, E; Kouloulias, V; Kouvaris, J; Mystakidou, K; Tsiatas, M; Vlahos, L,
)
0.13
" The acute pain models were not sufficiently sensitive to detect an analgesic effect of paracetamol or the combination with dextromethorphan."( Effects of paracetamol combined with dextromethorphan in human experimental muscle and skin pain.
Ali, Z; Arendt-Nielsen, L; Drewes, AM; Olesen, AE; Staahl, C, 2007
)
0.34
" The data also suggest a possible drug-drug interaction between flutamide and APAP, resulting in inhibition of flutamide metabolism and increased APAP bioactivation and toxicity."( Transport, metabolism, and hepatotoxicity of flutamide, drug-drug interaction with acetaminophen involving phase I and phase II metabolites.
Ellis, E; Kostrubsky, SE; Mutlib, AE; Nelson, SD; Strom, SC, 2007
)
0.56
"A number of case reports and well-controlled clinical trials were identified that provided evidence of the relatively well known drug-drug interactions between prescription/OTC NSAIDs and alcohol, antihypertensive drugs, high-dose methotrexate, and lithium, as well as between frequently prescribed narcotics and other central nervous system depressants."( Adverse drug interactions involving common prescription and over-the-counter analgesic agents.
Hersh, EV; Moore, PA; Pinto, A, 2007
)
0.34
"Considering the widespread use of analgesic agents, the overall incidence of serious drug-drug interactions involving these agents has been relatively low."( Adverse drug interactions involving common prescription and over-the-counter analgesic agents.
Hersh, EV; Moore, PA; Pinto, A, 2007
)
0.34
" Detection was by positive ion TurboIonSpray ionisation combined with selected reaction monitoring MS."( Application of dried blood spots combined with HPLC-MS/MS for the quantification of acetaminophen in toxicokinetic studies.
Barfield, M; Fowles, S; Lad, R; Parry, S; Spooner, N, 2008
)
0.57
"The present study describes a new analytical approach for the detection and characterization of chemically reactive metabolites using glutathione ethyl ester (GSH-EE) as the trapping agent in combination with hybrid triple quadrupole linear ion trap mass spectrometry."( Screening and characterization of reactive metabolites using glutathione ethyl ester in combination with Q-trap mass spectrometry.
Fitch, WL; Wen, B, 2009
)
0.35
" We investigated the analgesic effect of pregabalin and dexamethasone in combination with paracetamol after abdominal hysterectomy."( Pregabalin and dexamethasone in combination with paracetamol for postoperative pain control after abdominal hysterectomy. A randomized clinical trial.
Dahl, JB; Dierking, G; Fomsgaard, JS; Hilsted, KL; Lech, K; Lose, G; Mathiesen, O; Rasmussen, ML, 2009
)
0.35
" We, therefore, investigated the analgesic effect of gabapentin, dexamethasone and low-dose ketamine in combination with paracetamol and ketorolac as compared with paracetamol and ketorolac alone after hip arthroplasty."( Multimodal analgesia with gabapentin, ketamine and dexamethasone in combination with paracetamol and ketorolac after hip arthroplasty: a preliminary study.
Christensen, BV; Dahl, JB; Dierking, G; Hilsted, KL; Larsen, TK; Mathiesen, O; Rasmussen, ML, 2010
)
0.36
"Preoperative gabapentin, dexamethasone and ketamine combined with paracetamol and ketorolac reduced overall pain scores in patients after hip arthroplasty as compared with paracetamol and ketorolac alone."( Multimodal analgesia with gabapentin, ketamine and dexamethasone in combination with paracetamol and ketorolac after hip arthroplasty: a preliminary study.
Christensen, BV; Dahl, JB; Dierking, G; Hilsted, KL; Larsen, TK; Mathiesen, O; Rasmussen, ML, 2010
)
0.36
"Two randomized, open-label, crossover, drug-drug interaction studies."( Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: results of two randomized, open-label, crossover, drug-drug interaction studies.
Mangold, B; Oh, C; Ravenstijn, PG; Rengelshausen, J; Smit, JW; Terlinden, R; Upmalis, D; Wang, SS, 2010
)
0.75
" In the 2-way crossover study, tapentadol IR was also given with the fifth of seven doses of acetaminophen 1000 mg; in the 3-way crossover study, tapentadol IR was also given with the third of four doses of naproxen 500 mg and the second of two doses of acetylsalicylic acid 325 mg."( Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: results of two randomized, open-label, crossover, drug-drug interaction studies.
Mangold, B; Oh, C; Ravenstijn, PG; Rengelshausen, J; Smit, JW; Terlinden, R; Upmalis, D; Wang, SS, 2010
)
0.97
" The current study evaluated the efficacy of the non-opiate analgesic acetaminophen, which has several putative analgesic mechanisms, combined with analgesic drugs used to treat neuropathic pain in a rat model of below-level neuropathic SCI pain."( Cannabinoid receptor-mediated antinociception with acetaminophen drug combinations in rats with neuropathic spinal cord injury pain.
Hama, AT; Sagen, J,
)
0.62
" Inhibition of UGT phosphorylation by PKC inhibitor drugs may represent a novel mechanism for drug-drug interactions."( Role for protein kinase C delta in the functional activity of human UGT1A6: implications for drug-drug interactions between PKC inhibitors and UGT1A6.
Court, MH; Volak, LP, 2010
)
0.36
"The antiviral drug combination consisting of arbidol and acetaminophen was investigated for its 4-week repeated oral administration in Sprague-Dawley rats."( A 4-week oral toxicity study of an antiviral drug combination consisting of arbidol and acetaminophen in rats.
Bai, WX; Liu, J; Pan, WN; Pan, YY; Shu, B; Wang, M; Yao, J, 2010
)
0.83
"To determine the risk: benefit of paracetamol combined with caffeine in the short-term management of acute pain conditions."( A risk-benefit assessment of paracetamol (acetaminophen) combined with caffeine.
Day, R; Graham, G; Palmer, H; Williams, K, 2010
)
0.62
"Database searches were conducted to identify double-blind trials comparing paracetamol/caffeine with paracetamol alone (benefit analysis) and any data pertaining to hepatotoxicity of paracetamol when combined with caffeine (risk analysis)."( A risk-benefit assessment of paracetamol (acetaminophen) combined with caffeine.
Day, R; Graham, G; Palmer, H; Williams, K, 2010
)
0.62
" dose of dexamethasone in combination with caudal block on postoperative analgesia in children."( Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy.
Han, SW; Hong, JY; Kil, HK; Kim, EJ; Kim, WO, 2010
)
0.36
"5 mg kg(-1) in combination with a caudal block augmented the intensity and duration of postoperative analgesia without adverse effects in children undergoing day-case paediatric orchiopexy."( Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy.
Han, SW; Hong, JY; Kil, HK; Kim, EJ; Kim, WO, 2010
)
0.36
"To evaluate the efficacy of intraoperative local anesthetic infiltration in combination with intravenous paracetamol infusion on postoperative pain management in patients who underwent percutaneous nephrolithotomy (PCNL)."( Efficacy of levobupivacaine infiltration to nephrosthomy tract in combination with intravenous paracetamol on postoperative analgesia in percutaneous nephrolithotomy patients.
Dogan, HS; Gokten, OE; Kilicarslan, H; Kordan, Y; Turker, G, 2011
)
0.37
"Levobupivacaine infiltration through the nephrostomy tract in combination with intravenous paracetamol infusion was shown to be safe and efficacious as an analgesia method after PCNL."( Efficacy of levobupivacaine infiltration to nephrosthomy tract in combination with intravenous paracetamol on postoperative analgesia in percutaneous nephrolithotomy patients.
Dogan, HS; Gokten, OE; Kilicarslan, H; Kordan, Y; Turker, G, 2011
)
0.37
" First of all, once assessed that all drugs induced dose-related antinociceptive effects, they were mixed in fixed ratio (1:1) combinations and a synergistic drug-drug interaction was obtained in all circumstances."( Fentanyl-trazodone-paracetamol triple drug combination: multimodal analgesia in a mouse model of visceral pain.
Ciruela, F; Fernández, A; Fernández-Dueñas, V; Planas, E; Poveda, R; Sánchez, S, 2011
)
0.37
"This study compared the antipyretic effect of 3 different treatment regimens in children, using either ibuprofen alone, ibuprofen combined with acetaminophen, or ibuprofen followed by acetaminophen over a single 6-hour observation period."( Efficacy of standard doses of Ibuprofen alone, alternating, and combined with acetaminophen for the treatment of febrile children.
Berlin, CM; Engle, L; Paul, IM; Sturgis, SA; Watts, H; Yang, C, 2010
)
0.79
"Forty-four OA patients randomly divided into two groups underwent three weeks of comprehensive day hospital rehabilitation treatment alone (group A) or in combination with acetaminophen 1g three times a day."( Efficacy of a comprehensive rehabilitation programme combined with pharmacological treatment in reducing pain in a group of OA patients on a waiting list for total joint replacement.
Atzeni, F; Casale, R; Damiani, C; Nica, AS; Rosati, V; Sarzi-Puttini, P,
)
0.33
" Results show that rats administered with toxic doses (1000 mg/kg, 3000 mg/kg, 5000 mg/kg BW) of paracetamol exhibited significant increases in the levels of ALT, AST, γ- GT compared with controls."( Biochemical and histologic presentations of female Wistar rats administered with different doses of paracetamol/methionine.
Adeniyi, FA; Iyanda, AA, 2011
)
0.37
" The present pilot study demonstrated the feasibility of peripheral blood microsampling techniques in combination with quantitative liquid chromatography-high resolution mass spectrometry analysis for the determination of pharmacokinetics in clinical studies."( Evaluation of peripheral blood microsampling techniques in combination with liquid chromatography-high resolution mass spectrometry for the determination of drug pharmacokinetics in clinical studies.
Meesters, RJ; Rincón, JP, 2014
)
0.4
" Drugs were selected based not only on the knowledge that the 6-hydroxylation of exogenous melatonin, its principal pathway of metabolism, is mainly mediated by hepatic CYP1A2, but also on the likelihood of the drug being concurrently administered with melatonin."( Potential drug interactions with melatonin.
Ioannides, C; Papagiannidou, E; Skene, DJ, 2014
)
0.4
" We report the death of two young individuals after ingestion of AH-7921 in combination with other psychoactive drugs."( Lethal poisonings with AH-7921 in combination with other substances.
Frost, J; Johansen, U; Karinen, R; Peres, MD; Rogde, S; Tuv, SS; Vindenes, V; Øiestad, ÅM, 2014
)
0.4
" Given previous research supporting the potential efficacy of anodal transcranial direct current stimulation (tDCS) for modulating pain-related brain activity in individuals with refractory central pain, we hypothesized that anodal tDCS when applied over the primary motor cortex (M1) combined with standard treatment will be more effective for reducing pain in patients with MPS than standard treatment alone."( Pain reduction in myofascial pain syndrome by anodal transcranial direct current stimulation combined with standard treatment: a randomized controlled study.
Auvichayapat, N; Auvichayapat, P; Janyacharoen, T; Jensen, MP; Keeratitanont, K; Sakrajai, P; Sawanyawisuth, K; Tunkamnerdthai, O, 2014
)
0.4
"Five consecutive days of anodal tDCS over M1 combined with standard treatment appears to reduce pain intensity and may improve PROM, faster than standard treatment alone."( Pain reduction in myofascial pain syndrome by anodal transcranial direct current stimulation combined with standard treatment: a randomized controlled study.
Auvichayapat, N; Auvichayapat, P; Janyacharoen, T; Jensen, MP; Keeratitanont, K; Sakrajai, P; Sawanyawisuth, K; Tunkamnerdthai, O, 2014
)
0.4
"Increased bioavailability of phenylephrine is reported when combined with paracetamol in over-the-counter formulations for the symptomatic treatment of the common cold and influenza."( Potential cardiovascular adverse events when phenylephrine is combined with paracetamol: simulation and narrative review.
Anderson, BJ; Atkinson, HC; Potts, AL, 2015
)
0.42
"MEDLINE and EMBASE databases were searched for papers discussing or describing any adverse effect, hypersensitivity or safety concerns related to phenylephrine alone or in combination with other drugs."( Potential cardiovascular adverse events when phenylephrine is combined with paracetamol: simulation and narrative review.
Anderson, BJ; Atkinson, HC; Potts, AL, 2015
)
0.42
"Auricular point sticking before operation combined with conventional western medicine with oral administration for preventing and treating postoperative complications of external excision and internal ligation on mixed hemorrhoid achieves positive and reliable efficacy."( [Clinical observation of auricular point sticking combined with western medicine for preventing and treating postoperative complications of external excision and internal ligation on mixed hemorrhoid].
Li, J; Long, Q; Wen, Y, 2015
)
0.42
"This study was conducted to determine if intravenous dexamethasone combined with caudal block was able to prolong post-operative analgesia in pediatric daycare surgeries."( INTRAVENOUS DEXAMETHASONE IN COMBINATION WITH CAUDAL BLOCK PROLONGS POSTOPERATIVE ANALGESIA IN PEDIATRIC DAYCARE SURGERY.
Azarinah, I; Esa, K; Hamidah, I; Khairulamir, Z; Murni Sari Ahmad, A; Norsidah Abdul, M, 2015
)
0.42
"A single intravenous dexamethasone dose when combined with caudal block reduces postoperative pain, decreases paracetamol requirement and prolongs analgesic duration in children after open herniotomy."( INTRAVENOUS DEXAMETHASONE IN COMBINATION WITH CAUDAL BLOCK PROLONGS POSTOPERATIVE ANALGESIA IN PEDIATRIC DAYCARE SURGERY.
Azarinah, I; Esa, K; Hamidah, I; Khairulamir, Z; Murni Sari Ahmad, A; Norsidah Abdul, M, 2015
)
0.42
"Many patients treated with imatinib, used in cancer treatment, are using several other drugs that could interact with imatinib."( Drug-drug interactions with imatinib: An observational study.
Bondon-Guitton, E; Bourrel, R; Chebane, L; Despas, F; Lapeyre-Mestre, M; Montastruc, JL; Récoché, I; Rousseau, V, 2016
)
0.43
"Because nefopam's morphine-sparing is debated when combined with paracetamol, this study aimed to assess pain relief by IV nefopam in combination with paracetamol after major abdominal surgery."( Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study.
Alonso, S; Casano, F; Cuvillon, P; Demattei, C; L'hermite, J; Lefrant, JY; Muller, L; Ripart, J; Zoric, L, 2017
)
0.46
"This prospective randomized study suggested that nefopam in combination with paracetamol has no benefit after open abdominal surgery."( Opioid-sparing effect of nefopam in combination with paracetamol after major abdominal surgery: a randomized double-blind study.
Alonso, S; Casano, F; Cuvillon, P; Demattei, C; L'hermite, J; Lefrant, JY; Muller, L; Ripart, J; Zoric, L, 2017
)
0.46
" Drug-drug multicomponent adducts could help in combination of drugs at supramolecular level."( Fast dissolving drug-drug eutectics with improved compressibility and synergistic effects.
Chavan, R; Naidu, VGM; Shastri, NR; Thipparaboina, R; Thumuri, D, 2017
)
0.46
"This study was aimed to evaluate the efficacy of preemptive analgesia (PA) by using celecoxib combined with low-dose tramadol/acetaminophen (tramadol/APAP) in treating post-operative pain of patients undergoing unilateral total knee arthroplasty (TKA)."( Preemptive analgesia by using celecoxib combined with tramadol/APAP alleviates post-operative pain of patients undergoing total knee arthroplasty.
Luo, J; Xu, Z; Zhang, H; Zhang, J; Zhou, A, 2017
)
0.66
"To assess whether a "drugome-wide" screen with case-crossover design is a feasible approach for identifying candidate drugs and drug-drug interactions."( Screening approach for identifying candidate drugs and drug-drug interactions related to hip fracture risk in persons with Alzheimer disease.
Hartikainen, S; Koponen, M; Lavikainen, P; Paananen, J; Taipale, H; Tanskanen, A; Tiihonen, J; Tolppanen, AM, 2017
)
0.46
"Case-crossover analysis is a potential approach for identifying candidate drugs and drug-drug interactions associated with adverse events as it implicitly controls for fixed confounders."( Screening approach for identifying candidate drugs and drug-drug interactions related to hip fracture risk in persons with Alzheimer disease.
Hartikainen, S; Koponen, M; Lavikainen, P; Paananen, J; Taipale, H; Tanskanen, A; Tiihonen, J; Tolppanen, AM, 2017
)
0.46
" Based on these values and on the statistical model, the impact of drug combination versus single drug as well as of reversed order was small with changes in relative recovery of smaller equal 9%."( Drug combinations and impact of experimental conditions on relative recovery in in vitro microdialysis investigations.
Burau, D; Dorn, C; Ehmann, L; Kloft, C; Kratzer, A; Petroff, D; Simon, P; Weiser, C; Wrigge, H, 2019
)
0.51
" In this work, the quantitative analysis of polymorphic forms of Active Pharmaceutical Ingredients based on X-ray Powder Diffraction is performed for the first time by a method based on multivariate standard addition method combined with net analyte signal procedure; it allows for reliable quantification of polymorphs of active principles in solid formulations, which are rapidly analyzed without any sample pre-treatment."( Quantifying API polymorphs in formulations using X-ray powder diffraction and multivariate standard addition method combined with net analyte signal analysis.
Caliandro, R; Galimberti, G; Maini, L; Melucci, D; Zappi, A, 2019
)
0.51
"To evaluate the effect of postoperative intravenous (IV) acetaminophen (paracetamol) vs placebo combined with IV propofol vs dexmedetomidine on postoperative delirium among older patients undergoing cardiac surgery."( Effect of Intravenous Acetaminophen vs Placebo Combined With Propofol or Dexmedetomidine on Postoperative Delirium Among Older Patients Following Cardiac Surgery: The DEXACET Randomized Clinical Trial.
Banner-Goodspeed, V; Eikermann, M; Gallagher, J; Gasangwa, D; Marcantonio, ER; Mathur, P; Mueller, A; O'Gara, B; Packiasabapathy, S; Patxot, M; Shaefi, S; Shankar, P; Subramaniam, B; Talmor, D, 2019
)
1.07
"Among older patients undergoing cardiac surgery, postoperative scheduled IV acetaminophen, combined with IV propofol or dexmedetomidine, reduced in-hospital delirium vs placebo."( Effect of Intravenous Acetaminophen vs Placebo Combined With Propofol or Dexmedetomidine on Postoperative Delirium Among Older Patients Following Cardiac Surgery: The DEXACET Randomized Clinical Trial.
Banner-Goodspeed, V; Eikermann, M; Gallagher, J; Gasangwa, D; Marcantonio, ER; Mathur, P; Mueller, A; O'Gara, B; Packiasabapathy, S; Patxot, M; Shaefi, S; Shankar, P; Subramaniam, B; Talmor, D, 2019
)
1.06
" In this study, a new drug-drug cocrystal of LVFX and an APAP analog was developed using a grinding and heating approach."( A Novel Drug-Drug Cocrystal of Levofloxacin and Metacetamol: Reduced Hygroscopicity and Improved Photostability of Levofloxacin.
Higashi, K; Moribe, K; Ono, M; Shinozaki, T, 2019
)
0.51
"The primary purpose of this study was to identify the most common drug-drug interactions (DDI'S) in patients prescribed medications upon discharge from the emergency department."( Descriptive study of drug-drug interactions attributed to prescriptions written upon discharge from the emergency department.
Bridgeman, PJ; Jawaro, T; Mele, J; Wei, G, 2019
)
0.51
" The primary endpoint is the identification and characterization of drug-drug interactions caused by discharge prescriptions written by the treating physician."( Descriptive study of drug-drug interactions attributed to prescriptions written upon discharge from the emergency department.
Bridgeman, PJ; Jawaro, T; Mele, J; Wei, G, 2019
)
0.51
"To determine which non-narcotic analgesic, acetaminophen (Ofirmev®) or ketorolac (Toradol®), provides better post-operative pain control when combined with an opioid patient-controlled analgesia (PCA) pump."( A prospective randomized trial of intravenous ketorolac vs. acetaminophen administered with opioid patient-controlled analgesia in gynecologic surgery.
Ahmad, S; Bigsby, GE; Ghurani, GB; Holloway, RW; James, JA; Jeppson, CN; Kendrick, JE; Rakowski, JA, 2019
)
1.02
"To compare the therapeutic effects of continuous epidural block combined with drugs and oral drugs alone on postherpetic neuralgia (PHN)."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.62
" Patients in group A had epidural block combined with oral administration of gabapentin and oxycodone-acetaminophen, and patients in group B received oral gabapentin and oxycodone-acetaminophen."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.84
"Both treatments have certain effects on PHN, but epidural block combined with drug therapy is more effective, especially for patients with severe pain, early use can quickly relieve pain."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.62
" To evaluate their drug-drug interactions (DDIs) and the hepatotoxicity of co-administration, rats were randomly separated into four groups: Control, APAP (50 mg/kg), ROX (5."( Drug-drug interaction of acetaminophen and roxithromycin with the cocktail of cytochrome P450 and hepatotoxicity in rats.
Chen, C; Liu, X; Zhang, X, 2020
)
0.86
" Paracetamol is a non-opioid analgesic used alone or in combination with opioids for the treatment of cancer pain."( In vivo assessment of the drug interaction between sorafenib and paracetamol in rats.
Grabowski, T; Grześkowiak, E; Karbownik, A; Sobańska, K; Stanisławiak-Rudowicz, J; Szałek, E; Wolc, A, 2020
)
0.56
" The aim of this study was to better understand the drug-drug interaction (DDI) potential of CYP3A and P-gp inhibitors."( PBPK modeling of CYP3A and P-gp substrates to predict drug-drug interactions in patients undergoing Roux-en-Y gastric bypass surgery.
Chan, LN; Chen, KF; Lin, YS, 2020
)
0.56
" However, few data have been provided to clinicians about the pharmacokinetic drug-drug interactions of cannabinoids with other concomitant administered medications."( Potential Pharmacokinetic Drug-Drug Interactions between Cannabinoids and Drugs Used for Chronic Pain.
Guevara, N; Guido, PC; Maldonado, C; Schaiquevich, P; Vázquez, M, 2020
)
0.56
" Herein, we aimed to evaluate the hepatotoxic and genotoxic effects that ciprofloxacin alone and in combination with paracetamol may induce in Danio rerio adults."( Low concentrations of ciprofloxacin alone and in combination with paracetamol induce oxidative stress, upregulation of apoptotic-related genes, histological alterations in the liver, and genotoxicity in Danio rerio.
Elizalde-Velázquez, GA; Galar-Martínez, M; García-Medina, S; Gómez-Oliván, LM; Guzmán-García, X; Islas-Flores, H; Orozco-Hernández, JM; Raldua, D; Rosales-Pérez, K; Rosas-Ramírez, JR, 2022
)
0.72
" This open-label study (NCT03974932) evaluated the efficacy and safety of HTX-011 combined with an MMA regimen in patients undergoing TKA under spinal anesthesia."( HTX-011 in Combination with Multimodal Analgesic Regimen Minimized Severe Pain and Opioid Use after Total Knee Arthroplasty in an Open-Label Study.
Berkowitz, R; Hacker, S; Hu, J; Lee, GC; Rechter, A, 2023
)
0.91
" The prescribing of multiple analgesics leads to potential drug-drug interactions (pDDIs)."( Potential drug-drug interactions in patients presenting with osteoarthritis to community orthopaedic clinics of Abbottabad, Khyber Pakhtunkhwa: A cross-sectional study.
Amirzada, MI; Bashir, H; Iqbal, M; Khan, Q; Rehman, IU; Sharif, MJH, 2023
)
0.91
" However, there is limited Indian data available on the nimesulide/paracetamol fixed drug combination (FDC)."( An Open-label, Prospective, Multicentric, Cohort Study of Nimesulide/Paracetamol Fixed Drug Combination for Acute Pain Management: Sub-group Analysis.
Gondane, A; Muruganathan, A; Pawar, D; Tiwaskar, M, 2023
)
0.91
" As a result, this study shows that subtoxic dose of APAP treatment alone or in combination with acute or exhaustive treadmill exercise can cause oxidative liver damage by affecting Sirt1 levels and without affecting VEGF levels."( The effects of subtoxic dose of acetaminophen combined with exercise on the liver of rats.
Acikgoz, O; Aksu, I; Gencoglu, C; Kiray, M; Tas, A, 2023
)
1.19
" Therefore, the current study investigated the immune effects induced in healthy mice by repeated administration of tramadol alone or in combination with acetaminophen or dexketoprofen."( Immunomodulation by tramadol combined with acetaminophen or dexketoprofen: In vivo animal study.
Bryniarski, K; Cieślik, M; Fedor, A; Filipczak-Bryniarska, I; Gębicka, M; Kozlowski, M; Kruk, G; Nazimek, K; Nowak, B; Pełka-Zakielarz, J; Skalska, P, 2023
)
1.37

Bioavailability

Microtracer study to shed a light on this issue. The bioavailability of acetaminophen from gels formed in the stomach of gastric-acidity controlled rabbits following oral administration of the liquid formulations was not significantly affected either by the inclusion of 10% D-sorbitol or increase of pH to 3.

ExcerptReferenceRelevance
" The method was used to determine the effect of 3-methylcholanthrene (3-MC) on the disposition and bioavailability of phenacetin following its oral and iv administration to rats."( Effect of 3-methylcholanthrene pretreatment on the bioavailability of phenacetin in the rat.
Deangelis, RL; Hughes, CR; Welch, RM,
)
0.13
" Benorylate was well absorbed in rabbits, but more slowly than an equimolar mixture of aspirin and paracetamol."( Comparative metabolism of benorylate and an equivalent mixture of aspirin and paracetamol in neonate and adult rabbits.
Davison, C; Dorrbecker, BR; Edelson, J, 1977
)
0.26
"The synthesis, hydrolysis rate, and bioavailability of 1-(p-acetaminophenoxy)-1-ethoxyethane, an acetaminophen prodrug, are described."( Prodrug approaches to enhancement of physicochemical properties of drugs IX: acetaminophen prodrug.
Hussain, A; Kulkarni, P; Perrier, D, 1978
)
0.73
" An increase of the extent of bioavailability of paracetamol was observed after the atropine administration, however the absorption of the drug was delayed."( Effect of papaverine and atropine on pharmacokinetics of paracetamol administered orally.
Gawrońska-Szklarz, B; Kaźmierczyk, J; Samochowiec, L; Wójcicki, J,
)
0.13
"Descriptive statistics and statistical tests used in reporting bioavailability data are reviewed in order to give the practicing pharmacist the fundamental knowledge needed to evaluate such data."( Statistical inference as applied to bioavailability data--a guide for the practicing pharmacist.
Bennett, RW; Popovich, NG, 1977
)
0.26
"Using the rate of absorption of paracetamol following oral administration of the drug, gastric emptying was measured in 21 patients following hysterectomy."( Gastric emptying following hysterectomy with extradural analgesia.
Littlewood, DG; Nimmo, WS; Prescott, LF; Scott, DB, 1978
)
0.26
" No difference in the bioavailability of 500 mg paracetamol given orally was observed between the two groups."( Paracetamol (acetaminophen) kinetics in patients with Gilber's syndrome.
Douglas, AP; Rawlins, MD; Savage, RL, 1978
)
0.63
" This effect greatly decreases the bioavailability of phenacetin."( Enhanced phenacetin metabolism in human subjects fed charcoal-broiled beef.
Alvares, AP; Anderson, KE; Conney, AH; Garland, WA; Hsiao, KC; Kappas, A; Pantuck, EJ, 1976
)
0.26
"The period of time after administration over which blood level measurements are required to obtain a reliable bioavailability comparison of two or more formulations of the same drug was considered by the analysis of bioavailability data taken from the literature."( Comparative bioavailabilities from truncated blood level curves.
Lovering, EG; McGilveray, IJ; McMillan, I; Tostowaryk, W, 1975
)
0.25
" The rate of bioavailability differed markedly between products and, in one case, the suppository dose of acetaminophen was so slowly absorbed that the clinical effectiveness of the product is doubtful."( Bioavailability of acetaminophen suppositories.
Feldman, S, 1975
)
0.8
" In agreement with this finding, the bioavailability of a small oral dose of phenacetin (0."( On the pharmacokinetics of phenacetin in man.
Dubach, UC; Raaflaub, J, 1975
)
0.25
"49) corresponding to a mean oral bioavailability of paracetamol of 82."( Tolerance and pharmacokinetics of propacetamol, a paracetamol formulation for intravenous use.
de Schepper, PJ; Depré, M; Gerin, M; Tjandra-Maga, TB; van Hecken, A; Verbesselt, R, 1992
)
0.28
" The well known bioavailability parameters of absorption and the area under the curve of the fractional absorbed time profiles up to 30 min were used as an index of gastric emptying."( Influence of cisapride, metoclopramide and loperamide on gastric emptying of normal volunteers as measured by means of the area under the curve of the cumulative fraction absorbed-time profiles of paracetamol.
Moncrieff, J; Sommers, DK; van Wyk, M, 1992
)
0.28
"An open trial was carried out in eight healthy male and female volunteers to examine the bioavailability as well as the main kinetic parameters of Migränerton (metoclopramide and paracetamol; CAS 364-64-5 and CAS 103-90-2, resp)."( [Pharmacokinetic aspects of a combination of metoclopramide and paracetamol. Results of a human kinetic study and consequences for migraine patients].
Becker, A; Berner, G; Leuschner, F; Vögtle-Junkert, U, 1992
)
0.28
" The bioavailability was determined according to the time (tmax) of the concentration maximum in plasma (Cmax) and the area under the curve (AUC)."( The influence of food on the absorption of diclofenac as a pure substance.
Feller, K; Gramatte, T; Hrdlcka, P; Richter, K; Terhaag, B, 1991
)
0.28
" Simultaneously fittings (intravenous and oral curves showed significant statistical differences for bioavailability estimated parameters (AUCev, F and K01)."( Reduction of oral bioavailability of paracetamol by tolmetin in rat.
Domenech, J; Moreno, J; Obach, R; Peraire, C; Sabater, J, 1991
)
0.28
"To determine the absorption rate of a supratherapeutic dose of acetaminophen elixir and compare the effect of activated charcoal (AC) given at different time intervals on preventing acetaminophen absorption."( Simulated acetaminophen overdose: pharmacokinetics and effectiveness of activated charcoal.
Gorman, RL; Klein-Schwartz, W; Oderda, GM; Rose, SR; Watson, WA, 1991
)
0.92
" The results of a comparative pharmacokinetic investigation of MR 897 and benorilate in the rat confirm higher bioavailability and a more favourable plasma level profile with MR 897."( High-pressure liquid chromatographic evaluation of cyclic paracetamol-acetylsalicylate and its active metabolites with results of a comparative pharmacokinetic investigation in the rat.
Lucarelli, C; Marzo, A; Meroni, G; Quadro, G; Ripamonti, M; Treffner, E, 1990
)
0.28
" There was a good correlation between MATAAP and the extent of bioavailability of chlorothiazide, however, there was no correlation between TFASP and the extent of bioavailability of the drug."( Gastrointestinal absorption of chlorothiazide: evaluation of a method using salicylazosulfapyridine and acetaminophen as the marker compounds for determination of the gastrointestinal transit time in the dog.
Kawazoe, Y; Mizuta, H; Ogawa, K, 1990
)
0.49
"The bioavailability of paracetamol from suppositories was studied in 16 geriatric in-patients in stable clinical condition; 9 had significant amounts of feces in the rectum."( Absorption of paracetamol from suppositories in geriatric patients with fecal accumulation in the rectum.
Hagen, IJ; Haram, EM; Laake, K, 1991
)
0.28
" The extent of bioavailability was little affected by the gastric emptying time, but significantly influenced by the small intestinal transit time."( Effect of small intestinal transit time on gastrointestinal absorption of 2-[3-(3,5-di-tert-butyl-4-hydroxyphenyl)-1H-pyrazolo[3,4-b]pyridin-1-yl ] ethyl acetate, a new non-steroidal anti-inflammatory agent.
Kawazoe, Y; Mizuta, H; Ogawa, K, 1990
)
0.28
" The result also shows beta-cyclodextrin and HPMC markedly reduced the in vivo bioavailability of acetaminophen from both test formulations."( Effect of beta-cyclodextrin on the in vitro permeation rate and in vivo rectal absorption of acetaminophen hydrogel preparations.
Lin, SY; Yang, JC, 1990
)
0.72
" No significant differences in relative bioavailability were observed."( Egg albumin microspheres containing paracetamol for oral administration. II. In vivo investigation.
Cadorniga, R; Davis, SS; Illum, L; Torrado, JJ,
)
0.13
" Concentrations of TC above the critical micelle concentration (CMC) did not affect the absorption rate of the hydrophilic drugs PA and TP; the barrier function of the intestinal wall for PA and TP was not altered in the presence of taurocholate."( Intestinal absorption of drugs. III. The influence of taurocholate on the disappearance kinetics of hydrophilic and lipophilic drugs from the small intestine of the rat.
Breäs, R; Poelma, FG; Tukker, JJ, 1990
)
0.28
" atropine and pirenzepine) and the results were compared with the bioavailability (i."( The mean cumulative fraction absorbed-time profiles of paracetamol as an index of gastric emptying.
Meyer, EC; Moncrieff, J; Sommers, DK; van Wyk, M, 1990
)
0.28
"25 mg), codeine phosphate (8 mg) and paracetamol (500 mg) had any effect on the bioavailability of the analgesics."( The relative bioavailability of paracetamol and codeine after oral administration of a combination of buclizine, paracetamol and codeine, with or without docusate, and of paracetamol alone in healthy volunteers.
Johnson, ES; Merrington, D; Oliver, W; Persaud, N, 1985
)
0.27
" Inhibition of the formation of the reactive metabolite of paracetamol or reduction of the absorption rate of paracetamol seem to be unlikely as mechanisms underlying the ASA-induced effect."( Reduction by acetylsalicylic acid of paracetamol-induced hepatic glutathione depletion in rats treated with 4,4'-dichlorobiphenyl, phenobarbitone and pregnenolone-16-alpha-carbonitrile.
De Vries, J; Groot, EJ; van Bree, L, 1989
)
0.28
"Determination of the Relative Bioavailability of Paracetamol Following Administration of Solid and Liquid Oral Preparations and Rectal Dosage Forms."( [The relative bioavailability of paracetamol following administration of solid and liquid oral preparations and rectal dosage forms].
Guserle, R; Luckow, V; Walter-Sack, I; Weber, E, 1989
)
0.28
" These results indicate that absorption rate of droxicam has been modified but bioavailability does not suffer modification in conditions of altered gastric emptying."( The influence of gastric emptying on droxicam pharmacokinetics.
Bartlett, A; García-Barbal, J; Martínez, L; Roser, R; Sagarra, R; Sánchez, J, 1989
)
0.28
"A controlled study of the bioavailability of paracetamol in solid dispersion with PEG 6000, 10000 and 20000 has been made."( The effect of the molecular weight of polyethylene glycol on the bioavailability of paracetamol-polyethylene glycol solid dispersions.
Alonso, MJ; Blanco, J; Vila-Jato, JL, 1986
)
0.27
" The two drugs were found to have the same efficiency on the subjective parameters but high bioavailability glaphenine seems to have an effectiveness in the range of articulatory movements, which is not found with paracetamol."( Comparative study of high bio-availability glaphenine and paracetamol in cervical and lumbar arthrosis.
Albert, A; Crielaard, JM; Franchimont, P; Urbin Choffray, D, 1987
)
0.27
" Gastric emptying after each premedication was assessed indirectly from the rate of absorption of oral paracetamol."( Comparison of the effect of cisapride and metoclopramide on morphine-induced delay in gastric emptying.
Bamber, PA; Nimmo, WS; Rowbotham, DJ, 1988
)
0.27
" The relative bioavailability of paracetamol from the composite analgesic preparations, however, did not show a statistically significant difference as compared to the preparation where paracetamol was present as a single component."( The effect of guaiphenesin on absorption and bioavailability of paracetamol from composite analgesic preparations.
Janku, I; Kordac, V; Perlík, F, 1988
)
0.27
" The gastric emptying rates of dosage forms were extremely prolonged in beagle dogs after drug administration postprandially, and this restricted the use of beagle dogs as an animal model in bioavailability tests."( Gastric emptying rates of drug preparations. I. Effects of size of dosage forms, food and species on gastric emptying rates.
Aoyagi, N; Ejima, A; Kaniwa, N; Ogata, H, 1988
)
0.27
"Eight healthy male volunteers took part in this study to determine the relative bioavailability of Treuphadol oblong tablets (500 mg paracetamol), Treuphadol Plus oblong tablets (500 mg paracetamol, 30 mg codeine phosphate) and Treuphadol suppositories (750 mg paracetamol) against commercial tablets (500 mg paracetamol)."( [Relative bioavailability of paracetamol from tablets and suppositories as well as of paracetamol and codeine in a combination tablet].
Barkworth, MF; Birkenfeld, A; Cierpka, H; Dyde, CJ; Klein, G; Rehm, KD; Töberich, H, 1986
)
0.27
" In vivo bioavailability studies were carried out in six healthy volunteers who received the tablets or the standard solution in a single dose, cross-over study."( Comparative bioavailability of three commercial acetaminophen tablets.
Ayanoğlu-Dülger, G; Hekimoğlu, S; Hincal, AA, 1987
)
0.53
"Moment analysis was utilized in the evaluation of equivalency between test and reference formulations with respect to the rate of absorption for four drugs having different pharmacokinetic characteristics."( Application of moment analysis in assessing rates of absorption for bioequivalency studies.
Chen, ML; Jackson, AJ, 1987
)
0.27
" The relative oral/intramuscular bioavailability of amitriptyline was only 13%, and the steady-state concentrations of this drug on four consecutive days were acutely subtherapeutic (i."( Decreased drug absorption in a patient with Behçet's syndrome.
Atiyeh, M; Chaleby, K; el-Yazigi, A, 1987
)
0.27
" Gastric emptying in the immediate postoperative period was also assessed in each patient by measuring the rate of absorption of orally administered paracetamol."( Analgesic and gastrointestinal effects of nalbuphine--a comparison with pethidine.
Couch, RA; Mark, A; Slattery, PJ, 1986
)
0.27
"The absorption rate and the bioavailability of two commercially available paracetamol tablets were investigated in a panel of seven volunteers; one of these tablets contained a combination of 50 mg caffeine and paracetamol."( Bioavailability of paracetamol after oral administration to healthy volunteers. Influence of caffeine on rate and extent of absorption.
Gusdorf, CF; Sitsen, JM; Tukker, JJ, 1986
)
0.27
" Bioavailability data for paracetamol derived from the results were similar to those reported by other workers who studied suppositories containing paracetamol as the only active ingredient."( The relative bioavailability of paracetamol after rectal administration of suppositories containing a mixture of paracetamol, codeine phosphate and buclizine hydrochloride in healthy volunteers.
Burgess, HA; Merrington, DM; Oliver, WJ; Rogers, HJ; Thomson, A, 1985
)
0.27
" Absorption rate constant (Ka) was not altered in PCM."( Disposition of acetaminophen in children with protein calorie malnutrition.
Mathur, VS; Mehta, S; Nain, CK; Sharma, B; Yadav, D, 1985
)
0.62
"The effect of two antacids on the bioavailability of paracetamol has been investigated in 12 young healthy volunteers."( Effect of two antacids on the bioavailability of paracetamol.
Albin, H; Bedjaoui, A; Begaud, B; Demotes-Mainard, F; Vinçon, G, 1985
)
0.27
" Other similar absorption interactions probably occur since drugs are poorly absorbed from the stomach and many therapeutic agents influence gastrointestinal motility."( Pharmacological modification of gastric emptying: effects of propantheline and metoclopromide on paracetamol absorption.
Heading, RC; Nimmo, J; Prescott, LF; Tothill, P, 1973
)
0.25
" The pharmacokinetic parameters of levonorgestrel in control mice showed some similarity to those observed in human subjects, save the systemic bioavailability which was about 67% in mice compared to 100% in humans."( Influence of acetaminophen-induced hepatic necrosis on the pharmacokinetics of levonorgestrel.
Gommaa, AA; Osman, FH, 1983
)
0.64
" The results confirm that activated charcoal can reduce acetaminophen absorption and show that oral administration of activated charcoal with sodium sulfate does not alter the inhibitory effect of activated charcoal on acetaminophen absorption or the bioavailability of the sulfate."( Evaluation of activated charcoal-sodium sulfate combination for inhibition of acetaminophen absorption and repletion of inorganic sulfate.
Galinsky, RE; Levy, G, 1984
)
0.74
" The main pharmacokinetic parameters and the relative bioavailability were calculated."( [Comparative pharmacokinetics and biologic availability of paracetamol as suppositories].
Degen, J; Maier-Lenz, H, 1984
)
0.27
"The absolute bioavailability of paracetamol (Tachipirina) administered in single doses orally and rectally was studied in nine healthy adult volunteers."( Absolute bioavailability of paracetamol after oral or rectal administration in healthy volunteers.
Eandi, M; Ricci Gamalero, S; Viano, I, 1984
)
0.27
" No differences in absorption and elimination rate as well as in bioavailability are determined."( [Comparative studies on the bioavailability of paracetamol from suppositories].
Franzky, HJ; Kölln, CJ; Mengel, W; Müller, BW, 1984
)
0.27
" When bioavailability and kinetic parameters for both drugs were compared, there were no significant differences."( Ibuprofen and acetaminophen kinetics when taken concurrently.
Albert, KS; Antal, EJ; Gillespie, WR; Wright, CE, 1983
)
0.63
"The absorption and bioavailability of nabumetone, a novel anti-inflammatory drug, were investigated following administration of single oral doses alone, and with food, milk, antacids, and analgesics to healthy volunteers."( Nabumetone--a novel anti-inflammatory drug: the influence of food, milk, antacids, and analgesics on bioavailability of single oral doses.
Buscher, G; Dierdorf, D; Mügge, H; von Schrader, HW; Wolf, D, 1983
)
0.27
" The relative bioavailability from the two forms of application was also computed."( [Bioavailability of codeine and paracetamol in a combination preparation following oral and rectal administration].
Kummer, M; Mehlhaus, N, 1984
)
0.27
"The relative bioavailability and pharmacokinetics of a combination product containing pentazocine and acetaminophen were studied in 20 healthy human males."( Relative bioavailability and pharmacokinetics: a combination of pentazocine and acetaminophen.
Benziger, DP; Edelson, J; Fritz, AK; Park, GB; Peterson, JE, 1984
)
0.71
" Delayed treatment with ASA also reduced paracetamol-induced liver toxicity, suggesting that reduction of the absorption rate of paracetamol does not contribute essentially to the protection by ASA."( Protection against paracetamol-induced hepatotoxicity by acetylsalicylic acid in rats.
De Jong, J; De Vries, J; Lock, FM; Mullink, H; Van Bree, L; Veldhuizen, RW, 1984
)
0.27
" The net result was that the comparative bioavailability of the drug was higher in PEM as compared to the control."( Disposition of four drugs in malnourished children.
Mathur, VS; Mehta, S; Nain, CK; Sharma, B, 1982
)
0.26
" The influence of aluminum hydroxide on gastric emptying could be compromised by gastric absorption of acetaminophen, resulting in a negligible effect on the overall bioavailability of acetaminophen."( Acetaminophen-aluminum hydroxide interaction in rabbits.
Chen, MM; Imamura, Y; Lee, C; Perrin, JH, 1983
)
1.92
"1 The rate of absorption of oral paracetamol depends on the rate of gastric emptying and is usually rapid and complete."( Kinetics and metabolism of paracetamol and phenacetin.
Prescott, LF, 1980
)
0.26
" Dose-dependent changes in rate and extent of absorption, bioavailability (saturation of first-pass metabolism), distribution (saturation of protein binding sites) and metabolism are discussed."( Pharmacokinetics of drug overdose.
Benowitz, NL; Pond, S; Rosenberg, J,
)
0.13
" Following oral administration it is rapidly absorbed from the gastrointestinal tract, its systemic bioavailability being dose-dependent and ranging from 70 to 90%."( Clinical pharmacokinetics of paracetamol.
Clements, JA; Forrest, JA; Prescott, LF,
)
0.13
" Absolute bioavailability of both oral dosage forms was significantly less then 100 per cent in all groups."( Age does not alter acetaminophen absorption.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ, 1982
)
0.59
" Although food slowed the rate of absorption of both oral preparations, no significant difference in peak acetaminophen plasma concentration or time of peak concentration was observed as a function of age."( Effect of food on acetaminophen absorption in young and elderly subjects.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ,
)
0.68
" Application and verification of this method by comparison with another procedure run simultaneously during several human bioavailability studies are described."( A rapid quantitative determination of acetaminophen in plasma.
O'Connell, SE; Zurzola, FJ, 1982
)
0.54
" The bioavailability values are also higher when prep."( [On the pharmacokinetics and bioavailability of paracetamol in suppositories for paediatry (author's transl)].
Degen, H; Maier-Lenz, H; Windorfer, A, 1982
)
0.26
" Poor bioavailability of local acetaminophen formulations was ruled out as a factor in the dose-concentration discrepancy by comparison with a British formulation ingested by four volunteers."( Inadequacy of reported intake in assessing the potential hepatotoxicity of acetaminophen overdose.
Dany, S; Halkin, H; Shnaps, Y; Tirosh, M, 1980
)
0.78
" For AAP used as a marker compound here, the systemic bioavailability after oral dosing to intact beagle dogs at doses of 3, 10, and 20 mg/kg was about 55, 63, and 79%, suggesting that AAP undergoes a non-linear hepatic clearance."( Relationship between the phasic period of interdigestive migrating contraction and the systemic bioavailability of acetaminophen in dogs.
Haga, K; Mizuta, H; Ohshiko, M; Sagara, K; Shibata, M, 1995
)
0.5
" The method considers the probability that the bioavailability of the test product is close to the bioavailability of the reference product, against the probability that the bioavailability of the reference product is close to itself when administered on different occasions."( Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar.
Schall, R, 1995
)
0.29
"A rapid simple and robust reversed-phase HPLC method was developed for rapid screening in bioavailability studies or comparative bioequivalence studies."( Rapid high-performance liquid chromatographic determination of vancomycin in human plasma.
Luksa, J; Marusic, A, 1995
)
0.29
"A study was performed to determine bioavailability of medication delivered via nasogastric tube in patients after abdominal surgery."( Bioavailability of medication delivered via nasogastric tube is decreased in the immediate postoperative period.
Alexander, JB; Atabek, UM; Camishion, RC; Cencora, B; Elfant, AB; Levine, SM; Méndez, L; Peikin, SR; Pello, MJ; Spence, RK, 1995
)
0.29
"Decreased bioavailability of medications delivered via nasogastric tube may have important clinical implications and should be taken into consideration during the postoperative period."( Bioavailability of medication delivered via nasogastric tube is decreased in the immediate postoperative period.
Alexander, JB; Atabek, UM; Camishion, RC; Cencora, B; Elfant, AB; Levine, SM; Méndez, L; Peikin, SR; Pello, MJ; Spence, RK, 1995
)
0.29
" An absorption rate was also derived from the 60 min sample using only a calibration curve (alpha 1)."( Relationship between fractional calcium absorption and gastric emptying.
Horowitz, M; Jones, KL; Morris, HA; Need, AG; Nordin, BE; Russo, A; Sun, WM; Wishart, JM, 1995
)
0.29
" When AUC in tablet was 100%, the relative bioavailability of acetaminophen oral drop was 105."( [Pharmacokinetics and bioavailability study on acetaminophen oral drop in healthy volunteers].
Hong, Z; Li, L; Li, Z; Qiang, W; Wang, M; Wang, Y; Zou, J, 1994
)
0.79
"Relative Bioavailability of Paracetamol as Suppositories Compared to Tablets."( [Relative bioavailability of paracetamol in suppositories preparations in comparison to tablets].
Ali, SL; Blume, H; Elze, M; Krämer, J; Scholz, ME; Wendt, G, 1994
)
0.29
" The absorption rate was related directly to the amount of paracetamol perfused per unit time as well as to the rate of transmucosal water fluxes."( Paracetamol absorption from different sites in the human small intestine.
Gramatté, T; Richter, K, 1994
)
0.29
" Chronic doses of ethanol (5% in drinking water for 14 days) caused an increase in bioavailability and other pharmacokinetic parameters, but changes were not as significant as following acute doses."( Pharmacokinetic studies using microdialysis probes in subcutaneous tissue: effects of the co-administration of ethanol and acetaminophen.
Kissinger, PT; Linhares, MC, 1994
)
0.5
"In a traditional assessment of the bioequivalence of two formulations of a drug one compares the average bioavailability from the two formulations."( On population and individual bioequivalence.
Luus, HG; Schall, R, 1993
)
0.29
" In comparison with a gavage study in the same rat (strain and age), bioavailability was lower in the diet study with relative bioavailabilities of 27, 22 and 61% for paracetamol, antipyrine and phenylbutazone, respectively."( Assessment of drug exposure in rat dietary studies.
Bazot, D; Brillanceau, MH; Jochemsen, R; Lupart, M, 1993
)
0.29
" 30, 1891-1896) that this thiazolidine, D-glucose-L-cysteine (DGC), offered no significant protection against the hepatic injury caused by 5 mmol/kg of acetaminophen in mice, suggesting that the cysteine present as DGC is poorly bioavailable in vivo."( Attenuation of acetaminophen hepatotoxicity in mice as evidence for the bioavailability of the cysteine in D-glucose-L-cysteine in vivo.
Benzick, AE; Gomez, MR; Heird, WC; Rogers, LK; Smith, CV, 1994
)
0.84
"To investigate the ability of a supranormal dose of N-acetylcysteine to overcome the effects of activated charcoal on N-acetylcysteine bioavailability and to determine the effects of activated charcoal on serum acetaminophen levels."( Use of activated charcoal in a simulated poisoning with acetaminophen: a new loading dose for N-acetylcysteine?
Chamberlain, JM; Gorman, RL; Klein, BL; Klein-Schwartz, W; Oderda, GM, 1993
)
0.72
" If N-acetylcysteine is needed because of a toxic serum acetaminophen level, bioavailability can be ensured by increasing the N-acetylcysteine loading dose from 140 mg/kg to 235 mg/kg."( Use of activated charcoal in a simulated poisoning with acetaminophen: a new loading dose for N-acetylcysteine?
Chamberlain, JM; Gorman, RL; Klein, BL; Klein-Schwartz, W; Oderda, GM, 1993
)
0.78
"To learn the influence of polyethylene glycol (PEG) on bioavailability, this study compared the bioavailability of acetaminophen in the presence of 10% ethanol (acetaminophen-ethanol liquid) to that in the presence of 10% PEG (acetaminophen-PEG liquid) since these two preparations are commonly used in hospital formulary."( Comparative bioavailability study of acetaminophen solutions used in hospital formulary.
Nagai, T; Prakongpan, S; Puncoke, R, 1993
)
0.77
" It was a prerequisite to establish the bioavailability of oxazepam prior to succeeding studies on the oral disposition of the drug."( Factors and conditions affecting the glucuronidation of oxazepam.
Sonne, J, 1993
)
0.29
" The bioavailability of the prodrug is incomplete and, according to the urinary excretion data, a fraction of the dose reaches the blood stream in the form of metabolites."( Pharmacokinetic study of 4'-acetamidophenyl-2-(5'-p-toluyl-1'-methylpyrrole)acetate in the rat.
Domenéch, J; Obach, R; Sabater, J, 1993
)
0.29
" The absolute bioavailability of frusemide during hypoxaemia (0."( The effect of hypoxaemia on drug disposition in chronic respiratory failure.
Hayball, PJ; Henderson, G; Latimer, K; May, F; Rowett, D; Ruffin, RE; Sansom, LN, 1996
)
0.29
" These results taken together with hydrolysis and bioavailability data show that ester is a potential candidate as a prodrug of paracetamol."( Synthesis, physical properties, toxicological studies and bioavailability of L-pyroglutamic and L-glutamic acid esters of paracetamol as potentially useful prodrugs.
Bousquet, E; Marrazzo, A; Puglisi, G; Spadaro, A; Tirendi, S, 1996
)
0.29
" The apparent AUC for paracetamol in the camel following intramuscular administration was larger than that following intravenous administration, however, when the bioavailability (F) was determined, with correction for altered half-life, within the animal and between study phases it was 71 +/- 17% in goats and 105 +/- 26% in camels."( Comparative pharmacokinetics of paracetamol (acetaminophen) and its sulphate and glucuronide metabolites in desert camels and goats.
Ali, BH; Bashir, AK; Cheng, Z; el Hadrami, G; McKellar, QA, 1996
)
0.55
"Relative Bioavailability Studies on Paracetamol in Suppositories as Compared to Tablets."( [The relative bioavailability of paracetamol in suppositories in comparison to tablets].
Ali, SL; Blume, H; Elze, M; Krämer, J; Scholz, ME, 1996
)
0.29
"A bioavailability study of two lots of paracetamol tablets was carried out in 5 healthy volunteers, using a crossover aleatory design, and drug monitoring in urine and saliva by high performance liquid chromatography (HPLC)."( Bioavailability study of paracetamol tablets in saliva and urine.
González, M; Pizzorno, MT; Retaco, P; Volonté, MG,
)
0.13
"The purpose of the present study was to examine the time dependence of oral paracetamol (acetaminophen) bioavailability in an experimental model of spinal cord injury (SCI)."( Oral paracetamol bioavailability in rats subjected to experimental spinal cord injury.
Castañeda-Hernández, G; García-López, P; Guízar-Sahagún, G; Madrazo, I; Pérez-Urizar, J, 1997
)
0.52
" The absorption rate of paracetamol was significantly impaired in the vegetarians compared with the non-vegetarians as shown by a lower mean Cmax (11."( Impaired absorption of paracetamol in vegetarians.
Makarananda, K; Prescott, LF; Saivises, R; Sriwatanakul, K; Yoovathaworn, K, 1993
)
0.29
"In this study, the bioavailability of aspirin and paracetamol was compared in plain and soluble combination formulations in fasting, healthy volunteers."( Comparative bioavailability of aspirin and paracetamol following single dose administration of soluble and plain tablets.
Muir, N; Nichols, JD; Stillings, MR; Sykes, J, 1997
)
0.3
" It has been shown that ascortic acid present in Paravit enhances the bioavailability of paracetamol."( [An experimental study of the pharmacokinetics of a new pediatric drug form--Paravit tablets].
Shapovalova, VA,
)
0.13
" This corresponds to decreases in bioavailability of 67, 11, and 21%."( Efficacy of ipecac during the first hour after drug ingestion in human volunteers.
Saincher, A; Sitar, DS; Tenenbein, M, 1997
)
0.3
"Concomitant administration of zolmitriptan and paracetamol resulted in a slight increase in bioavailability of zolmitriptan and a reduced rate and extent of paracetamol absorption."( The novel anti-migraine compound zolmitriptan (Zomig 311C90) has no clinically significant interactions with paracetamol or metoclopramide.
Layton, G; Peck, RW; Posner, J; Ridout, G; Seaber, EJ, 1997
)
0.3
"To determine if treatment with low-dose aspirin (ASA) influences the bioavailability of orally administered alcohol and to assess whether this is caused by altered gastric emptying as measured by the paracetamol absorption test."( Low-dose aspirin decreases blood alcohol concentrations by delaying gastric emptying.
Carlsson, B; Jones, AW; Jönsson, KA; Kechagias, S; Norlander, B, 1997
)
0.3
"To evaluate the effect of a standard meal on bioavailability of bromfenac, and on the relative analgesic efficacy and adverse effect liability of bromfenac 25 mg, naproxen sodium 550 mg, and acetaminophen 325 mg in the treatment of pain after orthopedic surgery."( The effect of food on bromfenac, naproxen sodium, and acetaminophen in postoperative pain after orthopedic surgery.
Bood-Björklund, L; Forbes, JA; Sandberg, RA,
)
0.57
" There were statistically significant differences in all bioavailability parameters (t(max), C(max) and AUC) between the three treatments."( Is one paracetamol suppository of 1000 mg bioequivalent with two suppositories of 500 mg.
Halsas, M; Marvola, M; Närvänen, T; Smal, J,
)
0.13
"To determine the relative bioavailability and plasma paracetamol concentration profiles following administration of a proprietary formulation of paracetamol suppositories to postoperative children."( Relative bioavailability and plasma paracetamol profiles of Panadol suppositories in children.
Coulthard, KP; Covino, A; Matthews, NT; Murray, RS; Nielson, HW; Schroder, M; Van Der Walt, JH, 1998
)
0.3
" The mean relative rectal bioavailability was 78% (95% confidence interval of 55-101%)."( Relative bioavailability and plasma paracetamol profiles of Panadol suppositories in children.
Coulthard, KP; Covino, A; Matthews, NT; Murray, RS; Nielson, HW; Schroder, M; Van Der Walt, JH, 1998
)
0.3
"A decrease in the rate of gastric emptying can delay resumption of enteral feeding, alter bioavailability of orally administered drugs, and result in larger residual gastric volumes, increasing the risk of nausea and vomiting."( Delayed postoperative gastric emptying following intrathecal morphine and intrathecal bupivacaine.
Cooke, T; Duggan, F; Lydon, AM; Shorten, GD, 1999
)
0.3
" A shorter hospital stay, patient and doctor convenience, and the concerns over the reduction in bioavailability of oral N-acetylcysteine by charcoal and vomiting make intravenous N-acetylcysteine preferable for most patients with acetaminophen poisoning."( Oral or intravenous N-acetylcysteine: which is the treatment of choice for acetaminophen (paracetamol) poisoning?
Buckley, NA; Dawson, AH; O'Connell, DL; Whyte, IM, 1999
)
0.72
" However, the rate of absorption of ethanol, as reflected in Cmax and AUC, was greatest after drinking the alcohol on an empty stomach."( Impact of gastric emptying on the pharmacokinetics of ethanol as influenced by cisapride.
Jones, AW; Jönsson, KA; Kechagias, S, 1999
)
0.3
" This study was designed to compare the bioavailability of paracetamol of a generic versus original drug."( Comparative bioavailability of paracetamol.
Kaojarern, S; Sirivarasai, J; Sriapa, C; Thareerach, M; Tongpoo, A, 1999
)
0.3
" The mean reduction in acetaminophen bioavailability because of gastric lavage was 20%+/-28% (95% confidence interval 3 to 37)."( Gastric lavage for liquid poisons.
Green, R; Grierson, R; Sitar, DS; Tenenbein, M, 2000
)
0.62
"In this experimental model for the ingestion of liquids, gastric lavage at 1 hour resulted in a significant decrease in the mean serum bioavailability of acetaminophen."( Gastric lavage for liquid poisons.
Green, R; Grierson, R; Sitar, DS; Tenenbein, M, 2000
)
0.5
" The results demonstrated that addition of sodium bicarbonate (630 mg) to paracetamol tablets, increased the rate of absorption of paracetamol relative to conventional paracetamol tablets and soluble paracetamol tablets."( A five way crossover human volunteer study to compare the pharmacokinetics of paracetamol following oral administration of two commercially available paracetamol tablets and three development tablets containing paracetamol in combination with sodium bicar
Boyce, M; Darby-Dowman, A; Grattan, T; Hayward, M; Hickman, R; Warrington, S, 2000
)
0.31
"The aim of this study was to compare the rate of absorption between ordinary paracetamol tablets and effervescent paracetamol tablets."( Absorption of effervescent paracetamol tablets relative to ordinary paracetamol tablets in healthy volunteers.
Rygnestad, T; Samdal, FA; Zahlsen, K, 2000
)
0.31
"The quantitative structure-bioavailability relationship of 232 structurally diverse drugs was studied to evaluate the feasibility of constructing a predictive model for the human oral bioavailability of prospective new medicinal agents."( QSAR model for drug human oral bioavailability.
Topliss, JG; Yoshida, F, 2000
)
0.31
"To determine if changes in the in vitro dissolution of hard and soft gelatin acetaminophen capsules, which result from gelatin crosslinking, are predictive of changes in the bioavailability of the capsules in humans."( The effect of gelatin cross-linking on the bioequivalence of hard and soft gelatin acetaminophen capsules.
Bottom, CB; Cole, ET; Hussain, A; Lesko, LL; Mallinowski, H; Meyer, MC; Mhatre, RM; Shah, VP; Straughn, AB; Williams, RL, 2000
)
0.76
" The bioavailability of the different formulations and routes of administration vary with age."( Treatment with paracetamol in infants.
Arana, A; Hansen, TG; Morton, NS, 2001
)
0.31
"The aim of the present study was to evaluate the bioavailability of a drug from rapidly disintegrating tablets prepared using fine spherical crystalline cellulose (PH-M-06) and spherical sugar granules (Nonpareil, NP)."( Pharmacokinetics of acetaminophen from rapidly disintegrating compressed tablet prepared using microcrystalline cellulose (PH-M-06) and spherical sugar granules.
Endo, H; Fujii, M; Ishikawa, T; Koizumi, N; Matsumoto, M; Mukai, B; Shirotake, S; Utoguchi, N; Watanabe, Y, 2001
)
0.63
" The properties of the products were initially tested via dissolution studies, and then via bioavailability studies in healthy volunteers."( Correlation of in vitro and in vivo acetaminophen availability from albumin microaggregates oral modified release formulations.
Carrascosa, C; Torrado, G; Torrado-Santiago, S, 2001
)
0.59
" That spaceflight may alter bioavailability was proposed when drugs prescribed to alleviate space motion sickness (SMS) had little therapeutic effect."( Pharmacokinetic consequences of spaceflight.
Cintrón, NM; Putcha, L, 1991
)
0.28
" A solubilized 200 mg liquigel formulation of ibuprofen has been shown to have a more rapid rate of absorption compared with ibuprofen 200 mg tablets."( Onset of analgesia for liquigel ibuprofen 400 mg, acetaminophen 1000 mg, ketoprofen 25 mg, and placebo in the treatment of postoperative dental pain.
Cooper, S; Doyle, G; Jayawardena, S; Marrero, I; Olson, NZ; Otero, AM; Sunshine, A; Tirado, S, 2001
)
0.56
"Oral bioavailability is a consequence of intestinal absorption, exsorption, and metabolism and is further modulated by the difference in activities among segmental regions."( Absorption of benzoic acid in segmental regions of the vascularly perfused rat small intestine preparation.
Cong, D; Fong, AK; Lee, R; Pang, KS, 2001
)
0.31
" The decrease of bioavailability at 1 hour was 30."( How long after drug ingestion is activated charcoal still effective?
Green, R; Grierson, R; Sitar, DS; Tenenbein, M, 2001
)
0.31
" Clinically relevant interactions may be exemplified by the effects of some fluoroquinolone antibiotics, such as pefloxacin and ciprofloxacin, which probably have a steroid-sparing effect in some patients with frequently relapsing nephrotic syndrome, and an increased bioavailability of several drugs following concomitant intake with freshly pressed grapefruit juice, eventually caused by inhibition of their metabolism, mediated mainly by CYP3A and specifically inhibited by naturally occurring flavonoids."( Important role of prodromal viral infections responsible for inhibition of xenobiotic metabolizing enzymes in the pathomechanism of idiopathic Reye's syndrome, Stevens-Johnson syndrome, autoimmune hepatitis, and hepatotoxicity of the therapeutic doses of
Prandota, J,
)
0.13
" Food did not affect the extent of absorption from either formulation, as indicated by AUC, however, food did reduce the rate of absorption from both formulations, as indicated by a longer tmax and a lower Cmax."( A new rapidly absorbed paracetamol tablet containing sodium bicarbonate. I. A four-way crossover study to compare the concentration-time profile of paracetamol from the new paracetamol/sodium bicarbonate tablet and a conventional paracetamol tablet in fed
Ayesh, R; Burnett, I; Darby-Dowman, A; Grattan, TJ; Rostami-Hodjegan, A; Shiran, MR; Tucker, GT, 2002
)
0.31
" These changes could be due to increased first-pass metabolism and decreased bioavailability of paracetamol during the ovulatory phase."( Influence of menstrual cycle on the pharmacokinetics of paracetamol through salivary compartment in healthy subjects.
Boinpally, RR; Bolla, SM; Devaraj, R; Gugilla, SR, 2002
)
0.31
" Acetaminophen is not absorbed from the stomach but is rapidly absorbed from the small intestine, and the rate of gastric emptying therefore determines the rate of absorption of acetaminophen administered into the stomach."( Perioperative gastric emptying is not a predictor of early postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
Klockhoff, H; Larsson, LG; Lövqvist, A; Näslund, I; Thörn, SE; Wattwil, L; Wattwil, M, 2002
)
1.22
" The relative rectal bioavailability is formulation dependent and decreases with age."( Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis.
Anderson, BJ; Hansen, TG; Holford, NH; Lin, YC; van Lingen, RA, 2002
)
1.76
"The use of biopolymers in sustained release systems has been studied by many research groups because of the bioavailability and biodegradability of these compounds."( Physicochemical characterization and enzymatic degradation of casein microcapsules prepared by aqueous coacervation.
Freitas, O; Pereira, NL; Santinho, AJ; Ueta, JM,
)
0.13
" The dosage forms best masking bitter taste showed good release of the drug, indicating little change in bioavailability by masking."( Development of oral acetaminophen chewable tablets with inhibited bitter taste.
Iwata, M; Machida, Y; Onishi, H; Suzuki, H; Takahashi, Y, 2003
)
0.64
"To understand the bioavailability and mechanistic pathways of cytoprotection by IH636 grape seed proanthocyanidin extract (GSPE, commercially known as ActiVin) a series of in vitro and in vivo studies were conducted."( Mechanistic pathways of antioxidant cytoprotection by a novel IH636 grape seed proanthocyanidin extract.
Bagchi, D; Bagchi, M; Preuss, HG; Ray, SD; Stohs, SJ, 2002
)
0.31
"To investigate the relationship between the dissolution rate and bioavailability of paracetamol tablets."( Relationship between dissolution rate and bioavailability of paracetamol tablet.
Huang, XP; Liu, Q; Wan, XX, 2003
)
0.32
" Ultraviolet spectrophotometry was employed to measure urine concentration of paracetamol, and the relative bioavailability was determined in 25 male healthy volunteers, with the relationship between the dissolution rate and bioavailability of paracetamol assessed."( Relationship between dissolution rate and bioavailability of paracetamol tablet.
Huang, XP; Liu, Q; Wan, XX, 2003
)
0.32
"83 respectively, with their bioavailability of 86."( Relationship between dissolution rate and bioavailability of paracetamol tablet.
Huang, XP; Liu, Q; Wan, XX, 2003
)
0.32
"As there is a good linear relationship between the dissolution rate and bioavailability of paracetamol tablets, the latter parameter can be derived from the measurement of the former."( Relationship between dissolution rate and bioavailability of paracetamol tablet.
Huang, XP; Liu, Q; Wan, XX, 2003
)
0.32
" The bioavailability of paracetamol from the gels formed in situ in the stomachs of rabbits following oral administration of the liquid formulations was similar to that of a commercially available suspension containing an identical dose of paracetamol."( Oral sustained delivery of paracetamol from in situ-gelling gellan and sodium alginate formulations.
Attwood, D; Kubo, W; Miyazaki, S, 2003
)
0.32
" While the absorption rate (indicated by tmax) of brand C was significantly faster (i."( Correlation between in vitro and in vivo parameters of commercial paracetamol tablets.
Babalola, CP; Femi-Oyewo, MN; Oladimeji, FA, 2001
)
0.31
" It could be useful for biopharmaceutical characterisation of drug products (monitoring of the levels of paracetamol in urine in bioavailability testing, for the evaluation of in vitro-in vivo correlation and screening of different formulations during drug product development)."( Development of the second-order derivative UV spectrophotometric method for direct determination of paracetamol in urine intended for biopharmaceutical characterisation of drug products.
Durić, Z; Ibrić, S; Jovanović, M; Karljiković-Rajić, K; Parojcić, J, 2003
)
0.32
" To try to improve the bioavailability of these tablets, the effect of their core composition of compression-coated tablet on in vivo pharmacokinetics was investigated."( A new index, the core erosion ratio, of compression-coated timed-release tablets predicts the bioavailability of acetaminophen.
Fukui, M; Hayashi, M; Sako, K; Sawada, T; Yokohama, S, 2003
)
0.53
"The aim of this study was to determine the influence of the type of paracetamol formulation on the rate of absorption when subjects are in the supine position, with or without taking concomitant morphine."( The influence of morphine on the absorption of paracetamol from various formulations in subjects in the supine position, as assessed by TDx measurement of salivary paracetamol concentrations.
Davey, AK; Kennedy, JM; Tyers, NM, 2003
)
0.32
"It would seem that a combination of faster disintegration and gastric emptying of the new tablets is responsible for the faster rate of absorption of paracetamol from PA compared to P observed in both this study and in previous studies."( Comparison of the rates of disintegration, gastric emptying, and drug absorption following administration of a new and a conventional paracetamol formulation, using gamma scintigraphy.
Grattan, TJ; Jones, T; Kelly, K; Lindsay, B; O'Mahony, B; Rostami-Hodjegan, A; Stevens, HN; Wilson, CG, 2003
)
0.32
" Although the bioavailability of paracetamol is not impaired in patients with chronic, benign liver diseases, the agent is contraindicated in those with hepatic insufficiency."( [Pharmacologic basis for using paracetamol: pharmacokinetic and pharmacodynamic issues].
Bannwarth, B; Péhourcq, F, 2003
)
0.32
" We also showed that (i) paracetamol absorption was faster when it was administered as a free powder than in sustained-release tablet form, (ii) a slow passage time resulted in a delay in the absorption of paracetamol, and (iii) there was a lower rate of absorption when paracetamol was ingested with a standard breakfast as opposed to water."( A dynamic artificial gastrointestinal system for studying the behavior of orally administered drug dosage forms under various physiological conditions.
Alric, M; Beyssac, E; Blanquet, S; Denis, S; Havenaar, R; Meunier, JP; Zeijdner, E, 2004
)
0.32
" The primary aim of this pilot project was to study the early bioavailability for two fixed doses of orally administrated paracetamol and one dose of intravenous propacetamol, all of which were given after minor surgery."( Early bioavailability of paracetamol after oral or intravenous administration.
Holmér Pettersson, P; Jakobsson, J; Owall, A, 2004
)
0.32
" Species differences were observed in the systemic clearance of theophylline (approximately 5-fold higher in CHPs), a low clearance compound, and the bioavailability of propranolol and verapamil (lower in CHPs), both high clearance compounds."( The chimpanzee (Pan troglodytes) as a pharmacokinetic model for selection of drug candidates: model characterization and application.
Bai, SA; Christ, DD; Diamond, S; Grace, JE; Grossman, SJ; He, K; Qian, M; Wong, H; Wright, MR; Yeleswaram, K, 2004
)
0.32
"A three-limbed randomized crossover study in 10 healthy volunteers was completed to determine the ability of a 50 g dose of activated charcoal to reduce the bioavailability of a simulated overdose of acetaminophen (12 x 325 mg tablets) in the presence and absence of a concurrently present anticholinergic drug, atropine (0."( Effect of anticholinergic drugs on the efficacy of activated charcoal.
Green, R; Sitar, DS; Tenenbein, M, 2004
)
0.51
" time curve, a single dose of activated charcoal 1 h after drug ingestion reduced acetaminophen bioavailability by 20% (95% CI 4-36%) and by 47% (95% CI 35-59%) in the presence of atropine (P<0."( Effect of anticholinergic drugs on the efficacy of activated charcoal.
Green, R; Sitar, DS; Tenenbein, M, 2004
)
0.55
" When a levodopa or droxidopa preparation, judged as grade 3 in screening, was concomitantly administered with an iron preparation, a significant reduction in bioavailability of the test drug was observed, indicating possible drug interaction between the test drug and oral iron."( [Simple method for precognition of drug interaction between oral iron and phenolic hydroxyl group-containing drugs].
Kamimura, N; Murayama, N; Sunagane, N; Terawaki, Y; Uruno, T; Yoshinobu, E, 2005
)
0.33
" Time-concentration profiles (503 observations) from a further 86 children (PCA: 37 weeks-14 years) given paracetamol elixir orally were included in the analysis to assess relative bioavailability of intravenous propacetamol."( Pediatric intravenous paracetamol (propacetamol) pharmacokinetics: a population analysis.
Allegaert, K; Anderson, BJ; Autret-Leca, E; Boccard, E; Pons, G, 2005
)
0.33
"Evaluation of the double-peak phenomenon during absorption of the beta(1)-selective blocker talinolol relative to paracetamol, which is well absorbed from all parts of the gut, and relative to vitamin A, which is absorbed via the lymphatic pathway."( The talinolol double-peak phenomenon is likely caused by presystemic processing after uptake from gut lumen.
Bernsdorf, A; Giessmann, T; Hartmann, V; Modess, C; Mrazek, C; Nagel, S; Siegmund, W; Wegner, D; Weitschies, W; Zschiesche, M, 2005
)
0.33
"Bioavailability of talinolol in enteric-coated and rectal capsules was significantly reduced by about 50% and 80%, respectively, despite unchanged bioavailability of paracetamol."( The talinolol double-peak phenomenon is likely caused by presystemic processing after uptake from gut lumen.
Bernsdorf, A; Giessmann, T; Hartmann, V; Modess, C; Mrazek, C; Nagel, S; Siegmund, W; Wegner, D; Weitschies, W; Zschiesche, M, 2005
)
0.33
" Therefore, even though the sustainability of release may be compromised by aging the gelucire matrices, the bioavailability of the incorporated drug is unlikely to be affected."( Significance of lipid matrix aging on in vitro release and in vivo bioavailability.
Choy, YW; Khan, N; Yuen, KH, 2005
)
0.33
" A mean bioavailability of 78% was estimated; the total clearance averaged 41 L/h."( Inter- and intraindividual variabilities in pharmacokinetics of fentanyl after repeated 72-hour transdermal applications in cancer pain patients.
Bressolle, F; Caumette, L; Culine, S; Garcia, F; Pinguet, F; Poujol, S; Solassol, I, 2005
)
0.33
" However, it should be noted that there is a difference in the bioavailability between the 2 formulations of up to 30%, which may explain the findings."( The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery.
Lirk, P; Ong, CK; Sow, BW; Tan, JM, 2005
)
0.33
" No significant in vivo bioavailability differences were observed in healthy human volunteers."( Formulation, release characteristics and bioavailability of novel monolithic hydroxypropylmethylcellulose matrix tablets containing acetaminophen.
Cao, QR; Choi, YW; Cui, JH; Lee, BJ, 2005
)
0.53
" The second purpose was to establish a level A in vitro/in vivo correlation that could predict the bioavailability of a drug instead of using difficult, time-consuming and expensive in vivo bioequivalence studies."( A level A in vitro/in vivo correlation in fasted and fed states using different methods: applied to solid immediate release oral dosage form.
Beyssac, E; Blanquet, S; Cardot, JM; Souliman, S, 2006
)
0.33
" However, some studies show differences in rate of absorption between brands and formulations."( Biowaiver monographs for immediate release solid oral dosage forms: acetaminophen (paracetamol).
Amidon, GL; Barends, DM; Dressman, JB; Junginger, HE; Kalantzi, L; Midha, KK; Reppas, C; Shah, VP; Stavchansky, SA, 2006
)
0.57
" The bioavailabilities of these drugs were not significantly different when released from gels formed at the two pH limits suggesting that normal variations of gastric acidity in the fasting state will have no effect on the bioavailability of these drugs when delivered using this vehicle."( The influence of variation of gastric pH on the gelation and release characteristics of in situ gelling pectin formulations.
Attwood, D; Dairaku, M; Fujiwara, M; Hirayama, T; Itoh, K; Kubo, W; Mikami, R; Miyazaki, S; Togashi, M, 2006
)
0.33
" The objective of this pharmacokinetic study was to compare the rate of absorption of PS versus P at a 500 mg dose."( A pharmacokinetic study investigating the rate of absorption of a 500 mg dose of a rapidly absorbed paracetamol tablet and a standard paracetamol tablet.
Burnett, I; Grattan, TJ; Ibáñez, Y; Luján, M; Martin, AJ; Rodríguez, JM, 2006
)
0.33
" The current investigation explores an alternative model to describe the absorption rate based on the convection-dispersion equation describing the transport of chemicals through the GI tract."( Application of the convection-dispersion equation to modelling oral drug absorption.
Danhof, M; DeJongh, J; Freijer, JI; Ploeger, BA; Post, TM, 2007
)
0.34
"A postoperative decrease in the gastric emptying (GE) rate may delay the early start of oral feeding and alter the bioavailability of orally administered drugs."( The effect of anesthetic technique on early postoperative gastric emptying: comparison of propofol-remifentanil and opioid-free sevoflurane anesthesia.
Lövqvist, A; Thörn, SE; Walldén, J; Wattwil, L; Wattwil, M, 2006
)
0.33
" However, pellets with higher coating level and correspondingly longer lag time showed decreased bioavailability of acetaminophen."( In vitro and in vivo performance of a multiparticulate pulsatile drug delivery system.
Dashevsky, A; Mohamad, A, 2007
)
0.55
"Pharmacokinetic drug interactions may result in a decrease or increase in the oral bioavailability of some drugs."( Effects of paracetamol on the pharmacokinetics of ciprofloxacin in plasma using a microbiological assay.
El-Abadla, NS; El-Naby, MK; Issa, MM; Kheiralla, ZA; Nejem, RM; Roshdy, AA, 2007
)
0.34
" While comparing the results to those previously obtained from the bioavailability studies it could be concluded that it is possible to develop colon specific drug products that begin releasing the drug in the ileo-caecal junction or at the beginning of the ascending colon and spread the drug dose to a larger surface area by using enteric coats and hydrophilic polymers."( Neutron activation based gamma scintigraphic evaluation of enteric-coated capsules for local treatment in colon.
Ahonen, A; Kanerva, H; Lindevall, K; Marvola, J; Marvola, M; Marvola, T, 2008
)
0.35
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
"the aim of this relative bioavailability study was to determine the rate and extent of absorption of Alikal Dolor (effervescent powder containing paracetamol 500 mg/sodium bicarbonate 2318 mg)--test formulation (T) in relation to Parageniol (paracetamol 500 mg coated tablets)--reference formulation (R)."( Relative bioavailability of new formulation of paracetamol effervescent powder containing sodium bicarbonate versus paracetamol tablets: a comparative pharmacokinetic study in fed subjects.
de los Santos, MC; Di Girolamo, G; Gonzalez, CD; Keller, G; Lopez, MI; Massa, JM; Opezzo, JA; Schere, D, 2007
)
0.34
" Etoricoxib is partly metabolised by the cytochrome P450 isoenzyme CYP 3A4 and increases the bioavailability of ethinylestradiol."( Etoricoxib: new drug. Avoid using cox-2 inhibitors for pain.
, 2007
)
0.34
"The aim of this work was to assess paracetamol bioavailability after administering 1 g in oral solution."( Study of paracetamol 1-g oral solution bioavailability.
Abanades, S; Alvarez, Y; Baena, A; Farre, M; Menoyo, E; Roset, PN; Rovira, M,
)
0.13
" The ability of IT as well as oral acetaminophen to reverse this spinally initiated hyperalgesia emphasizes the likely central action and bioavailability of the systemically delivered drug."( Acetaminophen prevents hyperalgesia in central pain cascade.
Crawley, B; Fitzsimmons, B; Hua, XY; Malkmus, S; Saito, O; Yaksh, TL, 2008
)
2.07
" Therefore, even if traces of opioids are absorbed into the mother's milk, the doses will be very small and the infant's oral bioavailability at this time is likely to be low."( [Do women with Caesarean section have to choose between pain relief and breastfeeding?].
Breivik, H; Hestenes, S; Høymork, SC; Løland, BF; Nylander, G; Rosseland, LA, 2008
)
0.35
"Grapefruit juice increases bioavailability of a number of drugs because of inhibition of the P-glycoprotein pump and inhibition of intestinal cytochrome P450 3A4 enzyme."( Interaction of white and pink grapefruit juice with acetaminophen (paracetamol) in vivo in mice.
Actor, JK; Dasgupta, A; Reyes, MA; Risin, SA, 2008
)
0.6
" The bioavailability study was carried out in healthy volunteers in a crossover sequence using saliva drug levels as a parameter."( Paracetamol bioavailability study by means of salivary samples.
Issa, MM; Nejem, RM; Shaat, NT, 2007
)
0.34
"The results of this study show that the nasogastric route of administration does not appear to cause marked, clinically unsuitable alterations in the bioavailability of the tested drugs."( The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube.
Berger-Gryllaki, M; Buclin, T; Pannatier, A; Podilsky, G; Roulet, M; Testa, B, 2009
)
0.35
"The aim of these 2 studies was to compare the bioavailability and to determine the bioequivalence of 2 test formulations (an oral-tablet formulation containing the combination of naproxen sodium/paracetamol 275/300 mg and an oral-suspension formulation containing the combination of naproxen sodium/paracetamol 375/300 mg per 15 mL) with their corresponding listed reference-drug formulations in Mexico (a list issued by Mexican health authorities)."( Bioavailability of two oral-tablet and two oral-suspension formulations of naproxen sodium/paracetamol (acetaminophen): single-dose, randomized, open-label, two-period crossover comparisons in healthy Mexican adult subjects.
Burke-Fraga, V; Cariño, L; González-de la Parra, M; López-Bojórquez, E; Namur, S; Novoa-Heckel, G; Oliva, I; Palma-Aguirre, JA; Villalpando-Hernández, J, 2009
)
0.57
"Cocoa drinks containing flavan-3-ols are associated with many health benefits, and conflicting evidence exists as to whether milk adversely affects the bioavailability of flavan-3-ols."( Milk decreases urinary excretion but not plasma pharmacokinetics of cocoa flavan-3-ol metabolites in humans.
Borges, G; Crozier, A; Donovan, JL; Edwards, CA; Lean, ME; Mullen, W; Serafini, M, 2009
)
0.35
"The objective was to determine the effect of milk on the bioavailability of cocoa flavan-3-ol metabolites."( Milk decreases urinary excretion but not plasma pharmacokinetics of cocoa flavan-3-ol metabolites in humans.
Borges, G; Crozier, A; Donovan, JL; Edwards, CA; Lean, ME; Mullen, W; Serafini, M, 2009
)
0.35
" Studies that showed protective effects of cocoa and those that showed no effect of milk on bioavailability used products that have a much higher flavan-3-ol content than does the commercial cocoa used in the present study."( Milk decreases urinary excretion but not plasma pharmacokinetics of cocoa flavan-3-ol metabolites in humans.
Borges, G; Crozier, A; Donovan, JL; Edwards, CA; Lean, ME; Mullen, W; Serafini, M, 2009
)
0.35
"The dietary bioavailability of the isoflavone genistein is decreased in older rats compared to young adults."( The kinetic basis for age-associated changes in quercetin and genistein glucuronidation by rat liver microsomes.
Blumberg, JB; Bolling, BW; Chen, CY; Court, MH, 2010
)
0.36
"Currently, herbal preparations are clinically used as functional food, food supplements or as add on therapy, which affects the bioavailability and also the net therapeutic potential of co-administered allopathic drugs."( Pharmacokinetic-interaction of Vitex negundo Linn. & paracetamol.
Mishra, B; Nagwani, S; Tiwari, OP; Tripathi, YB, 2009
)
0.35
" Further, compared to control, the relative bioavailability of paracetamol, in presence of VN extract, decreased significantly."( Pharmacokinetic-interaction of Vitex negundo Linn. & paracetamol.
Mishra, B; Nagwani, S; Tiwari, OP; Tripathi, YB, 2009
)
0.35
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" The absolute bioavailability was 42."( Species comparison of oral bioavailability, first-pass metabolism and pharmacokinetics of acetaminophen.
Croubels, S; Daminet, S; De Backer, P; De Boever, S; Gommeren, K; Neirinckx, E; Remon, JP; Vervaet, C, 2010
)
0.58
" Toxicity, pharmacokinetics and clinical bioavailability of resveratrol are also reviewed in this article."( Resveratrol and liver disease: from bench to bedside and community.
Bishayee, A; Darvesh, AS; McGory, R; Politis, T, 2010
)
0.36
" To show the importance of physicochemical properties, the classic QSAR and CoMFA of neonicotinoids and prediction of bioavailability of pesticides in terms of membrane permeability in comparison with drugs are described."( Importance of physicochemical properties for the design of new pesticides.
Akamatsu, M, 2011
)
0.37
" We propose that through its critical role in testosterone metabolism, CYP2A5 regulates 1) the bioavailability of APAP and APAP-GSH (presumably through modulation of the rates of xenobiotic excretion from the LNG) and 2) the expression of ABP, which can quench reactive APAP metabolites and thereby spare critical cellular proteins from inactivation."( A novel defensive mechanism against acetaminophen toxicity in the mouse lateral nasal gland: role of CYP2A5-mediated regulation of testosterone homeostasis and salivary androgen-binding protein expression.
Ding, X; Gu, J; Karn, RC; Kluetzman, K; Laukaitis, CM; Roberts, DW; Wei, Y; Xie, F; Zhang, QY; Zhou, X, 2011
)
0.64
" A positive impact on the bioavailability of acetaminophen in coated capsules was attested."( Duodenum-specific drug delivery: in vivo assessment of a pharmaceutically developed enteric-coated capsule for a broad applicability in rat studies.
Bietiger, W; Guhmann, P; Jeandidier, N; Pinget, M; Reix, N; Sigrist, S, 2012
)
0.64
" CSF bioavailability over 6 hours (AUC(0-6)) for IV, PO, and PR 1 g was 24."( Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen.
Ang, R; Beja, EG; Bushnell, R; Hutchinson, J; Parulan, C; Royal, MA; Samson, R; Singla, NK, 2012
)
0.59
" Additional important factors that may affect drugs' bioavailability and toxicity are gestational age, birth weight, intrauterine growth restriction, gender and, especially, liver function immaturity."( Hepatic injury to the newborn liver due to drugs.
Ambu, R; Faa, G; Nemolato, S; Van Eyken, P, 2012
)
0.38
" ACET concentrations were measured by using a validated HPLC method, and PK behavior and bioavailability were compared for the 2 preparations."( Pharmacokinetic comparison of acetaminophen elixir versus suppositories in vaccinated infants (aged 3 to 36 months): a single-dose, open-label, randomized, parallel-group design.
Casavant, MJ; Edge, J; Halvorsen, M; Kelley, MT; Walson, PD, 2013
)
0.68
" Paracetamol (acetaminophen in North America) has better bioavailability when given intravenously than orally and has been successfully used in the postoperative care of orthopedic patients."( Can intravenous paracetamol reduce opioid use in preoperative hip fracture patients?
Mackenney, P; Page, J; Tsang, KS, 2013
)
0.75
"No difference was observed between neostigmine and placebo for time to reach peak plasma acetaminophen concentration and absorption rate constant."( In vivo and in vitro effects of neostigmine on gastrointestinal tract motility of horses.
Harmon, FA; Morales, B; Nieto, JE; Snyder, JR; Stanley, SD; Yamout, SZ, 2013
)
0.61
"There is a need for information on the bioavailability in pediatric patients of drugs from manipulated dosage forms when applied in combination with food and/or co-medication under realistic daily practice circumstances."( In vitro gastrointestinal model (TIM) with predictive power, even for infants and children?
Anneveld, B; de Koning, BA; de Wildt, SN; Hanff, LM; Havenaar, R; Lelieveld, JP; Minekus, M; Mooij, MG, 2013
)
0.39
" APAP may lead to a changed bioavailability of a subsequently administered drug or diet in the body."( Acetaminophen changes intestinal epithelial cell membrane properties, subsequently affecting absorption processes.
Höglinger, O; Lornejad-Schäfer, MR; Schäfer, C; Schröder, KR; Tollabimazraehno, S, 2013
)
1.83
" In conclusion, this study suggests that the increase of the bioavailability of propranolol in ESRD is partly induced by the inhibition of the hepatic metabolism of CYP1A2 by xanthine in the uremic serum."( Possibility of decrease in CYP1A2 function in patients with end-stage renal disease.
Furukubo, T; Izumi, S; Minegaki, T; Nagatomo, M; Nishiguchi, K; Sugimoto, S; Tsujimoto, M; Yamakawa, T, 2014
)
0.4
" Previous studies showed that acetaminophen might affect bioavailability of ethanol by inhibiting gastric alcohol dehydrogenase (ADH)."( Inhibition of human alcohol and aldehyde dehydrogenases by acetaminophen: Assessment of the effects on first-pass metabolism of ethanol.
Cheng, YW; Lee, SL; Lee, YP; Liao, JT; Liu, JK; Wu, TL; Yin, SJ, 2013
)
0.92
"26 L kg(-1) and increased the rate of absorption with shorter absorption half-life (t(1/2ka)) for phenacetin in inflammation."( Turpentine oil induced inflammation decreases absorption and increases distribution of phenacetin without altering its elimination process in rats.
Anand Kumar, P; Prasad, VG; Rao, GS; Ravi Kumar, P; Vivek, Ch, 2015
)
0.42
"The primary objective of this study was to compare the bioavailability of paracetamol, phenylephrine hydrochloride and guaifenesin in a new oral syrup with an established oral reference product."( Bioavailability of paracetamol, phenylephrine hydrochloride and guaifenesin in a fixed-combination syrup versus an oral reference product.
Janin, A; Monnet, J, 2014
)
0.4
"h/ml along with relative bioavailability =91."( Report: pharmacokinetic and drug interaction studies of pefloxacin with paracetamol (NNAID) in healthy volunteers in Pakistan.
Ali, SA; Gauhar, S; Naqvi, SB; Shoaib, MH, 2014
)
0.4
"EMBASE and Medline were searched to obtain values for volume of distribution, absorption, and elimination constants and bioavailability for acetaminophen."( Four-hour acetaminophen concentration estimation after ingested dose based on pharmacokinetic models.
Gosselin, S; Villeneuve, E; Whyte, I, 2014
)
1.01
"Paracetamol and ibuprofen acutely hinder pleural fluid recycling by lowering the fluid absorption rate (higher remaining hydrothorax volume), while they increased total white cell counts."( Paracetamol and ibuprofen block hydrothorax absorption in mice.
Gourgoulianis, KI; Kalomenidis, I; Kouritas, VK; Magkouta, S; Psallidas, I; Zisis, C, 2015
)
0.42
"In view of the changes in the pharmacokinetics of paracetamol and tramadol in the patients after gastric resection for both formulations compared the conventional tablet seems to be more appropriate due to the comparable rate of absorption of both substances, higher concentrations of tramadol and comparable exposure to paracetamol."( The pharmacokinetics of the effervescent vs. conventional tramadol/paracetamol fixed-dose combination tablet in patients after total gastric resection.
Burchardt, P; Cieśla, S; Grabowski, T; Grześkowiak, E; Karbownik, A; Kokot, ZJ; Murawa, D; Murawa, P; Połom, K; Szałek, E; Urbaniak, B; Więckiewicz, A; Wolc, A, 2014
)
0.4
" The aim of the present study was to develop lecithin-based carrier system of silymarin by incorporating phytosomal-liposomal approach to increase its oral bioavailability and to make it target-specific to the liver for enhanced hepatoprotection."( Silymarin liposomes improves oral bioavailability of silybin besides targeting hepatocytes, and immune cells.
Deshpande, P; Jain, P; Kumar, N; Kutty, NG; Mathew, G; Rai, A; Raj, PV; Rao, CM; Reddy, ND; Udupa, N, 2014
)
0.4
" The liposomal formulation yielded a three and half fold higher bioavailability of silymarin as compared with silymarin suspension."( Silymarin liposomes improves oral bioavailability of silybin besides targeting hepatocytes, and immune cells.
Deshpande, P; Jain, P; Kumar, N; Kutty, NG; Mathew, G; Rai, A; Raj, PV; Rao, CM; Reddy, ND; Udupa, N, 2014
)
0.4
"Incorporating the phytosomal form of silymarin in liposomal carrier system increased the oral bioavailability and showed better hepatoprotection and better anti-inflammatory effects compared with silymarin suspension."( Silymarin liposomes improves oral bioavailability of silybin besides targeting hepatocytes, and immune cells.
Deshpande, P; Jain, P; Kumar, N; Kutty, NG; Mathew, G; Rai, A; Raj, PV; Rao, CM; Reddy, ND; Udupa, N, 2014
)
0.4
" Therefore, we studied the protective effects of N-acetylcysteineamide (NACA), a novel antioxidant, with higher bioavailability and compared it with NAC in APAP-induced hepatotoxicity in a human-relevant in vitro system, HepaRG."( Comparative evaluation of N-acetylcysteine and N-acetylcysteineamide in acetaminophen-induced hepatotoxicity in human hepatoma HepaRG cells.
Ercal, N; Fan, W; Khayyat, A; Tobwala, S, 2015
)
0.65
" Hence, without dietary sulphur amino acid increase, peripheral bioavailability of Cys and muscle GSH are potential players in the control of muscle mass under chronic treatment with APAP, an analgesic medication of widespread use, especially in the elderly."( Skeletal muscle wasting occurs in adult rats under chronic treatment with paracetamol when glutathione-dependent detoxification is highly activated.
Dardevet, D; Joly, C; Mast, C; Papet, I; Remond, D; Savary-Auzeloux, I, 2014
)
0.4
"Paracetamol has an extensive first-pass metabolism that highly affects its bioavailability (BA); thus, dose may be repeated several times a day in order to have longer efficacy."( Glucosamine enhances paracetamol bioavailability by reducing its metabolism.
Al-Jbour, N; Badwan, AA; Ghattas, MA; Matalka, KZ; Qinna, NA; Shubbar, MH, 2015
)
0.42
"The relative bioavailability of phenylephrine was increased when co-administered with acetaminophen."( Increased bioavailability of phenylephrine by co-administration of acetaminophen: results of four open-label, crossover pharmacokinetic trials in healthy volunteers.
Anderson, BJ; Atkinson, HC; Potts, AL; Salem, II; Stanescu, I, 2015
)
0.88
" This research aimed to evaluate bioavailability and compare pharmacokinetic (PK) properties of the new SR paracetamol formulation (2x1,000 mg) with those of immediate-release (IR) paracetamol (2x500 mg) and existing extended-release (ER) paracetamol (2x665 mg)."( Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation.
Collaku, A; Liu, DJ; Youngberg, SP, 2015
)
0.42
"The estimates of relative bioavailability of new SR with IR formulation based on dose-adjusted AUC0-inf were 91% (0."( Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation.
Collaku, A; Liu, DJ; Youngberg, SP, 2015
)
0.42
"The new SR formulation was well absorbed, with more than 90% relative bioavailability as compared to the currently marketed IR and ER products and better sustained-release PK characteristics, which make it suitable for twice-daily paracetamol treatment."( Bioavailability and pharmacokinetic profile of a newly-developed twice-a-day sustained-release paracetamol formulation.
Collaku, A; Liu, DJ; Youngberg, SP, 2015
)
0.42
" Increase in the bioavailability of both diclofenac and carbamazepine following multiple GFJ ingestion was revealed."( Evidence of reduced oral bioavailability of paracetamol in rats following multiple ingestion of grapefruit juice.
Alhussainy, TM; Arafat, TA; Idkaidek, NM; Ismail, OA; Qinna, NA, 2016
)
0.43
"An early prediction of solubility in physiological media (PBS, SGF and SIF) is useful to predict qualitatively bioavailability and absorption of lead candidates."( Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
Bharate, SS; Vishwakarma, RA, 2015
)
0.42
"Although amorphous solid drug formulations may be advantageous for enhancing the bioavailability of poorly soluble active pharmaceutical ingredients, they exhibit poor physical stability and undergo recrystallization."( Enhanced Physical Stability of Amorphous Drug Formulations via Dry Polymer Coating.
Capece, M; Davé, R, 2015
)
0.42
" Since acetaminophen was stable in rumen juice for 24 hr, the extremely low bioavailability (16%) was attributed to its hepatic extensive first-pass effect."( Oral pharmacokinetics of acetaminophen to evaluate gastric emptying profiles of Shiba goats.
Aboubakr, M; Elbadawy, M; Khalil, WF; Miyazaki, Y; Sasaki, K; Shimoda, M, 2015
)
1.18
"Increased bioavailability of phenylephrine is reported when combined with paracetamol in over-the-counter formulations for the symptomatic treatment of the common cold and influenza."( Potential cardiovascular adverse events when phenylephrine is combined with paracetamol: simulation and narrative review.
Anderson, BJ; Atkinson, HC; Potts, AL, 2015
)
0.42
" The influence of excipients on solubility and, hence, oral bioavailability was confirmed for ibuprofen, a second BCS class II compound."( Evaluation of changes in oral drug absorption in preterm and term neonates for Biopharmaceutics Classification System (BCS) class I and II compounds.
Coboeken, K; Ince, I; Meyer, M; Schmidt, S; Schnizler, K; Somani, AA; Thelen, K; Trame, MN; Willmann, S; Zheng, S, 2016
)
0.43
" Under fed conditions, the absorption rate constant of OC and APAP decreased significantly, although there was no effect on CL/F and V/F."( Pooled post hoc analysis of population pharmacokinetics of oxycodone and acetaminophen following a single oral dose of biphasic immediate-release/extended-release oxycodone/acetaminophen tablets.
Devarakonda, K; Franke, RM; Morton, T, 2015
)
0.65
" The study also assessed the relative bioavailability of the same doses of the active ingredients when they were administered as an oral formulation."( Pharmacokinetics and Bioavailability of a Fixed-Dose Combination of Ibuprofen and Paracetamol after Intravenous and Oral Administration.
Atkinson, HC; Beasley, CP; Frampton, C; Robson, R; Salem, II; Stanescu, I, 2015
)
0.42
" The relative bioavailability of paracetamol (93."( Pharmacokinetics and Bioavailability of a Fixed-Dose Combination of Ibuprofen and Paracetamol after Intravenous and Oral Administration.
Atkinson, HC; Beasley, CP; Frampton, C; Robson, R; Salem, II; Stanescu, I, 2015
)
0.42
"Amphotericin B (AmB) is poorly absorbed from the gastrointestinal tract."( Effect of Food Status on the Gastrointestinal Transit of Amphotericin B-Containing Solid Lipid Nanoparticles in Rats.
Amekyeh, H; Billa, N; Lim, SC; Yuen, KH, 2016
)
0.43
" The bioavailability of orally applied caffeine was also significantly decreased (p = 0."( Pharmacokinetic Herb-Drug Interaction between Essential Oil of Aniseed (Pimpinella anisum L., Apiaceae) and Acetaminophen and Caffeine: A Potential Risk for Clinical Practice.
Božin, B; Mijatović, V; Petković, S; Samojlik, I; Stilinović, N; Vukmirović, S, 2016
)
0.65
" Only pCGS is given as a highly bioavailable once daily dose (1500 mg) with a proven pharmacological effect."( A review of glucosamine for knee osteoarthritis: why patented crystalline glucosamine sulfate should be differentiated from other glucosamines to maximize clinical outcomes.
Bruyère, O; Cooper, C; Kovalenko, V; Kucharz, EJ; Reginster, JY; Szántó, S, 2016
)
0.43
" The relative bioavailability of oral syrup was 84."( Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria.
Chierakul, W; Chotivanich, K; Dondorp, AM; Newton, PN; Plewes, K; Ruengweerayut, R; Silamut, K; Tarning, J; Teerapong, P; Wattanakul, T; White, NJ, 2016
)
0.43
" Relative oral bioavailability compared to intramuscular dosing was estimated as 84."( Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria.
Chierakul, W; Chotivanich, K; Dondorp, AM; Newton, PN; Plewes, K; Ruengweerayut, R; Silamut, K; Tarning, J; Teerapong, P; Wattanakul, T; White, NJ, 2016
)
0.43
"The preparation of amorphous solid dispersion (ASD) formulations is a promising strategy to improve the bioavailability of an active pharmaceutical ingredient (API)."( Long-Term Physical Stability of PVP- and PVPVA-Amorphous Solid Dispersions.
Degenhardt, M; Heinzerling, O; Kyeremateng, SO; Lehmkemper, K; Sadowski, G, 2017
)
0.46
"Ψ-Glutathione (ψ-GSH) is an orally bioavailable and metabolism-resistant glutathione analogue that has been shown previously to substitute glutathione in most of its biochemical roles."( Hepatoprotective Effect of ψ-Glutathione in a Murine Model of Acetaminophen-Induced Liver Toxicity.
More, SS; Nugent, J; Nye, SM; Vartak, AP; Vince, R, 2017
)
0.7
" The two studied bariatric surgical techniques normalize paracetamol oral bioavailability without impairing the liver function (measured by cytochrome P450 1A2 activity)."( Pharmacokinetics in Morbid Obesity: Influence of Two Bariatric Surgery Techniques on Paracetamol and Caffeine Metabolism.
Boix, DB; Civit, E; de la Torre, R; Farré, M; Goday Arno, A; Grande, L; Langohr, K; Le Roux, JAF; Lí Carbó, M; Nino, OC; Papaseit, E; Pera, M; Pérez-Mañá, C; Ramon, JM; Rodríguez-Morató, J, 2017
)
0.46
" The relative bioavailability of eriodictyol was increased to 216."( Eriodictyol, Not Its Glucuronide Metabolites, Attenuates Acetaminophen-Induced Hepatotoxicity.
Chen, M; Hu, Y; Lan, Y; Liu, Z; Wang, Z; Wen, C; Ye, L, 2017
)
0.7
"The oral bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs) can be improved by the preparation of amorphous solid dispersions (ASDs) where the API is dissolved in polymeric excipients."( Influence of Low-Molecular-Weight Excipients on the Phase Behavior of PVPVA64 Amorphous Solid Dispersions.
Degenhardt, M; Kyeremateng, SO; Lehmkemper, K; Sadowski, G, 2018
)
0.48
" Moreover, in vivo performance of IR ADF technologies was investigated in an open-label, randomized, cross-over, phase 1, relative oral bioavailability study with another opioid (model compound)."( Application of hot-melt extrusion technology in immediate-release abuse-deterrent formulations.
Galia, E; Schwier, S; Stahlberg, HJ; Wening, K,
)
0.13
"Single-center bioavailability trial."( Application of hot-melt extrusion technology in immediate-release abuse-deterrent formulations.
Galia, E; Schwier, S; Stahlberg, HJ; Wening, K,
)
0.13
" The premise that acetaminophen increases phenylephrine bioavailability by competition for presystemic sulfation was corroborated by increased phenylephrine sulfate in urine."( An open-label, randomized, four-treatment crossover study evaluating the effects of salt form, acetaminophen, and food on the pharmacokinetics of phenylephrine.
Gelotte, CK, 2018
)
1.03
" Intravenous acetaminophen, with its increased bioavailability and more rapid onset of action, may have benefit in the intrapartum setting by reducing adverse neonatal and maternal outcomes associated with febrile morbidity."( Intravenous acetaminophen for the treatment of intrapartum fever and resolution of fetal tachycardia: a novel use for an old medication.
Burgess, APH; Lakhi, N; Moretti, M; Ope-Adenuga, S; Reilly, JG, 2017
)
1.2
"High inter-individual variability in the production of reactive paracetamol metabolites exists, and factors leading to increased bioavailability of reactive paracetamol metabolites are being uncovered."( The potential role of pharmacogenomics and biotransformation in hypersensitivity reactions to paracetamol.
Agúndez, JAG; García-Martin, E; Gómez-Tabales, J; Ruano, F, 2018
)
0.48
" An increase of 106% in absorption rate was observed between 3 and 4 dpf, but no further increase at 5 dpf, and an increase of 17."( Impact of post-hatching maturation on the pharmacokinetics of paracetamol in zebrafish larvae.
Hankemeier, T; Harms, AC; Kantae, V; Krekels, EHJ; Spaink, HP; van der Graaf, PH; van Wijk, RC, 2019
)
0.51
" Finally, in vivo studies in rats showed a higher bioavailability compared to conventional dosage forms and confirm the potential of biodegradable microcontainers for oral drug delivery."( Biodegradable microcontainers - towards real life applications of microfabricated systems for oral drug delivery.
Abid, Z; Boisen, A; Gundlach, C; Javed, MM; Keller, SS; Mazzoni, C; Müllertz, A; Nielsen, LH; Petersen, RS; Strindberg, S; Vaut, L, 2019
)
0.51
" One of the biggest problems of these compounds, however, is their very short bioavailability due to instant metabolism and rapid excretion."( Poly(ornithine)-based self-assembling drug for recovery of hyperammonemia and damage in acute liver injury.
Ibayashi, Y; Lee, Y; Nagasaki, Y; Ngo, DN; Nishikawa, Y; Vong, LB, 2019
)
0.51
"Polymer-based amorphous solid dispersions (ASDs) comprise one of the most promising formulation strategies devised to improve the oral bioavailability of poorly water-soluble drugs."( Use of Terahertz-Raman Spectroscopy to Determine Solubility of the Crystalline Active Pharmaceutical Ingredient in Polymeric Matrices during Hot Melt Extrusion.
Bordos, E; Florence, AJ; Halbert, GW; Islam, MT; Robertson, J, 2019
)
0.51
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" As the oral bioavailability of acetaminophen in critically ill children is unknown, we designed a microtracer study to shed a light on this issue."( Enteral Acetaminophen Bioavailability in Pediatric Intensive Care Patients Determined With an Oral Microtracer and Pharmacokinetic Modeling to Optimize Dosing.
Calvier, E; de Wildt, SN; Kleiber, N; Knibbe, CAJ; Krekels, EHJ; Mooij, MG; Tibboel, D; Vaes, WHJ, 2019
)
1.23
"8-20 mo) the mean enteral bioavailability was 72% (range, 11-91%)."( Enteral Acetaminophen Bioavailability in Pediatric Intensive Care Patients Determined With an Oral Microtracer and Pharmacokinetic Modeling to Optimize Dosing.
Calvier, E; de Wildt, SN; Kleiber, N; Knibbe, CAJ; Krekels, EHJ; Mooij, MG; Tibboel, D; Vaes, WHJ, 2019
)
0.95
" Furthermore, the bioavailability of the APIs from the dosage form depends largely on these characteristics."( Fiber-Array-Based Raman Hyperspectral Imaging for Simultaneous, Chemically-Selective Monitoring of Particle Size and Shape of Active Ingredients in Analgesic Tablets.
Frosch, T; Popp, J; Wyrwich, E; Yan, D, 2019
)
0.51
" In the third study, the bioavailability of ibuprofen and acetaminophen from a single oral dose of the FDC was assessed in healthy adolescents aged 12-17 years, inclusive."( Phase I Pharmacokinetic Study of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in Healthy Adult and Adolescent Populations.
Cruz-Rivera, M; Kellstein, DE; Kelsh, D; Leyva, R; Matschke, K; Meeves, S; Song, D; Tarabar, S; Vince, B, 2020
)
1.03
" This study is conducted to investigate the relative bioavailability and bioequivalence between one fixed dose paracetamol/orphenadrine combination test preparation and one fixed dose paracetamol/orphenadrine combination reference preparation in healthy volunteers under fasted condition for marketing authorization in Malaysia."( A randomized single-dose, two-period crossover bioequivalence study of two fixed-dose Paracetamol/Orphenadrine combination preparations in healthy volunteers under fasted condition.
Cheah, KY; Mah, KY; Ng, SM; Pang, LH; Tan, HZ; Tan, SS; Wong, JW; Yuen, KH, 2020
)
0.56
" The simulations suggest that for highly soluble drugs, such as verapamil, the predicted bioavailability was comparable pre- and post-RYGBS."( PBPK modeling of CYP3A and P-gp substrates to predict drug-drug interactions in patients undergoing Roux-en-Y gastric bypass surgery.
Chan, LN; Chen, KF; Lin, YS, 2020
)
0.56
" No significant statistical differences were found between fasted and fed dogs regarding maximum plasma concentration, time at maximum concentration and bioavailability as measured by the AUC."( Pharmacokinetics of acetaminophen after intravenous and oral administration in fasted and fed Labrador Retriever dogs.
Cuniberti, B; Giorgi, M; Lisowski, A; Poapolathep, A; Sartini, I; Łebkowska-Wieruszewska, B, 2021
)
0.94
" Although bioavailability of rectal acetaminophen is unpredictable, rectal route is a usual and acceptable method of prescription."( Bioavailability of rectal acetaminophen in children following anorectal surgery.
Afshari, R; Alizadeh Ghamsari, A; Hiradfar, M; Mohammadipour, A; Shojaeian, R; Vakili, R, 2021
)
1.2
" Nonetheless, ethical concerns limit clinical testing in pediatric populations and data collected from oral bioavailability and food effect studies in adults are often extrapolated to the target pediatric (sub)populations."( Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions.
Fotaki, N; Holm, R; Reppas, C; Statelova, M; Vertzoni, M, 2020
)
0.56
" Overall, these systems could significantly enhance the bioavailability of paracetamol and prolong its therapeutic effect in numerous diseases such as cold, flu, COVID-19, and severe pain."( Overcoming the paracetamol dose challenge with wrinkled mesoporous carbon spheres.
Ejsmont, A; Galarda, A; Goscianska, J; Olejnik, A; Wuttke, S, 2021
)
0.62
" Moreover, compared to native CORM2, SMA/CORM2 exhibited superior bioavailability and protective effect."( Nano-designed carbon monoxide donor SMA/CORM2 exhibits protective effect against acetaminophen induced liver injury through macrophage reprograming and promoting liver regeneration.
Fang, J; Guo, C; Hu, W; Jiang, W; Lv, J; Qin, M; Song, B; Xia, Z; Xu, D; Zhang, C; Zhang, S, 2021
)
0.85
"Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations."( Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging.
Dimmitt, NH; Green, AM; Hubbard, ND; Khan, SM; McVey, PA; Taulbee-Cotton, BV; Van Meter, MI; Webster, GK, 2021
)
0.62
"The objective of this study was to develop a novel acetaminophen and tramadol hydrochloride-loaded soft capsule (ATSC) with enhanced bioavailability of tramadol."( Acetaminophen and tramadol hydrochloride-loaded soft gelatin capsule: preparation, dissolution and pharmacokinetics in beagle dogs.
Cho, JH; Choi, HG, 2021
)
2.32
" Compared with traditional pharmaceutical manufacturing, this should facilitate the following: (1) the ability to manipulate drug release by adjusting structures, (2) enhanced solubility and bioavailability of poorly water-soluble drugs and (3) on-demand production of more complex structured dosages for personalized treatment."( Oral drug delivery systems using core-shell structure additive manufacturing technologies: a proof-of-concept study.
Repka, MA; Vo, AQ; Xu, P; Zhang, J, 2021
)
0.62
" The intravenous formulation offers a more predictable bioavailability compared to oral and rectal acetaminophen."( Effect of Intravenous Acetaminophen on Mean Arterial Blood Pressure: A Post Hoc Analysis of the EFfect of Intravenous ACetaminophen on PosToperative HypOxemia After Abdominal SurgeRy Trial.
AlGharrash, A; Bakal, O; Bravo, M; Essber, H; Mascha, EJ; Mosteller, L; Pu, X; Rivas, E; Rodriguez-Patarroyo, F; Turan, A, 2021
)
1.15
" Here, a microstirring pill technology is reported with built-in mixing capability for oral drug delivery that greatly enhances bioavailability of its therapeutic payload."( A Microstirring Pill Enhances Bioavailability of Orally Administered Drugs.
Esteban-Fernández de Ávila, B; Fang, RH; Karshalev, E; Litvan, I; Mundaca-Uribe, R; Nguyen, B; Wang, J; Wei, X; Zhang, L, 2021
)
0.62
"This study aimed to improve the in vitro dissolution, permeability and oral bioavailability of adefovir dipivoxil (ADD) by cocrystal technology and clarify the important role of coformer selection on the cocrystal's properties."( Effect of Coformer Selection on In Vitro and In Vivo Performance of Adefovir Dipivoxil Cocrystals.
Gao, Y; Li, L; Ma, K; Pang, Z; Qian, S; Wei, Y; Zhang, J; Zheng, D, 2021
)
0.62
"Coformer selection had an important role on cocrystal's properties, and cocrystallization of ADD with a suitable coformer was an effective approach to enhance both dissolution and bioavailability of ADD."( Effect of Coformer Selection on In Vitro and In Vivo Performance of Adefovir Dipivoxil Cocrystals.
Gao, Y; Li, L; Ma, K; Pang, Z; Qian, S; Wei, Y; Zhang, J; Zheng, D, 2021
)
0.62
" Pirfenidone (PFD), an orally bioavailable pyridone derivative, is clinically used for idiopathic pulmonary fibrosis treatment and has antifibrotic, anti-inflammatory, and antioxidant effects."( Pirfenidone attenuates acetaminophen-induced liver injury via suppressing c-Jun N-terminal kinase phosphorylation.
Aoyagi, T; Goya, T; Imoto, K; Kato, M; Kohjima, M; Kurokawa, M; Kuwano, A; Ogawa, Y; Suzuki, H; Takahashi, M; Tanaka, M; Tashiro, S, 2022
)
1.03
"Common cold symptoms may be mitigated by products in caplet, nasal spray, and oral solution formulations, although variations exist in the bioavailability of the active ingredients contained within these products."( A single-dose, open-label, randomized, scintigraphic study to investigate the gastrointestinal behavior of 2 triple-combination cold products (acetaminophen, phenylephrine, and dextromethorphan) in healthy male volunteers.
Armogida, M; Doll, WJ; Mallefet, P; Page, RC; Sandefer, EP, 2022
)
0.92
" After IV treatment, the APAP area under the curve value was statistically higher than that after PO administration, resulting in an oral bioavailability of 46%."( Acetaminophen pharmacokinetics in geese.
Gajda, A; Gbylik-Sikorska, M; Giorgi, M; Krawczyk, A; Lisowski, A; Pietruk, K; Poapolathep, A; Sartini, I; Łebkowska-Wieruszewska, B, 2022
)
2.16
" Bioavailability and absorption half-life were 86% and 12 min for acetaminophen and 94% and 27 min for ibuprofen."( Population Pharmacokinetic Modelling of Acetaminophen and Ibuprofen: the Influence of Body Composition, Formulation and Feeding in Healthy Adult Volunteers.
Anderson, BJ; Atkinson, HC; Morse, JD; Stanescu, I, 2022
)
1.23
" Intravenous (iv) acetaminophen has been reported to have superior efficacy and bioavailability than oral acetaminophen."( Effect of intravenous acetaminophen on postoperative outcomes in hip fracture patients: a systematic review and narrative synthesis.
Cho, JSH; Clarke, H; Engelsakis, M; Jacob, B; Karkouti, K; McCarthy, K; McCluskey, S; Schiavo, S; Wong, J; Zywiel, M, 2022
)
1.37
"To study the pharmacokinetics and relative bioavailability of drugs of different chemical structure and pharmacological action under conditions simulating the effects of some factors of spaceflight, as well as the peculiarities of the pharmacokinetics of acetaminophen under long-term spaceflight conditions."( Study of the pharmacokinetics of various drugs under conditions of antiorthostatic hypokinesia and the pharmacokinetics of acetaminophen under long-term spaceflight conditions.
Badriddinova, LY; Kondratenko, SN; Kovachevich, IV; Polyakov, AV; Repenkova, LG; Savelyeva, MI; Shikh, EV; Svistunov, AA, 2021
)
1.01
" Like other long-acting GLP-1 analogues, semaglutide reduces gastric emptying and, potentially, alters the rate of absorption of orally co-administered drugs."( Population pharmacokinetic of paracetamol and atorvastatin with co-administration of semaglutide.
Kristensen, K; Langeskov, EK, 2022
)
0.72
"Amorphization is a powerful approach for improving the aqueous solubility and bioavailability of poorly water-soluble compounds."( Influence of the crystallization tendencies of pharmaceutical glasses on the applicability of the Adam-Gibbs-Vogel and Vogel-Tammann-Fulcher equations in the prediction of their long-term physical stability.
Kawakami, K; Miyazaki, T; Mizoguchi, R; Yamaguchi, K, 2022
)
0.72
"The encapsulation of three drug components in the emulsion can improve the oral bioavailability to varying degrees and can effectively prevent the acute liver injury caused by acetaminophen."( [Preparation of salvianolic acid B, tanshinone Ⅱ_A, and glycyrrhetinic acid lipid emulsion and its protective effect against acute liver injury induced by acetaminophen].
Gu, H; Lin, T; Wang, XJ; Wang, XL; Zhang, XR, 2022
)
1.11
" The fixed dose combination of ibuprofen and paracetamol significantly increases the rate of absorption of paracetamol, which has potential therapeutic benefits in terms of a faster analgesias onset."( [Clinical and pharmacological approaches to the choice of a drug for a tension-type headache relief].
Khaytovich, ED; Perkov, AV; Shikh, EV, 2021
)
0.62
" An exploratory, single-dose, crossover bioavailability study in six beagles was performed."( Usefulness of the Beagle Model in the Evaluation of Paracetamol and Ibuprofen Exposure after Oral Administration to Pediatric Populations: An Exploratory Study.
Fotaki, N; Holm, R; Reppas, C; Statelova, M; Vertzoni, M, 2023
)
0.91
" However, curcumin's low solubility and bioavailability are its primary drawbacks and prevent its use as a therapeutic agent."( The Effect of Curcumin Nanoparticles on Paracetamol-induced Liver Injury in Male Wistar Rats.
Damayanti, IP; Mahati, E; Nugroho, T; Suhartono, S; Suryono, S; Susanto, H; Susilaningsih, N; Suwondo, A, 2023
)
0.91
" Silymarin extract and its major compound silibinin (SLB) possess robust antioxidant properties by inducing ROS elimination; however, low bioavailability and rapid metabolism limit their applications."( Alleviation of acetaminophen-induced liver failure using silibinin nanoliposomes: An in vivo study.
Alavizadeh, SH; Doagooyan, M; Gheybi, F; Hoseinian, A; Houshangi, K; Jaafari, MR; Khoddamipour, Z; Khooei, A; Papi, A; Sahebkar, A, 2023
)
1.26

Dosage Studied

High-performance liquid chromatographic (HPLC) method has been developed for the quantitation of acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylpropanolamine hydrochloride. No significant differences were found in the dosing regimen across the studies.

ExcerptRelevanceReference
"Male Wistar rats were dosed daily by gavage for 200 days with either (1) aspirin, 200 mg/kg; (2) acetaminophen, 200 mg/kg; (3) aspirin and acetaminophen, 200 mg/kg of each; (4) aspirin and acetaminophen, 100 mg/kg of each or (5) vehicle alone."( Failure to observe pathology in the rat following chronic dosing with acetaminophen and acetylsalicylic acid.
Nera, EA; Thomas, BH; Zeitz, W, 1977
)
0.71
" For each medicine the information is presented under four headings: nature and purpose of the drug, dosage and administration, unwanted effects, and keeping qualities."( Minimun information for sensible use of self-prescribed medicines. An international consensus.
, 1977
)
0.26
" One group of golden Syrian hamsters was administered a toxic dosage of acetaminophen (600 mg ."( Experimental acetaminophen-induced hepatic necrosis: biochemical and electron microscopic study of cysteamine protection.
Bhakthan, NM; Chiu, S, 1978
)
0.86
" A control of the actual rectal dosage scheme for repetitive applications is recommended and the combination of paracetamol with sedatives is to be discussed."( [On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application (author's transl)].
Götte, R; Liedtke, R, 1978
)
0.26
" The total amount of paracetamol and its metabolites excreted and the peak excretion rates were lower from the suppository bases than from the oral dosage forms."( Antipyretic therapy. Comparison of rectal and oral paracetamol.
Hietula, M; Keinänen, S; Kouvalainen, K; Similä, S, 1977
)
0.26
" This would suggest that the frequency of acetaminophen administration in children should be similar to the schedule recommended for adults and that a dosing interval of four hours should not result in drug accumulation."( Pharmacokinetics of acetaminophen in children.
Peterson, RG; Rumack, BH, 1978
)
0.85
" The estimation of the pharmacokinetic constants by a simultaneous curve fitting with a direct search procedure, based on an open two-compartment model, showed for the liquid as well as for the tablet formulation a good conformable and dosage proportional behaviour of the relative bioavailability."( [Comparative pharmacokinetics of paracetamol in humans following single oral and rectal administration (author's transl)].
Berner, G; Haase, W; Liedtke, R; Nicolai, W; Staab, R; Wagener, HH, 1979
)
0.26
" With the same dosage serum concentrations are lower after rectal application than after oral."( [Investigations concerning temperature and serum concentrations of paracetamol in febrile infants following rectal application of paracetamol (author's transl)].
Windofer, A, 1978
)
0.26
" The dosage of analgesic compound required to control each episode of tension headache was smaller than that of acetaminophen."( Study of a new analgesic compound in the treatment of tension headache.
Borges, J; Zavaleta, C, 1976
)
0.47
" The hallmark of severe (grade III) damage is centrizonal necrosis, for which there is probably a dosage threshold."( Evaluation of paracetamol-induced damage in liver biopsies. Acute changes and follow-up findings.
Douglas, AP; Hamlyn, AN; James, OF; Lesna, M; Watson, AJ, 1976
)
0.26
" Daily dosing with acetaminophen for up to 3 weeks increased the rate of elimination of 14C from the blood after 4 h, and increased the urinary excretion of both total 14C and the glucuronide and sulfate conjugates."( Effect of subacute dosing and phenobarbital and 3-methylcholanthrene pretreatment on the metabolism of acetaminophen in rats.
Beaubien, AR; Thomas, BH; Zeitz, W, 1977
)
0.8
" The pharmacokinetic characteristics of a drug as well as the severity of liver disease should be taken into account when considering drug dosage in patients with chronic liver disease."( Antipyrine, paracetamol, and lignocaine elimination in chronic liver disease.
Adjepon-Yamoah, KK; Finlayson, ND; Forrest, JA; Prescott, LF, 1977
)
0.26
" The effect of activated charcoal on acetaminophen absorption by normal volunteers was determined as a function of the dose of charcoal, the dosage form of acetaminophen, and the charcoal-to-acetaminophen dose ratio."( Effect of activated charcoal on acetaminophen absorption.
Houston, JB; Levy, G, 1976
)
0.81
" The children were divided into 3 groups on the basis of dosage (5, 10 and 20 mg/kg body weight)."( [Investigations concerning serum concentration and temperature following oral application of a new paracetamol preparation (author's transl)].
Vogel, C; Windorfer, A, 1976
)
0.26
" Ibuprofen showed suppression in most tissues three hours after dosing with a return to control values by twenty-four hours."( In vivo suppression of prostaglandin biosynthesis by non-steroidal anti-inflammatory agents.
Fitzpatrick, FA; Wynalda, MA, 1976
)
0.26
" Between the effects of this dosage of phenylbutazone and other non-steroidal antirheumatic drugs, however, no significant difference could be detected."( [Clinical study on a new acetylsalicylic acid/paracetamol preparation with gastric acid resistant coating (Safapryn), and on two various phenylbutazone dosages in patients with primary chronic polyarthritis as based on a new evaluation method].
Anderson, JA; Bell, AM; Brooks, PM; Buchanan, WW; Fowler, PD; Lee, P; Walker, JJ,
)
0.13
" Application to liquid and solid dosage forms and body fluids has been demonstrated."( Determination of acetaminophen in pharmaceutical preparations and body fluids by high-performance liquid chromatography with electrochemical detection.
Kissinger, PT; Riggin, RM; Schmidt, AL, 1975
)
0.59
" The procedure was applied to commercial dosage forms."( Differentiating nonaqueous titration of aspirin, acetaminophen, and salicylamide mixtures.
Blake, MI; Bode, DW; DeNardo, JJ; Rhodes, HJ, 1975
)
0.51
"Urinary excretion of acetaminophen after rectal administration of three suppository formatulations obtained from hospital and commercial sources was compared to that after oral administration of a tablet dosage form."( Bioavailability of acetaminophen suppositories.
Feldman, S, 1975
)
0.9
" Groups of homozygotes were dosed by gavage with aspirin, phenacetin and paracetamol for 4 weeks."( The induction of renal papillary necrosis in Gunn rats by analgesics and analgesic mixtures.
Axelsen, RA, 1975
)
0.25
" The effect of administering activated charcoal at varying intervals after dosing on the blood drug-level profiles of paracetamol and amylobarbitone was assessed by comparison with the profiles obtained when charcoal therapy was withheld."( Studies with activated charcoal in the treatment of drug overdosage using the pig as an animal model.
Lipscomb, DJ; Widdop, B, 1975
)
0.25
" The trend tests for the evidence of dose-response effects for both SCE and CA were significant."( Sister-chromatid exchange and chromosome aberrations induced by paracetamol in vivo in bone-marrow cells of mice.
Giri, AK; Khan, KA; Sivam, SS, 1992
)
0.28
"Relationships between pharmacodynamics (drug concentration and effect) and pharmacokinetics were used to develop an oral, controlled-release-bead dosage form."( Pharmacokinetics and pharmacodynamics in the design of controlled-release beads with acetaminophen as model drug.
Ayres, JW; Hossain, M, 1992
)
0.51
" The clinico-pathophysiology and toxicology of paracetamol poisoning is briefly reviewed in an attempt to establish how low a fatal paracetamol dosage can go."( The fatal paracetamol dosage--how low can you go?
Patel, F, 1992
)
0.28
" Tolerance in terms of withdrawals or side-effect profile did not appear to the dosage of each preparation administered."( The efficacy and tolerability of controlled-release dihydrocodeine tablets and combination dextropropoxyphene/paracetamol tablets in patients with severe osteoarthritis of the hips.
Costello, F; Eves, MJ; James, IG; Lloyd, RS; Miller, AJ, 1992
)
0.28
" Further pharmacokinetic-pharmacodynamic studies with use of individual ibuprofen stereoisomers and other dosing regimens are indicated."( Pharmacokinetics and pharmacodynamics of ibuprofen isomers and acetaminophen in febrile children.
Cox, S; Edge, JH; Kelley, MT; Mortensen, ME; Walson, PD, 1992
)
0.52
" This trial design (crossover with multiple dosing in outpatients) is a sensitive way of testing for analgesia, and is potentially more predictive of adverse effect problems than single-dose studies."( A multiple dose comparison of combinations of ibuprofen and codeine and paracetamol, codeine and caffeine after third molar surgery.
Carroll, D; Guest, P; Juniper, RP; McQuay, HJ; Moore, RA, 1992
)
0.28
" The failure to antagonize ethanol-induced subjective and physiologic effects by acetaminophen in humans may be due to species differences or inadequate dosage of the PGSI."( Acetaminophen fails to inhibit ethanol-induced subjective effects in human volunteers.
George, FR; Henningfield, JE; Klein, SA; Pickworth, WB, 1992
)
1.95
", 2 hr after dosing depleted 60 to 80% of hepatic PAPS."( Homeostasis of sulfate and 3'-phosphoadenosine 5'-phosphosulfate in rats after acetaminophen administration.
Kim, HJ; Klaassen, CD; Madhu, C; Rozman, P, 1992
)
0.51
" In some circumstances, osmolality and pH affected drug release from dosage forms coated with this polymer system."( Mechanisms to control drug release from pellets coated with a silicone elastomer aqueous dispersion.
Dahl, TC; Sue, II, 1992
)
0.28
" Six children were withdrawn from the study, two because of dosing errors, three because of hypothermia (temperature of less than 35."( Comparison of multidose ibuprofen and acetaminophen therapy in febrile children.
Braden, NJ; Chomilo, F; Galletta, G; Sawyer, LA; Scheinbaum, ML; Walson, PD, 1992
)
0.55
"03) at 4 hr after dosing following SURc 800."( Plasma concentration of paracetamol and its major metabolites after p.o. dosing with paracetamol or concurrent administration of paracetamol and its N-acetyl-DL-methionine ester in mice.
Ingebrigtsen, K; Lausund, P; Nafstad, I; Skoglund, LA, 1992
)
0.28
" However, these results do not favor vidarabine dosage supplementation in this indication because the duration of PE is less than 8 per cent of a daily administration period."( Diclofenac, paracetamol, and vidarabine removal during plasma exchange in polyarteritis nodosa patients.
Fauvelle, F; Guillevin, L; Leon, A; Nicolas, P; Perret, G; Petitjean, O; Tod, M,
)
0.13
" However, pain intensity scores indicate that APAP double dose gave less analgesia toward the end of the dosing interval than the standard regimen."( Effects of acetaminophen after bilateral oral surgery: double dose twice daily versus standard dose four times daily.
Pettersen, N; Skoglund, LA, 1991
)
0.67
" We have studied the effects of multiple dosing of levodopa on gastric emptying and levodopa absorption in eight healthy young volunteers in a randomised two-way cross-over study."( Gastric emptying in healthy volunteers after multiple doses of levodopa.
George, CF; Macklin, B; Renwick, AG; Roseveare, C; Waller, DG, 1991
)
0.28
"Second derivative UV spectrophotometry proved to be a useful tool for the determination of acetaminophen, even in the presence of high amounts of the impurity, 4-aminophenol and the background effect caused by dissolved excipients of some dosage forms."( Derivative spectrophotometric assay of acetaminophen and spectrofluorimetric determination of its main impurity.
Milch, G; Szabó, E, 1991
)
0.77
" Incidence of side effects and toxicity may be reduced by choice of drug and modification of dosing regimen."( Nonnarcotic analgesics and tricyclic antidepressants for the treatment of chronic nonmalignant pain.
Richlin, DM, 1991
)
0.28
" Peak plasma concentrations were lower for the two GMS formulations after single dosing compared to the oral solution."( Kinetics of acetaminophen after single- and multiple-dose oral administration as a gradient matrix system to healthy male subjects.
Raghoebar, M; Tukker, JJ; van Bommel, EM, 1991
)
0.66
" Flurbiprofen in 50 mg and 100 mg dosages demonstrated effective analgesic activity with the 100 mg dosage being at least as effective as the acetaminophen/codeine combination."( The analgesic efficacy of flurbiprofen compared to acetaminophen with codeine.
Cooper, SA; Kupperman, A, 1991
)
0.73
" In the therapeutic setting of treatment of fever and pain in children, paracetamol is regarded as a drug with a higher therapeutic index, and as such, there seems to be little concern with strict adherence to dosage regimes."( Paracetamol poisoning in children and hepatotoxicity.
Buchanan, N; Penna, A, 1991
)
0.28
"Ibuprofen was evaluated as an antipyretic agent in 178 children (aged 3 months to 12 years) to compare dosage (5 vs 10 mg/kg), establish absolute efficacy (with a placebo control group), determine relative efficacy (ibuprofen vs acetaminophen), evaluate maximum efficacy, and identify potential confounding variables."( Single-dose, placebo-controlled comparative study of ibuprofen and acetaminophen antipyresis in children.
Bertrand, KM; Brown, RD; Eichler, VF; Johnson, VA; Kearns, GL; Lowe, BA; Wilson, JT, 1991
)
0.7
" For 13 patients, the unit dosage of acetaminophen was 325 mg for 3 days; for 8 patients, the dosage was 650 mg for 3 days; and, for 6 patients, the dosage was 650 mg for 7 days."( Acetaminophen does not impair clearance of zidovudine.
Antoniskis, D; Cohen, J; Ko, R; Koda, R; Leedom, J; Nicoloff, J; Sattler, FR; Shields, M, 1991
)
2
" Thus no change in acetaminophen dosage would be required in patients treated with disulfiram."( The influence of disulfiram on acetaminophen metabolism in man.
Jørgensen, L; Poulsen, HE; Ranek, L, 1991
)
0.9
"The effects of oral dosing with paracetamol (40 mg/kg/day for 3 days) on serum thromboxane B2 (TXB2), glomerular filtration rate (GFR), sodium homeostasis, urinary excretion of prostaglandin E2 (PGE2) and on some other renal function parameters were investigated in 10 healthy young controls aged 23-26 years, 9 healthy elderly persons with normal renal function aged 66-78 years and 9 patients with chronic stable impaired renal function."( Acute effects of paracetamol on prostaglandin synthesis and renal function in normal man and in patients with renal failure.
Berg, KJ; Djøseland, O; Gjellan, A; Hundal, O; Knudsen, ER; Rugstad, HE; Rønneberg, E, 1990
)
0.28
" Two moderate respiratory depressions occurred in 1989 due to error in dosage with no consequence for the child."( [Intraoperative and postoperative analgesia in pediatric surgery. 1 years' experience].
Charles-Guillard, S; Heloury, Y; Meignier, M; Pannier, M; Ricard, P; Rogez, JM; Zaouter, M, 1990
)
0.28
"In this study we evaluated subjects with Down's syndrome for the possibility that direct or indirect gene dosage effects of trisomy 21 alter the fate of acetaminophen."( Noninvasive determination of acetaminophen disposition in Down's syndrome.
Cooke, RE; Corcoran, GB; Griener, JC; Msall, ME, 1990
)
0.77
" This side effect can be found in excessive overdosages exceeding the therapeutical dosage significantly."( [Paracetamol hepatotoxicity].
Lubec, G, 1990
)
0.28
" Both plasma elimination half life and area under the plasma concentration time curve were significantly increased in neonates after suppository dosing compared with older children."( Pharmacokinetics of paracetamol after cardiac surgery.
Booker, PD; Hopkins, CS; Underhill, S, 1990
)
0.28
" Dose-response studies showed that minoxidil sulfate is 14 times more potent than minoxidil in stimulating cysteine incorporation in cultured follicles."( Minoxidil sulfate is the active metabolite that stimulates hair follicles.
Baker, CA; Buhl, AE; Johnson, GA; Waldon, DJ, 1990
)
0.28
" No significant differences were found in the disposition kinetics of acetaminophen and its glucuronide and sulfate conjugates during two consecutive dosing intervals (08."( Circadian rhythm of serum sulfate levels in man and acetaminophen pharmacokinetics.
Hoffman, DA; Verbeeck, RK; Wallace, SM, 1990
)
0.76
" Ranitidine reduced the expected acetaminophen-induced hepatoxicity in a dose-response manner."( Effect of ranitidine on acetaminophen-induced hepatotoxicity in dogs.
Barone, M; Bell, S; Demetris, J; Guglielmi, FW; Makowka, L; Panella, C; Polimeno, L; Prelich, JG; Rizzi, S; Van Thiel, DH, 1990
)
0.87
" Dosage was repeated after 2 h if the attack had not abated."( Randomized double-blind comparison of tolfenamic acid and paracetamol in migraine.
Andersen, B; Christiansen, LV; Larsen, BH; Olesen, J, 1990
)
0.28
" 3-(Cystein-S-yl)acetaminophen adducts were detected in the 55-kDa liver protein 30 min after dosing and prior to the development of significant toxicity."( Immunoblot analysis of protein containing 3-(cystein-S-yl)acetaminophen adducts in serum and subcellular liver fractions from acetaminophen-treated mice.
Benson, RW; Hinson, JA; Pumford, NR; Roberts, DW, 1990
)
0.86
" The dose-response relationship varied in the three systems (stomach, salivary glands and heart rate) studied."( Effect of intravenous atropine on gastric emptying, paracetamol absorption, salivary flow and heart rate in young and fit elderly volunteers.
Bateman, DN; Rashid, MU, 1990
)
0.28
"A modified enzyme-based colorimetric method has been used to determine plasma paracetamol profiles following single dose (2 x 500 mg) administration of three dosage forms to non-patient volunteers."( Application of a modified colorimetric enzyme assay to monitor plasma paracetamol levels following single oral doses to non-patient volunteers.
Edwardson, PA; Nichols, JD; Sugden, K, 1989
)
0.28
" Changes in the activity of indicatory enzymes may be better expressed in the dose-response arrangement."( Dynamics of glutathione levels in liver and indicatory enzymes in serum in acetaminophen intoxication in mice.
Brzeźnicka, EA; Piotrowski, JK, 1989
)
0.51
"Two spectrophotometric methods have been developed for the simultaneous determination of chlorzoxazone and acetaminophen in their combined dosage forms."( Simultaneous determination of chlorzoxazone and acetaminophen in combined dosage forms by an absorbance ratio technique and difference spectrophotometry.
Chatterjee, PK; Jain, CL; Sethi, PD, 1989
)
0.75
" Analysis of the concentration-time curve for antipyrine after simultaneous dosing and start of the 23% regimen suggests that the increase in metabolic capacity occurred within a few hours."( Effects of parenteral amino acid nutritional regimens on oxidative and conjugative drug metabolism.
Lee, YJ; Pantuck, CB; Pantuck, EJ; Weissman, C, 1989
)
0.28
" Patients treated with benorylate 4 g reported significantly less pain between 3-6 h after dosage than those treated with placebo."( The efficacy of benorylate in postoperative dental pain.
Moore, U; Nicholson, E; Rawlins, MD; Seymour, RA; Williams, FM, 1989
)
0.28
" Following 750 mg/kg APAP, ip, a nephrotoxic dosage in 12-month-old but not 3-month-old rats, renal cortical APAP concentrations were significantly greater in 12-month-old compared with 3-month-old SD rats at 3, 4, and 6 hr after treatment."( Role of pharmacokinetics and metabolism in the enhanced susceptibility of middle-aged male Sprague-Dawley rats to acetaminophen nephrotoxicity.
Goldstein, RS; Hook, JB; Mico, BA; Tarloff, JB,
)
0.34
" In general, dosage escalation and compulsive drug-seeking behaviors were not seen."( Pharmacologic management of pain in children and adolescents.
Berde, CB; Shannon, M, 1989
)
0.28
" The dosage schedule for intravenous N-acetylcysteine should probably be modified since adverse reactions invariably occur early when plasma concentrations are at their highest, and liver damage was prevented just as effectively at the lowest as at the highest Cmax."( The disposition and kinetics of intravenous N-acetylcysteine in patients with paracetamol overdosage.
Donovan, JW; Jarvie, DR; Prescott, LF; Proudfoot, AT, 1989
)
0.28
"The influence of two liquid formula diets on the systemic availability of paracetamol was investigated in 12 healthy normal volunteers using a liquid and a solid paracetamol dosage form."( The influence of different formula diets and different pharmaceutical formulations on the systemic availability of paracetamol, gallbladder size, and plasma glucose.
de Vries, JX; Nickel, B; Stenzhorn, G; Walter-Sack, IE; Weber, E, 1989
)
0.28
" It was found that the composition has a considerable influence on the behaviour of the dosage form and this must be taken into account when judging the applicabilities of the three dissolution tests."( Comparative dissolution studies of rectal formulations using the Basket, the Paddle and the Flow-Through methods. I. Paracetamol in suppositories and soft gelatin capsules of both hydrophilic and lipophilic types.
Gjellan, K; Graffner, C, 1989
)
0.28
"A double-blind, parallel-group, triple-dummy-designed, single-oral-dose study compared the efficacy, tolerability, safety, and dose-response of 5 mg/kg (n = 32) and 10 mg/kg (n = 28) ibuprofen suspension, 10 mg/kg acetaminophen elixir (n = 33), and placebo liquids (n = 34) in 127 children (2 to 11 years of age) with fever (101 degrees to 104 degrees F)."( Ibuprofen, acetaminophen, and placebo treatment of febrile children.
Alexander, L; Braden, NJ; Galletta, G; Walson, PD, 1989
)
0.85
"Determination of the Relative Bioavailability of Paracetamol Following Administration of Solid and Liquid Oral Preparations and Rectal Dosage Forms."( [The relative bioavailability of paracetamol following administration of solid and liquid oral preparations and rectal dosage forms].
Guserle, R; Luckow, V; Walter-Sack, I; Weber, E, 1989
)
0.28
" These preliminary results are relevant with the use of pharmacologic dosage of ADT in hepatotoxicity prevention."( Protective effect of anethol dithiolthione against acetaminophen hepatotoxicity in mice.
Biard, D; Christen, MO; Claude, JR; Jacqueson, A; Thevenin, M; Warnet, JM, 1989
)
0.53
" The time course of the decline in PAPS values after 600 mg acetaminophen/kg showed that PAPS concentrations reached a nadir 1 hr after dosing (40% of control values)."( Acetaminophen decreases adenosine 3'-phosphate 5'-phosphosulfate and uridine diphosphoglucuronic acid in rat liver.
Hazelton, GA; Hjelle, JJ; Klaassen, CD,
)
1.82
" Due to many different pharmacokinetic properties, no perfect rules for dosage in acute or chronic hemodialysis exist."( Tranquilizers, analgetics and antidepressants in patients treated with hemodialysis.
Forycki, Z; Ibe, K; Martens, F; Thalhofer, S, 1985
)
0.27
" This indicates that although the preparation is hepatotoxic when taken acutely in overdose, in chronic therapeutic dosage it appears to be free from this hazard."( Liver function in patients on long-term paracetamol (co-proxamol) analgesia.
Hutchinson, DR; Parke, DV; Schilds, AF, 1986
)
0.27
" The effects of chronic acetaminophen dosing (1000 mg three times/day for 7 days) on a single 100 mg tablet of fenoldopam were studied in a second crossover study in seven additional volunteers."( The effect of acetaminophen on the disposition of fenoldopam: competition for sulfation.
Allison, N; Boppana, VK; Dubb, J; Stote, R; Ziemniak, JA, 1987
)
0.94
"Using a recently developed enzyme-linked immunosorbent assay specific for 3-(cystein-S-yl)acetaminophen adducts we have quantitated the formation of these specific adducts in liver and serum protein of B6C3F1 male mice dosed with acetaminophen."( Immunochemical quantitation of 3-(cystein-S-yl)acetaminophen adducts in serum and liver proteins of acetaminophen-treated mice.
Benson, RW; Hinson, JA; Potter, DW; Pumford, NR; Roberts, DW; Rowland, KL, 1989
)
0.76
" Since the normal human dosage of paracetamol is up to 4 g/day, which is equivalent to 1% of the diet, the possibility of induction of amino acid deficiency by chronic use of paracetamol in normal dosage is raised."( Effect of D- or L-methionine and cysteine on the growth inhibitory effects of feeding 1% paracetamol to rats.
Armstrong, GR; Beales, D; McLean, AE, 1989
)
0.28
" The same dosage of zinc was not hepatoprotective when given 1 hr after acetaminophen."( Protection by zinc against acetaminophen induced hepatotoxicity in mice.
Chengelis, CP; Dodd, DC; Kotsonis, FN; Means, JR, 1986
)
0.8
" Despite the decreased clearance by these pathways, reduction in paracetamol dosage should not be necessary in the elderly."( Comparison of paracetamol metabolism in young adult and elderly males.
Birkett, DJ; Miners, JO; Penhall, R; Robson, RA, 1988
)
0.27
" A close correlation between administered dosage of the drug, acetaminophen blood levels and methemoglobinemia was found."( [Paracetamol poisoning in a swine model].
Artwohl, J; Dziwisch, L; Henne-Bruns, D; Kremer, B, 1988
)
0.52
"The gastric emptying rates of oral dosage forms of different sizes were studied in humans and beagle dogs measuring of marker drugs such as acetaminophen, aspirin and pyridoxal phosphate in plasma or urine."( Gastric emptying rates of drug preparations. I. Effects of size of dosage forms, food and species on gastric emptying rates.
Aoyagi, N; Ejima, A; Kaniwa, N; Ogata, H, 1988
)
0.48
" A close correlation between administered dosage of the drug, acetaminophen blood levels, and methemoglobinemia was found."( Acetaminophen-induced acute hepatic failure in pigs: controversical results to other animal models.
Artwohl, J; Broelsch, C; Henne-Bruns, D; Kremer, B, 1988
)
1.96
" Adjustment of dosage of drugs that are metabolized by the microsomal enzymes may be required in patients on anti-tubercular drug regimen in which rifampicin is included."( Effect of short course chemotherapy on salivary paracetamol elimination.
Adithan, C; Bahadur, P; Bapna, JS; Kamatchi, GL; Madhusudanarao, K; Ray, K; Seetharaman, ML; Venkatadri, N, 1988
)
0.27
"A case of acetaminophen poisoning following the ingestion of 26 g of acetaminophen by incremental dosing over a 25-h period is reported."( Subacute acetaminophen overdose after incremental dosing.
Kuhns, DW; Mathis, RD; Walker, JS,
)
0.95
" Their occurrence varies, both qualitatively and quantitatively, and an attempt is made to assess these differences, although it may be that they are related directly to differences in dosage and therapeutic efficacy."( Aspirin, paracetamol and non-steroidal anti-inflammatory drugs. A comparative review of side effects.
Fowler, PD,
)
0.13
" dosage schedule produces average steady-state blood levels equivalent to the peak response for a single 200 mg dose."( Clinical experience with flupirtine in the U.S.
Arndt, WF; McMahon, FG; Montgomery, PA; Newton, JJ; Perhach, JL, 1987
)
0.27
" As such dosage involves pronounced side-effects, it seems more appropriate to employ the combination of 50 mg indomethacin and 4 g paracetamol, whereby similar analgesia can be obtained without an increase in side-effects."( Equianalgesic effects of paracetamol and indomethacin in rheumatoid arthritis.
Melander, A; Seideman, P, 1988
)
0.27
" A dose-response relation for cataractogenesis was evident in C57BL/6 mice using doses of 300 and 400 mg/kg, with the higher dose producing similar plasma acetaminophen concentrations but twofold higher glucuronide concentrations."( Pharmacological studies on the in vivo cataractogenicity of acetaminophen in mice and rabbits.
Avaria, M; Basu, PK; Lubek, BM; Wells, PG, 1988
)
0.71
" The slopes of the dose-response plots for individual chemicals were markedly different."( Comparison of cell death and adenosine triphosphate content as indicators of acute toxicity in vitro.
Cross, DM; Kemp, RB; Meredith, RW, 1988
)
0.27
" Rabbits were dosed intravenously with acetaminophen (NAPA, 30 mg/kg)."( A method for the preparation of calibration curves for acetaminophen glucuronide and acetaminophen sulfate in rabbit urine without use of authentic compounds in high-performance liquid chromatography.
Baba, S; Nakamura, J; Nakamura, T; Sasaki, H; Shibasaki, J, 1987
)
0.79
" It is a process of limited capacity; the extent of sulfate conjugate formation and the metabolic clearance of drugs subject to conjugation with sulfate depend therefore on the dose, the dosage form, the route of administration, and the rate and duration of administration as well as on the pharmacokinetic parameters of competing processes."( Sulfate conjugation in drug metabolism: role of inorganic sulfate.
Levy, G, 1986
)
0.27
" A double-placebo method was used, as dosage regimens for the two treatments were different."( The effects of indoprofen vs paracetamol on swelling, pain and other events after surgery.
Olstad, OA; Skjelbred, P, 1986
)
0.27
" About 50% of patients given salicylate in full anti-inflammatory dosage develop minor abnormalities of liver function."( Liver damage with non-narcotic analgesics.
Prescott, LF, 1986
)
0.27
" The dosage was two tablets taken as early as possible in the acute attack."( A treatment for the acute migraine attack.
Adam, EI,
)
0.13
" Route of administration was found to influence both the pattern and magnitude of the M/P ratio after acetaminophen dosing in the goat."( Pharmacologic factors contributing to variance in the milk to plasma ratio for acetaminophen in the goat.
Brown, RD; Hinson, JL; Johnson, VA; Smith, IJ; Wilson, JT; Woods, TW, 1987
)
0.72
" Continuous dose-response and step-function parameterizations of aspirin exposure were both statistically significant and not clearly distinguishable from each other."( Aspirin and acetaminophen use by pregnant women and subsequent child IQ and attention decrements.
Barr, HM; Bleyer, WA; Martin, DC; Sampson, PD; Shepard, TH; Streissguth, AP; Treder, RP, 1987
)
0.65
" From 8 h post dosing a decrease of 14C-APAP or its metabolites coincided with recovery of the hepatic GHS level and the regeneration of the hepatic cells caused by APAP 400 mg."( Time development of distribution and toxicity following single toxic APAP doses in male BOM:NMRI mice.
Ingebrigtsen, K; Jansen, JH; Nafstad, I; Skoglund, LA, 1987
)
0.27
" Bile was collected prior to dosing and for 5-6 hours after dosing at varying time intervals."( BHA (2(3)-tert-butyl-4-hydroxyanisole)-mediated modulation of acetaminophen phase II metabolism in vivo in Fisher 344 rats.
Boroujerdi, M; McLaughlin, WJ, 1987
)
0.51
" Cortisol hydroxylation was increased in the group of epileptics with large inter-individual variations notwithstanding a similar dosage of inducers."( Urinary 6-beta-OH-cortisol and paracetamol metabolites as a probe for assessing oxidation and conjugation of chemicals in humans.
Dolara, P; Lodovici, M; Muscas, GC; Salvadori, M; Zaccara, G, 1987
)
0.27
" In Australia, the pediatric usage of aspirin has been extremely low for the past 25 years (less than 1% of total dosage units sold), with paracetamol (acetaminophen) dominating the pediatric analgesic and antipyretic market."( A catch in the Reye.
Gillis, J; Kilham, HA; Orlowski, JP, 1987
)
0.47
" The data suggest normal single dosage for these drugs in acute viral hepatitis, and dosage modification only in severe cases."( Reduction of paracetamol and aspirin metabolism during viral hepatitis.
Beermann, B; Britton, S; Jorup-Rönström, C; Melander, A; Wåhlin-Boll, E,
)
0.13
" Patients were maintained on their normal treatment and dosage schedules (600 mg every 3 to 8 h) for the study."( The effect of acetaminophen administration on its disposition and body stores of sulphate.
Danilkewich, A; Hendrix-Treacy, S; Hindmarsh, KW; Wallace, SM; Wyant, GM, 1986
)
0.63
" In group P a statistically significant, but transitory, rise in plasma ALAT level following dosage was seen."( Efficacy of paracetamol-esterified methionine versus cysteine or methionine on paracetamol-induced hepatic GSH depletion and plasma ALAT level in mice.
Aalen, O; Ingebrigtsen, K; Nafstad, I; Skoglund, LA, 1986
)
0.27
" Acetaminophen, cimetidine, or ranitidine were begun 24 hours prior to oxaprozin dosage and continued for the 10-day duration of each trial."( Interaction of oxaprozin with acetaminophen, cimetidine, and ranitidine.
Greenblatt, DJ; Harmatz, JS; Matlis, R; Scavone, JM, 1986
)
1.47
" The dosage of the suppositories depended upon body weight; medication was applied up to 3 times a day."( Clinical experience and results of treatment with suprofen in pediatrics. 2nd communication: Use of suprofen suppositories as an antipyretic in children with fever due to acute infections/A single-blind controlled study of suprofen versus paracetamol.
Michos, N; Stocker, H; Sundal, EJ; Weippl, G, 1985
)
0.27
" N-Acetyl-L-cysteine, L-2-oxothiazolidine-4-carboxylate or the L- or D-isomers of 2-methylthiazolidine-4-carboxylate were administered to male mice immediately after a hepatotoxic dosage of acetaminophen (5."( Effects of cysteine pro-drugs on acetaminophen-induced hepatotoxicity.
Hazelton, GA; Hjelle, JJ; Klaassen, CD, 1986
)
0.74
" Since cimetidine did not affect acetaminophen pharmacokinetics to any significant extent, clinical combination of both medications at therapeutic dosage presumably would not produce adverse interactions."( Cimetidine--acetaminophen interaction in humans.
Chen, MM; Lee, CS, 1985
)
0.93
"Oral N-acetylcysteine (NAC), IV NAC, and IV sodium sulfate were evaluated as treatments for cats dosed orally with toxic sublethal doses of acetaminophen (APAP)."( Effects of various antidotal treatments on acetaminophen toxicosis and biotransformation in cats.
Leipold, HW; Oehme, FW; Savides, MC, 1985
)
0.73
" Plasma drug concentration vs time curves were obtained after dosage at 08."( Chronopharmacokinetics of paracetamol in normal subjects.
Bosch, E; Malan, J; Moncrieff, J, 1985
)
0.27
" Codeine and paracetamol tested individually were effective only at relatively high dosage and, like the combination, their analgesic effects were greater after rectal administration and more clearly dose-dependent than after oral administration."( Acute toxicity and analgesic action of a combination of buclizine, codeine and paracetamol ('Migraleve') in tablet and suppository form in rats.
Behrendt, WA; Cserepes, J, 1985
)
0.27
"0% dosage level, 20% of rats of both sexes developed neoplastic nodules of the liver, a statistically significant incidence."( Induction by paracetamol of bladder and liver tumours in the rat. Effects on hepatocyte fine structure.
Flaks, A; Flaks, B; Shaw, AP, 1985
)
0.27
" Almost half of the patients taking aspirin were unable to tolerate the drug in adequate dosage for six months."( Treatment of rheumatoid arthritis with fenoprofen: comparison with aspirin.
Balme, HW; Berry, H; Hart, FD; Huskisson, EC; Scott, J; Wojtulewski, JA, 1974
)
0.25
" A starting dose of 200 mg/kg/day should be used, and the salicylate level checked at seven days and the dosage adjusted to give an anti-inflammatory effect-that is, a blood salicylate level of between 25 and 30 mg/100 ml."( Benorylate in management of Still's disease.
Ansell, BM; Powell, RH, 1974
)
0.25
" At low dosage this amounts to 33% of the administered dose in this species."( Formation and disposition of the minor metabolites of acetaminophen in the hamster.
Gemborys, MW; Mudge, GH,
)
0.38
" Data are presented in 46 patients who took aspirin continuously for 10 or more years (mean total dosage 35 kg) in whom there was no evidence of significant renal dysfunction."( Aspirin and renal disease.
Emkey, RD, 1983
)
0.27
" The teratogenic potential of a drug is related to dosage and time of administration."( Analgesics during pregnancy.
Niederhoff, H; Zahradnik, HP, 1983
)
0.27
" A clinical dose-response relationship has been established, and time-effect curves indicate that the total threshold-raising effect depends on dosage frequency."( Review of the comparative analgesic efficacy of salicylates, acetaminophen, and pyrazolones.
Mehlisch, DR, 1983
)
0.51
" Interpretation of single dose studies with extrapolation to repeated dosing in the practice setting is difficult."( An appraisal of codeine as an analgesic: single-dose analysis.
Honig, S; Murray, KA,
)
0.13
" Some of the newer NSAIDs seem at normal dosage to be far less damaging than traditional ASA or indomethacin."( Gastroduodenal damage due to drugs, alcohol and smoking.
Domschke, S; Domschke, W, 1984
)
0.27
" The mean elimination half-life of dextropropoxyphene after multiple dosing was 35."( Pharmacokinetics of dextropropoxyphene and nordextropropoxyphene in elderly hospital patients after single and multiple doses of distalgesic. Preliminary analysis of results.
Crome, P; Flanagan, RJ; Gain, R; Ghurye, R, 1984
)
0.27
"A high-performance liquid chromatographic (HPLC) method has been developed for the quantitation of acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylpropanolamine hydrochloride in combination in pharmaceutical dosage forms using a single column and three different mobile phases."( Quantitation of acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylpropanolamine hydrochloride in combination using high-performance liquid chromatography.
Das Gupta, V; Heble, AR, 1984
)
0.83
"Knowledge of pharmacokinetics (action of organisms on drugs) and pharmacodynamics (drug action on living organisms) allows for the proper assessment of the most suitable dose, dosing intervals, route of administration, as well as dose adjustment when clinically indicated."( Pharmacokinetic considerations of common analgesics and antipyretics.
Hartwig-Otto, H, 1983
)
0.27
" A similar dosing of hepatocytes from phenobarbital-induced or normal rats is ineffective in that respect."( Paracetamol-stimulated lipid peroxidation in isolated rat and mouse hepatocytes.
Albano, E; Biasi, F; Chiarpotto, E; Dianzani, MU; Poli, G, 1983
)
0.27
" The dosage used was 1 tablet 3-times daily."( Effect of a combination of orphenadrine/paracetamol tablets ('Norgesic') on myalgia: a double-blind comparison with placebo in general practice.
Høivik, HO; Moe, N, 1983
)
0.27
" Patients were allocated at random to receive 2 tablets 3-times daily of either treatment for 6 weeks and were then crossed over to the alternative treatment at the same dosage for a further 6 weeks."( Paracetamol plus metoclopramide ('Paramax') as an adjunct analgesic in the treatment of arthritis.
Boston, PF; Matts, SG, 1983
)
0.27
" Based on available clinical and pharmacokinetic data, acetaminophen should be dosed with single doses in the range of 10-15 mg/kg at 4-hour intervals."( Pediatric dosing of acetaminophen.
Temple, AR, 1983
)
0.84
" The 0-24 h and the 0-72 h areas under the plasma level curves together with the maximum plasma concentration reached, correlated strongly with the dosage level used."( Nabumetone--a novel anti-inflammatory drug: the influence of food, milk, antacids, and analgesics on bioavailability of single oral doses.
Buscher, G; Dierdorf, D; Mügge, H; von Schrader, HW; Wolf, D, 1983
)
0.27
" Biliary excretion of the various metabolites of acetaminophen increased from 20 to 49% as the dosage was increased from 37."( Glucuronidation and biliary excretion of acetaminophen in rats.
Hjelle, JJ; Klaassen, CD, 1984
)
0.79
" In cats, APAP-sulfate was the major metabolite in urine at all three dosage levels, but the fraction of the total urinary metabolites represented by APAP-sulfate decreased as the dosage increased."( The toxicity and biotransformation of single doses of acetaminophen in dogs and cats.
Leipold, HW; Nash, SL; Oehme, FW; Savides, MC, 1984
)
0.52
" A statiscally significant dose-response relationship was obtained between the supplementary doses of codeine and analgesic efficacy."( Paracetamol plus supplementary doses of codeine. An analgesic study of repeated doses.
Ahlström, U; Bångens, S; Hellem, S; Johansson, G; Jönsson, E; Nordh, PG; Persson, G; Quiding, H, 1982
)
0.26
" The non-steroid antirheumatic benoxaprofen was used alone in a dosage of a 1 x 600 mg tablet daily."( [Benoxaprofen in the treatment of spondylosis and spondylarthrosis (author's transl)].
Hevelke, G; Schilling, E, 1981
)
0.26
" On the basis of kinetics data alone, adjustment of acetaminophen dosage for the elderly is generally not necessary."( Acetaminophen kinetics in the elderly.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ, 1982
)
1.96
" Absolute bioavailability of both oral dosage forms was significantly less then 100 per cent in all groups."( Age does not alter acetaminophen absorption.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ, 1982
)
0.59
" In 87% of the cases receiving aspirin, their maximum daily dosage did not exceed recommended levels, but their doses were higher than those of controls receiving aspirin."( Reye's syndrome and medication use.
Campbell, RJ; Correa-Villaseñor, A; Hall, LJ; Halpin, TJ; Holtzhauer, FJ; Hurwitz, ES; Lanese, R; Rice, J, 1982
)
0.26
" Thus, age as such does not appear to be a critical determinant in the design of oral acetaminophen dosage schedules."( Effect of food on acetaminophen absorption in young and elderly subjects.
Abernethy, DR; Ameer, B; Divoll, M; Greenblatt, DJ,
)
0.69
" Single voided urine samples were collected from the infants three to five hours after maternal dosing (two hours after nursing at peak maternal milk levels)."( Disposition of acetaminophen in milk, saliva, and plasma of lactating women.
Berlin, CM; Ragni, M; Yaffe, SJ, 1980
)
0.61
" In the present work, human serum has been dosed with the phenolic compounds of immediate relevance in exogenous and endogenous intoxication, and the effectiveness of various adsorbent materials for the elimination of the toxins from the serum has been investigated."( Properties of agarose-encapsulated adsorbents. II. Elimination of endogenous and exogenous phenolic compounds from human serum.
Brunner, G; Harstick, K; Holloway, CJ; Neumann, E, 1981
)
0.26
" As total weight may exceed 200 per cent of the ideal weight in this patient group, dosing according to total rather than ideal weight could lead to toxic or lethal effects when using the 10 mg/kg dosing recommendation."( The effect of obesity on acetaminophen pharmacokinetics in man.
Granville, GE; Kramer, WG; Lee, WH, 1981
)
0.57
" Five of the cats were given antidotal treatment with acetylcysteine (140 mg/kg, per os) at the time of the second dosing with acetaminophen and at 8-hour intervals thereafter for a total of three treatments."( Acetylcysteine for treatment of acetaminophen toxicosis in the cat.
McKnight, ED; St Omer, VV, 1980
)
0.75
" Hence, the chronic hemodialysis patient may not need a dosage adjustment during or following hemodialysis."( Hemodialysis of acetaminophen in uremic patients.
Lee, CS; Marbury, TC; Wang, LH, 1980
)
0.61
" relative to acetaminophen dosing to inhibit CYP2E1 and CYP1A2, respectively."( Cytochrome P4502E1 inhibition by propylene glycol prevents acetaminophen (paracetamol) hepatotoxicity in mice without cytochrome P4501A2 inhibition.
Loft, S; Poulsen, HE; Roberts, DW; Thomsen, MS, 1995
)
0.9
"This study was undertaken to examine the effects of mechanical destructive forces on drug release from controlled release (CR) dosage forms in vitro and in vivo and their colonic release, using two CR tablets of acetaminophen A and B, showing slower and faster erosion rates, respectively."( Oral solid controlled release dosage forms: role of GI-mechanical destructive forces and colonic release in drug absorption under fasted and fed conditions in humans.
Aoyagi, N; Katori, N; Kojima, S; Shameem, M, 1995
)
0.48
" The release from both tablets was markedly reduced at 3-4 hrs after dosing irrespective of feeding conditions which can be attributed to release inhibition in the colon."( Oral solid controlled release dosage forms: role of GI-mechanical destructive forces and colonic release in drug absorption under fasted and fed conditions in humans.
Aoyagi, N; Katori, N; Kojima, S; Shameem, M, 1995
)
0.29
"Effects of GI destructive forces on the tablet erosion and the release inhibition in the colon must be considered in the development of CR dosage forms."( Oral solid controlled release dosage forms: role of GI-mechanical destructive forces and colonic release in drug absorption under fasted and fed conditions in humans.
Aoyagi, N; Katori, N; Kojima, S; Shameem, M, 1995
)
0.29
"00mM resulted in a dose-response relationship with regard to LDH release (243% to 750% of control) and to the loss of cell viability (0 to 67% of control)."( Protective effect of nifedipine against cytotoxicity and intracellular calcium alterations induced by acetaminophen in rat hepatocyte cultures.
Claude, JR; Dutertre-Catella, H; Ellouk-Achard, S; Mawet, E; Thevenin, M; Thibault, N,
)
0.35
" Accumulation of the toxic metabolite due to depleted glutathione stores may have occurred with prolonged high dosing in our subject and been responsible for his abnormal rise in liver enzymes."( Abnormal serum transaminases following therapeutic doses of acetaminophen in the absence of known risk factors.
Bartle, WR; Kwan, D; Walker, SE, 1995
)
0.53
" Hepatotoxic doses of acetaminophen to mice significantly altered the abundances of several liver proteins 2 h after dosing as revealed by densitometric analysis of two-dimensional electrophoretic patterns of these proteins."( A comparative study of mouse liver proteins arylated by reactive metabolites of acetaminophen and its nonhepatotoxic regioisomer, 3'-hydroxyacetanilide.
Anderson, NL; Cohen, SD; Dietz, EC; Khairallah, EA; Myers, TG; Nelson, SD,
)
0.67
"The relationships of the phasic period of interdigestive migrating contraction to gastrointestinal (GI) transit of drugs and their oral absorption were investigated in mongrel dogs by simultaneous oral dosing of acetaminophen (AAP) and salicylazosulfapyridine (SASP) at the starting points of the phase I and phase III periods of gastric contractions."( Relationship between the phasic period of interdigestive migrating contraction and the systemic bioavailability of acetaminophen in dogs.
Haga, K; Mizuta, H; Ohshiko, M; Sagara, K; Shibata, M, 1995
)
0.69
" Morphine can also be administered subcutaneously, intravenously, and rectally, which provides enhanced flexibility for dosing patients unable to take oral medications."( Management of pain in the cancer patient.
Skaer, TL,
)
0.13
" The best single dose of aspirin is that which is adequate to relieve pain; the proper dosage interval is that which sustains relief without causing toxicity."( Acetylsalicylic acid and acetaminophen.
Kacso, G; Terézhalmy, GT, 1994
)
0.59
" 30 mg/kg/day paracetamol) is sufficient, corresponding to the dosage recommended by the French pharmacopoeia."( Pharmacokinetics of paracetamol in the neonate and infant after administration of propacetamol chlorhydrate.
Autret, E; Breteau, M; Dutertre, JP; Furet, Y; Jonville, AP; Laugier, J, 1993
)
0.29
" We examined urine and bile samples from Syrian golden hamsters after dosing with (2H4)acetaminophen (D4-APAP), with particular emphasis on the rich range of conjugated metabolites that are known to be produced."( Application of high-performance liquid chromatography/chemical reaction interface mass spectrometry for the analysis of conjugated metabolites: a demonstration using deuterated acetaminophen.
Abramson, F; Teffera, Y, 1994
)
0.7
" After correction of recovery values using in vivo retrodialysis prior to dosing the animal, we obtained similar data as compared to conventional sampling techniques."( Application of microdialysis to the pharmacokinetics of analgesics: problems with reduction of dialysis efficiency in vivo.
Brune, K; Geisslinger, G; Sauernheimer, C; Williams, KM, 1994
)
0.29
"01) but not with the weight of the control women, this suggests that weight gain might be used to determine the women in whom dosage adjustment is needed."( Paracetamol pharmacokinetics during the first trimester of human pregnancy.
Beaulac-Baillargeon, L; Rocheleau, S, 1994
)
0.29
" The prescribed and administered mean dosages were less than the minimum recommended dosage for morphine."( Postoperative pain management in preverbal children: the prescription and administration of analgesics with and without caudal analgesia.
Altimier, L; Dick, MJ; Holditch-Davis, D; Lawless, S; Norwood, S, 1994
)
0.29
" Oral temperature was measured before dosing and then every 4 h until apyrexia."( Antipyretic efficacy of indomethacin and acetaminophen in uncomplicated falciparum malaria.
Looareesuwan, S; Wilairatana, P, 1994
)
0.55
" The dosage usually applied in France ranges from 20 to 30 mg/kg/d, which is low and probably with little efficiency in many cases."( [Paracetamol and other antipyretic analgesics: optimal doses in pediatrics].
Stamm, D, 1994
)
0.29
"The purpose of this study was to evaluate the dose-response of paracetamol and to assess its plasma concentration-effect relationship."( [Which analgesic dosage of paracetamol?].
Collart, L; Dayer, P; Desmeules, JA; Piguet, V, 1994
)
0.29
" It is concluded that at the dosage used omeprazole does not increase the rate of oxidative and conjugative reactions involved in the metabolism of phenacetin and paracetamol respectively."( Omeprazole does not enhance the metabolism of phenacetin, a marker of CYP1A2 activity, in healthy volunteers.
Bartoli, A; Cipolla, G; Crema, F; Gatti, G; Perucca, E; Xiaodong, S, 1994
)
0.29
" With some dosing regimens, PTX-treated animals proved to be slightly more susceptible to AAP, which may be related to the reported potentiation of the cytotoxicities of a number of alkylating anti-cancer drugs by PTX and other methylxanthines."( Investigation of possible mechanisms of hepatic swelling and necrosis caused by acetaminophen in mice.
Benzick, AE; Hansen, TN; Montgomery, CA; Smith, CV; Welty, SE, 1993
)
0.51
" It is not clear why regular dosing with paracetamol in haemodialysis patients did not cause the accumulation of paracetamol glucuronide or sulphate as predicted."( The disposition of paracetamol and its conjugates during multiple dosing in patients with end-stage renal failure maintained on haemodialysis.
Martin, U; Prescott, LF; Temple, RM; Winney, RJ, 1993
)
0.29
" While complete acetaminophen release occurred in 25 min from Starch 1500 tablets, the drug dissolution time from Preflo starch tablets varied from 4 to 12 hr, indicating a potential use for some of these starches in solid oral modified-release dosage forms."( Evaluation of Preflo modified starches as new direct compression excipients. I. Tabletting characteristics.
Collins, CC; Sanghvi, PP; Shukla, AJ, 1993
)
0.63
" The experimental group received a standard dosage of oral postoperative corticosteroids."( Arthroscopy of the knee. Ten-day pain profiles and corticosteroids.
Highgenboten, CL; Jackson, AW; Meske, NB,
)
0.13
" This unusually high concentration of 5OXP in the urine and its prevention by methionine indicates that chronic high level paracetamol dosing leads to severe depletion of sulphur-containing amino acids including cysteine with consequent disruption of the glutathione cycle."( Induction of 5-oxoprolinuria in the rat following chronic feeding with N-acetyl 4-aminophenol (paracetamol).
Beales, D; Ghauri, FY; McLean, AE; Nicholson, JK; Wilson, ID, 1993
)
0.29
" Second, dose-response relationships for phenylpropanolamine and acetaminophen were such that increased toxicity was observed only when the interaction was sufficient to lower hepatic glutathione concentrations below a level regarded as critical in preventing acetaminophen-induced hepatotoxicity."( Phenylpropanolamine potentiation of acetaminophen-induced hepatotoxicity: evidence for a glutathione-dependent mechanism.
Harbison, RD; James, RC; Roberts, SM, 1993
)
0.8
" Since the therapeutic concentrations of acetaminophen in man range approximately from 50 to 150 microM, the results of this study indicate that stimulation of myeloperoxidase activity is achieved within the safe dosage of the drug."( Interaction of acetaminophen with myeloperoxidase intermediates: optimum stimulation of enzyme activity.
Dunford, HB; Marquez, LA, 1993
)
0.9
"To determine the renovascular effects of nonprescription ibuprofen in the maximum labeled over-the-counter (OTC) dosage for 7 days, and to compare these effects with those of two other available OTC analgesics, aspirin and acetaminophen, we evaluated 25 elderly patients with mild thiazide-treated hypertension and mild renal insufficiency."( Renovascular effects of nonprescription ibuprofen in elderly hypertensive patients with mild renal impairment.
Furey, SA; McMahon, FG; Vargas, R,
)
0.32
" In the initial 3-week dose-response study, as the daily dose of VA increased so did the degree of potentiation of CCl4 hepatotoxicity."( Characterization of vitamin A potentiation of carbon tetrachloride-induced liver injury.
Earnest, DL; elSisi, AE; Hall, P; Sim, WL; Sipes, IG, 1993
)
0.29
" Studies of the relationship between genotoxicity and toxic effects in the rat (induction of micronuclei in rat bone marrow including dose-response relationship, biotransformation of paracetamol at different dosages, concomitant toxicity and biochemical markers) have recently been completed."( Series: current issues in mutagenesis and carcinogenesis, No. 65. The genotoxicity and carcinogenicity of paracetamol: a regulatory (re)view.
Bergman, K; Müller, L; Teigen, SW, 1996
)
0.29
"The purpose of this trial was to compare the pharmacokinetics of the two available acetaminophen dosage forms in simulated human overdose."( Pharmacokinetics of extended relief vs regular release Tylenol in simulated human overdose.
Goldfrank, L; Hoffman, RS; Howland, MA; Kaplan, L; Rees, S; Stork, CM, 1996
)
0.52
" Therapy should be initiated in all settings with the lowest possible dosage since the incidence of the major AEs is dose related."( Nonrenal toxicities of acetaminophen, aspirin, and nonsteroidal anti-inflammatory agents.
Matzke, GR, 1996
)
0.6
" There are three main reasons for measuring drugs: to test patient compliance, to ensure that dosage is high enough to have therapeutic effect but sufficiently low to avoid toxicity and, finally, to identify drugs taken during deliberate or accidental overdose."( Measurement of aspirin and paracetamol metabolites.
Higgins, C,
)
0.13
" The results of the eight drugs revealed that ciliary movement is frequently affected by many drugs and, therefore, care must be taken in developing any nasal dosage form to ensure its least ciliotoxicity."( [Toxicity of drugs on nasal mucocilia and the method of its evaluation].
Cui, JB; Fang, XL; Jiang, XG; Wei, Y; Xi, NZ, 1995
)
0.29
" Follow-up by the certified Regional Poison Information Center at 1-3 w post-discharge determined dosing compliance to be 83%."( Outpatient N-acetylcysteine treatment for acetaminophen poisoning: an ethical dilemma or a new financial mandate?
Bricker, JD; Dean, BS; Krenzelok, EP, 1996
)
0.56
" Dipyrone, administered for 2 weeks, has effects on the gastric and duodenal mucosa comparable to those of paracetamol and placebo, though noticeable damage is detectable at a dosage of 3 g/day."( Endoscopic assessment of the effects of dipyrone (metamizol) in comparison to paracetamol and placebo on the gastric and duodenal mucosa of healthy adult volunteers.
Ardizzone, S; Bianchi Porro, G; Caruso, I; Montrone, F; Petrillo, M, 1996
)
0.29
" Outcome variables included overall pain scores (AUC(0,360 min), maximum pain relief, pain relief at 1 h after dosage and the number of patients taking escape analgesics."( The efficacy of ketoprofen and paracetamol (acetaminophen) in postoperative pain after third molar surgery.
Hawkesford, JE; Kelly, PJ; Seymour, RA, 1996
)
0.56
" This was accompanied by elevated biliary APAP-GSH content in CFB-pretreated mice at 2 hr after APAP dosing with diminished levels in bile at 12 hr."( Protection by clofibrate against acetaminophen hepatotoxicity in male CD-1 mice is associated with an early increase in biliary concentration of acetaminophen-glutathione adducts.
Cohen, SD; Hoivik, DJ; Khairallah, EA; Manautou, JE; Tveit, A, 1996
)
0.58
" These results will suggest that with repeated dosing of AAP special care must be taken in schistosomal patients since the elimination of AAP from plasma is remarkably reduced."( Acetaminophen plasma level after oral administration in liver cirrhotic patients suffering from schistosomal infection.
el-Azab, G; Higashi, Y; Murakami, T; Yata, N; Youssef, MK, 1996
)
1.74
"The pharmacokinetics and tolerability of two dosage forms for rectal administration of paracetamol were compared."( Rectal administration of paracetamol: a comparison of a solution and suppositories in adult volunteers.
Driessen, FG; Goldhoorn, PB; Kollöffel, WJ, 1996
)
0.29
" The average dosage administered per day represented only 76% of the recommended dosage."( Assessment of nurses' judgement for analgesic requirements of postoperative children.
Rømsing, J, 1996
)
0.29
" Plasma concentrations were measured in four additional animals of all high dose groups after the last dosing at seven time points."( Studies on the chronic oral toxicity of an analgesic drug combination consisting of acetylsalicylic acid, paracetamol and caffeine in rats including an electron microscopical evaluation of kidneys.
Bauer, E; Bauer, M; Greischel, A; Hirsch, U; Lehmann, H; Schmid, J; Schneider, P, 1996
)
0.29
" There are no dosing guidelines for paracetamol use in children under 1 month of age."( Paracetamol prescribing habits in a children's hospital.
Anderson, B; Anderson, M; Hastie, B, 1996
)
0.29
" Similarly, more practitioners either did not use or did not know safe dosing schedules in children 3 months and younger."( Paracetamol prescribing habits in a children's hospital.
Anderson, B; Anderson, M; Hastie, B, 1996
)
0.29
"Many medical staff were unsure of current safe dosing regimens, particularly in the younger age groups."( Paracetamol prescribing habits in a children's hospital.
Anderson, B; Anderson, M; Hastie, B, 1996
)
0.29
"This study examined the effects of mechanical destructive forces on drug release from controlled release (CR) multiple unit dosage forms in vitro and in vivo and their colonic release, using two CR granules of acetaminophen, AG and BG, which differed in hardness (AG was hard and BG was soft), but which did not depend on agitation speed or pH for their release."( Effect of destruction force on drug release from multiple unit controlled release dosage forms in humans.
Aoyagi, N; Katori, N; Kojima, S; Ma, WS, 1996
)
0.48
" To identify the arylated proteins CD-1 mice were administered 600 mg/kg APAP and Western blots of mitochondrial proteins collected 4 hr after dosing were probed with anti-APAP antibodies."( Identification of a 54-kDa mitochondrial acetaminophen-binding protein as aldehyde dehydrogenase.
Cohen, SD; Khairallah, EA; Landin, JS, 1996
)
0.56
" Accuracy of antipyretic medication dosage was improved (chi-squared analysis, 13."( Improving caretakers' knowledge of fever management in preschool children: is it possible?
Kelly, L; Morin, K; Young, D,
)
0.13
"05) dose-response relationship."( Analgesic efficacy of paracetamol and its combination with codeine and caffeine in surgical pain--a meta-analysis.
Li Wan Po, A; Zhang, WY, 1996
)
0.29
" Combined UV, 1H NMR, and positive-ion electrospray MS detection was achieved in the continuous-flow mode using whole human urine from a subject dosed with acetaminophen."( Combined HPLC, NMR spectroscopy, and ion-trap mass spectrometry with application to the detection and characterization of xenobiotic and endogenous metabolites in human urine.
Foxall, PJ; Lindon, JC; Nicholson, JK; Shockcor, JP; Unger, SE; Wilson, ID, 1996
)
0.49
" Tramadol showed a dose-response for analgesia in both postsurgical and dental pain patients."( Single-patient data meta-analysis of 3453 postoperative patients: oral tramadol versus placebo, codeine and combination analgesics.
McQuay, JH; Moore, AR, 1997
)
0.3
" These findings suggest that onset of analgesia should be more rapid following dosing with soluble aspirin, a conclusion supported by comparative efficacy studies conducted with differing formulations of aspirin."( Comparative bioavailability of aspirin and paracetamol following single dose administration of soluble and plain tablets.
Muir, N; Nichols, JD; Stillings, MR; Sykes, J, 1997
)
0.3
"5 mg/kg CyA/day and dosage was increased cautiously to 5 mg/kg/day or less if the serum creatinine rose by > or = 30% above baseline."( Interaction between cyclosporin A and nonsteroidal antiinflammatory drugs.
Baker, P; Bensen, W; Gent, M; Grace, E; Ludwin, D; Roberts, R; Tugwell, P, 1997
)
0.3
" Tablets "Paravit" have mark, which allows exact dosing for children of different age."( [The physiological properties of the action of a new analgesic and antipyretic preparation].
Chernykh, VP; Shapovalova, VO, 1997
)
0.3
"To evaluate caregiver (parent or guardian) use of over-the-counter medications (OTCs) as related to the accuracy and correctness of dosing for children seen at a pediatric emergency department with nonemergent concerns."( Over-the-counter medications. Do parents give what they intend to give?
Simon, HK; Weinkle, DA, 1997
)
0.3
" During the dosing scenario, only 40% of the caregivers stated an appropriate dose for their child and only 67% accurately measured the amount of acetaminophen they intended."( Over-the-counter medications. Do parents give what they intend to give?
Simon, HK; Weinkle, DA, 1997
)
0.5
"Although a large number of caregivers administer OTCs, knowledge of these medications, and accuracy and correctness of dosing remain a marked concern."( Over-the-counter medications. Do parents give what they intend to give?
Simon, HK; Weinkle, DA, 1997
)
0.3
" At therapeutic dosage levels the drug is relatively non-toxic."( Determination of paracetamol in pure form and in dosage forms using N,N-dibromo dimethylhydantoin.
Kumar, KG; Letha, R, 1997
)
0.3
" The dose-response curves were first obtained for each drug alone."( Isobolographic analysis of interactions between intravenous morphine, propacetamol, and diclofenac in carrageenin-injected rats.
Benoist, JM; Fletcher, D; Gautron, M; Guilbaud, G, 1997
)
0.3
" Pelliculation frequently differs in soft shell capsules from hard shell capsules because of the larger mass of gelatin in the softshell dosage form."( Dissolution testing of soft shell capsules-acetaminophen and nifedipine.
Bottom, CB; Carstensen, JT; Clark, M, 1997
)
0.56
"A pharmacokinetic dynamic simulation model was used to predict rectal paracetamol dosing schedules which would maintain steady state plasma concentrations of 10-20 mg."( Rectal paracetamol dosing regimens: determination by computer simulation.
Anderson, BJ; Holford, NH, 1997
)
0.3
" They were found fairly potent in rat tail flick and mouse phenylquinone writhing assays but the dose-response curves were rather shallow as compared to that of morphine."( Apparent antinociceptive and anti-inflammatory effects of GYKI 52466.
Kedves, R; Máté, I; Székely, JI; Tarnawa, I; Török, K, 1997
)
0.3
" Male Sprague-Dawley rats were each dosed with either phenacetin or phenacetin-C2H3 at 50 mg kg-1."( NMR spectroscopic studies on the metabolism and futile deacetylation of phenacetin in the rat.
Caddick, S; Farrant, RD; Lindon, JC; Nicholls, AW; Nicholson, JK; Wilson, ID, 1997
)
0.3
") After initiating morphine or making any change of dose or route of administration, the dosage should be evaluated after approximately 24 hours."( The management of chronic pain in patients with breast cancer. The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Canadian Society of Palliative Care Physicians. Canadian Association of Radiation Oncologist
, 1998
)
0.3
" However, smaller doses provided less effective pain relief, and a linear dose-response relationship was demonstrated."( The dose-response relationship of ketorolac as a component of intravenous regional anesthesia with lidocaine.
Gardner, G; Reuben, SS; Steinberg, RB, 1998
)
0.3
"5 days of dosing were used to detect newly occurring hemorrhages and erosions."( Clinical endoscopic evaluation of the gastroduodenal tolerance to (R)- ketoprofen, (R)- flurbiprofen, racemic ketoprofen, and paracetamol: a randomized, single-blind, placebo-controlled trial.
Caubet, JF; Handley, DA; Jerussi, TP; McCray, JE, 1998
)
0.3
" Repair of both strands in the UNG gene was consistently lower in the presence of paracetamol, but this reduction reached significance only at 8 h after irradiation and no dose-response was observed."( Paracetamol increases sensitivity to ultraviolet (UV) irradiation, delays repair of the UNG-gene and recovery of RNA synthesis in HaCaT cells.
Aas, PA; Alm, B; Krokan, HE; Skjelbred, C; Skorpen, F, 1998
)
0.3
"We have examined acetaminophen (paracetamol) dosing for outpatient management of posttonsillectomy pain in children."( Examination of acetaminophen for outpatient management of postoperative pain in children.
Harder, A; Hertel, S; Rasmussen, M; Rømsing, J, 1998
)
0.99
" Comparison of the dose-response to APAP (200-1200 mg/kg) indicated that double-null animals were highly resistant to APAP-induced toxicity whereas the wild-type animals were sensitive."( Protection against acetaminophen toxicity in CYP1A2 and CYP2E1 double-null mice.
Bruno, MK; Buters, JT; Cohen, SD; Gonzalez, FJ; Lucas, AM; Stern, ST; Ward, JM; Zaher, H, 1998
)
0.63
" The risk factors for the development of liver cell necrosis following ingestion of paracetamol in therapeutic dosage are discussed."( [Severe hepatocellular damage after administration of paracetamol and chlorzoxazone in therapeutic dosage].
Krähenbühl, S; Kronenberg, A; Streuli, R; Zimmermann, A, 1998
)
0.3
" Acetaminophen is a phenolic compound which produces a clear inhibitory dose-response curve with peroxynitrite in its range of clinical effectiveness."( A new screening method to detect water-soluble antioxidants: acetaminophen (Tylenol) and other phenols react as antioxidants and destroy peroxynitrite-based luminol-dependent chemiluminescence.
Qazi, N; Sacks, M; Van Dyke, K,
)
1.28
" In addition, the most current and efficacious dosage regimen for the rectal administration of acetaminophen (40."( Blocks and other techniques pediatric surgeons can employ to reduce postoperative pain in pediatric patients.
Broadman, LM, 1999
)
0.52
" We propose that different "therapeutic" APAP dosing may be needed for those with underlying risk factors for hepatotoxicity."( "The silent killer": chronic acetaminophen toxicity in a toddler.
King, W; Nichols, M; Pershad, J, 1999
)
0.59
" Dose-response relationships show that higher doses of ibuprofen may be particularly effective."( Postoperative analgesia and vomiting, with special reference to day-case surgery: a systematic review.
McQuay, HJ; Moore, RA, 1998
)
0.3
" The study methods and the process used to resolve noncompliance with recommended dosing guidelines are presented below."( Drug use evaluation of acetaminophen-containing products at a community hospital.
Jablonski, HI; Vanantwerp, J; Ward, TS, 1992
)
0.59
"5, 1, 2, 3 and 4 h after dosing to evaluate eight upper gastrointestinal symptoms, which were stomach pain, burning sensation, nausea, heartburn, gas, burping, indigestion and upset stomach."( Subjective gastrointestinal tolerability of acetylsalicylic acid and paracetamol after single dose treatment.
Amin, D; Elfström, C; Grahnén, A; Loose, I; Nilsson, LG; Rolfsen, W, 1999
)
0.3
"To investigate the pharmacokinetics, metabolism, and dose-response relation of a single rectal dose of paracetamol in preterm infants in two different age groups."( Pharmacokinetics and metabolism of rectally administered paracetamol in preterm neonates.
Anand, KJ; Deinum, JT; Kuizenga, AJ; Okken, A; Quak, JM; Tibboel, D; van Dam, JG; van Lingen, RA, 1999
)
0.3
" They are organized into four classes: specific pharmaceuticals, biologicals, pharmaceutical dosage forms, and chemicals."( Delayed toxidromes.
Bosse, GM; Matyunas, NJ,
)
0.13
" The third group allows a precise dosage but is restricted to one molecule."( [Critical analysis of different methods used for toxicology screening in emergency laboratory].
Berny, C; Besson, AS; Manchon, M; Mialon, A; Pechard, A,
)
0.13
" The equipotent morphine dosage requirements were also not statistically different."( Patient-controlled analgesia in postoperative cardiac surgery.
Brush, B; Tsang, J, 1999
)
0.3
"For solid dosage forms, a better understanding of the fundamental properties of the binders helps in developing better formulations and products."( Investigating the fundamental effects of binders on pharmaceutical tablet performance.
Barnum, PE; Guo, JH; Harcum, WW; Joneja, SK; Skinner, GW, 1999
)
0.3
"A method is presented for the direct determination of mephenoxalone and acetaminophen in combined pharmaceutical dosage forms without prior separation."( Application of derivative-differential UV spectrophotometry and ratio derivative spectrophotometric determination of mephenoxalone and acetaminophen in combined tablet preparation.
Erk, N, 1999
)
0.74
"The primary purpose of the study was to examine the absorption of acetaminophen by measuring serum and saliva concentrations produced by a standard postoperative acetaminophen dosing regimen and secondary to examine the correlation between saliva and serum concentrations of acetaminophen after rectal and oral dosing."( High-dose rectal and oral acetaminophen in postoperative patients--serum and saliva concentrations.
Hahn, TW; Lund, C; Mogensen, T; Rasmussen, M; Schouenborg, L, 2000
)
0.84
"At 1, 2, 3, and 4 h after rectal dosing the saliva concentrations (mean+/-SD) were 15."( High-dose rectal and oral acetaminophen in postoperative patients--serum and saliva concentrations.
Hahn, TW; Lund, C; Mogensen, T; Rasmussen, M; Schouenborg, L, 2000
)
0.61
" Forty-three percent of the parents administered the recommended dosage (10-20 mg/kg), whereas 24."( Parental knowledge of the treatment of fever in children.
Barzilai, A; Davidovitch, N; Eisen, I; Kaplan, G; Linder, N; Sirota, L; Snapir, A, 1999
)
0.3
" It is considered one of the most important quality control tests performed on pharmaceutical dosage forms, and validation of dissolution methods is an important part of good manufacturing practices (GMP)."( Validation of tablet dissolution method by high-performance liquid chromatography.
Dluzneski, PR; Guo, JH; Harcum, WW; Skinner, GW; Trumbull, DE, 2000
)
0.31
" Animals were dosed with either phenacetin or phenacetin-C2H3 and urine samples were collected for -24-0 (pre-dosing), 0-8."( Directly-coupled HPLC-NMR spectroscopic studies of metabolism and futile deacetylation of phenacetin in the rat.
Farrant, RD; Lindon, JC; Nicholls, AW; Nicholson, JK; Shockcor, JP; Wilson, ID, 1999
)
0.3
" As is true for most all potentially beneficial medicines used in pediatrics, awareness of the actual amount of drug received from all sources and caution to not exceed the age-appropriate dosing guidelines (i."( Acetaminophen intoxication during treatment: what you don't know can hurt you.
Kearns, GL; Leeder, JS; Wasserman, GS, 2000
)
1.75
" In this study, nine different paracetamol tablet dosage forms available on the Turkish Drug Market have been investigated and physical controls were realized."( Comparative dissolution testing of paracetamol commercial tablet dosage forms.
Ozalp, Y; Ozkan, SA; Ozkan, Y; Savaşer, A,
)
0.13
" The mutual interferences of the compounds in the mixtures and the electroactive compounds in the pharmaceutical dosage forms, especially effervescent ones, also made the object of the research."( The development of spectrophotometric and electroanalytical methods for ascorbic acid and acetaminophen and their applications in the analysis of effervescent dosage forms.
Mirel, S; Oprean, R; Săndulescu, R, 2000
)
0.53
"Repeated dosing of acetaminophen (paracetamol) to rats is reported to decrease their sensitivity to its hepatotoxic effects, which are associated with oxidative stress and glutathione depletion."( Repeated acetaminophen dosing in rats: adaptation of hepatic antioxidant system.
Birmingham, JM; Bugelski, PJ; Elcock, F; Greenhill, RW; O'Brien, PJ; Slaughter, MR; Swain, A, 2000
)
1.05
" A combination of opioids, NSAIDs and paracetamol in order to relieve pain allows both for a significant reduction in the dosage of respective drugs, fewer side effects and an improved pain relief."( [Pharmacotherapy of postoperative pain].
Cieniawa, T; Dobrogowski, J; Przeklasa-Muszyńska, A; Wordliczek, J, 2000
)
0.31
" This dosage of paracetamol is lower than the current recommended dosage, which is 40 mg kg(-1) loading dose followed by 20 mg kg(-1) 8 h(-1)."( Double-blind randomized study of tramadol vs. paracetamol in analgesia after day-case tonsillectomy in children.
Dort, JP; Pendeville, PE; Veyckemans, F; Von Montigny, S, 2000
)
0.31
" There was no evidence of accumulation leading to supratherapeutic concentrations during this dosing schedule for a mean of approximately 2-3 days."( Pharmacokinetics of rectal paracetamol after repeated dosing in children.
Eriksen, K; Hahn, TW; Henneberg, SW; Holm-Knudsen, RJ; Rasmussen, M; Rasmussen, SN, 2000
)
0.31
"An accurate HPLC determination of acetaminophen in tablet dosage form is reported, together with an effective separation of five of its para-substituted derivatives using an isocratic reversed-phase system."( A quantitative and qualitative high performance liquid chromatographic determination of acetaminophen and five of its para-substituted derivatives.
Sakhnini, N; Shervington, LA, 2000
)
0.81
"The headache response rate 2 hours after dosing was 57."( Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study.
Baggish, JS; Codispoti, JR; Fu, M; Lipton, RB; Stewart, WF,
)
0.44
" We sought to determine the prevalence of and risk factors for inaccurate dosing by parents seeking care for their children in the emergency department (ED)."( Acetaminophen and ibuprofen dosing by parents.
Crain, EF; Lacher, B; Li, SF, 2000
)
1.75
" Caregivers were asked about quantity and frequency of antipyretic use prior to the ED visit, the source of information used to determine dosage, and which factor (eg, age, sex, height, weight, height of fever, severity of illness) they considered most important in determining the correct dosage of medication."( Acetaminophen and ibuprofen dosing by parents.
Crain, EF; Lacher, B; Li, SF, 2000
)
1.75
" Caregivers who reported that antipyretic dosage was based on weight were less likely to misdose medication, suggesting a valuable role for patient education."( Acetaminophen and ibuprofen dosing by parents.
Crain, EF; Lacher, B; Li, SF, 2000
)
1.75
" Most studies have focused on the administration of one single paracetamol dose, and the problem of cumulative toxicity with repeated dosing has not been addressed."( Treatment with paracetamol in infants.
Arana, A; Hansen, TG; Morton, NS, 2001
)
0.31
"The pharmacokinetics and pharmacodynamics of paracetamol differ substantially in neonates and infants from those in older children and adults; hence, dosing should be adjusted accordingly."( Treatment with paracetamol in infants.
Arana, A; Hansen, TG; Morton, NS, 2001
)
0.31
" In conclusion, the long half-life and excellent safety profile of telmisartan were unaffected by concurrent acetaminophen or ibuprofen medication; thus, once-daily dosing of telmisartan can be maintained, which may help to optimize patient compliance, and patients may self-administer concomitant acetaminophen or ibuprofen."( Pharmacokinetics of acetaminophen and ibuprofen when coadministered with telmisartan in healthy volunteers.
Fraunhofer, A; Stangier, J; Su, CA; Tetzloff, W, 2000
)
0.84
"To determine whether multiple dosing of acetaminophen would result in drug accumulation in polymedicated elderly patients with rheumatic pain."( Single and multiple dose pharmacokinetics of acetaminophen (paracetamol) in polymedicated very old patients with rheumatic pain.
Bannwarth, B; Lagrange, F; Le Bars, M; Matoga, M; Maury, S; Palisson, M; Pehourcq, F, 2001
)
0.84
"No drug accumulation occurred during multiple dosing with acetaminophen in these very old subjects."( Single and multiple dose pharmacokinetics of acetaminophen (paracetamol) in polymedicated very old patients with rheumatic pain.
Bannwarth, B; Lagrange, F; Le Bars, M; Matoga, M; Maury, S; Palisson, M; Pehourcq, F, 2001
)
0.81
" ICG significantly decreased the bile flow rate and biliary concentration of APAP-glutathione, APAP-glucuronide and APAP-mercapturate within the first hour after dosing without affecting the biliary concentration of APAP."( Effects of clofibrate and indocyanine green on the hepatobiliary disposition of acetaminophen and its metabolites in male CD-1 mice.
Chen, C; Hennig, GE; Manautou, JE; McCann, DJ, 2000
)
0.53
" The result was supported a rational dose-response relationship for different doses of paracetamol and codeine in 17 additional trials with 1,195 patients."( Using evidence from different sources: an example using paracetamol 1000 mg plus codeine 60 mg.
Gavaghan, D; McQuay, HJ; Moore, RA; Smith, LA, 2001
)
0.31
" To investigate this, groups of overnight-fasted male CD-1 mice received 30 micromol ICG/kg, intravenously, immediately prior to APAP dosing (500 mg/kg, ip)."( Changes in susceptibility to acetaminophen-induced liver injury by the organic anion indocyanine green.
Chen, C; Hennig, GE; Manautou, JE; Silva, VM; Whiteley, HE, 2001
)
0.6
" The dosage of paracetamol must take into account the pharmacokinetic properties of the drug in children."( Nonsteroidal anti-inflammatory drugs and paracetamol in children.
Camu, F; Van de Velde, A; Vanlersberghe, C, 2001
)
0.31
" In contrast, non-NSAID analgesics, such as paracetamol or tramadol, have essentially no renal or related cardiovascular side effects when used at recommended dosing schedules."( Renal and related cardiovascular effects of conventional and COX-2-specific NSAIDs and non-NSAID analgesics.
Whelton, A, 2000
)
0.31
" In summary, all methodologically sound studies available indicate that therapeutic dosing of paracetamol to the alcoholic patient is not associated with hepatic injury."( Treatment of pain or fever with paracetamol (acetaminophen) in the alcoholic patient: a systematic review.
Dart, RC; Kuffner, EK; Rumack, BH, 2000
)
0.57
" immediately after paracetamol overdose (T0) and 6 h after dosing (T6) and those administered S-adenosyl-L-methionine at doses of 20 mg/kg (0."( Effect of different doses of S-adenosyl-L-methionine on paracetamol hepatotoxicity in a mouse model.
Carrasco, R; Caturla, J; Esteban, A; Gutiérrez, A; Mayol, MJ; Ortiz, P; Pérez-Mateo, M, 2000
)
0.31
"To compare the hepatic and renal safety profiles of two daily dosage regimens of paracetamol (acetaminophen) (3 g versus 4 g) in patients with painful chronic rheumatoid diseases."( [Liver and renal tolerance to paracetamol: 3 g or 4 g per day?].
Ganry, H; Pruvot, F; Schmidely, N; Vesque, D, 2001
)
0.53
" Using the decision tree method, daily dosage of paracetamol (3 g or 4 g) was never identified as a discriminating variable capable of explaining the occurrence of hepatorenal adverse events."( [Liver and renal tolerance to paracetamol: 3 g or 4 g per day?].
Ganry, H; Pruvot, F; Schmidely, N; Vesque, D, 2001
)
0.31
" They also assessed their dosing regimen by determining the fraction of time each individual maintained the target concentration."( Initial and subsequent dosing of rectal acetaminophen in children: a 24-hour pharmacokinetic study of new dose recommendations.
Birmingham, PK; Coté, CJ; Fisher, DM; Hall, SC; Henthorn, TK; Tobin, MJ, 2001
)
0.58
" The highest serum concentration with initial or subsequent dosing was 38."( Initial and subsequent dosing of rectal acetaminophen in children: a 24-hour pharmacokinetic study of new dose recommendations.
Birmingham, PK; Coté, CJ; Fisher, DM; Hall, SC; Henthorn, TK; Tobin, MJ, 2001
)
0.58
"The moist granulation technique (MGT), which involves agglomeration and moisture absorption, has only been applied to immediate-release dosage forms."( Use of a moist granulation technique (MGT) to develop controlled-release dosage forms of acetaminophen.
Railkar, AM; Schwartz, JB, 2001
)
0.53
" No effect of therapeutic dosage of acetaminophen on the accuracy of the glucose readings was found."( Effect of acetaminophen on the accuracy of glucose measurements obtained with the GlucoWatch biographer.
Ackerman, NR; Fermi, SJ; Garg, S; Kennedy, J; Lopatin, M; Potts, RO; Tamada, JA; Tierney, MJ, 2000
)
0.98
" These derivatives represent a novel generation of pharmaceutical excipients, recommended for high loading dosage formulations."( Cross-linked high amylose starch derivatives as matrices for controlled release of high drug loadings.
Ispas-Szabo, P; Lenaerts, V; Mateescu, MA; Mulhbacher, J, 2001
)
0.31
"The permeabilities of mixed films of pectin/chitosan/HPMC have been studied to assess their value in producing a dosage form with biphasic drug release characteristics."( Biphasic drug release: the permeability of films containing pectin, chitosan and HPMC.
Fell, JT; Ofori-Kwakye, K, 2001
)
0.31
" We explore the toxicities of OTC cough and cold medications, discuss mechanisms of dosing errors, and suggest why physicians should be more vigilant in specifically inquiring about OTCs when evaluating an ill child."( Toxicity of over-the-counter cough and cold medications.
Gunn, VL; Liebelt, EL; Serwint, JR; Taha, SH, 2001
)
0.31
" The specific objectives of research are to identify physiologic, pharmacokinetic, and pharmacodynamic changes in space; to develop simple, reliable, non-invasive, safe and effective acute and sustained-release dosage forms and regimens for pharmacological interventions in space; and to create and maintain a comprehensive space PK-PD and therapeutics database."( Pharmacotherapeutics in space.
Putcha, L, 1999
)
0.3
"To determine if hepatic injury was associated with maximal therapeutic dosing of acetaminophen to chronic alcohol abuse patients immediately following cessation of alcohol intake (the presumed time of maximal vulnerability)."( Effect of maximal daily doses of acetaminophen on the liver of alcoholic patients: a randomized, double-blind, placebo-controlled trial.
Bogdan, GM; Casper, E; Dart, RC; Darton, L; Hill, RE; Kuffner, EK, 2001
)
0.82
" Less frequently, acetaminophen toxicity is attributable to unintended inappropriate dosing or the failure to recognize children at increased risk in whom standard acetaminophen doses have been administered."( Acetaminophen toxicity in children.
, 2001
)
2.09
" Mice, either with a human bcl-2 transgene (-/+) or wild-type mice (WT; -/-), were dosed with 500 or 600 mg/kg (i."( Enhanced acetaminophen hepatotoxicity in transgenic mice overexpressing BCL-2.
Adams, ML; Bruschi, SA; Fausto, N; Kavanagh, TJ; Nelson, SD; Pierce, RH; Tonge, RP; Vail, ME; White, CC, 2001
)
0.73
" This article will address the safety and efficacy of acetaminophen, aspirin, and ibuprofen independently and in combination with currently available prescription dosage forms with a focus on pharmacology, pharmacotherapeutics, pharmacodynamics, and pharmacokinetics, including drug interactions at the CYP450 system."( Acetaminophen, aspirin, or Ibuprofen in combination analgesic products.
Barkin, RL,
)
1.82
" We have examined prospectively in routine clinical practice the concentrations of intravenous infusions of a drug (acetylcysteine) which is given according to a complicated dosing schedule."( Random and systematic medication errors in routine clinical practice: a multicentre study of infusions, using acetylcysteine as an example.
Anton, C; Bateman, DN; Ferner, RE; Hutchings, A; Langford, NJ; Routledge, PA, 2001
)
0.31
"Our data suggest that there is large random variation in administered dosage of intravenous infusions."( Random and systematic medication errors in routine clinical practice: a multicentre study of infusions, using acetylcysteine as an example.
Anton, C; Bateman, DN; Ferner, RE; Hutchings, A; Langford, NJ; Routledge, PA, 2001
)
0.31
"According to the degree of importance to the combined analgesic effect, Ace > Caf > Bul; Ace showed a significant dose-response relationship, whereas in Caf and Bul, this relationship was not apparent."( Quantitative design of optimal analgesic combination of acetaminophen, caffeine, and butalbital.
Gui, CQ; Sun, RY; Wang, XW; Zheng, QS, 2001
)
0.56
" OTC NSAID users should be carefully advised as to recommended dose, and all patients should be reminded to stay within the dosing limits regardless which OTC analgesic is used."( The use and effect of analgesics in patients who regularly drink alcohol.
Dart, RC, 2001
)
0.31
"The in vitro dissolution and in vivo disposition of these formulations were examined by using a USP type III dissolution apparatus and a single-dose, three-way, crossover study that included an immediate-release acetaminophen dosage form, respectively."( Predictive ability of level A in vitro-in vivo correlation for ringcap controlled-release acetaminophen tablets.
Dalton, JT; Dickason, DA; Grandolfi, GP; Straughn, AB, 2001
)
0.72
" The recommended dosing of the study medications was 1 tablet every 4 to 6 hours, not to exceed 5 tablets per day."( Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of moderate or severe acute low back pain.
Dornseif, BE; Doyle, RT; Morris, E; Palangio, M; Valente, TJ, 2002
)
0.55
" The proposed liquid chromatographic method was successfully applied to the analysis of commercially available paracetamol dosage forms with recoveries of 98-103%."( Simultaneous LC determination of paracetamol and related compounds in pharmaceutical formulations using a carbon-based column.
Darghouth, F; Monser, L, 2002
)
0.31
" One study of single-dose administration of rectal paracetamol 40-60 mg kg(-1) and three studies of repeat dosing with 14-20 mg kg(-1) showed significant analgesic efficacy, while studies of a single dose of 10-20 mg kg(-1) were negative."( Rectal and parenteral paracetamol, and paracetamol in combination with NSAIDs, for postoperative analgesia.
Dahl, JB; Møiniche, S; Rømsing, J, 2002
)
0.31
"A rapid, precise, and specific high-performance liquid chromatographic method is described for the simultaneous determination of paracetamol, phenylephrine HCI, and chlorpheniramine maleate in combined pharmaceutical dosage forms."( Simultaneous high-performance liquid chromatographic determination of paracetamol, phenylephrine HCl, and chlorpheniramine maleate in pharmaceutical dosage forms.
Ozden, T; Senyuva, H, 2002
)
0.31
" Acetaminophen protein adducts were detected in liver and serum as early as 15 min after hepatotoxic dosing of acetaminophen to mice."( Determination of acetaminophen-protein adducts in mouse liver and serum and human serum after hepatotoxic doses of acetaminophen using high-performance liquid chromatography with electrochemical detection.
Coop, L; Hendrickson, HP; Hinson, JA; James, LP; Mayeux, PR; McCullough, SS; Muldrew, KL, 2002
)
1.56
"A recent case control study suggests that paracetamol at a dosage above 1300 mg/day increases the anticoagulant effects of warfarin."( No clinically relevant drug interaction between paracetamol and phenprocoumon based on a pharmacoepidemiological cohort study in medical inpatients.
Braunschweig, S; Fattinger, K; Frisullo, R; Masche, U; Meier, PJ; Roos, M, 2002
)
0.31
"These results suggest that paracetamol co-administration at a dosage of 2000-2500 mg/day for 3 days has no clinically relevant effects on the anticoagulant effects of phenprocoumon."( No clinically relevant drug interaction between paracetamol and phenprocoumon based on a pharmacoepidemiological cohort study in medical inpatients.
Braunschweig, S; Fattinger, K; Frisullo, R; Masche, U; Meier, PJ; Roos, M, 2002
)
0.31
" During repeated dosage with the specific COX-2 inhibitors, the 24 hour urinary excretion of sodium is only inhibited for the first day of treatment while the excretion of sodium is still decreased over the first 3 hours after the individual doses."( Comparative analgesia, cardiovascular and renal effects of celecoxib, rofecoxib and acetaminophen (paracetamol).
Day, RO; Graham, GG; Graham, RI, 2002
)
0.54
" In practice, argatroban coadministered with these frequently prescribed drugs should require no dosage adjustments."( Investigation of the interaction between argatroban and acetaminophen, lidocaine, or digoxin.
DiCicco, RA; Graham, AM; Hursting, MJ; Inglis, AM; Sheth, SB; Tenero, DM, 2002
)
0.56
"The aim of this study was to describe acetaminophen developmental pharmacokinetics in premature neonates through infancy to suggest age-appropriate dosing regimens."( Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis.
Anderson, BJ; Hansen, TG; Holford, NH; Lin, YC; van Lingen, RA, 2002
)
2.03
" However, if paracetamol is dosed according to traditional recommendations (about 20 mg/kg body weight) frequently a sufficient analgetic effect cannot be achieved immediately after painful interventions."( [Paracetamol in childhood. Current state of knowledge and indications for a rational approach to postoperative analgesia].
Brambrink, AM; Mantzke, US, 2002
)
0.31
" At a higher dose (1500 mg), free paracetamol excretion showed a minimum from dosing at 20."( Circadian rhythms of paracetamol metabolism in healthy subjects; a preliminary report.
Ngong, JM; Waring, RH, 1994
)
0.29
" The developed method is rapid and sensitive and therefore suitable for routine control of these drugs in dosage form."( HPLC assay of acetylsalicylic acid, paracetamol, caffeine and phenobarbital in tablets.
Agbaba, D; Aleksic, M; Eric, S; Franeta, JT; Pavkov, S; Vladimirov, S, 2002
)
0.31
" While usual dosing of acetaminophen is considered harmless, both acute and chronic overdoses can be fatal."( Chronic acetaminophen toxicity: a case report and review of the literature.
Belson, MG; Brown, DK; Lane, JE; Scheetz, A, 2002
)
1.06
" This technique enables to display the path and the disintegration of the magnetic marked pharmaceutical dosage form via the decrease of its magnetic moment."( Investigation of gastrointestinal transport by magnetic marker localization.
Hartman, V; Kosch, O; Mönnikes, H; Osmanoglou, E; Strenzke, A; Trahms, L; Weitschies, W; Wiedenmann, B, 2002
)
0.31
"To evaluate whether a dose-response curve exists for erythromycin, determine the lowest effective dose of erythromycin needed to improve gastric motility, and compare erythromycin's effectiveness with that of metoclopramide in improving gastric emptying."( Erythromycin accelerates gastric emptying in a dose-response manner in healthy subjects.
Boivin, MA; Carey, MC; Levy, H, 2003
)
0.32
"Erythromycin increased gastric emptying in a dose-response manner."( Erythromycin accelerates gastric emptying in a dose-response manner in healthy subjects.
Boivin, MA; Carey, MC; Levy, H, 2003
)
0.32
" The dosage forms best masking bitter taste showed good release of the drug, indicating little change in bioavailability by masking."( Development of oral acetaminophen chewable tablets with inhibited bitter taste.
Iwata, M; Machida, Y; Onishi, H; Suzuki, H; Takahashi, Y, 2003
)
0.64
" We report a severely malnourished 53-year-old woman who developed severe hepatotoxicity whilst receiving paracetamol at recommended dosage (4 g daily) following a period of fasting, in the absence of enzyme-inducing agents."( Paracetamol-induced hepatotoxicity at recommended dosage.
Kurtovic, J; Riordan, SM, 2003
)
0.32
" These findings suggest that potent nonsteroidal anti-inflammatory agents, such as flunixin, may be useful alternatives to opioid-based agents for the control of acute postoperative pain associated with a minor surgical procedure and highlight the importance of assessing the risk-benefit ratio when selecting analgesics and dosing regimens."( Evaluation of postoperative analgesia in a rat model of incisional pain.
Martin, WJ; St A Stewart, L, 2003
)
0.32
", mg/kg) appears to provide a more predictable dose-response relationship."( Acetaminophen levels 4 and 7 hours after 2000 and 3000 mg single doses in healthy adults.
Sato, RL; Sumida, SM; Wong, JJ; Yamamoto, LG, 2003
)
1.76
"A dosage of rectal paracetamol 1000 mg four times daily is too low, as all displayed a suboptimal serum paracetamol concentration."( Randomized, double-blind, placebo-controlled study of the effect of rectal paracetamol on morphine consumption after abdominal hysterectomy.
Borchgrevink, PC; Dale, O; Hagen, L; Kvalsvik, O, 2003
)
0.32
"A newly designed flow-through type dissolution test method (FT method) was applied to predict in vivo drug release behaviors in dogs of controlled-release multiple unit dosage forms."( Prediction of in vivo drug release behavior of controlled-release multiple-unit dosage forms in dogs using a flow-through type dissolution test method.
Ikegami, K; Kobayashi, M; Osawa, T; Tagawa, K, 2003
)
0.32
" Presentation is similar to narcotic over dosage or poisoning."( Accidental dextropropoxyphene poisoning.
Hegde, SR; Karunakara, BP; Maiya, PP; Pradeep, GC, 2003
)
0.32
"All prior analgesics were discontinued, and oxycodone/acetaminophen was dosed three times a day (TID), titrated to clinically meaningful pain relief."( Effectiveness and safety of new oxycodone/acetaminophen formulations with reduced acetaminophen for the treatment of low back pain.
Domingos, J; Galer, BS; Gammaitoni, AR; Lacouture, P; Schlagheck, T, 2003
)
0.83
"The currently recommended dosing scheme for treating acetaminophen overdose in the United States consists of a loading dose of oral N-acetylcysteine 140 mg/kg, followed by 70 mg/kg every 4 hours for 17 doses, for a total of 72 hours of oral N-acetylcysteine therapy."( Acetaminophen intoxication and length of treatment: how long is long enough?
Kociancic, T; Reed, MD, 2003
)
2.01
"Acetaminophen, a safe analgesic when dosed properly but hepatotoxic at overdoses, has been reported to induce DNA strand breaks but it is unclear whether this event preceeds hepatocyte toxicity or is only obvious in case of overt cytotoxicity."( Antioxidants protect primary rat hepatocyte cultures against acetaminophen-induced DNA strand breaks but not against acetaminophen-induced cytotoxicity.
El-Bahay, C; Hanelt, S; Kahl, R; Lewerenz, V; Nastevska, C; Röhrdanz, E, 2003
)
2
"A flow injection method is proposed for the determination of paracetamol in pharmaceutical dosage forms."( Flow-injection spectrophotometric determination of paracetamol in tablets and oral solutions.
Giglio, J; Knochen, M; Reis, BF, 2003
)
0.32
" In therapeutic dosage of 6 to 12 mg."( The sublingual administration of curare.
MAYER, H; NEFF, WB, 1953
)
0.23
"5 mg) vs paracetamol (500 mg) and placebo given in a flexible dosage regimen to treat pain resulting from extraction of impacted third molar teeth."( Analgesic efficacy of low-dose diclofenac versus paracetamol and placebo in postoperative dental pain.
Gold, MS; Ionescu, E; Kubitzek, F; Liu, JM; Ziegler, G, 2003
)
0.32
" Given the low rates of events, at low or intermittent dosage without concurrent treatment, these 3 analgesics cannot be distinguished from each other or from background rates of serious GI toxicity."( Rates of serious gastrointestinal events from low dose use of acetylsalicylic acid, acetaminophen, and ibuprofen in patients with osteoarthritis and rheumatoid arthritis.
Bruce, B; Fries, JF, 2003
)
0.54
" The drug's effect as well as adverse effects should be actively sought, and dosage alterations made in order to enhance the drug's effect."( Introduction to monitoring. What is what you prescribed actually doing?
George, A; Shakib, S, 2003
)
0.32
" The maximum daily dosage is 4 g, consistent with the decline in analgesic activity, which is usually over 6 hours."( [Pharmacologic basis for using paracetamol: pharmacokinetic and pharmacodynamic issues].
Bannwarth, B; Péhourcq, F, 2003
)
0.32
" Better dosage forms are also required for rectal administration."( [New perspectives on paracetamol].
Prescott, LF, 2003
)
0.32
"The quality and performance of a solid oral dosage form depends on the choice of the solid phase, the formulation design, and the manufacturing process."( Phase transformation considerations during process development and manufacture of solid oral dosage forms.
Law, D; Qiu, Y; Schmitt, EA; Zhang, GG, 2004
)
0.32
" We report on a 12-month-old boy who presented with hepatotoxicity, disseminated intravascular coagulation and persistent renal insufficiency 4 days after repeated ingestion of a supratherapeutic dosage of paracetamol."( Hepatotoxicity and persistent renal insufficiency after repeated supratherapeutic paracetamol ingestion in a Chinese boy.
Fu, YM; Kwok, KL; Ng, DK, 2004
)
0.32
" The RP-HPLC method was done for the determination of paracetamol, caffeine and propyphenazone in a multicomponent pharmaceutical dosage form."( Optimization of the RP-HPLC method for multicomponent analgetic drug determination.
Ivanovic, D; Jancic, B; Malenovic, A; Medenica, M; Misljenovic, Dj, 2003
)
0.32
"Gene chip array (Affymetrix) data from liver tissue and high resolution 1H NMR spectra from intact liver tissue, tissue extracts and plasma have been analyzed to identify biochemical changes arising from hepatotoxicity in mice dosed with acetaminophen."( Integrated application of transcriptomics and metabonomics yields new insight into the toxicity due to paracetamol in the mouse.
Coen, M; Lenz, EM; Lindon, JC; Nicholson, JK; Pognan, F; Ruepp, SU; Wilson, ID, 2004
)
0.51
"The aim of this study was to describe propacetamol pharmacokinetics in term and preterm neonates to suggest dosing regimens."( Intravenous paracetamol (propacetamol) pharmacokinetics in term and preterm neonates.
Allegaert, K; Anderson, BJ; de Hoon, J; Debeer, A; Devlieger, H; Naulaers, G; Tibboel, D; Verbesselt, R, 2004
)
0.32
"Eudragit RL (ERL) and RS (ERS) are polymethacrylate co-polymers, used in film coating of sustained release dosage forms, possessing some hydrophilic properties due to the presence of quaternary ammonium groups (QAG), where ERL contains more of such groups, hence more permeable, than ERS."( Lactic acid-induced modifications in films of Eudragit RL and RS aqueous dispersions.
Abd-Elbary, A; El-Samaligy, M; Omari, DM; Sallam, A, 2004
)
0.32
" Adding charcoal to the model overcame the suggested beneficial effect of CCK alone in the dosing arm."( The use of cholecystokinin as an adjunctive treatment for toxin ingestion.
Hofbauer, RD; Holger, JS, 2004
)
0.32
"The purpose of this study was to demonstrate the potential of a dynamic, multicompartmental in vitro system simulating the human stomach and small intestine (TIM-1) for studying the behavior of oral drug dosage forms under various physiological gastrointestinal conditions."( A dynamic artificial gastrointestinal system for studying the behavior of orally administered drug dosage forms under various physiological conditions.
Alric, M; Beyssac, E; Blanquet, S; Denis, S; Havenaar, R; Meunier, JP; Zeijdner, E, 2004
)
0.32
" The availability for absorption of paracetamol from two oral dosage forms was investigated by measuring the drug concentration in jejunal dialysis fluid."( A dynamic artificial gastrointestinal system for studying the behavior of orally administered drug dosage forms under various physiological conditions.
Alric, M; Beyssac, E; Blanquet, S; Denis, S; Havenaar, R; Meunier, JP; Zeijdner, E, 2004
)
0.32
" The practical benefit of these simulations is to optimize the geometry and dimensions of a controlled release device and reduce the number of experiments involved in the development of new controlled release dosage forms."( An investigation into the factors influencing drug release from hydrophilic matrix tablets based on novel carbomer polymers.
Durić, Z; Ibrić, S; Jovanović, M; Parojcić, J,
)
0.13
"Several descriptions of acetaminophen-associated liver injury caused by therapeutic or a dosage slightly above the recommended dosage have been described."( Silent acetaminophen-induced hepatotoxicity in febrile children: does this entity exist?
Jaffe, M; Maor, I; Novikov, J; Shaoul, R, 2004
)
1.09
"(1) To correlate serum acetaminophen levels in febrile infants and children with the following parameters: aspartate aminotransferase (AST) levels, fever, vomiting and/or decreased caloric intake; and (2) to assess parental knowledge regarding the medication dosage and hazards of acetaminophen."( Silent acetaminophen-induced hepatotoxicity in febrile children: does this entity exist?
Jaffe, M; Maor, I; Novikov, J; Shaoul, R, 2004
)
1.09
"To introduce a simple method of dosing over-the-counter medication in a home setting using a color-coding concept and to compare dosing deviation from recommended dosage using the color-coded method with dosing deviation using conventional package labeling."( Evaluation of a method to reduce over-the-counter medication dosing error.
Frush, KS; Higgins, JN; Hutchinson, P; Luo, X, 2004
)
0.32
" One group used a conventional dosing method and the other group used a color-coded method to determine and measure a dose of acetaminophen for their child."( Evaluation of a method to reduce over-the-counter medication dosing error.
Frush, KS; Higgins, JN; Hutchinson, P; Luo, X, 2004
)
0.53
"For both dose determination and dose measuring, percentage of deviation from recommended acetaminophen dosage was calculated and compared between the 2 groups."( Evaluation of a method to reduce over-the-counter medication dosing error.
Frush, KS; Higgins, JN; Hutchinson, P; Luo, X, 2004
)
0.55
"7%) and median deviation (1% vs 0%) from recommended dosage were both higher for the group using conventional methods compared with the group using the color-coded method."( Evaluation of a method to reduce over-the-counter medication dosing error.
Frush, KS; Higgins, JN; Hutchinson, P; Luo, X, 2004
)
0.32
" ATC) dosing of acetaminophen with codeine, with or without nurse coaching, compared to standard care with as needed (i."( A randomized clinical trial of the effectiveness of a scheduled oral analgesic dosing regimen for the management of postoperative pain in children following tonsillectomy.
Holdridge-Zeuner, D; Lanier, B; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2004
)
0.67
" As active ingredients may also change their solid-state form during formulation processing or storage and as this can adversely affect the final dosage performance, monitoring of pharmaceutical ingredients is essential for a 'right-first-time' philosophy within the industry."( Applications of terahertz spectroscopy to pharmaceutical sciences.
Taday, PF, 2004
)
0.32
" Mean total pain relief and the sum of pain intensity difference were also similar in the early period after dosing (0-4 hours)."( Onset of analgesia and analgesic efficacy of tramadol/acetaminophen and codeine/acetaminophen/ibuprofen in acute postoperative pain: a single-center, single-dose, randomized, active-controlled, parallel-group study in a dental surgery pain model.
Cha, IH; Jung, YS; Kim, DK; Kim, HJ; Kim, MK; Lee, EW, 2004
)
0.57
" Postoperatively the propacetamol dosage was repeated twice and diclofenac once on the ward."( Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy.
Hiller, A; Savolainen, S; Silvanto, M; Tarkkila, P, 2004
)
0.32
"This was a prospective case series of consecutive patients aged 12 years and older with acetaminophen dosage greater than 4 g per 24 hours referred to our poison center."( Prospective evaluation of repeated supratherapeutic acetaminophen (paracetamol) ingestion.
Bogdan, GM; Daly, FF; Dart, RC; Heard, K; O'Malley, GF, 2004
)
0.8
" These findings demonstrate the need for better education of parents about correct dosage of first-line malaria drugs, and for particular attention in the treatment of very young children."( Community effectiveness of chloroquine and traditional remedies in the treatment of young children with falciparum malaria in rural Burkina Faso.
Kouyate, B; Mueller, O; Razum, O; Traore, C, 2004
)
0.32
"5 mg/kg of the study drug was injected and this dosage was added to the total amount."( The postoperative analgesic effect of tramadol when used as subcutaneous local anesthetic.
Altunkaya, H; Babuccu, O; Demirel, CB; Hosnuter, M; Kargi, E; Ozer, Y; Ozkocak, I, 2004
)
0.32
"Experience with dose response and mechanisms of toxicity has shown that multiple mechanisms may exist for a single agent along the continuum of the full dose-response curve."( Dose-dependent transitions in mechanisms of toxicity: case studies.
Andersen, ME; Bogdanffy, MS; Bus, JS; Cohen, SD; Conolly, RB; David, RM; Doerrer, NG; Dorman, DC; Gaylor, DW; Hattis, D; Rogers, JM; Setzer, RW; Slikker, W; Swenberg, JA; Wallace, K, 2004
)
0.32
" Mice were dosed [vehicle, nontoxic APAP (1 mmol/kg), and toxic APAP (3."( Time course toxicogenomic profiles in CD-1 mice after nontoxic and nonlethal hepatotoxic paracetamol administration.
Brain, P; Garcia-Allan, C; Hanton, G; Johnston, GI; LeNet, JL; Park, BK; Provost, JP; Smith, DA; Walsh, R; Williams, DP, 2004
)
0.32
" Fentanyl (in post-anesthesia care unit) and paracetamol (at home) were supplementary analgesics and the dosage was also recorded."( [Comparison of preemptive analgesia efficacy between etoricoxib and rofecoxib in ambulatory gynecological surgery].
Liu, W; Loo, CC; Ren, HZ; Tan, HM; Ye, TH, 2004
)
0.32
" Regarding possible risk factors 5 patients concomitantly ingested nephrotoxic substances, 4 presented with dehydration due to vomiting, 4 with chronic excessive dosing (overdose) of acetaminophen, 3 showed pre-existing renal insufficiency, 2 pre-existing liver disease and 2 died with multiple organ failure."( Experiences of a poison center network with renal insufficiency in acetaminophen overdose: an analysis of 17 cases.
Hengstler, JG; Hermanns-Clausen, M; Kaes, J; Koch, I; Lauterbach, M; von Mach, MA; Weilemann, LS, 2005
)
0.76
" Conditions which might play a role as influencing factors for renal complications included concomitant ingestion of nephrotoxic drugs, dehydration, chronic excessive dosing (overdose) of acetaminophen, pre-existing renal or liver disease and multiple organ failure."( Experiences of a poison center network with renal insufficiency in acetaminophen overdose: an analysis of 17 cases.
Hengstler, JG; Hermanns-Clausen, M; Kaes, J; Koch, I; Lauterbach, M; von Mach, MA; Weilemann, LS, 2005
)
0.76
" After three days, a cumulative dosage of 200 mg of CE in refracted doses were given."( Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and nimesulide associated or not with common non-steroidal anti-inflammatory drugs.
D'Amato, G; D'Amato, M; Liccardi, G; Piccolo, A; Piscitelli, E; Salzillo, A; Senna, G, 2005
)
0.57
" The present study compared thermodynamic data on acetaminophen melting and vaporization processes of pure acetaminophen with those found for several solid mixtures and in some commercially available acetaminophen-based dosage forms."( Thermal analysis study of the interactions between acetaminophen and excipients in solid dosage forms and in some binary mixtures.
Catalani, A; Rossi, V; Tomassetti, M; Vecchio, S, 2005
)
0.83
" In vitro dissolution of Apotel tablets in milk was delayed less than of Panodil and the effect of dosing conditions on the in vivo disintegration was not apparent."( The delayed dissolution of paracetamol products in the canine fed stomach can be predicted in vitro but it does not affect the onset of plasma levels.
Abrahamsson, B; Albery, T; Dressman, J; Kalantzi, L; Laitmer, D; Polentarutti, B; Reppas, C, 2005
)
0.33
" The method was applied to the analysis of various commercially available acetaminophen dosage forms with recoveries of 98."( Migration behaviour and separation of acetaminophen and p-aminophenol in capillary zone electrophoresis: analysis of drugs based on acetaminophen.
Galera, R; Martínez-Lozano, C; Pérez-Ruiz, T; Tomás, V, 2005
)
0.83
" The primary outcome measures were total pain relief through 6 hours after dosing (TOTPAR6), sum of pain intensity differences through 6 hours (SPID6), and adverse events."( Analgesic efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg compared with those of oxycodone 5 mg/acetaminophen 325 mg and hydrocodone 7.5 mg/acetaminophen 500 mg in patients with moderate to severe postoperative pain: a randomized, double-blin
Adamson, DN; Christensen, SE; Han, SH; Litkowski, LJ; Newman, KB; Van Dyke, T, 2005
)
0.54
"To determine the importance of tumour necrosis factor receptor 1 in hepatocyte regeneration in acetaminophen toxicity, wild type and tumour necrosis factor receptor 1 knock-out mice were dosed with acetaminophen (300 mg/kg intraperitoneally) and sacrificed at 4, 24, 48, 72, and 96 hr."( Tumour necrosis factor receptor 1 and hepatocyte regeneration in acetaminophen toxicity: a kinetic study of proliferating cell nuclear antigen and cytokine expression.
Hinson, JA; James, LP; Kurten, RC; Lamps, LW; McCullough, S, 2005
)
0.78
"As part of a randomized clinical trial that compared three different analgesic dosing regimens ( Sutters et al."( Time-contingent dosing of an opioid analgesic after tonsillectomy does not increase moderate-to-severe side effects in children.
Holdridge-Zeuner, D; Lanier, B; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2005
)
0.33
"With the increased interest in modified release dosage forms and drug delivery systems, there is an increasing concern for biopharmaceutical characterization of the formulation in the early stages of drug product development."( Biopharmaceutical characterization of sustained release matrix tablets based on novel carbomer polymers: formulation and in vivo investigation.
Djurić, Z; Evic, IK; Ibrić, S; Jelena, P; Jovanović, D; Jovanović, M; Kilibarda, V,
)
0.13
" The results of the proposed method were in excellent agreement with those obtained from PLS and HPLC methods and can be satisfactorily used for routine analysis of multicomponent dosage forms."( Content uniformity and dissolution tests of triplicate mixtures by a double divisor-ratio spectra derivative method.
Koundourellis, JE; Malliou, ET; Markopoulou, CK, 2005
)
0.33
"Despite extensive clinical experience, no dose-response curve exists for acetaminophen toxicity in man."( A new predictor of toxicity following acetaminophen overdose based on pretreatment exposure.
Good, AM; Johnson, DW; Juurlink, DN; Sivilotti, ML; Yarema, MC, 2005
)
0.83
" tables of normal and abnormal ranges of temperature, recommended temperature measurement techniques, dosage regimen of antipyretic drugs, guidelines to parents), justifying the implementation of a pharmaceutical follow-up."( When fever, paracetamol? Theory and practice in a paediatric outpatient clinic.
Cotting, JQ; Di Paolo, ER; Djahnine, SR; Gehri, M; Guignard, E; Krahenbuhl, JD; Pannatier, A; Yersin, C, 2005
)
0.33
" In these studies, overnight fasted male CD-1 mice were dosed (i."( Cholestasis induced by model organic anions protects from acetaminophen hepatotoxicity in male CD-1 mice.
Hennig, GE; Manautou, JE; Silva, VM, 2006
)
0.58
" The intensity of other symptoms of URTI was rated by patients at baseline and at 2, 4, and 6 hours after dosing (scale from 0 = none to 10 = severe)."( Aspirin compared with acetaminophen in the treatment of fever and other symptoms of upper respiratory tract infection in adults: a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single-dose, 6-hour dose-ranging st
Bachert, C; Chuchalin, AG; Eisebitt, R; Netayzhenko, VZ; Voelker, M, 2005
)
0.64
"A large percentage of Israeli paediatricians do not provide parents proper instructions regarding the correct dosing of acetaminophen."( How much acetaminophen do paediatricians prescribe? A survey among Israeli paediatricians.
Berkovitch, M; Goldstein, L; Greenberg, R; Grossman, Z; Kozer, E, 2005
)
0.95
"To assess clinical efficacy of IV paracetamol 1 g and IV metamizol 1 IV metamizol 1 g on a 24-h dosing schedule in this randomized, double-blinded, placebo-controlled study of 38 ASA physical status I-III patients undergoing retinal surgery."( A comparison between IV paracetamol and IV metamizol for postoperative analgesia after retinal surgery.
Eggert, D; Giesecke, T; Kampe, S; Kiencke, P; Landwehr, S; Thumann, G, 2005
)
0.33
"As our society is becoming increasingly aged, the development of an appropriate dosage form for the elderly patients is mostly desirable."( Formulation design of a novel fast-disintegrating tablet.
Masuda, Y; Mizumoto, T; Terada, K; Yamamoto, T; Yonemochi, E, 2005
)
0.33
" In this survey, 30% believed there was less risk with OTC analgesics, and 44% consumed more than the recommended dosage on the label."( Patterns of use and public perception of over-the-counter pain relievers: focus on nonsteroidal antiinflammatory drugs.
Cryer, B; Triadafilopoulos, G; Wilcox, CM, 2005
)
0.33
" Appropriately dosed and monitored use of opioids for OA pain, when more conservative methods have failed, has potentially fewer life-threatening complications associated with it than the more commonly and often less successfully employed pharmacotherapeutic approaches to care."( The use of opioids in the treatment of osteoarthritis: when, why, and how?
Bajwa, ZH; Goodwin, JL; Kraemer, JJ, 2005
)
0.33
"Gels dosage forms are successfully used as drug delivery systems considering their ability to control drug release and to protect medicaments from an hostile environment."( Rheological, adhesive and release characterisation of semisolid Carbopol/tetraglycol systems.
Bonacucina, G; Cespi, M; Misici-Falzi, M; Palmieri, GF, 2006
)
0.33
" In clinical practice, combinations are usually given at the above-mentioned dosage three to four times a day."( Comparative trial of tramadol/paracetamol and codeine/paracetamol combination tablets on the vigilance of healthy volunteers.
Dubray, C; Estrade, M; Pickering, G, 2005
)
0.33
" Treatment response was higher for tramadol/APAP than a placebo at 2 hours after dosing (55."( Tramadol/acetaminophen for the treatment of acute migraine pain: findings of a randomized, placebo-controlled trial.
Fisher, AC; Freitag, FG; Hewitt, DJ; Jordan, DM; Kudrow, DB; Rosenthal, NR; Rozen, TD; Silberstein, SD,
)
0.55
" paludosa pretreatment (100-500 mg kg(-1)) in a dose-response manner."( Protective effect of crude extract from Wedelia paludosa (Asteraceae) on the hepatotoxicity induced by paracetamol in mice.
Bagio, A; Balz, D; Brocardo, PS; Dafre, AL; Goulart, EC; Meotti, FC; Rodrigues, AL; Rosa, JM; Santos, AR; Waltrick, AP, 2006
)
0.33
" After three days, a cumulative dosage of 200 mg of CE in refracted doses was given."( Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and other non-steroidal anti-inflammatory drugs.
Cazzola, M; D'Amato, G; D'Amato, M; De Giglio, C; Liccardi, G; Manfredi, D; Piscitelli, E, 2005
)
0.57
" The effective dose that produced 50% antinociception (ED50) was calculated from the log dose-response curves of fixed ratio combinations of paracetamol with each NSAID."( Synergism between paracetamol and nonsteroidal anti-inflammatory drugs in experimental acute pain.
Miranda, HF; Pinardi, G; Prieto, JC; Puig, MM, 2006
)
0.33
"Adsorption characteristics of medicinal carbon powder (JP 14) for acetaminophen were examined at 37 degrees C using conventional incubation in an attempt to obtain an effective oral dosage form."( Medicinal carbon tablets for treatment of acetaminophen intoxication: adsorption characteristics of medicinal carbon powder and its tablets.
Ito, A; Machida, Y; Onishi, H; Yamamoto, K, 2006
)
0.84
" Lower basal Cyp1a2 mRNA levels and lower expression of Cyp1a2 and Cyp3a11 mRNAs after APAP dosing were also observed in females compared with males."( Acetaminophen metabolism does not contribute to gender difference in its hepatotoxicity in mouse.
Chou, N; Dai, G; He, L; Wan, YJ, 2006
)
1.78
" By generating two-dimensional loadings plots, it was also possible to identify the m/z values of the substances responsible for the differentiation between control and dosed samples."( Urine profiling using capillary electrophoresis-mass spectrometry and multivariate data analysis.
Bäckström, D; Bergquist, J; Danielsson, R; Sjöberg, P; Ullsten, S, 2006
)
0.33
" Because acetaminophen has a different mechanism of action from the conventional NSAIDs, it does not inhibit peripheral PGs at recommended dosing and therefore appears to have a more favorable cardiovascular and gastrointestinal safety profile."( Clinical implications of nonopioid analgesia for relief of mild-to-moderate pain in patients with or at risk for cardiovascular disease.
Whelton, A, 2006
)
0.75
" Dosing of both drug groups is tempered by concerns about toxicity."( Pain control: non-steroidal anti-inflammatory agents.
Anderson, BJ; Jacqz-Aigrain, E, 2006
)
0.33
" Following dosing of CFA-injected rats with rofecoxib (Vioxx) or paracetamol, there was a significant decrease in the number of ipsilateral CGRP-IR small and medium DRG neurones in rofecoxib- but not paracetamol-treated rats."( Changes in dorsal root ganglion CGRP expression in a chronic inflammatory model of the rat knee joint: differential modulation by rofecoxib and paracetamol.
Bountra, C; Chessell, IP; Day, NC; Staton, PC; Wilson, AW, 2007
)
0.34
" Patient-controlled analgesia was used for the first 3 postoperative days in all patients, and the cumulative dosage used was recorded."( Analgesic effect of electroacupuncture in postthoracotomy pain: a prospective randomized trial.
Chan, SK; Lee, TW; Liang, YM; Ng, CS; Sihoe, AD; Wan, IY; Wong, RH; Wong, WW; Yim, AP, 2006
)
0.33
" The subsequent 6 patients (group 2) were treated using a formal heparin anticoagulation protocol that included 2000 units in prime solution and 30 units/kg induction, activated clotting time (ACT) measurements, and heparin administered by dose-response curve to maintain 300-second ACT."( Formal heparin anticoagulation protocol improves safety of charcoal-based liver-assist treatments.
Bull, B; Cottrell, A; Hay, K; Hill, KB; Hillebrand, DJ; Hu, KQ; Strutt, M; Teichman, S; Wilson, B,
)
0.13
" The following medications were randomly given to the patients who declared pain in the sixth hour after the operation: naproxen sodium, meloxicam, rofecoxib, paracetamol, dipyrone, and etodolac in proper dosage to form groups of 20 for each medication."( [Postoperative pain management in clinics of otolaryngology].
Cağici, CA; Calişkan, EE; Erkan, AN; Gencay, S; Ozlüoğlu, LN; Sener, M; Yavuz, H; Yilmaz, I; Yilmazer, C, 2006
)
0.33
"5, 2, 3, 4, 5, 7, and 9 h after dosing for determination of the plasma levels of PCM and its metabolites by high-performance liquid chromatography."( A pharmacokinetic study of paracetamol in Thai beta-thalassemia/HbE patients.
Chantharaksri, U; Fucharoen, P; Fucharoen, S; Howard, TA; Morales, NP; Sanvarinda, Y; Sirankapracha, P; Tankanitlert, J; Temsakulphong, A; Ware, RE, 2006
)
0.33
"This patient with multiple risk factors and severe hepatotoxicity after therapeutic dosage of acetaminophen was successfully treated with N-acetylcysteine."( Severe hepatotoxicity after therapeutic doses of acetaminophen.
Cairon, E; Mian, P; Moling, O; Pristerá, R; Rimenti, G; Rizza, F, 2006
)
0.81
" The experimental design, which can be easily adapted to different cell types, provides an improved testing protocol to evaluate under reliable conditions the dose-response relationships of the thiol-redox state in a variety of biological processes."( An experimental design for the controlled modulation of intracellular GSH levels in cultured hepatocytes.
Esteban-Pretel, G; Pilar López-García, M, 2006
)
0.33
"Establishing the dose-response relationship for clinically useful doses of aspirin, ibuprofen and paracetamol has been difficult."( Dose-response in direct comparisons of different doses of aspirin, ibuprofen and paracetamol (acetaminophen) in analgesic studies.
McQuay, HJ; Moore, RA, 2007
)
0.56
"Use of trials making direct comparison of two different doses of target drugs revealed the underlying dose-response curve for clinical analgesia."( Dose-response in direct comparisons of different doses of aspirin, ibuprofen and paracetamol (acetaminophen) in analgesic studies.
McQuay, HJ; Moore, RA, 2007
)
0.56
" Thus, granules and tablet are useful as a compact dosage form of MC; though the reduced adsorption capacity must be taken into account in order to expect efficacy equivalent to that of MC alone."( In vitro and in vivo evaluation of medicinal carbon granules and tablet on the adsorption of acetaminophen.
Ito, A; Machida, Y; Onishi, H; Yamamoto, K, 2007
)
0.56
"The role of Mrp2, Bcrp, and P-glycoprotein in the biliary excretion of acetaminophen sulfate (AS) and glucuronide (AG), 4-methylumbelliferyl sulfate (4MUS) and glucuronide (4MUG), and harmol sulfate (HS) and glucuronide (HG) was studied in Abcc2(-/-), Abcg2(-/-), and Abcb1a(-/-)/Abcb1b(-/-) mouse livers perfused with the respective parent compounds using a cassette dosing approach."( The important role of Bcrp (Abcg2) in the biliary excretion of sulfate and glucuronide metabolites of acetaminophen, 4-methylumbelliferone, and harmol in mice.
Brouwer, KL; Kalvass, JC; Nezasa, K; Patel, NJ; Raub, TJ; Tian, X; Zamek-Gliszczynski, MJ, 2006
)
0.78
"The safety of paracetamol when given in the recommended dosage is well documented."( Repeated supratherapeutic doses of paracetamol in children--a literature review and suggested clinical approach.
Berkovitch, M; Greenberg, R; Kozer, E; Zimmerman, DR, 2006
)
0.33
"Liver injury secondary to repeated dosing of paracetamol is rare but may result in severe morbidity and mortality."( Repeated supratherapeutic doses of paracetamol in children--a literature review and suggested clinical approach.
Berkovitch, M; Greenberg, R; Kozer, E; Zimmerman, DR, 2006
)
0.33
" It is recommended to use the same dosages and dosage forms that the patient used before the trial, to start the trial with a run-in period, to formulate both general and individualized decision rules regarding the efficacy of treatment, to adjust treatment policies immediately after the trial, and to provide adequate instructions and support if treatment is adjusted."( Conducting research in individual patients: lessons learnt from two series of N-of-1 trials.
de Vries, TP; Stalman, WA; van der Windt, DA; Wegman, AC, 2006
)
0.33
" In the present study, the involvement in this process of Mrp3 and Mrp4, two basolateral efflux transporters, was evaluated by analyzing the hepatic basolateral excretion of the glucuronide and sulfate metabolites of acetaminophen, 4-methylumbelliferone, and harmol in Abcc3(-/-) and Abcc4(-/-) mice using a cassette dosing approach."( Evaluation of the role of multidrug resistance-associated protein (Mrp) 3 and Mrp4 in hepatic basolateral excretion of sulfate and glucuronide metabolites of acetaminophen, 4-methylumbelliferone, and harmol in Abcc3-/- and Abcc4-/- mice.
Belinsky, MG; Bridges, AS; Brouwer, KL; Kruh, GD; Lee, K; Nezasa, K; Tian, X; Zamek-Gliszczynski, MJ, 2006
)
0.72
" Conditions for the complete biodegradation of paracetamol dosage forms (pills) were optimized."( [Catalysis of the biodegradation of unusable medicines by alkanotrophic rhodococci].
Chekryshkina, LA; Ivshina, IB; Mishenina, II; Rychkova, MI; Vikhareva, EV,
)
0.13
"To assess clinical efficacy of IV paracetamol 1 g and IV dipyrone 1 g on a 24-h dosing schedule in this randomised, double-blinded study of 40 ASA I-III (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer."( Clinical equivalence of IV paracetamol compared to IV dipyrone for postoperative analgesia after surgery for breast cancer.
Dagtekin, O; Haussmann, S; Kampe, S; Kiencke, P; Landwehr, S; Paul, M; Pilgram, B; Warm, M, 2006
)
0.33
" Thus, the proposed method is simple and suitable for the simultaneous analysis of active ingredients in tablet dosage forms."( Method development and validation for the simultaneous determination of cetirizine dihydrochloride, paracetamol, and phenylpropanolamine hydrochloride in tablets by capillary zone electrophoresis.
Azhagvuel, S; Sekar, R, 2007
)
0.34
" In the writhing test, the intraperitoneal administration of dexketoprofen or ketoprofen resulted in parallel dose-response curves with equal efficacy, but higher relative potency for dexketoprofen."( Dexketoprofen-induced antinociception in animal models of acute pain: synergy with morphine and paracetamol.
Dursteler, C; Miranda, HF; Pinardi, G; Prieto, JC; Puig, MM, 2007
)
0.34
" The pooled data set consisted of patient demographics, dosing records, aminotransferase and bilirubin laboratory values, and adverse events."( Retrospective analysis of transient elevations in alanine aminotransferase during long-term treatment with acetaminophen in osteoarthritis clinical trials.
Baggish, JS; Cooper, KM; Kuffner, EK; Parenti, DL; Temple, AR, 2006
)
0.55
" Although initial response to all pediatric poisonings begins with basic stabilization, knowledge of specific antidotes, their mechanisms of action, safety profile in pediatrics, and dosing regimens can be life-saving for pediatric victims of nerve gas exposure, acetaminophen toxicity, methanol and ethylene glycol ingestion, and snakebites."( Update on antidotes for pediatric poisoning.
Liebelt, EL; White, ML, 2006
)
0.51
" The effective dose that produced 50% antinociception (ED(50,mix)) was calculated from the log dose-response curve of fixed-ratio combinations of paracetamol with ketoprofen."( Isobolographic analysis of the antinociceptive interactions between ketoprofen and paracetamol.
Kong, H; Liu, J; Liu, Y; Mei, XG; Qiu, HX, 2007
)
0.34
" Primary hepatocytes isolated from mice dosed with CFB are resistant to APAP toxicity."( Role of NAD(P)H:quinone oxidoreductase 1 in clofibrate-mediated hepatoprotection from acetaminophen.
Aleksunes, LM; Kardas, MJ; Klaassen, CD; Manautou, JE; Moffit, JS; Slitt, AL, 2007
)
0.56
" These results suggest that these parameters can be used to determine an effective APAP dosage regimen for Japanese patients with chronic pain."( Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
Aoyama, T; Aoyama, Y; Matsumoto, Y; Ohe, Y; Shinoda, S; Tomioka, S, 2007
)
0.61
" The limited efficacy of rofecoxib in this study contrasts to the results of previous surgical studies evaluating rofecoxib, and may be partially explained by the postoperative dosing in this arthroscopic surgical model."( The efficacy of rofecoxib 50 mg and hydrocodone/acetaminophen 7.5/750 mg in patients with post-arthroscopic pain.
Chelly, JE; Nissen, CW; Rodgers, AJ; Smugar, SS; Tershakovec, AM, 2007
)
0.6
" Patients then dosed up to three times daily for 3 days and recorded nasal congestion and pain intensity scores."( Efficacy of a paracetamol-pseudoephedrine combination for treatment of nasal congestion and pain-related symptoms in upper respiratory tract infection.
Burnett, I; Eccles, R; Jawad, M; Jawad, S; Jones, E; North, M; Ridge, D, 2006
)
0.33
" This case report supports the use of N-acetylcysteine to treat neonatal acetaminophen toxicity and highlights the need for better education of parents regarding the appropriate use and dosage of acetaminophen in newborns."( Acetaminophen-induced hepatic failure with encephalopathy in a newborn.
Baker, CF; Sarkar, S; Walls, L, 2007
)
2.01
"The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating knee OA symptoms."( Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator.
Araújo, D; Benito, P; Blanco, FJ; Branco, J; Del Carmen Trabado, M; Figueroa, M; Herrero-Beaumont, G; Ivorra, JA; Laffon, A; Marenco, JL; Martín-Mola, E; Paulino, J; Porto, A, 2007
)
0.54
" dry mixing of drug and SA, followed by compression, which is the easiest way to manufacture an oral dosage form."( High-amylose carboxymethyl starch matrices for oral sustained drug-release: in vitro and in vivo evaluation.
Amores da Silva, P; Bataille, B; Brouillet, F; Cartilier, L; Chebli, C; Kyriacos, S; Mroueh, M; Nabais, T, 2007
)
0.34
" There was a wide variability of the dosing interval."( Alternating antipyretics for fever reduction in children: an unfounded practice passed down to parents from pediatricians.
Liebelt, EL; Wright, AD, 2007
)
0.34
" The described method was applied for the determination of these combinations in synthetic mixtures and dosage forms."( Derivative-ratio spectrophotometric method for the determination of ternary mixture of aspirin, paracetamol and salicylic acid.
Assi, SA; El-Yazbi, FA; Hammud, HH, 2007
)
0.34
"This multiple-dose pharmacokinetic study has a randomized, double-blind, placebo-controlled, parallel-group design with three dosing regimens."( Aminotransferase activities in healthy subjects receiving three-day dosing of 4, 6, or 8 grams per day of acetaminophen.
Auiler, JF; Gelotte, CK; Lynch, JM; Temple, AR; Vena, J, 2007
)
0.55
"This paper presents a simple, specific, and precise high-performance liquid chromatographic method for the simultaneous determination of paracetamol (PCM), chlorzoxazone (CXZ), and their related impurities in bulk raw materials and solid dosage forms."( Simultaneous determination of paracetamol, chlorzoxazone, and related impurities 4-aminophenol, 4'-chloroacetanilide, and p-chlorophenol in pharmaceutical preparations by high-performance liquid chromatography.
Ali, MS; Ghori, M; Kahtri, AR; Rafiuddin, S,
)
0.13
" The sensitivity of the proposed method to detect changes in the NMR spectra 24 and 48 h after single dosing was compared with histopathology and biochemical parameters in plasma and urine."( Sensitivity of (1)H NMR analysis of rat urine in relation to toxicometabonomics. Part I: dose-dependent toxic effects of bromobenzene and paracetamol.
Horbach, GJ; Kloks, CP; Mellema, JR; Ploemen, JP; Schoonen, WG; Smit, MJ; Tas, AC; van Nesselrooij, JH; Vogels, JT; Zandberg, P; Zuylen, CT, 2007
)
0.34
" Depending on the intended indication and dosing regimen, PPL can delay or stop development of a compound in the drug discovery process."( Evaluation of a published in silico model and construction of a novel Bayesian model for predicting phospholipidosis inducing potential.
Gehlhaar, D; Greene, N; Johnson, TO; Pelletier, DJ; Tilloy-Ellul, A,
)
0.13
"The characteristics of various pharmaceutical dosage forms are influenced by surface properties such as the friction behavior."( Nanoscopic friction behavior of pharmaceutical materials.
Lee, J, 2007
)
0.34
" Ibuprofen dosage was 51% (P<0."( Paediatric analgesia in the emergency department, are we getting it right?
Blair, L; Clark, M; Donald, C; Duncan, R; Thakore, S, 2007
)
0.34
" Through the printing of release-retardation materials, 3DP processes could easily prepare tablets with high dosage and special design features for furnishing the desired drug release characteristics."( Tablets with material gradients fabricated by three-dimensional printing.
Huang, WD; Liu, J; Wang, YG; Xu, H; Yang, XL; Yu, DG, 2007
)
0.34
" Our hypothesis was that common liver tests would be unaffected by administration of the maximum recommended daily dosage of acetaminophen for 3 consecutive days to newly-abstinent alcoholic subjects."( The effect of acetaminophen (four grams a day for three consecutive days) on hepatic tests in alcoholic patients--a multicenter randomized study.
Bogdan, GM; Dart, RC; Green, JL; Heard, K; Knox, PC; Kuffner, EK; Palmer, RB; Slattery, JT, 2007
)
0.91
" Present paper introduces the development and validation of analytical methods suitable for quantitative determination of paracetamol containing dosage forms in FoNo VII."( [Current problems in the quality control of pharmaceutical preparations manufactured in pharmacies II. Paracetamol contraining preparations].
Horváth, P; Sinkó, B; Takaćsne, NK; Völgyi, G, 2006
)
0.33
" This study assessed the ability of doctors and nurses to calculate correct doses using manual calculation skills and a weight-based NAC dosing chart when prescribing and preparing NAC infusions."( Weight-based N-acetylcysteine dosing chart to minimise the risk of calculation errors in prescribing and preparing N-acetylcysteine infusions for adults presenting with paracetamol overdose in the emergency department.
Calvert, SH; Cavell, G; Glucksman, E; Gonzalez, J; Kerins, M; Selvan, VA, 2007
)
0.34
"Therapeutic dosing of paracetamol administered for 10 days appears to elevate serum ALT in moderate drinkers, but does not produce clinically evident liver injury."( A randomized trial to determine the change in alanine aminotransferase during 10 days of paracetamol (acetaminophen) administration in subjects who consume moderate amounts of alcohol.
Bailey, JE; Bogdan, GM; Dart, RC; Green, JL; Heard, K, 2007
)
0.55
" Dosage was determined by weight (86."( Over-the-counter medication use for childhood fever: a cross-sectional study of Australian parents.
Edwards, H; Fraser, J; Walsh, A, 2007
)
0.34
" In both groups, if pain intensity was rated as > 3 on the VAS at week 1 or 2, the dosage was doubled."( Codeine/acetaminophen and hydrocodone/acetaminophen combination tablets for the management of chronic cancer pain in adults: a 23-day, prospective, double-blind, randomized, parallel-group study.
Angel, AM; Castillo, JM; Del Pilar Castillo, M; Nuñez, PD; Ortiz, Y; Restrepo, JM; Rodriguez, JM; Rodriguez, MF; Rodriguez, RF, 2007
)
0.77
" Of the patients who received C/A, 58% responded to the initial dosage of 150/2500 mg/d, and 8% of the patients responded to the double dosage; 34% did not experience pain relief."( Codeine/acetaminophen and hydrocodone/acetaminophen combination tablets for the management of chronic cancer pain in adults: a 23-day, prospective, double-blind, randomized, parallel-group study.
Angel, AM; Castillo, JM; Del Pilar Castillo, M; Nuñez, PD; Ortiz, Y; Restrepo, JM; Rodriguez, JM; Rodriguez, MF; Rodriguez, RF, 2007
)
0.77
" Physicians should be aware of potential hepatotoxicity and nephrotoxicity of acetaminophen, even if given at therapeutic dosage in acute febrile illness."( Therapeutic dose of acetaminophen with fatal hepatic necrosis and acute renal failure.
Lohachit, P; Ruamvang, T; Satirapoj, B, 2007
)
0.89
" near-infrared; Raman) should be equivalent to a single dosage size."( Drug product characterization by macropixel analysis of chemical images.
Ellison, CD; Hamad, ML; Khan, MA; Lyon, RC, 2007
)
0.34
"The dissolution characteristics of melt granulations of paracetamol in capsule and tablet dosage form were compared to determine whether the dissolution characteristics of the granules can be actualized by formulating them as rapidly disintegrating tablets."( A comparative study of the dissolution characteristics of capsule and tablet dosage forms of melt granulations of paracetamol--diluent effects.
Okor, RS; Uhumwangho, MU,
)
0.13
" Mice were dosed with single-AA injection (500 mg/kg via the intra peritoneal route) with or without L-carnitine (500 mg/kg for 5 days starting 5 days before AA injection via intra peritoneal route) and sampled at 4, 8 and 24 h following AA injection."( Hepatoprotective effect of L-carnitine against acute acetaminophen toxicity in mice.
Atakisi, O; Citil, M; Erginsoy, S; Karapehlivan, M; Kart, A; Tunca, R; Yapar, K, 2007
)
0.59
"Adults who received repeated dosing of acetaminophen 4 g/day or lower for at least 24 hours."( Does therapeutic use of acetaminophen cause acute liver failure?
Bailey, E; Dart, RC, 2007
)
0.92
"8%) received the maximum recommended therapeutic dosage (3."( Does therapeutic use of acetaminophen cause acute liver failure?
Bailey, E; Dart, RC, 2007
)
0.65
"Prospective studies indicated that repeated use of a true therapeutic acetaminophen dosage may slightly increase the level of serum aminotransferase activity, but hepatic failure or death was not reported."( Does therapeutic use of acetaminophen cause acute liver failure?
Bailey, E; Dart, RC, 2007
)
0.88
" As disintegration time is shortest at a certain ratio of disintegrant, a calculation of this value is important for solid dosage from design to enhance disintegration and dissolution process."( Rational estimation of the optimum amount of non-fibrous disintegrant applying percolation theory for binary fast disintegrating formulation.
Betz, G; Krausbauer, E; Leuenberger, H; Puchkov, M, 2008
)
0.35
"The estimation of paracetamol and orphenadrine citrate in a multicomponent pharmaceutical dosage form by spectrophotometric method has been reported."( Determination of paracetamol and orphenadrine citrate in pharmaceutical tablets by modeling of spectrophotometric data using partial least-squares and artificial neural networks.
Ruangwises, N; Sratthaphut, L, 2007
)
0.34
"On the second postoperative day, facial edema showed a statistically significant reduction in both dexamethasone 4-mg and dexamethasone 8-mg groups compared with the control group, but no statistically significant differences were observed between the 2 dosage regimens of dexamethasone."( Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study.
Beretta, M; Borgonovo, A; Farronato, D; Garramone, RA; Grossi, GB; Maiorana, C; Santoro, F, 2007
)
0.34
" Based on the pharmacokinetic parameters, an appropriate intravenous dosage regimen for levofloxacin would be 5 mg/kg repeated at 24 h intervals when prescribed with paracetamol in calves."( Disposition kinetics and dosage regimen of levofloxacin on concomitant administration with paracetamol in crossbred calves.
Dumka, VK, 2007
)
0.34
" Cisapride (1, 3 and 10 mg/kg) caused non-significant increases in the indices of gastric emptying, with roughly bell-shaped dose-response curves."( Oral mitemcinal (GM-611), an erythromycin-derived prokinetic, accelerates normal and experimentally delayed gastric emptying in conscious dogs.
Akima, M; Itoh, Z; Kamei, K; Koga, H; Omura, S; Onoma, M; Ozaki, K; Takanashi, H; Yogo, K, 2008
)
0.35
"Administration of erythromycin, tilmicosin, and tylosin at the label dosage increased abomasal emptying rate in calves."( Effect of parenteral administration of erythromycin, tilmicosin, and tylosin on abomasal emptying rate in suckling calves.
Constable, PD; Nouri, M, 2007
)
0.34
"To assess adult consumers' previous experience with measuring devices for oral liquids, compare the accuracy of an oral syringe with that of a dosing cup, and determine consumer perceptions of accuracy and ease of use of an oral syringe and a dosing cup."( Accuracy of oral liquid measuring devices: comparison of dosing cup and oral dosing syringe.
Ambrose, PJ; Christopherson, J; Corelli, RL; Sobhani, P, 2008
)
0.35
" They were then asked to measure a 5 mL (1 teaspoon) dose of Tylenol (acetaminophen) suspension, using the EZY Dose oral syringe and the dosing cup provided by the manufacturer."( Accuracy of oral liquid measuring devices: comparison of dosing cup and oral dosing syringe.
Ambrose, PJ; Christopherson, J; Corelli, RL; Sobhani, P, 2008
)
0.58
" Participants more commonly reported use of droppers (68%), dosing cups (67%), and teaspoons (62%) versus cylindrical spoons (49%) or oral syringes (49%) for measuring oral liquids."( Accuracy of oral liquid measuring devices: comparison of dosing cup and oral dosing syringe.
Ambrose, PJ; Christopherson, J; Corelli, RL; Sobhani, P, 2008
)
0.35
"Droppers and dosing cups were the most commonly used devices in the home for measuring liquid medications."( Accuracy of oral liquid measuring devices: comparison of dosing cup and oral dosing syringe.
Ambrose, PJ; Christopherson, J; Corelli, RL; Sobhani, P, 2008
)
0.35
"Capability of fast analysis of a novel miniaturized capillary electrophoresis with carbon disk electrode amperometric detection (mini-CE-AD) system was demonstrated by determining acetaminophen and p-aminophenol in dosage forms."( Rapid determination of acetaminophen and p-aminophenol in pharmaceutical formulations using miniaturized capillary electrophoresis with amperometric detection.
Chu, Q; Jiang, L; Tian, X; Ye, J, 2008
)
0.85
" In C57BL/6J mice, streptozotocin caused a dosage dependent increase in fasting blood glucose (FBG), from 100 to >600mg/dl."( Acetaminophen normalizes glucose homeostasis in mouse models for diabetes.
Clegg, DJ; D'Alessio, DA; Genter, MB; Kendig, EL; Schneider, SN; Shertzer, HG, 2008
)
1.79
" It can be concluded that a combination of mannitol, erythritol, Glucidex 9, Kollidon CL, colloidal silicon dioxide and polyoxyethylene 20 sorbitan monooleate allowed the spray drying of highly dosed drug substances (acetaminophen, ibuprofen, cimetidine) in order to obtain 'ready-to-compress' powder mixtures on lab-scale and production-scale equipment."( Coprocessing via spray drying as a formulation platform to improve the compactability of various drugs.
Gonnissen, Y; Peeters, E; Remon, JP; Verhoeven, E; Vervaet, C, 2008
)
0.53
"Most glucose meter comparisons to date have focused on performance specifications likely to impact subcutaneous dosing of insulin."( Evaluation of the impact of hematocrit and other interference on the accuracy of hospital-based glucose meters.
Bryant, SC; Dubois, JA; Griesmann, L; Karon, BS; Presti, S; Santrach, PJ; Scott, R; Shirey, TL, 2008
)
0.35
" However, prepared samples of normal human serum with added bilirubin showed a dose-response curve for only one of the 4 colorimetric assays."( False positive acetaminophen concentrations in patients with liver injury.
Balko, JA; Fuller, D; Hynan, LS; Khan, AI; Koff, JM; Lee, WM; Murray, NG; Orsulak, P; Polson, J; Wians, FH, 2008
)
0.7
"Commonly used dosage protocols for antimicrobial agents may alter the rate of gastric emptying."( Effect of erythromycin and gentamicin on abomasal emptying rate in suckling calves.
Constable, PD; Hajikolaee, MR; Nouri, M; Omidi, A,
)
0.13
" The DHA impurity values found in dosage forms were < or =0."( Development and validation of a liquid chromatographic method for the determination of ascorbic acid, dehydroascorbic acid and acetaminophen in pharmaceuticals.
Andreatta, P; Boschetti, S; Gatti, R; Gioia, MG, 2008
)
0.55
" The developed methodology would be beneficial to formulation scientists in dosage form design and optimization."( Effect of drug solubility on polymer hydration and drug dissolution from polyethylene oxide (PEO) matrix tablets.
Gu, X; Hardy, RJ; Li, H, 2008
)
0.35
"As a result, WLP-S-10 200 mg/kg significantly reduced liver injury induced by CCl(4) and decreased the mortality rate of mice because of acute liver failure caused by lethal dosage of acetaminophen or d-galactosamine plus LPS."( Protection by bicyclol derivatives against acetaminophen-induced acute liver failure in mice and its active mechanism.
Hou, Y; Li, L; Liu, G; Tong, Y; Wei, H; Wu, L; Wu, S, 2008
)
0.8
" The dosing regimen is complex, consisting of a loading dose followed by 2 maintenance doses, each with different infusion rates."( Frequency of medication errors with intravenous acetylcysteine for acetaminophen overdose.
Doyon, S; Hayes, BD; Klein-Schwartz, W, 2008
)
0.58
"To analyze the frequency of medication errors related to the complex dosing regimen for intravenous acetylcysteine."( Frequency of medication errors with intravenous acetylcysteine for acetaminophen overdose.
Doyon, S; Hayes, BD; Klein-Schwartz, W, 2008
)
0.58
" The survey showed a wide variation in morphine and paracetamol dosing and the absence of a paracetamol loading dose in a fourth of the units."( Pain management in Swedish neonatal units--a national survey.
Eriksson, M; Gradin, M, 2008
)
0.35
" The principal component analysis (PCA) of NMR or UPLC/MS spectra showed that metabolic changes observed in both acute and chronic dosing of acetaminophen were similar."( Metabonomics evaluation of urine from rats given acute and chronic doses of acetaminophen using NMR and UPLC/MS.
Beger, RD; Cantor, GH; Dragan, YP; Holland, RD; Schmitt, TC; Schnackenberg, LK; Sun, J, 2008
)
0.78
" acetaminophen dosed according to postmenstrual age (PMA): 28-32 weeks, 10 mg kg(-1); 32-36 weeks, 12."( I.V. acetaminophen pharmacokinetics in neonates after multiple doses.
Anderson, BJ; Atkins, M; Chalkiadis, GA; Culnane, TJ; Hunt, RW; McNally, CM; Palmer, GM; Perkins, EJ; Smith, KR, 2008
)
1.77
" This novel taste-masking system has the potential to be a useful multiparticulate dosage form for effective, safe, and user-friendly drug therapy."( Salting-out taste-masking system generates lag time with subsequent immediate release.
Katsuma, M; Maeda, A; Sako, K; Tasaki, H; Uchida, T; Yoshida, T, 2009
)
0.35
" In 24 (33%) of the 72 infusions, systolic blood pressure decreased to below 90 mm Hg and required intervention with fluid bolus administration on six occasions; a fluid bolus was accompanied by a dosage increase or initiation of a norepinephrine infusion on 18 occasions."( Effect of intravenous propacetamol on blood pressure in febrile critically ill patients.
Hersch, M; Izbicki, G; Raveh, D, 2008
)
0.35
" This case suggests that individualized dosing of antidotal therapy may be needed for preparations of acetaminophen that result in delayed absorption or after massive overdose."( Development of hepatic failure despite use of intravenous acetylcysteine after a massive ingestion of acetaminophen and diphenhydramine.
Hayes, BD; Sarmiento, KF; Schwartz, EA, 2009
)
0.78
" The dosage of the DDD can be adjusted independently by changing the heights of the DDDs."( Novel drug delivery devices for providing linear release profiles fabricated by 3DP.
Branford-White, C; Li, XY; Ma, ZH; Yang, XL; Yu, DG; Zhu, LM, 2009
)
0.35
" Appropriate dosing and managing of these drugs do not likely lead to organ toxicity."( Acute non-oliguric kidney failure and cholestatic hepatitis induced by ibuprofen and acetaminophen: a case report.
Angeli, S; Brugnara, M; Cuzzolin, L; Zaffanello, M, 2009
)
0.58
" However, this does not appear to be clinically relevant given the usual dosage range and the drug's half-life (approx."( The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube.
Berger-Gryllaki, M; Buclin, T; Pannatier, A; Podilsky, G; Roulet, M; Testa, B, 2009
)
0.35
"5 g/kg bw) and sub-toxic (150 mg/kg bw) dosage of paracetamol-induced liver injury in Sprague-Dawley rat."( Protective effect of a phytocompound on oxidative stress and DNA fragmentation against paracetamol-induced liver damage.
Gumaste, U; Helmy, A; Jain, S; Marotta, F; Minelli, E; Yadav, H,
)
0.13
"Neonatal drug dosing needs to be based on the physiological characteristics of the newborn, the pharmacokinetic parameters of the drug and has to take maturational aspects of drug disposition into account."( Neonatal clinical pharmacology: recent observations of relevance for anaesthesiologists.
Allegaert, K; de Hoon, J; Naulaers, G; Van De Velde, M, 2008
)
0.35
" The use of such mechanistic approaches improves understanding of paediatric pharmacokinetics; improving dosing predictions and allowing projection in exploratory drug development."( Mechanistic basis of using body size and maturation to predict clearance in humans.
Anderson, BJ; Holford, NH, 2009
)
0.35
" A dose-response study showed that the accumulation of long-chain acylcarnitines in serum contributes to the separation of wild-type mice undergoing APAP-induced hepatotoxicity from other mouse groups in a multivariate model."( Serum metabolomics reveals irreversible inhibition of fatty acid beta-oxidation through the suppression of PPARalpha activation as a contributing mechanism of acetaminophen-induced hepatotoxicity.
Chen, C; Gonzalez, FJ; Idle, JR; Krausz, KW; Shah, YM, 2009
)
0.55
"Multiparticulate drug delivery systems, such as pellets, are frequently used as they offer therapeutic advantages over single-unit dosage forms."( Porous pellets as drug delivery system.
Cosijns, A; De Beer, T; Evrard, B; Nikolakakis, I; Nizet, D; Remon, JP; Siepmann, F; Siepmann, J; Vervaet, C, 2009
)
0.35
"The aims of this study were to assess the feasibility of conducting a repeated-measures study of pain in PWDs and to investigate the effect of the scheduled dosing of acetaminophen in reducing observable pain behaviors in community-dwelling PWDs."( Effects of an analgesic trial in reducing pain behaviors in community-dwelling older adults with dementia.
Elliott, AF; Horgas, AL,
)
0.33
" Over 80% of total daily dosing from age 36 weeks PCA to 1 year fell within dosing suggested by pharmacokinetic studies."( Survey of i.v. paracetamol (acetaminophen) use in neonates and infants under 1 year of age by UK anesthetists.
Morton, NS; Wilson-Smith, EM, 2009
)
0.65
" paracetamol dosing in infants in the UK and Ireland is frequently above the licensed dose and outside the licensed age range but is in keeping with doses suggested by pharmacokinetic studies."( Survey of i.v. paracetamol (acetaminophen) use in neonates and infants under 1 year of age by UK anesthetists.
Morton, NS; Wilson-Smith, EM, 2009
)
0.65
"Oral sustained release gel formulations may provide a means of administering drugs to dysphagic and geriatric patients who have difficulties with handling and taking oral dosage forms."( Preparation and evaluation of gel formulations for oral sustained delivery to dysphagic patients.
Attwood, D; Dairaku, M; Ishitani, M; Itoh, K; Mikami, R; Miyazaki, S; Takahashi, A; Togashi, M, 2009
)
0.35
" The authors did not observe a dose-response relation with increased frequency or duration of regular use of any of these medications and ovarian cancer incidence."( Use of nonsteroidal antiinflammatory agents and incidence of ovarian cancer in 2 large prospective cohorts.
Cramer, DW; Hankinson, SE; Pinheiro, SP; Rosner, BA; Tworoger, SS, 2009
)
0.35
" Patients were randomized in a 1:1 ratio to receive either low-dose 7-day buprenorphine patches (patch strengths of 5, 10, and 20 microg/h, with a maximum dosage of 20 microg/h) or twice-daily prolonged-release tramadol tablets (tablet strengths of 75, 100, 150, and 200 mg, with a maximum dosage of 400 mg/d) over a 12-week open-label treatment period."( Efficacy and safety of low-dose transdermal buprenorphine patches (5, 10, and 20 microg/h) versus prolonged-release tramadol tablets (75, 100, 150, and 200 mg) in patients with chronic osteoarthritis pain: a 12-week, randomized, open-label, controlled, pa
Berggren, AC; Karlsson, M, 2009
)
0.35
"Early switching from morphine to methadone was a safe and efficient strategy for the reduction of side effects and improvement of analgesia, allowing for a comfortable dosing regimen."( Early switching from morphine to methadone is not improved by acetaminophen in the analgesia of oncologic patients: a prospective, randomized, double-blind, placebo-controlled study.
Cubero, DI; del Giglio, A, 2010
)
0.6
" Patients in group B who were receiving gabapentin continued this treatment up to a maximum daily dosage of 2400 mg during the observation period."( Adequacy assessment of oxycodone/paracetamol (acetaminophen) in multimodal chronic pain : a prospective observational study.
Bertini, L; Carucci, A; Gatti, A; Mammucari, M; Occhioni, R; Sabato, AF, 2009
)
0.61
"In this systematic review we present information relating to the benefits and harms of the following interventions: alternative analgesics, H(2) blockers, misoprostol, NSAIDs (systemic, topical, differences in efficacy between, dose-response relationship of), proton pump inhibitors."( NSAIDs.
Gøtzsche, PC, 2007
)
0.34
" Differences between the protocols were frequency of pain measurement, more frequent use of local anesthesia and higher dosage of Acetaminophen."( Perioperative analgesia strategies in fast-track pediatric surgery of the kidney and renal pelvis: lessons learned.
Dingemann, J; Kuebler, JF; Osthaus, WA; Reismann, M; Ure, BM; von Kampen, M; Wolters, M, 2010
)
0.57
" Current intravenous dosing regimens may not provide enough N-acetylcysteine to effectively metabolise paracetamol to non-toxic adducts."( Early presentation following overdose of modified-release paracetamol (Panadol Osteo) with biphasic and prolonged paracetamol absorption.
Chan, B; Graudins, A; Naidoo, D; Pham, HN; Salonikas, C, 2009
)
0.35
" To better understand the contributions of different signaling pathways, the expression and role of Ras activation was evaluated after oral dosing of mice with APAP (400-500 mg/kg)."( Farnesyltransferase inhibitors reduce Ras activation and ameliorate acetaminophen-induced liver injury in mice.
Nandi, D; Saha, B, 2009
)
0.59
"The oral administration of liquid dosage forms of suitable consistency and with sustained release characteristics may provide a means of improving the compliance of geriatric patients who experience difficulties in swallowing conventional solid dosage forms."( In situ gelling xyloglucan/alginate liquid formulation for oral sustained drug delivery to dysphagic patients.
Attwood, D; D'Emanuele, A; Itoh, K; Miyazaki, S; Shimoyama, T; Tsuruya, R; Watanabe, H, 2010
)
0.36
"To assess clinical equivalence of 20 mg controlled-release oxycodone (Oxygesic; Mundipharma, Limburg, Germany) and 200 mg controlled-release tramadol (Tramal long; Grunenthal, Aachen, Germany) on a 12-hour dosing schedule in a randomized, double-blinded study of 54 ASA I-III physical status (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer."( Clinical equivalence of controlled-release oxycodone 20 mg and controlled-release tramadol 200 mg after surgery for breast cancer.
Dagtekin, O; Kampe, S; Landwehr, S; Shaheen, S; Warm, M; Wolter, K, 2009
)
0.35
" Therefore, we recommend preparing the tablets with XYL or SOR as a binder using the wet granule compression method to produce a compact dosage form of MC."( Preparation and evaluation of medicinal carbon tablets with different saccharides as binders.
Ito, A; Machida, Y; Yamamoto, K, 2009
)
0.35
" Analysis of whole-body mouse thin tissue sections from animals dosed with propranolol, adhered to an adhesive tape substrate, provided semiquantitative information for propranolol and its hydroxyproranolol glucuronide metabolite within specific organs of the tissue."( Application of a liquid extraction based sealing surface sampling probe for mass spectrometric analysis of dried blood spots and mouse whole-body thin tissue sections.
Kertesz, V; Van Berkel, GJ, 2009
)
0.35
" A tablet dosage form of MC is useful to solve such problems."( Preparation of medicinal carbon tablets by modified wet compression method.
Machida, Y; Miyachi, M; Onishi, H; Yumoto, T, 2009
)
0.35
" In addition, the effectiveness and toxicity of many drugs vary depending on dosing time associated with 24-h rhythms of biochemical, physiological, and behavioral processes under the control of the circadian clock."( [Dosing time based on molecular mechanism of biological clock of hepatic drug metabolic enzyme].
Matsunaga, N, 2009
)
0.35
" The dosing range for acetaminophen was 10-15 mg/kg every four to six hours as needed, and the regimen for ibuprofen was 5-10 mg/kg every six to eight hours as needed."( Effect of a weight-based prescribing method within an electronic health record on prescribing errors.
Barr, WB; Ginzburg, R; Harris, M; Munshi, S, 2009
)
0.67
"An automated weight-based dosing calculator integrated into an EHR system in the outpatient setting significantly reduced medication prescribing errors for antipyretics prescribed to pediatric patients."( Effect of a weight-based prescribing method within an electronic health record on prescribing errors.
Barr, WB; Ginzburg, R; Harris, M; Munshi, S, 2009
)
0.35
" Additional measures included NPRS scores at predefined times over 48 hours, the summed pain intensity difference over 48 hours (SPID48), the time-weighted sum of pain relief scores over the first 8 hours, the mean dosing interval (the time from dosing to the time rescue medication or the next dose of study medication was administered, whichever was less), the proportion of patients requiring rescue medication, and the onset of perceptible and meaningful pain relief (2-stopwatch method)."( Diclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days.
Boesing, SE; Diamond, E; Duckor, S; Gottlieb, I; Raymond, G; Riff, DS; Soulier, S, 2009
)
0.35
"001), and overall mean dosing interval (331."( Diclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days.
Boesing, SE; Diamond, E; Duckor, S; Gottlieb, I; Raymond, G; Riff, DS; Soulier, S, 2009
)
0.35
" It can be a useful tool in the development of novel solid dosage forms."( A novel fast disintegrating tablet fabricated by three-dimensional printing.
Branford-White, C; Welbeck, EW; Yang, XL; Yang, YC; Yu, DG; Zhu, LM, 2009
)
0.35
" The added convenience of three times daily dosing may enhance compliance and, therefore, pain relief."( Patient preference for sustained-release versus standard paracetamol (acetaminophen): a multicentre, randomized, open-label, two-way crossover study in subjects with knee osteoarthritis.
Benson, M; Collaku, A; Durocher, J; Marangou, A; Russo, MA; Starkey, YY,
)
0.37
" The results indicated that repeated arsenic preexposure decreased susceptibility of rat kidney to acute AP-mediated oxidative stress; on the contrary, its coexposure rendered the rat kidney more vulnerable to oxidative stress induced by the repeated dosing of AP."( Repeated preexposure or coexposure to arsenic differentially alters acetaminophen-induced oxidative stress in rat kidney.
Manimaran, A; Sankar, P; Sarkar, SN, 2011
)
0.6
" LPS co-treatment produced a leftward shift of the dose-response curve for APAP-induced hepatotoxicity and led to significantly greater tumor necrosis factor-alpha (TNF) production than APAP alone."( Bacterial- and viral-induced inflammation increases sensitivity to acetaminophen hepatotoxicity.
Amuzie, CJ; Cantor, GH; Cuff, CF; Ganey, PE; Li, M; Maddox, JF; Newport, SW; Pestka, JJ; Roth, RA; Sparkenbaugh, E, 2010
)
0.6
" They were divided into two groups according to the dosage regimen Betaferon was administered."( Adverse drug reactions after 24-month treatment with two-dosage regimens of betaferon in patients with multiple sclerosis.
Kostadinova, II; Manova, MG,
)
0.13
"The reduced dosage regimen and corrective treatment reduce the adverse drug reactions and improve drug tolerability."( Adverse drug reactions after 24-month treatment with two-dosage regimens of betaferon in patients with multiple sclerosis.
Kostadinova, II; Manova, MG,
)
0.13
" These values are lower than the maximal therapeutic plasma concentrations of acetaminophen (< or =150microM) resulting from typical dosing regimes."( Acetaminophen (paracetamol) inhibits myeloperoxidase-catalyzed oxidant production and biological damage at therapeutically achievable concentrations.
Davies, MJ; Fu, S; Graham, GG; Hawkins, CL; Kajer, T; Keh, JS; Kettle, AJ; Koelsch, M; Mallak, R; Milligan, MK; Newsham, DW; Nguyen, LQ; Pattison, DI; Rees, MD; Scott, KF; Ziegler, JB, 2010
)
2.03
" Maxigesic tablets combine acetaminophen and ibuprofen in clinically appropriate doses to simplify administration and dosage regimen."( Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: a randomized controlled trial.
Anderson, BJ; Davies, E; Edwards, J; Frampton, C; Gibbs, RD; Merry, AF; Ting, GS, 2010
)
1.07
"No clinically relevant changes were noted in the serum concentrations of tapentadol, and accordingly, no dosage adjustments with respect to the investigated pharmacokinetic mechanism of interaction are warranted for the administration of tapentadol given concomitantly with acetaminophen, naproxen, or acetylsalicylic acid."( Effects of acetaminophen, naproxen, and acetylsalicylic acid on tapentadol pharmacokinetics: results of two randomized, open-label, crossover, drug-drug interaction studies.
Mangold, B; Oh, C; Ravenstijn, PG; Rengelshausen, J; Smit, JW; Terlinden, R; Upmalis, D; Wang, SS, 2010
)
0.93
"To determine the effectiveness of around-the-clock (ATC) analgesic administration, with or without nurse coaching, compared with standard care with as needed (PRN) dosing in children undergoing outpatient tonsillectomy."( A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy.
Holdridge-Zeuner, D; Lanier, B; Mahoney, K; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2010
)
0.6
" With the exception of constipation, scheduled analgesic dosing did not increase the frequency or severity of opioid-related adverse effects."( A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy.
Holdridge-Zeuner, D; Lanier, B; Mahoney, K; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2010
)
0.6
"Scheduled dosing of acetaminophen and hydrocodone is more effective than PRN dosing in reducing pain intensity in children after tonsillectomy."( A randomized clinical trial of the efficacy of scheduled dosing of acetaminophen and hydrocodone for the management of postoperative pain in children after tonsillectomy.
Holdridge-Zeuner, D; Lanier, B; Mahoney, K; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2010
)
0.92
" Mean metabolic ratios of [acetaminophen glucuronide]/[acetaminophen] between 0 and 1h were significantly higher after oral dosing in turkeys, dogs and pigs, revealing the role of first-pass metabolism in incomplete bioavailability."( Species comparison of oral bioavailability, first-pass metabolism and pharmacokinetics of acetaminophen.
Croubels, S; Daminet, S; De Backer, P; De Boever, S; Gommeren, K; Neirinckx, E; Remon, JP; Vervaet, C, 2010
)
0.88
" We chose to use random-effects meta-analyses because of the heterogeneity in dosage used."( Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period.
Abalos, E; Chou, D; Gülmezoglu, AM; Gyte, GM, 2010
)
0.74
" The treatment started with oxycodone/acetaminophen at the dosage of 5 mg/325 mg, and then the dosage was titrated until the attainment of good pain relief."( Oxycodone/acetaminophen at low dosage: an alternative pain treatment for patients with rheumatoid arthritis.
Biasi, G; Corvetta, A; Di Sabatino, V; Galeazzi, M; Pari, C; Raffaeli, W; Sarti, D,
)
0.8
" We sought to assess the value of acetaminophen dosing information in patients with acute liver failure (ALF) due to acetaminophen toxicity to determine the role of dose as a prognostic indicator."( Acetaminophen dose does not predict outcome in acetaminophen-induced acute liver failure.
Gregory, B; Larson, AM; Lee, WM; Reisch, J, 2010
)
2.08
" Acetaminophen dosing information is not always obtainable."( Acetaminophen dose does not predict outcome in acetaminophen-induced acute liver failure.
Gregory, B; Larson, AM; Lee, WM; Reisch, J, 2010
)
2.71
" In general, acetaminophen at reduced dosing is a safe option."( Pain management in the cirrhotic patient: the clinical challenge.
Chandok, N; Watt, KD, 2010
)
0.73
" Our patients were divided in two groups, erythromycin in doses of 200 mg four times per day was given to the first group (51 patients) over the first 3 months of the study and in the second group we used placebo with the same dosage and schedule (53 patients)."( A double blind, randomized, placebo controlled study to evaluate the efficacy of erythromycin in patients with knee effusion due to osteoarthritis.
Ardalan, MR; Ghojazadeh, M; Molaeefard, M; Moloudi, R; Noshad, H; Sadreddini, S, 2009
)
0.35
" This study suggests that nanoclays may be utilized to tailor the drug's releasing rate and to improve the dosage form's stability by dramatically shortening the lengthy recrystallization process."( Solid dispersion of acetaminophen and poly(ethylene oxide) prepared by hot-melt mixing.
Gogos, C; Huang, CY; Ku, MS; Liu, H; Wang, P; Yang, M, 2010
)
0.68
" Acetaminophen with normal dosage is considered a nontoxic drug for therapeutic applications, but when taken at overdose levels it produces liver damage in human and various animal species."( The effect of acetaminophen nanoparticles on liver toxicity in a rat model.
Asefnejad, A; Biazar, E; Mahmoudi, M; Mazinani, R; Montazeri, N; Pourshamsian, K; Rahimi, M; Rezayat, SM; Zadehzare, M; Zeinali, R; Ziaei, M, 2010
)
1.63
"Some medication dosing protocols are logistically complex for traditional physician ordering."( Computerized N-acetylcysteine physician order entry by template protocol for acetaminophen toxicity.
Blackwood, L; Leikin, JB; Lu, JJ; Thompson, TM,
)
0.36
" To formulate regimens properly, it is essential to appreciate basic pharmacological principles and appropriate dosage strategies for each of the available analgesic classes."( Pain management: Part 1: Managing acute and postoperative dental pain.
Becker, DE, 2010
)
0.36
" Consistent with the observed transcriptional changes, FXR gene dosage is positively correlated with the degree of protection from APAP-induced hepatotoxicity in vivo."( Activation of the farnesoid X receptor provides protection against acetaminophen-induced hepatic toxicity.
Chong, HK; de Aguiar Vallim, TQ; Edwards, PA; Jones, SA; Lee, FY; Liu, Y; Osborne, TF; Zhang, Y, 2010
)
0.6
" Three times daily dosing may offer enhanced therapeutic effect for longer than twice daily dosing."( The pharmacokinetic profile of a novel fixed-dose combination tablet of ibuprofen and paracetamol.
Aspley, S; Munn, A; Tanner, T; Thomas, T, 2010
)
0.36
"Degree of patient knowledge regarding acetaminophen safety, dosing recommendations, toxicity, alternative names and abbreviations, and products."( Survey of patient knowledge related to acetaminophen recognition, dosing, and toxicity.
Donaldson, A; Hester, EK; Hornsby, LB; Thompson, M; Whitley, HP,
)
0.67
" Information on the pain condition and number of patients studied, dosing regimen, study design and analgesic outcome measures (total pain relief scores) was extracted and dichotomous outcomes were obtained by calculating the number of patients in each treatment group who achieved at least 50% of the maximum total pain relief score."( A risk-benefit assessment of paracetamol (acetaminophen) combined with caffeine.
Day, R; Graham, G; Palmer, H; Williams, K, 2010
)
0.62
" AEs were assessed at 8 hours after dosing in stage 1, at 72 hours after dosing in stage 2, and at the follow-up visit (7-10 days after surgery); in addition, patients were instructed to report any AE that occurred between scheduled assessments."( A single-tablet fixed-dose combination of racemic ibuprofen/paracetamol in the management of moderate to severe postoperative dental pain in adult and adolescent patients: a multicenter, two-stage, randomized, double-blind, parallel-group, placebo-control
Aspley, S; Christensen, KS; Daniels, SE; Mehlisch, DR; Southerden, KA, 2010
)
0.36
" The Parental Analgesia Slide is a new device developed with the objective of improving parental dosing accuracy."( Parental calculation of pediatric paracetamol dose: a randomized trial comparing the Parental Analgesia Slide with product information leaflets.
Franke, U; Hamilton, M; Hixson, R; Mittal, R, 2010
)
0.36
" Absolute percentage dose error and the number of correct dosage intervals, frequencies, and demonstrated drug volumes were compared."( Parental calculation of pediatric paracetamol dose: a randomized trial comparing the Parental Analgesia Slide with product information leaflets.
Franke, U; Hamilton, M; Hixson, R; Mittal, R, 2010
)
0.36
" Recent human clinical trials of drugs, including acetaminophen (APAP) and ximelagatran, have shown that the metabonomics of biofluids (plasma and urine) collected before and immediately after dosing can identify individual patients who are likely to develop DILI."( The application of metabonomics to predict drug-induced liver injury.
O'Connell, TM; Watkins, PB, 2010
)
0.61
"It indicates that clinical consideration must be given to the drug dosage and the possible influence of electroacupuncture on the metabolism of some drugs in order to avoid and reduce adverse reactions."( [Effects of electroacupuncture at "Zusanli" (ST 36) on Pharmacokinetics of paracetamol in rates].
Chen, SH; Meng, GY; Wang, LP; Yan, M; Yang, B, 2010
)
0.36
" Piritramide dosage and incidence of side effects were not reduced."( Efficacy of intravenous paracetamol compared to dipyrone and parecoxib for postoperative pain management after minor-to-intermediate surgery: a randomised, double-blind trial.
Brodner, G; Cosanne, I; Ellger, B; Freise, H; Gogarten, W; Hahnenkamp, K; Huppertz-Thyssen, M; Van Aken, H; Wempe, C, 2011
)
0.37
" Previous dose-response studies have had conflicting results."( Diphenhydramine dose-response: a novel approach to determine triage thresholds.
Aleguas, A; Benson, BE; Borys, DJ; Farooqi, MF; Klein-Schwartz, W; Litovitz, T; Lung, D; Rutherfoord Rose, S; Seifert, SA; Sollee, DR; Webb, AN, 2010
)
0.36
" To progress to quantitative dose-response analysis needed for hazard characterization, in hepatic systems toxicology studies, generation of toxicogenomic data of multiple doses/concentrations and time points is required."( Application of toxicogenomics in hepatic systems toxicology for risk assessment: acetaminophen as a case study.
Bessems, JG; Driessen, M; Kienhuis, AS; Luijten, M; Peijnenburg, AA; Pennings, JL; van Delft, JH; van der Ven, LT, 2011
)
0.6
"Concern exists about the potential for liver injury with therapeutic dosing of acetaminophen in children."( Therapeutic acetaminophen is not associated with liver injury in children: a systematic review.
Dart, RC; Lavonas, EJ; Reynolds, KM, 2010
)
0.97
"Hepatoxicity after therapeutic dosing of acetaminophen in children is rarely reported in defined-population studies."( Therapeutic acetaminophen is not associated with liver injury in children: a systematic review.
Dart, RC; Lavonas, EJ; Reynolds, KM, 2010
)
1.01
" Formal meta-analysis pooling was not performed because the studies had different primary end points, and the IV acetaminophen dosing regimens varied in dose, and duration and timing."( A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain.
Macario, A; Royal, MA,
)
0.58
" Although acetylcysteine prevents or minimizes acetaminophen-induced hepatotoxicity and reduces mortality, some patients presenting with complicated overdose scenarios (massive ingestions or combination or modified-release formulations) may develop toxicity despite administration of recommended dosage regimen."( Intravenous acetylcysteine for the treatment of acetaminophen overdose.
Doyon, S; Klein-Schwartz, W, 2011
)
0.88
" Acetylcysteine dosing should be individualized in patients with complicated presentations and in particular situations in which plasma acetaminophen concentrations may be persistently elevated at the end of the infusion or in late presenters."( Intravenous acetylcysteine for the treatment of acetaminophen overdose.
Doyon, S; Klein-Schwartz, W, 2011
)
0.83
" The utility and efficacy of acetaminophen is well established; however, due to chronic excessive dosing of over-the-counter acetaminophen products and prescription opioid combination products resulting in the potential for hepatic toxicity, concerns remain about acetaminophen safety."( Safety of multiple-dose intravenous acetaminophen in adult inpatients.
Bergese, SD; Candiotti, KA; Royal, MA; Singla, NK; Singla, SK; Viscusi, ER, 2010
)
0.93
"The data presented here establish, for the first time, a direct neurotoxic action by AAP both in vivo and in vitro in rats at doses below those required to produce hepatotoxicity and suggest that this neurotoxicity might be involved in the general toxic syndrome observed during patient APP overdose and, possibly, also when AAP doses in the upper dosing schedule are used, especially if other risk factors (moderate drinking, fasting, nutritional impairment) are present."( Acetaminophen induces apoptosis in rat cortical neurons.
Blanco, A; Ceña, V; Muñoz-Fernández, M; Posadas, I; Santos, P, 2010
)
1.8
" Practitioners should caution patients to follow recommended dosage instructions and avoid taking multiple APAP-containing products."( The therapeutic applications of and risks associated with acetaminophen use: a review and update.
Guggenheimer, J; Moore, PA, 2011
)
0.61
" The paper gives examples of MRI application of in vitro imaging of pharmaceutical dosage based on hydroxypropyl methylcellulose which have focused on water-penetration, diffusion, polymer swelling, and drug release, characterized with respect to other physical parameters such as pH and the molecular weight of polymer."( A possible application of magnetic resonance imaging for pharmaceutical research.
Kowalczuk, J; Tritt-Goc, J, 2011
)
0.37
" The dosing times were 1 hour before separator placement and 3 and 7 hours after separator placement."( Effects of analgesics on orthodontic pain.
Fillingim, R; Logan, H; McGorray, SP; Patel, S; Wheeler, TT; Yezierski, R, 2011
)
0.37
"We determined acetaminophen protein adduct levels, in combination with a literature review and systematic evaluation of the cases, using the Roussel Uclaf Causality Assessment Method for drug-induced liver injury to assess causality between recommended acetaminophen dosing and acute liver failure in two children with myopathies."( Acute liver failure after recommended doses of acetaminophen in patients with myopathies.
Ceelie, I; de Wildt, SN; Gijsen, V; Ito, S; James, LP; Koren, G; Mathot, RA; Tesselaar, CD; Tibboel, D, 2011
)
0.99
" Absorption of the drug can be impacted by dosage form; this may have implications for pain relief in some individuals, potentially accounting for suboptimal efficacy in analgesia."( Comparison of a novel fast-dissolving acetaminophen tablet formulation (FD-APAP) and standard acetaminophen tablets using gamma scintigraphy and pharmacokinetic studies.
Clarke, CP; Clarke, GD; Starkey, YY; Wilson, CG, 2011
)
0.64
"Medication dosing errors by parents are frequent."( Use of a pictographic diagram to decrease parent dosing errors with infant acetaminophen: a health literacy perspective.
Bazan, IS; Dreyer, BP; Fierman, A; Mendelsohn, AL; van Schaick, L; Yin, HS,
)
0.36
" The primary outcome variable was dosing accuracy (error defined as >20% deviation above/below dose; large overdosing error defined as >1."( Use of a pictographic diagram to decrease parent dosing errors with infant acetaminophen: a health literacy perspective.
Bazan, IS; Dreyer, BP; Fierman, A; Mendelsohn, AL; van Schaick, L; Yin, HS,
)
0.36
" Pictogram benefit varied by health literacy, with a statistically significant difference in dosing error evident in the text-plus-pictogram group compared to the text-only group among parents with low health literacy (50."( Use of a pictographic diagram to decrease parent dosing errors with infant acetaminophen: a health literacy perspective.
Bazan, IS; Dreyer, BP; Fierman, A; Mendelsohn, AL; van Schaick, L; Yin, HS,
)
0.36
"Inclusion of pictographic dosing diagrams as part of written medication instructions for infant acetaminophen may help parents provide doses of medication more accurately, especially those with low health literacy."( Use of a pictographic diagram to decrease parent dosing errors with infant acetaminophen: a health literacy perspective.
Bazan, IS; Dreyer, BP; Fierman, A; Mendelsohn, AL; van Schaick, L; Yin, HS,
)
0.58
" dosing can cause symptomatic hyponatraemia in children."( Using 0.45% saline solution and a modified dosing regimen for infusing N-acetylcysteine in children with paracetamol poisoning.
Deasy, C; Oakley, E; Robinson, J, 2011
)
0.37
"45% saline plus 5% dextrose, and a novel two-stage dosing regimen between January 2003 and July 2006 were undertaken."( Using 0.45% saline solution and a modified dosing regimen for infusing N-acetylcysteine in children with paracetamol poisoning.
Deasy, C; Oakley, E; Robinson, J, 2011
)
0.37
"Managing persistent pain is challenging, particularly in older adults who often have comorbidities and physiological changes that affect dosing and adverse effect profiles."( Pharmacological management of persistent pain in older persons: focus on opioids and nonopioids.
Gloth, FM, 2011
)
0.37
" Interestingly, drug dosage reduction permitted to reduce the incidence of possible adverse effects, namely exploratory activity and motor coordination, thus it was demonstrated that it improved the benefit/risk profile of such treatment."( Fentanyl-trazodone-paracetamol triple drug combination: multimodal analgesia in a mouse model of visceral pain.
Ciruela, F; Fernández, A; Fernández-Dueñas, V; Planas, E; Poveda, R; Sánchez, S, 2011
)
0.37
"The aim was to describe intravenous paracetamol pharmacokinetics, determine major covariates and suggest a dosing regimen for (pre)term neonates."( The pharmacokinetics of intravenous paracetamol in neonates: size matters most.
Allegaert, K; Anderson, BJ; Palmer, GM, 2011
)
0.37
"The aim of this work was to evaluate the analgesic efficacy and safety of repeated doses of 2 dosing regimens of intravenous acetaminophen compared with placebo over 24 hours in subjects with moderate to severe pain after abdominal laparoscopic surgery."( A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery.
Ang, RY; Breitmeyer, JB; Miller, H; Minkowitz, HS; Royal, MA; Singla, NK; Wininger, SJ, 2010
)
0.78
"Medicines are most often oral solid dosage forms made into tablets or capsules, and there is little room for individualized doses."( Inkjet printing of drug substances and use of porous substrates-towards individualized dosing.
Ihalainen, P; Kronberg, L; Määttänen, A; Meierjohann, A; Peltonen, J; Sandler, N; Viitala, T, 2011
)
0.37
" However, the concentrations of APAP-CYS during therapeutic dosing, in cases of acetaminophen toxicity from repeated dosing and in cases of hepatic injury from non-acetaminophen hepatotoxins have not been well characterized."( Acetaminophen-cysteine adducts during therapeutic dosing and following overdose.
Dart, RC; Green, JL; Heard, KJ; James, LP; Judge, BS; Rhyee, S; Zolot, L, 2011
)
2.04
" Trial 1 consisted of non-drinkers who received APAP for 10 days, Trial 2 consisted of moderate drinkers dosed for 10 days and Trial 3 included subjects who chronically abuse alcohol dosed for 5 days."( Acetaminophen-cysteine adducts during therapeutic dosing and following overdose.
Dart, RC; Green, JL; Heard, KJ; James, LP; Judge, BS; Rhyee, S; Zolot, L, 2011
)
1.81
" In cases of massive acetaminophen overdose, standard acetylcysteine dosing may not be adequate."( Hepatic failure despite early acetylcysteine following large acetaminophen-diphenhydramine overdose.
Bagdure, D; Heard, K; Monte, A; Wang, GS, 2011
)
0.93
" C3H/HeOuJ mice were dosed by oral gavage with diclofenac (DF), APAP, AMAP, OFLX, MET, or CMZ."( Oral exposure to drugs with immune-adjuvant potential induces hypersensitivity responses to the reporter antigen TNP-OVA.
Bleumink, R; Boon, L; Fiechter, D; Hassing, I; Kwast, LM; Ludwig, IS; Pieters, RH, 2011
)
0.37
"Oral-sustained release gel formulations with suitable rheological properties have been proposed as a means of improving the compliance of dysphagic and geriatric patients who have difficulties with handling and swallowing oral dosage forms."( In situ gelling formulation based on methylcellulose/pectin system for oral-sustained drug delivery to dysphagic patients.
Attwood, D; D'Emanuele, A; Hatakeyama, T; Itoh, K; Miyazaki, S; Shimoyama, T, 2011
)
0.37
"Conventional solid oral dosage forms are unsuitable for children due to problems associated with swallowing and unpleasant taste."( Use of the direct compression aid Ludiflash(®) for the preparation of pellets via wet extrusion/spheronization.
Griesbacher, M; Khinast, J; Radl, S; Roblegg, E; Schrank, S; Zimmer, A, 2011
)
0.37
" Questions were designed to assess physician knowledge of acetaminophen dosing and toxicity, recognition of prescription and over-the-counter products containing acetaminophen, and education provided to patients when prescribing acetaminophen-containing products."( Survey of physician knowledge and counseling practices regarding acetaminophen.
Andrus, M; Hornsby, LB; Przybylowicz, J; Starr, J, 2010
)
0.84
"Many physicians are unaware of acetaminophen dosing and toxicity issues and have some difficulty identifying acetaminophen-containing products."( Survey of physician knowledge and counseling practices regarding acetaminophen.
Andrus, M; Hornsby, LB; Przybylowicz, J; Starr, J, 2010
)
0.88
"An 89-year-old man receiving long-term anticoagulation with warfarin sodium (total weekly dosage of 19 mg) arrived at the anticoagulation clinic for his monthly visit."( Moxifloxacin-acetaminophen-warfarin interaction during bacille Calmette-Guerin treatment for bladder cancer.
Berube, C; Lee, R; Wen, A, 2011
)
0.74
" For each drug, 6 healthy male volunteers were dosed with 100 μg (14)C-labelled compound."( Comparative pharmacokinetics between a microdose and therapeutic dose for clarithromycin, sumatriptan, propafenone, paracetamol (acetaminophen), and phenobarbital in human volunteers.
Alder, J; Bjerrum, OJ; Brian Houston, J; Garner, C; Gesson, C; Grynkiewicz, G; Jochemsen, R; Lappin, G; Oosterhuis, B; Rowland, M; Shishikura, Y; Weaver, RJ, 2011
)
0.57
"Elicit subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons."( Developing consumer-centered, nonprescription drug labeling a study in acetaminophen.
Bailey, SC; Davis, TC; Di Francesco, L; Hedlund, LA; Jacobson, KL; King, JP; Parker, RM; Wolf, MS, 2011
)
0.82
" The labeled dosing regimen for Acetadote, the only intravenous N-acetylcysteine (IV-NAC) product approved by the Food and Drug Administration (FDA) for treatment of acetaminophen toxicity, is a complex 3-step process that produces frequent medication errors."( Evaluation of a simplified N-acetylcysteine dosing regimen for the treatment of acetaminophen toxicity.
Halcomb, SE; Johnson, MT; McCammon, CA; Mullins, ME, 2011
)
0.79
" Charts were reviewed for prescribing practices, dosing errors, and clinical outcomes."( Evaluation of a simplified N-acetylcysteine dosing regimen for the treatment of acetaminophen toxicity.
Halcomb, SE; Johnson, MT; McCammon, CA; Mullins, ME, 2011
)
0.6
" A further 15% (668) of prescriptions contained insufficient dosage data to determine their status, 13."( Paracetamol prescribing in primary care: too little and too much?
Helms, PJ; Kazouini, A; McLay, JS; Mohammed, BS; Simpson, CR, 2011
)
0.37
"To predict drug dissolution and understand the mechanisms of drug release from wax matrix dosage forms containing glyceryl monostearate (GM; a wax base), aminoalkyl methacrylate copolymer E (AMCE; a pH-dependent functional polymer), and acetaminophen (APAP; a model drug), we tried to derive a novel mathematical model with respect to erosion and diffusion theory."( A theoretical approach to evaluate the release rate of acetaminophen from erosive wax matrix dosage forms.
Agata, Y; Itai, S; Iwao, Y; Miyagishima, A; Shiino, K, 2011
)
0.8
" None of the treatments significantly affected the central models of pain at this dosage level."( A randomized, controlled trial validates a peripheral supra-additive antihyperalgesic effect of a paracetamol-ketorolac combination.
Besson, M; Daali, Y; Dayer, P; Desmeules, J; Ing Lorenzini, K; Salomon, D, 2011
)
0.37
" Low clinical heterogeneity was found for comparisons with low dosage of acetaminophen, normal dosage of NSAIDs, and moderate pain intensity at baseline."( NSAIDs vs acetaminophen in knee and hip osteoarthritis: a systematic review regarding heterogeneity influencing the outcomes.
Bierma-Zeinstra, SM; Bohnen, AM; Koes, BW; Luijsterburg, PA; Verkleij, SP, 2011
)
1
"Acetaminophen (APAP) is safe at therapeutic dosage but can cause severe hepatotoxicity if used at overdose."( Acetaminophen overdose-induced liver injury in mice is mediated by peroxynitrite independently of the cyclophilin D-regulated permeability transition.
Boelsterli, UA; LoGuidice, A, 2011
)
3.25
" formulation of APAP represents a safe and effective first-line analgesic agent for the treatment of acute mild-to-moderate pain in the perioperative setting when oral agents may be impractical or when rapid onset with predictable therapeutic dosing is required."( Perioperative intravenous acetaminophen and NSAIDs.
Smith, HS, 2011
)
0.67
"" By contrast, patients had difficulty developing a routine around using acetaminophen at the recommended maximum dose because of the implicit frequency of dosing required and an aversion to the associated "pill load."( "It looks after me": how older patients make decisions about analgesics for osteoarthritis.
Day, RO; Lipworth, WL; Milder, TY; Ritchie, JE; Williams, KM, 2011
)
0.6
"The aim of this study was to explore the pharmacokinetic profiles of the new ER tramadol/acetaminophen fixed-dose combination and compare them with those of a conventional immediate-release (IR) formulation after multiple dosing as a Phase I clinical exploratory trial."( Pharmacokinetics of extended-release versus conventional tramadol/acetaminophen fixed-dose combination tablets: an open-label, 2-treatment, multiple-dose, randomized-sequence crossover study in healthy korean male volunteers.
Cho, JY; Chung, YJ; Jang, IJ; Kim, TE; Shin, HS; Shin, SG; Yi, S; Yoon, SH; Yu, KS, 2011
)
0.83
"In this systematic review we present information relating to the benefits and harms of the following interventions: differences in efficacy among different oral NSAIDs, between oral and topical NSAIDs, and between oral NSAIDs and alternative analgesics; dose-response relationship of oral NSAIDs; and H(2) blockers, misoprostol, or proton pump inhibitors to mitigate gastrointestinal adverse effects of oral NSAIDs."( NSAIDs.
Gøtzsche, PC, 2010
)
0.36
" Toxicity studies with Diclofenac, Paracetamol and Verapamil in both cell lines show dose-response characteristics and EC(50) values similar to hHeps."( Comparative analysis of phase I and II enzyme activities in 5 hepatic cell lines identifies Huh-7 and HCC-T cells with the highest potential to study drug metabolism.
Dooley, S; Ehnert, S; Hao, L; Lin, J; Liu, L; Mühl-Benninghaus, R; Neumann, J; Nussler, AK; Nussler, N; Schyschka, L; Stöckle, U, 2012
)
0.38
" While dosing errors are common, in most cases, overdoses produce minimal clinical effects."( Massive acetylcysteine overdose associated with cerebral edema and seizures.
Heard, K; Schaeffer, TH, 2011
)
0.37
" The prognostic value of patient-reported dosage cut-offs of 8, 10 and 12 g was determined."( Reliability of the reported ingested dose of acetaminophen for predicting the risk of toxicity in acetaminophen overdose patients.
Awang, R; Sulaiman, SA; Zyoud, SH, 2012
)
0.64
"8 percent vomiting, which affected adherence to prescribed dosing regimens and, thus, is inversely associated with the level of pain relief."( Oxycodone-related side effects: impact on degree of bother, adherence, pain relief, satisfaction, and quality of life.
Ackerman, SJ; Anastassopoulos, KP; Benson, C; Chow, W; Kim, MS; Tapia, C,
)
0.13
" This may result in dosing errors, a delay in treatment, or possibly more adverse effects - due to the use of a high dose rate for the first infusion when treatment is initiated."( A dosing regimen for immediate N-acetylcysteine treatment for acute paracetamol overdose.
Coulter, CV; Duffull, SB; Isbister, GK; Shen, F, 2011
)
0.37
"Our aim was to investigate a novel dosing regimen for the immediate administration of NAC on admission at a lower infusion rate."( A dosing regimen for immediate N-acetylcysteine treatment for acute paracetamol overdose.
Coulter, CV; Duffull, SB; Isbister, GK; Shen, F, 2011
)
0.37
" We investigated an NAC infusion using a lower dosing rate initiated immediately on presentation."( A dosing regimen for immediate N-acetylcysteine treatment for acute paracetamol overdose.
Coulter, CV; Duffull, SB; Isbister, GK; Shen, F, 2011
)
0.37
"Lower dosing rates of NAC initiated immediately resulted in a similar exposure to NAC."( A dosing regimen for immediate N-acetylcysteine treatment for acute paracetamol overdose.
Coulter, CV; Duffull, SB; Isbister, GK; Shen, F, 2011
)
0.37
"The novel dosing regimen allowed immediate treatment of a patient using a lower dosing rate."( A dosing regimen for immediate N-acetylcysteine treatment for acute paracetamol overdose.
Coulter, CV; Duffull, SB; Isbister, GK; Shen, F, 2011
)
0.37
" One of these is the increase in 5-oxoproline and ophthalmic acid concentrations with increased dosage of paracetamol."( A mathematical modelling approach to assessing the reliability of biomarkers of glutathione metabolism.
du Preez, FB; Geenen, S; Kenna, JG; Nijhout, HF; Reed, M; Snoep, JL; Westerhoff, HV; Wilson, ID, 2012
)
0.38
" The average lengths of treatment and stay for IV dosing were 23."( Assessment of the clinical use of intravenous and oral N-acetylcysteine in the treatment of acute acetaminophen poisoning in children: a retrospective review.
Blackford, MG; Felter, T; Gothard, MD; Reed, MD, 2011
)
0.59
"Based on our review, the majority of patients received recommended dosing of NAC therapy; however, 3 patients received extended NAC therapy."( Assessment of the clinical use of intravenous and oral N-acetylcysteine in the treatment of acute acetaminophen poisoning in children: a retrospective review.
Blackford, MG; Felter, T; Gothard, MD; Reed, MD, 2011
)
0.59
" Sigmoidal dose-response curves were plotted and IC(50) values were estimated."( In vitro and in situ evaluation of herb-drug interactions during intestinal metabolism and absorption of baicalein.
Fong, YK; Li, CR; Lin, G; Wang, S; Wo, SK; Zhang, L; Zhou, L; Zuo, Z, 2012
)
0.38
" Three hundred milligrams per kilogram APAP was chosen because this dosage induces hepatotoxicity but is not lethal."( 3,5,5-trimethyl-hexanoyl-ferrocene diet protects mice from moderate transient acetaminophen-induced hepatotoxicity.
Aliaga, C; Amin, S; Isom, HC; Kang, BH; Kocher, S; Krzeminski, J; McDevitt, EI; Moon, MS; Richie, JP; Zhu, J, 2011
)
0.6
" The objective of this study was to determine if caregivers give children with fever an accurate dose of acetaminophen and determine factors associated with dosing inaccuracy."( Accuracy of acetaminophen dosing in children by caregivers in Saudi Arabia.
Alenazi, F; Alomar, M; Alruwaili, N,
)
0.72
"To study the proportion of APAP users potentially consuming APAP over the currently recommended dosage (4 g/day) and a toxic dosage (10 g/day)."( Prescription-acquired acetaminophen use and potential overuse patterns: 2001-2008.
Gokhale, M; Martin, BC, 2012
)
0.69
" In several small prospective studies, INR results were elevated to a statistically significant extent that would require a change in warfarin dosing and monitoring in clinical practice."( Effect of acetaminophen on international normalized ratio in patients receiving warfarin therapy.
Hughes, GJ; Patel, PN; Saxena, N, 2011
)
0.77
" Dosing adjustments are not required when switching between oral and injectable acetaminophen formulations in adult and adolescent patients."( Acetaminophen injection: a review of clinical information.
Jones, VM, 2011
)
2.04
" Subanaesthetic doses of ketamine have an opioid-sparing effect, but the optimal dosing regimen is uncertain."( [Post-operative pain management in hospitals].
Borchgrevink, PC; Fredheim, OM; Kvarstein, G, 2011
)
0.37
" Age-based dosing guidelines can lead to inappropriate dosing."( British National Formulary for Children: the risk of inappropriate paracetamol prescribing.
Beasley, R; Eastwood, A; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
"Underweight and overweight children are at risk of inappropriate paracetamol administration based on BNFC age-based dosing instructions."( British National Formulary for Children: the risk of inappropriate paracetamol prescribing.
Beasley, R; Eastwood, A; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
"18), and no dose-response effects were present in either analysis."( The use of nonsteroidal anti-inflammatory drugs and the risk of Barrett's oesophagus.
Green, AC; Pandeya, N; Smith, KJ; Thrift, AP; Webb, PM; Whiteman, DC, 2011
)
0.37
" However, the complicated dosing regimen is prone to errors in preparation and administration."( Hemolysis and hemolytic uremic syndrome following five-fold N-acetylcysteine overdose.
Mullins, ME; Vitkovitsky, IV, 2011
)
0.37
" Efforts to curtail this practice may involve provision of prescriber and pharmacist education, utilization of benefit manager systems to flag excessive dosing or that require confirmation of dosing, and implementation of US FDA recommendations supported by these data."( Opioid-paracetamol prescription patterns and liver dysfunction: a retrospective cohort study in a population served by a US health benefits organization.
Mort, JR; Ndehi, LN; Shiyanbola, OO; Stacy, JN; Xu, Y, 2011
)
0.37
" Rescue medication consumption, requests, and actual administration were all significantly lower in the IV acetaminophen group compared with placebo for each dosing interval, except in the 6- to 12-hours interval where a numerical trend was observed."( Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis.
Breitmeyer, JB; Groudine, SB; Jahr, JS; Reynolds, L; Royal, MA; Sinatra, RS; Viscusi, ER, 2012
)
0.97
" A variety of observations suggest that acetaminophen use has contributed to the recent increase in asthma prevalence in children: (1) the strength of the association; (2) the consistency of the association across age, geography, and culture; (3) the dose-response relationship; (4) the timing of increased acetaminophen use and the asthma epidemic; (5) the relationship between per-capita sales of acetaminophen and asthma prevalence across countries; (6) the results of a double-blind trial of ibuprofen and acetaminophen for treatment of fever in asthmatic children; and (7) the biologically plausible mechanism of glutathione depletion in airway mucosa."( The association of acetaminophen and asthma prevalence and severity.
McBride, JT, 2011
)
0.97
" The dogs were dosed with phenacetin orally at 5 and 15 mg/kg and intravenously at 15 mg/kg."( Phenacetin pharmacokinetics in CYP1A2-deficient beagle dogs.
Lentz, KA; Morgan, DG; Orcutt, TL; Sinz, MW; Whiterock, VJ, 2012
)
0.38
" Based on these data, dosing suggestions were formulated."( Pharmacokinetics and pharmacodynamics of intravenous acetaminophen in neonates.
Allegaert, K; van den Anker, J, 2011
)
0.62
" A ten-fold IV paracetamol dosing error ocurred, with delayed recognition and treatment resulting in transient hepatotoxicity, with a peak alanine transaminase (ALT) of 1378 IU/L in a 3-year-old child."( Intravenous paracetamol toxicity in a malnourished child.
Anscombe, M; Berling, I; Isbister, GK, 2012
)
0.38
" We conclude that repeated dosing through transversus abdominis plane catheters may be offered to women as an alternative or adjuvant to intrathecal morphine."( Transversus abdominis plane catheters for post-cesarean delivery analgesia: a series of five cases.
Bollag, L; Landau, R; Ortner, C; Richebe, P, 2012
)
0.38
" Influent pH 3, initial H(2)O(2) dosage 60 mg/L, [H(2)O(2)]/[Fe(2+)] ratio 60 : 1 are the optimum conditions observed for 20 mg/L initial paracetamol concentration."( Enhanced degradation of paracetamol by UV-C supported photo-Fenton process over Fenton oxidation.
Mahamood, S; Manu, B, 2011
)
0.37
"Bioadhesive buccal films are innovative dosage forms with the ability to adhere to the mucosal surface and subsequently hydrate to release and deliver drugs across the buccal membrane."( Novel films for drug delivery via the buccal mucosa using model soluble and insoluble drugs.
Antonijevic, MD; Boateng, JS; Chowdhry, BZ; Kianfar, F, 2012
)
0.38
" The European Medicines Agency (EMEA) imposes analytical testing limits in the order of μg/g, depending on drug dosage and exposure period, that means the need of a sensitive and selective method of analysis."( A new liquid chromatography-mass spectrometry approach for generic screening and quantitation of potential genotoxic alkylation compounds without derivatization.
Cappiello, A; Famiglini, G; Palma, P; Termopoli, V; Trufelli, H, 2012
)
0.38
" Microfluidic bioartificial organs enable the spatial and temporal control of cell growth and biochemistry, critical for organ-specific metabolic functions and particularly relevant to testing the metabolic dose-response signatures associated with both pharmaceutical and environmental toxicity."( Metabolomics-on-a-chip and predictive systems toxicology in microfluidic bioartificial organs.
Baudoin, R; Blaise, BJ; Brochot, C; Defernez, M; Domange, C; Dumas, ME; Leclerc, E; Legallais, C; Navratil, V; Péry, AR; Pontoizeau, C; Prot, JM; Shintu, L; Toulhoat, P, 2012
)
0.38
" Experience from Europe indicates that serious dosing errors are likely to occur."( Intravenous acetaminophen in the United States: iatrogenic dosing errors.
Dart, RC; Rumack, BH, 2012
)
0.76
"The purpose of this study, in a sample of preschool children (ages 3-5 years; N = 47), was to evaluate the feasibility of scheduled analgesic dosing following outpatient tonsillectomy in order to optimize pain management."( A descriptive feasibility study to evaluate scheduled oral analgesic dosing at home for the management of postoperative pain in preschool children following tonsillectomy.
Holdridge-Zeuner, D; Lanier, B; Mahoney, K; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2012
)
0.38
" Time-contingent dosing was associated with moderate to severe side effects and should be addressed in discharge teaching with parents."( A descriptive feasibility study to evaluate scheduled oral analgesic dosing at home for the management of postoperative pain in preschool children following tonsillectomy.
Holdridge-Zeuner, D; Lanier, B; Mahoney, K; Miaskowski, C; Paul, SM; Savedra, MC; Sutters, KA; Waite, S, 2012
)
0.38
" This commentary addresses the reasons for this, and the background to choice of dose of acetylcysteine utilized in the oral and IV dosing regimens."( Acetaminophen and acetylcysteine dose and duration: past, present and future.
Bateman, DN; Rumack, BH, 2012
)
1.82
" In addition, we compiled dose-response data for 4 commonly used analgesics: buprenorphine, carprofen, ketoprofen, and acetaminophen."( Using the Mouse Grimace Scale to reevaluate the efficacy of postoperative analgesics in laboratory mice.
King, OD; Matsumiya, LC; Mogil, JS; Sorge, RE; Sotocinal, SG; Tabaka, JM; Wieskopf, JS; Zaloum, A, 2012
)
0.59
" However, dosing and differential effects on peripheral and central hyperalgesia are still to be determined."( Dose response of tramadol and its combination with paracetamol in UVB induced hyperalgesia.
Gustorff, B; Margeta, K; Ortner, CM; Schulz, M; Steiner, I, 2012
)
0.38
"From wax matrix dosage forms, drug and water-soluble polymer are released into the external solvent over time."( A novel mathematical model considering change of diffusion coefficient for predicting dissolution behavior of acetaminophen from wax matrix dosage form.
Agata, Y; Itai, S; Iwao, Y; Nitanai, Y, 2012
)
0.59
"Adult patients with pain from osteoarthritis receiving a stable dosage of HCD/APAP (i."( A randomized, 14-day, double-blind study evaluating conversion from hydrocodone/acetaminophen (Vicodin) to buprenorphine transdermal system 10 μg/h or 20 μg/h in patients with osteoarthritis pain.
Landau, CJ; McCarberg, BH; Munera, C; Ripa, SR; Wen, W, 2012
)
0.61
" Cumulative APAP dosage greater than 1 kg and APAP use for longer than 30 days in the pre-index year were not significantly associated with an increased risk of renal disease (both P values = 0."( Acute and chronic acetaminophen use and renal disease: a case-control study using pharmacy and medical claims.
Cleves, MA; Foster, HR; Hogan, WR; James, LP; Kelkar, M; Martin, BC, 2012
)
0.71
" The value for area under the concentration-time curve over the 6h dosing interval of venous plasma (45."( Investigating paracetamol pharmacokinetics using venous and capillary blood and saliva sampling.
McLachlan, AJ; Rittau, AM, 2012
)
0.38
" For preventative treament of migraine, cyproheptadine should be reserved for younger children unable to swallow tablets while amitriptyline is preferred due to its once daily dosing and minimal side effects."( Treating pediatric migraine: an expert opinion.
Hershey, AD; Kabbouche, MA; O'Brien, HL, 2012
)
0.38
" The FDA has conducted multiple advisory committee meetings to evaluate acetaminophen and its safety profile, and has suggested (but not mandated) a reduction in the maximum daily dosage from 3900-4000 mg to 3000-3250 mg."( Confusion: acetaminophen dosing changes based on NO evidence in adults.
Krenzelok, EP; Royal, MA, 2012
)
1
" The final model shows that for commonly used dosing regimens, the population mean PG peak and trough concentrations range between 33-144 and 28-218 mg l(-1) (peak) and 19-109 and 6-112 mg l(-1) (trough) for paracetamol and phenobarbital formulations, respectively, depending on birth weight and age of the neonates."( Developmental pharmacokinetics of propylene glycol in preterm and term neonates.
Allegaert, K; Danhof, M; De Cock, RF; de Hoon, J; Knibbe, CA; Kulo, A; Verbesselt, R, 2013
)
0.39
" In one case, we found that the use of estimated APAP dosage alone led to inappropriate NAC medication."( [Study of the serum concentrations of acetaminophen overdose].
Hosoya, J; Iseki, K; Shiraishi, T; Suzuki, T; Takahashi, N; Tominaga, A; Toyoguchi, T, 2012
)
0.65
" A recent study highlighted the risk of overdose of paracetamol using British National Formulary for Children (BNFC) age-based dosing guidelines."( Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study.
Beasley, R; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
"Theoretical comparison of the proposed MHRA dosing system with the product dosing instructions of a commonly prescribed form of paracetamol in the UK."( Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study.
Beasley, R; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
"United Kingdom Participants Proposed MHRA dosing recommendations and current product dosing instructions were compared using a previously validated model."( Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study.
Beasley, R; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
"For both dosing recommendations, single and cumulative daily doses of paracetamol for boys and girls at the 9th, 50th and 91st centiles for weight were calculated for 3 month, 1 year, 6 year and 12 year age groups."( Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study.
Beasley, R; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
"With the current product dosing instructions, underweight children are at risk of receiving approximately two times the recommended single and cumulative daily dose of paracetamol, particularly at age 1 year and 6 years."( Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study.
Beasley, R; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
"The proposed MHRA dosing recommendations for paracetamol use in children are effective at reducing the risk of paracetamol overdose in children of all ages, when compared with current product dosing instructions."( Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study.
Beasley, R; Eyers, S; Fingleton, J; Perrin, K, 2012
)
0.38
" Mkp-1⁺/⁺ and Mkp-1⁻/⁻ mice were dosed ip with vehicle or acetaminophen at 300 mg/kg (for mechanistic studies) or 400 mg/kg (for survival studies)."( Mitogen-activated protein kinase phosphatase (Mkp)-1 protects mice against acetaminophen-induced hepatic injury.
Liu, Y; Meng, X; Rogers, LK; Wancket, LM, 2012
)
0.85
"2 % made serious errors by dosing out more than six grams."( Risk of unintentional overdose with non-prescription acetaminophen products.
Bailey, SC; Davis, TC; Di Francesco, L; Jacobson, K; King, J; McCarthy, D; Mullen, R; Parker, RM; Serper, M; Wolf, MS, 2012
)
0.63
"A reproducible, rapid and sensitive method has been developed for the assay of chlorzoxazone (CHL), paracetamol (PCM) and aceclofenac (ACE) in their combined solid dosage forms using packed-column supercritical fluid chromatography (SFC)."( Development and validation of packed column supercritical fluid chromatographic technique for quantification of chlorzoxazone, paracetamol and aceclofenac in their individual and combined dosage forms.
Desai, PP; Mehta, PJ; Patel, NR; Sherikar, OD, 2012
)
0.38
"Using plasma from APAP poisoned mice, either lethally (500 mg/kg) or sublethally (150 mg/kg) dosed, we screened commercially available murine microRNA libraries (SABiosciences, Qiagen Sciences, MD) to evaluate for unique miRNA profiles between these two dosing parameters."( Plasma microRNA profiles distinguish lethal injury in acetaminophen toxicity: a research study.
Bala, S; Petrasek, J; Szabo, G; Ward, J, 2012
)
0.63
"We distinguished numerous, unique plasma miRNAs both up- and downregulated in lethally compared to sublethally dosed mice."( Plasma microRNA profiles distinguish lethal injury in acetaminophen toxicity: a research study.
Bala, S; Petrasek, J; Szabo, G; Ward, J, 2012
)
0.63
"70), though an increase of similar magnitude among past users and lack of a dose-response effect did not support a pharmacologic mechanism."( Non-steroidal anti-inflammatory drugs, acetaminophen, and risk of skin cancer in the Nurses' Health Study.
Alberts, DS; Feskanich, D; Han, J; Jeter, JM; Martinez, ME; Qureshi, AA, 2012
)
0.65
"This study aims to explore the knowledge of a randomly selected cohort of Iranian general practitioners (GPs) on the topic of acetaminophen dosing for fever in children."( Knowledge of Iranian general practitioners for acetaminophen dosing in children.
Bagheri, M; Mirmoghtadaee, P; Sabzghabaee, AM; Soltani, R, 2012
)
0.84
" Questions were designed to evaluate the knowledge of GPs on acetaminophen dosing amount and interval for fever in children and were formatted as multiple choice answers."( Knowledge of Iranian general practitioners for acetaminophen dosing in children.
Bagheri, M; Mirmoghtadaee, P; Sabzghabaee, AM; Soltani, R, 2012
)
0.88
"7% did not routinely give parents instructions on the dosing of antipyretics."( Knowledge of Iranian general practitioners for acetaminophen dosing in children.
Bagheri, M; Mirmoghtadaee, P; Sabzghabaee, AM; Soltani, R, 2012
)
0.64
"We found that some GPs do not strictly adhere to the dosing guidelines of acetaminophen, so intense clinical courses of pharmacology and rational usage of drugs and other relevant educational programs for medical students and practitioners seems to be necessary for the sake of safety of pediatric patients in Iran."( Knowledge of Iranian general practitioners for acetaminophen dosing in children.
Bagheri, M; Mirmoghtadaee, P; Sabzghabaee, AM; Soltani, R, 2012
)
0.87
" There was a significant inverse dose-response (p-trend <0."( Aspirin, nonsteroidal anti-inflammatory drugs, paracetamol and risk of endometrial cancer: a case-control study, systematic review and meta-analysis.
Nagle, CM; Neill, AS; Obermair, A; Protani, MM; Spurdle, AB; Webb, PM, 2013
)
0.39
" The tested group (group UP) was administered Sp at a dosage of 10(9) cells/day for 5 weeks, after receiving 500 mg/kg per day of acetaminophen intraperitoneally for 7 days."( In vivo assessment of bacteriotherapy on acetaminophen-induced uremic rats.
Das, K; Mandal, A; Mondal, KCh; Nandi, DK; Roy, S,
)
0.6
" The extent of errors of dosage was within the intervals [90-120 mg/kg/d] and greater than 120 mg/kg/d for 87 and 11 patients respectively, who were prescribed a single non-combination paracetamol containing product."( Overdosed prescription of paracetamol (acetaminophen) in a teaching hospital.
Allenet, B; Charpiat, B; Henry, A; Leboucher, G; Tod, M, 2012
)
0.65
"The selected studies showed great heterogeneity of participants, temperature for fever diagnosis, interventions (dose and dosing intervals) and assessed outcomes."( Alternating antipyretics in the treatment of fever in children: a systematic review of randomized clinical trials.
Dagostini, JM; Pereira, GL; Pizzol, Tda S, 2012
)
0.38
" The selection of drug-excipient blends with inadequate powder flow can lead to quality issues of the final dosage form."( Toward better understanding of powder avalanching and shear cell parameters of drug-excipient blends to design minimal weight variability into pharmaceutical capsules.
Kuentz, M; Nalluri, VR; Puchkov, M, 2013
)
0.39
" Results did not vary appreciably by past or current use, days per week of use, or dosage of use."( Use of aspirin, other nonsteroidal anti-inflammatory drugs, and acetaminophen and postmenopausal breast cancer incidence.
Collins, LC; Hankinson, SE; Rosner, B; Smith-Warner, SA; Willett, WC; Zhang, X, 2012
)
0.62
" Up until now, manual dosing of H(2)O(2) has led to low process performance."( Automatic dosage of hydrogen peroxide in solar photo-Fenton plants: development of a control strategy for efficiency enhancement.
Alvarez Hervás, JD; Casas López, JL; Moreno Úbeda, JC; Ortega-Gómez, E; Sánchez Pérez, JA; Santos-Juanes Jordá, L, 2012
)
0.38
" An exit survey elicited: attitudes/knowledge related to product ingredients, label reading, dosing behavior; demographics, medical history, general physical, and mental health status."( Prevalence and correlates of exceeding the labeled maximum dose of acetaminophen among adults in a U.S.-based internet survey.
Kaufman, DW; Kelly, JP; Malone, MK; Rohay, JM; Shiffman, S; Weinstein, RB, 2012
)
0.62
"N-Acetylcysteine (NAC) dosing for acetaminophen (APAP) overdose is weight based (150 mg/kg intravenous or 140-mg/kg oral loading dose) and, in the United States, the dosing protocol recommends using a maximum patient weight of 100 and 110 kg, respectively."( Acetylcysteine for acetaminophen overdose in patients who weigh >100 kg.
Buchanan, JA; Heard, K; Kokko, J; Varney, SM,
)
0.74
" In this study, hepatotoxicity in mice post oral dosing of acetaminophen was investigated using liver and sera samples with Fourier Transform Infrared microspectroscopy."( Identification of early biomarkers during acetaminophen-induced hepatotoxicity by fourier transform infrared microspectroscopy.
Chandrasekar, B; Deobagkar-Lele, M; Gautam, R; Kumar B N, V; Nandi, D; Rakshit, S; Umapathy, S, 2012
)
0.89
" However, some patients encounter hepatotoxicity after repeated APAP dosing at therapeutic doses."( Enhancement of acetaminophen-induced chronic hepatotoxicity in restricted fed rats: a nonclinical approach to acetaminophen-induced chronic hepatotoxicity in susceptible patients.
Hashimoto, T; Kobayashi, A; Kondo, K; Kuno, H; Shoda, T; Sugai, S; Suzuki, Y; Takahashi, A; Toyoda, K; Yamada, N, 2012
)
0.73
"These results indicated the possible therapeutic action of flower and leaf extract from MO in protecting liver damage in rats given an over dosage of APAP."( Therapeutic potential of Moringa oleifera extracts against acetaminophen-induced hepatotoxicity in rats.
Arulselvan, P; Fakurazi, S; Hairuszah, I; Hidayat, MT; Moklas, MA; Sharifudin, SA, 2013
)
0.63
" The effects of ferrous ion dosage and [Fe(2+)]/[H(2)O(2)] (FH ratio) were integrated into the derived pseudo second-order kinetic model."( Kinetics of acetaminophen degradation by Fenton oxidation in a fluidized-bed reactor.
Briones, RM; de Luna, MD; Lu, MC; Su, CC, 2013
)
0.77
"Acetaminophen is a safe antipyretic and analgesic drug within the clinically recommended dosage range, but overdose can cause fatal liver and or kidney damage."( Effect of acetaminophen on the progression of renal damage in adenine induced renal failure model rats.
Arimizu, K; Chuang, VT; Hirata, S; Irie, T; Ishitsuka, Y; Kadowaki, D; Kitamura, K; Maruyama, T; Narita, Y; Otagiri, M; Sumikawa, S; Taguchi, K, 2012
)
2.22
"The acetaminophen dosage schedule in pediatric patients below 12 years of age for the over-the-counter (OTC) monograph is one of the many issues being evaluated and discussed in the development of the Proposed Rule for Internal Analgesic, Antipyretic, and Anti-rheumatic drug products."( Regulatory review of acetaminophen clinical pharmacology in young pediatric patients.
Doddapaneni, S; Furness, S; Hertz, S; Ji, P; Li, Z; Sahajwalla, CG; Wang, Y, 2012
)
1.26
"Glucose metabolic changes in CM patients taking different dosage of analgesic during headache-free periods and clear distinctions in several brain regions were observed."( Overuse of paracetamol caffeine aspirin powders affects cerebral glucose metabolism in chronic migraine patients.
Di, W; Fang, Y; Luo, N; Miao, J; Qi, W; Shi, X; Tao, Y; Xiao, Z; Yi, C; Zhang, A; Zhang, X; Zhu, Y, 2013
)
0.39
" However, ibuprofen has the advantage of less frequent dosing (every 6-8 h vs."( Optimising the management of fever and pain in children.
van den Anker, JN, 2013
)
0.39
"This study evaluated the mechanical properties, uniformity of dosage units and drug release from the tablets prepared by continuous direct compression process."( Continuous direct tablet compression: effects of impeller rotation rate, total feed rate and drug content on the tablet properties and drug release.
Järvinen, K; Järvinen, MA; Juuti, M; Leiviskä, K; Muzzio, F; Paaso, J; Paavola, M, 2013
)
0.39
" Therefore, the proposed method is suitable for the routine control of these ingredients in multicomponent dosage forms."( Capillary electrophoretic determination of antimigraine formulations containing caffeine, ergotamine, paracetamol and domperidone or metoclopramide.
Alshehri, MM; Alzoman, NZ; Elshahed, MS; Maher, HM; Olah, IV; Rizk, MS; Sultan, MA, 2013
)
0.39
" In fed mice dosed with 300 mg/kg acetaminophen, we observed that liver mitochondria in HCV-Tg mice exhibited signs of dysfunction showing the potential mechanism for increased susceptibility."( Acetaminophen-induced acute liver injury in HCV transgenic mice.
Boorman, GA; Bradford, BU; Chatterjee, S; Jeannot, E; Kosyk, O; Macdonald, JM; Mason, RP; Melnyk, SB; Pogribny, IP; Rusyn, I; Tech, K; Tryndyak, VP; Uehara, T, 2013
)
2.11
" It appears that, while acetaminophen levels remain relatively constant over a six hour period, dosing adjustments may be required for use in a circuit beyond the initial 24 hour period, depending on physiologic clearance of the drug."( In vitro clearance of intravenous acetaminophen in extracorporeal membrane oxygenation.
Annich, G; Gillogly, A; Kilbourn, C; Martin, J; Wagner, D; Waldvogel, J, 2013
)
0.98
"Near-infrared spectroscopy (NIRS) is a valuable tool in the pharmaceutical industry, presenting opportunities for online analyses to achieve real-time assessment of intermediates and finished dosage forms."( Effect of experimental design on the prediction performance of calibration models based on near-infrared spectroscopy for pharmaceutical applications.
Anderson, CA; Bondi, RW; Drennen, JK; Igne, B, 2012
)
0.38
" Finally, it can be used to predict patient metabolic and physiological responses to APAP doses and different NAC dosing strategies."( The biochemistry of acetaminophen hepatotoxicity and rescue: a mathematical model.
Ben-Shachar, R; Chen, Y; Hartman, C; Luo, S; Nijhout, HF; Reed, M, 2012
)
0.7
" Formalized pharmacokinetic studies of piperacillin/tazobactam removal in patients on MARS therapy are necessary to make clear dosing recommendations."( Molecular Adsorbent Recirculating System (MARS(®)) removal of piperacillin/tazobactam in a patient with acetaminophen-induced acute liver failure.
Argento, AC; Heavner, MS; Ruggero, MA; Topal, JE, 2013
)
0.6
" The most common information provided was dosage and adverse effects."( Using the simulated patient methodology to assess paracetamol-related counselling for headache.
Horvat, N; Koder, M; Kos, M, 2012
)
0.38
"4] kg), sex (7 of 12 males vs 7 of 15 males), or racial distribution (5 white, 5 black, and 2 biracial vs 4 white and 11 black) between the 2 dosing groups (oral vs rectal, respectively)."( Pharmacokinetic comparison of acetaminophen elixir versus suppositories in vaccinated infants (aged 3 to 36 months): a single-dose, open-label, randomized, parallel-group design.
Casavant, MJ; Edge, J; Halvorsen, M; Kelley, MT; Walson, PD, 2013
)
0.68
" This study evaluated the effect of a weight-based dosing chart (WBDC) introduced to decrease NAC prescription errors."( Introduction of an N-acetylcysteine weight-based dosing chart reduces prescription errors in the treatment of paracetamol poisoning.
Greene, S; McD Taylor, D; McIntyre, S, 2013
)
0.39
"001), NAC dosage (13."( Introduction of an N-acetylcysteine weight-based dosing chart reduces prescription errors in the treatment of paracetamol poisoning.
Greene, S; McD Taylor, D; McIntyre, S, 2013
)
0.39
"We investigated acetaminophen use and identify factors contributing to supratherapeutic dosing of acetaminophen in hospitalized patients."( Supratherapeutic dosing of acetaminophen among hospitalized patients.
Bates, DW; Boulware, LJ; Chang, F; Mahoney, LM; Maviglia, SM; Orav, EJ; Plasek, J; Rocha, RA; Zhou, L, 2012
)
1.02
" The main outcome measures included acetaminophen exposure rate and supratherapeutic dosing rate among hospitalized patients, hazard ratios (HRs) and 95% confidence intervals (CIs) for risk factors for supratherapeutic dosing, and changes in liver function test before and after supratherapeutic dosing."( Supratherapeutic dosing of acetaminophen among hospitalized patients.
Bates, DW; Boulware, LJ; Chang, F; Mahoney, LM; Maviglia, SM; Orav, EJ; Plasek, J; Rocha, RA; Zhou, L, 2012
)
0.95
"Supratherapeutic dosing of acetaminophen was significantly associated with multiple factors."( Supratherapeutic dosing of acetaminophen among hospitalized patients.
Bates, DW; Boulware, LJ; Chang, F; Mahoney, LM; Maviglia, SM; Orav, EJ; Plasek, J; Rocha, RA; Zhou, L, 2012
)
0.97
" We conclude that future studies are urgently needed to reconsider the safety and dosage of APAP during pregnancy and - based on the advances made in the field of reproduction as well as APAP metabolism - we propose pathways, which should be addressed in future research and clinical endeavors."( Acetaminophen and pregnancy: short- and long-term consequences for mother and child.
Arck, P; Erhardt, A; Kessler, T; Thiele, K; Tiegs, G, 2013
)
1.83
" We chose to use random-effects meta-analyses because of the heterogeneity in dosage used."( Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period.
Abalos, E; Chou, D; Gülmezoglu, AM; Gyte, GM, 2013
)
0.77
" Postoperatively, all patients were prescribed paracetamol (acetaminophen) on the basis of their weight; the standard pediatric dosage of this agent at the time of our study was 60 mg/kg/day."( A prospective study of parents' compliance with their child's prescribed analgesia following tonsillectomy.
Amin, M; Colreavy, MP; Lennon, P, 2013
)
0.63
"We compared an approach using scheduled analgesic dosing with as-needed analgesic dosing in patients after hip fracture surgery, to compare these approaches in terms of (1) resting and dynamic pain intensity, (2) postoperative patient mobility, and (3) functional end points."( Scheduled analgesic regimen improves rehabilitation after hip fracture surgery.
Cheung, LP; Chin, RP; Ho, CH, 2013
)
0.39
" Complications include frequent nausea and vomiting, anaphylactoid reactions and dosing errors."( Scottish and Newcastle antiemetic pre-treatment for paracetamol poisoning study (SNAP).
Bateman, DN; Coyle, J; Dear, JW; Eddleston, M; Gray, A; Lewis, S; Sandilands, EA; Thanacoody, HK; Thomas, SH; Webb, DJ, 2013
)
0.39
" We propose here a strategy based on in vitro tests and QSAR (Quantitative Structure Activity Relationship) models to calibrate a dose-response model predicting hepatotoxicity."( Prediction of dose-hepatotoxic response in humans based on toxicokinetic/toxicodynamic modeling with or without in vivo data: a case study with acetaminophen.
Brochot, C; Desmots, S; Fioravanzo, E; Mombelli, E; Pavan, M; Péry, AR; Zaldívar, JM; Zeman, FA, 2013
)
0.59
" However, comprehensive dose-response and time course studies have not yet been done."( Plasma and liver acetaminophen-protein adduct levels in mice after acetaminophen treatment: dose-response, mechanisms, and clinical implications.
Bajt, ML; Jaeschke, H; Lebofsky, M; McGill, MR; Norris, HR; Rollins, DE; Slawson, MH; Wilkins, DG; Williams, CD; Xie, Y, 2013
)
0.73
" N-acetylcysteine (NAC) is the antidote of choice for the treatment of APAP toxicity; however, due to its short-half-life repeated dosing of NAC is required."( Therapeutic effect of liposomal-N-acetylcysteine against acetaminophen-induced hepatotoxicity.
Alipour, M; Buonocore, C; Omri, A; Pucaj, K; Suntres, ZE; Szabo, M, 2013
)
0.64
"To estimate the extents of dosing variability in prescriptions of acetaminophen to children among pediatricians, family physicians and otolaryngologists."( Dosing variability in prescriptions of acetaminophen to children: comparisons between pediatricians, family physicians and otolaryngologists.
Chen, TJ; Chiang, SC; Chou, LF; Chou, YC; Jeng, MJ; Lin, SY, 2013
)
0.9
" Further investigations can be undertaken to estimate the accuracy of dosing variability as an indicator of prescribing quality."( Dosing variability in prescriptions of acetaminophen to children: comparisons between pediatricians, family physicians and otolaryngologists.
Chen, TJ; Chiang, SC; Chou, LF; Chou, YC; Jeng, MJ; Lin, SY, 2013
)
0.66
" The new insight into chitosan-alginate matrix tablets can help to broaden the application of this type of dosage forms."( Drug release characteristics from chitosan-alginate matrix tablets based on the theory of self-assembled film.
Li, L; Mao, S; Ni, R; Shao, Y; Wang, L; Zhang, T, 2013
)
0.39
" The effects of the initial concentration of APAP, pH value, ozone dosage and AC dosage on the variation of reaction rate were carefully discussed."( [Mechanism of catalytic ozonation for the degradation of paracetamol by activated carbon].
Chen, JM; Dai, QZ; Wang, JY; Yan, YZ; Yu, J, 2013
)
0.39
"Acetaminophen or paracetamol, a commonly used over-the-counter analgesic, is known to elicit severe adverse reactions when taken in overdose, chronically at therapeutic dosage or, sporadically, following single assumptions of a therapeutic dose."( Possible fatal acetaminophen intoxication with atypical clinical presentation.
Carbone, A; Chiarotti, M; d'Aloja, E; De-Giorgio, F; Lodise, M; Valerio, L, 2013
)
2.19
" Dose-response curves were constructed and the values of ED50 for treatment alone and combined were statistically compared."( Synergistic effect of the L-tryptophan and kynurenic acid with dipyrone or paracetamol in mice.
Carvalho, AM; de França Fonteles, MM; de Sousa, FC; Dias, ML; Freire, LV; Rios, ER; Rocha, NF, 2013
)
0.39
"There is a need for information on the bioavailability in pediatric patients of drugs from manipulated dosage forms when applied in combination with food and/or co-medication under realistic daily practice circumstances."( In vitro gastrointestinal model (TIM) with predictive power, even for infants and children?
Anneveld, B; de Koning, BA; de Wildt, SN; Hanff, LM; Havenaar, R; Lelieveld, JP; Minekus, M; Mooij, MG, 2013
)
0.39
" This study aimed to assess the health literacy skills of parents and caregivers of preschool-aged children, using a progressive scenario describing a child with fever and presenting tasks relating to selection of a medicine and hypothetical dosing of their child."( Management of children's fever by parents and caregivers: Practical measurement of functional health literacy.
Chaw, XY; Emmerton, L; Kairuz, T; Kelly, F; Marriott, J; Moles, R; Wheeler, A, 2014
)
0.4
" The type of interaction between components was determined by isobolographic analysis or by analysis of the log dose-response curves for drug combination and drugs alone."( Levetiracetam interacts synergistically with nonsteroidal analgesics and caffeine to produce antihyperalgesia in rats.
Micov, AM; Stepanović-Petrović, RM; Tomić, MA, 2013
)
0.39
"A standardized approach to dosing acetaminophen in pediatric populations was published in 1983."( Dosing and antipyretic efficacy of oral acetaminophen in children.
Kuffner, EK; Temple, AR; Temple, BR, 2013
)
0.94
"This article reviewed published and unpublished pediatric antipyretic data to provide a critical assessment of the 10-15-mg/kg oral dose and the current pediatric oral dosing schedules for acetaminophen."( Dosing and antipyretic efficacy of oral acetaminophen in children.
Kuffner, EK; Temple, AR; Temple, BR, 2013
)
0.85
" Data from published literature containing sufficient detail to verify doses; dosing frequency; and, when necessary, estimates from figures, and from acetaminophen arms of the unpublished studies were analyzed."( Dosing and antipyretic efficacy of oral acetaminophen in children.
Kuffner, EK; Temple, AR; Temple, BR, 2013
)
0.86
" Efficacy and rapid onset also reduce the risk of excessive dosing with the analgesic."( Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies.
Brown, J; Buchanan, WL; Collaku, A; Cooper, SA; Otto, J; Reed, K; Yue, Y, 2013
)
0.39
"We sought to investigate the dose-response efficacy and speed of onset of pain relief of a fast-dissolving APAP formulation compared with lower doses of APAP and placebo in dental patients after impacted third molar extraction."( Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies.
Brown, J; Buchanan, WL; Collaku, A; Cooper, SA; Otto, J; Reed, K; Yue, Y, 2013
)
0.39
" Forty-six parents (32%) had an acetaminophen dosing error."( Parental language and dosing errors after discharge from the pediatric emergency department.
Porter, SC; Samuels-Kalow, ME; Stack, AM, 2013
)
0.67
"Recent studies have linked patient misunderstanding of label instructions for as needed (PRN) medications to dosing errors."( Take-Wait-Stop: a patient-centered strategy for writing PRN medication instructions.
Bailey, SC; Davis, TC; Jacobson, KL; King, JP; McCarthy, DM; Mullen, RJ; Parker, RM; Serper, M; Wolf, MS, 2013
)
0.39
" No clear dose-response relationship existed between the quantity of paracetamol ingested and the observed concentrations of 5-oxoproline."( What is the clinical significance of 5-oxoproline (pyroglutamic acid) in high anion gap metabolic acidosis following paracetamol (acetaminophen) exposure?
Liss, DB; Mullins, ME; Paden, MS; Schwarz, ES, 2013
)
0.59
" A rapid, simple, selective and precise densitometric method was developed and validated for simultaneous estimation of six synthetic binary mixtures and their pharmaceutical dosage forms."( Thin layer chromatography-densitometric determination of some non-sedating antihistamines in combination with pseudoephedrine or acetaminophen in synthetic mixtures and in pharmaceutical formulations.
Atia, NN; El-Gizawy, SM; El-Kommos, ME; Hosny, NM, 2014
)
0.61
" Urine was collected daily before and during dosing and 6 days after the final dose."( Pattern recognition analysis for hepatotoxicity induced by acetaminophen using plasma and urinary 1H NMR-based metabolomics in humans.
Kim, JW; Kim, KB; Kim, S; Lee, HW; Lim, MS; Ryu, SH; Seong, SJ; Yoon, YR, 2013
)
0.63
" The method was applied successfully on tablet dosage form."( Gradient HPLC-DAD determination of paracetamol, phenylephrine hydrochloride, cetirizine in tablet formulation.
Bakal, RL; Chandewar, AV; Dewani, AP; Jaybhaye, SS; Patra, S; Shelke, PG, 2014
)
0.4
" This method allows to assess purity and polymorphic form of drug compounds, to detect interactions between ingredients of solid dosage forms and to analyze stability of solid formulations."( Application of differential scanning calorimetry in evaluation of solid state interactions in tablets containing acetaminophen.
Czajkowska-Kośnik, A; Czyzewska, U; Mazurek-Wadołkowska, E; Miltyk, W; Winnicka, K,
)
0.34
"889 patients were randomised with computer generated random numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice: advice on analgesia (take paracetamol, ibuprofen, or both), dosing of analgesia (take as required v regularly), and steam inhalation (no inhalation v steam inhalation)."( Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial.
Kelly, J; Leydon, G; Little, P; McDermott, L; Moore, M; Mullee, M; Stuart, B; Williamson, I, 2013
)
0.39
"Neither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes."( Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial.
Kelly, J; Leydon, G; Little, P; McDermott, L; Moore, M; Mullee, M; Stuart, B; Williamson, I, 2013
)
0.39
" The formulation factors such as the viscosity grade of polyethylene oxide as the primary polymer as well as the level and location of osmogen within the bilayer tablets led to a difference in performance of osmotic tablets and hence should be critically evaluated in the design of such dosage forms."( Investigation of critical core formulation and process parameters for osmotic pump oral drug delivery.
Farrell, TP; Huatan, H; Missaghi, S; Patel, P; Rajabi-Siahboomi, AR, 2014
)
0.4
" In 19-month-old male offspring, epididymal sperm counts were lower than controls, and in ventral prostate an overrepresentation of findings related to hyperplasia was observed in exposed groups compared with controls, particularly in the group dosed with anti-androgens."( Late-life effects on rat reproductive system after developmental exposure to mixtures of endocrine disrupters.
Axelstad, M; Boberg, J; Christiansen, S; Hass, U; Isling, LK; Jacobsen, PR; Kortenkamp, A; Mandrup, KR; Taxvig, C; Vinggaard, AM, 2014
)
0.4
" Analgesic requirements are influenced by age-related changes in both pharmacokinetic and pharmacodynamic response, and increasing data are available to guide safe and effective dosing with opioids and paracetamol."( Neonatal pain.
Walker, SM, 2014
)
0.4
"The purpose of this work was to develop a new pressure-sensitive dosage form that breaks and releases its content in a fasted stomach at the predominant pressure at the pylorus."( Development of a pressure-sensitive glyceryl tristearate capsule filled with a drug-containing hydrogel.
Bock, M; Garbacz, G; Glöckl, G; Weitschies, W; Wilde, L, 2014
)
0.4
"The present study examines how drug's inherent properties and product design influence the evaluation and applications of in vitro-in vivo correlation (IVIVC) for modified-release (MR) dosage forms consisting of extended-release (ER) and immediate-release (IR) components with bimodal drug release."( Influence of drug property and product design on in vitro-in vivo correlation of complex modified-release dosage forms.
Duan, JZ; Li, X; Qiu, Y, 2014
)
0.4
" Secondary endpoints included SPIDs and total pain relief (TOTPAR) over the dosing intervals; time to perceptible, meaningful, and confirmed pain relief; and the proportion of patients with ≥30% reduction in pain intensity scores."( A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain.
Barrett, T; Giuliani, M; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.4
"OC/APAP ER was efficacious and generally well tolerated in an established model of moderate to severe acute pain, providing an onset of analgesia in approximately 30 minutes and sustained pain relief over the 12 hour dosing period."( A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain.
Barrett, T; Giuliani, M; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.4
"OBJECTIVES To evaluate patient knowledge of over-the-counter (OTC) products containing acetaminophen and to determine patients' accuracy in dosing adult, child, and infant formulations."( Patient knowledge and use of acetaminophen in over-the-counter medications.
Davis, E; Hurwitz, J; Nielsen, J; Sands, S; Warholak, T,
)
0.65
" Based on the final model, dosing guidelines are proposed from preterm neonates to adolescents resulting in similar exposure across all age ranges."( Population pharmacokinetics of paracetamol across the human age-range from (pre)term neonates, infants, children to adults.
Allegaert, K; Danhof, M; Knibbe, CA; Mathot, RA; Tibboel, D; van der Marel, CD; Wang, C, 2014
)
0.4
" In vivo evaluation and histopatholgical study of the selected QT SNEDDSs were achieved after administration of paracetamol over dosage to albino rats."( Design and optimization of self-nanoemulsifying delivery system to enhance quercetin hepatoprotective activity in paracetamol-induced hepatotoxicity.
Ahmed, OA; Ahmed, TA; Badr, JM; Badr-Eldin, SM; El-Say, KM; Tawfik, MK, 2014
)
0.4
" Despite many years of intense research, the precise mechanisms of paracetamol-induced liver injury in humans are still not defined, and few studies have examined the optimal dosing regimen for clinical NAC use."( Stratification of paracetamol overdose patients using new toxicity biomarkers: current candidates and future challenges.
Antoine, DJ; Dear, JW, 2014
)
0.4
" Following implant surgery, postoperative pain was rated moderate or severe in 25/28 patients (89 percent), requiring prn analgesic dosing for up to 3 days in 14/25 individuals (56 percent)."( Characterization and treatment of postsurgical dental implant pain employing intranasal ketorolac.
Bockow, R; Bodner, L; Hersh, EV; Hutcheson, M; Korostoff, J; Pinto, A; Secreto, SA, 2013
)
0.39
" Increasing carbon dosage and contact time enhanced the removal of micropollutants."( Adsorption characteristics of selected hydrophilic and hydrophobic micropollutants in water using activated carbon.
Choi, DJ; Her, N; Kim, SK; Nam, SW; Zoh, KD, 2014
)
0.4
" Moreover, there is evidence that the maximum recommended dosage can induce hepatic cytolysis in some individuals."( Acetaminophen-induced liver injury in obesity and nonalcoholic fatty liver disease.
Fromenty, B; Michaut, A; Moreau, C; Robin, MA, 2014
)
1.85
" marked tensile strength and porosity), FCC promises to be suitable for the preparation of solid dosage forms."( Compaction of functionalized calcium carbonate, a porous and crystalline microparticulate material with a lamellar surface.
Alles, R; Atria, S; Gane, PA; Huwyler, J; Puchkov, M; Schoelkopf, J; Stirnimann, T, 2014
)
0.4
" Therefore, a particular dosing regimen should be followed due to the toxicity risk of cumulative doses."( Acute liver failure in a term neonate after repeated paracetamol administration.
Branco, MM; Bucaretchi, F; Caldas, JP; De Capitani, EM; Fernandes, CB; Hyslop, S; Moreno, CA; Porta, G, 2014
)
0.4
" Since some of these dosing errors are the result of system design flaws, analysis of large overdoses can lead to the discovery of needed system changes."( Analysis of electronic medication orders with large overdoses: opportunities for mitigating dosing errors.
Kirkendall, ES; Kouril, M; Minich, T; Spooner, SA, 2014
)
0.4
" User response was characterized by the dosing alert salience rate, which expresses the proportion of time users take corrective action."( Analysis of electronic medication orders with large overdoses: opportunities for mitigating dosing errors.
Kirkendall, ES; Kouril, M; Minich, T; Spooner, SA, 2014
)
0.4
" Our studies indicate that di-paracetamol and 3-nitro-paracetamol appear in plasma and urine when paracetamol is given orally to healthy humans at the therapeutic dosage of 5-7 mg/kg."( LC-MS/MS and GC-MS/MS measurement of plasma and urine di-paracetamol and 3-nitro-paracetamol: proof-of-concept studies on a novel human model of oxidative stress based on oral paracetamol administration.
Batkai, S; Jordan, J; Madunic, S; Modun, D; Radman, M; Thum, T; Trettin, A; Tsikas, D; Vukovic, J, 2014
)
0.4
"A pharmacokinetic crossover study using different dosage forms of paracetamol (intravenous and oral solution, capsule and tablet) was conducted in four male and four female Göttingen minipigs after an overnight fast."( Pharmacokinetics of paracetamol in Göttingen minipigs: in vivo studies and modeling to elucidate physiological determinants of absorption.
Flament, C; Grimm, HP; Lorentsen, H; Parrott, N; Suenderhauf, C; Tuffin, G, 2014
)
0.4
"Diclofenac dosing in children for analgesia is currently extrapolated from adult data."( Postoperative analgesia using diclofenac and acetaminophen in children.
Anderson, BJ; Hannam, JA; Holford, NH; Mahadevan, M, 2014
)
0.66
" When comparing all three groups, a statistically significant dose-response relationship was seen for present, average and worst pain intensity after 8 h and on the following morning."( Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial.
Bjørnholdt, KT; Mønsted, PN; Nikolajsen, L; Søballe, K, 2014
)
0.4
"Although our data supported a dose-response relationship, increasing the dexamethasone dose from 8 to 40 mg did not improve analgesia significantly after outpatient shoulder surgery."( Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial.
Bjørnholdt, KT; Mønsted, PN; Nikolajsen, L; Søballe, K, 2014
)
0.4
" No problems related to norepinephrine administration and/or increase in dosage were observed."( Intravenous paracetamol for fever control in acute brain injury patients: cerebral and hemodynamic effects.
Antonini, MV; Caspani, ML; De Angelis, A; Picetti, E; Rossi, I; Servadei, F; Villani, F, 2014
)
0.4
" However, it is highly toxic when the dosage surpasses the detoxification capability of an exposed organism, with involvement of an already described oxidative stress pathway."( Biochemical and standard toxic effects of acetaminophen on the macrophyte species Lemna minor and Lemna gibba.
Antunes, SC; Gonçalves, F; Martins, L; Nunes, B; Pinto, G, 2014
)
0.67
" In this study we evaluate whether interindividual variation in baseline enzyme activity (EA)/gene expression (GE) levels in liver predispose for the variation in toxicity responses by assessing dose-response relationships for several prototypical hepatotoxicants."( Interindividual variation in response to xenobiotic exposure established in precision-cut human liver slices.
Castell, JV; Claessen, SM; Dejong, CH; Jetten, MJ; Kleinjans, JC; Lahoz, A; van Delft, JH, 2014
)
0.4
" Le dosage en paracétamol a également été mesuré."( Interchangeability between paracetamol tablets marketed in Palestine. Is there a quality reason for a higher price?
Jaradat, N; Jodeh, S; Khammash, S; Rinno, T; Zaid, A, 2013
)
0.39
" The dosage of narcotics can be decreased (that of trimeperidine on an average from 80 to 45 mg/day) in the early postoperative period if non-narcotic analgesics, such as paracetamol 4 g/day, are incorporated into the analgesic regimen."( [Analgesia in hemophiliac patients during orthopedic surgery].
Gemdzhian, ÉG; Gorodetskiĭ, VM; Koniashina, NI; Krechetova, AV; Levchenko, OK; Shulutko, EM, 2014
)
0.4
" Morphine was required by only two patients per group (no difference in dosage or frequency)."( Is single incision pediatric endoscopic surgery more painful than standard laparoscopy in children? Personal experience and review of the literature.
Ade-Ajayi, N; Cancelliere, LA; Desai, AP; Kemal, KI; Patel, S; Zani, A, 2015
)
0.42
" This study explored the dose-response relationship between ingested acetaminophen and hepatotoxicity, the early biochemical and clinical predictors of hepatotoxicity, the impact of early N-acetylcysteine treatment on hepatotoxicity and the incidence of nephrotoxicity."( Early predictors of severe acetaminophen-induced hepatotoxicity in a paediatric population referred to a tertiary paediatric department.
Andersen, J; Askbo, N; Hedeland, RL; Iskandar, A; Jørgensen, MH, 2014
)
0.93
"Our findings suggest that regular or as-needed dosing with paracetamol does not affect recovery time compared with placebo in low-back pain, and question the universal endorsement of paracetamol in this patient group."( Efficacy of paracetamol for acute low-back pain: a double-blind, randomised controlled trial.
Day, RO; Hancock, MJ; Latimer, J; Lin, CW; Maher, CG; McLachlan, AJ; Williams, CM, 2014
)
0.4
" However, the current dosage form of the drug does not target the liver and inflammatory cells selectively."( Silymarin liposomes improves oral bioavailability of silybin besides targeting hepatocytes, and immune cells.
Deshpande, P; Jain, P; Kumar, N; Kutty, NG; Mathew, G; Rai, A; Raj, PV; Rao, CM; Reddy, ND; Udupa, N, 2014
)
0.4
" To illustrate the potential of this approach, the method was applied to quantify NAPQI-modified SA in plasma from rats dosed with acetaminophen."( Absolute quantitation of NAPQI-modified rat serum albumin by LC-MS/MS: monitoring acetaminophen covalent binding in vivo.
LeBlanc, A; Roy, R; Shiao, TC; Sleno, L, 2014
)
0.83
" However, body weight-based hydrocodone and acetaminophen dosing regimens provided close approximation of adult exposures in pediatric patients with approximately 22% to 24% lower hydrocodone and acetaminophen dose/BW-normalized AUC in pediatric patients compared to adults."( Pharmacokinetics of hydrocodone/acetaminophen combination product in children ages 6-17 with moderate to moderately severe postoperative pain.
Awni, W; Dutta, S; Kearns, G; Liu, W; Neville, KA, 2015
)
0.96
" We accepted any formulation, dosage regimen, and route of administration of codeine, and both placebo and active controls."( Codeine, alone and with paracetamol (acetaminophen), for cancer pain.
Bell, RF; Derry, S; Jackson, KC; Strassels, S; Straube, C; Straube, S; Wiffen, PJ, 2014
)
0.68
"A new HPLC method for separation and determination of impurities in paracetamol, codeine phosphate hemihydrate and pitophenone hydrochloride in the presence of fenpiverinium bromide in combined suppository dosage form was developed and validated."( Separation and determination of impurities in paracetamol, codeine and pitophenone in the presence of fenpiverinium in combined suppository dosage form.
Coufal, P; Hanzlík, P; Jedlička, A; Vojta, J, 2015
)
0.42
" There was no difference in the mean frequency or dosage of rescue medication required by both groups, and the majority of patients in both the TA-ER and TA-IR groups rated their pain improvement as 'much' or 'somewhat better'."( A randomized study to compare the efficacy and safety of extended-release and immediate-release tramadol HCl/acetaminophen in patients with acute pain following total knee replacement.
Bin, SI; Chang, N; Cho, SD; Choi, CH; Ha, CW; Kang, SB; Kyung, HS; Lee, JH; Lee, MC; Park, YB; Rhim, HY; Seo, SS, 2015
)
0.63
"Although separation in paracetamol dosing is likely to be achieved with a liberal vs."( Randomized controlled trial of asthma risk with paracetamol use in infancy--a feasibility study.
Beasley, R; Bowden, V; Braithwaite, I; Caswell-Smith, R; Crane, J; Hunt, A; Ingham, T; Mitchell, EA; Power, S; Riley, J; Shirtcliffe, P; Stanley, T; Weatherall, M, 2015
)
0.42
" Dosing periods were separated by a minimum 5-day washout."( Pharmacokinetics of hydrocodone extended-release tablets formulated with different levels of coating to achieve abuse deterrence compared with a hydrocodone immediate-release/acetaminophen tablet in healthy subjects.
Bond, M; Darwish, M; Robertson, P; Tracewell, W; Yang, R, 2015
)
0.61
" The proposed methods were applied successfully for the determination of ORP and PAR in their dosage form."( Application of normalized spectra in resolving a challenging Orphenadrine and Paracetamol binary mixture.
Abd El-Rahman, MK; Yehia, AM, 2015
)
0.42
" Patients treated concomitantly with VKA and acetaminophen should be monitored more regularly for possible VKA dosage adjustment."( How safe is acetaminophen use in patients treated with vitamin K antagonists? A systematic review and meta-analysis.
Barra, M; Caldeira, D; Costa, J; Ferreira, JJ; Pinto, FJ, 2015
)
1.06
"Patients were randomized 1:1 to enteral acetaminophen 1 g every 6 hours for 3 days (n = 18) or placebo (n = 22) with the same dosing schedule and duration."( Randomized, placebo-controlled trial of acetaminophen for the reduction of oxidative injury in severe sepsis: the Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis trial.
Bastarache, JA; Bernard, GR; Janz, DR; Oates, JA; Rice, TW; Roberts, LJ; Sills, G; Ware, LB; Warren, MA; Wickersham, N, 2015
)
0.95
" Two hundred forty-one patients (80%) were appropriately dosed, whereas 59 (20%) patients were not appropriately dosed based on the FDA-approved dosing."( Postmarketing review of intravenous acetaminophen dosing based on Food and Drug Administration prescribing guidelines.
dela Cruz Ubaldo, C; Hall, NS; Le, B, 2014
)
0.68
" Dosing for patients weighing less than 50 kg needs to be appropriately weight adjusted."( Postmarketing review of intravenous acetaminophen dosing based on Food and Drug Administration prescribing guidelines.
dela Cruz Ubaldo, C; Hall, NS; Le, B, 2014
)
0.68
" Ten percent of literate respondents were unable to understand the dosage requirements for children."( "But it's just paracetamol": Caregivers' ability to administer over-the-counter painkillers to children with the information provided.
Bennin, F; Rother, HA, 2015
)
0.42
" The selectivity of the developed methods was investigated by analyzing laboratory prepared mixtures of the drugs and their combined dosage form."( A comparative study of smart spectrophotometric methods for simultaneous determination of a skeletal muscle relaxant and an analgesic in combined dosage form.
Mohamed, D; Salem, H, 2015
)
0.42
" During the same period, narcotic analgesic dosage requirement was cut down by 20% in the study group (average of 29."( Scheduled intravenous acetaminophen reduces postoperative narcotic analgesic demand and requirement after laparoscopic Roux-en-Y gastric bypass.
Jose, P; Nau, P; Pedersen, M; Samuel, I; Saurabh, S; Smith, JK,
)
0.45
" The cellular uptake of α-T3 was higher than α-TP at the same treatment dosage after 24h."( Comparative hepatoprotective effects of tocotrienol analogs against drug-induced liver injury.
Fong, CW; Ho, HK; Saw, TY; Tan, CY, 2015
)
0.42
" Both methods were applied successfully for the determination of the selected drugs in their combined dosage form."( Smart manipulation of ratio spectra for resolving a pharmaceutical mixture of Methocarbamol and Paracetamol.
Abd-El Rahman, MK; Essam, HM, 2015
)
0.42
" The dosing recommendations of paracetamol may need to be reconsidered after cleft palate surgery."( Acute Liver Failure and Hepatic Encephalopathy After Cleft Palate Repair.
Celebiler, O; Kocaaslan, ND; Tuncer, FB; Tutar, E, 2015
)
0.42
" However, the dose-response seen for most endpoints suggests a considerable degree of paracetamol toxicity especially at the upper end of standard analgesic doses."( Paracetamol: not as safe as we thought? A systematic literature review of observational studies.
Bernstein, I; Birrell, F; Buckner, S; Conaghan, PG; Constanti, M; Delgado Nunes, V; Doherty, M; Dziedzic, K; Latchem, S; Miller, P; Porcheret, M; Roberts, E; Wise, E; Zhang, W, 2016
)
0.43
" The results clearly indicate that the physico-chemical properties of the drug and the matrix systems are crucial for the design of ethanol-resistant dosage forms."( Alcohol dose dumping: The influence of ethanol on hot-melt extruded pellets comprising solid lipids.
Feichtinger, A; Jedinger, N; Khinast, J; Mohr, S; Roblegg, E; Schrank, S, 2015
)
0.42
" Six lignans pretreatment before APAP dosing could prevent the depletions of total liver glutathione (GSH) and mitochondrial GSH caused by APAP."( Hepato-protective effects of six schisandra lignans on acetaminophen-induced liver injury are partially associated with the inhibition of CYP-mediated bioactivation.
Bi, H; Chen, P; Fan, X; Huang, M; Jiang, Y; Tan, H; Wang, Y; Zeng, H, 2015
)
0.66
" The dose-response relationship of the integrated insulinotropic and gastrostatic response to lixisenatide in healthy volunteers after a standardized liquid meal was investigated."( Lixisenatide reduces postprandial hyperglycaemia via gastrostatic and insulinotropic effects.
Becker, RH; Golor, G; Pellissier, F; Stechl, J; Steinstraesser, A, 2015
)
0.42
"Combined paracetamol and ibuprofen has been shown to be more effective than either constituent alone for acute pain in adults, but the dose-response has not been confirmed."( Combination paracetamol and ibuprofen for pain relief after oral surgery: a dose ranging study.
Atkinson, HC; Bisley, E; Carson, S; Currie, J; Evans, S; Frampton, C; Moodie, J; Steenberg, LJ; Worthington, JP, 2015
)
0.42
" Given the widespread use of nonsteroidal anti-inflammatory drugs and acetaminophen worldwide, further investigations of the possible role of analgesics in cervical cancer, using a larger sample size with better-defined dosing regimens, are warranted."( Aspirin and Acetaminophen Use and the Risk of Cervical Cancer.
Cannioto, RA; Friel, G; Hampras, SS; Kolomeyevskaya, NV; Kruszka, B; Lele, SB; Liu, CS; Moysich, KB; Odunsi, KO; Schmitt, K, 2015
)
1.03
" If asked about medications, the SP portraying a parent was trained to disclose that she was administering acetaminophen and to produce a package with dosing instructions on the label."( Can medical students identify a potentially serious acetaminophen dosing error in a simulated encounter? a case control study.
Barone, MA; Dudas, RA, 2015
)
0.88
" Thirty-seven students (11%) determined that the dosage exceeded recommended dosages."( Can medical students identify a potentially serious acetaminophen dosing error in a simulated encounter? a case control study.
Barone, MA; Dudas, RA, 2015
)
0.67
" We show that for the rat chronically dosed with dexamethasone (an artificial glucocorticoid which induces a catabolic state) the model can be used to explain empirically observed facts such as the linear decline in intramuscular Gln and the drop in plasma glutamine."( The role of skeletal muscle in liver glutathione metabolism during acetaminophen overdose.
Bilinsky, LM; Nijhout, HF; Reed, MC, 2015
)
0.65
"Recent studies in laboratory rodents have revealed that circadian oscillation in the physiologic functions affecting drug disposition underlies the dosing time-dependent change in pharmacokinetics."( Circadian modulation in the intestinal absorption of P-glycoprotein substrates in monkeys.
Iwasaki, M; Izumi, T; Katamune, C; Koyanagi, S; Matsunaga, N; Ohdo, S; Suzuki, N; Takahashi, M; Watanabe, N, 2015
)
0.42
" IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval."( Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain.
Barrett, T; Chen, Y; Giuliani, MJ; Hisaw, E; Kostenbader, K; Young, JL; Zheng, Y, 2015
)
0.66
" Plasma and urinary glutathione-related metabolomes and liver function parameters were measured during the dosing period."( [Investigation of Predisposition Biomarkers to Identify Risk Factors for Drug-induced Liver Injury in Humans: Analyses of Endogenous Metabolites in an Animal Model Mimicking Human Responders to APAP-induced Hepatotoxicity].
Kobayashi, A; Kondo, K; Sugai, S, 2015
)
0.42
" Further studies are required to establish the dose-response and treatment-duration relationships to delineate the maximum dose and treatment period without this adverse effect."( Prolonged exposure to acetaminophen reduces testosterone production by the human fetal testis in a xenograft model.
Anderson, RA; Camacho-Moll, ME; Chetty, T; Dean, A; Homer, NZ; Johnston, ZC; Jorgensen, A; Macdonald, J; Mckinnell, C; Mitchell, RT; Sharpe, RM; Smith, LB; van den Driesche, S, 2015
)
0.73
"Acetaminophen (APAP) consumption is large and sometimes excessive, and guidelines suggest to diminish the dosage prescription."( A New Transmucous-Buccal Formulation of Acetaminophen for Acute Traumatic Pain: A Non-inferiority, Randomized, Double-Blind, Clinical Trial.
Dubray, C; Macian, N; Moustafa, F; Pereira, B; Pickering, G; Schmidt, J,
)
1.84
" It would diminish APAP consumption per dosage unit, limit the risk of adverse events and toxicity, and adhere to actual guidelines of APAP prescription."( A New Transmucous-Buccal Formulation of Acetaminophen for Acute Traumatic Pain: A Non-inferiority, Randomized, Double-Blind, Clinical Trial.
Dubray, C; Macian, N; Moustafa, F; Pereira, B; Pickering, G; Schmidt, J,
)
0.4
" The obtained new knowledge can be helpful for the development of novel coating materials (based on QPM-MAS blends) for controlled-release dosage forms."( Quaternary polymethacrylate-magnesium aluminum silicate films: Water uptake kinetics and film permeability.
Pongjanyakul, T; Rongthong, T; Siepmann, F; Siepmann, J; Sungthongjeen, S, 2015
)
0.42
"The pharmacokinetics of acetaminophen was investigated following oral dosing to Shiba goats in order to evaluate the properties of gastric emptying."( Oral pharmacokinetics of acetaminophen to evaluate gastric emptying profiles of Shiba goats.
Aboubakr, M; Elbadawy, M; Khalil, WF; Miyazaki, Y; Sasaki, K; Shimoda, M, 2015
)
1.03
"The use of OTC (over-the-counter) drugs containing Ibuprofen and Paracetamol in solid peroral dosage forms was researched."( Use of selected OTC drugs: comparing Greece and the Czech Republic.
Macešková, B; Pipinou, E,
)
0.13
" Caverage, calculated within the first hour of dosing of acetaminophen (average concentration at 0-1 hour, C0-1havg), can be used as a key surrogate to distinguish the effects of gastric emptying on the absorption of acetaminophen."( Acetaminophen absorption kinetics in altered gastric emptying: establishing a relevant pharmacokinetic surrogate using published data.
Srinivas, NR, 2015
)
2.1
" The evidence was usually either low quality or very low quality, reflecting study limitations, indirectness such from as suboptimal dosing of single comparators, imprecision, or one or more of these."( Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury.
Dalziel, SR; Frampton, C; Jones, P; Lamdin, R; Miles-Chan, JL, 2015
)
0.42
" Acetaminophen should be used at the lowest effective dosage and for the shortest time in all OA patients."( Safety and efficacy of paracetamol and NSAIDs in osteoarthritis: which drug to recommend?
Frazier, A; Latourte, A; Richette, P, 2015
)
1.33
" This study investigates paracetamol clearance in neonates and infants after single and multiple dosing using a population modelling approach."( Developmental changes rather than repeated administration drive paracetamol glucuronidation in neonates and infants.
Allegaert, K; Danhof, M; de Hoon, J; Knibbe, CA; Krekels, EH; Tibboel, D; van Ham, S, 2015
)
0.42
"Excess dosing of acetaminophen is associated with deviations from label directions and by use of both OTC and Rx medications containing acetaminophen within a single concomitant use day."( Patterns of acetaminophen medication use associated with exceeding the recommended maximum daily dose.
Battista, D; Kaufman, DW; Kelly, JP; Malone, MK; Rohay, JM; Shiffman, S; Weinstein, RB, 2015
)
1.14
" Group 2 received only paracetamol (PARA) (administered orally at a dosage of 300 mg/kg)."( The Role of Urotensin Receptors in the Paracetamol-Induced Hepatotoxicity Model in Mice: Ameliorative Potential of Urotensin II Antagonist.
Akpinar, E; Bayir, Y; Halici, Z; Karakus, E; Kose, D; Palabiyik, SS; Yayla, M, 2016
)
0.43
" Together with these new biomarkers of hepatotoxicity, a 12-hour acetylcysteine protocol offers clinicians and patients the possibility for better targeting of therapy, fewer adverse effects, a simpler dosing regimen, and shorter hospital stay."( Changing the Management of Paracetamol Poisoning.
Bateman, DN, 2015
)
0.42
" Thus, we conclude that concomitant oral dosing with APAP and NAC can provide a convenient and effective way of preventing toxicity associated with large dosage of APAP."( Co-administration of N-Acetylcysteine and Acetaminophen Efficiently Blocks Acetaminophen Toxicity.
Andrus, JP; Herzenberg, LA; Owumi, SE, 2015
)
0.68
" Dosage reduction and/or increased dose interval are often required."( [Analgesia in patients with hepatic impairment].
Innaurato, G; Piguet, V; Simonet, ML, 2015
)
0.42
" Morphine dosage was calculated as the cumulative dose administered during the neonatal intensive care unit period."( Intravenous Paracetamol Decreases Requirements of Morphine in Very Preterm Infants.
Aikio, O; Hallman, M; Härmä, A; Saarela, T, 2016
)
0.43
"Simulations of paracetamol time course concentrations in the blood were in close agreement with experimental data under a wide range of dosing conditions."( A novel approach for estimating ingested dose associated with paracetamol overdose.
Heard, K; Reisfeld, B; Zurlinden, TJ, 2016
)
0.43
" This article reviews the importance of explaining the therapeutic and nontherapeutic effects of these agents, cautions, contraindications, dosing parameters, and the avoidance of acetaminophen/aspirin and multiple nonsteroidal anti-inflammatory drug use to patients and prescribers."( Pharmacist's evolving role in the nonopioid, over-the-counter, analgesic selection process.
Barkin, RL,
)
0.32
"Although 60 years have passed since it became widely available on the therapeutic market, paracetamol dosage in patients with liver disease remains a controversial subject."( Can paracetamol (acetaminophen) be administered to patients with liver impairment?
Hayward, KL; Irvine, KM; Martin, JH; Powell, EE, 2016
)
0.77
" depression), so these results should be complied in analgesic dosage adjustment."( Impairment in Pain Perception in Adult Rats Lesioned as Neonates with 5.7-Dihydroxytryptamine.
Lewkowicz, Ł; Malinowska-Borowska, J; Muchacki, R; Nowak, PG; Szkilnik, R; Żelazko, A,
)
0.13
" Although antidote, acetylcysteine, is potentially extracted by renal replacement therapies, pharmacokinetic data are lacking to guide potential dosing alterations."( The pharmacokinetics and extracorporeal removal of N-acetylcysteine during renal replacement therapies.
Hernandez, SH; Hoffman, RS; Howland, M; Schiano, TD, 2015
)
0.42
"The present immediate-release solid dosage forms, such as the oral tablets and capsules, comprise granular matrices."( Melt-processed polymeric cellular dosage forms for immediate drug release.
Blaesi, AH; Saka, N, 2015
)
0.42
"In Australia, legislation requires medication containing paracetamol display warning of co-administration with other paracetamol products, and safe maximum daily dosing (4 g)."( High-visibility warning labels on paracetamol-containing products do not prevent supratherapeutic ingestion in a simulated scenario.
Greene, S; Howell, J; Robotham, A; Rotella, JA; Wong, A, 2015
)
0.42
" After cross-reference searches of both trials and 38 reviews, seven studies comparing acetaminophen in continuous dosing regimens of more than 2 weeks with placebo were included."( Acetaminophen for Chronic Pain: A Systematic Review on Efficacy.
Dideriksen, D; Ennis, ZN; Handberg, G; Pottegård, A; Vaegter, HB, 2016
)
2.1
" Limitations include retrospective review, selection bias, and absence of data on detail medications used, laboratory investigations and dosage of APAP intoxication."( Risk of Acute Kidney Injury and Long-Term Outcome in Patients With Acetaminophen Intoxication: A Nationwide Population-Based Retrospective Cohort Study.
Chang, PY; Chen, JH; Chen, YG; Dai, MS; Huang, TC; Kao, CH; Lin, CL; Wu, YY, 2015
)
0.65
" Adducts are detectable after a few doses and can persist for over a week after dosing is stopped."( Paracetamol (acetaminophen) protein adduct concentrations during therapeutic dosing.
Anderson, V; Bucher-Bartelson, B; Dart, RC; Green, JL; Heard, K, 2016
)
0.8
" Patients were divided into 3 groups according to the dosage of postoperative intravenous-patient-controlled analgesia: paracetamol, dipyrone, or placebo."( Administration of paracetamol versus dipyrone by intravenous patient-controlled analgesia for postoperative pain relief in children after tonsillectomy.
Aribogan, A; Caliskan, E; Caylakli, F; Kocum, A; Sener, M; Yilmaz, I,
)
0.13
" Pre-dosing mice were scored for the mouse clinical frailty index, and after dosing serum and liver tissue were collected for assessment of toxicity and mechanisms."( Acetaminophen hepatotoxicity in mice: Effect of age, frailty and exposure type.
Cogger, V; de Cabo, R; Hilmer, SN; Huizer-Pajkos, A; Jones, B; Kane, AE; Le Couteur, DG; Mach, J; McKenzie, C; Mitchell, SJ, 2016
)
1.88
" Single dosed matrices are prepared by cutting the semi elastic strand with a rotary fly cutter."( Continuous production of controlled release dosage forms based on hot-melt extruded gum arabic: Formulation development, in vitro characterization and evaluation of potential application fields.
Kipping, T; Rein, H, 2016
)
0.43
" Parental education material in the form of weight-based dosing guides has been proposed; however, validation of current recommended APAP dosages using pharmacokinetic models is needed."( Are Recommended Doses of Acetaminophen Effective for Children Aged 2 to 3 Years? A Pharmacokinetic Modeling Answer.
Abourbih, DA; Gosselin, S; Kazim, S; Villeneuve, E, 2016
)
0.74
" However, these results indicate that dosages for APAP in children should be weight based and manufacturers should review their dosing recommendations."( Are Recommended Doses of Acetaminophen Effective for Children Aged 2 to 3 Years? A Pharmacokinetic Modeling Answer.
Abourbih, DA; Gosselin, S; Kazim, S; Villeneuve, E, 2016
)
0.74
" Because the safe limit of APAP dosing is controversial, our aim was to evaluate the role of the mitochondrial permeability transition (MPT) and JNK in mitochondrial dysfunction after APAP dosing considered nontoxic by criteria of serum alanine aminotransferase (ALT) release and histological necrosis in vivo."( Low Dose Acetaminophen Induces Reversible Mitochondrial Dysfunction Associated with Transient c-Jun N-Terminal Kinase Activation in Mouse Liver.
Hu, J; Jaeschke, H; Lemasters, JJ; McGill, MR; Ramshesh, VK, 2016
)
0.85
"Ethylcellulose is one of the most commonly used polymers to develop reservoir type extended release multiparticulate dosage forms."( Investigation into the Effect of Ethylcellulose Viscosity Variation on the Drug Release of Metoprolol Tartrate and Acetaminophen Extended Release Multiparticulates-Part I.
Ferrizzi, D; Mehta, R; Rajabi-Siahboomi, A; Schoener, C; Teckoe, J; Workentine, S, 2016
)
0.64
" For residents with scheduled medication, dosage and duration of use were analysed."( Pain medication in German nursing homes: a whole lot of metamizole.
Hoffmann, F; Schmiemann, G, 2016
)
0.43
"8%), the mean daily dosage was 1843 mg (interquartile range [IQR]: 1500-2250); 66."( Pain medication in German nursing homes: a whole lot of metamizole.
Hoffmann, F; Schmiemann, G, 2016
)
0.43
"81 μM on hospital day 5; expected range for therapeutic dosing <1."( Acute hepatotoxicity associated with therapeutic doses of intravenous acetaminophen.
Anderson, VE; Dart, RC; Green, JL; Heard, KJ; Kovnat, D; Seifert, SA, 2016
)
0.67
"We have identified a case of acute liver injury associated with therapeutic dosing of IV acetaminophen."( Acute hepatotoxicity associated with therapeutic doses of intravenous acetaminophen.
Anderson, VE; Dart, RC; Green, JL; Heard, KJ; Kovnat, D; Seifert, SA, 2016
)
0.89
"Recent advances in accuracy and reliability of continuous glucose monitoring (CGM) devices have focused renewed interest on the use of such technology for therapeutic dosing of insulin without the need for independent confirmatory blood glucose meter measurements."( Direct Evidence of Acetaminophen Interference with Subcutaneous Glucose Sensing in Humans: A Pilot Study.
Basu, A; Basu, R; Dyer, R; Peyser, T; Veettil, S, 2016
)
0.76
" Mice were then dosed orally eight times over 3 days with additional paracetamol (250 mg/kg) or saline, followed by either one or two doses of oral NAC (1200 mg/kg) or saline."( N-Acetyl cysteine does not prevent liver toxicity from chronic low-dose plus subacute high-dose paracetamol exposure in young or old mice.
Cogger, V; de Cabo, R; Hilmer, SN; Huizer-Pajkos, A; Jones, B; Kane, AE; Le Couteur, DG; Mach, J; McKenzie, C; Mitchell, SJ, 2016
)
0.43
" Further studies are needed to evaluate the influence of liver damage on paracetamol pharmacokinetics whenever repeated dosing is applied, to avoid possible drug accumulation."( Bioavailability of paracetamol with/without caffeine in Egyptian patients with hepatitis C virus.
Abdel-Aziz, AA; Ashour, AA; Atta, R; Botros, SS; El-Lakkany, NM; Hendawy, AS; Mansour, AM; Seif El-Din, SH, 2016
)
0.43
" This study is designed to evaluate the appropriateness of antipyretics dosages generally administered to children with fever, and to identify factors that may influence dosage accuracy."( Acetaminophen administration in pediatric age: an observational prospective cross-sectional study.
Bonci, M; Cecchetti, C; Di Ruzza, L; Falsaperla, R; Gentile, I; Lubrano, R; Matin, N; Paoli, S; Pavone, P; Vitaliti, G, 2016
)
1.88
" In a clinical study, healthy human subjects were dosed daily with 4 g of either acetaminophen or placebo pills for 7 days and evaluated over the course of 14 days."( Blood gene expression profiling of an early acetaminophen response.
Bushel, PR; Fannin, RD; Gerrish, K; Paules, RS; Watkins, PB, 2017
)
0.94
" Although not dramatic at therapeutic dosing levels, these results demonstrated the divergence in the liver-specific APAP concentrations and AUC between the two groups and suggested that differences in glucuronidation capacity may play a role in this disparity."( Characterizing the Effects of Race/Ethnicity on Acetaminophen Pharmacokinetics Using Physiologically Based Pharmacokinetic Modeling.
Reisfeld, B; Zurlinden, TJ, 2017
)
0.71
" In the future this technology could become a manufacturing technology for the elaboration of oral dosage forms, for industrial production or even for personalised dose."( Stereolithographic (SLA) 3D printing of oral modified-release dosage forms.
Basit, AW; Gaisford, S; Goyanes, A; Wang, J, 2016
)
0.43
"006) and higher average dexmedetomidine dosing per patient-day (0."( Assessment of Antishivering Medication Requirements During Therapeutic Normothermia: Effect of Cooling Methods.
Kirk, A; McDaniel, C; Rincon, F; Szarlej, D, 2016
)
0.43
"The most prevalent pharmaceutical dosage forms at present-the oral immediate-release tablets and capsules-are granular solids."( On the exfoliating polymeric cellular dosage forms for immediate drug release.
Blaesi, AH; Saka, N, 2016
)
0.43
" Significantly, both patients had recently had a dose escalation from 'as needed' dosing to 4 g daily, and the medication was being administered by nursing staff."( Unexpected paracetamol (acetaminophen) hepatotoxicity at standard dosage in two older patients: time to rethink 1 g four times daily?
Ging, P; Mikulich, O; O'Reilly, KM, 2016
)
0.74
" The presence of α-amylase in the gastrointestinal tract and the variations of the gastric residence time of non-disintegrating dosage forms may affect the presystemic metabolism of this excipient and, consequently, the drug-release profile from formulations produced with SD HASCA."( Spray-dried high-amylose sodium carboxymethyl starch: impact of α-amylase on drug-release profile.
Leclair, G; Nabais, T; Zaraa, S, 2016
)
0.43
"Hydrophilic aliphatic thermoplastic polyurethane (Tecophilic™ grades) matrices for high drug loaded oral sustained release dosage forms were formulated via hot melt extrusion/injection molding (HME/IM)."( Hydrophilic thermoplastic polyurethanes for the manufacturing of highly dosed oral sustained release matrices via hot melt extrusion and injection molding.
De Beer, T; De Geest, BG; Kasmi, S; Remon, JP; Van Bockstal, PJ; Van Renterghem, J; Verstraete, G; Vervaet, C, 2016
)
0.43
"A randomized, open-label, two-treatment, crossover, pharmacokinetic study of paracetamol dosed orally and intramuscularly was conducted."( Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria.
Chierakul, W; Chotivanich, K; Dondorp, AM; Newton, PN; Plewes, K; Ruengweerayut, R; Silamut, K; Tarning, J; Teerapong, P; Wattanakul, T; White, NJ, 2016
)
0.43
" Dosing simulations showed that 1000 mg of intramuscular or oral syrup administered six-hourly reached therapeutic steady state concentrations for antipyresis, but more favourable concentration-time profiles were achieved with a loading dose of 1500 mg, followed by a 1000 mg maintenance dose."( Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria.
Chierakul, W; Chotivanich, K; Dondorp, AM; Newton, PN; Plewes, K; Ruengweerayut, R; Silamut, K; Tarning, J; Teerapong, P; Wattanakul, T; White, NJ, 2016
)
0.43
" Relative oral bioavailability compared to intramuscular dosing was estimated as 84."( Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria.
Chierakul, W; Chotivanich, K; Dondorp, AM; Newton, PN; Plewes, K; Ruengweerayut, R; Silamut, K; Tarning, J; Teerapong, P; Wattanakul, T; White, NJ, 2016
)
0.43
" Peak inhibition of urinary metabolite excretion across 8 hours following dosing was the primary end point."( Inhibition of prostacyclin and thromboxane biosynthesis in healthy volunteers by single and multiple doses of acetaminophen and indomethacin.
Gottesdiener, KM; Greenberg, HE; Mehta, A; Musser, BJ; Schwartz, JI; Taggart, WV; Tanaka, WK, 2015
)
0.63
" Raising ferrate (VI) dosage with optimal pH 7 improved the AAP degradation."( Reaction kinetics and oxidation product formation in the degradation of acetaminophen by ferrate (VI).
Jiang, JQ; Liu, Y; Wang, H, 2016
)
0.67
" Less frequent dosing of the ERP formulation may explain the difference in usage patterns."( Prescription usage patterns of two formulations of paracetamol in osteoarthritis: Australia-wide experience 2008-11.
Calcino, G; Dunagan, F; Ortiz, M, 2016
)
0.43
" Due to hepatotoxicity worries, there are no dose-response studies in children."( A Long-term Co-perfused Disseminated Tuberculosis-3D Liver Hollow Fiber Model for Both Drug Efficacy and Hepatotoxicity in Babies.
Cirrincione, KN; Crosswell, HE; Deshpande, D; Gumbo, T; Pasipanodya, JG; Ramachandran, G; Sherman, CM; Shuford, S; Srivastava, S; Swaminathan, S, 2016
)
0.43
" Recommendations to achieve optimal patient safety outcomes include the adoption and integration of available technologies with full functionality configured to meet the institution's policies and processes, initial training and retraining of all staff who use these systems, continuing education of the patient care staff on the dosing safety requirements, and assigning a prominent role to the clinical pharmacist in the entire drug-use and reconciliation process."( NCPDP recommendations for dose accumulation monitoring in the inpatient setting: Acetaminophen case model, version 1.0.
, 2016
)
0.66
" These patients required higher dosing and prolonged infusions of naloxone."( Fatal Fentanyl: One Pill Can Kill.
Adams, AJ; Albertson, TE; Black, HB; Chenoweth, JA; Colby, DK; Davis, MT; Ford, JB; Gerona, RR; Owen, KP; Roche, BM; Sutter, ME, 2017
)
0.46
" IV and PO APAP doses administered with a predose pain score ≥4 within 1 h of dosing were compared."( Intravenous Versus Oral Acetaminophen for Pain Control in Neurocritical Care Patients.
Brophy, GM; Nadpara, PA; Nichols, DC; Taylor, PD, 2016
)
0.74
"We compared plasma and cerebrospinal fluid (CSF) pharmacokinetics of paracetamol after intravenous (IV) and oral administration to determine dosing regimens that optimize CSF concentrations."( Comparative Plasma and Cerebrospinal Fluid Pharmacokinetics of Paracetamol After Intravenous and Oral Administration.
Bjorksten, AR; Hogg, M; Jamsen, K; Kirkpatrick, C; Langford, RA; Leslie, K; Williams, DL, 2016
)
0.43
" In 2012, the UK Commission on Human Medicines made recommendations for the management of paracetamol overdose, including provision of weight-based acetylcysteine dosing tables."( An assessment of the variation in the concentration of acetylcysteine in infusions for the treatment of paracetamol overdose.
Archer, JR; Bailey, GP; Dargan, PI; Flanagan, RJ; Rab, E; Wood, DM, 2017
)
0.46
"Three multivariate calibration spectrophotometric methods were developed for simultaneous estimation of Paracetamol (PARA), Enalapril maleate (ENM) and Hydrochlorothiazide (HCTZ) in tablet dosage form; namely multi-linear regression calibration (MLRC), trilinear regression calibration method (TLRC) and classical least square (CLS) method."( Development and validation of multivariate calibration methods for simultaneous estimation of Paracetamol, Enalapril maleate and hydrochlorothiazide in pharmaceutical dosage form.
Daharwal, SJ; Singh, VD, 2017
)
0.46
", age) within two study sites on Guam, a secondary limestone forest (upland) and an abandoned coconut plantation (coastal), to determine how experimentally dosing snakes with acetaminophen is likely to influence carrion availability."( Brown tree snake (Boiga irregularis) population density and carcass locations following exposure to acetaminophen.
Beasley, JC; DeVault, TL; Pitt, WC; Rhodes, OE; Smith, JB; Turner, KL, 2016
)
0.84
" The versatility of this method was demonstrated by different examples, including the excipients mixture and commercial solid dosage forms (e."( Application of
Pisklak, DM; Szeleszczuk, Ł; Zielińska-Pisklak, M, 2016
)
0.43
" It was found that the protonated CMS exhibited a better stability in simulated gastric fluid in comparison to its sodium salt in monolithic dosage forms, whereas both excipients afforded a complete gastric protection of drugs when formulated as dry-coated dosages."( Carboxymethyl Starch Excipients for Drug Chronodelivery.
Calinescu, C; De Koninck, P; Ispas-Szabo, P; Mateescu, MA, 2017
)
0.46
"The dissolution is one of the critical quality attributes (CQAs) of oral solid dosage forms because it relates to the absorption of drug."( Latent variable modeling to analyze the effects of process parameters on the dissolution of paracetamol tablet.
Dai, S; Qiao, Y; Shi, X; Sun, F; Xu, B; Zhang, Y, 2017
)
0.46
" Prescribing and dosing patterns in hospitalised children are not well known."( Analgesic Drug Prescription Patterns on Five International Paediatric Wards.
Botzenhardt, S; Neubert, A; Rashed, AN; Tomlin, S; Wong, IC, 2016
)
0.43
" Dosing data were compared with local recommendations and WHO guidelines for children."( Analgesic Drug Prescription Patterns on Five International Paediatric Wards.
Botzenhardt, S; Neubert, A; Rashed, AN; Tomlin, S; Wong, IC, 2016
)
0.43
" C57BL/6N and C57BL/6J mice were dosed with 200 mg/kg APAP and sacrificed at different time points."( Differential susceptibility to acetaminophen-induced liver injury in sub-strains of C57BL/6 mice: 6N versus 6J.
Bourdi, M; Cahkraborty, M; Davis, JS; Du, K; Duan, L; Jaeschke, H; Weemhoff, J; Woolbright, BL, 2016
)
0.72
"Fused deposition modeling (FDM) 3-Dimensional (3D) printing is becoming an increasingly important technology in the pharmaceutical sciences, since it allows the manufacture of personalized oral dosage forms by deposition of thin layers of material."( Fused-filament 3D printing of drug products: Microstructure analysis and drug release characteristics of PVA-based caplets.
Basit, AW; Gaisford, S; Goyanes, A; Kobayashi, M; Martínez-Pacheco, R, 2016
)
0.43
" Dosing could not be determined, so it was not possible to quantify utilization of IV-APAP or ascertain differences in opioid consumption between the 2 groups."( Hospitalization Costs for Patients Undergoing Orthopedic Surgery Treated With Intravenous Acetaminophen (IV-APAP) Plus Other IV Analgesics or IV Opioid Monotherapy for Postoperative Pain.
Eaddy, MT; Lunacsek, OE; Maiese, BA; Pham, AT; Shah, MV; Wan, GJ, 2017
)
0.68
" Study participants were randomised to one of the three treatment groups as well as two dosing groups (regular versus as required) and two steam inhalation groups (steam versus no steam)."( Paracetamol (acetaminophen) or non-steroidal anti-inflammatory drugs, alone or combined, for pain relief in acute otitis media in children.
Damoiseaux, RA; Hay, AD; Little, P; Schilder, AG; Sjoukes, A; van de Pol, AC; Venekamp, RP, 2016
)
0.8
"001); in a greater reduction in change from baseline temperature compared to treatment with acetaminophen, and it reduced fever throughout a 24 h dosing period."( A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients.
Chumpitazi, CE; Hahn, BJ; Kaelin, BA; Khalil, SN; Macias, CG; Rock, AD, 2017
)
0.68
" Alanine aminotransferase at baseline and following paracetamol administration was noted, as well as dosage and duration of paracetamol, along with participants' demographic details."( Frequency of worsening liver function in severe dengue hepatitis patients receiving paracetamol: A retrospective analysis of hospital data.
Aslam, F; Hakeem, H; Nasir, N; Siddiqui, F; Syed, AA, 2017
)
0.46
" More large scale prospective cohort studies are warranted to confirm our findings and carry out the dose-response analysis of aforementioned association."( Use of acetaminophen and risk of endometrial cancer: evidence from observational studies.
Ding, YY; Han, ZK; Hong, T; Li, HX; Verma, S; Yao, P; Zhu, YQ, 2017
)
0.91
" In conclusion, administration of acetaminophen at the recommended dosage of 1 g per 6 hours to critically ill multiple-trauma patients yields serum concentrations below 10 μg/mL due to increased elimination."( Pharmacokinetic Study of Intravenous Acetaminophen Administered to Critically Ill Multiple-Trauma Patients at the Usual Dosage and a New Proposal for Administration.
Fuster-Lluch, O; Gerónimo-Pardo, M; Zapater-Hernández, P, 2017
)
1.01
" Due to their bulk properties many APIs require processing to improve pharmaceutical formulation and manufacturing in the preparation for various drug dosage forms."( Surface modification of acetaminophen particles by atomic layer deposition.
Bimbo, LM; Cameron, DC; Correia, A; George, SM; Hirvonen, J; Hoppu, P; Kääriäinen, ML; Kääriäinen, TO; Kemell, M; Leskelä, M; Ritala, M; Santos, HA; Vehkamäki, M, 2017
)
0.76
" Dosage variances and route of temperature measurement ranged between studies, limiting the comparability of studies."( Effectiveness of paracetamol versus ibuprofen administration in febrile children: A systematic literature review.
Cooper, S; Innes, K; Morphet, J; Narayan, K, 2017
)
0.46
" We included information about the number of participants treated and demographic details, type of cancer, drug and dosing regimen, study design (placebo or active control) and methods, study duration and follow-up, analgesic outcome measures and results, withdrawals, and adverse events."( Tramadol with or without paracetamol (acetaminophen) for cancer pain.
Derry, S; Moore, RA; Wiffen, PJ, 2017
)
0.73
" One study compared tramadol with placebo and a combination of cobrotoxin, tramadol, and ibuprofen, but the dosing schedule poorly explained."( Tramadol with or without paracetamol (acetaminophen) for cancer pain.
Derry, S; Moore, RA; Wiffen, PJ, 2017
)
0.73
"3% indicated risks associated with use even when following the dosing instructions."( A population-based study of risk perceptions of paracetamol use among Swedes-with a special focus on young adults.
Håkonsen, H; Hedenrud, T, 2017
)
0.46
"In formulation development, certain excipients, even though used in small quantities, can have a significant impact on the processability and performance of the dosage form."( The Impact of Disintegrant Type, Surfactant, and API Properties on the Processability and Performance of Roller Compacted Formulations of Acetaminophen and Aspirin.
Koo, O; Marin, A; Morkhade, D; Pan, D; Rana, S; Saha, P; Wu, Y; Zhao, J, 2017
)
0.66
" We also simulated extended duration acetylcysteine regimens and other increased dosing strategies that have been recommended in specific paracetamol poisoning scenarios."( Pharmacokinetic modelling of modified acetylcysteine infusion regimens used in the treatment of paracetamol poisoning.
Graudins, A; Landersdorfer, C; Wong, A, 2017
)
0.46
" Unfortunately, excessive dosage of APAP could cause severe liver injury due to lack of effective therapy."( Glycyrrhetinic acid prevents acetaminophen-induced acute liver injury via the inhibition of CYP2E1 expression and HMGB1-TLR4 signal activation in mice.
Chen, X; Gong, X; Jiang, R; Kuang, G; Li, K; Ma, L; Tie, H; Wan, J; Wang, B; Xie, T; Yang, G; Zhang, L, 2017
)
0.75
" Suggested dosing regimens are proposed."( Oral Multimodal Analgesia for Total Joint Arthroplasty.
Balch, KR; Dalury, DF; Golladay, GJ; Jiranek, WA; Satpathy, J, 2017
)
0.46
" This resulted in proposed dosing regimens containing higher doses than currently prescribed in the label for term neonates."( Perinatal and neonatal use of paracetamol for pain relief.
Allegaert, K; van den Anker, JN, 2017
)
0.46
" The recommended dosage in the UK, Europe, Australia, and the USA for children and adolescents is generally 10 to 15 mg/kg every four to six hours, with specific age ranges from 60 mg (6 to 12 months old) up to 500 to 1000 mg (over 12 years old)."( Paracetamol (acetaminophen) for chronic non-cancer pain in children and adolescents.
Anderson, B; Cooper, TE; Eccleston, C; Fisher, E; Wilkinson, NM; Williams, DG, 2017
)
0.82
"Continuous manufacturing of solid oral dosage forms is promising for increasing the efficiency and quality of pharmaceutical production and products."( Provoking an end-to-end continuous direct compression line with raw materials prone to segregation.
Abrahmsén-Alami, S; Ervasti, T; Folestad, S; Fransson, M; Karttunen, AP; Ketolainen, J; Korhonen, O; Lakio, S; Tajarobi, P; Wikström, H, 2017
)
0.46
" A variety of dosing regimens is therefore used off-label."( Intravenous Paracetamol Dosing Guidelines for Pain Management in (pre)term Neonates Using the Paediatric Study Decision Tree.
Allegaert, K; Calvier, EAM; Knibbe, CAJ; Mian, P; Tibboel, D, 2017
)
0.46
"First, a systematic search was performed to provide pharmacokinetic (PK)-based dosing guidelines for pain in neonates (with subsequent searches on safety in these papers)."( Intravenous Paracetamol Dosing Guidelines for Pain Management in (pre)term Neonates Using the Paediatric Study Decision Tree.
Allegaert, K; Calvier, EAM; Knibbe, CAJ; Mian, P; Tibboel, D, 2017
)
0.46
" Only one study suggested a dosing resulting in a tailored concentration (8."( Intravenous Paracetamol Dosing Guidelines for Pain Management in (pre)term Neonates Using the Paediatric Study Decision Tree.
Allegaert, K; Calvier, EAM; Knibbe, CAJ; Mian, P; Tibboel, D, 2017
)
0.46
"The number of intramuscularly applied dosage forms has been continuously increasing during the last decades."( In vitro dissolution testing of parenteral aqueous solutions and oily suspensions of paracetamol and prednisolone.
Klein, S; Probst, M; Schmidt, M; Seidlitz, A; Tietz, K; Weitschies, W, 2017
)
0.46
"Pediatric acute-liver-failure due to acetaminophen (APAP) administration at therapeutic dosage is rare, while viral infections and metabolic defects are the prevalent causes."( NBAS mutations cause acute liver failure: when acetaminophen is not a culprit.
Brunati, A; Calvo, PL; Haak, TB; Olio, DD; Pinon, M; Romagnoli, R; Spada, M; Tandoi, F, 2017
)
0.99
"There is growing need to develop efficient methods for early-stage drug discovery, continuous manufacturing of drug delivery vehicles, and ultra-precise dosing of high potency drugs."( Printing of small molecular medicines from the vapor phase.
Amidon, GE; Clarke, R; Fleck, E; Jones, CM; Mazzara, JM; Mehta, G; Raghavan, S; Rockwell, C; Schwendeman, A; Senabulya, N; Shalev, O; Shtein, M; Simopoulos, N; Sinko, PD, 2017
)
0.46
" Acetaminophen should be used at the lowest effective dosage and for the shortest time."( Is acetaminophen safe in pregnancy?
Toda, K, 2017
)
1.99
" Additional studies are needed to assess the relationship between caffeine dosing and clinical benefits in patients with TTH and migraine."( Caffeine in the management of patients with headache.
Diener, HC; Garas, SY; Lipton, RB; Patel, K; Robbins, MS, 2017
)
0.46
"To evaluate college-age women's knowledge of appropriate doses and potential toxicities of acetaminophen, competency in interpreting Drug Facts label dosing information, and ability to recognize products containing acetaminophen."( Knowledge of appropriate acetaminophen use: A survey of college-age women.
Alaniz, C; Liao, AC; Nguyen, S; Skyles, AJ; Stumpf, JL,
)
0.66
" Blood samples were taken, and Drug Liking scores (assessed on a bipolar visual analog scale) were obtained throughout each dosing interval."( Pharmacokinetics and Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone, After Intranasal Administration in Recreational Drug Users.
Barrett, AC; Dickerson, D; Guenther, SM; Mickle, TC; Roupe, KA; Webster, LR; Zhou, J, 2018
)
0.48
" Further research to assess adverse events and other dosing may be warranted."( Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial.
Baer, J; Barnaby, DP; Bijur, PE; Chang, AK; Esses, D, 2017
)
0.46
" The intake frequency and dosage of Paracetamol varied between the women and was overall low with a tendency towards higher frequencies and higher dosages in the third trimester."( Paracetamol Medication During Pregnancy: Insights on Intake Frequencies, Dosages and Effects on Hematopoietic Stem Cell Populations in Cord Blood From a Longitudinal Prospective Pregnancy Cohort.
Arck, PC; Becher, H; Bremer, L; Diemert, A; Gehbauer, C; Goletzke, J; Hecher, K; Pagenkemper, M; Tiegs, G; Tolosa, E; Wiessner, C, 2017
)
0.46
"Routine oral dosing practices in a SSA hospital resulted in substantial underexposure to paracetamol."( Paracetamol clinical dosing routine leads to paracetamol underexposure in an adult severely ill sub-Saharan African hospital population: a drug concentration measurement study.
Bos, JC; Mathôt, RAA; Mistício, MC; Nunguiane, G; Prins, JM; van Hest, RM, 2017
)
0.46
" The proposed method was validated according to the ICH guidelines and was successfully applied to the analysis of these drugs in their tablet dosage forms with high accuracy."( Simultaneous Determination of Tizanidine, Nimesulide, Aceclofenac and Paracetamol in Tablets and Biological Fluids Using Micellar Liquid Chromatography.
Belal, F; Derayea, S; Hammad, MA; Omar, MA; Saleh, SF; Zayed, S, 2018
)
0.48
" However, to be considered as a viable processing option for solid oral dosage forms there is a need to understand all critical sources of variability which could affect this granulation technique."( Downstream processing from melt granulation towards tablets: In-depth analysis of a continuous twin-screw melt granulation process using polymeric binders.
De Beer, T; Grymonpré, W; Remon, JP; Vanhoorne, V; Verstraete, G; Vervaet, C, 2018
)
0.48
" In the present study, the dose-response and time-course model in C57/BL6 mice were established by intraperitoneal injection of APAP."( Activation of p62-keap1-Nrf2 antioxidant pathway in the early stage of acetaminophen-induced acute liver injury in mice.
Kou, R; Shen, Z; Song, F; Su, Z; Wang, Y; Xie, K, 2018
)
0.71
" In the present study, a robust electromagnetic (valvejet) inkjet technology has been successfully applied to deposit prototype dosage forms from solutions with a wide range of viscosities, and from suspensions with particle sizes exceeding 2 μm."( Inkjet printing of paracetamol and indomethacin using electromagnetic technology: Rheological compatibility and polymorphic selectivity.
Croker, DM; Glowacki, BA; Hopkins, SC; Kollamaram, G; Walker, GM, 2018
)
0.48
" We isolated virtual hepatocytes, created a virtual culture, and then conducted dose-response experiments in both culture and mice."( A Model Mechanism-Based Explanation of an In Vitro-In Vivo Disconnect for Improving Extrapolation and Translation.
Hunt, CA; Ropella, GEP; Smith, AK; Xu, Y, 2018
)
0.48
" With the increasing administration of intravenous (IV) paracetamol, there will be the associated risk of medication dosing errors."( Intravenous Paracetamol Overdose: A Pediatric Case Report.
Arslan, D; Aslan, N; Bilen, S; Horoz, OO; Yildizdas, D; Yilmaz, HL, 2019
)
0.51
"At delivery, we randomized women with preeclampsia with severe features to receive around-the-clock oral dosing with either 600 mg of ibuprofen or 650 mg of acetaminophen every 6 hours."( Effect of ibuprofen vs acetaminophen on postpartum hypertension in preeclampsia with severe features: a double-masked, randomized controlled trial.
Blue, NR; Drake-Lavelle, S; Holbrook, BD; Katukuri, VR; Leeman, L; Mozurkewich, EL; Murray-Krezan, C; Weinberg, D, 2018
)
0.99
" Pharmacists should warn users to follow labelled dosing directions, especially during CFS."( Prevalence of exceeding maximum daily dose of paracetamol, and seasonal variations in cold-flu season.
Battista, DR; Kaufman, DW; Kelly, JP; Malone, MK; Shiffman, S; Weinstein, RB, 2018
)
0.48
"At present, the most prevalent pharmaceutical dosage forms, the orally-delivered immediate-release tablets and capsules, are porous, granular solids."( 3D-micro-patterned fibrous dosage forms for immediate drug release.
Blaesi, AH; Saka, N, 2018
)
0.48
" Caregivers involved with exposures in children <2 years of age cited health professionals as the source of dosing information in only 69% of cases despite the absence of specific dosing directions for these children on product labels."( Medication Errors With Pediatric Liquid Acetaminophen After Standardization of Concentration and Packaging Improvements.
Brass, EP; Burnham, RI; Green, JL; Reynolds, KM, 2018
)
0.75
" Medication errors are particularly problematic for children <2 years of age, for whom there are no specific labeled dosing instructions."( Medication Errors With Pediatric Liquid Acetaminophen After Standardization of Concentration and Packaging Improvements.
Brass, EP; Burnham, RI; Green, JL; Reynolds, KM, 2018
)
0.75
" Any substance producing sensor bias that exceeded the International Organization for Standardization (ISO) document 15197:2013 limits was then tested using an in vitro dose-response method to determine whether the concentration producing a significant sensor bias was within physiologic/therapeutic concentration ranges."( Interference Assessment of Various Endogenous and Exogenous Substances on the Performance of the Eversense Long-Term Implantable Continuous Glucose Monitoring System.
Lorenz, C; Mortellaro, M; Sandoval, W, 2018
)
0.48
" Cholestasis was significantly elevated in model mice when pretreatment with routine or high dosage of PRP, but had no effect on normal mice."( Pinelliae Rhizoma Praeparatum Involved in the Regulation of Bile Acids Metabolism in Hepatic Injury.
Dang, X; Guo, S; Hu, N; Liu, L; Shi, L; Wei, H; Yang, P; Zhang, S; Zhang, Y, 2018
)
0.48
" Previously marketed prescription products contained phenylephrine tannate, an extended-release salt, which allowed dosing every 8-12 h."( An open-label, randomized, four-treatment crossover study evaluating the effects of salt form, acetaminophen, and food on the pharmacokinetics of phenylephrine.
Gelotte, CK, 2018
)
0.7
"Paracetamol is widely available and has an excellent safety profile; if a renoprotective effect is demonstrated, this trial will support the administration of regularly dosed paracetamol to all patients with knowlesi malaria."( The effect of regularly dosed paracetamol versus no paracetamol on renal function in Plasmodium knowlesi malaria (PACKNOW): study protocol for a randomised controlled trial.
Anstey, NM; Barber, BE; Chatfield, MD; Cooper, DJ; Dondorp, AM; Grigg, MJ; Piera, KA; Plewes, K; Rajahram, GS; William, T; Yeo, TW, 2018
)
0.48
"To assess dose-response effects of the anti-CD20 monoclonal antibody ofatumumab on efficacy and safety outcomes in a phase 2b double-blind study of relapsing forms of multiple sclerosis (RMS)."( Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.
Austin, DJ; Bar-Or, A; Derosier, FJ; Grove, RA; Kavanagh, ST; Lewis, EW; Lopez, MC; Miller, AE; Sorensen, PS; Tolson, JM; VanMeter, SA, 2018
)
0.48
" This treatment effect also occurred with dosage regimens that only partially depleted circulating B cells."( Subcutaneous ofatumumab in patients with relapsing-remitting multiple sclerosis: The MIRROR study.
Austin, DJ; Bar-Or, A; Derosier, FJ; Grove, RA; Kavanagh, ST; Lewis, EW; Lopez, MC; Miller, AE; Sorensen, PS; Tolson, JM; VanMeter, SA, 2018
)
0.48
" The mean age, weight and area under the concentration-time curve for the sampled dosing interval were 34."( Population pharmacokinetics of intravenous paracetamol in critically ill patients with traumatic brain injury.
Gowardman, J; Lipman, J; Myburgh, J; Parker, SL; Roberts, JA; Saxena, M, 2018
)
0.48
" However, further study should be conducted to find the optimal dosage of paracetamol for relieving the pain in amniocentesis along with a large RCT with a long-term follow-up to evaluate the side effects of paracetamol."( Oral paracetamol premedication effect on maternal pain in amniocentesis: a randomised double blind placebo-controlled trial.
Pattanavijarn, L; Sudjai, D; Tuaktaew, T, 2018
)
0.48
" Dosing of the drug is easy to control and change, hence it is possible to cancel the drug administering as soon as the required result is achieved so as to minimize any complications."( ACETAMINOPHEN ADMINISTERING IN ORDER TO OBLITERATE HEMODYNAMICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN NEONATES WITH EXTREMELY LOW BIRTH WEIGHT.
Aleksandrovich, YS; Chupaeva, OY; Khubulava, GG; Li, AG; Marchenko, SP; Melashenko, TB; Naumov, AB; Pshenisnov, KV, 2016
)
1.88
"Paracetamol is the most commonly used analgesic in older people, and is mainly dosed according to empirical dosing guidelines."( Paracetamol in Older People: Towards Evidence-Based Dosing?
Allegaert, K; Mian, P; Petrovic, M; Spriet, I; Tibboel, D, 2018
)
0.48
" Solid dosage forms containing amoxicillin alone or in combination with clavulanic acid as well as analgesics containing paracetamol alone or in combination with other drugs were sampled in a randomized fashion from the formal market (pharmacies) and by convenient sampling from the informal market."( Drug Quality in South Africa: A Field Test.
Dressman, J; Katerere, DR; Lehmann, A, 2018
)
0.48
" On the other hand, acetaminophen challenged mice treated with 14 days of coconut water vinegar were recorded with reduction of serum liver profiles, improved liver histology, restored liver antioxidant, reduction of liver inflammation and decreased level of liver cytochrome P450 2E1 in dosage dependent level."( Coconut water vinegar ameliorates recovery of acetaminophen induced liver damage in mice.
Alitheen, NB; Beh, BK; Ho, WY; Ky, H; Lim, KL; Long, K; Mohamad, NE; Sharifuddin, SA; Yeap, SK, 2018
)
1.06
" The results suggest that 3D printing is therefore a suitable manufacturing method for personalized dosage forms."( Influence of Geometry on the Drug Release Profiles of Stereolithographic (SLA) 3D-Printed Tablets.
Basit, AW; Gaisford, S; Goyanes, A; Martinez, PR, 2018
)
0.48
"We evaluated postoperative pain control and narcotic usage after thumb carpometacarpal (CMC) arthroplasty or open reduction and internal fixation (ORIF) of the distal radius in patients given opiates with or without other non-opiate medication using a specific dosing regimen."( Multi-Modal Pain Control in Ambulatory Hand Surgery.
Awan, HM; DiMeo, T; Harrison, RK; Klinefelter, RD; Ruff, ME, 2018
)
0.48
" Users of 650-mg ER formulations were significantly less likely to know their dosing interval of 8 hours (33% vs."( Exceeding the maximum daily dose of acetaminophen with use of different single-ingredient OTC formulations.
Battista, DR; Kaufman, DW; Kelly, JP; Malone, MK; Shiffman, S; Weinstein, RB,
)
0.41
"Usage of 500-mg OTC SI acetaminophen formulations does not contribute differently to exceeding dosage compared with other OTC SI acetaminophen formulations."( Exceeding the maximum daily dose of acetaminophen with use of different single-ingredient OTC formulations.
Battista, DR; Kaufman, DW; Kelly, JP; Malone, MK; Shiffman, S; Weinstein, RB,
)
0.72
"Users should know the active ingredients and dosing directions to optimize the safe use of acetaminophen-containing medications."( Knowledge of dosing directions among current users of acetaminophen-containing medications.
Battista, DR; Kaufman, DW; Kelly, JP; Malone, MK; Shiffman, S; Weinstein, RB,
)
0.6
" Users were asked about ingredients of medications taken; specific dosing instructions were asked for each OTC medication taken."( Knowledge of dosing directions among current users of acetaminophen-containing medications.
Battista, DR; Kaufman, DW; Kelly, JP; Malone, MK; Shiffman, S; Weinstein, RB,
)
0.38
" The four models PLS, ANN, GA-PLS and GA-ANN were successfully applied for the determination of PAR and CZX in their pure and pharmaceutical dosage form."( Traditional versus advanced chemometric models for the impurity profiling of paracetamol and chlorzoxazone: Application to pure and pharmaceutical dosage forms.
AlAlamein, AMA; Galal, MM; Saad, AS; Zaazaa, HE, 2018
)
0.48
" This study investigates attenuated total reflectance-fourier transform infrared (ATR-FTIR) spectroscopy as a simple and rapid method for determination of drug content in tablet dosage forms."( Quantitative screening of the pharmaceutical ingredient for the rapid identification of substandard and falsified medicines using reflectance infrared spectroscopy.
Lawson, G; Ogwu, J; Tanna, S, 2018
)
0.48
" Cell sensitivity was assessed based on the total area under and over the dose-response curves (AUOC) in relation to baselines."( Differentiated mitochondrial function in mouse 3T3 fibroblasts and human epithelial or endothelial cells in response to chemical exposure.
Boncler, M; Dastych, J; Golanski, J; Lukasiak, M; Watala, C, 2019
)
0.51
"The in-line control of pharmaceutical processes has become a necessary tool for the evaluation and follow-up of pharmaceutical dosage forms."( A novel insight into fluid bed melt granulation: Temperature mapping for the determination of granule formation with the in-situ and spray-on techniques.
Daoud, K; Korteby, Y; Mahdi, Y; Regdon, G, 2019
)
0.51
" Thus, dosing is usually derived by extrapolation from adult and pediatric pharmacologic data with scaling by body weight or body surface area."( Suggestions for Model-Informed Precision Dosing to Optimize Neonatal Drug Therapy.
Akinbi, HT; Euteneuer, JC; Fukuda, T; Kamatkar, S; Vinks, AA, 2019
)
0.51
" This article presents different analgesic drugs, their mode of action, indications, dosage and adverse drug reactions."( [Pharmacological Basis of Pain Treatment].
Schüning, J; Schwarzer, A, 2018
)
0.48
" Analysed dosage forms contained cyproheptadine and dexamethasone in concentrations higher than therapeutic doses."( Determination of synthetic pharmaceutical adulterants in herbal weight gain supplements sold in herb shops, Tehran, Iran.
Akhgari, M; Bahmanabadi, L; Bazmi, E; Mousavi, Z; Saberi, N, 2018
)
0.48
" More than 2-fold increase in area under the curve from 0 to 24 h from the dispersions was noticed on the third day of oral dosing to animals."( Glucosamine-paracetamol spray-dried solid dispersions with maximized intrinsic dissolution rate, bioavailability and decreased levels of in vivo toxic metabolites.
Abourehab, MA; Ali, AMA; Alrobaian, MM; Hamaidi, M; Khames, A, 2018
)
0.48
"The shallow dose-response relationship and good tolerability of the fixed-dose combination over an extended study period supports the utility of both doses of the fixed-dose combination in the home setting."( Analgesic effectiveness, pharmacokinetics, and safety of a paracetamol/ibuprofen fixed-dose combination in children undergoing adenotonsillectomy: A randomized, single-blind, parallel group trial.
Anderson, BJ; Atkinson, HC; Frampton, C; Playne, R; Stanescu, I, 2018
)
0.48
"The present study involved segmental testing of hair in two clinical cases with known dosage histories."( Segmental Hair Analysis-Interpretation of the Time of Drug Intake in Two Patients Undergoing Drug Treatment.
Johansen, SS; Linnet, K; Nielsen, MKK; Wang, X, 2019
)
0.51
" Although promising, acetaminophen treatment requires further studies regarding long-term safety as well as ideal dosing and route of administration."( Pharmacotherapy for patent ductus arteriosus closure.
Ferguson, JM, 2019
)
0.83
"Human liver slice function was stressed by daily dosing of acetaminophen (APAP) or diclofenac (DCF) to investigate injury and repair."( Progression of Repair and Injury in Human Liver Slices.
Fisher, RL; Ulyanov, AV; Vickers, AEM, 2018
)
0.72
"This project was initiated by Cincinnati Children's Hospital after an increase in perioperative acetaminophen dosing errors was reported."( Increasing compliance of safe medication administration in pediatric anesthesia by use of a standardized checklist.
Adler, AC; Buck, D; Kanjia, MK; Varughese, AM, 2019
)
0.73
" A total of 24 patients will be assigned into one of three dosing cohorts of eight patients (n = 6 for PP100-01 and NAC; n = 2 for NAC alone)."( Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose-the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomi
Dear, J, 2019
)
0.51
"Temporal patterns of acetaminophen use exceeding the recommended daily maximum dosage of 4 g over a 5-year period (4/1/2011-3/31/2016) were evaluated in an online 1-week diary study of 14 434 adult acetaminophen users who also reported acetaminophen use in the previous month."( Five-year trends in acetaminophen use exceeding the recommended daily maximum dose.
Battista, DR; Kaufman, DW; Kelly, JP; Malone, MK; Shiffman, S; Weinstein, RB, 2019
)
1.16
" Les sensibilité et spécificité du dosage des IgE spécifiques pour le paracétamol, les tests cutanés et les autres tests de provocation in vitro ont été très peu étudiés."( [How I explore... a suspicion of paracetamol allergy in children].
El Abd, K; Gadisseur, R; Sciacca, M; Thimmesch, M, 2019
)
0.51
"An observational study was carried out to determine the magnitude of dosing errors made by parents, the most-preferred drug delivery device and the association of age, gender, education of the caregiver and number of children with the proportion of accurate doses."( Liquid Drug Dosage Measurement Errors with Different Dosing Devices.
Bavdekar, SB; Joshi, P, 2019
)
0.51
" Moreover, the fabricated sensor was also successfully applied for the determination of AP in pharmaceutical dosage forms and human urine sample, and satisfactory recoveries were obtained."( An electrochemical sensor based on electro-polymerization of caffeic acid and Zn/Ni-ZIF-8-800 on glassy carbon electrode for the sensitive detection of acetaminophen.
Ding, X; Jiang, B; Liu, S; Pei, S; Zhang, W; Zhang, Y; Zong, L, 2019
)
0.71
" It was hypothesized that 1000 mg of intravenous acetaminophen (IA) dosed every 6 hours would significantly reduce the postoperative pain score at rest and the opioid consumption volume in patients who would undergo total hip arthroplasty (THA) when compared to a control group."( Evaluating the Effect of Intravenous Acetaminophen in Multimodal Analgesia After Total Hip Arthroplasty: A Randomized Controlled Trial.
Fukunishi, S; Hashimoto, K; Nishio, S; Simura, Y; Takeda, Y; Yoshiya, S, 2019
)
1.04
" We also investigate the effect of scaling up the manufacturing process (from single to batch) by evaluating dosage uniformity and possibility of segregation in blends."( Investigating the Effect of APAP Crystals on Tablet Behavior Manufactured by Direct Compression.
Bhatt, C; Cuitino, A; Ghazi, N; Kiang, S; Liu, Z, 2019
)
0.51
" In this study, we evaluated acetaminophen pharmacokinetics (PK) and changes in microRNA-122 (miR-122) levels after multiple dosing of acetaminophen with or without Ojeok-san."( Pharmacokinetic Analysis and Biomarker-Assisted Safety Assessment of Acetaminophen in Combination With Ojeok-san Compared With Acetaminophen Alone.
Kim, BH; Lee, JH; Lee, KT; Park, JY; Park, MS; Park, SI; Yim, SV; Yoon, YR, 2019
)
1.04
" Model dosage forms containing acetaminophen and an excipient, lactose monohydrate, were prepared."( Pharmaceutical quantification with univariate analysis using transmission Raman spectroscopy.
Fukami, T; Goda, Y; Hisada, H; Inoue, M; Katori, N; Koide, T; Shimamura, R, 2019
)
0.8
" The level of certainty for dosing recommendations obtainable from reviewing the evidence is low due to a small number of studies meeting search criteria, small samples sizes, inadequate information regarding cirrhosis etiology and compensated versus uncompensated liver disease, and lack of information on patient centered health outcomes."( A Systematic Review of the Evidence Behind Use of Reduced Doses of Acetaminophen in Chronic Liver Disease.
Juba, KM; Schweighardt, AE, 2018
)
0.72
" This review covers aspects of curcumin in relation to prevention of drug-induced nephrotoxicity: dosage and schedule, effect on kidney biomarkers and histological changes, and mechanisms of curcumin's protective effects."( Efficacy of curcumin on prevention of drug-induced nephrotoxicity: A review of animal studies.
Barreto, GE; Beiraghdar, F; Motaharinia, J; Panahi, Y; Sahebkar, A, 2019
)
0.51
"Fabrication of personalized dosage oral pharmaceuticals using additive manufacturing (AM) provides patients with customizable, locally manufactured, and cost-efficient tablets, while reducing the probability of side effects."( Comparison of Linear and 4-Arm Star Poly(vinyl pyrrolidone) for Aqueous Binder Jetting Additive Manufacturing of Personalized Dosage Tablets.
Bai, Y; Long, TE; Ma, D; Williams, CB; Wilts, EM, 2019
)
0.51
" There is concern that current NAC dosing is not large enough to adequately treat large APAP ingestions."( Evaluation and treatment of acetaminophen toxicity.
Curry, SC; Fisher, ES, 2019
)
0.81
" Finally, in vivo studies in rats showed a higher bioavailability compared to conventional dosage forms and confirm the potential of biodegradable microcontainers for oral drug delivery."( Biodegradable microcontainers - towards real life applications of microfabricated systems for oral drug delivery.
Abid, Z; Boisen, A; Gundlach, C; Javed, MM; Keller, SS; Mazzoni, C; Müllertz, A; Nielsen, LH; Petersen, RS; Strindberg, S; Vaut, L, 2019
)
0.51
" High dosage ibuprofen was associated with a faster clinical improvement and higher rate of PDA closure."( Oral ibuprofen is superior to oral paracetamol for patent ductus arteriosus in very low and extremely low birth weight infants.
Chen, C; Li, Q; Li, Z; Lu, J; Zhu, L, 2019
)
0.51
" Plasma samples were collected at 17 hr after dosing (during the manifestation of symptoms) and at one month (after recovery) and were subjected to LC-MS analysis of NAPQI-adducts."( LC-MS analyses of N-acetyl-p-benzoquinone imine-adducts of glutathione, cysteine, N-acetylcysteine, and albumin in a plasma sample: A case study from a patient with a rare acetaminophen-induced acute swelling rash.
Kubo, T; Lee, SH; Oe, T; Ozawa, M, 2019
)
0.71
" Focusing on paracetamol, this study has explored the appropriateness of pharmaceutical products in different dosage forms to achieve adequate patient acceptability from infants to centenarians."( Dosage form suitability in vulnerable populations: A focus on paracetamol acceptability from infants to centenarians.
Belissa, É; Boudy, V; Chevallier, A; de Pontual, L; Dufaÿ Wojcicki, A; Fontan, JE; Laribe-Caget, S; Nathanson, S; Ruiz, F; Vallet, T, 2019
)
0.51
"By better integrating patient characteristics when choosing dosage forms, clinicians and caregivers may improve treatment acceptability and adherence."( Dosage form suitability in vulnerable populations: A focus on paracetamol acceptability from infants to centenarians.
Belissa, É; Boudy, V; Chevallier, A; de Pontual, L; Dufaÿ Wojcicki, A; Fontan, JE; Laribe-Caget, S; Nathanson, S; Ruiz, F; Vallet, T, 2019
)
0.51
" Furthermore, autophagy intervention experiments were achieved by the administration of rapamycin (RAPA) or chloroquine (CQ) one hour prior to dosing 300 mg/kg APAP."( Mitophagy protects against acetaminophen-induced acute liver injury in mice through inhibiting NLRP3 inflammasome activation.
Kou, R; Shan, S; Shen, Z; Song, F; Xie, K; Zhang, C, 2019
)
0.81
" After dissolution of the PVP interlayer, the capsule separates in two, with inner and outer capsules for continuous drug dosing and targeting."( Precision Printing of Customized Cylindrical Capsules with Multifunctional Layers for Oral Drug Delivery.
Chang, MW; Chen, X; Li, X; Mai, J; Wu, S; Zhang, C, 2019
)
0.51
" IV dosing may be preferable to ensure adequate pain relief."( Enteral Acetaminophen Bioavailability in Pediatric Intensive Care Patients Determined With an Oral Microtracer and Pharmacokinetic Modeling to Optimize Dosing.
Calvier, E; de Wildt, SN; Kleiber, N; Knibbe, CAJ; Krekels, EHJ; Mooij, MG; Tibboel, D; Vaes, WHJ, 2019
)
0.95
"Cord biomarkers of fetal exposure to acetaminophen were associated with significantly increased risk of childhood ADHD and ASD in a dose-response fashion."( Association of Cord Plasma Biomarkers of In Utero Acetaminophen Exposure With Risk of Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder in Childhood.
Azuine, RE; Hong, X; Hou, W; Ji, Y; Pearson, C; Riley, A; Wang, G; Wang, X; Zhang, Y; Zuckerman, B, 2020
)
1.08
" ER2 mRNA expression shows a downregulated trend, with a clearer dose-response relationship in males."( Effects of short-term exposure of paracetamol in the gonads of blue mussels Mytilus edulis.
Ciocan, C; Koagouw, W, 2020
)
0.56
" Furthermore, the bioavailability of the APIs from the dosage form depends largely on these characteristics."( Fiber-Array-Based Raman Hyperspectral Imaging for Simultaneous, Chemically-Selective Monitoring of Particle Size and Shape of Active Ingredients in Analgesic Tablets.
Frosch, T; Popp, J; Wyrwich, E; Yan, D, 2019
)
0.51
"cit, CAF and PAP in pure powder and in combined tablets dosage form without interference from excipients."( Development and Validation of Chromatographic Methods for Simultaneous Determination of Paracetamol, Orphenadrine Citrate and Caffeine in Presence of P-aminophenol; Quantification of P-aminophenol Nephrotoxic Impurity Using LC-MS/MS.
Boltia, SA; Elzanfaly, ES; Soudi, AT; Zaazaa, HE, 2020
)
0.56
"We measured the acetaminophen dose-response in isometrically mounted arteries and pharmacologically evaluated the factors accounting for its vasomotor effects."( Acetaminophen increases pulmonary and systemic vasomotor tone in the newborn rat.
Belik, J; McNamara, PJ; Pan, J; Tamir Hostovsky, L, 2020
)
2.35
" Results The scheduled dosing group was found to have a statistically significant decrease in pain scores at all time intervals."( The effect of a scheduled regimen of acetaminophen and ibuprofen on opioid use following cesarean delivery.
Chappelle, J; Poljak, D, 2020
)
0.83
" In a simulation of expected steady-state plasma concentrations following multiple dosing of 650 mg APAP every 4 hours, post-RYGBS patients had higher steady-state peak APAP concentrations compared to healthy individuals and obese pre-RYGBS patients, though APAP exposure was unchanged compared to healthy individuals."( The Impact of Proximal Roux-en-Y Gastric Bypass Surgery on Acetaminophen Absorption and Metabolism.
Chan, LN; Chen, KF; Flum, DR; Horn, JR; Lin, YS; Oelschlager, BK; Senn, TD; Shen, DD, 2020
)
0.8
" We sought to evaluate the effectiveness and safety of over the counter dosing of ibuprofen on pain and bleeding rates following ESS."( Effect of Over the Counter Ibuprofen Dosing after Sinus Surgery for Chronic Rhinosinusitis: A Prospective Cohort Pilot Study.
Davis, GE; Humphreys, IM; Miller, C, 2020
)
0.56
"Over the counter dosing of ibuprofen along with acetaminophen may yield better pain control after sinus surgery compared to acetaminophen alone."( Effect of Over the Counter Ibuprofen Dosing after Sinus Surgery for Chronic Rhinosinusitis: A Prospective Cohort Pilot Study.
Davis, GE; Humphreys, IM; Miller, C, 2020
)
0.81
"The aim of the current study was the development of pediatric-friendly 3D printed chocolate-based oral dosage forms."( Pediatric-friendly chocolate-based dosage forms for the oral administration of both hydrophilic and lipophilic drugs fabricated with extrusion-based 3D printing.
Fatouros, DG; Gkaragkounis, A; Karavasili, C; Moschakis, T; Ritzoulis, C, 2020
)
0.56
" A clinical dosage (4 mg/mL) of dexamethasone (Dex) showed toxic effects on chondrocytes, and the long-time treatment by lower doses (4-400 μg/mL) induced hypertrophic changes in the chondrocytes."( Primary Human Chondrocytes Affected by Cigarette Smoke-Therapeutic Challenges.
Arnscheidt, C; Aspera-Werz, RH; Chen, T; Ehnert, S; Nussler, AK; Tendulkar, G; Zhu, S, 2020
)
0.56
"Some patients encounter hepatotoxicity after repeated acetaminophen (APAP) dosing even at therapeutic doses."( Enhancement of acetaminophen-induced chronic hepatotoxicity in spontaneously diabetic torii (SDT) rats.
Hashimoto, T; Kobayashi, A; Kondo, K; Sugai, S; Suzuki, Y; Takahashi, T; Toyoda, K; Yamada, N; Yoshinari, K, 2020
)
1.16
"N-Acetylcysteine (NAC) is an effective antidote for the treatment of acetaminophen (APAP) poisoning; however, due to its low stability and bioavailability, repeated dosing of NAC is needed."( Improvement of therapeutic potential N-acetylcysteine in acetaminophen hepatotoxicity by encapsulation in PEGylated nano-niosomes.
Azandaryani, MT; Firozian, F; Karami, S; Nili-Ahmadabadi, A; Ranjbar, A, 2020
)
1.04
" Notably, slow addition of any of the four therapeutics to cultured macrophages, mimicking the slowly increasing plasma concentration reported for standard oral dosage in patients, yielded no detectable change in pseudopod morphology."( Rapid exposure of macrophages to drugs resolves four classes of effects on the leading edge sensory pseudopod: Non-perturbing, adaptive, disruptive, and activating.
Buckles, TC; Djukovic, D; Falke, JJ; Ziemba, BP, 2020
)
0.56
"Oral drug delivery systems for time-controlled release, intended for chronotherapy or colon targeting, are often in the form of coated dosage forms provided with swellable/soluble hydrophilic polymer coatings."( Erodible coatings based on HPMC and cellulase for oral time-controlled release of drugs.
Cerea, M; Foppoli, A; Gazzaniga, A; Maroni, A; Melocchi, A; Moutaharrik, S; Palugan, L; Zema, L, 2020
)
0.56
" Concentration levels in the designed mixture were carefully considered to recede the challenging dosage form ratio."( Spectral resolution of quaternary components in a sinus and congestion mixture; Multivariate algorithms to approach extremes of concentration levels.
Abbas, SS; Badawey, AM; Nabil, M; Yehia, AM, 2020
)
0.56
"In this Quality Improvement (QI project) it was hypothesized that an increase in dosing intervals for postoperative analgesia when alternating Ibuprofen and Acetaminophen would reduce post-tonsillectomy hemorrhage (PTH) rates for those undergoing tonsillectomies with or without adenoidectomy, while maintaining the standard of postoperative analgesia and reducing visits to the Emergency Room (ER) for reasons other than PTH."( The Effect of Ibuprofen Dosing Interval on Post-Tonsillectomy Outcomes in Children: A Quality Improvement Study.
Carr, MM; Henderson, K; Mast, G, 2020
)
0.76
" Starting January of 2018 through November of 2018, the dosage interval was lengthened 1 hour."( The Effect of Ibuprofen Dosing Interval on Post-Tonsillectomy Outcomes in Children: A Quality Improvement Study.
Carr, MM; Henderson, K; Mast, G, 2020
)
0.56
" This study aimed to develop an oral dosage form that is palatable and easy to swallow by pediatric patients as well as to overcome the shortcomings of liquid formulations."( Formulation development of paracetamol instant jelly for pediatric use.
Ahmed Saeed Aljapairai, K; Akkawi, ME; Almurisi, SH; Chatterjee, B; Doolaanea, AA; Islam Sarker, MZ, 2020
)
0.56
" The palatability assessment carried out on 12 human subjects established the similar palatability and texture of the paracetamol instant jelly dosage comparable to the commercial paracetamol suspension and was found to be even better in overcoming the aftertaste of paracetamol."( Formulation development of paracetamol instant jelly for pediatric use.
Ahmed Saeed Aljapairai, K; Akkawi, ME; Almurisi, SH; Chatterjee, B; Doolaanea, AA; Islam Sarker, MZ, 2020
)
0.56
"Such findings indicate that paracetamol instant jelly will compensate for the use of sweetening and flavoring agents as well as develop pediatric dosage forms with limited undesired excipients."( Formulation development of paracetamol instant jelly for pediatric use.
Ahmed Saeed Aljapairai, K; Akkawi, ME; Almurisi, SH; Chatterjee, B; Doolaanea, AA; Islam Sarker, MZ, 2020
)
0.56
"Orally disintegrating tablets (ODTs) manufactured by freeze-drying, also called oral lyophilizates, are a patient-centred dosage form."( Application of polyvinyl acetate in an innovative formulation strategy for lyophilized orally disintegrating tablets.
De Beer, T; Vanbillemont, B, 2020
)
0.56
"This study sought to determine whether a brief intervention at the time of emergency department (ED) discharge can improve safe dosing of liquid acetaminophen and ibuprofen by parents or guardians."( Medication Education for Dosing Safety: A Randomized Controlled Trial.
Camargo, CA; Cohen, A; Espinola, JA; Faridi, M; Hayes, BD; Naureckas Li, C; Porter, S; Samuels-Kalow, M, 2020
)
0.76
" Families were randomized to standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing."( Medication Education for Dosing Safety: A Randomized Controlled Trial.
Camargo, CA; Cohen, A; Espinola, JA; Faridi, M; Hayes, BD; Naureckas Li, C; Porter, S; Samuels-Kalow, M, 2020
)
0.56
"A multifaceted intervention at the time of ED discharge-consisting of a simplified dosing handout, a teaching session, teach-back, and provision of a standardized dosing device-can improve parents' knowledge of safe dosing of liquid medications at 48 to 72 hours."( Medication Education for Dosing Safety: A Randomized Controlled Trial.
Camargo, CA; Cohen, A; Espinola, JA; Faridi, M; Hayes, BD; Naureckas Li, C; Porter, S; Samuels-Kalow, M, 2020
)
0.56
" An efficient and sensitive method to measure multiple serum drugs and metabolites could inform drug dosing in polypharmacy."( Quantification of serum levels in mice of seven drugs (and six metabolites) commonly taken by older people with polypharmacy.
Hilmer, SN; Mach, J; Wang, X, 2021
)
0.62
"To determine the degree of cross-contamination and to validate a cleaning process for an Automated Personalised Dosing System (APDS), respecting the permitted residue transfer limits."( Determination of the cross-contamination and validation of the cleaning process for an automated personalised dosing system.
Beobide Telleria, I; Ferro Uriguen, A; Martínez Arrechea, S; Miró Isasi, B; Sampedro Yangüela, C; Urretavizcaya Anton, M, 2022
)
0.72
" Validated HPLC method was successfully applied to the analysis of PAR and CZ in their combined capsules dosage form, and assay results were favorably compared with a published reference HPLC method."( Validated specific HPLC-DAD method for simultaneous estimation of paracetamol and chlorzoxazone in the presence of five of their degradation products and toxic impurities.
Bedair, MM; Belal, TS; El-Yazbi, AF; Guirguis, KM, 2020
)
0.56
" This review analyzes available data on paracetamol dosing for pain and fever in children and adolescents who are overweight or obese to identify gaps and challenges in optimal dosing strategies."( Practical Challenges-Use of Paracetamol in Children and Youth Who are Overweight or Obese: A Narrative Review.
Bhagat, PK; Siddiqui, K; Zempsky, WT, 2020
)
0.56
" A dose-response association was detected; each doubling of exposure increased the odds of ADHD by 10% (OR, 1."( Association of Prenatal Acetaminophen Exposure Measured in Meconium With Risk of Attention-Deficit/Hyperactivity Disorder Mediated by Frontoparietal Network Brain Connectivity.
Aw, N; Baccarelli, AA; Baker, BH; Bellenger, JP; Boivin, A; Gillet, V; Laue, HE; Lepage, JF; Lugo-Candelas, C; Posner, J; Rahman, T; Takser, L; Whittingstall, K; Wu, H, 2020
)
0.87
" In the present study, a physiologically based pharmacokinetic (PBPK) approach for modeling paracetamol suspension data collected in adults was proposed with the ultimate aim to investigate whether extrapolation to infants is substantially affected by the dosing conditions applied to adults."( Successful Extrapolation of Paracetamol Exposure from Adults to Infants After Oral Administration of a Pediatric Aqueous Suspension Is Highly Dependent on the Study Dosing Conditions.
Fotaki, N; Holm, R; Reppas, C; Statelova, M; Vertzoni, M, 2020
)
0.56
" Opioid outcomes calculated in morphine milligram equivalents per kilogram (MME/kg) per dosage and total prescribed."( Pediatric Post-Tonsillectomy Opioid Prescribing Practices.
Agamawi, YM; Brinkmeier, JV; Cass, LM; Mouzourakis, M; Pannu, JS, 2021
)
0.62
" This was compared with the patients for which the e-agent had, during the same period, prospectively made an alert for absolute or relative overdosing or for a dosing interval < 4 h (potentially leading to an absolute overdose)."( Implementation and outcome of an electronic tool for detection of paracetamol overdose in a tertiary care hospital.
Blum, K; Cabrera-Diaz, F; Lim, S; Salili, AR; Zaugg, C, 2021
)
0.62
" baseline glutathione (GSH) levels, pharmacokinetics, and capacity of hepatic antioxidants) leads to potential differences in carcinogenic hazard potential at different dosing schemes: maximum labeled doses of 4 g/day, repeated doses above the maximum labeled dose (>4-12 g/day), and acute overdoses of acetaminophen (>15 g)."( Application of the DILIsym® Quantitative Systems Toxicology drug-induced liver injury model to evaluate the carcinogenic hazard potential of acetaminophen.
Atillasoy, E; Eichenbaum, G; Gebremichael, Y; Gelotte, CK; Howell, BA; Jacobson-Kram, D; Jaeschke, H; Kuffner, E; Lai, JCK; Murray, FJ; Wikoff, D; Yang, K, 2020
)
0.93
" The accumulated dosage of acetaminophen given by postoperative day 2 was significantly higher in the Single group versus the Continuous group (55."( The Effect of Continuous Field Block through Intercostal Muscles after Atrial Septal Defect Closure via a Mini-Right Thoracotomy in Pediatric Patients.
Ishii, Y; Kishikawa, H; Miyagi, Y; Mori, K; Nitta, T; Sakamoto, A; Sasaki, T; Suzuki, K, 2021
)
0.92
" administration of acetaminophen with polyvinylpyrrolidone (PVP; a mucoadhesive agent) and poly-l-arginine (PLA; an absorption enhancer) were investigated to improve retention of the dosage solution in the olfactory epithelium region and enhance the transfer of acetaminophen to the brain."( Delivery of acetaminophen to the central nervous system and the pharmacological effect after intranasal administration with a mucoadhesive agent and absorption enhancer.
Kimura, M; Matsuzaki, H; Natsume, H; Ogawa, K; Okazaki, M; Uchida, H; Uchida, M; Yamaki, T, 2021
)
1.33
" For PK assessments, we dosed the APAP in the media at preset timepoints after administering it either over the intestinal barrier (emulating the oral route) or in the media (emulating the intravenous route), at 12 µM and 2 µM respectively."( An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment.
Bortot, LO; de Carvalho, M; Dias, MM; Indolfo, NC; Lorencini, M; Marin, TM; Pagani, E; Rocco, SA; Schuck, DC; Vasconcelos Bento, GI, 2020
)
0.56
" N-Acetylcysteine should be given according to specific regimens through weight-based dosing tables."( Paracetamol overdose in the newborn and infant: a life-threatening event.
Antonucci, R; Capobianco, G; Cuzzolin, L; Locci, C, 2021
)
0.62
" While repeated dosing with the milder 75 mg/kg dose did not cause mitochondrial protein adduct formation, JNK activation, or liver injury, autophagy inhibition resulted in hepatocyte death even at this lower dose."( Impaired protein adduct removal following repeat administration of subtoxic doses of acetaminophen enhances liver injury in fed mice.
Akakpo, JY; Ding, WX; Jaeschke, H; Nguyen, NT; Ramachandran, A; Weemhoff, JL, 2021
)
0.85
" The dosage of paracetamol ingested was within current guidance yet there was sudden derangement of liver function."( Normal dose paracetamol in muscular dystrophy patients - is it normal?
Philipose, Z; Teo, KS; Yin, JL, 2020
)
0.56
"62) in a dose-response manner."( Prenatal exposure to acetaminophen increases the risk of atopic dermatitis in children: A nationwide nested case-control study in Taiwan.
Bai, YM; Chang, YT; Chen, MH; Chen, TJ; Dai, YX; Li, CY; Tsai, SJ, 2021
)
0.94
" We aimed in this study to assess parents' knowledge, attitudes, and practice regarding paracetamol dosing and toxicity, as well as their awareness regarding paracetamol-containing products."( An assessment of parents' knowledge and awareness regarding paracetamol use in children: a cross-sectional study from Palestine.
Al-Jabi, SW; Al-Tawil, F; Daifallah, A; Elkourdi, M; Jabr, R; Koni, A; Salman, Z; Samara, A; Zyoud, SH, 2021
)
0.62
"8% preferred the suppository dosage form."( An assessment of parents' knowledge and awareness regarding paracetamol use in children: a cross-sectional study from Palestine.
Al-Jabi, SW; Al-Tawil, F; Daifallah, A; Elkourdi, M; Jabr, R; Koni, A; Salman, Z; Samara, A; Zyoud, SH, 2021
)
0.62
"Recent recognition of "massive" acetaminophen (APAP) overdoses has led to the question of whether standard dosing of N-acetylcysteine (NAC) is adequate to prevent hepatoxicity in these patients."( Clinical outcome of massive acetaminophen overdose treated with standard-dose N-acetylcysteine.
Cumpston, KL; Downs, JW; Kershner, EK; Rose, SR; Troendle, MM; Wills, BK, 2021
)
1.2
" Dosing regimens of frusemide, and acetaminophen, and the sizes of ductus arteriosus following treatment, were evaluated."( Intravenous frusemide does not interact pharmacodynamically with acetaminophen in critically ill preterm neonates with patent ductus arteriosus.
Al Ansari, E; Al Jufairi, M; Al Madhoob, A; Al Marzooq, R; Sridharan, K, 2021
)
1.14
" Variations were observed in the dosing regimen of acetaminophen across the studies."( Intravenous acetaminophen (at 15 mg/kg/dose every 6 hours) in critically ill preterm neonates with patent ductus arteriosus: A prospective study.
Al Ansari, E; Al Jufairi, M; Al Madhoob, A; Al Marzooq, R; Hasan, SJR; Hubail, Z; Sridharan, K, 2021
)
1.25
"The optimal dosing of post-operative total knee arthroplasty (TKA) narcotics is unclear."( Average narcotic usage in a group of TKA patients following a modern TKA protocol.
Chapman, DM; Costales, TG; Dalury, DF; Greenwell, PH; Volkmann, MC, 2021
)
0.62
" Investigations that evaluate more typical dosing regimens are required."( The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews.
Abdel Shaheed, C; Ahedi, H; Day, RO; Dmitritchenko, A; Ferreira, GE; Kamper, S; Langendyk, V; Latimer, J; Lin, C; Maher, CG; McLachlan, AJ; McLachlan, H; Saragiotto, B; Stanaway, F, 2021
)
0.62
" Coupling abovementioned technologies for personalized drug delivery can improve access to complex dosage formulations at a reasonable cost."( Oral drug delivery systems using core-shell structure additive manufacturing technologies: a proof-of-concept study.
Repka, MA; Vo, AQ; Xu, P; Zhang, J, 2021
)
0.62
"The favourable drug-release profiles of 3D-printed tablets demonstrated the advantage of coupling HME with 3D printing technology to produce personalized dosage formulations."( Oral drug delivery systems using core-shell structure additive manufacturing technologies: a proof-of-concept study.
Repka, MA; Vo, AQ; Xu, P; Zhang, J, 2021
)
0.62
"Evaluate the appropriateness of acetaminophen dosing by caregivers seeking care for their children/wards at the emergency department of a pediatric hospital."( Appropriateness of Acetaminophen Dosing by Caregivers of Pediatric Patients Presenting to the Emergency Department at the University Pediatric Hospital in Puerto Rico.
Hernández-Muñoz, JJ; Ortiz-Vera, YA; Parambil, A; Rodríguez-Rodríguez, NJ; Vélez-Rivera, SM, 2021
)
1.23
" The product's dosage form and strength, measurement device used (if any), and demographic data (of the caregiver and child) were also collected."( Appropriateness of Acetaminophen Dosing by Caregivers of Pediatric Patients Presenting to the Emergency Department at the University Pediatric Hospital in Puerto Rico.
Hernández-Muñoz, JJ; Ortiz-Vera, YA; Parambil, A; Rodríguez-Rodríguez, NJ; Vélez-Rivera, SM, 2021
)
0.95
" Only 9% of the caregivers consulted a pharmacist for dosing recommendations."( Appropriateness of Acetaminophen Dosing by Caregivers of Pediatric Patients Presenting to the Emergency Department at the University Pediatric Hospital in Puerto Rico.
Hernández-Muñoz, JJ; Ortiz-Vera, YA; Parambil, A; Rodríguez-Rodríguez, NJ; Vélez-Rivera, SM, 2021
)
0.95
" We performed a retrospective, multi-center analysis to determine if a capped NAC dosing scheme is similar to a non-capped dosing scheme in patients weighing over 100 kg."( Evaluation of Dosing Strategies of N-acetylcysteine for Acetaminophen Toxicity in Patients Greater than 100 Kilograms: Should the Dosage Cap Be Used?
Akpunonu, P; Bailey, AM; Baum, RA; Geraghty, L; Howell, MM; Mohan, S; Su, MK; Weant, KA; Webb, AN; Woolum, JA, 2021
)
0.87
" A capped NAC dosing scheme resulted in no difference in hepatic injury when compared to a non-capped regimen (49."( Evaluation of Dosing Strategies of N-acetylcysteine for Acetaminophen Toxicity in Patients Greater than 100 Kilograms: Should the Dosage Cap Be Used?
Akpunonu, P; Bailey, AM; Baum, RA; Geraghty, L; Howell, MM; Mohan, S; Su, MK; Weant, KA; Webb, AN; Woolum, JA, 2021
)
0.87
"A capped NAC dosing scheme was not associated with higher rates of hepatic injury or hepatotoxicity in obese patients in the setting of acetaminophen poisoning when compared to a non-capped regimen."( Evaluation of Dosing Strategies of N-acetylcysteine for Acetaminophen Toxicity in Patients Greater than 100 Kilograms: Should the Dosage Cap Be Used?
Akpunonu, P; Bailey, AM; Baum, RA; Geraghty, L; Howell, MM; Mohan, S; Su, MK; Weant, KA; Webb, AN; Woolum, JA, 2021
)
1.07
"Paediatric practice requires various dosing forms that are acceptable for children of different ages and abilities."( A straw for paediatrics: How to administer highly dosed, bitter tasting paracetamol granules.
Baumgartner, A; Minova, J; Nolimal, B; Planinšek, O; Simšič, T, 2021
)
0.62
"At physician-directed dosing (acetaminophen 15 mg/kg vs ibuprofen 10 mg/kg), no significant differences in antipyretic effects from 0‒6 h and between 0‒6, ‒12, ‒24, or ‒48 h, with single or multiple-doses, respectively, were observed."( Acetaminophen and ibuprofen in the treatment of pediatric fever: a narrative review.
Paul, IM; Walson, PD, 2021
)
2.35
" Voluntary Paracetamol intake via drinking water reached the target dosage of 200 mg/kg in most animals."( Lidocaine and bupivacaine as part of multimodal pain management in a C57BL/6J laparotomy mouse model.
Arras, M; Durst, MS; Jirkof, P; Palme, R; Talbot, SR, 2021
)
0.62
" Steady-state LX9211 plasma concentrations were rapidly attained and maintained by a dosing regimen of a loading dose, followed by daily maintenance doses (1/10 the loading dose)."( Results of two Phase 1, Randomized, Double-blind, Placebo-controlled, Studies (Ascending Single-dose and Multiple-dose Studies) to Determine the Safety, Tolerability, and Pharmacokinetics of Orally Administered LX9211 in Healthy Participants.
Banks, P; Boehm, KA; Bundrant, L; Gopinathan, S; Hunt, TL; Kassler-Taub, K; Tyle, P; Warner, C; Wason, S; Wilson, A, 2021
)
0.62
"To assess the safety of dosing more than 4 grams of acetaminophen in a 24-hour period in hospitalized patients and develop a method to evaluate the ongoing practice of acetaminophen dosing."( A Retrospective Review of Hospitalized Patients Receiving a Higher than Maximum Dose of Acetaminophen.
Clark, AT; Clark, RF; Derry, K; Miller, M; Minns, AB; Stevens, C, 2023
)
1.38
"152 cases of dosing more than 4 grams were initially identified."( A Retrospective Review of Hospitalized Patients Receiving a Higher than Maximum Dose of Acetaminophen.
Clark, AT; Clark, RF; Derry, K; Miller, M; Minns, AB; Stevens, C, 2023
)
1.13
"Supratherapeutic dosing of acetaminophen in our patients did not lead to death or liver transplant."( A Retrospective Review of Hospitalized Patients Receiving a Higher than Maximum Dose of Acetaminophen.
Clark, AT; Clark, RF; Derry, K; Miller, M; Minns, AB; Stevens, C, 2023
)
1.43
" Several novel approaches to the management of acetaminophen overdose have been suggested to improve patient safety by reducing adverse drug reactions and dosing errors."( A review of alternative intravenous acetylcysteine regimens for acetaminophen overdose.
Burnham, K; Knight, S; Smith, H; Yang, T, 2021
)
1.12
" Many of these dosing regimens have supporting safety data but most lack robust data."( A review of alternative intravenous acetylcysteine regimens for acetaminophen overdose.
Burnham, K; Knight, S; Smith, H; Yang, T, 2021
)
0.86
" The suggested method was applied for the estimation of the proposed drugs in their dosage form."( Quantitative Determination of Anti-Migraine Quaternary Mixture in Presence of p-Aminophenol and 4-Chloroacetanilide.
Abdelhamid, NS; Anwar, BH; Farid, NF; Magdy, MA; Naguib, IA, 2022
)
0.72
" Acetaminophen plasma levels were measured at 2 timepoints to evaluate safety and determine plasma levels attained by each dosing regimen."( Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial.
Aizenberg, DA; Applegate, RL; Funamura, JL; Hall, B; Kriss, RS; Lammers, CR; Nittur, V; Schwinghammer, AJ; Senders, CW, 2021
)
1.79
" The primary outcome was opioid dosage within the first ten postoperative days."( An assessment of dexmedetomidine as an opioid-sparing agent after neonatal open thoracic and abdominal operations.
Gollin, G; Oviedo, P; Rooney, AS; Sykes, AG, 2022
)
0.72
" Opioid was dosed >0."( An assessment of dexmedetomidine as an opioid-sparing agent after neonatal open thoracic and abdominal operations.
Gollin, G; Oviedo, P; Rooney, AS; Sykes, AG, 2022
)
0.72
" IV acetaminophen dosed at 40 mg/kg/day or greater may yield the most substantial opioid-sparing effect."( An assessment of dexmedetomidine as an opioid-sparing agent after neonatal open thoracic and abdominal operations.
Gollin, G; Oviedo, P; Rooney, AS; Sykes, AG, 2022
)
1.28
" Our results suggest that the dosage used in this study (i."( Pharmacokinetics of Intravenous Paracetamol (Acetaminophen) and Ductus Arteriosus Closure After Premature Birth.
Aikio, O; Bouazza, N; Foissac, F; Hallman, M; Roze, JC; Treluyer, JM; Urien, S, 2021
)
0.88
" However, current pharmaceutical manufacturing is not suitable for personalized dosage forms."( 3D Printing and Dissolution Testing of Novel Capsule Shells for Use in Delivering Acetaminophen.
Deng, J; Dromgoole, G; Gaurkhede, SG; Osipitan, OO; Pasqua, AJD; Spencer, SA, 2021
)
0.85
" Orodispersible tablets are oral solid dosage forms which rapidly disintegrate after contact with saliva, leaving a liquid dispersion, which can be easily swallowed."( Evaluation of two novel co-processed excipients for direct compression of orodispersible tablets and mini-tablets.
Breitkreutz, J; Kokott, M; Lura, A; Wiedey, R, 2021
)
0.62
" To investigate differences in APAP metabolism in specific patient populations and to optimize dosing regimens, quantification of metabolites from the different metabolic pathways is needed to perform pharmacokinetic (PK) studies."( Determination of paracetamol and its metabolites via LC-MS/MS in dried blood volumetric absorptive microsamples: A tool for pharmacokinetic studies.
Baerdemaeker, L; Delahaye, L; Stove, CP, 2021
)
0.62
" It is metabolised by the liver and appropriate administration and dosage is in question in in patients undergoing hepatectomy."( The efficacy and safety of acetaminophen use following liver resection: a systematic review.
Koea, J; Murphy, V; Srinivasa, S, 2022
)
1.02
"Use of acetaminophen for adult patients undergoing liver resection surgery as post-operative analgesia at a standard dosage is safe for baseline analgesia."( The efficacy and safety of acetaminophen use following liver resection: a systematic review.
Koea, J; Murphy, V; Srinivasa, S, 2022
)
1.47
" Hence, the goal of this pilot study was to test the effects of regularly scheduled APAP dosing in a well-defined compensated cirrhosis group compared to control subjects without cirrhosis, using the abovementioned outcomes."( Short-Term Safety of Repeated Acetaminophen Use in Patients With Compensated Cirrhosis.
Dranoff, JA; Fleming, DP; James, LP; Kennon-McGill, S; Mathews, SE; McCullough, SS; McGill, MR; Moran, JH; Peterson, EC; Spencer, HJ; Tripod, ME; Vazquez, JH, 2022
)
1.01
" There was no evidence of a dose-response for duration of use of paracetamol (linear trend p = 0."( Analgesic use and the risk of renal cell carcinoma - Findings from the Consortium for the Investigation of Renal Malignancies (CONFIRM) study.
Aitken, T; Bassett, JK; Bruinsma, FJ; Carroll, R; Davis, ID; Dudding-Byth, T; English, DR; Giles, GG; Jefford, M; Jenkins, M; Jordan, S; MacInnis, RJ; Milne, RL; Severi, G; Tucker, K; Walsh, J; Winship, I, 2021
)
0.62
" Analysis of lower paracetamol dosing (3."( Efflux transporters in rat placenta and developing brain: transcriptomic and functional response to paracetamol.
Banati, RB; Chiou, SY; Dziegielewska, KM; Habgood, MD; Huang, Y; Koehn, LM; Nie, S; Saunders, NR, 2021
)
0.62
" The proposed methods were successfully applied to the determination of ACT and ASC in their combined dosage form."( Cost-effective and earth-friendly chemometrics-assisted spectrophotometric methods for simultaneous determination of Acetaminophen and Ascorbic Acid in pharmaceutical formulation.
Dalia, F; Hadef, Y; Lalaouna, AED; Nekkaa, A; Titel, F, 2022
)
0.93
" Paracetamol has a very flat analgesic dose-response profile."( Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study.
Lyngstad, G; Skjelbred, P; Skoglund, LA; Swanson, DM, 2021
)
0.62
" Until the findings are confirmed in clinical drug interaction studies, APAP dosage should not exceed 3 g per day in dasabuvir-treated patients to avoid potentially hepatotoxic APAP exposures."( Mechanism of dasabuvir inhibition of acetaminophen glucuronidation.
Duan, SX; Greenblatt, DJ; Harmatz, JS; Singleton, CA; Wei, Z; Zhang, Q, 2022
)
0.99
" After culture, embryo morphological and developmental parameters were documented using standardized scoring systems at each dosage concentration."( Assessment of embryo morphology following perinatal exposure to aspirin, ibuprofen and paracetamol using whole embryo culture system.
Leung, BW; Leung, TY; Moungmaithong, S; Poon, LC; Sahota, DS; Wang, CC, 2022
)
0.72
"Efficacy and rapid onset of postsurgical oral pain relief are critical to improve clinical outcomes and reduce the risk of excessive dosing with analgesic drugs."( COMPARATIVE ANALGESIC EFFECTS OF SINGLE-DOSE PREOPERATIVE ADMINISTRATION OF PARACETAMOL (ACETAMINOPHEN) 500 mg PLUS CODEINE 30 mg AND IBUPROFEN 400 mg ON PAIN AFTER THIRD MOLAR SURGERY.
Annibali, S; Cristalli, MP; La Monaca, G; Polimeni, A; Pompa, G; Pranno, N; Vozza, I, 2021
)
0.84
" Clinical trial evidence supporting shorter NAC dosing now allows the possibility for intensifying treatment without the risk of very high rates of ADRs."( Large paracetamol overdose-Higher dose acetylcysteine is required.
Bateman, DN, 2023
)
0.91
" The standard oral or intravenous dosing regimen of NAC is highly effective for patients with moderate overdoses who present within 8 h of APAP ingestion."( Comparing N-acetylcysteine and 4-methylpyrazole as antidotes for acetaminophen overdose.
Akakpo, JY; Curry, SC; Jaeschke, H; Ramachandran, A; Rumack, BH, 2022
)
0.96
"A combination of paracetamol, pseudoephedrine, chlorpheniramine, and sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form is specified for the treatment of common cold and flu symptoms."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"The functional role of this study is to develop a novel, reliable, and selective stability-indicating reversed-phase ultra-performance liquid chromatography (RP-UPLC) method for simultaneous identification of a quaternary mixture of paracetamol, pseudoephedrine, chlorpheniramine, and sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"The proposed stability-indicating UPLC method for simultaneous determination of the three drugs, paracetamol, pseudoephedrine, and chlorpheniramine, with a preservative sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form is successfully accomplished, developed, and validated, and can be easily used in the analysis of drugs in pure or dosage form."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"The novelty of the current research work lies in the development of the UPLC method for simultaneous determination of a quaternary mixture of paracetamol, pseudoephedrine, chlorpheniramine, and sodium benzoate in (Cold-Flu) 1,2,3 Syrup dosage form."( Stability-Indicating New RP-UPLC Method for Simultaneous Determination of a Quaternary Mixture of Paracetamol, Pseudoephedrine, Chlorpheniramine, and Sodium Benzoate in (Cold-Flu) Syrup Dosage Form.
Mohamed, MA, 2022
)
0.72
"To identify the 10 drugs most frequently administered to children in liquid dosage forms which are eligible for replacement with suitable authorized solid dosage forms and to assess the expected economic impact of this substitution."( Replacing liquid with solid dosage forms in pediatric practice: Feasibility and economic impact from a hospital-based study.
Arab, R; Cornu, C; Dagonneau, T; Gomes, E; Kassai, B; Kilo, R,
)
0.13
" Ten drugs were selected according to their frequency of administration in liquid dosage forms, the availability of solid form alternatives, and the suitability of these alternatives for the children receiving the corresponding liquid forms."( Replacing liquid with solid dosage forms in pediatric practice: Feasibility and economic impact from a hospital-based study.
Arab, R; Cornu, C; Dagonneau, T; Gomes, E; Kassai, B; Kilo, R,
)
0.13
" Thirty-four point six of the administrations of these drugs in liquid dosage forms could be delivered using suitable solid dosage forms without additional cost."( Replacing liquid with solid dosage forms in pediatric practice: Feasibility and economic impact from a hospital-based study.
Arab, R; Cornu, C; Dagonneau, T; Gomes, E; Kassai, B; Kilo, R,
)
0.13
"Opportunities exist for substituting liquid dosage forms with market-available solid dosage forms suitable in size and dosage for the pediatric population."( Replacing liquid with solid dosage forms in pediatric practice: Feasibility and economic impact from a hospital-based study.
Arab, R; Cornu, C; Dagonneau, T; Gomes, E; Kassai, B; Kilo, R,
)
0.13
" We, therefore, studied the effects of regular acetaminophen dosing on BP in individuals with hypertension."( Regular Acetaminophen Use and Blood Pressure in People With Hypertension: The PATH-BP Trial.
Dear, JW; Farrah, TE; Graham, C; MacIntyre, IM; Turtle, EJ; Webb, DJ, 2022
)
1.41
" Despite the frequent use of paracetamol, concerns have been raised regarding the high variability in neonatal dosing regimens and the long-term safety of early life exposure."( Long-Term Safety of Prenatal and Neonatal Exposure to Paracetamol: A Systematic Review.
Patel, R; Samiee-Zafarghandy, S; Sushko, K; van den Anker, J, 2022
)
0.72
" APAP dosed rats showed remarkable elevation in hepatic biomarkers viz."( Ameliorative effect of Spatoglossum asperum and its solvent fractions against acetaminophen-induced liver dysfunction in rats.
Ara, J; Azam, M; Ehteshamul-Haque, S; Khan, H; Qureshi, SA; Tariq, A, 2022
)
0.95
" Animals were sacrificed at 5, 10 and 24 hours post-APAP dosing (hpd)."( Prophylactic effect of edible bird's nest on acetaminophen-induced liver injury response in mice model.
Ain-Fatin, R; Muhammad-Azam, F; Noordin, MM; Nur-Fazila, SH; Yasmin, AR; Yimer, N, 2022
)
0.98
" Rather, dosing for adults who are older and/or have decompensated cirrhosis, advanced kidney failure, or analgesic-induced asthma that is known to be cross-sensitive to paracetamol, should be individualized in consultation with their physician, who may recommend a lower effective dose appropriate to the circumstances."( Why paracetamol (acetaminophen) is a suitable first choice for treating mild to moderate acute pain in adults with liver, kidney or cardiovascular disease, gastrointestinal disorders, asthma, or who are older.
Alchin, J; Christo, PJ; Dhar, A; Siddiqui, K, 2022
)
1.06
" The results showed that in the 3-hour period there was an increase in creatinine dosage and lipid peroxidation (TBARS) compared to the control group."( Temporal analysis of paracetamol-induced hepatotoxicity.
Coelho, AM; Costa, DC; Lima, WG; Oliveira de Souza, M; Perucci, LO; Queiroz, IF; Talvani, A, 2023
)
0.91
" Other advancements include individualized acetylcysteine dosing regimens for acetaminophen toxicity and carnitine supplementation in valproic acid toxicity."( The Roles of Antidotes in Emergency Situations.
Dart, RC; Kaiser, SK, 2022
)
0.95
"To describe paracetamol dosing and liver function test (LFT) monitoring in older hospital inpatients who are frail or have low body weight."( Paracetamol dosing in hospital and on discharge for older people who are frail or have low body weight.
Elliott, RA; Lalic, S; Ngo, J; Reid, O; Su, E, 2022
)
0.72
" The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600 mg was shown to be effective, and it was less certain whether 800 mg was effective."( Pain management for medical abortion before 14 weeks' gestation.
Cameron, S; Morroni, C; Reynolds-Wright, JJ; Woldetsadik, MA, 2022
)
0.72
" In critically ill children, we sought to evaluate drug-associated hepatic injury following enteral acetaminophen error, defined as acetaminophen dosing that exceeds daily maximum recommendations."( Liver enzymes after short-term acetaminophen error in critically ill children: a cohort study.
Parshuram, C; Pullenayegum, E; Rochon, P; Roumeliotis, N; Taddio, A, 2022
)
1.22
"• Acetaminophen dosing errors are common in pediatric outpatients."( Liver enzymes after short-term acetaminophen error in critically ill children: a cohort study.
Parshuram, C; Pullenayegum, E; Rochon, P; Roumeliotis, N; Taddio, A, 2022
)
1.73
" Adult evidence demonstrates that alternative dosing regimens decrease NAARs and medication errors (MEs)."( Comparison of Two-Bag Versus Three-Bag N-Acetylcysteine Regimens for Pediatric Acetaminophen Toxicity.
Camarena-Michel, A; Hoyte, C; Leonard, J; Pennington, S; Sudanagunta, S; Wang, GS, 2023
)
1.14
"Acetaminophen is a popular, universally used, over-the-counter pain medication contained in more than 600 different products and available in a plethora of dosage forms."( Acetaminophen: Is Too Much of a Good Thing Too Much?
Donaldson, M; Goodchild, JH, 2022
)
3.61
" Gabapentenoid dosing varied among studies."( Gabapentinoids and Acetaminophen as Adjuvants for Managing Postoperative Pain.
Gill, C; Giuliano, K, 2022
)
1.05
" The developed method was successfully applied to determine tramadol and paracetamol in various dosage forms and in urine biological samples."( Capillary zone electrophoresis in combination with UV detection for simultaneous determination of tramadol and paracetamol in pharmaceutical and biological samples.
Čižmárová, I; Horniaková, A; Matušková, M; Mikuš, P; Piešťanský, J; Štefánik, O, 2022
)
0.72
"The presentation of 3D printing in drug innovation especially focuses on the advancement of patient-centered dosage forms based on the structural design."( A Recent Review On 3D-Printing: Scope and Challenges with Special Focus on Pharmaceutical Field.
Doolaanea, AA; Kumar, M; Mandal, UK; Singh, S, 2022
)
0.72
" An electronic order set provided weight-based dosing and defaulted to non-opioid prescriptions (acetaminophen and ibuprofen)."( Sustaining standardized opioid prescribing practices after pediatric tonsillectomy.
Alfonso, K; Brown, C; Cordray, H; Evans, S; Goudy, S; Govil, N; Landry, AM; Prickett, KK; Raol, N; Smith, K, 2022
)
0.94
" Distinct from known genetic, physiologic, and dosage associations dictating severity of hepatic injury, no known factors predict an absence of protein adduct formation at therapeutic APAP dosing."( Metabolomic Evaluation of N-Acetyl-p-Benzoquinone Imine Protein Adduct Formation with Therapeutic Acetaminophen Administration: Sex-based Physiologic Differences.
Arnold, CG; D'Alessandro, A; Dart, R; Dylla, L; Heard, K; Heard, S; Monte, AA; Reynolds, K; Rumack, B; Sonn, B, 2022
)
0.94
"This retrospective study interrogated serum samples collected for a prior study investigating fluctuations of alanine aminotransferase (ALT) over time with 4G daily APAP dosing for ≥ 16 days in subjects from Denver, Colorado."( Metabolomic Evaluation of N-Acetyl-p-Benzoquinone Imine Protein Adduct Formation with Therapeutic Acetaminophen Administration: Sex-based Physiologic Differences.
Arnold, CG; D'Alessandro, A; Dart, R; Dylla, L; Heard, K; Heard, S; Monte, AA; Reynolds, K; Rumack, B; Sonn, B, 2022
)
0.94
" These should be used in reduced doses, avoiding tizanidine with liver disease and reducing baclofen dosing with kidney disease."( Pharmacotherapy for Spine-Related Pain in Older Adults.
Fu, JL; Perloff, MD, 2022
)
0.72
"A range of 3D printing methods have been investigated intensively in the literature for manufacturing personalised solid dosage forms, with infill density commonly used to control release rates."( An investigation into the effects of geometric scaling and pore structure on drug dose and release of 3D printed solid dosage forms.
Belton, P; McDonagh, T; Qi, S, 2022
)
0.72
"Liquid medication dosing errors are common in pediatrics."( Improving Caregiver Understanding of Liquid Acetaminophen Administration at Primary Care Visits.
Abramson, EA; Cullen, SM; Kyvelos, E; Osorio, SN, 2022
)
0.98
" Knowledge of accurate dosage improved from 50."( Improving Caregiver Understanding of Liquid Acetaminophen Administration at Primary Care Visits.
Abramson, EA; Cullen, SM; Kyvelos, E; Osorio, SN, 2022
)
0.98
"The developed methods are successfully applied for concurrent quantification of the studied components in the marketed dosage form without interference from matrix excipients."( Novel Spectrophotometric Approaches for the Simultaneous Quantification of Ternary Common Cold Mixture Containing Paracetamol with a Challenging Formulation Ratio: Greenness Profile Evaluation.
Fayez, YM; Monir, HH; Mostafa, NM; Rostom, Y; Soliman, RM, 2022
)
0.72
"Successful drug therapy in children is contingent upon hassle-free administration of pediatric dosage forms."( Process Modelling, Scale-Up and Characterization of Acetaminophen Spray Dried Milk Powder as Novel Pediatric Dosage Form.
Butani, S; Chaudhari, K; Savjani, J; Shah, HS; Syamala, U, 2022
)
0.97
"In very preterm infants on significant respiratory support, low dose-short course intravenous paracetamol treatment was non-inferior to a conventional dosing regime of paracetamol for closure of hsPDA in the first week of postnatal age."( Low dose paracetamol for management of patent ductus arteriosus in very preterm infants: a randomised non-inferiority trial.
Balasubramanian, H; Bhalgat, P; Jain, V; Kabra, N; Mohan, D; Parikh, S; Sheth, K, 2023
)
0.91
" Most importantly, the dose-response effects and time course of APAP accumulation and metabolism agree well with those of the liver injury development."( Metabolic Competency of Larval Zebrafish in Drug-Induced Liver Injury: A Case Study of Acetaminophen Poisoning.
Chen, Y; Ge, W; Song, W; Yan, R, 2022
)
0.94
"Binder jetting (BJ) 3D printing is especially suitable for the fabrication of an orodispersible solid dosage form, as it is an efficient way to avoid the use of mechanical forces typical for compaction-based processes."( Coating of Primary Powder Particles Improves the Quality of Binder Jetting 3D Printed Oral Solid Products.
Genina, N; Müllertz, A; Rantanen, J; Wang, Y, 2023
)
0.91
" Genetic variation associated with acetaminophen-induced alanine aminotransferase elevation during therapeutic dosing has not been examined."( Genetic variants associated with ALT elevation from therapeutic acetaminophen.
Arriaga Mackenzie, I; Dart, RC; Heard, KJ; Kaiser, S; Monte, AA; Pattee, J; Reynolds, KM; Rumack, B; Willems, E, 2022
)
1.24
" In mice, acute liver injury induced by orally dosing APAP (500 mg/kg) was severely exacerbated by Gpbar1 gene ablation and attenuated by anti-Cysltr1 small interfering RNA pretreatment."( Combinatorial targeting of G-protein-coupled bile acid receptor 1 and cysteinyl leukotriene receptor 1 reveals a mechanistic role for bile acids and leukotrienes in drug-induced liver injury.
Bellini, R; Biagioli, M; Bordoni, M; Cassiano, C; Catalanotti, B; di Giorgio, C; Distrutti, E; Fiorillo, B; Fiorucci, S; Marchianò, S; Monti, MC; Roselli, R; Sepe, V; Zampella, A, 2023
)
0.91
"Once a baseline incidence is known, predictors for serious ORADEs in surgical inpatients are useful in guiding medical-surgical nurses' opioid safety practices, with more frequent focused respiratory assessments before opioid dosing and closer monitoring when opioids are prescribed postoperatively, especially in higher-risk surgical inpatients."( Incidence of and predictors for serious opioid-related adverse drug events.
Atem, FD; Denke, L; Khazzam, M, 2022
)
0.72
" For 137 sessions, in 36 patients the total daily dosage of UV-absorbing drugs was less than 500 mg, and for 6 sessions 3 patients received additional UV-absorbing drugs."( Treatment with Paracetamol Can Interfere with the Intradialytic Optical Estimation in Spent Dialysate of Uric Acid but Not of Indoxyl Sulfate.
Adoberg, A; Arund, J; Dhondt, A; Fridolin, I; Glorieux, G; Holmar, J; Lauri, K; Leis, L; Luman, M; Paats, J; Pilt, K; Tanner, R; Uhlin, F, 2022
)
0.72
" This diagnosis was confirmed by an organic acid dosage in the urine."( [A case of pyroglutamic metabolic acidosis after cotreatment by flucloxacillin and paracetamol].
Desgranges, A; Hu, K; Monney Chaubert, C, 2022
)
0.72
" Although factors such as route of administration or dosage may explain some heterogeneity, more work is needed to identify which subgroups will have a more favorable benefit-risk balance for one analgesic over another."( Effectiveness of Opioid Analgesic Medicines Prescribed in or at Discharge From Emergency Departments for Musculoskeletal Pain : A Systematic Review and Meta-analysis.
Abdel Shaheed, C; Dinh, M; Harris, IA; Jamshidi, M; Jones, CMP; Lin, CC; Maher, CG; Mathieson, S; Patanwala, AE, 2022
)
0.72
"The fixed dose combination of ibuprofen and paracetamol provides faster and long-term anaesthesia with a comparatively lower dosage of each analgesic."( [Clinical and pharmacological approaches to the choice of a drug for a tension-type headache relief].
Khaytovich, ED; Perkov, AV; Shikh, EV, 2021
)
0.62
"Although N-acetyl-cysteine (NAC) has long been used for the treatment of acetaminophen poisoning/overdose, the optimal NAC dosing regimen for varying patterns or severity of the poisoning/overdose is still unknown."( Acetaminophen toxicity and overdose: current understanding and future directions for NAC dosing regimens.
Janković, SM, 2022
)
2.4
" Physical exam parameters were recorded prior to, during, and after the dosing period."( Ocular penetration of oral acetaminophen in horses.
Hector, RC; Knych, HK; Lee, S; Peraza, J; Terhaar, HM; Wotman, KL, 2023
)
1.21
"The additive nature and versatility of 3D printing show great promise in the rapid prototyping of solid dosage forms for clinical trials and mass customization for personalized medicine applications."( Pilot-scale binder jet 3D printing of sustained release solid dosage forms.
Chang, SY; Chaudhuri, B; Dharani, D; Dong, X; Ma, AWK; Maiorana, C; Nagapudi, K; Tan, M, 2023
)
0.91
"Analytical techniques must be sensitive, specific, and accurate to assess the active pharmaceutical ingredients in pharmaceutical dosage forms."( An effective and stability-indicating method development and optimization utilizing the Box-Behnken design for the simultaneous determination of acetaminophen, caffeine, and aspirin in tablet formulation.
Ettaboina, SK; Gundla, R; Katari, NK; Muchakayala, SK; Satheesh, B; Yenda, P, 2023
)
1.11
" The advantages of the proposed method qualify it for routine analysis of the studied drugs either in single or co-formulated dosage form in quality control labs."( A quality-by-design eco-friendly UV-HPLC method for the determination of four drugs used to treat symptoms of common cold and COVID-19.
Abdallah, NA; El-Brashy, AM; Fathy, ME; Ibrahim, FA; Tolba, MM, 2023
)
0.91
" Statistically significant changes were found by comparing bile acid profiles between dosing levels."( Semi-Targeted Profiling of Bile Acids by High-Resolution Mass Spectrometry in a Rat Model of Drug-Induced Liver Injury.
Mireault, M; Ohlund, L; Prinville, V; Sleno, L, 2023
)
0.91
" The majority reported a frequency of use of 1-3 times a week (n = 197), with oral dosing being the most common route of administration (n = 440)."( Current perceptions and use of paracetamol in dogs among veterinary surgeons working in the United Kingdom.
Bello, AM; Dye, C, 2023
)
0.91
"The FDA mandate limiting acetaminophen dosage to 325 mg/tablet in prescription acetaminophen and opioid products was associated with a statistically significant decrease in the yearly rate of hospitalizations and proportion per year of ALF cases involving acetaminophen and opioid toxicity."( Association of FDA Mandate Limiting Acetaminophen (Paracetamol) in Prescription Combination Opioid Products and Subsequent Hospitalizations and Acute Liver Failure.
Fontana, RJ; Karvellas, CJ; Lee, WM; Lewis, CE; Locke, JE; MacLennan, PA; McGuire, BM; McLeod, MC; Orandi, BJ; Terrault, NM, 2023
)
1.49
" Globally, the pharmacologic treatment of pain in pediatric patients is limited largely to nonopioid analgesics, and dosing must account for differences in age, weight, metabolism, and risk of adverse effects."( Common Selfcare Indications of Pain Medications in Children.
Bell, J; Kachroo, P; Mossali, VM; Siddiqui, K; Zempsky, W, 2023
)
0.91
"For solid oral dosage forms drug solubility in intestinal fluid is an important parameter influencing product performance and bioavailability."( Fed intestinal solubility limits and distributions applied to the Developability classification system.
Halbert, GW; Khadra, I; Pyper, K; Silva, MI, 2023
)
0.91
" Several studies report that long-term exposure to paracetamol in utero is associated with adverse neurodevelopmental outcomes in children, indicating a dose-response effect."( Paracetamol use in pregnancy: Not as safe as we may think?
Krogsrud, SK; Nilsen, K; Staff, AC, 2023
)
0.91
"Monitoring the acetaminophen dosage is important to prevent the occurrence of adverse reactions such as liver failure and kidney damage."( Wearable Plasmonic Sweat Biosensor for Acetaminophen Drug Monitoring.
Luo, Y; Wang, J; Xiao, J; Xu, T; Zhang, X, 2023
)
1.53
" The suitability of the beagle as a preclinical model to understand pediatric drug product performance under different dosing conditions deserves further evaluation with a broader spectrum of drugs and drug products and comparisons with pediatric in vivo data."( Usefulness of the Beagle Model in the Evaluation of Paracetamol and Ibuprofen Exposure after Oral Administration to Pediatric Populations: An Exploratory Study.
Fotaki, N; Holm, R; Reppas, C; Statelova, M; Vertzoni, M, 2023
)
0.91
"To evaluate age-banded dosing in paediatric inpatients by determining the proportion of patients whose dose would fall outside the therapeutic range (by weight)."( Evaluation of age-banded dosing of oral paracetamol in hospitalised children: a retrospective analysis using clinical data in a tertiary paediatric hospital.
Arnold, P; Craske, J; Gill, A; Jenson, J; Wright, K, 2023
)
0.91
" Dosage which would be given according to age-banded dosing was then compared with their weight."( Evaluation of age-banded dosing of oral paracetamol in hospitalised children: a retrospective analysis using clinical data in a tertiary paediatric hospital.
Arnold, P; Craske, J; Gill, A; Jenson, J; Wright, K, 2023
)
0.91
" Secondary outcomes were to examine this in children of different ages and to examine the impact of alternative size-based dosing strategies."( Evaluation of age-banded dosing of oral paracetamol in hospitalised children: a retrospective analysis using clinical data in a tertiary paediatric hospital.
Arnold, P; Craske, J; Gill, A; Jenson, J; Wright, K, 2023
)
0.91
" If age-banded dosing had been used, a subtherapeutic dose (less than 10 mg/kg) would be given during 19 829 (20%) of the admissions and a supratherapeutic dose (over 18."( Evaluation of age-banded dosing of oral paracetamol in hospitalised children: a retrospective analysis using clinical data in a tertiary paediatric hospital.
Arnold, P; Craske, J; Gill, A; Jenson, J; Wright, K, 2023
)
0.91
"Age-banded dosing is not suitable for an inpatient paediatric population as approximately a quarter of patients receive a dose outside the recommended range of 10."( Evaluation of age-banded dosing of oral paracetamol in hospitalised children: a retrospective analysis using clinical data in a tertiary paediatric hospital.
Arnold, P; Craske, J; Gill, A; Jenson, J; Wright, K, 2023
)
0.91
"3D printing offers new opportunities to customize oral dosage forms of pharmaceuticals for different patient populations, improving patient safety, care, and compliance."( 3D screen printing technology enables fabrication of oral drug dosage forms with freely tailorable release profiles.
Enke, M; Fischer, D; Gruschwitz, F; Hanf, F; Jescheck, L; Schneeberger, A; Schwarz, N; Seyferth, S; Winkler, D, 2023
)
0.91
" As a result, dosing based on bodyweight alone will not lead to consistent paracetamol concentrations among preterm neonates."( Maturation of Paracetamol Elimination Routes in Preterm Neonates Born Below 32 Weeks of Gestation.
Flint, RB; Knibbe, CAJ; Krekels, EHJ; Roofthooft, DWE; Simons, SHP; Tibboel, D; Völler, S; Wu, Y, 2023
)
0.91
" Furthermore, APOE ε4 dosage and genetic risk scores (GRS) of Alzheimer's disease calculated by 25 single nucleotide polymorphisms did not significantly modify the relationship of regular use of paracetamol and ibuprofen with new-onset all-cause dementia (Both P-interactions >0."( Association of regular use of ibuprofen and paracetamol, genetic susceptibility, and new-onset dementia in the older population.
He, P; Liu, M; Qin, X; Wu, Q; Yang, S; Ye, Z; Zhang, Y; Zhou, C,
)
0.13
"2%) was the most common; the dosage was age-dependent in 65."( [Evaluation of self-medication practices and their characteristics among Uvira in Democratic Republic of Congo students].
Akiba, DB; Chirubagula, VB; Kanyegere, AM; Mboni, HM; Mushobekwa, SS; Rugema, BB; Rusati, NM; Shakalenga, CM; Tshikongo, AK, 2023
)
0.91
"The aim of this study is to assess the current situation in out of hospital pain management in Germany regarding the substances, indications, dosage and the delegation of the use of analgesics to emergency medical service (EMS) staff."( Application of analgesics in emergency services in Germany: a survey of the medical directors.
Scharonow, M; Scharonow, O; Vilcane, S; Weilbach, C, 2023
)
0.91
" Based on clinical dosing characteristics, fetal mouse femurs were obtained for detection after oral gavage of acetaminophen at different doses (0, 100 or 400 mg/kg d), courses (single or multiple times) or stages (mid- or late pregnancy) during pregnancy in Kunming mice."( Course-, dose-, and stage-dependent toxic effects of prenatal acetaminophen exposure on fetal long bone development.
Chen, L; Gu, H; Guo, Y; Li, B; Li, X; Ma, C; Wang, H; Wen, Y; Xiao, H, 2023
)
1.36
" Appropriate dosing will be determined based on the participant's gestational age."( Intravenous acetaminophen for postoperative pain in the neonatal intensive care unit: A protocol for a pilot randomized controlled trial (IVA POP).
Archer, VA; Braga, LH; Briatico, D; Farrokyhar, F; Samiee-Zafarghandy, S; Walton, JM, 2023
)
1.29
"A tablet is a compact dosage form that includes both the active pharmaceutical ingredient (API) and various excipients, where a binder acts as an excipient, imparting cohesive quality in the powdered material."( Exploring the potential of natural polymers from plants as tablet binder and accessing their release profiles: A comparative analysis.
Arshad, L; Manzar, R; Massey, S; Waqar, I, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (4 Items)

ItemProcessFrequency
Non food productscore-ingredient2
Medicinecore-ingredient1
Open Beauty Factscore-ingredient1
Open Products Factscore-ingredient1

Roles (12)

RoleDescription
cyclooxygenase 2 inhibitorA cyclooxygenase inhibitor that interferes with the action of cyclooxygenase 2.
cyclooxygenase 1 inhibitorA cyclooxygenase inhibitor that interferes with the action of cyclooxygenase 1.
non-narcotic analgesicA drug that has principally analgesic, antipyretic and anti-inflammatory actions. Non-narcotic analgesics do not bind to opioid receptors.
antipyreticA drug that prevents or reduces fever by lowering the body temperature from a raised state. An antipyretic will not affect the normal body temperature if one does not have fever. Antipyretics cause the hypothalamus to override an interleukin-induced increase in temperature. The body will then work to lower the temperature and the result is a reduction in fever.
non-steroidal anti-inflammatory drugAn anti-inflammatory drug that is not a steroid. In addition to anti-inflammatory actions, non-steroidal anti-inflammatory drugs have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins.
cyclooxygenase 3 inhibitorA cyclooxygenase inhibitor that interferes with the action of cyclooxygenase 3.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
environmental contaminantAny minor or unwanted substance introduced into the environment that can have undesired effects.
human blood serum metaboliteAny metabolite (endogenous or exogenous) found in human blood serum samples.
hepatotoxic agentA role played by a chemical compound exihibiting itself through the ability to induce damage to the liver in animals.
ferroptosis inducerAny substance that induces or promotes ferroptosis (a type of programmed cell death dependent on iron and characterized by the accumulation of lipid peroxides) in organisms.
geroprotectorAny compound that supports healthy aging, slows the biological aging process, or extends lifespan.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
acetamidesCompounds with the general formula RNHC(=O)CH3.
phenolsOrganic aromatic compounds having one or more hydroxy groups attached to a benzene or other arene ring.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (15)

PathwayProteinsCompounds
Metabolism14961108
Biological oxidations150276
Phase I - Functionalization of compounds69175
Cytochrome P450 - arranged by substrate type30110
Xenobiotics450
CYP2E1 reactions019
Phase II - Conjugation of compounds73122
Cytosolic sulfonation of small molecules1747
Acetaminophen Metabolism Pathway3016
Acetaminophen Action Pathway2967
Drug ADME6387
APAP ADME1730
Acetaminophen synthesis07
Ethanol metabolism resulting in production of ROS by CYP2E1117
Ethanol metabolism production of ROS by CYP2E1117

Protein Targets (77)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
RAR-related orphan receptor gammaMus musculus (house mouse)Potency33.49150.006038.004119,952.5996AID1159521
ATAD5 protein, partialHomo sapiens (human)Potency21.84380.004110.890331.5287AID504466; AID504467
GLS proteinHomo sapiens (human)Potency22.98330.35487.935539.8107AID624170
Microtubule-associated protein tauHomo sapiens (human)Potency44.66840.180013.557439.8107AID1460
Smad3Homo sapiens (human)Potency3.54810.00527.809829.0929AID588855
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency28.18380.011212.4002100.0000AID1030
thyroid stimulating hormone receptorHomo sapiens (human)Potency0.15850.001318.074339.8107AID926
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency50.29110.001022.650876.6163AID1224838
progesterone receptorHomo sapiens (human)Potency15.35530.000417.946075.1148AID1346795
EWS/FLI fusion proteinHomo sapiens (human)Potency25.91410.001310.157742.8575AID1259255; AID1259256
retinoic acid nuclear receptor alpha variant 1Homo sapiens (human)Potency20.02130.003041.611522,387.1992AID1159552
retinoid X nuclear receptor alphaHomo sapiens (human)Potency7.16450.000817.505159.3239AID1159527
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency0.03060.001530.607315,848.9004AID1224841
estrogen nuclear receptor alphaHomo sapiens (human)Potency47.46780.000229.305416,493.5996AID1259244; AID588513
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency46.82370.001019.414170.9645AID743094; AID743191
aryl hydrocarbon receptorHomo sapiens (human)Potency27.30600.000723.06741,258.9301AID743085
chromobox protein homolog 1Homo sapiens (human)Potency39.81070.006026.168889.1251AID540317
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency63.31280.000323.4451159.6830AID743066
peripheral myelin protein 22Rattus norvegicus (Norway rat)Potency0.01280.005612.367736.1254AID624032
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency15.84890.031610.279239.8107AID884; AID885
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Voltage-dependent calcium channel gamma-2 subunitMus musculus (house mouse)Potency63.31280.001557.789015,848.9004AID1259244
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Glutamate receptor 2Rattus norvegicus (Norway rat)Potency63.31280.001551.739315,848.9004AID1259244
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Nuclear receptor ROR-gammaHomo sapiens (human)Potency21.13170.026622.448266.8242AID651802
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
GABA theta subunitRattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency15.84891.000012.224831.6228AID885
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Solute carrier family 22 member 6Rattus norvegicus (Norway rat)Ki2,099.00001.60005.744010.0000AID681340
Carbonic anhydrase 12Homo sapiens (human)Ki147.66150.00021.10439.9000AID1798641; AID342484
Bile salt export pumpRattus norvegicus (Norway rat)IC50 (µMol)1,000.00000.40002.75008.6000AID1209456
Bile salt export pumpHomo sapiens (human)IC50 (µMol)567.00000.11007.190310.0000AID1209455; AID1443980; AID1449628; AID1473738
Carbonic anhydrase 1Homo sapiens (human)Ki129.70000.00001.372610.0000AID1257050; AID1798641; AID331291; AID342475
Carbonic anhydrase 2Homo sapiens (human)Ki128.94000.00000.72369.9200AID1257051; AID1798641; AID331292; AID342476
MyoglobinHomo sapiens (human)IC50 (µMol)2.30002.30002.30002.3000AID760171
Prostaglandin G/H synthase 1Ovis aries (sheep)IC50 (µMol)372.00000.00032.177410.0000AID760172
Carbonic anhydrase 3Homo sapiens (human)Ki147.89230.00022.010210.0000AID1798641; AID342477
Cytochrome P450 3A4Homo sapiens (human)IC50 (µMol)10.00000.00011.753610.0000AID1703189
Cytochrome P450 2D6Homo sapiens (human)IC50 (µMol)10.00000.00002.015110.0000AID1703190
Cytochrome P450 2C9 Homo sapiens (human)IC50 (µMol)50.00000.00002.800510.0000AID1210069
Polyunsaturated fatty acid lipoxygenase ALOX15Oryctolagus cuniculus (rabbit)IC50 (µMol)28.38000.11003.26419.0330AID625146
Arachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)IC50 (µMol)44.00000.00160.07630.5800AID405531
Carbonic anhydrase 4Homo sapiens (human)Ki148.22310.00021.97209.9200AID1798641; AID342478
Prostaglandin G/H synthase 1Homo sapiens (human)IC50 (µMol)200.00000.00021.557410.0000AID1307967
Carbonic anhydrase 6Homo sapiens (human)Ki197.96150.00011.47109.9200AID1798641; AID342481
Carbonic anhydrase 5A, mitochondrialHomo sapiens (human)Ki209.03850.00001.27259.9000AID1798641; AID342479
Carbonic anhydrase 7Homo sapiens (human)Ki148.04620.00021.37379.9000AID1798641; AID342482
Cytochrome P450 2J2Homo sapiens (human)IC50 (µMol)50.00000.01202.53129.4700AID1210069
Carbonic anhydrase 9Homo sapiens (human)Ki146.92140.00010.78749.9000AID1257052; AID1798641; AID342483
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
Carbonic anhydrase 15Mus musculus (house mouse)Ki9.23000.00091.884610.0000AID331293
Carbonic anhydrase 13Mus musculus (house mouse)Ki149.67690.00021.39749.9000AID1798641; AID342486
Carbonic anhydrase 14Homo sapiens (human)Ki148.16150.00021.50999.9000AID1798641; AID342485
Carbonic anhydrase 5B, mitochondrialHomo sapiens (human)Ki170.11540.00001.34129.9700AID1798641; AID342480
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
UDP-glucuronosyltransferase 1A9Homo sapiens (human)Km20,900.00005.00006.830010.0000AID624637
Cytochrome P450 2B1Rattus norvegicus (Norway rat)Ks800.00001.10001.10001.1000AID54373
Cytochrome P450 1A1Rattus norvegicus (Norway rat)Ks870.00001.70001.70001.7000AID54205
Cytochrome P450 1A2Homo sapiens (human)Km120.00005.00007.00009.0000AID1212278
Sulfotransferase 1A1 Rattus norvegicus (Norway rat)Km92.00005.00007.571410.0000AID39219
UDP-glucuronosyltransferase 1A1 Homo sapiens (human)Km9,400.00004.49006.51339.0000AID624630
toxin BClostridioides difficile 630AC5020.870020.870031.260037.0600AID720512
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (224)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
estrous cycleCarbonic anhydrase 12Homo sapiens (human)
chloride ion homeostasisCarbonic anhydrase 12Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 12Homo sapiens (human)
xenobiotic metabolic processUDP-glucuronosyltransferase 1A9Homo sapiens (human)
retinoic acid metabolic processUDP-glucuronosyltransferase 1A9Homo sapiens (human)
flavone metabolic processUDP-glucuronosyltransferase 1A9Homo sapiens (human)
cellular glucuronidationUDP-glucuronosyltransferase 1A9Homo sapiens (human)
flavonoid glucuronidationUDP-glucuronosyltransferase 1A9Homo sapiens (human)
xenobiotic glucuronidationUDP-glucuronosyltransferase 1A9Homo sapiens (human)
liver developmentUDP-glucuronosyltransferase 1A9Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 1Homo sapiens (human)
morphogenesis of an epitheliumCarbonic anhydrase 2Homo sapiens (human)
positive regulation of synaptic transmission, GABAergicCarbonic anhydrase 2Homo sapiens (human)
positive regulation of cellular pH reductionCarbonic anhydrase 2Homo sapiens (human)
angiotensin-activated signaling pathwayCarbonic anhydrase 2Homo sapiens (human)
regulation of monoatomic anion transportCarbonic anhydrase 2Homo sapiens (human)
secretionCarbonic anhydrase 2Homo sapiens (human)
regulation of intracellular pHCarbonic anhydrase 2Homo sapiens (human)
neuron cellular homeostasisCarbonic anhydrase 2Homo sapiens (human)
positive regulation of dipeptide transmembrane transportCarbonic anhydrase 2Homo sapiens (human)
regulation of chloride transportCarbonic anhydrase 2Homo sapiens (human)
carbon dioxide transportCarbonic anhydrase 2Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 2Homo sapiens (human)
response to hypoxiaMyoglobinHomo sapiens (human)
heart developmentMyoglobinHomo sapiens (human)
removal of superoxide radicalsMyoglobinHomo sapiens (human)
enucleate erythrocyte differentiationMyoglobinHomo sapiens (human)
brown fat cell differentiationMyoglobinHomo sapiens (human)
oxygen transportMyoglobinHomo sapiens (human)
cellular response to organic cyclic compoundCytochrome P450 1A1Homo sapiens (human)
response to hypoxiaCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid metabolic processCytochrome P450 1A1Homo sapiens (human)
lipid hydroxylationCytochrome P450 1A1Homo sapiens (human)
fatty acid metabolic processCytochrome P450 1A1Homo sapiens (human)
steroid biosynthetic processCytochrome P450 1A1Homo sapiens (human)
porphyrin-containing compound metabolic processCytochrome P450 1A1Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 1A1Homo sapiens (human)
steroid metabolic processCytochrome P450 1A1Homo sapiens (human)
estrogen metabolic processCytochrome P450 1A1Homo sapiens (human)
amine metabolic processCytochrome P450 1A1Homo sapiens (human)
response to nematodeCytochrome P450 1A1Homo sapiens (human)
response to herbicideCytochrome P450 1A1Homo sapiens (human)
ethylene metabolic processCytochrome P450 1A1Homo sapiens (human)
coumarin metabolic processCytochrome P450 1A1Homo sapiens (human)
flavonoid metabolic processCytochrome P450 1A1Homo sapiens (human)
response to iron(III) ionCytochrome P450 1A1Homo sapiens (human)
insecticide metabolic processCytochrome P450 1A1Homo sapiens (human)
dibenzo-p-dioxin catabolic processCytochrome P450 1A1Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 1A1Homo sapiens (human)
response to foodCytochrome P450 1A1Homo sapiens (human)
response to lipopolysaccharideCytochrome P450 1A1Homo sapiens (human)
response to vitamin ACytochrome P450 1A1Homo sapiens (human)
response to immobilization stressCytochrome P450 1A1Homo sapiens (human)
vitamin D metabolic processCytochrome P450 1A1Homo sapiens (human)
retinol metabolic processCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 1A1Homo sapiens (human)
9-cis-retinoic acid biosynthetic processCytochrome P450 1A1Homo sapiens (human)
camera-type eye developmentCytochrome P450 1A1Homo sapiens (human)
nitric oxide metabolic processCytochrome P450 1A1Homo sapiens (human)
response to arsenic-containing substanceCytochrome P450 1A1Homo sapiens (human)
digestive tract developmentCytochrome P450 1A1Homo sapiens (human)
tissue remodelingCytochrome P450 1A1Homo sapiens (human)
hydrogen peroxide biosynthetic processCytochrome P450 1A1Homo sapiens (human)
response to hyperoxiaCytochrome P450 1A1Homo sapiens (human)
maternal process involved in parturitionCytochrome P450 1A1Homo sapiens (human)
hepatocyte differentiationCytochrome P450 1A1Homo sapiens (human)
cellular response to copper ionCytochrome P450 1A1Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 1A1Homo sapiens (human)
positive regulation of G1/S transition of mitotic cell cycleCytochrome P450 1A1Homo sapiens (human)
response to 3-methylcholanthreneCytochrome P450 1A1Homo sapiens (human)
steroid catabolic processCytochrome P450 1A2Homo sapiens (human)
porphyrin-containing compound metabolic processCytochrome P450 1A2Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 1A2Homo sapiens (human)
cholesterol metabolic processCytochrome P450 1A2Homo sapiens (human)
estrogen metabolic processCytochrome P450 1A2Homo sapiens (human)
toxin biosynthetic processCytochrome P450 1A2Homo sapiens (human)
post-embryonic developmentCytochrome P450 1A2Homo sapiens (human)
alkaloid metabolic processCytochrome P450 1A2Homo sapiens (human)
regulation of gene expressionCytochrome P450 1A2Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 1A2Homo sapiens (human)
dibenzo-p-dioxin metabolic processCytochrome P450 1A2Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 1A2Homo sapiens (human)
lung developmentCytochrome P450 1A2Homo sapiens (human)
methylationCytochrome P450 1A2Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 1A2Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 1A2Homo sapiens (human)
retinol metabolic processCytochrome P450 1A2Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 1A2Homo sapiens (human)
cellular respirationCytochrome P450 1A2Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 1A2Homo sapiens (human)
hydrogen peroxide biosynthetic processCytochrome P450 1A2Homo sapiens (human)
oxidative demethylationCytochrome P450 1A2Homo sapiens (human)
cellular response to cadmium ionCytochrome P450 1A2Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 1A2Homo sapiens (human)
response to bacteriumCarbonic anhydrase 3Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 3Homo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2D6Homo sapiens (human)
steroid metabolic processCytochrome P450 2D6Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2D6Homo sapiens (human)
estrogen metabolic processCytochrome P450 2D6Homo sapiens (human)
coumarin metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid catabolic processCytochrome P450 2D6Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2D6Homo sapiens (human)
isoquinoline alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2D6Homo sapiens (human)
retinol metabolic processCytochrome P450 2D6Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2D6Homo sapiens (human)
negative regulation of bindingCytochrome P450 2D6Homo sapiens (human)
oxidative demethylationCytochrome P450 2D6Homo sapiens (human)
negative regulation of cellular organofluorine metabolic processCytochrome P450 2D6Homo sapiens (human)
arachidonic acid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C9 Homo sapiens (human)
steroid metabolic processCytochrome P450 2C9 Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2C9 Homo sapiens (human)
estrogen metabolic processCytochrome P450 2C9 Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C9 Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
urea metabolic processCytochrome P450 2C9 Homo sapiens (human)
monocarboxylic acid metabolic processCytochrome P450 2C9 Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C9 Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
amide metabolic processCytochrome P450 2C9 Homo sapiens (human)
icosanoid biosynthetic processCytochrome P450 2C9 Homo sapiens (human)
oxidative demethylationCytochrome P450 2C9 Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C9 Homo sapiens (human)
xenobiotic metabolic processUDP-glucuronosyltransferase 1-6Homo sapiens (human)
cellular glucuronidationUDP-glucuronosyltransferase 1-6Homo sapiens (human)
leukotriene production involved in inflammatory responseArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
positive regulation of acute inflammatory responseArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
leukotriene biosynthetic processArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
lipoxygenase pathwayArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
protein homotrimerizationArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
cellular response to calcium ionArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
cellular oxidant detoxificationArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
liver developmentUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
bilirubin conjugationUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
xenobiotic metabolic processUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
acute-phase responseUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
response to nutrientUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
steroid metabolic processUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
estrogen metabolic processUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
animal organ regenerationUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
response to lipopolysaccharideUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
retinoic acid metabolic processUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
response to starvationUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
negative regulation of steroid metabolic processUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
flavone metabolic processUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
cellular glucuronidationUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
flavonoid glucuronidationUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
xenobiotic glucuronidationUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
biphenyl catabolic processUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
cellular response to ethanolUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
cellular response to glucocorticoid stimulusUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
cellular response to estradiol stimulusUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
bicarbonate transportCarbonic anhydrase 4Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 4Homo sapiens (human)
prostaglandin biosynthetic processProstaglandin G/H synthase 1Homo sapiens (human)
response to oxidative stressProstaglandin G/H synthase 1Homo sapiens (human)
regulation of blood pressureProstaglandin G/H synthase 1Homo sapiens (human)
cyclooxygenase pathwayProstaglandin G/H synthase 1Homo sapiens (human)
regulation of cell population proliferationProstaglandin G/H synthase 1Homo sapiens (human)
cellular oxidant detoxificationProstaglandin G/H synthase 1Homo sapiens (human)
detection of chemical stimulus involved in sensory perception of bitter tasteCarbonic anhydrase 6Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 6Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
prostaglandin biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
angiogenesisProstaglandin G/H synthase 2Homo sapiens (human)
response to oxidative stressProstaglandin G/H synthase 2Homo sapiens (human)
embryo implantationProstaglandin G/H synthase 2Homo sapiens (human)
learningProstaglandin G/H synthase 2Homo sapiens (human)
memoryProstaglandin G/H synthase 2Homo sapiens (human)
regulation of blood pressureProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of cell population proliferationProstaglandin G/H synthase 2Homo sapiens (human)
response to xenobiotic stimulusProstaglandin G/H synthase 2Homo sapiens (human)
response to nematodeProstaglandin G/H synthase 2Homo sapiens (human)
response to fructoseProstaglandin G/H synthase 2Homo sapiens (human)
response to manganese ionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of vascular endothelial growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
cyclooxygenase pathwayProstaglandin G/H synthase 2Homo sapiens (human)
bone mineralizationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of prostaglandin biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of fever generationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of synaptic plasticityProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of synaptic transmission, dopaminergicProstaglandin G/H synthase 2Homo sapiens (human)
prostaglandin secretionProstaglandin G/H synthase 2Homo sapiens (human)
response to estradiolProstaglandin G/H synthase 2Homo sapiens (human)
response to lipopolysaccharideProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of peptidyl-serine phosphorylationProstaglandin G/H synthase 2Homo sapiens (human)
response to vitamin DProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to heatProstaglandin G/H synthase 2Homo sapiens (human)
response to tumor necrosis factorProstaglandin G/H synthase 2Homo sapiens (human)
maintenance of blood-brain barrierProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of protein import into nucleusProstaglandin G/H synthase 2Homo sapiens (human)
hair cycleProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of apoptotic processProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of nitric oxide biosynthetic processProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of cell cycleProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of vasoconstrictionProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of smooth muscle contractionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of smooth muscle contractionProstaglandin G/H synthase 2Homo sapiens (human)
decidualizationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of smooth muscle cell proliferationProstaglandin G/H synthase 2Homo sapiens (human)
regulation of inflammatory responseProstaglandin G/H synthase 2Homo sapiens (human)
brown fat cell differentiationProstaglandin G/H synthase 2Homo sapiens (human)
response to glucocorticoidProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of calcium ion transportProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of synaptic transmission, glutamatergicProstaglandin G/H synthase 2Homo sapiens (human)
response to fatty acidProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to mechanical stimulusProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to lead ionProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to ATPProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to hypoxiaProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to non-ionic osmotic stressProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to fluid shear stressProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of transforming growth factor beta productionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of cell migration involved in sprouting angiogenesisProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of fibroblast growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of brown fat cell differentiationProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of platelet-derived growth factor productionProstaglandin G/H synthase 2Homo sapiens (human)
cellular oxidant detoxificationProstaglandin G/H synthase 2Homo sapiens (human)
regulation of neuroinflammatory responseProstaglandin G/H synthase 2Homo sapiens (human)
negative regulation of intrinsic apoptotic signaling pathway in response to osmotic stressProstaglandin G/H synthase 2Homo sapiens (human)
cellular response to homocysteineProstaglandin G/H synthase 2Homo sapiens (human)
response to angiotensinProstaglandin G/H synthase 2Homo sapiens (human)
positive regulation of synaptic transmission, GABAergicCarbonic anhydrase 7Homo sapiens (human)
positive regulation of cellular pH reductionCarbonic anhydrase 7Homo sapiens (human)
neuron cellular homeostasisCarbonic anhydrase 7Homo sapiens (human)
regulation of chloride transportCarbonic anhydrase 7Homo sapiens (human)
regulation of intracellular pHCarbonic anhydrase 7Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 7Homo sapiens (human)
negative regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
xenobiotic metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of glucose metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
regulation of steroid metabolic processNuclear receptor ROR-gammaHomo sapiens (human)
intracellular receptor signaling pathwayNuclear receptor ROR-gammaHomo sapiens (human)
circadian regulation of gene expressionNuclear receptor ROR-gammaHomo sapiens (human)
cellular response to sterolNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of circadian rhythmNuclear receptor ROR-gammaHomo sapiens (human)
regulation of fat cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
positive regulation of DNA-templated transcriptionNuclear receptor ROR-gammaHomo sapiens (human)
adipose tissue developmentNuclear receptor ROR-gammaHomo sapiens (human)
T-helper 17 cell differentiationNuclear receptor ROR-gammaHomo sapiens (human)
regulation of transcription by RNA polymerase IINuclear receptor ROR-gammaHomo sapiens (human)
fatty acid metabolic processCytochrome P450 2J2Homo sapiens (human)
icosanoid metabolic processCytochrome P450 2J2Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2J2Homo sapiens (human)
regulation of heart contractionCytochrome P450 2J2Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2J2Homo sapiens (human)
linoleic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
organic acid metabolic processCytochrome P450 2J2Homo sapiens (human)
response to hypoxiaCarbonic anhydrase 9Homo sapiens (human)
morphogenesis of an epitheliumCarbonic anhydrase 9Homo sapiens (human)
response to xenobiotic stimulusCarbonic anhydrase 9Homo sapiens (human)
response to testosteroneCarbonic anhydrase 9Homo sapiens (human)
secretionCarbonic anhydrase 9Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 9Homo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 14Homo sapiens (human)
response to bacteriumCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
one-carbon metabolic processCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (101)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 12Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 12Homo sapiens (human)
retinoic acid bindingUDP-glucuronosyltransferase 1A9Homo sapiens (human)
glucuronosyltransferase activityUDP-glucuronosyltransferase 1A9Homo sapiens (human)
enzyme bindingUDP-glucuronosyltransferase 1A9Homo sapiens (human)
protein homodimerization activityUDP-glucuronosyltransferase 1A9Homo sapiens (human)
protein heterodimerization activityUDP-glucuronosyltransferase 1A9Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
arylesterase activityCarbonic anhydrase 1Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 1Homo sapiens (human)
protein bindingCarbonic anhydrase 1Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 1Homo sapiens (human)
hydro-lyase activityCarbonic anhydrase 1Homo sapiens (human)
cyanamide hydratase activityCarbonic anhydrase 1Homo sapiens (human)
arylesterase activityCarbonic anhydrase 2Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 2Homo sapiens (human)
protein bindingCarbonic anhydrase 2Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 2Homo sapiens (human)
cyanamide hydratase activityCarbonic anhydrase 2Homo sapiens (human)
peroxidase activityMyoglobinHomo sapiens (human)
oxygen carrier activityMyoglobinHomo sapiens (human)
heme bindingMyoglobinHomo sapiens (human)
metal ion bindingMyoglobinHomo sapiens (human)
nitrite reductase activityMyoglobinHomo sapiens (human)
oxygen bindingMyoglobinHomo sapiens (human)
monooxygenase activityCytochrome P450 1A1Homo sapiens (human)
iron ion bindingCytochrome P450 1A1Homo sapiens (human)
protein bindingCytochrome P450 1A1Homo sapiens (human)
arachidonic acid monooxygenase activityCytochrome P450 1A1Homo sapiens (human)
oxidoreductase activityCytochrome P450 1A1Homo sapiens (human)
oxidoreductase activity, acting on diphenols and related substances as donorsCytochrome P450 1A1Homo sapiens (human)
flavonoid 3'-monooxygenase activityCytochrome P450 1A1Homo sapiens (human)
oxygen bindingCytochrome P450 1A1Homo sapiens (human)
enzyme bindingCytochrome P450 1A1Homo sapiens (human)
heme bindingCytochrome P450 1A1Homo sapiens (human)
Hsp70 protein bindingCytochrome P450 1A1Homo sapiens (human)
demethylase activityCytochrome P450 1A1Homo sapiens (human)
Hsp90 protein bindingCytochrome P450 1A1Homo sapiens (human)
aromatase activityCytochrome P450 1A1Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid omega-hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
hydroperoxy icosatetraenoate dehydratase activityCytochrome P450 1A1Homo sapiens (human)
long-chain fatty acid omega-1 hydroxylase activityCytochrome P450 1A1Homo sapiens (human)
monooxygenase activityCytochrome P450 1A2Homo sapiens (human)
iron ion bindingCytochrome P450 1A2Homo sapiens (human)
protein bindingCytochrome P450 1A2Homo sapiens (human)
electron transfer activityCytochrome P450 1A2Homo sapiens (human)
oxidoreductase activityCytochrome P450 1A2Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 1A2Homo sapiens (human)
enzyme bindingCytochrome P450 1A2Homo sapiens (human)
heme bindingCytochrome P450 1A2Homo sapiens (human)
demethylase activityCytochrome P450 1A2Homo sapiens (human)
caffeine oxidase activityCytochrome P450 1A2Homo sapiens (human)
aromatase activityCytochrome P450 1A2Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 1A2Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 1A2Homo sapiens (human)
hydroperoxy icosatetraenoate dehydratase activityCytochrome P450 1A2Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 3Homo sapiens (human)
protein bindingCarbonic anhydrase 3Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 3Homo sapiens (human)
nickel cation bindingCarbonic anhydrase 3Homo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
monooxygenase activityCytochrome P450 2D6Homo sapiens (human)
iron ion bindingCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activityCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2D6Homo sapiens (human)
heme bindingCytochrome P450 2D6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
iron ion bindingCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
caffeine oxidase activityCytochrome P450 2C9 Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C9 Homo sapiens (human)
aromatase activityCytochrome P450 2C9 Homo sapiens (human)
heme bindingCytochrome P450 2C9 Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C9 Homo sapiens (human)
retinoic acid bindingUDP-glucuronosyltransferase 1-6Homo sapiens (human)
glucuronosyltransferase activityUDP-glucuronosyltransferase 1-6Homo sapiens (human)
enzyme bindingUDP-glucuronosyltransferase 1-6Homo sapiens (human)
protein homodimerization activityUDP-glucuronosyltransferase 1-6Homo sapiens (human)
protein heterodimerization activityUDP-glucuronosyltransferase 1-6Homo sapiens (human)
arachidonate 5-lipoxygenase activityArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
protein bindingArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
enzyme activator activityArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
enzyme bindingArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
identical protein bindingArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
protein-containing complex bindingArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
arachidonic acid bindingArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
glutathione transferase activityArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
glutathione peroxidase activityArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
leukotriene-C4 synthase activityArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
retinoic acid bindingUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
enzyme inhibitor activityUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
steroid bindingUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
glucuronosyltransferase activityUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
enzyme bindingUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
protein homodimerization activityUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
protein heterodimerization activityUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
protein bindingCarbonic anhydrase 4Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 4Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 4Homo sapiens (human)
peroxidase activityProstaglandin G/H synthase 1Homo sapiens (human)
prostaglandin-endoperoxide synthase activityProstaglandin G/H synthase 1Homo sapiens (human)
protein bindingProstaglandin G/H synthase 1Homo sapiens (human)
heme bindingProstaglandin G/H synthase 1Homo sapiens (human)
metal ion bindingProstaglandin G/H synthase 1Homo sapiens (human)
oxidoreductase activity, acting on single donors with incorporation of molecular oxygen, incorporation of two atoms of oxygenProstaglandin G/H synthase 1Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 6Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 6Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
zinc ion bindingCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
peroxidase activityProstaglandin G/H synthase 2Homo sapiens (human)
prostaglandin-endoperoxide synthase activityProstaglandin G/H synthase 2Homo sapiens (human)
protein bindingProstaglandin G/H synthase 2Homo sapiens (human)
enzyme bindingProstaglandin G/H synthase 2Homo sapiens (human)
heme bindingProstaglandin G/H synthase 2Homo sapiens (human)
protein homodimerization activityProstaglandin G/H synthase 2Homo sapiens (human)
metal ion bindingProstaglandin G/H synthase 2Homo sapiens (human)
oxidoreductase activity, acting on single donors with incorporation of molecular oxygen, incorporation of two atoms of oxygenProstaglandin G/H synthase 2Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 7Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 7Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificNuclear receptor ROR-gammaHomo sapiens (human)
DNA-binding transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
protein bindingNuclear receptor ROR-gammaHomo sapiens (human)
oxysterol bindingNuclear receptor ROR-gammaHomo sapiens (human)
zinc ion bindingNuclear receptor ROR-gammaHomo sapiens (human)
ligand-activated transcription factor activityNuclear receptor ROR-gammaHomo sapiens (human)
sequence-specific double-stranded DNA bindingNuclear receptor ROR-gammaHomo sapiens (human)
nuclear receptor activityNuclear receptor ROR-gammaHomo sapiens (human)
monooxygenase activityCytochrome P450 2J2Homo sapiens (human)
iron ion bindingCytochrome P450 2J2Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 14,15-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 11,12-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
isomerase activityCytochrome P450 2J2Homo sapiens (human)
linoleic acid epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
hydroperoxy icosatetraenoate isomerase activityCytochrome P450 2J2Homo sapiens (human)
arachidonic acid 5,6-epoxygenase activityCytochrome P450 2J2Homo sapiens (human)
heme bindingCytochrome P450 2J2Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2J2Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 9Homo sapiens (human)
protein bindingCarbonic anhydrase 9Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 9Homo sapiens (human)
molecular function activator activityCarbonic anhydrase 9Homo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
zinc ion bindingCarbonic anhydrase 14Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 14Homo sapiens (human)
carbonate dehydratase activityCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
zinc ion bindingCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (54)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneCarbonic anhydrase 12Homo sapiens (human)
membraneCarbonic anhydrase 12Homo sapiens (human)
basolateral plasma membraneCarbonic anhydrase 12Homo sapiens (human)
apical plasma membraneCarbonic anhydrase 12Homo sapiens (human)
plasma membraneCarbonic anhydrase 12Homo sapiens (human)
endoplasmic reticulumUDP-glucuronosyltransferase 1A9Homo sapiens (human)
endoplasmic reticulum membraneUDP-glucuronosyltransferase 1A9Homo sapiens (human)
endoplasmic reticulumUDP-glucuronosyltransferase 1A9Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
cytosolCarbonic anhydrase 1Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 1Homo sapiens (human)
cytoplasmCarbonic anhydrase 2Homo sapiens (human)
cytosolCarbonic anhydrase 2Homo sapiens (human)
plasma membraneCarbonic anhydrase 2Homo sapiens (human)
myelin sheathCarbonic anhydrase 2Homo sapiens (human)
apical part of cellCarbonic anhydrase 2Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 2Homo sapiens (human)
cytoplasmCarbonic anhydrase 2Homo sapiens (human)
plasma membraneCarbonic anhydrase 2Homo sapiens (human)
apical part of cellCarbonic anhydrase 2Homo sapiens (human)
cytosolMyoglobinHomo sapiens (human)
sarcoplasmMyoglobinHomo sapiens (human)
extracellular exosomeMyoglobinHomo sapiens (human)
mitochondrial inner membraneCytochrome P450 1A1Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 1A1Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A1Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 1A2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 1A2Homo sapiens (human)
cytosolCarbonic anhydrase 3Homo sapiens (human)
cytosolCarbonic anhydrase 3Homo sapiens (human)
cytoplasmCarbonic anhydrase 3Homo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
mitochondrionCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulumCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2D6Homo sapiens (human)
cytoplasmCytochrome P450 2D6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2C9 Homo sapiens (human)
plasma membraneCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
cytoplasmCytochrome P450 2C9 Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C9 Homo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
endoplasmic reticulumUDP-glucuronosyltransferase 1-6Homo sapiens (human)
endoplasmic reticulum membraneUDP-glucuronosyltransferase 1-6Homo sapiens (human)
intracellular membrane-bounded organelleUDP-glucuronosyltransferase 1-6Homo sapiens (human)
endoplasmic reticulumUDP-glucuronosyltransferase 1-6Homo sapiens (human)
plasma membraneGlutamate receptor 2Rattus norvegicus (Norway rat)
nuclear envelopeArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
endoplasmic reticulumArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
endoplasmic reticulum membraneArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
membraneArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
nuclear membraneArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
nuclear envelopeArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
endoplasmic reticulumArachidonate 5-lipoxygenase-activating proteinHomo sapiens (human)
endoplasmic reticulumUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
endoplasmic reticulum membraneUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
plasma membraneUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
perinuclear region of cytoplasmUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
endoplasmic reticulum chaperone complexUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
cytochrome complexUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
endoplasmic reticulumUDP-glucuronosyltransferase 1A1 Homo sapiens (human)
basolateral plasma membraneCarbonic anhydrase 4Homo sapiens (human)
rough endoplasmic reticulumCarbonic anhydrase 4Homo sapiens (human)
endoplasmic reticulum-Golgi intermediate compartmentCarbonic anhydrase 4Homo sapiens (human)
Golgi apparatusCarbonic anhydrase 4Homo sapiens (human)
trans-Golgi networkCarbonic anhydrase 4Homo sapiens (human)
plasma membraneCarbonic anhydrase 4Homo sapiens (human)
external side of plasma membraneCarbonic anhydrase 4Homo sapiens (human)
cell surfaceCarbonic anhydrase 4Homo sapiens (human)
membraneCarbonic anhydrase 4Homo sapiens (human)
apical plasma membraneCarbonic anhydrase 4Homo sapiens (human)
transport vesicle membraneCarbonic anhydrase 4Homo sapiens (human)
secretory granule membraneCarbonic anhydrase 4Homo sapiens (human)
brush border membraneCarbonic anhydrase 4Homo sapiens (human)
perinuclear region of cytoplasmCarbonic anhydrase 4Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 4Homo sapiens (human)
plasma membraneCarbonic anhydrase 4Homo sapiens (human)
photoreceptor outer segmentProstaglandin G/H synthase 1Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 1Homo sapiens (human)
endoplasmic reticulum membraneProstaglandin G/H synthase 1Homo sapiens (human)
Golgi apparatusProstaglandin G/H synthase 1Homo sapiens (human)
intracellular membrane-bounded organelleProstaglandin G/H synthase 1Homo sapiens (human)
extracellular exosomeProstaglandin G/H synthase 1Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 1Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 1Homo sapiens (human)
extracellular regionCarbonic anhydrase 6Homo sapiens (human)
extracellular spaceCarbonic anhydrase 6Homo sapiens (human)
cytosolCarbonic anhydrase 6Homo sapiens (human)
extracellular exosomeCarbonic anhydrase 6Homo sapiens (human)
extracellular spaceCarbonic anhydrase 6Homo sapiens (human)
mitochondrial matrixCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
mitochondrionCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
cytoplasmCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
mitochondrionCarbonic anhydrase 5A, mitochondrialHomo sapiens (human)
nuclear inner membraneProstaglandin G/H synthase 2Homo sapiens (human)
nuclear outer membraneProstaglandin G/H synthase 2Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulumProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulum lumenProstaglandin G/H synthase 2Homo sapiens (human)
endoplasmic reticulum membraneProstaglandin G/H synthase 2Homo sapiens (human)
caveolaProstaglandin G/H synthase 2Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 2Homo sapiens (human)
protein-containing complexProstaglandin G/H synthase 2Homo sapiens (human)
neuron projectionProstaglandin G/H synthase 2Homo sapiens (human)
cytoplasmProstaglandin G/H synthase 2Homo sapiens (human)
cytosolCarbonic anhydrase 7Homo sapiens (human)
cytoplasmCarbonic anhydrase 7Homo sapiens (human)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
nucleoplasmNuclear receptor ROR-gammaHomo sapiens (human)
nuclear bodyNuclear receptor ROR-gammaHomo sapiens (human)
chromatinNuclear receptor ROR-gammaHomo sapiens (human)
nucleusNuclear receptor ROR-gammaHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2J2Homo sapiens (human)
extracellular exosomeCytochrome P450 2J2Homo sapiens (human)
cytoplasmCytochrome P450 2J2Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2J2Homo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
nucleolusCarbonic anhydrase 9Homo sapiens (human)
plasma membraneCarbonic anhydrase 9Homo sapiens (human)
membraneCarbonic anhydrase 9Homo sapiens (human)
basolateral plasma membraneCarbonic anhydrase 9Homo sapiens (human)
microvillus membraneCarbonic anhydrase 9Homo sapiens (human)
plasma membraneCarbonic anhydrase 9Homo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
plasma membraneCarbonic anhydrase 14Homo sapiens (human)
membraneCarbonic anhydrase 14Homo sapiens (human)
basolateral plasma membraneCarbonic anhydrase 14Homo sapiens (human)
apical plasma membraneCarbonic anhydrase 14Homo sapiens (human)
plasma membraneCarbonic anhydrase 14Homo sapiens (human)
mitochondrionCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
mitochondrial matrixCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
mitochondrionCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
cytoplasmCarbonic anhydrase 5B, mitochondrialHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (666)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID118284Number of mice with necrosis was measured for compound along with acetaminophen showing necrosis rating of 4+ was reported.1987Journal of medicinal chemistry, Oct, Volume: 30, Issue:10
Prodrugs of L-cysteine as protective agents against acetaminophen-induced hepatotoxicity. 2-(Polyhydroxyalkyl)- and 2-(polyacetoxyalkyl)thiazolidine-4(R)-carboxylic acids.
AID1728916Inhibition of prostanoid synthesis in FAAH+/+ mouse assessed as TXB2 level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID24771Percent of total excretion of 3-(thiomethyl)acetaminophen glucuronide1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID304907Hepatotoxicity in CD1 mouse assessed as increased plasma GPT levels at 6 mmol/kg2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID28681Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1288648Metabolic stability in human liver S9 fraction assessed as parent compound remaining at 100 uM preincubated for 5 mins followed by glutathione addition measured after 2 hrs by LC-MS/MS analysis2016MedChemComm, Jan-01, Volume: 7, Issue:1
Phase II Metabolic Pathways of Spectinamide Antitubercular Agents: A Comparative Study of the Reactivity of 4-Substituted Pyridines to Glutathione Conjugation.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID191478Nephrotoxicity upon intraperitoneal administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID317956Antiparasitic activity against chloroquine-sensitive Plasmodium falciparum 3D72008Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5
Antimalarial dual drugs based on potent inhibitors of glutathione reductase from Plasmodium falciparum.
AID191472Nephrotoxicity upon intragastric administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID624634Drug glucuronidation reaction catalyzed by human recombinant UGT1A62005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID1289074Drug uptake in human after 4 hrs2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1292870Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving NAC treatment assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1292857Drug recovery in poisoned human patient (15 patients) without liver damage receiving cysteamine treatment assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID118281Number of mice with necrosis was measured for compound along with acetaminophen showing necrosis rating of 1+ was reported.1987Journal of medicinal chemistry, Oct, Volume: 30, Issue:10
Prodrugs of L-cysteine as protective agents against acetaminophen-induced hepatotoxicity. 2-(Polyhydroxyalkyl)- and 2-(polyacetoxyalkyl)thiazolidine-4(R)-carboxylic acids.
AID191485Nephrotoxicity upon intraperitoneal administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1728921Hepatotoxicity in C57BL/6 mouse assessed as change in ALT level at 300 mg/kg, ip measured after 12 hrs2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID191483Nephrotoxicity upon intraperitoneal administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID304920Activation of CAR in HEPG2 cells at 100 uM by Western blot2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID24778Percent of total excretion of acetaminophen1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1288650Half life in human liver S9 fraction at 100 uM preincubated for 5 mins followed by glutathione addition measured after 2 hrs by LC-MS/MS analysis2016MedChemComm, Jan-01, Volume: 7, Issue:1
Phase II Metabolic Pathways of Spectinamide Antitubercular Agents: A Comparative Study of the Reactivity of 4-Substituted Pyridines to Glutathione Conjugation.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID22718Time course of Distribution of Radioactivity in Mice lungs/heart after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1289056Apparent volume of distribution in Japanese healthy volunteer (5 volunteers) at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID304912Hepatotoxicity against HEPG2 cells at 100 uM after 6 to 8 hrs by tryptan blue exclusion test2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID229377Ratio of kcat/Km determined for catalytic efficiency in sulfonation against AST IV2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
Comparative molecular field analysis of substrates for an aryl sulfotransferase based on catalytic mechanism and protein homology modeling.
AID288185Permeability coefficient through artificial membrane in presence of stirred water layer2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
AID27580Partition coefficient (logP)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID625295Drug Induced Liver Injury Prediction System (DILIps) validation dataset; compound DILI positive/negative as observed in Pfizer data2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1217728Intrinsic clearance for reactive metabolites formation per mg of protein based on cytochrome P450 (unknown origin) inactivation rate by TDI assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1212279Ratio of Kcat to Km for CYP1A1 (unknown origin) expressed in Escherichia coli DH5alpha preincubated for 5 mins before NADPH addition measured after 30 mins by HPLC analysis2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Preferred binding orientations of phenacetin in CYP1A1 and CYP1A2 are associated with isoform-selective metabolism.
AID342475Inhibition of human carbonic anhydrase 1 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID1292850Drug recovery in poisoned human patient (8 patients) without liver damage receiving methionine treatment assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID331293Inhibition of mouse recombinant carbonic anhydrase 15 by stopped-flow CO2 hydrase assay2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Carbonic anhydrase inhibitors: Inhibition of the new membrane-associated isoform XV with phenols.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID22719Time course of Distribution of Radioactivity in Mice lungs/heart after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID304900Analgesic activity in CD1 mouse upto 6620 umol/kg by hot plate assay2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1728898Antipyretic activity against LPS-induced C57BL/6 mouse model of hyperthermia assessed as reduction in body temperature at 100 mg/kg, ip measured after 75 mins2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID26380Dissociation constant (pKa)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID54205Spectral dissociation constant for rat liver Cytochrome P450 1A11994Journal of medicinal chemistry, Mar-18, Volume: 37, Issue:6
Preferred orientations in the binding of 4'-hydroxyacetanilide (acetaminophen) to cytochrome P450 1A1 and 2B1 isoforms as determined by 13C- and 15N-NMR relaxation studies.
AID118413Tested for Protection from Acetaminophen-Induced Liver Necrosis in Mice, Number of animals(mice) with liver necrosis was determined after 4 hr1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Prodrugs of L-cysteine as liver-protective agents. 2(RS)-Methylthiazolidine-4(R)-carboxylic acid, a latent cysteine.
AID461318Inhibition of human recombinant MGL at 300 uM2010Journal of medicinal chemistry, Mar-11, Volume: 53, Issue:5
Synthesis and evaluation of paracetamol esters as novel fatty acid amide hydrolase inhibitors.
AID1292861Drug recovery in poisoned human patient (3 patients) with severe liver damage receiving methionine treatment assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID481440Dissociation constant, pKa of the compound2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
How well can the Caco-2/Madin-Darby canine kidney models predict effective human jejunal permeability?
AID1289070Analgesic activity in Japanese chronic pain patient (5 patients) assessed as sigmoid factor at 800 +/- 141 mg, po administered as single dose measured over 15 mins to 6 hrs2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1289064Apparent volume of distribution in Japanese chronic pain patient (5 patients) at 800 +/- 141 mg, po administered as single dose by fluorescence polarization immunoassay2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1292883Volume of distribution at central compartment in healthy adult male human subject at 12 mg/kg, iv1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID436670Antipyretic activity against yeast-induced hyperpyrexia in hyperthermic rat assessed as rectal temperature at 100 mg/kg, sc administered 18 hrs after yeast challenge measured after 2 hrs (Rvb=39.11 +/- 0.26 degC)2009Bioorganic & medicinal chemistry, Jul-15, Volume: 17, Issue:14
Synthesis, biological evaluation and docking studies of novel benzopyranone congeners for their expected activity as anti-inflammatory, analgesic and antipyretic agents.
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID120614Nephrotoxicity upon intraperitoneal administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID373867Hepatic clearance in human hepatocytes in absence of fetal calf serum2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
First-principle, structure-based prediction of hepatic metabolic clearance values in human.
AID461305Inhibition of FAAH-mediated [3H]AEA hydrolysis in rat brain homogenate at 300 uM by liquid scintillation spectroscopy2010Journal of medicinal chemistry, Mar-11, Volume: 53, Issue:5
Synthesis and evaluation of paracetamol esters as novel fatty acid amide hydrolase inhibitors.
AID1289066Absorption rate constant in Japanese chronic pain patient (5 patients) at 800 +/- 141 mg, po administered as single dose by fluorescence polarization immunoassay2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1703177Hepatotoxicity in human HepaRG cells assessed as increase in lactate dehydrogenase release at 50 to 5000 uM measured after 6 to 24 hrs by fluorescence based analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1703176Hepatotoxicity in primary human hepatocytes assessed as decrease in GSH level at 500 to 1000 uM measured after 3 to 12 hrs by Thiol tracker violet dye based fluorescence analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID1728914Inhibition of prostanoid synthesis in FAAH+/+ mouse assessed as PGF2alpha level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID304913Hepatotoxicity against HEPG2 cells at 200 uM after 6 to 8 hrs by tryptan blue exclusion test2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1292901Drug excretion in urine of human at 20 mg/kg assessed as mercapturic conjugate level after 24 hrs1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID304910Toxicity in CD1 mouse assessed as mortality at 6 mmol/kg2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID342486Inhibition of mouse carbonic anhydrase 13 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID120619Nephrotoxicity upon intraperitoneal administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID304894Hepatotoxicity in C57BL/6 mouse2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID681153TP_TRANSPORTER: inhibition of Daunorubicin efflux in NIH-3T3-G185 cells2001Chemical research in toxicology, Dec, Volume: 14, Issue:12
Quantitative distinctions of active site molecular recognition by P-glycoprotein and cytochrome P450 3A4.
AID374259Antipyretic activity in yeast-induced pyrexia albino rat model assessed as mean rectal temperature at 135 mg/kg, po administered 30 mins after 18 hrs of yeast challenge measured after 2 hrs postdosing (Rvb=39.2 degC)2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
Synthesis and pharmacological evaluation of a novel series of 5-(substituted)aryl-3-(3-coumarinyl)-1-phenyl-2-pyrazolines as novel anti-inflammatory and analgesic agents.
AID1292881Distribution half life in healthy adult male human subject at 12 mg/kg, iv1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1193495Thermodynamic equilibrium solubility, log S of the compound in simulated intestinal fluid at pH 6.8 at RT after 4 hrs by 96 well plate method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1292876Mean drug recovery in poisoned human patient (8 patients) with severe liver damage receiving supportive treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID120617Nephrotoxicity upon intraperitoneal administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID111465Tested for Protection from Acetaminophen-Induced Liver Necrosis in Mice (in 17 animals) and the deaths were observed after the 48 hours due to liver necrosis1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Prodrugs of L-cysteine as liver-protective agents. 2(RS)-Methylthiazolidine-4(R)-carboxylic acid, a latent cysteine.
AID1703179Hepatotoxicity in CD1 mouse assessed as increase in apoptotic nuclei at 600 mg/kg, po measured after 12 hrs by TUNEL staining2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1212314Drug uptake in lysosomes of human Fa2N-4 cells assessed as inhibition of LysoTracker Red fluorescence after 30 mins2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Lysosomal sequestration (trapping) of lipophilic amine (cationic amphiphilic) drugs in immortalized human hepatocytes (Fa2N-4 cells).
AID120608Nephrotoxicity upon intragastric administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1289068Analgesic activity in Japanese chronic pain patient (5 patients) assessed as maximum pain relief score at 800 +/- 141 mg, po administered as single dose measured over 15 mins to 6 hrs2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1155769Antipyretic activity in Wistar rat assessed as reduction in Brewer's yeast-induced hyperthermia measured as rectal temperature at 150 mg/kg, po administered 18 hrs post challenge measured after 1 hr post dose (Rvb = 39.300 +/- 0.071 degC)2014European journal of medicinal chemistry, Jul-23, Volume: 82Syntheses, characterization and evaluation of novel 2,6-diarylpiperidin-4-ones as potential analgesic-antipyretic agents.
AID1141086Antipyretic activity in albino rat assessed as yeast-induced pyrexia at 135 mg/kg, po measured at 2 hrs by telethermometer (Rvb = 38.20 degC)2014Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10
Synthesis, pharmacological screening and in silico studies of new class of Diclofenac analogues as a promising anti-inflammatory agents.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID22894Time course of Distribution of Radioactivity in Mice kidney after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID449663Lipophilicity, log P of the compound2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Antinociceptive properties of caffeic acid derivatives in mice.
AID268024Permeability across hairless mouse skin2006Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13
Synthesis, hydrolyses and dermal delivery of N-alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) derivatives of phenol, imide and thiol containing drugs.
AID1635441Intrinsic clearance in C57BL/6 mouse liver microsomes at 3 uM measured over 60 mins by HPLC analysis2016Journal of medicinal chemistry, 06-23, Volume: 59, Issue:12
Tetrahydroisoquinoline-Derived Urea and 2,5-Diketopiperazine Derivatives as Selective Antagonists of the Transient Receptor Potential Melastatin 8 (TRPM8) Channel Receptor and Antiprostate Cancer Agents.
AID387097Antinociceptive activity against acetic acid-induced abdominal constrictions in ip dosed Swiss mouse pretreated 30 mins before acetic acid challenge2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis of new 1-phenyl-3-{4-[(2E)-3-phenylprop-2-enoyl]phenyl}-thiourea and urea derivatives with anti-nociceptive activity.
AID1217708Time dependent inhibition of CYP2D6 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID288192Partition coefficient, log P of the compound2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
AID1193494Thermodynamic equilibrium solubility, log S of the compound in simulated gastric fluid at pH 1.2 at RT after 4 hrs by 96 well plate method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID540235Phospholipidosis-negative literature compound
AID1288649Half life in rat liver S9 fraction at 100 uM preincubated for 5 mins followed by glutathione addition measured after 2 hrs by LC-MS/MS analysis2016MedChemComm, Jan-01, Volume: 7, Issue:1
Phase II Metabolic Pathways of Spectinamide Antitubercular Agents: A Comparative Study of the Reactivity of 4-Substituted Pyridines to Glutathione Conjugation.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1141090Antipyretic activity in albino rat assessed as yeast-induced pyrexia at 135 mg/kg, po measured at 4 hrs by telethermometer (Rvb = 38 degC)2014Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10
Synthesis, pharmacological screening and in silico studies of new class of Diclofenac analogues as a promising anti-inflammatory agents.
AID555372Induction of toxin TSST-1 production in Staphylococcus aureus MN8 at 0.50 % after 24 hrs relative to control2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Surfactants, aromatic and isoprenoid compounds, and fatty acid biosynthesis inhibitors suppress Staphylococcus aureus production of toxic shock syndrome toxin 1.
AID304909Hepatotoxicity in CD1 mouse assessed as increased plasma GOT levels at 6 mmol/kg2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID342484Inhibition of human carbonic anhydrase 12 catalytic domain by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID1289061AUC (0 to infinity) in Japanese healthy volunteer (5 volunteers) assessed as acetaminophen-glucuronide at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID191474Nephrotoxicity upon intragastric administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1292865Drug recovery in poisoned human patient (15 patients) without liver damage receiving cysteamine treatment assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1414236Hepatotoxicity in human HepaRG cells assessed as GSH depletion at 500 uM after 3 to 12 hrs by ThiolTracker Violet dye-based fluorescence assay2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID1179254Antiangiogenic activity in chicken chorioallantoic membrane assessed as inhibition of VEGF-induced blood vessel formation at 0.01 nmol/CAM treated 30 mins after VEGF addition measured after 3 days relative to control2014Bioorganic & medicinal chemistry letters, Jul-15, Volume: 24, Issue:14
Synthesis and antiangiogenic activity of 6-amido-2,4,5-trimethylpyridin-3-ols.
AID1288647Metabolic stability in rat liver S9 fraction assessed as parent compound remaining at 100 uM preincubated for 5 mins followed by glutathione addition measured after 2 hrs by LC-MS/MS analysis2016MedChemComm, Jan-01, Volume: 7, Issue:1
Phase II Metabolic Pathways of Spectinamide Antitubercular Agents: A Comparative Study of the Reactivity of 4-Substituted Pyridines to Glutathione Conjugation.
AID374268Antipyretic activity in yeast-induced pyrexia albino rat model assessed as temperature index measured by sum of mean rectal temperature changes from 0 to 5 hrs at 135 mg/kg, po administered 30 mins after 18 hrs of yeast challenge (Rvb=39.0 degC)2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
Synthesis and pharmacological evaluation of a novel series of 5-(substituted)aryl-3-(3-coumarinyl)-1-phenyl-2-pyrazolines as novel anti-inflammatory and analgesic agents.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID380862Antinociceptive activity in ip dosed Swiss mouse assessed as reduction of formalin-induced neurogenic pain administered 60 mins before formalin challenge measured during 0 to 5 mins1999Journal of natural products, Aug, Volume: 62, Issue:8
Antinociceptive activity of niga-ichigoside F1 from Rubus imperialis.
AID408486Inhibition of recombinant Curvularia lunata trihydroxynaphthalene reductase2008Bioorganic & medicinal chemistry, Jun-01, Volume: 16, Issue:11
Towards the first inhibitors of trihydroxynaphthalene reductase from Curvularia lunata: synthesis of artificial substrate, homology modelling and initial screening.
AID39220Maximal velocity (Vmax) against Arylsulfotransferase (AST IV)2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
Comparative molecular field analysis of substrates for an aryl sulfotransferase based on catalytic mechanism and protein homology modeling.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID470920Analgesic activity in Swiss mouse at 100 umol/kg, po after 60 mins by hot plate test2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID191471Nephrotoxicity upon intragastric administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID501586Antiparasitic activity against Trichomonas vaginalis G3 at 100 uM after 24 hrs by hemocytometric analysis2010Bioorganic & medicinal chemistry letters, Sep-01, Volume: 20, Issue:17
Preliminary studies of 3,4-dichloroaniline amides as antiparasitic agents: structure-activity analysis of a compound library in vitro against Trichomonas vaginalis.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1257052Inhibition of human carbonic anhydrase 9 incubated for 15 mins prior to testing by stopped flow CO2 hydration assay2015Bioorganic & medicinal chemistry letters, Dec-01, Volume: 25, Issue:23
Interaction of carbonic anhydrase isozymes I, II, and IX with some pyridine and phenol hydrazinecarbothioamide derivatives.
AID24773Percent of total excretion of 3-methoxyacetaminophen glucuronide1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1292885AUC (infinity) in healthy adult male human subject at 12 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID380864Antinociceptive activity in ip dosed Swiss mouse assessed as reduction of formalin-induced inflammatory pain administered 60 mins before formalin challenge measured during 15 to 30 mins1999Journal of natural products, Aug, Volume: 62, Issue:8
Antinociceptive activity of niga-ichigoside F1 from Rubus imperialis.
AID28235Unbound fraction (plasma)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID20053Urinary Metabolic (3-cysteinnylacetaminophen) profile in the mouse 24 hr after dose of 3 mmol/kg of the compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID555341Effect on growth in Staphylococcus aureus MN8 at 0.10 % after 24 hrs (Rvb = 100%)2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Surfactants, aromatic and isoprenoid compounds, and fatty acid biosynthesis inhibitors suppress Staphylococcus aureus production of toxic shock syndrome toxin 1.
AID31109The compound tested for toxicity in liver against female mouse after intragastric administration of 10 mmol/kg; signifies centrilobular necrosis of liver1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID624630Drug glucuronidation reaction catalyzed by human recombinant UGT1A12005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID374579Apparent permeability across bovine cornea assessed as lag time of permeation by UV-visible spectrophotometer2009European journal of medicinal chemistry, May, Volume: 44, Issue:5
Synthesis, pharmacological screening, quantum chemical and in vitro permeability studies of N-Mannich bases of benzimidazoles through bovine cornea.
AID1292882Total body clearance in healthy adult male human subject at 12 mg/kg, iv1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID602755Maximum permeability flux through hairless mouse skin applied topically as suspension in isopropyl myristate2011Bioorganic & medicinal chemistry letters, Jul-01, Volume: 21, Issue:13
N,N'-Dialkylaminoalkylcarbonyl (DAAC) prodrugs and aminoalkylcarbonyl (AAC) prodrugs of 4-hydroxyacetanilide and naltrexone with improved skin permeation properties.
AID588208Literature-mined public compounds from Lowe et al phospholipidosis modelling dataset2010Molecular pharmaceutics, Oct-04, Volume: 7, Issue:5
Predicting phospholipidosis using machine learning.
AID118282Number of mice with necrosis was measured for compound along with acetaminophen showing necrosis rating of 2+ was reported.1987Journal of medicinal chemistry, Oct, Volume: 30, Issue:10
Prodrugs of L-cysteine as protective agents against acetaminophen-induced hepatotoxicity. 2-(Polyhydroxyalkyl)- and 2-(polyacetoxyalkyl)thiazolidine-4(R)-carboxylic acids.
AID1292886AUC (infinity) in healthy adult male human subject at 12 mg/kg, iv1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID24775Percent of total excretion of N-hydroxyacetaminophen sulfate1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID212012Toxicity in mice 24 hr after ip administration1982Journal of medicinal chemistry, Aug, Volume: 25, Issue:8
Synthesis, decomposition kinetics, and preliminary toxicological studies of pure N-acetyl-p-benzoquinone imine, a proposed toxic metabolite of acetaminophen.
AID120819Hepatotoxicity in Swiss-Webster Mice Caused by compound at 400 mg/kg (i.p.) dose; 8/101986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID646014Binding affinity to His-6 tagged BRD2 expressed in Escherichia coli at 100 uM after 60 mins by fluorescence anisotropic analysis2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1289072Toxicity in Japanese chronic pain patient at 600 to 1000 mg, po administered as single dose2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1212277Activity of His-tagged CYP1A1 (unknown origin) expressed in Escherichia coli DH5alpha preincubated for 5 mins before NADPH addition measured after 30 mins by HPLC analysis2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Preferred binding orientations of phenacetin in CYP1A1 and CYP1A2 are associated with isoform-selective metabolism.
AID118152Hepatotoxicity in Swiss-Webster Mice Caused by compound at 750 mg/kg (i.p.) dose1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID624615Specific activity of expressed human recombinant UGT2B102000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID120616Nephrotoxicity upon intraperitoneal administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID263727Drug level in mouse brain at 50 mg/kg, po2006Bioorganic & medicinal chemistry letters, Apr-15, Volume: 16, Issue:8
The geminal dimethyl analogue of Flurbiprofen as a novel Abeta42 inhibitor and potential Alzheimer's disease modifying agent.
AID461303Inhibition of FAAH-mediated [3H]AEA hydrolysis in rat brain homogenate by liquid scintillation spectroscopy2010Journal of medicinal chemistry, Mar-11, Volume: 53, Issue:5
Synthesis and evaluation of paracetamol esters as novel fatty acid amide hydrolase inhibitors.
AID191470Nephrotoxicity upon intragastric administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID481442Transcellular permeability at pH 6.5 calculated from in vitro P app values in Caco-2 and/or MDCK cells2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
How well can the Caco-2/Madin-Darby canine kidney models predict effective human jejunal permeability?
AID304893Hepatotoxicity in mouse assessed as plasma GPT levels at 3.7 mmol/kg, po after 24 hrs2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID405530Inhibition of mPGES1 up to 1000 uM2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Microsomal prostaglandin E2 synthase-1 (mPGES-1): a novel anti-inflammatory therapeutic target.
AID24930Percent of total excretion of acetaminophen-mercapturic acid1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID191481Nephrotoxicity upon intraperitoneal administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1728923Hepatotoxicity in C57BL/6 mouse assessed as centrilobular necrosis at 300 mg/kg, ip measured after 12 hrs by H and E staining based microscopic analysis2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID22708Time course of Distribution of Radioactivity in Mice brain after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1331298Lipophilicity, log P of the compound
AID1292841Drug recovery in poisoned human patient (15 patients) without liver damage receiving cysteamine treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1703196Antipyretic activity against Baker's yeast-induced hyperthermia model in CD1 mouse at 80 mg/kg, po at 2 hrs post-injection by thermometer based analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID470919Analgesic activity in Swiss mouse at 100 umol/kg, po after 30 mins by hot plate test2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID1210069Inhibition of human recombinant CYP2J2 assessed as reduction in astemizole O-demethylation by LC-MS/MS method2013Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 41, Issue:1
Discovery and characterization of novel, potent, and selective cytochrome P450 2J2 inhibitors.
AID1289075Analgesic activity in Japanese chronic pain patient assessed as equilibration half life of delay onset of effect at 600 to 1000 mg, po administered as single dose2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID760171Inhibition of myoglobin (unknown origin)-mediated arachidonic acid oxidation using [14C]AA as substrate after 3 hrs by GC/NICI/MS analysis2013ACS medicinal chemistry letters, Aug-08, Volume: 4, Issue:8
Rational Design of Novel Pyridinol-Fused Ring Acetaminophen Analogues.
AID1292898Half life in elderly human1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID8002Observed volume of distribution2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID681340TP_TRANSPORTER: inhibition of PAH uptake in Xenopus laevis oocytes1999Molecular pharmacology, May, Volume: 55, Issue:5
Transport properties of nonsteroidal anti-inflammatory drugs by organic anion transporter 1 expressed in Xenopus laevis oocytes.
AID1703184Inhibition of CYP2E1 (unknown origin) in baculosomes preincubated for 20 mins followed by addition of CYP enzyme-specific substrate and NADP+ and measured after 30 mins by fluorescence based analysis relative to control2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID409956Inhibition of mouse brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID19262Aqueous solubility2000Bioorganic & medicinal chemistry letters, Jun-05, Volume: 10, Issue:11
Prediction of drug solubility from Monte Carlo simulations.
AID22702Time course of Distribution of Radioactivity in Mice Urine after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID120606Nephrotoxicity upon intragastric administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID22890Time course of Distribution of Radioactivity in Mice Liver after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID91481Binding constant against human serum albumin (HSA)2001Journal of medicinal chemistry, Dec-06, Volume: 44, Issue:25
Cheminformatic models to predict binding affinities to human serum albumin.
AID39219Apparent Michaelis constant (Km) against Arylsulfotransferase (AST IV)2002Journal of medicinal chemistry, Dec-05, Volume: 45, Issue:25
Comparative molecular field analysis of substrates for an aryl sulfotransferase based on catalytic mechanism and protein homology modeling.
AID22703Time course of Distribution of Radioactivity in Mice Urine after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1414242Inhibition of human CYP2E1 expressed in baculosomes at 1 uM using EOMCC as substrate preincubated for 20 mins followed by substrate and NADP+ addition and measured after 30 mins by fluorescence assay2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID191489Nephrotoxicity upon intravenous administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID304896Analgesic activity in CD1 mouse by formalin-induced pain model after 30 mins2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID123231Nephrotoxicity upon intraperitoneal administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID413977Inhibition of cyclooxygenase 2 in human whole blood assessed as prostaglandin H2 level2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide.
AID1292843Drug recovery in poisoned human patient (23 patients) without liver damage receiving NAC treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID449657Antinociceptive activity in ip dosed Swiss mouse by inhibition of acetic acid-induced abdominal constriction after 20 mins2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Antinociceptive properties of caffeic acid derivatives in mice.
AID470921Analgesic activity in Swiss mouse at 100 umol/kg, po after 90 mins by hot plate test2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID1728913Inhibition of prostanoid synthesis in FAAH+/+ mouse assessed as PGE2 level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1292833Volume of distribution in 70 kg adult human at 12 mg/kg, iv infused over 2 mins1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1728920Inhibition of prostanoid synthesis in FAAH-/- mouse assessed as TXB2 level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID1289055AUC (0 to infinity) in Japanese healthy volunteer (5 volunteers) at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID28236Unbound fraction (tissues)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID1289078Drug metabolism in Japanese healthy volunteer assessed as acetaminophen-cysteine metabolite formation at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID191475Nephrotoxicity upon intragastric administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID304892Analgesic activity in CD1 mouse assessed as acetic acid-induced writhing at 1 mmol/kg, po after 1 hr2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID191484Nephrotoxicity upon intraperitoneal administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID24772Percent of total excretion of 3-(thiomethyl)acetaminophen sulfate1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1292855Drug recovery in healthy human subjects (8 subjects) assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1292842Drug recovery in poisoned human patient (8 patients) without liver damage receiving methionine treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID317959Cytotoxicity against human KB cells by alamar blue assay2008Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5
Antimalarial dual drugs based on potent inhibitors of glutathione reductase from Plasmodium falciparum.
AID15026Concentration distributed until decomposition of N-acetyl-N-hydroxy-p-aminophenol at pH 7.21980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Mechanism of decomposition of N-hydroxyacetaminophen, a postulated toxic metabolite of acetaminophen.
AID304914Hepatotoxicity against human hepatocytes after 6 to 8 hrs by tryptan blue exclusion test2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID309363Antiinflammatory activity in CD1 mouse assessed as inhibition of croton oil-induced ear oedema at 0.3 umol/cm^2 after 6 hrs2007Bioorganic & medicinal chemistry letters, Oct-15, Volume: 17, Issue:20
Synthesis and anti-inflammatory activity of 3-(4'-geranyloxy-3'-methoxyphenyl)-2-trans propenoic acid and its ester derivatives.
AID624637Drug glucuronidation reaction catalyzed by human recombinant UGT1A92005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID1292835Tmax in 70 kg adult human at 12 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID448127Antinociceptive activity in mouse assessed as inhibition of acetic acid-induced abdominal constrictions at 100 umol/kg, po relative to untreated control2009Bioorganic & medicinal chemistry letters, Sep-01, Volume: 19, Issue:17
Design, synthesis and analgesic properties of novel conformationally-restricted N-acylhydrazones (NAH).
AID191490Nephrotoxicity upon intravenous administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1519674Chromatographic hydrophobicity index of compound at 250 uM at pH 7.4 by HPLC analysis2020European journal of medicinal chemistry, Jan-01, Volume: 185Design of novel monoamine oxidase-B inhibitors based on piperine scaffold: Structure-activity-toxicity, drug-likeness and efflux transport studies.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID15023Concentration distributed until decomposition of N-acetyl-N-hydroxy-p-aminophenol at pH 101980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Mechanism of decomposition of N-hydroxyacetaminophen, a postulated toxic metabolite of acetaminophen.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID436669Antipyretic activity against yeast-induced hyperpyrexia in hyperthermic rat assessed as rectal temperature at 100 mg/kg, sc administered 18 hrs after yeast challenge measured after 1 hr (Rvb=39.24 +/- 0.22 degC)2009Bioorganic & medicinal chemistry, Jul-15, Volume: 17, Issue:14
Synthesis, biological evaluation and docking studies of novel benzopyranone congeners for their expected activity as anti-inflammatory, analgesic and antipyretic agents.
AID112944Analgesic activity determined in mice using the Bradykinin-induced Writhing test1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1703191Drug metabolism in CD1 mouse serum assessed as NAPQI formation at 600 mg/kg, ip measured after 12 hrs by LC-MS/MS analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID20058Urinary Metabolic (Acetaminophen) profile in the mouse 24 h after dose of 3 mmol/kg of the compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1703183Inhibition of CYP3A4 (unknown origin) in baculosomes preincubated for 20 mins followed by addition of CYP enzyme-specific substrate and NADP+ and measured after 30 mins by fluorescence based analysis relative to control2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1443980Inhibition of human BSEP expressed in fall armyworm sf9 cell plasma membrane vesicles assessed as reduction in vesicle-associated [3H]-taurocholate transport preincubated for 10 mins prior to ATP addition measured after 15 mins in presence of [3H]-tauroch2010Toxicological sciences : an official journal of the Society of Toxicology, Dec, Volume: 118, Issue:2
Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development.
AID1449742Selectivity ratio of Ki for recombinant human carbonic anhydrase 2 to Ki for recombinant Malassezia globosa beta-carbonic anhydrase2017Bioorganic & medicinal chemistry, 05-01, Volume: 25, Issue:9
Inhibition of Malassezia globosa carbonic anhydrase with phenols.
AID760172Inhibition of ovine COX1-mediated arachidonic acid oxidation using [14C]AA as substrate after 5 mins by GC/NICI/MS analysis2013ACS medicinal chemistry letters, Aug-08, Volume: 4, Issue:8
Rational Design of Novel Pyridinol-Fused Ring Acetaminophen Analogues.
AID24928Percent of total excretion of acetaminophen glucuronide1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID449642Antinociceptive activity in Swiss mouse by inhibition of acetic acid-induced abdominal constriction at 10 mg/kg, ip after 20 mins2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Antinociceptive properties of caffeic acid derivatives in mice.
AID118150Hepatotoxicity in Swiss-Webster Mice Caused by compound at 400 mg/kg (i.p.) dose1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1489151Antiangiogenic activity in HUVEC assessed as inhibition of tube formation on matrigel at 12.5 ug/ml after 24 hrs by Mayer's hematoxylin staining based light microscopy relative to control2017Bioorganic & medicinal chemistry letters, 09-01, Volume: 27, Issue:17
Chemical constituents from the rare mushroom Calvatia nipponica inhibit the promotion of angiogenesis in HUVECs.
AID1292863Drug recovery in healthy human subjects (8 subjects) assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID118283Number of mice with necrosis was measured for compound along with acetaminophen showing necrosis rating of 3+ was reported.1987Journal of medicinal chemistry, Oct, Volume: 30, Issue:10
Prodrugs of L-cysteine as protective agents against acetaminophen-induced hepatotoxicity. 2-(Polyhydroxyalkyl)- and 2-(polyacetoxyalkyl)thiazolidine-4(R)-carboxylic acids.
AID22893Time course of Distribution of Radioactivity in Mice kidney after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID387101Antinociceptive activity against acetic acid-induced abdominal constrictions in po dosed Swiss mouse pretreated 30 mins before acetic acid challenge2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis of new 1-phenyl-3-{4-[(2E)-3-phenylprop-2-enoyl]phenyl}-thiourea and urea derivatives with anti-nociceptive activity.
AID22704Time course of Distribution of Radioactivity in Mice Urine after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID28233Fraction ionized (pH 7.4)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID120748Percentage survival of mice after 48 hr.1987Journal of medicinal chemistry, Oct, Volume: 30, Issue:10
Prodrugs of L-cysteine as protective agents against acetaminophen-induced hepatotoxicity. 2-(Polyhydroxyalkyl)- and 2-(polyacetoxyalkyl)thiazolidine-4(R)-carboxylic acids.
AID1217704Time dependent inhibition of CYP1A2 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID681118TP_TRANSPORTER: transepithelial transport in Caco-2 cells2003International journal of pharmaceutics, Sep-16, Volume: 263, Issue:1-2
Caco-2 permeability, P-glycoprotein transport ratios and brain penetration of heterocyclic drugs.
AID311367Permeability coefficient in human skin2007Bioorganic & medicinal chemistry, Nov-15, Volume: 15, Issue:22
Transdermal penetration behaviour of drugs: CART-clustering, QSPR and selection of model compounds.
AID268023Ratio for partition coefficient, log K in IPM to buffer at pH 42006Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13
Synthesis, hydrolyses and dermal delivery of N-alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) derivatives of phenol, imide and thiol containing drugs.
AID120611Nephrotoxicity upon intragastric administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1489149Cytotoxicity against HUVEC assessed as reduction in cell viability at 100 ug/ml after 24 hrs by MTT assay relative to control2017Bioorganic & medicinal chemistry letters, 09-01, Volume: 27, Issue:17
Chemical constituents from the rare mushroom Calvatia nipponica inhibit the promotion of angiogenesis in HUVECs.
AID408891Antinociceptive activity against formalin-induced nociceptive behavior in C57BL/6 mouse assessed as mean licking time at 200 mg/kg, ip administered 15 mins prior to formalin challenge measured after 15 to 45 mins relative to control2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide.
AID191493Nephrotoxicity upon intravenous administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID678718Metabolic stability in human liver microsomes assessed as high signal/noise ratio (S/N of >100) by measuring GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID13312991-octanol/D2O distribution coefficient, log D of the compound at pH 7.4 by 1H NMR spectroscopic analysis
AID1292900Drug excretion in urine of human at 20 mg/kg assessed as cysteine conjugate level after 24 hrs1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID120612Nephrotoxicity upon intragastric administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID304895Analgesic activity in CD1 mouse by acetic acid-induced writhing test after 30 to 40 mins2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID24929Percent of total excretion of acetaminophen sulfate1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1414239Hepatotoxicity in human HepaRG cells assessed as necrotic cell death at 500 uM measured over 12 hrs by LDH assay2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID1292854Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving NAC treatment assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1141094Antipyretic activity in albino rat assessed as decrease in yeast-induced pyrexia by measuring temperature index at 135 mg/kg, po measured over 5 hrs by telethermometer (Rvb = 1.04 degC)2014Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10
Synthesis, pharmacological screening and in silico studies of new class of Diclofenac analogues as a promising anti-inflammatory agents.
AID1155772Antipyretic activity in Wistar rat assessed as reduction in Brewer's yeast-induced hyperthermia measured as rectal temperature at 150 mg/kg, po administered 18 hrs post challenge measured after 3 hrs post dose (Rvb = 39.400 +/- 0.071 degC)2014European journal of medicinal chemistry, Jul-23, Volume: 82Syntheses, characterization and evaluation of novel 2,6-diarylpiperidin-4-ones as potential analgesic-antipyretic agents.
AID405541Inhibition of LPS-stimulated PGE2 production in human whole blood2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Microsomal prostaglandin E2 synthase-1 (mPGES-1): a novel anti-inflammatory therapeutic target.
AID1703194Analgesic activity in po dosed CD1 mouse assessed as inhibition of acetic acid-induced abdominal writhing treated with acetic acid 25 mins post drug administration and measured after 5 mins for 10 mins2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID1414237Hepatotoxicity in human HepaRG cells assessed as GSH depletion at 500 uM measured over 12 hrs by ThiolTracker Violet dye-based fluorescence assay2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID1292889Tmax in healthy human subjects1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID19424Partition coefficient (logD7.4)2001Journal of medicinal chemistry, Jul-19, Volume: 44, Issue:15
ElogD(oct): a tool for lipophilicity determination in drug discovery. 2. Basic and neutral compounds.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID760175Metabolic stability in rat liver microsomes assessed as compound remaining at 10 uM after 30 mins by LC-MS analysis2013ACS medicinal chemistry letters, Aug-08, Volume: 4, Issue:8
Rational Design of Novel Pyridinol-Fused Ring Acetaminophen Analogues.
AID304905Hepatotoxicity in CD1 mouse assessed as reduction in renal glutathione levels at 6 mmol/kg2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID29813Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1217712Time dependent inhibition of CYP2C8 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID30991The compound tested for toxicity in kidney against female mouse after intravenous administration of 2.0 mmol/kg; Normal1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1703189Inhibition of CYP3A4 (unknown origin) in baculosomes preincubated for 20 mins followed by addition of CYP enzyme-specific substrate and NADP+ and measured after 30 mins by fluorescence based analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID22707Time course of Distribution of Radioactivity in Mice blood after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292872Mean drug recovery in poisoned human patient (9 patients) without liver damage receiving supportive treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID342478Inhibition of human carbonic anhydrase 4 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID304918Upregulation of Fas-ligand in HEPG2 cells by Western blot2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1210884Drug metabolism in human liver microsomes assessed as retention time treated with 2 to 2000 uM phenacetin incubated for 5 mins prior to NADPH addition measured after 25 mins by HPLC analysis2012Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 40, Issue:5
Effect of albumin on human liver microsomal and recombinant CYP1A2 activities: impact on in vitro-in vivo extrapolation of drug clearance.
AID1155771Antipyretic activity in Wistar rat assessed as reduction in Brewer's yeast-induced hyperthermia measured as rectal temperature at 150 mg/kg, po administered 18 hrs post challenge measured after 2 hrs post dose (Rvb = 39.320 +/- 0.102 degC)2014European journal of medicinal chemistry, Jul-23, Volume: 82Syntheses, characterization and evaluation of novel 2,6-diarylpiperidin-4-ones as potential analgesic-antipyretic agents.
AID22716Time course of Distribution of Radioactivity in Mice intestine after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1179255Antiangiogenic activity in chicken chorioallantoic membrane assessed as inhibition of VEGF-induced blood vessel formation treated 30 mins after VEGF addition measured after 3 days2014Bioorganic & medicinal chemistry letters, Jul-15, Volume: 24, Issue:14
Synthesis and antiangiogenic activity of 6-amido-2,4,5-trimethylpyridin-3-ols.
AID374263Antipyretic activity in yeast-induced pyrexia albino rat model assessed as mean rectal temperature at 135 mg/kg, po administered 30 mins after 18 hrs of yeast challenge measured after 1 hr postdosing (Rvb=39.4 degreeC)2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
Synthesis and pharmacological evaluation of a novel series of 5-(substituted)aryl-3-(3-coumarinyl)-1-phenyl-2-pyrazolines as novel anti-inflammatory and analgesic agents.
AID155373Inhibition of microsomal PGH synthase isolated from sheep seminal vesicles (SSV) estimated as rate of oxygen consumption in presence of 500 uM of the compound1987Journal of medicinal chemistry, Feb, Volume: 30, Issue:2
Prostaglandin-H synthase inhibition by malonamides. Ring-opened analogues of phenylbutazone.
AID1728904Antipyretic activity against LPS-induced C57BL/6 mouse model of hyperthermia assessed as TXB2 level in diencephalon at 100 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID22892Time course of Distribution of Radioactivity in Mice kidney after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292836Systemic availability in healthy adult male human subject at 12 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1768730Relative lipophilicity of the compound in methanol assessed as retardation factor by reversed-phase TLC analysis2021Bioorganic & medicinal chemistry letters, 10-01, Volume: 49Estimation of the lipophilicity of purine-2,6-dione-based TRPA1 antagonists and PDE4/7 inhibitors with analgesic activity.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID1212278Activity of His-tagged CYP1A2 (unknown origin) expressed in Escherichia coli DH5alpha preincubated for 5 mins before NADPH addition measured after 30 mins by HPLC analysis2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Preferred binding orientations of phenacetin in CYP1A1 and CYP1A2 are associated with isoform-selective metabolism.
AID387109Antinociceptive activity against capsaicin-induced paw pain in Swiss mouse assessed as maximal inhibition at 10 mg/kg, ip pretreated 30 mins before capsaicin challenge2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis of new 1-phenyl-3-{4-[(2E)-3-phenylprop-2-enoyl]phenyl}-thiourea and urea derivatives with anti-nociceptive activity.
AID1489148Cytotoxicity against HUVEC assessed as reduction in cell viability up to 12.5 ug/ml after 24 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 09-01, Volume: 27, Issue:17
Chemical constituents from the rare mushroom Calvatia nipponica inhibit the promotion of angiogenesis in HUVECs.
AID1289063Toxicity in Japanese healthy volunteer (5 volunteers) at 1000 mg, po2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID15027Concentration distributed until decomposition of N-acetyl-N-hydroxy-p-aminophenol at pH 7.61980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Mechanism of decomposition of N-hydroxyacetaminophen, a postulated toxic metabolite of acetaminophen.
AID1292852Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving supportive treatment assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID536416Binding affinity to human CYP1A12010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Homology modeling and molecular dynamics of CYP1A1 and CYP2B1 to explore the metabolism of aryl derivatives by docking and experimental assays.
AID1292856Drug recovery in poisoned human patient (9 patients) without liver damage receiving supportive treatment assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1537637Cytoprotective activity against H2O2-induced toxicity in rat H9c2 cells assessed as increase in cell repair at 10 to 80 uM pretreated with compound followed by H2O2 addition and measured after 1 to 8 hrs by giemsa staining based microscopic method2019MedChemComm, May-01, Volume: 10, Issue:5
Toxicities and beneficial protection of H
AID1414238Hepatotoxicity in human HepaRG cells assessed as GSH depletion at 1000 uM after 12 hrs by ThiolTracker Violet dye-based fluorescence assay2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID527491Octanol-water partition coefficient, log P of the compound by deuterium-free NMR method2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
A practical deuterium-free NMR method for the rapid determination of 1-octanol/water partition coefficients of pharmaceutical agents.
AID1289071Tmax in Japanese chronic pain patient at 600 to 1000 mg, po administered as single dose by fluorescence polarization immunoassay2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID527494Octanol-water partition coefficient, log P of the compound2010Bioorganic & medicinal chemistry letters, Nov-15, Volume: 20, Issue:22
A practical deuterium-free NMR method for the rapid determination of 1-octanol/water partition coefficients of pharmaceutical agents.
AID1292880Elimination half life in healthy adult male human subject at 12 mg/kg, iv1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID22722Time course of Distribution of Radioactivity in Mice spleen after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292878Mean drug recovery in poisoned human patient (8 patients) with severe liver damage receiving NAC treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1292897Drug excretion in urine of healthy young adult human assessed as mercapturic conjugate level after 24 hrs1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1289062AUC (0 to infinity) in Japanese healthy volunteer (5 volunteers) assessed as acetaminophen-sulfate at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID471214Hypothermic activity in Swiss mouse assessed as decrease in rectal body temperature at 100 umol/kg, po after 1 hr at room temperature2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID29363Dissociation constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID118280Number of mice with necrosis was measured for compound along with acetaminophen showing necrosis rating of 0 was reported.1987Journal of medicinal chemistry, Oct, Volume: 30, Issue:10
Prodrugs of L-cysteine as protective agents against acetaminophen-induced hepatotoxicity. 2-(Polyhydroxyalkyl)- and 2-(polyacetoxyalkyl)thiazolidine-4(R)-carboxylic acids.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID22709Time course of Distribution of Radioactivity in Mice brain after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292840Drug recovery in poisoned human patient (9 patients) without liver damage receiving supportive treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID24927Percent of total excretion of acetaminophen cysteine conjugate1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID120613Nephrotoxicity upon intragastric administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1292848Drug recovery in poisoned human patient (9 patients) without liver damage receiving supportive treatment assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID22714Time course of Distribution of Radioactivity in Mice intestine after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID471216Hepatotoxicity in Swiss mouse assessed as changes in morphology of liver parenchyma at 100 umol/kg, po for five days after 24 hrs of last dose2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID120607Nephrotoxicity upon intragastric administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID191491Nephrotoxicity upon intravenous administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1193499Thermodynamic equilibrium solubility, log S of the compound simulated intestinal fluid at pH 6.8 at RT after 24 hrs by shake-flask method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1209456Inhibition of Sprague-Dawley rat Bsep expressed in plasma membrane vesicles of Sf21 cells assessed as inhibition of ATP-dependent [3H]taurocholate uptake2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
In vitro inhibition of the bile salt export pump correlates with risk of cholestatic drug-induced liver injury in humans.
AID625294Drug Induced Liver Injury Prediction System (DILIps) validation dataset; compound DILI positive/negative as observed in O'Brien data2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID30990The compound tested for toxicity in kidney against female mouse after intravenous administration of 10.0 mmol/kg; Normal1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID123230Nephrotoxicity upon intraperitoneal administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1519676Retention time of compound at pH 7.4 by LC-UV analysis2020European journal of medicinal chemistry, Jan-01, Volume: 185Design of novel monoamine oxidase-B inhibitors based on piperine scaffold: Structure-activity-toxicity, drug-likeness and efflux transport studies.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID22725Time course of Distribution of Radioactivity in Mice stomach after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292867Drug recovery in poisoned human patient (23 patients) without liver damage receiving NAC treatment assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1292846Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving NAC treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID263729Ratio of drug level in brain against plasma in mice at 50 mg/kg, po2006Bioorganic & medicinal chemistry letters, Apr-15, Volume: 16, Issue:8
The geminal dimethyl analogue of Flurbiprofen as a novel Abeta42 inhibitor and potential Alzheimer's disease modifying agent.
AID1414244Antipyretic activity in LPS-induced CD1 mouse fever model assessed as effect on rectal temperature at 50 ug/kg, po administered as single dose and measured every 2 hrs up to 24 hrs2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID15024Concentration distributed until decomposition of N-acetyl-N-hydroxy-p-aminophenol at pH 10.51980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Mechanism of decomposition of N-hydroxyacetaminophen, a postulated toxic metabolite of acetaminophen.
AID567091Drug absorption in human assessed as human intestinal absorption rate2011European journal of medicinal chemistry, Jan, Volume: 46, Issue:1
Prediction of drug intestinal absorption by new linear and non-linear QSPR.
AID1292834Total body clearance in 70 kg adult human at 12 mg/kg, iv infused over 2 mins1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1292851Drug recovery in poisoned human patient (23 patients) without liver damage receiving NAC treatment assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID15028Concentration distributed until decomposition of N-acetyl-N-hydroxy-p-aminophenol at pH 8.21980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Mechanism of decomposition of N-hydroxyacetaminophen, a postulated toxic metabolite of acetaminophen.
AID1292860Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving supportive treatment assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID54373Spectral dissociation constant for rat liver Cytochrome P450 2B11994Journal of medicinal chemistry, Mar-18, Volume: 37, Issue:6
Preferred orientations in the binding of 4'-hydroxyacetanilide (acetaminophen) to cytochrome P450 1A1 and 2B1 isoforms as determined by 13C- and 15N-NMR relaxation studies.
AID624613Specific activity of expressed human recombinant UGT1A102000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1217727Intrinsic clearance for reactive metabolites formation per mg of protein in human liver microsomes based on [3H]GSH adduct formation rate at 100 uM by [3H]GSH trapping assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1292868Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving supportive treatment assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID361986Lipophilicity, log D of compound at pH 7.4 by shake flask method2008Journal of medicinal chemistry, Aug-28, Volume: 51, Issue:16
Determination of log D via automated microfluidic liquid-liquid extraction.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID374261Antipyretic activity in yeast-induced pyrexia albino rat model assessed as mean rectal temperature at 135 mg/kg, po administered 30 mins after 18 hrs of yeast challenge measured after 4 hrs postdosing (Rvb=38.7 degC)2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
Synthesis and pharmacological evaluation of a novel series of 5-(substituted)aryl-3-(3-coumarinyl)-1-phenyl-2-pyrazolines as novel anti-inflammatory and analgesic agents.
AID1703192Hepatotoxicity in CD1 mouse assessed as centrilobular hepatic hemorrhagic necrosis at 600 mg/kg, po measured after 12 hrs by hematoxylin and eosin staining based optical microscopy2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID646019Inhibition of His-6 tagged BRD4-RD12 precoupled with biotinylated tetra-acetylated histone H4 expressed in Escherichia coli assessed as protein-protein interaction at 50 uM after 1 hr by TR-FRET assay2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1292859Drug recovery in poisoned human patient (23 patients) without liver damage receiving NAC treatment assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1414241Inhibition of human CYP3A4 expressed in baculosomes at 1 uM using BOMCC as substrate preincubated for 20 mins followed by substrate and NADP+ addition and measured after 30 mins by fluorescence assay2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID1292874Mean drug recovery in poisoned human patient (8 patients) without liver damage receiving methionine treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID304921Activation of CAR in human hepatocytes by Western blot2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID29421Partition coefficient (logP) (HPLC)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID342480Inhibition of human carbonic anhydrase 5B by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID432063Apparent permeability at pH 7.4 after 24 hrs by PAMPA method2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Determination of permeability and lipophilicity of pyrazolo-pyrimidine tyrosine kinase inhibitors and correlation with biological data.
AID304901Antiinflammatory activity in CD1 mouse by carrageenan-induced paw edema method2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID24777Percent of total excretion of N-methoxyacetaminophen sulfate1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1141088Antipyretic activity in albino rat assessed as yeast-induced pyrexia at 135 mg/kg, po measured at 3 hrs by telethermometer (Rvb = 38.11 degC)2014Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10
Synthesis, pharmacological screening and in silico studies of new class of Diclofenac analogues as a promising anti-inflammatory agents.
AID624618Specific activity of expressed human recombinant UGT2B42000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID29925Volume of distribution in man (IV dose)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID22724Time course of Distribution of Radioactivity in Mice stomach after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID304917Induction of apoptosis in human hepatocytes after 6 to 8 hrs by Hoechst staining2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1703195Analgesic activity in ip dosed complete freund's adjuvant-induced Sprague Dawley rat model of hyperalgesia assessed as inhibition of inflammatory pain measured after 30 mins by von Frey analgesimetric method2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID413976Inhibition of cyclooxygenase 1 in human whole blood assessed as thromboxane B2 level2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide.
AID449643Antinociceptive activity in po dosed Swiss mouse by inhibition of acetic acid-induced abdominal constriction2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Antinociceptive properties of caffeic acid derivatives in mice.
AID646018Inhibition of His-6 tagged BRD3-RD12 precoupled with biotinylated tetra-acetylated histone H4 expressed in Escherichia coli assessed as protein-protein interaction at 50 uM after 1 hr by TR-FRET assay2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1217713Time dependent inhibition of CYP3A4 (unknown origin) at 10 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID624616Specific activity of expressed human recombinant UGT2B152000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1703175Hepatotoxicity in primary human hepatocytes assessed as increase in lactate dehydrogenase release at 500 to 1000 uM measured after 3 to 12 hrs by fluorescence based analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID304899Analgesic activity in CD1 mouse upto 6620 umol/kg by tail flick test2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID461317Inhibition of human recombinant MGL at 1000 uM2010Journal of medicinal chemistry, Mar-11, Volume: 53, Issue:5
Synthesis and evaluation of paracetamol esters as novel fatty acid amide hydrolase inhibitors.
AID342479Inhibition of human carbonic anhydrase 5A by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID1292895Drug excretion in urine of healthy young adult human assessed as glucuronide conjugate level after 24 hrs1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID191482Nephrotoxicity upon intraperitoneal administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID342485Inhibition of human carbonic anhydrase 14 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID118994No of mice protected out of 12 against acetaminophen-induced Hepatotoxicity after 48 h1987Journal of medicinal chemistry, Oct, Volume: 30, Issue:10
Prodrugs of L-cysteine as protective agents against acetaminophen-induced hepatotoxicity. 2-(Polyhydroxyalkyl)- and 2-(polyacetoxyalkyl)thiazolidine-4(R)-carboxylic acids.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID1289077Analgesic activity in children with tonsillectomy assessed as equilibration half life of delay onset of effect administered at 40 mg/kg, po administered 0.5 to 1 hr prior to tonsillectomy or rectally at induction of anesthesia2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1091957Apparent permeability of the compound by PAMPA2011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID191488Nephrotoxicity upon intravenous administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1647832Toxicity in po dosed mouse
AID481444Octanol-water partition coefficient, log P of the compound2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
How well can the Caco-2/Madin-Darby canine kidney models predict effective human jejunal permeability?
AID268021Aqueous solubility of the compound2006Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13
Synthesis, hydrolyses and dermal delivery of N-alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) derivatives of phenol, imide and thiol containing drugs.
AID1292879Elimination half life in healthy adult male human subject at 12 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1489147Cytotoxicity against HUVEC assessed as reduction in cell viability after 24 hrs by MTT assay2017Bioorganic & medicinal chemistry letters, 09-01, Volume: 27, Issue:17
Chemical constituents from the rare mushroom Calvatia nipponica inhibit the promotion of angiogenesis in HUVECs.
AID1307967Inhibition of human recombinant COX1 expressed in Sf9 cell microsomes assessed as reduction in conversion of arachidonic acid to PGE2 incubated for 5 mins by HTRF assay2016Journal of medicinal chemistry, 05-12, Volume: 59, Issue:9
Impact of Binding Site Comparisons on Medicinal Chemistry and Rational Molecular Design.
AID1292844Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving supportive treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1289058Cmax in Japanese healthy volunteer (5 volunteers) at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID22721Time course of Distribution of Radioactivity in Mice spleen after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1761890Hepatoprotective activity against D-GalN-induced toxicity in human HL-7702 cells assessed as cell survival rate at 10 uM preincubated for 48 hrs followed by D-GalN stimulation for 8 hrs by MTT assay (Rvb = 33 %)2021Journal of natural products, 03-26, Volume: 84, Issue:3
Hepatoprotective Glucosyloxybenzyl 2-Hydroxy-2-isobutylsuccinates from
AID1091956Apparent hydrophobicity, log D of the compound in Octanol-buffer2011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID1728918Inhibition of prostanoid synthesis in FAAH-/- mouse assessed as PGF2alpha level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID304919Upregulation of Fas-ligand in human hepatocytes by Western blot2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1703190Inhibition of CYP2D6 (unknown origin) in baculosomes preincubated for 20 mins followed by addition of CYP enzyme-specific substrate and NADP+ and measured after 30 mins by fluorescence based analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID536418Binding affinity to human CYP1A1-heme complex2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Homology modeling and molecular dynamics of CYP1A1 and CYP2B1 to explore the metabolism of aryl derivatives by docking and experimental assays.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1768729Lipophilicity, logP of compound by shake flask method2021Bioorganic & medicinal chemistry letters, 10-01, Volume: 49Estimation of the lipophilicity of purine-2,6-dione-based TRPA1 antagonists and PDE4/7 inhibitors with analgesic activity.
AID646028Inhibition of human COX-2-mediated PGE2 production after 24 hrs2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID1212280Ratio of Kcat to Km for CYP1A2 (unknown origin) expressed in Escherichia coli DH5alpha preincubated for 5 mins before NADPH addition measured after 30 mins by HPLC analysis2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Preferred binding orientations of phenacetin in CYP1A1 and CYP1A2 are associated with isoform-selective metabolism.
AID1537630Cytotoxicity against rat H9c2 cells assessed as reduction in cell viability at 10 to 80 uM incubated for 24 hrs2019MedChemComm, May-01, Volume: 10, Issue:5
Toxicities and beneficial protection of H
AID342481Inhibition of human carbonic anhydrase 6 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID120609Nephrotoxicity upon intragastric administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1292847Drug recovery in healthy human subjects (8 subjects) assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID317957Antiparasitic activity against chloroquine-resistant Plasmodium falciparum K12008Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5
Antimalarial dual drugs based on potent inhibitors of glutathione reductase from Plasmodium falciparum.
AID1212341Cytotoxicity against human Fa2N-4 cells by lactate dehydrogenase assay2013Drug metabolism and disposition: the biological fate of chemicals, Apr, Volume: 41, Issue:4
Lysosomal sequestration (trapping) of lipophilic amine (cationic amphiphilic) drugs in immortalized human hepatocytes (Fa2N-4 cells).
AID361985Lipophilicity, log D of compound at pH 7.4 by microfluidic liquid-liquid extraction method2008Journal of medicinal chemistry, Aug-28, Volume: 51, Issue:16
Determination of log D via automated microfluidic liquid-liquid extraction.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID20057Urinary Metabolic (3-methoxyacetaminophen) profile in the mouse 24 hr after dose of 3 mmol/kg of the compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID342477Inhibition of human carbonic anhydrase 3 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID268022Solubility in IPM2006Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13
Synthesis, hydrolyses and dermal delivery of N-alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) derivatives of phenol, imide and thiol containing drugs.
AID760174Cytotoxicity against human HepG2 cells assessed as intracellular ATP level after 24 hrs by luciferase reporter gene assay2013ACS medicinal chemistry letters, Aug-08, Volume: 4, Issue:8
Rational Design of Novel Pyridinol-Fused Ring Acetaminophen Analogues.
AID1091955Dissociation constant, pKa of the compound at pH 7.32011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID1289073Drug uptake in Japanese chronic pain patient at 600 to 1000 mg, po administered as single dose after 4 hrs by fluorescence polarization immunoassay2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID646017Inhibition of His-6 tagged BRD2-RD12 precoupled with biotinylated tetra-acetylated histone H4 expressed in Escherichia coli assessed as protein-protein interaction at 50 uM after 1 hr by TR-FRET assay2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID331292Inhibition of human carbonic anhydrase 2 by stopped-flow CO2 hydrase assay2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Carbonic anhydrase inhibitors: Inhibition of the new membrane-associated isoform XV with phenols.
AID1209455Inhibition of human BSEP expressed in plasma membrane vesicles of Sf21 cells assessed as inhibition of ATP-dependent [3H]taurocholate uptake2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
In vitro inhibition of the bile salt export pump correlates with risk of cholestatic drug-induced liver injury in humans.
AID1193497Thermodynamic equilibrium solubility, log S of the compound PBS at pH 7.4 at RT after 24 hrs by shake-flask method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID24776Percent of total excretion of N-methoxyacetaminophen glucuronide1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID481446Effective permeability across human jejunum2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
How well can the Caco-2/Madin-Darby canine kidney models predict effective human jejunal permeability?
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID471212Antihyperalgesic activity in Swiss mouse assessed as inhibition of formalin-induced nociception at 100 umol/kg, po administered 40 mins before formalin challenge measured after 0 to 5 mins2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID22712Time course of Distribution of Radioactivity in Mice feces after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID413972Inhibition of FAAH in rat brain membrane assessed as [14C]anandamide hydrolysis at 50 uM by scintillation counting2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide.
AID1193493Thermodynamic equilibrium solubility, log S of the compound in PBS at pH 7.4 at RT after 4 hrs by 96 well plate method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID1217706Time dependent inhibition of CYP2C9 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1217710Covalent binding in human liver microsomes measured per mg of protein using radiolabelled compound at 10 uM after 1 hr incubation by liquid scintillation counting2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID374260Antipyretic activity in yeast-induced pyrexia albino rat model assessed as mean rectal temperature at 135 mg/kg, po administered 30 mins after 18 hrs of yeast challenge measured after 3 hrs postdosing (Rvb=38.9 degC)2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
Synthesis and pharmacological evaluation of a novel series of 5-(substituted)aryl-3-(3-coumarinyl)-1-phenyl-2-pyrazolines as novel anti-inflammatory and analgesic agents.
AID436672Antipyretic activity against yeast-induced hyperpyrexia in hyperthermic rat assessed as rectal temperature at 100 mg/kg, sc administered 18 hrs after yeast challenge measured after 4 hrs (Rvb=39.17 +/- 0.20 degC)2009Bioorganic & medicinal chemistry, Jul-15, Volume: 17, Issue:14
Synthesis, biological evaluation and docking studies of novel benzopyranone congeners for their expected activity as anti-inflammatory, analgesic and antipyretic agents.
AID15029Concentration distributed until decomposition of N-acetyl-N-hydroxy-p-aminophenol at pH 9.61980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Mechanism of decomposition of N-hydroxyacetaminophen, a postulated toxic metabolite of acetaminophen.
AID387095Antinociceptive activity against acetic acid-induced abdominal constrictions in Swiss mouse assessed as maximal inhibition at 10 mg/kg, ip pretreated 30 mins before acetic acid challenge2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis of new 1-phenyl-3-{4-[(2E)-3-phenylprop-2-enoyl]phenyl}-thiourea and urea derivatives with anti-nociceptive activity.
AID1289057Apparent total clearance in Japanese healthy volunteer (5 volunteers) at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID408890Antinociceptive activity against formalin-induced nociceptive behavior in C57BL/6 mouse assessed as mean licking time at 200 mg/kg, ip administered 15 mins prior to formalin challenge measured upto 10 mins relative to control2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide.
AID624608Specific activity of expressed human recombinant UGT1A42000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID257050Inhibition of recombinant human AKR1C3 at 50 uM2005Bioorganic & medicinal chemistry letters, Dec-01, Volume: 15, Issue:23
Nonsteroidal anti-inflammatory drugs and their analogues as inhibitors of aldo-keto reductase AKR1C3: new lead compounds for the development of anticancer agents.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1292896Drug excretion in urine of healthy young adult human assessed as cysteine conjugate level after 24 hrs1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID118409Tested for Protection from Acetaminophen-Induced Liver Necrosis in Mice, Number of animals(mice) with liver necrosis was determined after 0 hour1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Prodrugs of L-cysteine as liver-protective agents. 2(RS)-Methylthiazolidine-4(R)-carboxylic acid, a latent cysteine.
AID1289060AUC (0 to infinity) in Japanese healthy volunteer (5 volunteers) assessed as acetaminophen-cysteine at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID7783Unbound fraction (plasma)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID22710Time course of Distribution of Radioactivity in Mice brain after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292894Drug excretion in urine of healthy young adult human assessed as sulphate conjugate level after 24 hrs1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID536419Binding affinity to rat CYP2B1-heme complex2010European journal of medicinal chemistry, Nov, Volume: 45, Issue:11
Homology modeling and molecular dynamics of CYP1A1 and CYP2B1 to explore the metabolism of aryl derivatives by docking and experimental assays.
AID1289067Elimination rate constant in Japanese chronic pain patient (5 patients) at 800 +/- 141 mg, po administered as single dose by fluorescence polarization immunoassay2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1292892Half life in healthy young adult human1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID413975Displacement of [3H]CP-55940 from human recombinant CB2 receptor expressed in HEK293 cells at 10 uM2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID191477Nephrotoxicity upon intragastric administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1449741Selectivity ratio of Ki for recombinant human carbonic anhydrase 1 to Ki for recombinant Malassezia globosa beta-carbonic anhydrase2017Bioorganic & medicinal chemistry, 05-01, Volume: 25, Issue:9
Inhibition of Malassezia globosa carbonic anhydrase with phenols.
AID1728919Inhibition of prostanoid synthesis in FAAH-/- mouse assessed as 6-keto-PGF1alpha level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID405531Inhibition of FLAP2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Microsomal prostaglandin E2 synthase-1 (mPGES-1): a novel anti-inflammatory therapeutic target.
AID22711Time course of Distribution of Radioactivity in Mice feces after 3 mmol/kg dose of the Compound after 1 hr1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID20052Urinary Metabolic (acetaminophen-3-mecapturate) profile in the mouse 24 hr after dose of 3 mmol/kg of the compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID481441Aqueous diffusivity at 37C2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
How well can the Caco-2/Madin-Darby canine kidney models predict effective human jejunal permeability?
AID1289076Analgesic activity in children with tonsillectomy assessed as equilibration half life of delay onset of effect at 40 mg/kg administered 0.5 to 1 hr prior to tonsillectomy2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1091958Hydrophobicity, log P of the compound in octanol-water by shaking-flask method2011Journal of agricultural and food chemistry, Apr-13, Volume: 59, Issue:7
Importance of physicochemical properties for the design of new pesticides.
AID191479Nephrotoxicity upon intraperitoneal administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1292866Drug recovery in poisoned human patient (8 patients) without liver damage receiving methionine treatment assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID449662Antinociceptive activity against formalin-induced pain in ip dosed Swiss mouse assessed as reduction of time spent in paw licking2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Antinociceptive properties of caffeic acid derivatives in mice.
AID342483Inhibition of human carbonic anhydrase 9 catalytic domain by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID386623Inhibition of 4-(4-(dimethylamino)styryl)-N-methylpyridinium uptake at human OCT1 expressed in HEK293 cells at 100 uM by confocal microscopy2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Structural requirements for drug inhibition of the liver specific human organic cation transport protein 1.
AID1703193Toxicity in CD1 mouse assessed as animal survival rate at 600 mg/kg, ip measured for every 4 hrs upto 48 hrs by by Kaplan-Meier plot analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1292873Mean drug recovery in poisoned human patient (15 patients) without liver damage receiving cysteamine treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID405546Inhibition of LPS-stimulated TBX2 production in human whole blood2008Journal of medicinal chemistry, Jul-24, Volume: 51, Issue:14
Microsomal prostaglandin E2 synthase-1 (mPGES-1): a novel anti-inflammatory therapeutic target.
AID191476Nephrotoxicity upon intragastric administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID31110The compound tested for toxicity in liver against female mouse after intravenous administration of 2.0 mmol/kg; signifies centrilobular necrosis of liver1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1449738Inhibition of Malassezia globosa recombinant beta-carbonic anhydrase preincubated for 15 mins prior to testing measured for 10 to 100 secs by phenol red-based stopped-flow CO2 hydration assay2017Bioorganic & medicinal chemistry, 05-01, Volume: 25, Issue:9
Inhibition of Malassezia globosa carbonic anhydrase with phenols.
AID1292862Drug recovery in poisoned human patient (8 patients) with severe liver damage receiving NAC treatment assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1217707Time dependent inhibition of CYP2C19 in human liver microsomes at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID191492Nephrotoxicity upon intravenous administration was assessed in rat liver as centrilobular vacuolation or necrosis at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1703180Hepatotoxicity in CD1 mouse assessed as loss of chicken wire hepatic tight junctions at 600 mg/kg, po measured after 12 hrs by ZO-1 staining based optical microscopy2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID114426Hepatotoxicity in Swiss-Webster Mice Caused by compound at 750 mg/kg (i.p.) dose1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID118411Tested for Protection from Acetaminophen-Induced Liver Necrosis in Mice, Number of animals(mice) with liver necrosis was determined after 2 hours1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Prodrugs of L-cysteine as liver-protective agents. 2(RS)-Methylthiazolidine-4(R)-carboxylic acid, a latent cysteine.
AID29423HPLC capacity factor (k')2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID380860Antinociceptive activity in ip dosed Swiss mouse assessed as reduction of acetic acid-induced abdominal constructions administered 30 mins before acetic acid challenge measured for 20 mins1999Journal of natural products, Aug, Volume: 62, Issue:8
Antinociceptive activity of niga-ichigoside F1 from Rubus imperialis.
AID120824Hepatotoxicity in Swiss-Webster Mice Caused by compound at 750 mg/kg (i.p.) dose; 4/101986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID22726Time course of Distribution of Radioactivity in Mice Liver after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292849Drug recovery in poisoned human patient (15 patients) without liver damage receiving cysteamine treatment assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1292884Volume of distribution at central and peripheral compartment in healthy adult male human subject at 12 mg/kg, iv1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1728915Inhibition of prostanoid synthesis in FAAH+/+ mouse assessed as 6-keto-PGF1alpha level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID1309710Metabolic stability in mouse liver S9 fraction assessed as compound remaining after 30 mins2016Journal of medicinal chemistry, 05-26, Volume: 59, Issue:10
Discovery, Optimization, and Biological Evaluation of Sulfonamidoacetamides as an Inducer of Axon Regeneration.
AID29344Ionisation constant (pKa)2002Journal of medicinal chemistry, Jun-20, Volume: 45, Issue:13
Prediction of volume of distribution values in humans for neutral and basic drugs using physicochemical measurements and plasma protein binding data.
AID592681Apparent permeability across human Caco2 cell membrane after 2 hrs by LC-MS/MS analysis2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
QSAR-based permeability model for drug-like compounds.
AID1217711Metabolic activation in human liver microsomes assessed as [3H]GSH adduct formation rate measured per mg of protein at 100 uM by [3H]GSH trapping assay2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID22705Time course of Distribution of Radioactivity in Mice blood after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292891Drug excretion in human urine assessed as unchanged parent compound level1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID555340Effect on growth in Staphylococcus aureus MN8 at 0.50 % after 24 hrs (Rvb = 100%)2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Surfactants, aromatic and isoprenoid compounds, and fatty acid biosynthesis inhibitors suppress Staphylococcus aureus production of toxic shock syndrome toxin 1.
AID1209457Unbound Cmax in human plasma2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
In vitro inhibition of the bile salt export pump correlates with risk of cholestatic drug-induced liver injury in humans.
AID624647Inhibition of AZT glucuronidation by human UGT enzymes from liver microsomes2005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID22891Time course of Distribution of Radioactivity in Mice Liver after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1728901Antipyretic activity against LPS-induced C57BL/6 mouse model of hyperthermia assessed as PGE2 level in diencephalon at 100 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID1187059Hepatotoxicity in zebrafish larvae at 300 uM measured during 3 to 6 days of post-fertilization2014Bioorganic & medicinal chemistry letters, Sep-01, Volume: 24, Issue:17
2-Octadecynoic acid as a dual life stage inhibitor of Plasmodium infections and plasmodial FAS-II enzymes.
AID1703187Hepatotoxicity in CD1 mouse assessed as increase in serum alkaline phosphatase level at 600 mg/kg, po measured after 12 hrs2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID1193492Thermodynamic equilibrium solubility, log S of the compound in water at RT after 4 hrs by 96 well plate method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID646016Binding affinity to His-6 tagged BRD4 expressed in Escherichia coli at 100 uM after 60 mins by fluorescence anisotropic analysis2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1193498Thermodynamic equilibrium solubility, log S of the compound simulated gastric fluid at pH 1.2 at RT after 24 hrs by shake-flask method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1193496Thermodynamic equilibrium solubility, log S of the compound in water at RT after 24 hrs by shake-flask method2015Bioorganic & medicinal chemistry letters, Apr-01, Volume: 25, Issue:7
Thermodynamic equilibrium solubility measurements in simulated fluids by 96-well plate method in early drug discovery.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID24774Percent of total excretion of N-hydroxyacetaminophen glucuronide1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1703185Hepatotoxicity in CD1 mouse assessed as increase in serum alanine aminotransferase level at 600 mg/kg, po measured after 12 hrs2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID1292875Mean drug recovery in poisoned human patient (23 patients) without liver damage receiving NAC treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID624610Specific activity of expressed human recombinant UGT1A72000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1292877Mean drug recovery in poisoned human patient (3 patients) with severe liver damage receiving methionine treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID1289065Apparent total clearance in Japanese chronic pain patient (5 patients) at 800 +/- 141 mg, po administered as single dose by fluorescence polarization immunoassay2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID155368Inhibition of PGH synthase in tissues with lower lipid peroxide concentrations1987Journal of medicinal chemistry, Feb, Volume: 30, Issue:2
Prostaglandin-H synthase inhibition by malonamides. Ring-opened analogues of phenylbutazone.
AID22479Percent dose excreted in 0-48 hours administered ig to female rat1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID288184Permeability coefficient through artificial membrane in presence of unstirred water layer by PAMPA2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
AID1525501Antinociceptive activity in Wistar rat model of acetic-acid induced nociception pain assessed as reduction in writhes by measuring reduction in hind limb extension at 0.01 mmol/0.1kg, ip pretreated for 30 min followed by acetic-acid treatment and measured2019Journal of medicinal chemistry, 10-24, Volume: 62, Issue:20
Rational Design of Multitarget-Directed Ligands: Strategies and Emerging Paradigms.
AID114424Hepatotoxicity in Swiss-Webster Mice Caused by compound at 400 mg/kg (i.p.) dose1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1703197Hepatotoxicity in CD1 mouse assessed as increase in nitrotyrosine formation in liver at 600 mg/kg, po measured after 12 hrs by hematoxylin and eosin staining based optical microscopy2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID1292890Apparent volume of distribution in human1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID602757Maximum permeability flux through hairless mouse skin assessed as theophylline flux through skin from applied topically as suspension in isopropyl myristate2011Bioorganic & medicinal chemistry letters, Jul-01, Volume: 21, Issue:13
N,N'-Dialkylaminoalkylcarbonyl (DAAC) prodrugs and aminoalkylcarbonyl (AAC) prodrugs of 4-hydroxyacetanilide and naltrexone with improved skin permeation properties.
AID1217705Time dependent inhibition of CYP2B6 (unknown origin) at 100 uM by LC/MS system2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID481439Absolute bioavailability in human2010Journal of medicinal chemistry, May-13, Volume: 53, Issue:9
How well can the Caco-2/Madin-Darby canine kidney models predict effective human jejunal permeability?
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID191473Nephrotoxicity upon intragastric administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 5 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1292830Renal clearance in healthy human at 20 mg/kg1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID191487Nephrotoxicity upon intravenous administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID22715Time course of Distribution of Radioactivity in Mice intestine after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1141092Antipyretic activity in albino rat assessed as yeast-induced pyrexia at 135 mg/kg, po measured at 5 hrs by telethermometer (Rvb = 37.89 degC)2014Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10
Synthesis, pharmacological screening and in silico studies of new class of Diclofenac analogues as a promising anti-inflammatory agents.
AID1292887Systemic availability in human1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1292853Drug recovery in poisoned human patient (3 patients) with severe liver damage receiving methionine treatment assessed as sulphate conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID342476Inhibition of human carbonic anhydrase 2 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID22633Percent dose excreted in 0-48 hours administered iv to female mouse1981Journal of medicinal chemistry, Aug, Volume: 24, Issue:8
N-hydroxyacetaminophen: a postulated toxic metabolite of acetaminophen.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID191486Nephrotoxicity upon intravenous administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1292858Drug recovery in poisoned human patient (8 patients) without liver damage receiving methionine treatment assessed as glucuronide conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1257050Inhibition of human carbonic anhydrase 1 incubated for 15 mins prior to testing by stopped flow CO2 hydration assay2015Bioorganic & medicinal chemistry letters, Dec-01, Volume: 25, Issue:23
Interaction of carbonic anhydrase isozymes I, II, and IX with some pyridine and phenol hydrazinecarbothioamide derivatives.
AID374262Antipyretic activity in yeast-induced pyrexia albino rat model assessed as mean rectal temperature at 135 mg/kg, po administered 30 mins after 18 hrs of yeast challenge measured after 5 hrs postdosing (Rvb=38.2 degC)2009European journal of medicinal chemistry, Apr, Volume: 44, Issue:4
Synthesis and pharmacological evaluation of a novel series of 5-(substituted)aryl-3-(3-coumarinyl)-1-phenyl-2-pyrazolines as novel anti-inflammatory and analgesic agents.
AID20055Urinary Metabolic (3-hydroxyacetaminophen) profile in the mouse 24 h after dose of 3 mmol/kg of the compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID304904Hepatotoxicity in CD1 mouse assessed as reduction in hepatic glutathione levels at 6 mmol/kg2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID413974Displacement of [3H]CP-55940 from human recombinant CB1 receptor expressed in HEK293 cells at 10 uM2008Journal of medicinal chemistry, Dec-25, Volume: 51, Issue:24
New analgesics synthetically derived from the paracetamol metabolite N-(4-hydroxyphenyl)-(5Z,8Z,11Z,14Z)-icosatetra-5,8,11,14-enamide.
AID282835Cytotoxicity against mouse L1210 cells2005Journal of medicinal chemistry, Nov-17, Volume: 48, Issue:23
Cellular apoptosis and cytotoxicity of phenolic compounds: a quantitative structure-activity relationship study.
AID471213Antihyperalgesic activity in Swiss mouse assessed as inhibition of formalin-induced nociception at 100 umol/kg, po administered 40 mins before formalin challenge measured after 15 to 30 mins2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID1292893Drug excretion in urine of healthy young adult human assessed as unchanged parent drug level after 24 hrs1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID501585Antiparasitic activity against Trichomonas vaginalis T1 at 100 uM after 24 hrs by hemocytometric analysis2010Bioorganic & medicinal chemistry letters, Sep-01, Volume: 20, Issue:17
Preliminary studies of 3,4-dichloroaniline amides as antiparasitic agents: structure-activity analysis of a compound library in vitro against Trichomonas vaginalis.
AID304915Induction of apoptosis in HEPG2 cells at 100 uM after 6 to 8 hrs by Hoechst staining2007Bioorganic & medicinal chemistry, Mar-01, Volume: 15, Issue:5
Synthesis and in vivo evaluation of non-hepatotoxic acetaminophen analogs.
AID1289059Tmax in Japanese healthy volunteer (5 volunteers) at 1000 mg, po by HPLC method2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID1292864Drug recovery in poisoned human patient (9 patients) without liver damage receiving supportive treatment assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID22723Time course of Distribution of Radioactivity in Mice stomach after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID470917Analgesic activity in Swiss mouse assessed as inhibition of acetic acid-induced abdominal writhings at 100 mg/kg, po administered 60 mins before acetic acid challenge relative to control2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID555373Induction of toxin TSST-1 production in Staphylococcus aureus MN8 at 0.10 % after 24 hrs relative to control2009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Surfactants, aromatic and isoprenoid compounds, and fatty acid biosynthesis inhibitors suppress Staphylococcus aureus production of toxic shock syndrome toxin 1.
AID387102Antinociceptive activity against formalin-induced paw pain in ip dosed Swiss mouse pretreated 30 mins before formalin challenge assessed after 0 to 5 mins2008Bioorganic & medicinal chemistry, Sep-15, Volume: 16, Issue:18
Synthesis of new 1-phenyl-3-{4-[(2E)-3-phenylprop-2-enoyl]phenyl}-thiourea and urea derivatives with anti-nociceptive activity.
AID1292869Drug recovery in poisoned human patient (3 patients) with severe liver damage receiving methionine treatment assessed as mercapturate plus cysteine conjugate level at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID22713Time course of Distribution of Radioactivity in Mice feces after 3 mmol/kg dose of the Compound after 3 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID331291Inhibition of human carbonic anhydrase 1 by stopped-flow CO2 hydrase assay2008Bioorganic & medicinal chemistry letters, Jun-15, Volume: 18, Issue:12
Carbonic anhydrase inhibitors: Inhibition of the new membrane-associated isoform XV with phenols.
AID624611Specific activity of expressed human recombinant UGT1A82000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID342482Inhibition of human carbonic anhydrase 7 by stopped-flow CO2 hydration assay2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID27575HPLC capacity factor (k)2000Journal of medicinal chemistry, Jul-27, Volume: 43, Issue:15
ElogPoct: a tool for lipophilicity determination in drug discovery.
AID1141084Antipyretic activity in albino rat assessed as yeast-induced pyrexia at 135 mg/kg, po measured at 1 hr by telethermometer (Rvb = 38.26 degC)2014Bioorganic & medicinal chemistry, May-15, Volume: 22, Issue:10
Synthesis, pharmacological screening and in silico studies of new class of Diclofenac analogues as a promising anti-inflammatory agents.
AID380861Antinociceptive activity in Swiss mouse assessed as reduction of acetic acid-induced abdominal constructions at 1 to 10 mg/kg, ip administered 30 mins before acetic acid challenge measured after 20 mins relative to control1999Journal of natural products, Aug, Volume: 62, Issue:8
Antinociceptive activity of niga-ichigoside F1 from Rubus imperialis.
AID1703178Hepatotoxicity in human HepaRG cells assessed as decrease in GSH level at 50 to 5000 uM measured after 6 to 24 hrs by Thiol tracker violet dye based fluorescence analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID22717Time course of Distribution of Radioactivity in Mice lungs/heart after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID646015Binding affinity to His-6 tagged BRD3 expressed in Escherichia coli at 100 uM after 60 mins by fluorescence anisotropic analysis2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID1217729Intrinsic clearance for reactive metabolites formation assessed as summation of [3H]GSH adduct formation rate-based reactive metabolites formation and cytochrome P450 (unknown origin) inactivation rate-based reactive metabolites formation2011Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 39, Issue:7
Combination of GSH trapping and time-dependent inhibition assays as a predictive method of drugs generating highly reactive metabolites.
AID1414240Hepatotoxicity in human HepaRG cells assessed as necrotic cell death at 1000 uM measured over 12 hrs by LDH assay2018Bioorganic & medicinal chemistry letters, 12-15, Volume: 28, Issue:23-24
Synthesis, hepatotoxic evaluation and antipyretic activity of nitrate ester analogs of the acetaminophen derivative SCP-1.
AID22720Time course of Distribution of Radioactivity in Mice spleen after 3 mmol/kg dose of the Compound after 1 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID317958Relative IC50 against Plasmodium falciparum K1 and 3D72008Journal of medicinal chemistry, Mar-13, Volume: 51, Issue:5
Antimalarial dual drugs based on potent inhibitors of glutathione reductase from Plasmodium falciparum.
AID1292839Drug recovery in healthy human subjects (8 subjects) at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID282833Activity against caspase-mediated apoptosis in mouse L1210 cells at 0.1 mM2005Journal of medicinal chemistry, Nov-17, Volume: 48, Issue:23
Cellular apoptosis and cytotoxicity of phenolic compounds: a quantitative structure-activity relationship study.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1703186Hepatotoxicity in CD1 mouse assessed as increase in serum aspartate aminotransferase level at 600 mg/kg, po measured after 12 hrs2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID20051Urinary Metabolic (3-(methylthio)acetaminophen) profile in the mouse 24 h after dose of 3 mmol/kg of the compound1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1292845Drug recovery in poisoned human patient (3 patients) with severe liver damage receiving methionine treatment at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID120618Nephrotoxicity upon intraperitoneal administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1257051Inhibition of human carbonic anhydrase 2 incubated for 15 mins prior to testing by stopped flow CO2 hydration assay2015Bioorganic & medicinal chemistry letters, Dec-01, Volume: 25, Issue:23
Interaction of carbonic anhydrase isozymes I, II, and IX with some pyridine and phenol hydrazinecarbothioamide derivatives.
AID624606Specific activity of expressed human recombinant UGT1A12000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1728917Inhibition of prostanoid synthesis in FAAH-/- mouse assessed as PGE2 level in diencephalon at 150 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID470922Analgesic activity in Swiss mouse at 100 umol/kg, po after 120 mins by hot plate test2009European journal of medicinal chemistry, Sep, Volume: 44, Issue:9
Synthesis and pharmacological evaluation of N-phenyl-acetamide sulfonamides designed as novel non-hepatotoxic analgesic candidates.
AID15025Concentration distributed until decomposition of N-acetyl-N-hydroxy-p-aminophenol at pH 6.81980Journal of medicinal chemistry, Mar, Volume: 23, Issue:3
Mechanism of decomposition of N-hydroxyacetaminophen, a postulated toxic metabolite of acetaminophen.
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1292888Dissociation constant, pKa of the compound1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID22706Time course of Distribution of Radioactivity in Mice blood after 3 mmol/kg dose of the Compound after 24 h1986Journal of medicinal chemistry, Sep, Volume: 29, Issue:9
Comparative toxicities and analgesic activities of three monomethylated analogues of acetaminophen.
AID1703182Drug metabolism in CD1 mouse serum assessed as NAPQI formation at 600 mg/kg, po measured after 12 hrs by LC-MS/MS analysis2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID27167Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID191480Nephrotoxicity upon intraperitoneal administration was assessed in rat kidney as proximal tublar necrosis deep in the cortex at a dose of 2 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1728902Antipyretic activity against LPS-induced C57BL/6 mouse model of hyperthermia assessed as PGF2alpha level in diencephalon at 100 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID263728Drug level in mouse plasma at 50 mg/kg, po2006Bioorganic & medicinal chemistry letters, Apr-15, Volume: 16, Issue:8
The geminal dimethyl analogue of Flurbiprofen as a novel Abeta42 inhibitor and potential Alzheimer's disease modifying agent.
AID624619Specific activity of expressed human recombinant UGT2B72000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID646027Binding affinity to His-6 tagged BRD2 expressed in Escherichia coli at 10 mM after 60 mins by fluorescence anisotropic analysis2012Journal of medicinal chemistry, Jan-26, Volume: 55, Issue:2
Fragment-based discovery of bromodomain inhibitors part 1: inhibitor binding modes and implications for lead discovery.
AID118412Tested for Protection from Acetaminophen-Induced Liver Necrosis in Mice, Number of animals(mice) with liver necrosis was determined after 3 hours1982Journal of medicinal chemistry, May, Volume: 25, Issue:5
Prodrugs of L-cysteine as liver-protective agents. 2(RS)-Methylthiazolidine-4(R)-carboxylic acid, a latent cysteine.
AID1292871Mean drug recovery in healthy human subjects (8 subjects) at 20 mg/kg, po1980British journal of clinical pharmacology, Oct, Volume: 10 Suppl 2Kinetics and metabolism of paracetamol and phenacetin.
AID1728903Antipyretic activity against LPS-induced C57BL/6 mouse model of hyperthermia assessed as 6-keto-PGF1alpha level in diencephalon at 100 mg/kg, ip measured after 40 mins by LC-MS/MS analysis relative to control2021European journal of medicinal chemistry, Mar-05, Volume: 213Paracetamol analogues conjugated by FAAH induce TRPV1-mediated antinociception without causing acute liver toxicity.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID374562Analgesic activity in Wistar albino mouse assessed as protection against acetic acid-induced writhing at 100 mg/kg, po administered 30 mins prior to acetic acid challenge measured after 30 mins2009European journal of medicinal chemistry, May, Volume: 44, Issue:5
Synthesis, pharmacological screening, quantum chemical and in vitro permeability studies of N-Mannich bases of benzimidazoles through bovine cornea.
AID436671Antipyretic activity against yeast-induced hyperpyrexia in hyperthermic rat assessed as rectal temperature at 100 mg/kg, sc administered 18 hrs after yeast challenge measured after 3 hrs (Rvb=39.20 +/- 0.24 degC)2009Bioorganic & medicinal chemistry, Jul-15, Volume: 17, Issue:14
Synthesis, biological evaluation and docking studies of novel benzopyranone congeners for their expected activity as anti-inflammatory, analgesic and antipyretic agents.
AID1289069Analgesic activity in po dosed Japanese chronic pain patient (5 patients) assessed as compound dose require to cause 50% maximum pain relief score administered as single dose measured over 15 mins to 6 hrs2007Biological & pharmaceutical bulletin, Jan, Volume: 30, Issue:1
Pharmacokinetics/pharmacodynamics of acetaminophen analgesia in Japanese patients with chronic pain.
AID380865Antinociceptive activity in Swiss mouse assessed as reduction of formalin-induced inflammatory pain at 1 to 10 mg/kg, ip administered 60 mins before formalin challenge measured during 15 to 30 mins relative to control1999Journal of natural products, Aug, Volume: 62, Issue:8
Antinociceptive activity of niga-ichigoside F1 from Rubus imperialis.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID120615Nephrotoxicity upon intraperitoneal administration was assessed in mice kidney as proximal tublar necrosis deep in the cortex at a dose of 10 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID374578Apparent permeability across bovine cornea by UV-visible spectrophotometer2009European journal of medicinal chemistry, May, Volume: 44, Issue:5
Synthesis, pharmacological screening, quantum chemical and in vitro permeability studies of N-Mannich bases of benzimidazoles through bovine cornea.
AID1703188Renal toxicity in CD1 mouse assessed as increase in serum creatinine level at 600 mg/kg, po measured after 12 hrs2020European journal of medicinal chemistry, Sep-15, Volume: 202A novel pipeline of 2-(benzenesulfonamide)-N-(4-hydroxyphenyl) acetamide analgesics that lack hepatotoxicity and retain antipyresis.
AID120610Nephrotoxicity upon intragastric administration was assessed in mice liver as centrilobular vacuolation or necrosis at a dose of 1 mM1980Journal of medicinal chemistry, Nov, Volume: 23, Issue:11
Studies on the mechanism of toxicity of acetaminophen. Synthesis and reactions of N-acetyl-2,6-dimethyl- and N-acetyl-3,5-dimethyl-p-benzoquinone imines.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID1798641CA Inhibition Assay from Article 10.1016/j.bmc.2008.06.013: \\Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.\\2008Bioorganic & medicinal chemistry, Aug-01, Volume: 16, Issue:15
Carbonic anhydrase inhibitors: inhibition of mammalian isoforms I-XIV with a series of substituted phenols including paracetamol and salicylic acid.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1345284Human COX-1 (Cyclooxygenase)2008FASEB journal : official publication of the Federation of American Societies for Experimental Biology, Feb, Volume: 22, Issue:2
Acetaminophen (paracetamol) is a selective cyclooxygenase-2 inhibitor in man.
AID1345206Human COX-2 (Cyclooxygenase)2008FASEB journal : official publication of the Federation of American Societies for Experimental Biology, Feb, Volume: 22, Issue:2
Acetaminophen (paracetamol) is a selective cyclooxygenase-2 inhibitor in man.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (19,465)

TimeframeStudies, This Drug (%)All Drugs %
pre-19903700 (19.01)18.7374
1990's2674 (13.74)18.2507
2000's4315 (22.17)29.6817
2010's6295 (32.34)24.3611
2020's2481 (12.75)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 103.22

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index103.22 (24.57)
Research Supply Index10.07 (2.92)
Research Growth Index4.74 (4.65)
Search Engine Demand Index271.88 (26.88)
Search Engine Supply Index2.77 (0.95)

This Compound (103.22)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials2,848 (13.76%)5.53%
Reviews1,923 (9.29%)6.00%
Case Studies1,639 (7.92%)4.05%
Observational170 (0.82%)0.25%
Other14,116 (68.21%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (1140)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Quantifying Narcotic Use in Outpatient Otolaryngology Procedures [NCT03404518]Phase 3185 participants (Actual)Interventional2018-02-21Completed
A Single-dose, Randomized, Crossover Bioequivalence Study to Compare Two Formulations of Paracetamol/Phenylephrine [NCT01112462]Phase 140 participants (Actual)Interventional2010-03-31Completed
Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being [NCT01211912]Phase 156 participants (Actual)Interventional2010-09-30Completed
Effect of Paracetamol on the Status in Glutathione for the Aged Person [NCT01116596]Phase 118 participants (Actual)Interventional2007-02-28Completed
Symptomatic Effects of Long-term Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis: a Comparative Retrospective Study [NCT03911570]108 participants (Actual)Observational2018-09-01Completed
Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section [NCT03910088]Phase 430 participants (Actual)Interventional2019-04-20Completed
Paracetamol Plus Morphine in ED [NCT03865004]Phase 4136 participants (Actual)Interventional2015-10-17Completed
Comparison of Analgesic Efficacy of Morphine Sulfate Immediate Release (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) for Acute Pain in Emergency Department Patients [NCT03088826]Phase 280 participants (Actual)Interventional2017-08-18Completed
Paracetamol-induced Liver Toxicity in Septic Patients [NCT01182974]Phase 380 participants (Anticipated)Interventional2010-08-31Suspended(stopped due to Difficulty in patient enrollment)
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With ISN/RPS Class III or IV Lupus Nephritis [NCT00282347]Phase 3144 participants (Actual)Interventional2006-01-31Completed
Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery [NCT03783702]Phase 4118 participants (Actual)Interventional2019-04-04Completed
The Effect of Intraoperative Nefopam, Ketoprofen and Paracetamol Combination vs Ketoprofen and Paracetamol Combination on Postoperative Morphine Requirements After Laparoscopic Cholecystectomy: A Randomized, Controlled Trial [NCT04622813]Phase 390 participants (Actual)Interventional2021-04-08Completed
MORphine Use in the Fascia Iliaca Compartment Block With UltraSound [NCT03846102]Phase 455 participants (Actual)Interventional2019-01-28Terminated(stopped due to COVID-19 crisis.)
A Comparison of Single Preoperative Dose of Co-amoxiclav Versus Postoperative Full Course of Amoxicillin/ Co-amoxiclav in Prevention of Postoperative Complications in Dentoalveolar Surgery: a Randomized Controlled Trial [NCT03844776]135 participants (Anticipated)Interventional2019-10-02Recruiting
Effects of Preemptive Intravenous Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy [NCT03783312]60 participants (Actual)Interventional2018-12-20Completed
Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Pain in Patients Presenting to the Emergency Department With Sore Throat: A Double-Blinded, Randomized, Controlled Trial [NCT03768882]Phase 4200 participants (Actual)Interventional2017-12-01Completed
Early Treatment of Vulnerable Individuals With Non-Severe SARS-CoV-2 Infection: A Multi-Arm Multi-Stage Randomized Trial (MAMS) to Evaluate the Effectiveness of Several Specific Treatments in Reducing the Risk of Clinical Worsening or Death in Sub-Saharan [NCT04920838]Phase 2/Phase 3600 participants (Anticipated)Interventional2021-04-12Recruiting
Oseltamivir Versus Paracetamol for Influenza-like Illness During the Influenza Season: a Randomized Controlled Trial [NCT03754686]Phase 4436 participants (Anticipated)Interventional2019-02-10Not yet recruiting
Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone [NCT04399122]Phase 4200 participants (Actual)Interventional2017-03-21Completed
A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain [NCT04307940]Phase 4221 participants (Actual)Interventional2020-03-12Completed
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale [NCT03570554]Phase 241 participants (Actual)Interventional2018-06-29Completed
Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects [NCT03652818]Phase 2115 participants (Actual)Interventional2018-06-15Completed
Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial [NCT03435692]42 participants (Actual)Interventional2011-07-15Terminated(stopped due to Funding was exhausted prior to enrolling intended number of patients.)
Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets ; Multicenter, Open-label, Prospective, Observational Study [NCT00642837]982 participants (Actual)Observational2007-09-30Completed
Opioid-Free Shoulder Arthroplasty [NCT03540030]Phase 486 participants (Actual)Interventional2016-09-30Completed
A Phase 3, Double-Blind, Randomized, Safety And Efficacy Study Comparing A Single Oral Dose Of Ibuprofen (IBU) 250 Mg/Acetaminophen (APAP) 500 Mg (Administered As Two Tablets Of IBU/APAP 125 Mg/250 Mg) To Each Active Drug Monocomponent Alone And To Placeb [NCT02912650]Phase 3568 participants (Actual)Interventional2015-09-30Completed
Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen [NCT02994940]Phase 474 participants (Actual)Interventional2017-08-28Completed
Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial [NCT05974501]Phase 484 participants (Anticipated)Interventional2023-09-29Recruiting
Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair [NCT05974423]Phase 460 participants (Anticipated)Interventional2022-12-16Enrolling by invitation
Assessment of Cognitive Function and Mobility in Individuals With Pain [NCT02974114]Phase 421 participants (Actual)Interventional2016-10-31Terminated
The Effect of Multimodal Pain Therapy After Hernia Repair [NCT03792295]Phase 20 participants (Actual)Interventional2021-07-01Withdrawn(stopped due to no enrollment, reallocation of resources)
Pharmacokinetics and Safety of Treatment With Paracetamol in Children and Adults With Spinal Muscular Atrophy and Cerebral Palsy [NCT03648658]Phase 448 participants (Anticipated)Interventional2019-02-18Recruiting
Does Preoperative Acetaminophen Reduce Biochemical Markers of Oxidative Stress From Cardiopulmonary Bypass? [NCT01228305]30 participants (Actual)Interventional2011-07-31Completed
Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in Patients With Upper Respiratory Tract Infections Presenting With Fever in the Emergency Department [NCT03918135]Phase 4200 participants (Actual)Interventional2019-01-01Completed
Acetaminophen in Combination With N-Acetylcysteine (NAC) vs. Placebo in the Treatment of Fever: A Double-Blind, Randomized Control Study [NCT01137591]0 participants (Actual)Interventional2009-04-30Withdrawn(stopped due to Unable to recruit sufficient participants due to lack of funding; PI has left the institution.)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures [NCT01231191]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to study not funded)
Comparison of Multimodal Analgesic Regimen With Intravenous Acetaminophen to Standard Oral Multimodal Therapy in Primary Total Hip Arthroplasty: A Randomized Controlled Double Blind Trial [NCT02839876]Phase 481 participants (Actual)Interventional2017-03-14Completed
A Randomized-controlled Trial to Assess the Effect of Ibuprofen on Post-partum Blood Pressure in Women With Hypertensive Disorders of Pregnancy [NCT02891174]Phase 474 participants (Actual)Interventional2016-12-01Completed
Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations [NCT03562780]Phase 120 participants (Actual)Interventional2018-11-30Completed
The Prevention of Pain Associated With Rocuronium Injection: Effect of Pretreatment With Acetaminophen and Lidocaine [NCT02524743]Phase 4150 participants (Actual)Interventional2014-05-31Completed
Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair [NCT03818919]Phase 2100 participants (Anticipated)Interventional2019-01-22Recruiting
Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications [NCT03289390]11 participants (Actual)Observational2017-08-01Completed
Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery [NCT03261310]55 participants (Anticipated)Interventional2013-05-31Recruiting
Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery [NCT03244540]Phase 4105 participants (Actual)Interventional2017-09-04Completed
A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination of Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy [NCT04495283]Phase 287 participants (Actual)Interventional2020-07-28Completed
[NCT02452450]Phase 143 participants (Actual)Interventional2014-01-31Completed
The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy [NCT03221998]Early Phase 1126 participants (Anticipated)Interventional2017-07-31Not yet recruiting
Acetaminophen and Social Pain in Borderline Personality Disorder [NCT02108990]Phase 29 participants (Actual)Interventional2013-09-30Completed
Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study [NCT02439034]Phase 2120 participants (Anticipated)Interventional2015-02-28Recruiting
A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty [NCT03789318]Phase 254 participants (Actual)Interventional2018-12-03Completed
Efficacy and Safety of Paracetamol in Comparison to Ibuprofen for Patent Ductus Arteriosus Treatment in Preterm Infants: A Randomized, Open Label, Comparator-controlled, Prospective Study [NCT02422966]Phase 2110 participants (Actual)Interventional2015-12-31Completed
Gastrointestinal Nutrient Transit and Enteroendocrine Function After Upper Gastrointestinal Surgery [NCT03734627]40 participants (Actual)Observational2016-07-01Completed
A Randomized, Placebo-Controlled, Double-Blind, Two-Part, Cross-over Study in Healthy Adult Male Subjects to Compare the Reduction in Pain Intensity After Single-Dose Administration of Intravenous or Oral Acetaminophen and Intravenous Morphine by Using UV [NCT02678416]Phase 479 participants (Actual)Interventional2015-12-07Completed
IV vs. Oral Acetaminophen as a Component of Multimodal Analgesia After Total Hip Arthroplasty: a Randomized, Blinded Trial [NCT03020966]Phase 4154 participants (Actual)Interventional2017-02-16Completed
Postoperative Pain Control & Relief in Neonates [NCT03677830]Phase 411 participants (Actual)Interventional2019-04-19Active, not recruiting
Intravenous Paracetamol Versus Intravenous Dexketoprofen in Patients Presented With Dysmenorrhea in Emergency Department [NCT02373514]Phase 4100 participants (Anticipated)Interventional2015-01-31Recruiting
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial [NCT03073980]Phase 4161 participants (Actual)Interventional2019-09-01Completed
SAFER-SIM: Opiates and Benzodiazepines on Driving [NCT03447353]Phase 418 participants (Actual)Interventional2016-06-14Completed
Accelerated Recovery Following Opioid-free Anaesthesia in Supratentorial Craniotomy [NCT05681429]44 participants (Anticipated)Interventional2023-01-01Not yet recruiting
Reduction of Adverse Events and Re-Presentation to Medical Care After Intravenous Immunoglobulin Treatment in Children With Immune Thrombocytopenia With a Scheduled Post-Infusion Medication Strategy [NCT04741139]Phase 120 participants (Anticipated)Interventional2021-09-02Active, not recruiting
Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes [NCT02932579]Phase 459 participants (Actual)Interventional2017-07-01Terminated(stopped due to Study was halted permanently due to enrollment and logistic issues.)
Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea [NCT03697746]300 participants (Anticipated)Interventional2018-10-01Not yet recruiting
Autologous Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease [NCT04224558]Phase 1/Phase 215 participants (Anticipated)Interventional2020-12-15Recruiting
EFFICACY OF GINGER EXTRACT ON PAIN RELIEF FOR FIRST NORMAL POSTPARTUM WOMEN [NCT03617900]Phase 1/Phase 299 participants (Actual)Interventional2018-08-29Completed
Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial [NCT03080493]Phase 4121 participants (Actual)Interventional2017-03-20Completed
Alternative Acetaminophen Treatment of the Hemodynamivally Significant Patent Ductus Arteriosus in Preterm Neonates Who Are Not Candidates for Enteral Administration: A Pilot Study [NCT03604796]Phase 2/Phase 380 participants (Anticipated)Interventional2018-09-30Not yet recruiting
Multimodal Anesthesia and Analgesia for Total Shoulder and Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial [NCT03586934]Phase 30 participants (Actual)Interventional2018-06-01Withdrawn(stopped due to Difficult to enroll patients for the study)
Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED) [NCT03619785]Phase 470 participants (Anticipated)Interventional2018-11-06Recruiting
Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy [NCT02056678]Phase 40 participants (Actual)Interventional2014-02-28Withdrawn(stopped due to Investigator left institution)
Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial [NCT04662567]42 participants (Actual)Interventional2021-03-12Terminated(stopped due to It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.)
A Sequential Phase 1a/1b Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ARC-521 in Normal Adult Volunteers and Patients With Chronic Hepatitis B [NCT02797522]Phase 147 participants (Actual)Interventional2016-06-30Terminated(stopped due to Company decision to discontinue trial)
A Phase 2, Open-Label Study of HTX 011 in a Multimodal Analgesic Regimen for Decreased Opioid Use Following Unilateral Open Inguinal Herniorrhaphy [NCT03695367]Phase 263 participants (Actual)Interventional2018-10-01Completed
Prospective, Randomized, Double-blind, Placebo-Controlled Study to Compare the Effects of Intravenous Versus Oral Acetaminophen on Postoperative Clinical Outcomes After Ambulatory Lumbar Discectomy [NCT02067442]100 participants (Anticipated)Interventional2013-08-31Recruiting
A MULTICENTER, RANDOMIZED, CONTROLLED STUDY OF EPIDURAL ANALGESIA FOR SEVERE ACUTE PANCREATITIS [NCT02126332]Phase 3148 participants (Actual)Interventional2014-06-06Completed
A Phase I Study of Moxetumomab Pasudotox-tdfk (Lumoxiti (TM)) and Either Rituximab (Rituxan (R)) or Ruxience for Relapsed Hairy Cell Leukemia [NCT03805932]Phase 118 participants (Actual)Interventional2019-10-03Active, not recruiting
Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement [NCT03415555]Phase 419 participants (Actual)Interventional2018-02-07Completed
Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section [NCT02804126]Phase 4232 participants (Actual)Interventional2017-06-01Completed
Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain and Contramal Consumption After a Lumbar Disk Surgery [NCT02252614]Phase 475 participants (Anticipated)Interventional2014-09-30Not yet recruiting
Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis [NCT02252926]Phase 270 participants (Actual)Interventional2014-09-30Completed
Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma [NCT02132416]92 participants (Actual)Interventional2014-05-31Completed
A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort [NCT03965819]27 participants (Actual)Interventional2019-05-30Completed
Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers [NCT03131713]Phase 3101 participants (Actual)Interventional2016-07-01Completed
Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain : a Randomized, Double Blind, Controlled Clinical Trial [NCT01318187]Phase 473 participants (Actual)Interventional2011-01-31Completed
Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients [NCT02091830]2,262 participants (Actual)Observational2013-01-31Completed
Assessment of Preemptive Analgesic Effect of Caldolor® vs. Ofirmev® on Third Molar Surgery: A Prospective, Randomized, Double-blinded Clinical Trial [NCT02133326]Phase 267 participants (Actual)Interventional2014-03-31Active, not recruiting
Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants [NCT02238288]Phase 4154 participants (Anticipated)Interventional2013-12-31Enrolling by invitation
The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction. [NCT01366313]90 participants (Actual)Interventional2007-09-30Completed
A Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations [NCT01568749]Phase 114 participants (Actual)Interventional2008-12-31Completed
Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study [NCT04905563]Phase 4150 participants (Anticipated)Interventional2021-06-07Recruiting
Intravenous Acetaminophen and Morphine Versus Intravenous Morphine Alone for Acute Pain in the Emergency Department: a Multicenter Randomized Controlled Double-blind Non-inferiority Trial [NCT04148495]Phase 4572 participants (Anticipated)Interventional2019-12-03Recruiting
Morphine-sparing Effect of Intravenous Paracetamol for Post-operative Pain Management Following Laparoscopic Gastric Banding in Morbidly Obese Patients [NCT02154464]220 participants (Anticipated)Interventional2014-06-30Not yet recruiting
Validation of Paracetamol Absorption Technique as a Method for Measuring Gastric Tube Outlet to Golden Standard, to Scintigraphy. A Pilot Study [NCT02158286]13 participants (Actual)Observational2012-01-31Completed
Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients [NCT01073670]Phase 482 participants (Actual)Interventional2000-08-31Completed
Feasibility of Delivering Enhanced Recovery After Cardiac Surgery [NCT03859102]80 participants (Anticipated)Interventional2018-12-17Recruiting
Preoperative Controlled-Release Oxycodone or Intraoperative Morphine As Transition Opioid After Intravenous Anesthesia For Video-Assisted Thoracic Surgery: a Randomized, Double-blind, Controlled Trial. [NCT00681174]Phase 422 participants (Actual)Interventional2008-07-31Terminated(stopped due to Failure to enroll sufficient patients by expected deadline.)
Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate [NCT01291654]Phase 280 participants (Anticipated)Interventional2012-04-30Recruiting
Traditional vs. Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction [NCT03818932]Phase 2/Phase 362 participants (Actual)Interventional2019-01-22Completed
Factors Affecting the Speed of Recovery After Anterior Cruciate Ligament Reconstruction [NCT03770806]48 participants (Actual)Interventional2017-03-24Completed
Impact of Oral Acetaminophen Analgesia on Postoperative Delirium and Long-term Survival in Elderly Patients After Non-cardiac Surgery: A Randomized Controlled Trial [NCT03763084]Early Phase 1164 participants (Anticipated)Interventional2019-02-15Recruiting
Effect of Local Anesthetic Continuous Preperitoneal Wound Infiltration on Incisional Hyperalgesia Following Colorectal Laparoscopic Surgery [NCT01077752]Phase 395 participants (Actual)Interventional2010-02-28Completed
Single Dose Oral Celecoxib (With or Without Acetaminophen) for Acute Post-operative Pain Following Impacted Third Molar Surgery. [NCT04790812]Phase 4100 participants (Anticipated)Interventional2021-04-22Recruiting
Single Center, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus [NCT03701074]Phase 21 participants (Actual)Interventional2018-12-15Terminated(stopped due to very slow enrollment. Only one patient enrolled. Termination by PI)
A Randomized, Double-Blind, Multi-Dose, Single-Site, Placebo- and Active-Controlled, Efficacy, Tolerability, Safety and Pharmacokinetic Study of Two Different Dosing Regimens of Acetaminophen in Post-Surgical Dental Pain. [NCT04018612]Phase 2110 participants (Actual)Interventional2019-04-25Completed
An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gelcaps (Containing Acetaminophen 650 mg) of OHM Laboratories (A Subsidiary of Ranba [NCT01079078]26 participants (Actual)Interventional2007-10-31Completed
Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription [NCT03588910]Phase 2120 participants (Actual)Interventional2018-08-08Completed
Clinical Research of the Prognostic Influence of NSAIDS's Anti-inflammatory Effect on Senior Patients With Hip Fracture [NCT01583660]800 participants (Anticipated)Observational2012-01-31Recruiting
Multimodal Analgesia With Acetaminophen vs. Narcotics Alone After Hip Arthroscopy [NCT03510910]Phase 4100 participants (Actual)Interventional2018-04-10Completed
Effect of NSAID Use on Pain and Opioid Consumption Following Distal Radius Fracture: A Prospective, Randomized Study [NCT03749616]Phase 432 participants (Actual)Interventional2019-01-02Completed
IV Paracetamol vs IV Morphine vs Placebo in Sciatalgia in Patients Presented With Sciatalgia to Emergency Department: A Randomized Controlled Trial [NCT02504996]Phase 4300 participants (Anticipated)Interventional2015-01-31Recruiting
The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain [NCT02255955]Phase 475 participants (Anticipated)Interventional2014-10-31Not yet recruiting
Analgesic Efficacy of Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy [NCT03323684]159 participants (Actual)Interventional2017-10-01Completed
A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures [NCT05640674]Phase 4100 participants (Anticipated)Interventional2023-09-12Enrolling by invitation
Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial [NCT04837014]88 participants (Anticipated)Interventional2022-07-04Recruiting
Functional Consequences and Therapeutic Intervention in Hampered Production of Cysteine, Glutathione and Taurine in Classical Homocystinuria [NCT04015557]Phase 1/Phase 210 participants (Anticipated)Interventional2022-02-11Suspended(stopped due to Study was interrupted due to COVID-19 pandemic)
Consequences of Doing What Should Not be Done in Primary Care [NCT03482232]750,000 participants (Actual)Observational2018-10-14Completed
Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery [NCT05488847]Phase 480 participants (Anticipated)Interventional2022-06-25Recruiting
An Open-Label Pilot Study of the Analgesic Efficacy and Safety Of Q8003 and of the Conversion From IV Morphine PCA Analgesia to Q8003 or to Percocet® in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty or Total Hip Arthroplasty [NCT00818493]Phase 244 participants (Actual)Interventional2009-02-28Completed
The Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Obese Children and Adolescents [NCT03192566]Phase 36 participants (Anticipated)Interventional2016-08-31Recruiting
A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous [NCT03295214]Phase 3124 participants (Anticipated)Interventional2018-03-28Recruiting
[NCT00643383]Phase 3277 participants (Actual)Interventional2008-03-31Completed
NSAIDs Versus Paracetamol Versus Paracetamol + NSAIDs in Traumatic Pain Management [NCT03222518]Phase 31,500 participants (Actual)Interventional2017-03-01Completed
Gastric Assessment of Pediatric Patients Undergoing Surgery [NCT05674643]60 participants (Anticipated)Observational2023-02-01Recruiting
Ibuprofen Versus Acetaminophen for Treatment of Mild Traumatic Brain Injury [NCT02443142]Phase 20 participants (Actual)Interventional2015-05-01Withdrawn(stopped due to Lack of study participants.)
Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section Oral vs Intravenous [NCT03626753]Phase 2/Phase 3200 participants (Actual)Interventional2015-01-01Completed
Influence of SPI-guided Analgesia With Preemptive Analgesia Using Either Paracetamol or Metamizole on the Presence of Oculocardiac Reflex, Postoperative Pain, Postoperative Nausea and Vomiting in Patients Undergoing VRS Under General Anaesthesia: a Random [NCT03389243]165 participants (Actual)Interventional2018-01-15Completed
Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction? A Randomised Controlled Trial [NCT03496389]Phase 2/Phase 330 participants (Anticipated)Interventional2018-07-01Not yet recruiting
Use of a Non-Opioid Pain Regimen for Post-Operative Analgesia Following Intracapsular Adenotonsillectomy [NCT04791761]Phase 1/Phase 2300 participants (Anticipated)Interventional2021-04-13Recruiting
Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures [NCT03702023]Phase 4200 participants (Anticipated)Interventional2019-02-08Enrolling by invitation
Pain Management Efficiency at Latent Period of Labour [NCT03105830]150 participants (Anticipated)Interventional2017-05-31Not yet recruiting
Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery [NCT02691572]80 participants (Actual)Interventional2016-02-29Completed
Adjuncts to Intravenous Regional Anaesthesia, a Comparison Between Ketorolac and Paracetamol [NCT03485625]Phase 360 participants (Actual)Interventional2018-03-21Completed
A Multi-center, Randomized, Double-blind, Pilot Study on the Effect of Intravenous Multi-dose Acetaminophen on Readiness for Discharge in Patients Undergoing Surgery With General Anesthesia [NCT02832687]Phase 488 participants (Actual)Interventional2017-06-19Terminated(stopped due to The study was halted due to the worldwide COVID-19 pandemic and the cancellation of all elective cases.)
A Phase 1/2 First-in-human, Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Repeat Doses of UX053 in Patients With GSD III [NCT04990388]Phase 1/Phase 28 participants (Actual)Interventional2021-10-18Terminated(stopped due to Sponsor decision not related to safety concerns)
Relative Effectiveness and Safety of Pharmacotherapeutic Agents for Patent Ductus Arteriosus (PDA) in Preterm Infants: A National Comparative Effectiveness Research (CER) Project [NCT04347720]1,350 participants (Anticipated)Observational [Patient Registry]2020-01-01Recruiting
Topical 5% Imiquimod Cream for Vulvar Paget's Disease: Clinical Efficacy, Safety and Immunological Response [NCT02385188]Phase 325 participants (Actual)Interventional2015-05-31Completed
Comparing Protocols for Analgesia Following Elective Cesarean Section [NCT03622489]Phase 4120 participants (Anticipated)Interventional2017-03-01Recruiting
Pain Management With NSAIDS in Acute Ankle Fractures Type Supination, External Rotation (SER) II: A Prospective Randomized, Single Blinded Controlled Study [NCT02373254]Early Phase 11 participants (Actual)Interventional2015-01-31Completed
Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients [NCT04056845]80 participants (Anticipated)Interventional2019-09-01Recruiting
Observational Prospective Cohort Study to Evaluate the Incidence of Adverse Events (AE), Risk Factors, and Drug Utilization Patterns Related to Treatment With BUSCAPINA COMPOSITUM N From March to December 2016 in Patients From Metropolitan Lima [NCT02910167]360 participants (Actual)Observational2016-10-15Completed
Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial [NCT05161221]Phase 3154 participants (Anticipated)Interventional2021-12-06Enrolling by invitation
A Phase I, Open-label, Single-center Relative Bioavailability and Food Effect Randomized Crossover Study of New Granule and Capsule Formulations of Selumetinib (AZD6244) in Healthy Male Subjects [NCT03649165]Phase 124 participants (Actual)Interventional2018-09-05Completed
Additive Effect of Intravenous Acetaminophen Administered at the End of Surgery on Postoperative Pain Control With Nefopam and Fentanyl-based Patient-controlled Analgesia: A Double-blind Randomized Controlled Trial [NCT03644147]84 participants (Actual)Interventional2018-08-27Completed
Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy [NCT03640247]Phase 1126 participants (Actual)Interventional2018-11-15Completed
A COMPARATIVE STUDY BETWEEN TWO PHARMACOLOGICAL ASSOCIATIONS OXYCODONE/NALOXONE AND CODEINE / PARACETAMOL IN TREATMENT OF MODERATE-SEVERE CHRONIC PAIN DUE TO OSTEOARTHRITIS OF KNEE AND/OR HIP [NCT02032927]Phase 40 participants (Actual)Interventional2013-06-30Withdrawn
Efficacy of NSAID and Acetaminophen in the Control of Post-Operative Pain in Patients Undergoing Total Knee Replacement [NCT05393414]81 participants (Actual)Interventional2019-11-25Completed
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial [NCT06042426]Phase 4100 participants (Anticipated)Interventional2023-09-30Not yet recruiting
A Double Blind, Multi-arm Randomized Control Trial, for Efficacy of Intramuscular Diclofenac Versus Intravenous Morphine Versus Intravenous Paracetamol, in Renal Colic Emergency Department Pain Management [NCT02187614]Phase 41,645 participants (Actual)Interventional2014-08-31Completed
A Randomized, Multicenter Study Comparing the Analgesic Efficacy and Safety of Hydrocodone / Acetaminophen Extended Release to Placebo in Subjects With Acute Pain Following Bunionectomy [NCT01333722]Phase 2100 participants (Actual)Interventional2011-04-30Completed
Prophylactic Paracetamol or Dexamethasone for Post-spinal Anesthesia Shivering in Patients Undergoing Non-obstetric Surgeries: a Randomized Controlled Trial [NCT03679065]Phase 4300 participants (Actual)Interventional2018-03-01Completed
Analgesia of Acute Coronary Syndromes With ST-segment Elevation in a Pre-hospital Setting. Randomized Non-inferiority Trial of the Association MEOPA + Paracetamol Versus Morphine. [NCT02198378]Phase 4680 participants (Actual)Interventional2014-11-30Completed
Improving Post-Operative Pain and Recovery in Gynecologic Surgery [NCT04175509]Phase 440 participants (Actual)Interventional2019-12-23Completed
ACETAMINOPHEN ANTINOCICEPTIVE EFFECT WHEN ASSOCIATED WITH N-ACETYLCYSTENEINE [NCT02206178]Phase 124 participants (Actual)Interventional2013-09-30Completed
IV Acetaminophen Results in Lower Hospital Costs and Emergency Room Visits Following Bariatric Surgery: A Double-Blind Prospective Randomized Trial in A Single Accredited Bariatric Center [NCT02233400]Phase 4113 participants (Actual)Interventional2013-02-28Completed
Patient Perception of Pain Following Extraction and Bone Graft Surgery With or Without Preemptive Ibuprofen: A Randomized Clinical Trial [NCT05919745]Phase 450 participants (Anticipated)Interventional2023-10-31Not yet recruiting
An Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety of a Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents 12 to Less Than 17 Years of Age With Orthodontic Pain [NCT05845008]Phase 375 participants (Anticipated)Interventional2024-01-15Not yet recruiting
Extended Home-use Trial of a Novel Device to Reduce Chronic Neuropathic Pain [NCT04280562]102 participants (Actual)Interventional2020-01-16Completed
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy [NCT05626010]62 participants (Anticipated)Interventional2022-11-23Recruiting
[NCT02095704]Phase 16 participants (Actual)Interventional2013-05-31Completed
A Randomized, Open Label,Prospective Study of the Analgesic Efficacy of Oral Xartemis Compared to Generic Oxycodone/APAP (Acetaminophen) in the Treatment of Moderate to Severe Post Operative Pain [NCT02101476]Phase 4114 participants (Actual)Interventional2014-05-31Completed
A Double-Blind, Repeat-Dose, Parallel Group Study Comparing the Efficacy and Safety of Orally Administered Ibuprofen and Placebo in Delayed Onset Muscle Soreness. [NCT02113566]Phase 460 participants (Actual)Interventional2013-02-28Completed
Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption [NCT02544282]Phase 4140 participants (Actual)Interventional2014-04-30Completed
Effect of Combinations of Paracetamol, Ibuprofen, and Dexamethasone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty. The RECIPE Randomized Clinical Trial [NCT04123873]Phase 41,060 participants (Actual)Interventional2020-03-05Completed
The Comparative Efficacy of Oral vs. Intravenous Acetaminophen in Sinus Surgery Patients [NCT02643394]Phase 4110 participants (Actual)Interventional2015-08-17Completed
Migraine Abortive Treatment in Children and Adolescents in Israel [NCT05048914]50 participants (Anticipated)Observational2019-09-03Recruiting
Analgesic Efficacy of Oral Dexketoprofen Trometamol/Tramadol Hydrochloride Versus Tramadol Hydrochloride/Paracetamol: a Randomised, Double-blind, Placebo and Active-controlled, Parallel Group Study in Moderate to Severe Acute Pain After Removal of Impacte [NCT02777970]Phase 4654 participants (Actual)Interventional2016-04-30Completed
A Phase 3, Double-blind, Randomized, Placebo-controlled, Full Factorial, Safety And Efficacy Study Comparing The Antipyretic Effects Of A Single Oral Dose Of Ibuprofen (Ibu) 250 Mg/ Acetaminophen (Apap) 500 Mg Caplets To Ibu 250 Mg And Apap 500 Mg Caplets [NCT02761980]Phase 3290 participants (Actual)Interventional2016-12-06Completed
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Multidose Clinical Trial to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy [NCT05868122]Phase 3120 participants (Anticipated)Interventional2023-09-07Recruiting
An Open-label, Single-dose, Pharmacokinetic Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Orthodontic Pain [NCT05844995]Phase 130 participants (Anticipated)Interventional2023-09-13Recruiting
A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain [NCT05761574]Phase 3440 participants (Anticipated)Interventional2023-05-22Recruiting
An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Regimens for the Treatment of Subjects With Multiple Myeloma [NCT01998971]Phase 1242 participants (Actual)Interventional2014-02-18Active, not recruiting
Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Caesarean Section. A Double Blind, Randomized, Placebo Controlled Trial. [NCT03068260]Phase 472 participants (Actual)Interventional2017-03-15Completed
Comparison of the Efficacy of IV Acetaminophen Versus IV Indomethacin in Treatment of Hemodynamically Significant PDA in VLBW Infants [NCT03537144]Phase 337 participants (Actual)Interventional2016-06-30Terminated(stopped due to Difficulty enrolling patients)
The Effect of Combination of Mosapride and Dipeptidyl Peptidase-4 (DPP-4) Inhibitor on Plasma Concentration of Incretin Hormones [NCT02180334]Phase 412 participants (Actual)Interventional2014-07-31Completed
Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic Due to Ureteric Calculi: Randomized Controlled Trial [NCT03704623]Phase 4200 participants (Actual)Interventional2019-05-01Completed
A Double-blind, Randomized, Placebo-controlled Clinical Trial to Confirm the Rationale of the ASA + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients [NCT02183688]Phase 31,889 participants (Actual)Interventional1998-09-30Completed
Comparison of the Postoperative Analgesia Effectiveness of Preemptive Intravenous Ibuprofen and Paracetamol in Patients Undergoing Laparoscopic Cholecystectomy [NCT03063658]Phase 4108 participants (Anticipated)Interventional2017-02-01Recruiting
Bariatric Surgery and Pharmacokinetics of Paracetamol: BAR-MEDS Paracetamol [NCT03538457]12 participants (Anticipated)Observational2016-11-02Recruiting
Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial [NCT03482492]60 participants (Actual)Interventional2014-03-20Completed
The Effect of Preoperative Anxiety Level to Postoperative Pain and Analgesic Consumption in Patients Who Had Laparoscopic Sleeve Gastrectomy [NCT04432558]42 participants (Actual)Observational [Patient Registry]2017-04-12Completed
Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After Total Knee Arthroplasty [NCT05672784]63 participants (Anticipated)Interventional2022-11-05Recruiting
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group Study of the Efficacy and Safety of a Single Administration of F14 for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Replacement [NCT05603832]Phase 3151 participants (Actual)Interventional2022-11-17Active, not recruiting
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial [NCT05070650]Phase 31,002 participants (Anticipated)Interventional2024-09-20Not yet recruiting
Minimizing Narcotic Analgesics After Thyroid or Parathyroid Surgery [NCT03469310]Phase 4126 participants (Actual)Interventional2018-03-09Completed
OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris [NCT02613910]Phase 31 participants (Actual)Interventional2015-12-23Terminated(stopped due to Novartis has acquired the rights to ofatumumab and terminated the OPV116910 and OPV117059 studies. This decision is not linked to any safety consideration.)
Intraoperative Wound Instillation of Levobupivacaine is Effective in Postoperative Pain Management for Hernia Repair in Children: a Randomized Controlled Clinical Trial [NCT04869046]Phase 4100 participants (Actual)Interventional2013-03-31Completed
Buscopan® Plus, Buscopan®, Paracetamol and Placebo: Double-blind Randomized Group Comparison to Investigate the Efficacy and Tolerability of the Film-coated Tablets in Patients With Painful Gastric or Intestinal Spasms [NCT02229786]Phase 21,637 participants (Actual)Interventional1998-02-28Completed
Panadol Osteo PBS Claims Cohort Study [NCT02262702]0 participants (Actual)Observational2013-01-31Withdrawn
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy. [NCT04835116]Phase 468 participants (Actual)Interventional2019-04-11Completed
Pharmacokinetic Study of Paracetamol in Patients Over 80 Years Hospitalized to an Acute Geriatric Ward [NCT03617471]36 participants (Actual)Interventional2015-11-30Completed
Metabolism and Toxicity of Acetaminophen in Preterm Infants [NCT01328808]Phase 2/Phase 331 participants (Actual)Interventional2011-10-31Active, not recruiting
Comparison of Transversus Abdominis Plane Block Versus Patient-controlled Epidural Analgesia for Patients on Buprenorphine or Methadone, After Cesarean Section [NCT02091297]0 participants (Actual)Interventional2014-04-30Withdrawn(stopped due to two other institutions that were in the center thought they weren't going to be able to recruit enough patients)
A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures. [NCT02094807]0 participants (Actual)Interventional2014-04-30Withdrawn(stopped due to Slow inclusion rate. Awaiting results from NCT02132416.)
Ureteral Stent-related Pain and Mirabegron (SPAM) Trial [NCT02095665]Phase 422 participants (Actual)Interventional2014-01-01Completed
Does Acetaminophen Potentiate the Gastroduodenal Mucosal Injury of Aspirin? A Prospective, Randomized, Pilot Study. [NCT00594867]Phase 494 participants (Actual)Interventional2006-12-31Completed
Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study [NCT02110719]Phase 4138 participants (Actual)Interventional2014-03-31Completed
Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial [NCT03554018]Phase 3120 participants (Actual)Interventional2018-10-16Completed
Multicentre, Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Analgesic Effects of Different Maxigesic Doses Versus Acetaminophen, Ibuprofen and Placebo for the Teeth Extraction Pain [NCT01104844]Phase 20 participants (Actual)InterventionalWithdrawn(stopped due to The study was withdrawn due to administrative reason)
Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy [NCT02855866]240 participants (Actual)Interventional2013-09-03Completed
A Pharmacokinetic Drug Interaction and Tolerance Study of Paracetamol and Nefopam [NCT02174068]Phase 112 participants (Actual)Interventional2014-07-31Completed
Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair: Prospective Randomized Double-blinded Placebo Controlled Comparison of Lornoxicam and Paracetamol [NCT01069055]Phase 360 participants (Anticipated)Interventional2010-02-28Not yet recruiting
The Effect of Daily Acetaminophen on Patients With Non-alcoholic Fatty Liver Disease (NAFLD) Compared to Healthy Controls [NCT02194894]0 participants (Actual)Interventional2014-06-30Withdrawn(stopped due to No patients enrolled)
Symptomatic Treatment of Acute Uncomplicated Diverticulitis [NCT02219698]158 participants (Anticipated)Interventional2014-07-31Completed
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults [NCT04378114]104 participants (Actual)Interventional2020-05-18Completed
Randomized Clinical Trial of IV Acetaminophen as an Adjuvant Analgesic to IV Hydromorphone for Treatment of Acute Severe Pain in Non-Elderly Emergency Department Patients [NCT03553498]Phase 3162 participants (Actual)Interventional2018-11-27Completed
Dose-dependent Drug-drug Interaction Between Paracetamol and Warfarin in Adults Receiving Long-term Oral Anticoagulants: A Randomized Controlled Trial [NCT01104337]Phase 445 participants (Actual)Interventional2007-03-31Completed
Evaluation of Efficacy and Safety of Subcutaneous Acetaminophen in Geriatrics and Palliative Care [NCT03635684]Phase 231 participants (Actual)Interventional2018-05-17Completed
Effect of Gender-Affirming Testosterone Therapy on Drug Metabolism, Transport, and Gut Microbiota [NCT05116293]12 participants (Anticipated)Observational2021-05-01Active, not recruiting
Assessing Perceived Quality of Care With Differing Pain Management Protocols After Outpatient Otolaryngology Procedures [NCT04976387]Phase 3150 participants (Actual)Interventional2021-07-02Completed
Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity [NCT04879823]Phase 3300 participants (Anticipated)Interventional2021-08-05Recruiting
Opioid Based Analgesia vs Non-opioid Analgesia for Oocyte Retrieval Procedure - a Randomized Clinical Trial [NCT04933058]100 participants (Actual)Interventional2021-12-05Completed
The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study [NCT03858231]Phase 4148 participants (Anticipated)Interventional2018-10-29Recruiting
Efficacy and Safety of Intravenous Tramadol Versus Intravenous Paracetamol for Relief of Acute Pain of Primary Dysmenorrhea: A Randomized Controlled Trial [NCT03509740]Phase 4100 participants (Actual)Interventional2018-04-25Completed
Randomized, Open Label, Comparative, Parallel, Multicenter Trial to Determinate the Efficacy Anf Tolerability of Ibuprofen, Acetaminophen and Dipyrone Drops to Fever Control in Children [NCT01359020]Phase 4396 participants (Actual)Interventional2007-01-31Completed
The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion: a Prospective, Randomized Controlled Trial [NCT03104816]Phase 428 participants (Actual)Interventional2016-10-31Terminated(stopped due to Could not get an approval from Department Reviewer for the study continuation.)
Clinical Study Comparing the Efficacy of Transbuccal Paracetamol 125 mg Versus Paracetamol Injection 1g in Slow Infusion IV in Patients With Acute Pain [NCT01586143]Phase 343 participants (Actual)Interventional2012-05-31Completed
The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial [NCT01586299]40 participants (Anticipated)Interventional2012-03-31Recruiting
A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea [NCT03448536]Phase 4201 participants (Actual)Interventional2018-04-05Completed
NSAID Use and Healing After Tibia Fractures and Achilles Tendon Ruptures [NCT03880981]456 participants (Anticipated)Interventional2019-08-01Not yet recruiting
An Open, Randomised, Parallel Group Controlled, Single Centre Safety Study to Assess the Safety and Efficacy of Tri-Solfen in Providing Anaesthesia Prior to Surgical Debridement of Leg Ulcers and Post-operative Pain Relief [NCT03865147]Phase 290 participants (Anticipated)Interventional2019-01-15Recruiting
Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial [NCT03391284]75 participants (Actual)Interventional2016-02-29Completed
Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial [NCT05154682]Phase 3200 participants (Anticipated)Interventional2021-11-30Enrolling by invitation
Mechanisms of N-acetylcysteine Mediated Vascular Adverse Effects [NCT01209455]24 participants (Anticipated)Interventional2011-01-31Recruiting
PAIR (Paracetamol and Ibuprofen Research) Study: A Randomised Controlled Trial Comparing IV Paracetamol With IV Ibuprofen in the Management of Haemodynamically Significant Patent Ductus Arteriosus [NCT04986839]Phase 2/Phase 332 participants (Anticipated)Interventional2021-09-03Recruiting
Acetaminophen to Prevent Ischemic Oxidative Reperfusion Injury During Percutaneous Coronary Intervention for Acute Myocardial Infarction [NCT01120769]0 participants (Actual)Interventional2011-07-31Withdrawn(stopped due to Funding issue)
Hyoscine Hydrobromide (Buscopan) Versus Acetaminophen for Acute Abdominal Pain in Children: A Randomized Controlled Trial [NCT02582307]Phase 3236 participants (Actual)Interventional2017-03-20Completed
A Phase 2 Open-Label Study of the Pharmacokinetics (PK) and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section [NCT03955211]Phase 225 participants (Actual)Interventional2019-06-24Completed
A PHASE IV, OPEN LABEL, RANDOMIZED, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE, CROSSOVER BIOEQUIVALENCE STUDY TO COMPARE AN ORAL FORMULATION OF TRAMADOL HYDROCHLORIDE 37.5 MG/PARACETAMOL 325 MG TABLETS (TEST PRODUCT OF PFIZER) VERSUS ULTRACET(REGISTERED) (T [NCT03803371]Phase 460 participants (Actual)Interventional2019-03-26Completed
A Multi-centre Phase 2b Randomised Controlled Trial Investigating the Efficacy and Safety of Intravenous Paracetamol in Reducing Core Body Temperature After Traumatic Brain Injury [NCT01231139]Phase 241 participants (Actual)Interventional2010-10-31Completed
Use of Intravenous Acetaminophen in Adolescents and Pediatrics Undergoing Spinal Fusion Surgery: Randomized Controlled Trial [NCT04959591]Phase 399 participants (Actual)Interventional2021-06-01Completed
A PHASE 2b TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY INFANTS 2 AND 6 MONTHS OF AGE [NCT04645966]Phase 2326 participants (Actual)Interventional2020-11-26Terminated(stopped due to The Sponsor decided to discontinue the study based on Sponsor's careful review of available safety data in concert with the recommendation of an independent Data Monitoring Committee.)
A Single Dose Pharmacoscintigraphic Study Investigating the Differences in Gastrointestinal Behavior and Paracetamol Absorption Between Sustained Release Formula and Standard Release Formula [NCT01381640]Phase 10 participants (Actual)Interventional2010-04-30Withdrawn(stopped due to Study was cancelled prior to enrolling any subjects.)
A Pilot Study Comparing the Effectiveness of an Opioid- Sparing Analgesic Regimen and an Opioid Based Regimen on Post- Operative Pain Control in Cardiac Surgery Patients (INOVA OPIOID [NCT03679013]Phase 219 participants (Actual)Interventional2019-04-19Completed
A Double-Blind Comparative Study of JNS013 in Patients With Post-Tooth-Extraction Pain [NCT00737048]Phase 3328 participants (Actual)Interventional2008-03-31Completed
Optimizing Medication for Cancer Pain. The Effect of Paracetamol. A Clinical and Pharmacological Trial to Research Whether Paracetamol Gives an Additional Effect on Pain Relief When the Patient is Treated With High Doses of Opioids [NCT01313247]Phase 450 participants (Anticipated)Interventional2011-04-30Not yet recruiting
Evaluation of Postoperative Analgesic Effects of Bilateral Suprazygomatic Maxillary Nerve Block Using Bupivacaine and Dexmedetomidine in Children Undergoing Cleft Palate Repair Under General Anesthesia:Randomized Controlled Trial [NCT03412474]Phase 280 participants (Actual)Interventional2018-01-14Completed
A Randomized, Controlled Trial Comparing Combination Therapy of Ibuprofen + Acetaminophen Versus Hydrocodone + Acetaminophen for the Treatment of Pain After Carpal Tunnel Surgery [NCT01974609]Phase 4347 participants (Actual)Interventional2016-03-31Completed
[NCT00942565]Phase 460 participants (Actual)Interventional2007-04-30Completed
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery [NCT03084536]Phase 2134 participants (Actual)Interventional2017-06-07Completed
Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial [NCT04691856]66 participants (Actual)Interventional2020-12-24Completed
Neurobehavioral Effects of Positive Airway Pressure (PAP) Therapy in Children With Obstructive Sleep Apnea [NCT01156649]Phase 1/Phase 279 participants (Actual)Interventional2010-07-31Active, not recruiting
Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients [NCT03732469]Phase 44 participants (Actual)Interventional2019-11-01Terminated(stopped due to Significant change in our clinic structure prevented continued recruitment of patients to the study)
Paracetamol Discontinuation in the Elderly After Long-term Consumption [NCT04523740]98 participants (Anticipated)Interventional2020-08-31Recruiting
Randomized Clinical Trial of Non-Opioid Pain Medications After Adenotonsillectomy [NCT03618823]Phase 1/Phase 2268 participants (Actual)Interventional2018-10-25Terminated(stopped due to Early termination due to COVID-19 cases and cancelled surgeries.)
Open-Label Extended Administration of SCH 54031 (PEG Interferon Alfa-2b/PEG Intron) in Subjects With Solid Tumors [NCT03554005]Phase 129 participants (Actual)Interventional1997-12-29Completed
Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department [NCT03173456]Phase 2600 participants (Actual)Interventional2017-11-28Completed
A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy [NCT03599089]Phase 2147 participants (Actual)Interventional2018-07-09Completed
Efficacy of Paracetamol in Addition to Morphine to Improve Analgesia in the Emergency Department: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial [NCT03843281]Phase 4222 participants (Actual)Interventional2019-05-02Completed
EVALUATION OF THE RELATIONSHIP BETWEEN EFFERVESCENT PARACETAMOL AND BLOOD PRESSURE. CLINICAL TRIAL. [NCT02514538]Phase 449 participants (Actual)Interventional2012-02-29Active, not recruiting
Comparison of Pre-emptive Ibuprofen, Acetaminophen, and Placebo Administration in Reducing Local Anesthesia Injection Pain and Post-operative Pain in Primary Tooth Extraction. A Clinical Study [NCT03786029]Phase 2/Phase 366 participants (Actual)Interventional2019-04-01Completed
Effect of Intravenous Paracetamol in Combination With Caudal Ropivacaine on Quality of Postoperative Recovery in Paediatric Patients Undergoing Hypospadias Repair [NCT03781505]Phase 464 participants (Anticipated)Interventional2019-01-31Recruiting
A Prospective, Randomized, Double-blind Study Assessing the Efficacy of Intravenous (IV) Ibuprofen Versus IV Acetaminophen for the Treatment of Pain Following Orthopaedic Low Extremity Surgery [NCT03771755]62 participants (Actual)Interventional2017-07-01Completed
Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential [NCT04074174]Phase 131 participants (Actual)Interventional2019-09-12Completed
Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain [NCT01264965]Phase 425 participants (Actual)Interventional2011-01-31Terminated(stopped due to recruitment problems)
A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects With Idiopathic Intracranial Hypertension With Mild Visual Loss [NCT01003639]Phase 2/Phase 3165 participants (Actual)Interventional2010-01-31Completed
Improving Pain Relief For Those Who Need It Most After Cesarean Delivery [NCT01298778]69 participants (Actual)Interventional2010-08-31Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obinutuzumab In Patients With ISN/RPS 2003 Class III Or IV Lupus Nephritis (REGENCY) [NCT04221477]Phase 3252 participants (Anticipated)Interventional2020-08-10Active, not recruiting
Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines [NCT01235949]Phase 4850 participants (Actual)Interventional2010-11-12Completed
A Comparative Double Blind, Double Dummy, Randomized Study on the Effectiveness of Diclofenac Potassium vs. Acetaminophen in Febrile Children With Acute Upper Respiratory Tract Infections [NCT01019980]Phase 42 participants (Actual)Interventional2010-03-31Terminated(stopped due to Placebo - Active Drug Not Available. No patients received drug. There are no study results to disclose.)
The Effect of Injector and Pacifier Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever [NCT05366049]100 participants (Actual)Interventional2020-11-01Completed
Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis - A Prospective, Randomized, and Double-Blind Clinical Study Using a Two-by-Two Factorial Design [NCT00619203]Phase 3466 participants (Actual)Interventional2008-03-31Completed
MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers [NCT02570581]Phase 116 participants (Actual)Interventional2014-06-30Completed
Assessment of Use of Rapid Diagnostic Testing in the Context of Home Management With ACTs [NCT00720811]6,456 participants (Actual)Interventional2009-10-31Completed
PAracetamol and NSAID in Combination: A Randomised, Blinded, Parallel, 4-group Clinical Trial [NCT02571361]Phase 4556 participants (Actual)Interventional2015-11-30Completed
Ultrasound-Guided Bilateral Thoracic Paravertebral Blocks as an Adjunct to General Anaesthesia in Patients Undergoing Reduction Mammoplasty: A Historical Cohort Study [NCT02671851]64 participants (Actual)Observational2014-01-31Completed
Spinal Analgesia Versus Epidural Analgesia in Minor Laparotomic Liver Surgery in an Enhanced Recovery Programme: A Randomized Controlled Trial [NCT02647047]40 participants (Anticipated)Interventional2016-01-31Not yet recruiting
The Effect of Ibuprofen, Paracetamol and Their Combination on Reactive Oxygen Species (ROS)- Production in Leukocytes and Platelet Activation [NCT00921505]Phase 47 participants (Anticipated)Interventional2009-05-31Completed
A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Multiple-Dose Clinical Trial to Study the Efficacy and Safety of MK0663/Etoricoxib 90 and 120 mg, Ibuprofen 600 mg, and Acetaminophen 600 mg/Codeine 60 mg in the Treatment of [NCT00694369]Phase 3588 participants (Actual)Interventional2008-06-30Completed
Disposition of Intravenous Paracetamol in Young Women, Including During Pregnancy, in Postpartum or When on Oral Contraceptives [NCT02590900]69 participants (Actual)Observational2010-06-30Completed
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Pregabalin and Acetaminophen (Ofirmev®) in Healthy Volunteers [NCT04265456]Phase 163 participants (Actual)Interventional2020-01-14Completed
A Single-Centre, Single Dose, Randomized,Open Label, Exploratory, 5-way Crossover Study Evaluating the Pharmakokinetic Profiles of Various Egalet® Hydrocodone Formulations In Healthy Volunteers Under Fasting Conditions. [NCT00802087]Phase 128 participants (Actual)Interventional2008-11-30Completed
A Randomized Study of Codeine Plus Paracetamol Versus Placebo for PRK Post-operative Pain [NCT02625753]Phase 340 participants (Actual)Interventional2014-11-30Completed
An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee [NCT00324038]Phase 4219 participants (Actual)Interventional2006-03-31Completed
Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice [NCT00631514]Phase 488 participants (Actual)Interventional2005-01-31Completed
Comparative Study Between Different Approaches for the Management of Post-dural Puncture Headache [NCT05253014]120 participants (Actual)Interventional2018-01-01Completed
Lumbar Stenosis Outcomes Research II: Opana IR Versus Placebo and Active Control (Darvocet) for the Treatment of Walking Impairment in Lumbar Spinal Stenosis: A Double-Blind Randomized, Cross-Over Trial [NCT00652093]Phase 424 participants (Actual)Interventional2008-03-31Terminated(stopped due to Removal of Darvocet from US market)
The Impact of Intravenous Anaesthesia on Angiogenesis in Patients With Breast Cancer [NCT02839668]Phase 2120 participants (Actual)Interventional2016-08-31Completed
Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery [NCT02840526]58 participants (Actual)Interventional2013-05-31Completed
[NCT02833584]123 participants (Actual)Interventional2016-09-30Completed
Effect of Acetaminophen on the Incidence of Acute Kidney Injury in Patients Undergoing Aortic Surgery With Moderate Hypothermic Circulatory Arrest [NCT04882202]136 participants (Anticipated)Interventional2021-09-01Recruiting
A Randomized Crossover Study to Determine the Pharmacokinetics of Intranasally Administered Acetaminophen in Healthy Adults [NCT00855049]0 participants (Actual)Interventional2009-04-30Withdrawn(stopped due to Unable to obtain FDA approval)
An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420 as a Single Agent in Hematologic and Molecular Relapsed/Refractory Acute Myeloid Leukemia [NCT04580121]Phase 159 participants (Actual)Interventional2020-11-04Completed
A Multicenter Randomized Controlled Trial in Elderly Patients With Hip Fractures Comparing Continuous Fascia Iliaca Compartment Block to Systemic Opioids and Its Effect on Delirium Occurrence [NCT02689024]Phase 4239 participants (Actual)Interventional2016-05-31Terminated(stopped due to recruitment too slow; intervention was standard care in patients who were not included; acute care pathways changed due to policy regarding hip fracture patients)
Double Blinded Randomized Placebo Controlled Study on Mental Effects of Analgesic Drugs [NCT04424420]Phase 1150 participants (Anticipated)Interventional2019-11-07Recruiting
Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial. [NCT04038307]Phase 2/Phase 3120 participants (Actual)Interventional2019-08-01Active, not recruiting
Comparing Narcotics With Non-steroidal Anti-inflammatory Drugs (NSAIDS) Post-operatively in Pediatric Patients Undergoing Adenotonsillectomy [NCT02296840]Phase 445 participants (Actual)Interventional2014-11-30Terminated
Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients [NCT05690282]Phase 4100 participants (Anticipated)Interventional2021-05-17Active, not recruiting
A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Different Amounts of Tablets of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate 5 mg/Acetaminophen 325 mg (a New Abuse Deterrent Tablet and a Marketed Tablet) [NCT03137030]Phase 10 participants (Actual)Interventional2017-09-30Withdrawn(stopped due to program discontinued)
A Randomized, 2-Way, Parallel, Single-Blind Pharmacokinetic Study to Evaluate the Interaction Between Intravenous Morphine and Orally or Intravenously Administered Acetaminophen in Healthy Subjects [NCT02848729]Phase 450 participants (Actual)Interventional2016-02-29Completed
Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter [NCT05097950]200 participants (Anticipated)Interventional2021-11-30Not yet recruiting
Improving Perioperative Pain Management for Laparoscopic Surgery Due to Colon Cancer Using the Ultrasound-guided Transmuscular Quadratus Lumborum Block. A Double Blind, Randomized, Placebo Controlled Trial. [NCT03570541]Phase 469 participants (Actual)Interventional2018-06-28Completed
Efficacy of Expressed Breast Milk Alone or in Combination With Paracetamol in Reducing Pain During ROP Screening [NCT05354479]Phase 460 participants (Anticipated)Interventional2021-10-20Recruiting
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial [NCT05340582]Phase 2310 participants (Anticipated)Interventional2022-12-12Recruiting
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures [NCT05076110]Phase 4188 participants (Anticipated)Interventional2022-04-07Recruiting
Phase III Clinical Trial Studying Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children [NCT02477007]Phase 3304 participants (Actual)Interventional2015-12-03Completed
Combination of Acetaminophen and Ibuprofen in the Management of Patent Ductus Arteriosus in Premature Infants: A Pilot Study [NCT03103022]Phase 120 participants (Actual)Interventional2017-06-12Completed
Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain. [NCT04968158]Phase 3124 participants (Actual)Interventional2021-11-29Completed
The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Department for Renal Colics [NCT05722782]Phase 2500 participants (Anticipated)Interventional2023-07-01Recruiting
Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia [NCT03913559]Phase 232 participants (Anticipated)Interventional2019-05-14Recruiting
The Effect of Intraoperative Ketamine on Opioid Consumption and Pain After Spine Surgery in Opioid-dependent Patients [NCT02085577]Phase 4147 participants (Actual)Interventional2014-05-31Completed
The Management of Chronic Pain With Acetaminophen Four Times a Day [NCT02086747]Phase 4140 participants (Actual)Interventional2013-03-31Completed
[NCT02251249]Phase 423 participants (Actual)Interventional2014-12-08Completed
A Randomised, Open-label, Three-treatment, Single Dose, Crossover Study Investigating the Bioequivalence of Co-codamol 15/500mg Capsules With a Co-codamol 30/500mg Tablet in Healthy Subjects Under Fasting Conditions [NCT03280095]Phase 150 participants (Actual)Interventional2014-09-23Completed
Intravenous Acetaminophen Versus Saline in Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized, Double Blind, Placebo Controlled Trial [NCT02400580]Phase 4183 participants (Actual)Interventional2015-02-28Completed
Combined Effect of Preoperative Dexamethasone and Intraoperative Paracetamol on Postoperative Sore Throat for Patients Undergoing Urologic Surgery [NCT02252419]242 participants (Anticipated)Interventional2014-10-31Not yet recruiting
The Effect of Intravenous Paracetamol in Combination With NSAIDs for Postoperative Pain in Children [NCT02248493]Phase 454 participants (Actual)Interventional2012-11-30Completed
Postoperative Effects of Chewing Gum, Ibuprofen and Acetaminophen on Pain After Initial Archwire Placement: a Randomized Controlled Trial [NCT03568721]Phase 481 participants (Actual)Interventional2015-01-25Completed
A Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 4-Way Crossover Study to Evaluate the Relative Abuse Potential of Hydrocodone Bitartrate and Acetaminophen 6 × 10/325 mg Tablets Compared to NORCO® 6 × 10/325 mg Tablets and Placebo [NCT03567941]Phase 132 participants (Actual)Interventional2017-12-29Completed
Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus Closure in Preterm Infants. A Prospective, Randomized, Controlled, Double Blind, Multicenter Clinical Trial. [NCT02056223]Phase 2/Phase 3120 participants (Anticipated)Interventional2017-01-09Suspended(stopped due to We enrolled only 53 patients)
Acetaminophen 1g IV vs Hydromorphone 1mg IV for the Treatment of Acute Pain in the Emergency Department [NCT03107481]Phase 4220 participants (Actual)Interventional2017-06-04Completed
Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis : A Single-blind Randomized Controlled Trial. [NCT03224637]60 participants (Actual)Interventional2014-07-31Completed
A Single Site, Phase 2B, Randomized, Double-Blind, Study to Assess the Efficacy, Safety, and Tolerability of Low-Dose Naltrexone and Acetaminophen Combination vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4) [NCT03201393]Phase 212 participants (Actual)Interventional2017-08-15Completed
Effects of Intravenous Acetaminophen in Patients Undergoing Thoracoscopic Surgery [NCT03051932]0 participants (Actual)Interventional2018-06-01Withdrawn(stopped due to Not funded)
A Double-blind Randomized, Placebo-controlled Study to Determine the Effectiveness of Pre-operative IV Acetaminophen Administration in Reducing Post-operative Pain, Nausea, and Vomiting in the Outpatient Setting [NCT02102555]Phase 382 participants (Actual)Interventional2013-10-31Terminated(stopped due to study closed due to difficulty enrolling subjects - no results)
Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair [NCT03041948]88 participants (Anticipated)Interventional2015-09-01Recruiting
Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation (CTOT-21) [NCT02711826]Phase 1/Phase 214 participants (Anticipated)Interventional2016-09-20Completed
Variability of Sulfotransferase 1A1 Activity in Humans: an Approach to Improve Predictive Drug Response - Part I: Analysis of Intraindividual Variation in Healthy Adults [NCT03182595]Phase 136 participants (Actual)Interventional2017-03-17Completed
Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Nontraumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial [NCT03122314]Phase 4200 participants (Actual)Interventional2015-08-31Completed
Randomized Comparison of Two Pre-induction Analgesia Regimens: Multimodal vs Acetaminophen in the Reduction of Post-operative Pain Following Ureteroscopy With Lithotripsy for Kidney Stones Evaluated With Text Messaging [NCT03549611]Phase 40 participants (Actual)Interventional2018-08-01Withdrawn(stopped due to elected not to proceed with the study)
Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients [NCT02160301]Phase 40 participants (Actual)Interventional2017-11-30Withdrawn(stopped due to Insufficient infrastructure/funding for enrollment)
Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics [NCT02417337]Phase 2170 participants (Actual)Interventional2012-08-31Completed
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Abdominoplasty (Cohort 2) [NCT06109428]Phase 430 participants (Actual)Interventional2021-10-12Completed
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Total Shoulder Arthroplasty (TSA) [NCT06109415]Phase 430 participants (Actual)Interventional2021-10-20Completed
PROUD Study - Preventing Opioid Use Disorders [NCT04766996]Phase 457 participants (Actual)Interventional2021-05-17Terminated(stopped due to Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.)
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Laparoscopic Gynecology Surgery [NCT05509244]64 participants (Anticipated)Interventional2022-09-09Recruiting
Phase III Clinical Trial - Efficacy and Safety Assessment of a Compound Acetaminophen, Chlorpheniramine and Phenylephrine Combination in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome in Adults [NCT00940836]Phase 3146 participants (Anticipated)Interventional2009-06-30Recruiting
Evaluation of Effect of Intravenous Morphine vs Intravenous Ibuprofen and Acetaminophen vs Intravenous Ibuprofen on Pain Relief in Patients With Closed Extremity Fracture Admitted in Alzahra and Ayatollah Kashani Hospitals in 2022 [NCT05630222]Phase 3150 participants (Actual)Interventional2022-03-15Completed
PANDORA: Scheduled Prophylactic 6-hourly Intravenous Acetaminophen to Prevent Postoperative Delirium in Older Cardiac Surgical Patients [NCT04093219]Phase 3900 participants (Anticipated)Interventional2020-08-11Recruiting
A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever [NCT00493246]Phase 175 participants (Actual)Interventional2007-06-30Completed
The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial [NCT01021696]Phase 2/Phase 3352 participants (Actual)Interventional2009-11-30Completed
"ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial" [NCT03987022]Phase 466 participants (Actual)Interventional2019-08-01Completed
Paracetamol Route in Palliative Care Patients : Intravenous Versus Subcutaneous Route Pharmacokinetics, Study Protocol for a Randomized Equivalence Pilot Trial [NCT03944044]20 participants (Anticipated)Interventional2019-07-15Recruiting
Population Pharmacokinetics of Paracetamol in Overweight and Obese Children [NCT06135389]60 participants (Anticipated)Observational2023-11-30Not yet recruiting
A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma [NCT06043323]Phase 220 participants (Anticipated)Interventional2024-03-31Not yet recruiting
Cryoneurolysis of the Saphenous Nerve or Geniculate Nerves: Impact on Postoperative Pain and Rehabilitation in Prosthetic Knee Surgery [NCT05059535]Phase 490 participants (Anticipated)Interventional2022-01-12Recruiting
StudY of Effect of Nimodipine and Acetaminophen on Postictal Symptoms After ECT [NCT04028596]Phase 234 participants (Actual)Interventional2019-12-05Completed
Extremely Low Gestational Age Infants' Paracetamol Study: a Randomized Trial [NCT03641209]Phase 1/Phase 240 participants (Actual)Interventional2018-09-03Active, not recruiting
Open-label Study of the Safety and Effectiveness of Short-term Therapy With Extended-release Tramadol (TRAMADEX-OD) in the Management of Pain After Knee Arthroscopy. [NCT01024348]100 participants (Anticipated)Interventional2009-12-31Not yet recruiting
The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial [NCT02153177]Phase 40 participants (Actual)Interventional2015-01-31Withdrawn(stopped due to The study was withdrawn prior to any participants being enrolled.)
Evaluation of the Interaction of Rimonabant (Antagonist of CB1 Receptor) on the Analgesic Effect of Paracetamol in Intravenous Administration [NCT00750347]Phase 124 participants (Anticipated)Interventional2008-09-30Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen Versus Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males [NCT00493311]Phase 360 participants (Actual)Interventional2007-06-30Completed
Single and Multiple Dose Trial to Evaluate Pharmacokinetics, -Dynamics and Safety of iv Paracetamol in Preterm and Term Neonates [NCT00969176]Phase 2/Phase 360 participants (Anticipated)Interventional2009-09-30Completed
A Single-Centre, Open-Label, Randomised Study to Compare the Single Dose (Including the Effect of Food) and Multiple Dose Pharmacokinetic Profiles of Acetram Contramid® BID Tablets vs the Immediate-Release Tablet Reference Products Zaldiar® and Ultracet® [NCT00973232]Phase 158 participants (Actual)Interventional2008-05-31Completed
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty [NCT04003350]216 participants (Actual)Interventional2017-12-21Completed
Study of the Effect of Dipyrone, Ibuprofen, Paracetamol and Parecoxib on the Platelet Aggregation [NCT00763997]80 participants (Actual)Interventional2004-02-29Completed
Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic S [NCT00399568]Phase 3331 participants (Actual)Interventional2006-11-30Completed
Demonstration of OTC Naproxen Sodium's (Aleve's) Anti-inflammatory Action in Dental Implant Surgery Patients [NCT04694300]Phase 432 participants (Actual)Interventional2021-02-07Completed
Low-Dose Opiate Therapy for Discomfort in Dementia (L-DOT) [NCT00385684]Phase 411 participants (Actual)Interventional2007-10-31Completed
Pharmacokinetic/Pharmacodynamic Study of Paracetamol Taken as an Oral Chewing Capsule Versus Normal Tablet in Healthy Young Men. [NCT03953287]Phase 112 participants (Anticipated)Interventional2019-08-18Not yet recruiting
Comparison of Tramacet Versus Percocet in Post Surgical Patients [NCT02361567]Phase 4160 participants (Actual)Interventional2015-04-30Completed
The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study [NCT02602197]Phase 32 participants (Actual)Interventional2013-08-31Active, not recruiting
A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Dental Pain Relief [NCT01082081]Phase 4300 participants (Actual)Interventional2009-10-31Completed
TIME TO RE-EVALUATE THE KINDER GENTLER APPROACH TO PATENT DUCTUS ARTERIOSUS (PDA) IN THE PRETERM NEONATE [NCT02819414]Phase 280 participants (Anticipated)Interventional2016-06-30Active, not recruiting
The Effectiveness of Wet Cupping on Persistent Non-specific Low Back Pain: A Randomized, Waiting-list Controlled, Open-label, Parallel-group Pilot Study [NCT00925951]37 participants (Anticipated)Interventional2009-06-30Completed
Analgesic Efficacy of Combined Lumbar Erector Spinae Plane Block and Pericapsular Nerve Group Block in Patients Undergoing Hip Surgeries [NCT05930171]Phase 424 participants (Actual)Interventional2023-02-01Completed
Celecoxib vs. Acetaminophen-codeine-caffeine for Postoperative Pain in Primary Elective Open Septorhinoplasty With Osteotomies: a Randomized Controlled Trial. [NCT04259333]Phase 460 participants (Anticipated)Interventional2020-03-01Recruiting
Effects of Acetaminophen Preemptive Analgesia on Anesthesia Recovery Time and Postoperative Cognitive Function in Patients Undergoing Gastrointestinal Tumor Surgery [NCT06004687]Phase 1/Phase 2100 participants (Anticipated)Interventional2023-07-26Recruiting
Comparison of the Opioid-sparing Effect of Preemptive and Preventive Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy: A Double-blind Randomized Controlled Trial [NCT05685342]154 participants (Anticipated)Interventional2023-02-27Recruiting
Evaluation of the Efficacy of Different Drugs in the Treatment of the Pain in Patients With Temporomandibular Disorder [NCT05529290]Phase 4200 participants (Actual)Interventional2019-07-16Completed
An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients [NCT00576173]Phase 460 participants (Actual)Interventional2005-12-31Completed
Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial [NCT02600247]100 participants (Anticipated)Interventional2015-11-30Not yet recruiting
EVALUATION OF ORAL USE OF DEXKETOPROFEN/TRAMADOL IN ACUTE POSTOPERATIVE PAIN IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH A MINIMALLY INVASIVE ANTERIOR APPROACH (AMIS). [NCT04178109]Phase 2226 participants (Actual)Interventional2019-01-10Completed
Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures [NCT03651804]Phase 460 participants (Anticipated)Interventional2019-04-10Suspended(stopped due to Difficulty recruiting members)
Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial [NCT02750696]27 participants (Actual)Interventional2013-04-30Completed
Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients [NCT02737124]Phase 30 participants (Actual)Interventional2017-02-16Withdrawn(stopped due to Study is currently Lapsed)
A Phase 1, Fixed-Sequence, Open-label Study in Healthy Subjects to Estimate the Effects of ITCA 650 on Gastric Emptying and on the Absorption Pharmacokinetics of Each of 4 Commonly Studied Drug/Drug Interaction (DDI) Probe Compounds [NCT02641899]Phase 133 participants (Actual)Interventional2015-12-31Completed
Effect of Opioids and NSAIDs on Sympathetic Nervous System and Vascular Function in Healthy Subjects and Patients With Osteoarthritis [NCT03781544]Phase 490 participants (Anticipated)Interventional2019-01-01Recruiting
A Prospective,Open-label, Dose Escalation Phase 1 Study to Investigate the Safety, and Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of a HLX07, in Patients With Advanced Solid Cancers. [NCT02648490]Phase 119 participants (Actual)Interventional2016-09-30Completed
Efficacy and Safety of Different Dosage Regimens of the Combination Methocarbamol/Paracetamol in Acute Low Back Pain (LBP): MioPain Study [NCT05204667]Phase 4192 participants (Anticipated)Interventional2021-10-07Recruiting
Decreased Opioid Consumption and Enhance Recovery With the Addition of IV-Acetaminophen in Colorectal Patients: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study [NCT02804633]105 participants (Actual)Interventional2013-08-31Completed
An Open-label, Multicenter, Randomized, Parallel Group, Single-dose Study to Assess the Short Term Efficacy and Safety of Paracetamol 500 mg + Phenylephrine HCl 10 mg + Vitamin C 200 mg Powder for Oral Solution in Subjects With Symptoms of an Upper Respir [NCT02678234]Phase 30 participants (Actual)Interventional2017-02-01Withdrawn(stopped due to The clinical phase of the study (from FSFV to LSLV) was never initiated due to the sponsor's decision.)
Analgesia Postoperatoria Mediante Catetere Perdurare e Analgesia Postoperatoria Mediante Infusione Continua Periferia Nell'Intervento Chirurgico Per Riparazione Chirurgica di Aneurismi Dell'Aorta Addominale: Tecniche a Confronto [NCT02677532]Phase 451 participants (Actual)Interventional2011-12-31Completed
The Effect of Dexamethasone vs Vicodin in Reducing Post-operative Pain After Periodontal Surgery Among Patients at the Henry M. Goldman School of Dental Medicine Pilot Study [NCT04008043]Phase 40 participants (Actual)Interventional2020-02-29Withdrawn(stopped due to Inadequate resources to start the study at this site.)
Comparison Between Dexamethasone and Ibuprofen on Postoperative Pain Prevention and Control Following Surgical Implant Placement: a Double-Blind, Parallel-Group, Placebo-Controlled Randomized Clinical Trial [NCT02763059]Phase 4132 participants (Actual)Interventional2013-09-30Completed
The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Randomized Controlled Study. [NCT00679614]Phase 345 participants (Actual)Interventional2007-12-17Completed
Dipyrone Versus Acetaminophen in the Control of Postoperative Pain [NCT00841841]Phase 230 participants (Actual)Interventional2006-03-31Completed
Intravenous Lornoxicam is More Effective Than Paracetamol as a Supplemental Analgesic After Lower Abdominal Surgery; A Randomized Controlled Trial [NCT01564680]Phase 460 participants (Actual)Interventional2009-03-31Completed
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) [NCT04918147]Phase 275 participants (Anticipated)Interventional2021-10-13Recruiting
An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy [NCT03885596]Phase 236 participants (Actual)Interventional2019-03-25Completed
Randomized, Two-way, Two-period, Single Oral Dose, Open-label, Crossover, Bioequivalence Study to Compare Ibuprofen/ Paracetamol Tablets (200mg Ibuprofen/ 500mg Paracetamol) Versus Nuromol® Tablets (200mg Ibuprofen/ 500mg Paracetamol) in Healthy Subjects [NCT06180070]Phase 136 participants (Actual)Interventional2023-08-29Completed
Duloxetine for Post Operative Analgesia After Modified Radical Mastectomy:A Randomized Controlled Study [NCT05442268]40 participants (Anticipated)Interventional2022-07-16Recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy [NCT05553366]Phase 31,075 participants (Actual)Interventional2022-10-03Active, not recruiting
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty [NCT05558410]Phase 31,118 participants (Actual)Interventional2022-10-10Completed
A Randomized Study Comparing Intravenous (IV) Acetaminophen to Usual Care for Pain Management for Small Bowel Obstruction - Feasibility Study [NCT05878015]Phase 412 participants (Anticipated)Interventional2023-10-11Enrolling by invitation
A Double Blinded Randomized Control Trial of Intravenous Paracetamol vs. Placebo in Patients Receiving Radiofrequency Ablation of the Medial Branch Facet Nerve [NCT02539979]50 participants (Anticipated)Interventional2015-08-31Recruiting
Enhancement of Glucagon Counterregulation in Type 1 Diabetes by Basal Amylin Replacement [NCT03547427]13 participants (Actual)Interventional2018-05-20Terminated(stopped due to Clinical staffing issues and COVID-19 pandemic)
A Phase III, Randomized, Double-Blind, Double-Dummy, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen Versus Oral Acetaminophen for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males [NCT00564629]Phase 3105 participants (Actual)Interventional2007-08-31Completed
Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department [NCT03996564]26 participants (Actual)Interventional2016-02-22Completed
Randomized Clinical Trial to Evaluate Guidelines for Acute Rhinosinusitis (Phase IV Study) [NCT00377403]Phase 4172 participants (Actual)Interventional2006-10-31Completed
Efficacy of Intravenous Acetaminophen as Analgesic Adjuvant Therapy in Children Undergoing Posterior Fossa Surgery [NCT02532322]Phase 20 participants (Actual)Interventional2015-11-30Withdrawn(stopped due to not enough patients meeting criteria)
A Two Part Protocol Using Double Blind Placebo Control to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Intra-articular Doses Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Intra-arti [NCT02845271]Phase 2104 participants (Actual)Interventional2016-07-21Completed
Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery [NCT03558555]Phase 4103 participants (Actual)Interventional2017-12-08Completed
Symptomatic Management of Lyme Arthritis [NCT04038346]Phase 3300 participants (Anticipated)Interventional2019-10-01Recruiting
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions: A Randomized, Double-blinded, Controlled Trial [NCT04112550]Phase 1150 participants (Anticipated)Interventional2020-02-11Not yet recruiting
Traditional vs. Nonopioid Analgesia After Arthroscopic Meniscus Surgery [NCT03820193]Early Phase 161 participants (Actual)Interventional2019-01-22Completed
Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients [NCT04271917]Phase 368 participants (Actual)Interventional2020-02-24Completed
Analgesic Effect of Ibuprofen 400, 600 and 800 mg, Paracetamol 500 and 1000 mg, and Paracetamol 1000 mg Plus 60 mg Codeine: Single-dose, Randomized, Placebo-controlled and Double-blind Study on Acute Pain After Third Molar Surgery [NCT00699114]Phase 4350 participants (Anticipated)Interventional2007-06-30Completed
Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Endodontic Treatment Pain [NCT02614118]Phase 266 participants (Actual)Interventional2015-09-30Completed
Analgesic Effect of Ibuprofen 400 mg/Paracetamol 1000 mg, Ibuprofen 400 mg/ Paracetamol 1000 mg/60 mg Codeine, and Paracetamol 1000 mg/Codeine 60 mg: A Single-dose, Randomized, Placebo-controlled and Double-blind Study [NCT00921700]Phase 4200 participants (Actual)Interventional2009-06-30Completed
INTACT-HIP: INTravenous Acetaminophen vs. Oral Randomized Controlled Trial in HIP Fracture Patients - a Feasibility Trial [NCT05425355]Phase 442 participants (Anticipated)Interventional2022-11-04Not yet recruiting
A Phase III, Multi-Center, Open-Label, Prospective, Repeated Dose, Randomized, Controlled, Multi-Day Study of the Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients [NCT00598559]Phase 3213 participants (Actual)Interventional2008-01-31Completed
Pharmacokinetic Interaction Study Between Ibuprofen 200 mg and Acetaminophen 500 mg, Tablets Administered Individually or in Combination, Single Dose in Healthy Subjects, Both Genders Under Fasting Conditions [NCT05428306]Phase 142 participants (Actual)Interventional2018-10-23Completed
Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial [NCT01428375]Phase 3120 participants (Anticipated)Interventional2011-08-31Completed
Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery [NCT04087317]220 participants (Anticipated)Interventional2019-09-01Not yet recruiting
Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma [NCT01465984]Phase 460 participants (Actual)Interventional2011-11-30Completed
A Study to Evaluate the Clinical Benefits of Tramadol/Acetaminophen (Ultracet®) vs. Diclofenac (Voltaren®) in the Treatment of Pain in Patients With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) [NCT00766402]Phase 48 participants (Actual)Interventional2008-10-31Terminated
A Randomised Multi-centre Feasibility Study Investigating Post-operative Pain Following Single-port or Multi-port Video Assisted Thoracoscopic Surgical (VATS) Procedures [NCT02556970]0 participants (Actual)InterventionalWithdrawn(stopped due to Study never started and was abandoned.)
A Phase 2 Study of Isatuximab in Combination With Pomalidomide and Dexamethasone in MM Patients Who Received One Prior Line of Therapy Containing Lenalidomide and a Proteasome Inhibitor [NCT05298683]Phase 2108 participants (Anticipated)Interventional2022-05-31Not yet recruiting
A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery [NCT04015908]Phase 4100 participants (Actual)Interventional2019-08-01Completed
A Phase 3, Open-Label Period Followed by a Randomized, Double-blind, Placebo-controlled Study of the Analgesic Efficacy of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain [NCT00761150]Phase 3308 participants (Actual)Interventional2008-09-30Completed
Ultrasound Guidance or Electrical Nerve Stimulation for Interscalene Brachial Plexus Block: a Randomized, Controlled Trial [NCT00702416]Phase 450 participants (Anticipated)Interventional2008-05-31Completed
Efficacy of Intravenous Paracetamol as an Analgesic During the First Stage of Labor: A Randomized Controlled Trial [NCT02578251]Phase 2104 participants (Anticipated)Interventional2015-10-31Not yet recruiting
Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery [NCT04291508]Phase 2488 participants (Actual)Interventional2021-10-13Completed
A Randomized, Crossover, Double-Blind Study To Evaluate The Safety Of An Association Of Phenylephrine Hydrochloride 10mg + Acetaminophen 500mg + Dimethindene Maleate 1 Mg Compared To Phenylephrine Hydrochloride 10mg In Healthy Volunteers [NCT01026961]Phase 1/Phase 20 participants (Actual)Interventional2010-09-30Withdrawn(stopped due to Study is no longer required by Brazil health authority.)
Comparison of a Patient Controlled Oral Administration (PCOA) of Analgesic Protocol With an IV Administration After Planned Caesarian Section : Monocentric, Randomised and Controlled Study [NCT01566253]Phase 480 participants (Actual)Interventional2012-03-31Completed
Randomized, Double-Blind Clinical Study Evaluating Efficacy of Intravenous Versus Enteric Acetaminophen in Donor Nephrectomy and Robot-Assisted, Laparoscopic Nephrectomy. [NCT03365622]Phase 4265 participants (Anticipated)Interventional2018-08-08Recruiting
A Randomized, Double-Blind, Crossover Study to Evaluate the Mechanism of Action of Acetaminophen [NCT00646906]55 participants (Actual)Interventional2004-06-02Completed
A Phase 2 Study in Poor Risk Diffuse Large B-cell Lymphoma of Total Lymphoid Irradiation & Antithymocyte Globulin Followed by Matched Allogeneic Hematopoietic Transplantation as Consolidation to Autologous Hematopoietic Cell Transplantation [NCT00482053]Phase 23 participants (Actual)Interventional2006-10-31Terminated(stopped due to Low accrual)
Study of no Pharmacokinetic Interaction Between Ibuprofen 100 mg and Acetaminophen 125 mg, Suspension Administered Individually or in Combination, Single Dose in Healthy Subjects, Both Genders Under Fasting Conditions [NCT05428293]Phase 142 participants (Actual)Interventional2019-02-22Completed
A Double-blind Randomised Parallel Group Trial of Paracetamol Versus Placebo in Conjunction With Strong Opioids for Cancer Related Pain [NCT02706769]34 participants (Actual)Interventional2016-11-25Terminated(stopped due to Funding was terminated early due to slow recruitment.)
National, Phase III, Multicenter, Randomized, Open, Parallel, to Evaluate the Efficacy, Safety and Superiority of Cefalium® Compared to the Tylenol® in the Treatment of Migraine Attacks [NCT02582996]Phase 3336 participants (Anticipated)Interventional2020-04-30Suspended(stopped due to Strategic reasons of the company)
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease [NCT04278625]30 participants (Actual)Observational2021-03-23Active, not recruiting
Validation of a New Automatic Bi-level Algorithm in the Treatment of Sleep-disordered Breathing [NCT00910195]150 participants (Anticipated)Interventional2008-06-30Completed
Comparison of Ketorolac and Ketorolac/Acetaminophen on Success of Inferior Alveolar Nerve Block Injection [NCT02601911]Phase 260 participants (Actual)Interventional2015-09-30Completed
Randomized Controlled Study of Fever Probability, Risk Factors and Preventive Use of Non-steroidal Anti-inflammatory Drugs on Fever After Removal of Drainage Tube After Lumbar Fusion [NCT04042948]183 participants (Actual)Interventional2019-06-24Completed
Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery [NCT03404908]Phase 4105 participants (Actual)Interventional2018-02-07Completed
Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions [NCT04202224]45 participants (Actual)Interventional2018-10-01Completed
A Single-Center, Prospective, Randomized, Active Controlled, Single Blind, Parallel Design, Three Arms Trial Comparing Two Different Cervical Collar Combine With Acetaminophen and Acetaminophen Along for the Treatment in Patient With Cervical Radiculopath [NCT00880828]72 participants (Anticipated)Interventional2010-08-31Active, not recruiting
Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments [NCT04155229]104 participants (Actual)Interventional2016-10-03Completed
Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN: a Pilot Study [NCT02821468]Phase 420 participants (Anticipated)Interventional2016-06-30Recruiting
Evaluation of the Effectiveness of the Radiofrequency Ablation for Reducing Refractory Pain From Bone Metastases [NCT00712712]Phase 278 participants (Actual)Interventional2007-12-24Completed
Auricular Acupuncture for the Acute Management of Pain in the Emergency Department [NCT02540512]Early Phase 10 participants (Actual)Interventional2017-07-27Withdrawn(stopped due to No participants enrolled)
Comparisons of iv Ibuprofen and iv Paracetamol for Postoperative Pain Levels and Opioid Consumption During Bariatric Surgery [NCT02778958]Phase 440 participants (Actual)Interventional2016-01-31Completed
Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Sciatica Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial. [NCT02777320]Phase 4120 participants (Anticipated)Interventional2016-03-31Recruiting
Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction [NCT02749162]Phase 390 participants (Actual)Interventional2015-11-30Completed
An Open-label, Multicenter, Randomized, Parallel Group, Single-dose Study to Assess the Short Term Efficacy and Safety of Paracetamol 500 mg + Phenylephrine HCl 10 mg + Pheniramine Maleate 20 mg + Vitamin C 200 mg Powder for Oral Solution in Subjects With [NCT02730364]Phase 30 participants (Actual)Interventional2017-02-01Withdrawn(stopped due to The clinical phase of the study (from FSFV to LSLV) was never initiated due to the sponsor's decision.)
An Analgesic Trial to Reduce Pain and Behavior Disruptions in Nursing Home Residents With Alzheimer's Disease [NCT02719834]4 participants (Actual)Observational2016-04-30Completed
A Randomized, Placebo-Controlled, Parallel Group, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen Extended Release Tablet in Subjects With Chronic Low Back Pain [NCT01112267]Phase 3248 participants (Actual)Interventional2009-05-31Completed
A Cluster Randomised Trial to Measure the Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription [NCT02691754]16 participants (Actual)Interventional2012-11-30Completed
The Fever and Antipyretic in Critically Illness Evaluation Study [NCT00940654]1,426 participants (Actual)Observational2009-09-30Completed
Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars [NCT05602064]Phase 466 participants (Actual)Interventional2022-11-01Completed
Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers [NCT00750048]Phase 112 participants (Actual)Interventional2008-09-30Completed
Comparison of iv Paracetamol, iv Dexketoprofen and Topical Lidocaine in Scorpion Sting: a Placebo Randomized Controlled Trial [NCT05125796]106 participants (Actual)Interventional2020-09-01Completed
Comparison of The Effectiveness of Intravenous Paracetamol, Dexketoprofen and Ibuprofen In The Treatment of Non-Traumatic Acute Low Back Pain In The Emergency Department [NCT04609254]Phase 4210 participants (Actual)Interventional2018-12-15Completed
Transient Acetaminophen Induced Hypothermia in Pediatrics Population Undergoing General Anesthesia [NCT04608669]Phase 460 participants (Actual)Interventional2019-07-01Completed
Towards Enhanced Recovery After Cesarean: Scheduled Post-operative Medication: a Randomized Controlled Trial [NCT04612920]Early Phase 133 participants (Actual)Interventional2020-12-12Completed
Analgesic Effects of Intravenous Acetaminophen on Labor Pain [NCT01394731]Phase 40 participants Interventional2010-12-31Completed
Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy: A Randomized Controlled Trial [NCT05597878]Phase 2/Phase 3100 participants (Anticipated)Interventional2023-04-18Recruiting
Aspirin for Exercise in Multiple Sclerosis (ASPIRE): A Double-Blind RCT of Aspirin or Acetaminophen Pretreatment to Improve Exercise Performance in Multiple Sclerosis (MS) [NCT03824938]Phase 360 participants (Actual)Interventional2019-04-30Completed
A Randomized Control Trial Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision [NCT04646967]Phase 2100 participants (Anticipated)Interventional2022-11-25Recruiting
Aggressive Antipyretics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance Effects [NCT03399318]Phase 2256 participants (Actual)Interventional2018-07-02Completed
Double-blind, Randomized, Placebo-controlled, Single Dose, Parallel Group Study Evaluating Efficacy and Safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in Adult Patients With Sore Throat Associated With a Common Cold [NCT01465009]Phase 4508 participants (Actual)Interventional2003-11-30Completed
The Central Analgesic Effects of Paracetamol on Serotonergic Pathways [NCT00970450]16 participants (Actual)Interventional2009-11-30Completed
A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study of Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an i.v. Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausa [NCT00489424]Phase 4793 participants (Actual)Interventional2007-06-30Completed
Phase 3 Randomized, Double-Blind Placebo-Controlled, Multicenter, Parallel-Group, Repeated-Dose Study of the Analgesic Efficacy & Safety of IV Acetaminophen Versus Placebo for the Treatment of Postop Pain [NCT00564486]Phase 3244 participants (Actual)Interventional2007-11-30Completed
Randomized Non-inferiority Trial of Early Treatment Versus Expectant Management of Patent Ductus Arteriosus in Preterm Infants [NCT03860428]208 participants (Actual)Interventional2019-02-15Completed
Randomized Control Trial of Oral Narcotic Medication for Pain and Anxiety Management During Laceration Repair in the Pediatric Emergency Department [NCT01053637]85 participants (Actual)Interventional2009-02-28Completed
Randomized Control Trial of Intravenous Acetaminophen (OFIRMEV) for the Reduction of Intrapartum Maternal Fever and Fetal Tachycardia [NCT02625454]Phase 2168 participants (Anticipated)Interventional2016-12-31Active, not recruiting
Transplacental Transfer of Drugs Used in Pregnant Women [NCT02622802]250 participants (Actual)Interventional2012-11-30Completed
A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients [NCT00899847]Phase 29 participants (Actual)Interventional2009-05-31Completed
Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction [NCT03893175]Phase 186 participants (Actual)Interventional2019-05-10Completed
A Phase 3, Open-Label Period Followed by a Randomized, Double-blind Placebo-controlled Study of the Analgesic Efficacy of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain [NCT00763321]Phase 3287 participants (Actual)Interventional2008-09-30Completed
A Randomized Placebo-controlled Trial of Acetaminophen for Prevention of Post-vaccination Fever in Infants [NCT00325819]Phase 3374 participants (Actual)Interventional2006-05-31Completed
Effect of Preoperative Acetaminophen-Codeine-Caffeine Combination on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis: Randomized Double-blind Controlled Trial [NCT04202406]69 participants (Actual)Interventional2021-01-09Completed
Efficacy and Efficiency of Sphenopalatine Ganglion Block for Management of Post-dural Puncture Headache in Obstetric Patients-A Randomized Clinical Trial [NCT04793490]40 participants (Actual)Interventional2021-03-15Completed
Use of Enhanced Recovery After Surgery (ERAS) in Minimizing Opioid Use for Patients Undergoing Thyroidectomy [NCT03988075]100 participants (Actual)Interventional2018-07-24Completed
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Full-Factorial, Parallel-Group Study Evaluating Safety and Efficacy of Naltrexone-Acetaminophen Combination in Acute Migraine Treatment in Adults, With Exploratory Focus on Co-Occurring [NCT05685225]Phase 2300 participants (Anticipated)Interventional2024-03-01Not yet recruiting
A Study of a Long-term Administration of JNS013 in Patients With Chronic Pain [NCT00736957]Phase 3219 participants (Actual)Interventional2008-05-31Completed
A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain [NCT00315445]Phase 3134 participants (Actual)Interventional1997-12-31Completed
Randomized Prospective Study Investigating the Analgesic Efficacy of Intravenous Acetaminophen in Reducing Post-Tonsillectomy Pain in Pediatric Patients [NCT03883893]Phase 20 participants (Actual)Interventional2021-12-31Withdrawn(stopped due to Mentor for PI left institution. Study was not renewed.)
Serum Acetaminophen-Cysteine (APAP-CYS) Adduct Concentrations in Subjects Expected to Develop Aminotransferase Elevations With Liver-Directed Therapy Intended to Treat Hepatic Tumors [NCT02911961]Phase 40 participants (Actual)Interventional2021-08-31Withdrawn(stopped due to Due to lack of enrollment and organizational desire to focus recruitment efforts on other studies.)
Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion [NCT02025166]82 participants (Anticipated)Interventional2014-01-31Not yet recruiting
Switching From Morphine to Oral Methadone Plus Acetaminophen in the Treatment of Cancer Pain: A Randomized, Double-Blind Study [NCT00525967]Phase 2/Phase 350 participants (Anticipated)Interventional2006-02-28Recruiting
Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa [NCT00982215]Phase 120 participants (Actual)Interventional2009-09-30Completed
Cost-effectiveness Analysis of Oral Paracetamol and Ibuprofen for Treating Pain After Soft Tissue Limb Injuries: Double-blind, Randomised Controlled Trial [NCT00528658]Phase 2782 participants (Actual)Interventional2005-01-31Completed
A Phase 3 Study of JNS013 in Patients With Chronic Pain [NCT00736853]Phase 3321 participants (Actual)Interventional2008-06-30Completed
Paracetamol Versus Ibuprofen in Premature Infants With Hemodynamically Significant Patent Ductus Arteriosus: a Randomized Clinical Trial [NCT04037514]Phase 3300 participants (Anticipated)Interventional2017-07-07Recruiting
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain [NCT00092313]Phase 3271 participants (Actual)Interventional2002-06-30Completed
Outcomes Associated With the Application of the Normothermia Protocol in Patients With Severe Neurological Insult and Fever [NCT00890604]10 participants (Actual)Interventional2009-07-31Terminated(stopped due to Practice change created contamination of usual care arm)
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Dental Pain Model [NCT00406679]Phase 3135 participants (Actual)Interventional2006-11-30Completed
[NCT00536068]11 participants (Actual)Interventional2006-08-31Completed
Acetaminophen for Mood and Memory Changes Associated With Prednisone Therapy [NCT00377364]Phase 430 participants (Actual)Interventional2006-11-30Completed
Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked [NCT01048398]Phase 360 participants (Anticipated)Interventional2010-06-30Completed
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation [NCT00186628]Phase 236 participants (Actual)Interventional2005-06-30Completed
An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover, Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gelcaps of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceuticals Inc.), With Ty [NCT01073709]40 participants (Actual)Interventional2007-11-30Completed
Ultrasound Guided Erector Spinae Plane Block in Scoliotic Adolescents Undergoing Posterior Spine Instrumentation . A Randomized Controlled Trial [NCT03968146]Phase 230 participants (Actual)Interventional2019-06-18Completed
Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial [NCT03584152]Phase 251 participants (Anticipated)Interventional2019-08-09Active, not recruiting
Placebo Effect of Paracetamol in Healthy Volunteers [NCT01053650]Phase 140 participants (Actual)Interventional2010-01-31Completed
Tolerability Improvement of Tramadol/Acetaminophen (Ultracet) by Titration in Korean OA Patients:Multicenter, Randomized, Double-blind Study [NCT01063842]Phase 4250 participants (Actual)Interventional2005-08-31Completed
A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine [NCT00314340]Phase 412 participants (Actual)Interventional2005-11-30Completed
The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children [NCT01073748]60 participants (Anticipated)Interventional2010-03-31Recruiting
An Open-label Non-randomized Phase IV Trial of the Clinical Efficacy of Intravenously Administered 1000mg Paracetamol as Antipyretic and Analgesic Medication [NCT01070732]Phase 4100 participants (Actual)Interventional2010-01-31Completed
Comparison of The Effect of Continuous and Standard Intermittent Boluses Paracetamol Infusion on Patent Ductus Arteriosus [NCT04469413]138 participants (Actual)Observational2019-01-01Completed
A Randomised, Observer Blinded, Controlled Trial Of Femoral Nerve Block Versus Local Infiltration Analgesia for Post Operative Analgesia Following Total Knee Arthroplasty [NCT02288923]199 participants (Actual)Interventional2015-03-31Completed
Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial [NCT02369133]Phase 460 participants (Actual)Interventional2013-11-30Completed
Clinical Trial to Compare the Pharmacokinetics Profile of YJAT Sustained Release Tablet and ULTRACET® Immediate Release Tablet After Oral Administration to Healthy Male Subjects [NCT01880125]Phase 124 participants (Actual)Interventional2012-01-31Completed
Prospective, Controlled Versus Placebo, Randomized, Double-blind Study, Evaluating the Value of Non-opioid Analgesic Combination (Based on Paracetamol, Nefopam, Ketoprofen) for Postoperative Analgesia. [NCT01882530]Phase 4223 participants (Actual)Interventional2013-07-23Terminated(stopped due to Practice on postoperative pain management changed)
Comparing the Effect of Intravenous Morphine and Injectable Acetaminophen on Renal Colic Patients Presenting to the Emergency Department: A Randomized Controlled Trial [NCT01906762]Phase 2124 participants (Actual)Interventional2012-07-31Completed
Effect of Gender-Affirming Estrogen Therapy on Drug Metabolism, Transport, and Gut Microbiota [NCT05469204]13 participants (Anticipated)Observational2022-11-01Recruiting
The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions [NCT04788654]Phase 360 participants (Actual)Interventional2021-03-17Completed
An Open-Label Study Evaluating the Safety and Tolerability of Long Term Administration of Hydrocodone/Acetaminophen Extended ReleaseTablets (Vicodin® CR) in Subjects With Moderate to Severe Chronic, Non-Malignant Pain [NCT00195728]Phase 3431 participants (Actual)Interventional2005-06-30Completed
Investigating the Effect of a Perioperative Analgesia Protocol on Postoperative Opioid Usage and Pain Control in Patients Undergoing Major Head and Neck Cancer Surgery Requiring Microvascular Free Flap Reconstruction [NCT04176419]Phase 330 participants (Anticipated)Interventional2020-01-17Active, not recruiting
Three-day Clinical Evaluation Of The Efficacy And Safety Of Two Ibuprofen Combination Products For The Symptomatic Treatment Of The Common Cold And Flu: A Multicenter Study [NCT01938144]Phase 30 participants (Actual)Interventional2016-04-30Withdrawn
Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine [NCT01939379]0 participants (Actual)Interventional2013-09-30Withdrawn(stopped due to PI left institution. Efforts made to contact PI unsuccessful. No study data available.)
Percutaneous Pin Removal in the Outpatient Clinic - do Children Require Analgesia? A Randomized Controlled Trial [NCT01944085]240 participants (Actual)Interventional2008-10-31Completed
Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery [NCT05413902]Phase 4100 participants (Actual)Interventional2021-04-05Completed
Efficacy and Safety of Ivermectin for Treatment and Prophylaxis of COVID-19 Pandemic [NCT04668469]600 participants (Actual)Interventional2020-06-08Completed
Traditional vs. Nonopioid Analgesia After Labral Surgery [NCT03825809]Phase 2/Phase 3100 participants (Anticipated)Interventional2019-01-22Recruiting
Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Rates of Fever After 2013-2014 Inactivated Influenza Vaccine (IIV) in Young Children [NCT01946594]Phase 441 participants (Actual)Interventional2013-10-31Completed
[NCT01947205]111 participants (Actual)Interventional2012-11-30Completed
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain [NCT00240825]Phase 4222 participants (Actual)InterventionalCompleted
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study of Acetaminophen 1000 mg and Ibuprofen 400 mg in Postoperative Dental Pain [NCT00240864]Phase 4224 participants (Actual)InterventionalCompleted
Randomized, Double-blind, Placebo-controlled Exploratory Trial to Investigate Efficacy and Safety of IGN-ES001 in Patients With Chronic Widespread Pain With or Without Fibromyalgia [NCT03058224]230 participants (Actual)Interventional2017-02-16Completed
ULTRACET (Tramadol Hydrochloride and Acetaminophen) add-on Therapy for the Treatment of the Pain of Rheumatoid Arthritis: A Randomized, Double-blind, Placebo-controlled Study [NCT00246168]Phase 4277 participants (Actual)InterventionalCompleted
A Randomised Controlled Trial Examining the Effect of Premedicant Oral Paracetamol on Gastric Residual Volume and pH in Children, in the Context of a 1-hour Clear Fluid Fast [NCT04625608]Phase 4104 participants (Anticipated)Interventional2020-10-06Recruiting
The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen as Adjuvant, Postoperative Pain After Herniated Disc Surgery [NCT01953978]Phase 4160 participants (Actual)Interventional2012-12-31Completed
[NCT01958866]Phase 2/Phase 396 participants (Actual)Interventional2013-10-31Completed
Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial [NCT01966172]Phase 4180 participants (Actual)Interventional2007-03-31Completed
A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain [NCT01968018]Phase 435 participants (Actual)Interventional2004-07-31Completed
A Phase 1 Trial to Evaluate the Safety of Single Agent Flotetuzumab in Advanced CD123-Positive Hematological Malignancies [NCT04681105]Phase 113 participants (Actual)Interventional2020-11-18Active, not recruiting
A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery [NCT04144933]Phase 360 participants (Anticipated)Interventional2021-05-15Recruiting
Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial [NCT03951649]Phase 462 participants (Actual)Interventional2020-02-10Completed
A Phase III Randomized Clinical Trial to Evaluate the Safety and Efficacy of an Etoricoxib and Tizanidine Fixed Dose Combination in Subjects With Moderate to Severe Acute Low Back Pain [NCT01979510]Phase 30 participants (Actual)Interventional2013-11-30Withdrawn
Local Anesthesia and Analgesics in Post-Operative Endodontic Pain [NCT01982799]0 participants (Actual)Interventional2014-02-28Withdrawn(stopped due to Not enough funding)
Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery. [NCT01988298]Phase 2/Phase 3114 participants (Actual)Interventional2013-10-31Completed
Evidence Based Management of Acute Biliary Pancreatitis [NCT04615702]30 participants (Actual)Observational [Patient Registry]2017-05-15Completed
[NCT01993589]144 participants (Actual)Interventional2012-11-30Completed
Ketorolac Verses Paracetamol as an Adjunct to Nalbuphine in Post Operative Pain Management in Elective Cardiac Surgery [NCT05361824]Phase 460 participants (Actual)Interventional2021-01-01Completed
PAracetamol Treatment in Hypertension: Effect on Blood Pressure (PATH-BP) Study [NCT01997112]Phase 4100 participants (Actual)Interventional2014-01-31Completed
Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial [NCT04593160]72 participants (Anticipated)Interventional2021-01-31Not yet recruiting
Metabolic Effects of Chemical Interactions in Toxicity [NCT00253773]15 participants (Anticipated)Interventional2005-01-31Completed
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial [NCT02002741]Phase 2/Phase 324 participants (Actual)Interventional2014-08-01Completed
The Comparison of Supraperiosteal Nerve Block With Opiate Analgesia in Alleviating the Pain of Toothache [NCT00574015]Phase 418 participants (Actual)Interventional2007-12-31Completed
A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy [NCT05548582]120 participants (Anticipated)Interventional2023-01-12Recruiting
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy [NCT04429022]Phase 368 participants (Actual)Interventional2020-11-24Completed
A Phase I/II Study to Determine Efficacy, Safety and Immunogenicity of the Candidate Coronavirus Disease (COVID-19) Vaccine ChAdOx1 nCoV-19 in UK Healthy Adult Volunteers [NCT04324606]Phase 1/Phase 21,090 participants (Actual)Interventional2020-04-23Active, not recruiting
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty [NCT03859024]Phase 460 participants (Actual)Interventional2019-03-22Completed
A Comparison of the Analgesic Efficacy of Oral Opioid Medication vs. Injected Local Anesthetic in Emergency Department Patients With Toothache [NCT02862691]Phase 22 participants (Actual)Interventional2016-08-01Terminated(stopped due to Difficulty recruiting patients)
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving KRYSTEXXA® (Pegloticase) (MIRROR Randomized Controlled Trial [RCT]) [NCT03994731]Phase 4152 participants (Actual)Interventional2019-06-13Completed
NEUROTHERM: The Effect of Paracetamol on Brain Temperature in Acute Brain Injury in a Neuro Critical Care Unit: A Randomized Controlled Trial [NCT03648021]Phase 4100 participants (Actual)Interventional2018-05-03Completed
Intercostal Nerves Block in the Midaxillary Line Versus Paravertebral Block, Ultrasound Guided Blocks for no Reconstructive Breast Surgery. Randomized Trial [NCT02018601]Phase 4120 participants (Anticipated)Interventional2013-09-30Recruiting
Phase 2, Open-Label Randomized Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone vs Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [NCT04268498]Phase 2306 participants (Anticipated)Interventional2020-02-11Recruiting
A Phase 2 Randomised, Double-blind, Placebo-controlled Multiple Ascending Dose Study Evaluate the Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis [NCT02029599]Phase 2240 participants (Actual)Interventional2014-03-31Completed
Adding a Second Drug for Febrile Children Treated With Acetaminophen [NCT00389272]40 participants (Anticipated)Interventional2005-09-30Recruiting
Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting [NCT02884921]87 participants (Actual)Interventional2015-04-30Completed
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Vaccine GSK1024850A and DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa) and Assessment of Impact of Pneumococcal Vaccination on Nasopharyngeal Carriage [NCT00496015]Phase 3750 participants (Actual)Interventional2007-07-02Completed
Antipyretics for Preventing Recurrences of Febrile Seizures [NCT00568217]Phase 4231 participants (Actual)Interventional1997-09-30Completed
A Four-Week Comparative Study Evaluating Acetaminophen Extended Release (3900 mg/Day) and Rofecoxib (12.5 mg/Day and 25 mg/Day)in the Treatment of Osteoarthritis of the Knee [NCT00568295]Phase 3403 participants (Actual)Interventional1999-10-31Completed
Blood-Brain Barrier Penetration of Therapeutic Agents in Human - an Exploratory Repeated Dose Pharmacokinetic Study in Patients With Idiopathic Normal Pressure Hydrocephalus Treated With Cerebroventricular Shunting [NCT04571996]Phase 14 participants (Actual)Interventional2020-10-29Completed
A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine [NCT04536051]Phase 310,300 participants (Anticipated)Interventional2020-06-02Recruiting
Comparing the Efficacy of Intravenous Paracetamol and Ketoprofen When Treating Renal Colic in Emergency Situations: a Randomized, Bi-centric, Double-blind Controlled Trial [NCT01685658]Phase 40 participants (Actual)Interventional2016-09-30Withdrawn(stopped due to same study already published)
Phase 2, Exploratory, Single Center, Randomized, Open Label, Adaptive Clinical Trial to Compare Safety and Efficacy of Four Different Experimental Drug Regimens to Standard of Care for the Treatment of Symptomatic Outpatients With COVID-19 [NCT04532931]Phase 2192 participants (Actual)Interventional2020-09-03Completed
Haemodynamic Effects of Paracetamol (Acetaminophen) as Extended Intravenous Infusion Versus Intravenous Bolus in Septic Shock Patients [NCT06076980]Phase 461 participants (Actual)Interventional2020-11-01Completed
Paracetamol in Addition to WHO Step III Opioids in Chronic Cancer Pain Control - a Randomized, Double-blind, Placebo-controlled, Non-inferiority Study [NCT05088876]Phase 4140 participants (Anticipated)Interventional2023-10-31Recruiting
Randomized Trial of Two Analgesics in Elderly ED Patients [NCT02703610]Phase 40 participants (Actual)Interventional2024-07-01Withdrawn(stopped due to No participants were enrolled and the study will not be conducted.)
A Randomized, Open Label, 2-treatment, 2-sequence, Cross-over Study to Compare the Safety and Pharmacokinetics of DW-0919 and DW-0920 After Single Oral Administration in Healthy Male Volunteers [NCT01606059]Phase 130 participants (Actual)Interventional2012-05-31Completed
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-dose Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty [NCT05034952]Phase 2303 participants (Actual)Interventional2021-08-30Completed
Sleep Disruption in New Parents: An Intervention Trial [NCT01321710]152 participants (Actual)Interventional2004-12-31Completed
A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Pain Relief [NCT01075243]Phase 4401 participants (Actual)Interventional2009-11-30Completed
A Randomised, Double-blind, Evaluation of the Effects of Paracetamol on the BOLD fMRI Response to Painful Stimuli in Subjects With Osteoarthritis [NCT01105936]Phase 431 participants (Actual)Interventional2010-09-01Completed
Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After Shoulder Ambulatory Surgery [NCT04110665]Phase 4200 participants (Anticipated)Interventional2017-09-01Recruiting
Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery [NCT04018768]80 participants (Actual)Observational2017-12-01Completed
Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days [NCT00616018]Phase 435 participants (Actual)Interventional2007-08-31Completed
Preoperative Cesarean Section Intravenous Acetaminophen and Postoperative Pain Control: A Blinded Randomized Placebo-Controlled Trial [NCT02694653]Phase 1200 participants (Anticipated)Interventional2014-10-31Enrolling by invitation
Incretin Physiology and Beta-Cell Function Before and After Treatment With Steroid Hormone in Healthy Individuals [NCT00713440]10 participants (Actual)Interventional2008-07-31Completed
Evaluation of APAP With SensAwake in OSA and Insomnia Patients [NCT02721329]19 participants (Actual)Interventional2016-06-30Completed
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery [NCT04246541]Phase 348 participants (Actual)Interventional2019-04-23Completed
A Study to Investigate Safety and Tolerability of Higher Infusion Rate to shORten the duraTion of FabrazymE Infusion [NCT06019728]Phase 418 participants (Anticipated)Interventional2023-11-10Recruiting
Abatacept for Graft Versus Host Disease Prophylaxis After Hematopoietic Stem Cell Transplantation for Pediatric Sickle Cell Disease: a Sickle Transplant Alliance for Research Trial [NCT02867800]Phase 124 participants (Actual)Interventional2016-07-31Active, not recruiting
A Double Blind Randomised Controlled Trial of Preemptive and Preventive Use of Paracetamol for Pain Relief After Cesarean Section [NCT02714179]Phase 454 participants (Actual)Interventional2015-05-31Completed
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain [NCT01216163]Phase 3218 participants (Actual)Interventional2010-10-31Completed
A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients [NCT01002573]Phase 3118 participants (Actual)Interventional2010-07-31Completed
[NCT02837614]Early Phase 160 participants (Actual)Interventional2015-10-31Completed
Correlation Between Acute Analgesia and Long-Term Function Following Ankle [NCT02667730]Phase 4160 participants (Anticipated)Interventional2015-06-30Recruiting
Postoperative Pain After Laparoscopic Sleeve Gastrectomy: Comparison of Isolated Intravenous Analgesia, Epidural Analgesia Associated With Analgesia iv and Port-sites Infiltration With Bupivacaine Associated With Analgesia iv [NCT02662660]Phase 3147 participants (Actual)Interventional2012-01-31Completed
A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients. [NCT00598702]Phase 3100 participants (Actual)Interventional2008-01-31Completed
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section [NCT04290208]Phase 4130 participants (Anticipated)Interventional2019-08-22Recruiting
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Moderate-to-Severe Acute Pain and the Prevention of Opioid [NCT03657810]Phase 3349 participants (Actual)Interventional2017-08-02Completed
Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis: A Prospective, Pilot, Cohort Study [NCT03055507]Phase 2/Phase 342 participants (Actual)Interventional2017-04-01Completed
Incidence of Flare-ups and Apical Healing After Single-visit or Two-visits Treatment of Teeth With Necrotic Pulp and Apical Periodontitis After a Two-year Control Period. A Randomised Clinical Trial. [NCT02815189]Phase 2110 participants (Actual)Interventional2014-02-28Completed
Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia [NCT02815111]0 participants (Actual)Observational2016-07-31Withdrawn(stopped due to Not IRB approved)
A Double-Blind, Randomized, Active- and Placebo-Controlled, Multiple-Dose, Multi-Center Phase 3 Study of the Safety and Efficacy of CL-108 in the Treatment of Moderate to Severe Pain and Opioid-Induced Nausea and Vomiting (OINV) [NCT02462811]Phase 3552 participants (Actual)Interventional2014-09-30Completed
A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia-Multicentered, Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT02811991]Phase 2/Phase 3348 participants (Actual)Interventional2016-06-30Completed
A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen to Placebo in Subjects With Acute Pain Following Bunionectomy [NCT01038609]Phase 2250 participants (Actual)Interventional2009-12-31Completed
Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics [NCT02785549]Phase 4480 participants (Actual)Interventional2016-11-30Completed
Continuous Ketamine Infusion Versus Placebo in the Treatment of Acute Post-Surgical Pain: A Randomized Trial Evaluating the Efficacy of Ketamine in Colorectal Surgery [NCT02785003]Phase 40 participants (Actual)Interventional2016-07-31Withdrawn(stopped due to Lack of Funding)
Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study [NCT04771741]72 participants (Actual)Observational2020-12-01Completed
Effects of Acetaminophen on Hurt Feelings [NCT00561288]60 participants (Actual)Interventional2007-11-30Completed
The Effect of Magnesium Oral Supplementation for Acute Non-specific Low Back Pain: Prospective Randomized Clinical Trial [NCT04626063]240 participants (Actual)Interventional2018-06-10Completed
Intravenous Acetaminophen for Craniotomy Patients: A Single-blinded, Randomized Controlled Trial to Evaluate the Effect of Intravenous Acetaminophen Administered at Induction and Emergence From Craniotomy [NCT01474304]Phase 280 participants (Anticipated)Interventional2011-11-30Recruiting
Trigger Point Injection for Myofascial Pain Syndrome in the Low Back (T-PIMPS): A Randomized Controlled Trial. [NCT04704297]Phase 4180 participants (Anticipated)Interventional2020-12-28Recruiting
Comparative Onset of Action of a Fast Release Aspirin Tablet in a Dental Impaction Pain Model [NCT01420094]Phase 3510 participants (Actual)Interventional2011-06-16Completed
Maxi-Analgesic OA Study: Multicentre, Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 With Acetaminophen or Ibuprofen on Patients With Pain From Osteoarthritis [NCT01420666]Phase 30 participants (Actual)InterventionalWithdrawn(stopped due to The study was withdrawn for administrative reason)
Pain Management and Behavioral Outcomes in Patients With Dementia [NCT00012857]Phase 266 participants (Anticipated)InterventionalCompleted
Pamukkale University Medical School,Dept. of Emergency Medicine [NCT01422291]Phase 4120 participants (Actual)Interventional2011-01-31Completed
Phase 2, Single-Arm Study of Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma [NCT05896228]Phase 230 participants (Anticipated)Interventional2024-03-01Recruiting
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Center, Multiple-Dose, Parallel Trial Evaluating the Impact of Apraglutide on Gastric Emptying of Liquids in Healthy Subjects [NCT05995704]Phase 136 participants (Actual)Interventional2023-03-02Completed
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain [NCT00092326]Phase 3269 participants (Actual)Interventional2002-06-30Completed
A Single Dose Bioequivalence Study of Test Product (One Tablet of Paracetamol 1000 mg + Codeine 30 mg, Manufactured by A.C.R.A.F. S.p.A.) vs. Two Tablets of the Reference Product (Paracetamol 500 mg + Codeine 30 mg) in Healthy Volunteers [NCT02902666]Phase 146 participants (Actual)Interventional2016-04-30Completed
Comparison of Intravenous Ibuprofen and Paracetamol in Patients With Low Back Pain Presented to the Emergency Department: A Randomized, Double-Blind, Controlled Trial [NCT02836509]Phase 4200 participants (Anticipated)Interventional2016-09-30Not yet recruiting
Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia [NCT00766675]Phase 480 participants (Actual)Interventional2008-10-31Completed
Circulating Free Hemoglobin and Microcirculation After Administration of Paracetamol in Febrile Septic Patient [NCT02750163]50 participants (Actual)Observational2017-07-05Completed
A Double-blind, Double-dummy, Parallel Group, Randomised Study to Compare the Efficacy & Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR) & Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoa [NCT00784810]Phase 4247 participants (Actual)Interventional2009-02-28Completed
Analgetic Efficiency of Single-shot Perineural Low Dose Dexamethasone Added to Infraclavicular Block Anesthesia for Upper Limb Surgery [NCT02698995]Phase 3180 participants (Actual)Interventional2015-11-30Completed
A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Proof of Concept Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain [NCT02320708]Phase 2240 participants (Actual)Interventional2014-12-31Completed
Effect of Acetaminophen Versus Ibuprofen in Treating Recurrent Apthous Ulcers in Pediatric Celiac Disease: A Randomized Pilot Study [NCT06149507]Phase 412 participants (Anticipated)Interventional2024-03-01Not yet recruiting
A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation [NCT00405158]210 participants Interventional2002-01-31Completed
The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study [NCT01858402]Phase 22 participants (Actual)Interventional2009-12-31Completed
[NCT01872871]80 participants (Anticipated)Interventional2013-01-31Recruiting
Effect of Number of Meals on Metabolism After Weight Loss Surgery [NCT02929212]33 participants (Actual)Interventional2009-09-30Completed
Post-operative Pain Management Following Functional Endoscopic Sinus Surgery [NCT03822962]Early Phase 110 participants (Actual)Interventional2020-11-07Terminated(stopped due to Decrease in accrual during the COVID-19 pandemic and several sites withdrawing)
Erector Spinae Plane Block for Nefrectomy [NCT04686890]46 participants (Actual)Interventional2020-12-30Completed
A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamo [NCT01229449]Phase 3678 participants (Actual)Interventional2009-01-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain [NCT04447040]Phase 2304 participants (Actual)Interventional2020-11-09Completed
Evaluation of the Effects of Subcostal Transversus Abdominis Plane Block on Subacute Pain Development Following Inguinal Herniography: a Randomized Clinical Study [NCT02914028]2 participants (Actual)Interventional2016-04-30Completed
Pediatric Analgesia After Cardiac Surgery; Morphine IV Versus Paracetamol IV After Cardiac Surgery in Neonates and Infants. [NCT05853263]208 participants (Actual)Interventional2016-03-09Completed
Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial [NCT01527942]34 participants (Actual)Interventional2012-03-31Terminated(stopped due to Study Terminated per Principal Investigator's request)
A Randomized Double-blind Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache [NCT03472872]Phase 4500 participants (Actual)Interventional2017-09-05Terminated(stopped due to no longer recruiting or studying)
Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever [NCT00267293]Phase 460 participants (Actual)Interventional2006-01-31Completed
Analgesic Effect of a New Analgesic Based Gel(Douloff) Versus Oral Paracetamol in Acute Soft Injuries [NCT05647681]Phase 11,100 participants (Anticipated)Interventional2023-07-01Not yet recruiting
A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine [NCT01476176]Phase 130 participants (Actual)Interventional2009-07-31Completed
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study [NCT02987985]Phase 350 participants (Actual)Interventional2017-10-15Completed
A SingleDose Rand, TwoPeriod, Crossover Bioequivalence Study Between a Combination Tablet With Paracetamol, Guaifenesin and Penylephrine HCL (Wrafton Lab Ltd, UK) and Vicks Active SymptoMax Plus, Powder for Oral Solution (Wrafton Lab Ltd, UK) in Healthy A [NCT03213353]Phase 172 participants (Actual)Interventional2017-07-03Completed
Ibuprofen vs Acetaminophen in the Prevention of Acute Mountain Sickness: A Double Blind, Randomized Controlled Trial [NCT02244437]Phase 4288 participants (Actual)Interventional2014-10-31Completed
A Non-randomized, Open-label Study to Investigate the Effects of Imatinib Mesylate on the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) [NCT00428909]Phase 112 participants (Actual)Interventional2006-11-30Completed
Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan After Oral Administration Using 240 ml Non-caloric Water, a Carbohydrate Enriched Drink and Grapefruit Juice in Correlation to the Intestinal Availability of Water as Quantified by [NCT03012763]Phase 19 participants (Actual)Interventional2016-04-30Completed
Is Paracetamol an Effective Treatment for Chronic Moderate Pain in the Newborn After Operative Vaginal Delivery? [NCT00488540]Phase 4280 participants (Anticipated)Interventional2007-06-30Completed
Ibuprofen vs. Codeine. Is One Better for Post-operative Pain Relief Following Reduction of Paediatric Forearm Fractures? [NCT01605240]50 participants (Anticipated)Interventional2012-07-31Recruiting
A Multi-center, Randomized, Double-blind, Parallel-group Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine. [NCT01248468]Phase 4752 participants (Actual)Interventional2010-11-30Completed
A Phase 4 Study to Assess the Practical Management of Mild to Moderate Arthritic or Arthralgic Events in Patients With Chronic Plaque Psoriasis Receiving Efalizumab [NCT00510536]Phase 450 participants (Anticipated)Interventional2007-07-31Completed
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery [NCT04246554]Phase 349 participants (Actual)Interventional2019-05-21Completed
The Impact of Intravenous Administration of Perioperative Acetaminophen and Ibuprofen Combination (Maxigesic®) on Postoperative Delirium in Elderly Patients Undergoing Minimally Invasive Lung Segmentectomy or Lobectomy [NCT05834569]Phase 4176 participants (Anticipated)Interventional2023-06-15Recruiting
Multimodal Analgesia With NSAID vs. Narcotics Alone for Post-operative Meniscectomy: A Prospective Observational Study [NCT02915055]77 participants (Actual)Observational2016-09-01Completed
Paracetamol and Endothelial Function in Patients With Stable Coronary Artery Disease [NCT00534651]Phase 437 participants (Actual)Interventional2006-11-30Completed
Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study [NCT05312866]72 participants (Actual)Interventional2022-05-01Completed
Harnessing Chronomodulation to Enhance Osteogenesis - A Pilot Randomized Controlled Trial - [NCT03911336]Phase 40 participants (Actual)Interventional2023-01-01Withdrawn(stopped due to Decided not to proceed)
Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery [NCT04653506]1,000 participants (Anticipated)Interventional2020-11-28Recruiting
Comparison Of Intraperitoneal Instillation Of Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia In Laparoscopic Surgeries In Pediatrics [NCT04651556]Phase 466 participants (Actual)Interventional2019-04-04Completed
Prognostic Modification in Patients With COVID-19 Under Early Intervention Treatment at U.M.F 13 and U.M.F 20 [NCT04673214]Phase 3114 participants (Actual)Interventional2020-12-16Completed
A Double-Blind, Randomized, Placebo-Controlled, Multiple-dose Multi-Center Phase III Study of the Safety and Efficacy of Cl-108 in the Treatment of Moderate to Severe Pain [NCT01780428]Phase 3460 participants (Actual)Interventional2013-01-31Completed
Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy [NCT04762147]Phase 360 participants (Actual)Interventional2016-10-31Completed
A Phase III, Randomized, Active-Comparator-Controlled, 2-period, Crossover, Double-Blind Study in China to Assess the Safety and Efficacy of Etoricoxib 120 mg Versus Ibuprofen up to 2400 mg (600 mg Q6h) in the Treatment of Patients With Primary Dysmenorrh [NCT01462370]Phase 3139 participants (Actual)Interventional2011-11-30Completed
Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor [NCT03087877]70 participants (Actual)Interventional2017-02-03Completed
Pilot Study, Blinded Randomized Control Trial, Single Center Study to Compare Acetaminophen & Codeine Versus Ibuprofen/Acetaminophen for Pain Control and Patient Satisfaction After Ambulatory Hand Surgery [NCT02647788]Phase 4144 participants (Actual)Interventional2015-12-31Completed
Comparison of Auto-Adjusting Positive Airway Pressure Devices [NCT02357706]20 participants (Actual)Interventional2015-01-31Completed
Comparison of the Effectiveness and Safety Between Tramadol 37.5 Mg/Acetaminophen 325mg And Gabapentin for The Treatment of Painful Diabetic Neuropathy: Multicenter, Randomized, Open Comparative Study [NCT00634543]Phase 4162 participants (Actual)Interventional2006-12-31Completed
Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral? [NCT05025228]170 participants (Actual)Observational2019-06-01Completed
Does IV Acetaminophen Reduce Opioid Requirement in Pediatric Emergency Department Patients With Acute Sickle Cell Crises? [NCT03541980]Phase 471 participants (Actual)Interventional2018-02-20Completed
A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab and Pseudoephedrine on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold [NCT00378144]Phase 4469 participants (Actual)Interventional2007-01-31Completed
Peripheral Nerve Blocks in Pediatric Orthopedic Patients: Are There Any Post Recovery Benefits? [NCT02236130]49 participants (Actual)Interventional2014-06-30Terminated(stopped due to Poor response rate on follow up of patients)
A Repeat-Dose, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study to Determine the Safety and Efficacy of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis [NCT01048866]Phase 3198 participants (Actual)Interventional2009-11-30Completed
A Repeat Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations [NCT01476189]Phase 128 participants (Actual)Interventional2009-11-30Completed
A Pharmacokinetic Study Investigating the Rate and Extent of Paracetamol Absorption of Three Experimental Sustained Release Pediatric Suspensions [NCT01476215]Phase 118 participants (Actual)Interventional2009-11-30Completed
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Centric Study to Determine Whether Flexsure is Safe, Tolerable and Effective in Relieving Symptoms of Moderate Osteoarthritis of the Knee [NCT01478997]Phase 1/Phase 276 participants (Actual)Interventional2011-08-31Completed
Clinical Effects of Autologous Bone Marrow Mononuclear Cell Infusion in Knee Osteoarthritis. [NCT01485198]Phase 161 participants (Actual)Interventional2011-08-31Completed
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery as Part of an Enhanced Recovery After Surgery Protocol: A Randomized Prospective Single- Center Trial. [NCT02958566]Phase 480 participants (Anticipated)Interventional2017-01-31Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee. [NCT00240799]Phase 3542 participants (Actual)InterventionalCompleted
A Randomized, Double-Blind Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness. [NCT00240838]Phase 4483 participants (Actual)Interventional2003-05-31Completed
Effect of Analgesics on the Irreversible Inactivation of Cyclooxygenase-1 Activity by Low Dose Aspirin and Endoscopic Evaluation of the Gastric Mucosal Effect [NCT00261586]Phase 492 participants (Actual)InterventionalCompleted
Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery [NCT04730297]Phase 4120 participants (Actual)Interventional2018-01-01Completed
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Tramadol Consumption in Shoulder Surgery: Prospective, Randomized, Double-Blind Clinical Trial [NCT05401916]2 participants (Actual)Interventional2022-06-10Completed
Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression [NCT04574778]Phase 382 participants (Anticipated)Interventional2021-03-18Recruiting
Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study [NCT04246697]Phase 430 participants (Actual)Interventional2019-11-01Completed
A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy [NCT00402792]Phase 3150 participants (Actual)Interventional2006-12-31Completed
Efficacy and Safety of Glucosamine Sulfate Versus a Pure Analgesic (Acetaminophen/Paracetamol) and Placebo in Patients Suffering From Osteoarthritis of the Knee [NCT00110474]Phase 3300 participants Interventional2000-05-31Completed
A Randomized Blinded Comparison of Acetaminophen With Codeine and Ibuprofen for Treatment of Acute Pain in Children With Extremity Injuries [NCT00474721]68 participants (Actual)Interventional2002-11-30Completed
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement [NCT00484744]Phase 435 participants (Actual)Interventional2007-06-30Completed
A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery [NCT00404391]Phase 2210 participants (Actual)Interventional2003-10-31Completed
A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis [NCT00404183]Phase 2120 participants (Actual)Interventional2004-08-31Completed
A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following [NCT00404222]Phase 290 participants (Actual)Interventional2005-11-30Completed
Effect of Preemptive Dexamethasone and Paracetamol on Postoperative Period Following Adeno-tosillectomy in Pediatric Age Group-: A Randomized Clinical Trial [NCT05143762]Phase 290 participants (Actual)Interventional2021-10-15Completed
Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Total Hip Replacement Model [NCT00508495]Phase 3148 participants (Actual)Interventional2007-08-31Completed
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese [NCT05511025]Phase 154 participants (Actual)Interventional2022-09-20Completed
Acetaminophen for Fetal Tachycardia: a Randomized Pilot Trial [NCT00377832]13 participants (Actual)Interventional2007-07-31Terminated(stopped due to Poor recruitment and lack of funding)
An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g [NCT00381810]Phase 331 participants (Actual)Interventional2006-06-22Terminated(stopped due to During a safety review of studies U2970g and U2971g, the Data Monitoring Committee recommended that enrollment in this extension trial be terminated.)
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery [NCT05764707]Phase 260 participants (Actual)Interventional2020-01-10Completed
Effective Strategy to Cope the Pain and Discomfort Among Women Undergoing Mammography [NCT04381104]632 participants (Anticipated)Interventional2019-11-21Recruiting
[NCT03016650]Phase 480 participants (Anticipated)Interventional2017-01-31Not yet recruiting
The Effect of Paracetamol on Postoperative Nausea and Vomiting Following Maxillofacial Surgery: a Prospective, Randomised, Double-blind Study [NCT03588338]Phase 490 participants (Actual)Interventional2018-07-20Completed
Effect on Acetaminophen Metabolism by Liquid Formulations: Do Excipients in Liquid Formulation Prevent Production of Toxic Metabolites? [NCT01246713]15 participants (Actual)Interventional2010-12-31Completed
A Pilot Trial of WT1 Peptide-Loaded Allogeneic Dendritic Cell Vaccine and Donor Lymphocyte Infusion for WT1-Expressing Hematologic Malignancies [NCT00923910]Phase 1/Phase 210 participants (Actual)Interventional2008-02-22Completed
Satisfaction With Pain Relief After Carpal Tunnel Release Surgery [NCT01588158]Phase 47 participants (Actual)Interventional2012-07-31Terminated(stopped due to The PI of this study is leaving the institution and enrollment was progressing slowly so we decided to close the study.)
Evaluation of Re-administration of Recombinant Adeno-Associated Virus Acid Alpha-Glucosidase (rAAV9-DES-hGAA) in Patients With Late-Onset Pompe Disease (LOPD) [NCT02240407]Phase 12 participants (Actual)Interventional2017-10-17Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) for the Treatment of Acute Low Back Pain [NCT00210561]Phase 422 participants (Actual)Interventional2005-03-31Terminated(stopped due to Study was stopped shortly after initiation due to change in strategic direction of the company; no safety concerns were observed that impacted this decision.)
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release (1950 mg/Day or 3900 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee [NCT00240786]Phase 3483 participants (Actual)Interventional2002-04-30Completed
A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes [NCT02700451]178 participants (Actual)Interventional2016-03-31Completed
Phase I Study of the Administration of Multi-Virus-Specific Cytotoxic T Lymphocytes Expressing CD19 Chimeric Receptors for Prophylaxis or Therapy of Relapse of CD19 Positive Malignancies Post Hematopoietic Stem Cell Transplantation [NCT00840853]Phase 168 participants (Anticipated)Interventional2009-04-30Active, not recruiting
A Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers [NCT00429468]Phase 125 participants Interventional2007-01-31Completed
Randomized Controlled Trial of Chiropractic Manipulation Versus Medical Therapy for Chronic Neck Pain [NCT00429624]70 participants Interventional1994-09-30Completed
Multicentre, Open, Non-Comparative Study of the Acceptability and Safety of Paracetamol Oral Paediatric Suspension at 4.8%. [NCT00434681]Phase 348 participants Interventional2006-10-31Completed
[NCT00487110]Phase 440 participants (Anticipated)Interventional2008-06-30Completed
Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty: A Randomized Controlled Trial [NCT02954484]Phase 3116 participants (Actual)Interventional2015-04-30Completed
Does Acetaminophen Reduce Neuraxial Analgesic Requirement During Labor [NCT02181387]Phase 433 participants (Actual)Interventional2013-09-05Terminated(stopped due to funding and compounding issues)
An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gel Tabs (Containing Acetaminophen 650 mg) of OHM Laboratories (Subsidiary of Ranbax [NCT01513668]40 participants (Actual)Interventional2006-05-31Completed
A Single Centre, Randomised, Double-blind, Placebo Controlled Trial to Evaluate the Possible Drug-drug Interaction Between Liraglutide and Paracetamol and the Effects of Liraglutide on Postprandial Glucose and Insulin, Gastric Emptying, Appetite Sensation [NCT01517555]Phase 118 participants (Actual)Interventional2006-10-31Completed
Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand [NCT03849625]158 participants (Actual)Observational2015-05-01Completed
Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Orchiopexy Repair [NCT03041935]90 participants (Actual)Interventional2015-09-01Completed
Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients [NCT01520298]Phase 30 participants (Actual)Interventional2011-12-31Withdrawn(stopped due to Difficulty in recruiting subjects for the trial.)
Paracétamol and Pharmacogenetic in Healthy Volunteers [NCT01520792]Phase 1100 participants (Actual)Interventional2011-11-30Completed
An Open Label, Balanced, Randomised, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioavailability Study Comparing Acetaminophen 650 mg Extended Release Gel Tabs (Containing Acetaminophen 650 mg) of OHM Laboratories Inc. (Subsidiary of R [NCT01523080]32 participants (Actual)Interventional2006-05-31Completed
Post-Op Pain Control for Prophylactic Intramedullary Nailing. [NCT03823534]Phase 360 participants (Anticipated)Interventional2019-02-20Recruiting
Effect of Perioperative Electroacupuncture With Tramadol and Ketamine on Postoperative Analgesia in Prostatectomy: a Randomized Placebo-controlled Trial [NCT01526525]Phase 470 participants (Actual)Interventional2009-07-31Completed
Oral Paracetamol Versus Oral Ibuprofen Treatment [NCT01536158]Phase 480 participants (Actual)Interventional2012-02-29Completed
Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Tonsillectomy [NCT00378547]Phase 4147 participants (Actual)Interventional2006-01-31Terminated(stopped due to ENT surgery stopped at the recruiting hospital)
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Different Sustained Released Paracetamol Formulations [NCT01540721]Phase 128 participants (Actual)Interventional2009-12-31Completed
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations [NCT01540734]Phase 128 participants (Actual)Interventional2009-12-31Completed
Analgesic Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair; a Randomized, Double, Blinded, Placebo Controlled Study [NCT01500109]45 participants (Actual)Interventional2011-11-30Completed
Serum Level Measurement of Oral Paracetamol and Oral Ibuprofen [NCT01544972]Phase 480 participants (Anticipated)Interventional2012-02-29Recruiting
An Open, Randomized, Parallel Group Study in Patients With Cancer Pain, To Compare a Two-Step Analgesic Ladder (Non-Opioid to Oxycodone) With Conventional Management Using A Three-Step Approach [NCT00378937]Phase 430 participants (Anticipated)Interventional2004-01-31Completed
A Proof of Principal Study to Investigate the Pharmacokinetic Profiles of Sustained Release and Standard Paracetamol Formulations [NCT01551797]Phase 114 participants (Actual)Interventional2010-05-31Completed
A Randomised, Two Way Crossover Study to Determine the Time at Which Therapeutic Plasma Concentrations of Paracetamol Are Achieved in Two Marketed Formulations [NCT01551836]Phase 112 participants (Actual)Interventional2009-06-30Completed
A Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single Dose of Fast Release Aspirin 1000 mg and Acetaminophen 1000 mg in Tension Type Headache Pain [NCT01552798]Phase 39 participants (Actual)Interventional2012-03-12Terminated
Registration and Treatment of Pain During Eye Examination of Prematurity [NCT01552993]5 participants (Actual)Interventional2012-03-31Terminated(stopped due to the chosen intervention was obviously ineffective)
Effect of a Transversus Abdominis Plane Block on Operative Wound Healing, Stress, and Immune Response After a Cesarean Delivery [NCT05840406]120 participants (Anticipated)Interventional2024-04-01Not yet recruiting
Assessment of Hepatic Injury in Subjects Who Consume Moderate Amounts of Alcohol While Being Administered Therapeutic Doses of Acetaminophen: [NCT00400621]Phase 4150 participants Interventional2003-04-30Completed
Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up [NCT01535001]100 participants (Actual)Interventional2012-02-29Completed
Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain [NCT03879408]Phase 2290 participants (Actual)Interventional2019-05-28Completed
Paracetamol Versus Ibuprofen in Closure of Patent Ductus Arteriosus in Premature Neonates,at Upper Egypt [NCT06152796]Phase 256 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Toward Better Outcomes in Osteoarthritis (OA): Finding the Appropriate Role for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) [NCT00000425]Phase 3900 participants Interventional1996-07-31Completed
Chiropractic Care, Medication, and Self-Care for Neck Pain [NCT00029770]Phase 2270 participants Interventional2001-09-30Completed
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients [NCT04194528]2 participants (Actual)Interventional2020-01-22Terminated(stopped due to Study sponsor withdrew support.)
MAST Trial: Multi-modal Analgesic Strategies in Trauma [NCT03472469]Phase 41,561 participants (Actual)Interventional2018-04-02Completed
Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain [NCT00390260]Phase 3420 participants Interventional2002-02-28Completed
[NCT00137059]40 participants Interventional2002-11-30Completed
The Effect of Paracetamol in the Treatment of Non-severe Malaria in Children in Guinea-Bissau [NCT00137566]Phase 40 participants Interventional2004-05-31Active, not recruiting
Liberal Versus Restrictive Platelet Transfusion for Treatment of Hemodynamically Significant Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates- A Randomized Open Label, Controlled Trial [NCT03022253]Phase 344 participants (Anticipated)Interventional2016-03-31Completed
Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial [NCT04026464]Phase 20 participants (Actual)Interventional2021-04-30Withdrawn(stopped due to Unable to obtain funding to support this project)
Analgesic Effect of Paracetamol in Neuropathic Pain Patients [NCT03559985]Phase 243 participants (Actual)Interventional2018-08-20Terminated(stopped due to Recruitment difficulties)
A Randomized, Double-blind, Double-dummy, Single-dose, Parallel Group, Multicenter Study to Compare the Antipyretic Efficacy of Acetylsalicy-lic Acid 500 mg and 1,000 mg (2 x 500 mg) and Paracetamol 500 mg and 1,000 mg (2 x 500 mg) With Placebo in Patient [NCT01464944]Phase 4392 participants (Actual)Interventional2003-11-30Completed
Perioperative Regular Usage of Propacetamol to Reduce Post Cesarean Section Uterine Contraction Pain and Opioid Consumption [NCT03878082]100 participants (Actual)Interventional2019-08-12Completed
The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial [NCT02043704]Phase 4100 participants (Actual)Interventional2014-01-31Completed
Phase I-II Trial of High-Dose Acetaminophen With Carmustine in Patients With Metastatic Melanoma [NCT00003346]Phase 280 participants (Anticipated)Interventional1997-11-30Completed
A Study to Evaluate the Potential for Pharmacokinetic Interaction Between SB 462795 and SSRIs in Healthy Subjects [3A] [NCT00411190]Phase 132 participants (Actual)Interventional2006-10-19Completed
Incidence Of Hemidiaphragmatic Paralysis With Patient Controlled Infusion Of Low Volume Of Ropivacaine After Usg Guided Low Dose Interscalene Brachial Plexus Block [NCT03081728]56 participants (Actual)Interventional2017-04-01Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen for the Treatment of Painful Diabetic Neuropathy [NCT00210847]Phase 3313 participants (Actual)Interventional2003-12-31Completed
Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study [NCT00402571]Phase 4420 participants Interventional2002-01-31Completed
An Open-label, Randomised Study Comparing the Uptake of rIL-2 in HIV-1 Infected Individuals Receiving Different Combinations of Antiemetics and Analgesic Agents During rIL-2 Dosing in ESPRIT: Toxicity Substudy of ESPRIT: TOXIL-2 Substudy [NCT00147355]Phase 328 participants (Actual)Interventional2005-11-30Terminated(stopped due to 28 of 168 patients only were enrolled, numbers too low to be conclusive)
A Randomised, Placebo-controlled, Crossover Trial of Acetaminophen in Cancer Patients on Strong Opioids [NCT00152854]Phase 312 participants (Actual)Interventional2005-07-31Completed
A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction [NCT02601027]Phase 3120 participants (Actual)Interventional2015-11-30Completed
Postoperative Pain After Medical Abortion Under Local Anesthesia : a Prospective and Randomized Trial Comparing Several Analgesic Regimen [NCT00188071]240 participants Interventional2002-09-30Completed
Analgesic Strategies in Newborns Receiving Prostaglandin Therapy [NCT00200590]30 participants (Anticipated)Interventional2003-12-31Terminated(stopped due to More important number of SAE in one arms)
Influence of Age on the Absorption and Metabolism of Cocoa Flavanols [NCT01790009]Phase 140 participants (Actual)Interventional2011-02-28Completed
Bakirkoy Dr. Sadi Konuk Training and Research Hospital [NCT04767542]Phase 342 participants (Anticipated)Interventional2021-03-15Not yet recruiting
Phase 2 Study of Bexxar in Relapsed/Refractory Diffuse Large Cell Lymphoma (DLCL) [NCT00490009]Phase 29 participants (Actual)Interventional2004-09-30Completed
PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY [NCT03597308]210 participants (Actual)Interventional2017-03-17Completed
Management Of Pain After Cesarean Trial [NCT03929640]Phase 349 participants (Actual)Interventional2019-08-05Completed
Efficacy and Safety of Methoxyflurane Vaporized (PENTHROX®) in the Treatment of Acute Trauma Pain in Pre-hospital Setting and in the Emergency Department in Italy: a Multicentre, Randomized, Controlled, Open-label Study [NCT03585374]Phase 3272 participants (Actual)Interventional2018-02-08Completed
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes. [NCT02449369]Phase 4180 participants (Actual)Interventional2015-04-30Completed
The Preterm Infants' Paracetamol Study [NCT01938261]Phase 2120 participants (Anticipated)Interventional2013-08-31Recruiting
A Multi-center, Randomized, Double-blind, Parallel-group, Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of a Combination of Acetaminophen and Aspirin vs Placebo in the Acute Treatment of Migraine [NCT01973205]Phase 3900 participants (Actual)Interventional2013-10-31Completed
Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers [NCT02305017]Phase 128 participants (Actual)Interventional2014-03-31Completed
Safety and Antipyretic Efficacy of Acetaminophen in the Febrile Intensive Care Unit Patient. [NCT02280239]Phase 410 participants (Actual)Interventional2015-05-31Terminated(stopped due to Only enrolled 10 participants over 9 months which is less then anticipated (75).)
[NCT02359305]68 participants (Actual)Observational2014-06-30Completed
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy [NCT02369211]Phase 486 participants (Actual)Interventional2015-09-30Completed
B-Cell Targeted Therapy for Acute Renal Allograft Rejection With an Antibody Mediated Component: A Prospective, Randomized, Open-Label Study [NCT00771875]Phase 230 participants (Actual)Interventional2008-09-30Completed
Comparing Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol Administration for Carpal Tunnel Release and Distal Radius Fracture Surgeries [NCT02313675]Phase 444 participants (Actual)Interventional2015-05-31Completed
PARASTOP - Paracetamol With Strong Opioids. A Randomized, Double-blind, Parallel-group Non-inferiority Phase III Withdrawal Trial of Paracetamol Versus Placebo in Conjunction With Opioids for Moderate to Severe Cancer-related Pain [NCT05051735]Phase 3204 participants (Anticipated)Interventional2021-10-20Recruiting
A Randomized Controlled Trial on the Effects of NSAIDs on Postpartum Blood Pressure in Patients Hypertensive Disorders of Pregnancy [NCT03011567]202 participants (Actual)Interventional2017-01-31Completed
Multicentre Study to Assess the Effect of Prophylactic Antipyretic Treatment on the Rate of Febrile Reactions Following Concomitant Administration of GSK Biologicals' 10-valent Pneumococcal Conjugate, Infanrix Hexa and Rotarix Vaccines [NCT00370318]Phase 3400 participants Interventional2006-09-30Completed
Comparison of the Analgesic Effect of a New Paracetamol Formulation (Paracetamol UNIFLASH) for Buccal Use and Two Different Doses of an Oral Paracetamol Form Controlled Versus Placebo in Patients Suffering From Moderate Pain Due to a Tooth Extraction. [NCT04640376]Phase 3407 participants (Actual)Interventional2021-03-24Completed
Evaluation of Paracetamol as Post-operative Analgetic Modality Compared With Ketorolac [NCT05523102]Phase 485 participants (Actual)Interventional2022-03-31Completed
A Pilot Study Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision [NCT02973958]Phase 130 participants (Actual)Interventional2017-02-01Completed
A Randomized, Placebo Controlled, Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients [NCT01635101]Phase 3197 participants (Actual)Interventional2012-06-30Completed
A Double-blind, Randomized, Placebo-controlled Study to Compare the Effectiveness of IV Acetaminophen Administered Intra-operatively in Reducing the Use of Opiates to Treat Post-operative Pain [NCT01783236]Phase 416 participants (Actual)Interventional2013-06-30Completed
Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach. [NCT04149964]Phase 465 participants (Actual)Interventional2019-11-27Completed
A Phase 3b, Open-Label Study of HTX-011 as Part of a Scheduled Non-Opioid Multimodal Analgesic Regimen in Subjects Undergoing Total Knee Arthroplasty [NCT03974932]Phase 3116 participants (Actual)Interventional2019-06-05Completed
A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) [NCT01086540]Phase 257 participants (Actual)Interventional2011-06-24Completed
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen: [NCT02061774]Phase 421 participants (Actual)Interventional2013-10-31Terminated(stopped due to Preliminary analysis showed not clinically significant. Study ended and closed 1/11/2018)
Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients [NCT02069184]Phase 466 participants (Actual)Interventional2013-11-30Completed
Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications [NCT02156154]Phase 3580 participants (Actual)Interventional2014-12-31Completed
A Randomized, Controlled Trial of IV Acetaminophen Versus IV Morphine to Manage Pain in Pregnancy: Can Opioid Use be Reduced in Pregnant Women? [NCT02267772]163 participants (Actual)Interventional2014-01-31Terminated(stopped due to Difficulties in recruitment)
Aminotransferase Trends During Prolonged Therapeutic Acetaminophen Dosing [NCT00743093]Phase 4398 participants (Actual)Interventional2008-08-31Completed
Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial [NCT05722002]Phase 4900 participants (Anticipated)Interventional2023-02-06Recruiting
Psychosocial and Psychophysical Factors Influencing the Effect of Preemptive Systemic Analgesia in Combination With Regional Anesthesia on Postoperative Pain Following Upper Limb Surgery [NCT05248152]90 participants (Anticipated)Interventional2022-01-13Recruiting
A Phase 3b, Randomized, Open-Label Study of HTX-011 as the Foundation of a Non-opioid, Multimodal Analgesic Regimen to Decrease Opioid Use Following Unilateral Open Inguinal Herniorrhaphy [NCT03907176]Phase 3115 participants (Actual)Interventional2019-04-05Completed
Effects of Acetaminophen on Pain Response Among Overweight or Obese Women Exposed to Weight Stigmatization [NCT04573426]200 participants (Actual)Observational2019-11-15Completed
A Comparison of the Efficacy and Safety of Tramadol HCl/Acetaminophen Versus Hydrocodone Bitartrate/Acetaminophen Versus Placebo in Subjects With Acute Musculoskeletal Pain [NCT00236535]Phase 3603 participants (Actual)Interventional2003-12-31Completed
Clinical Immunization Safety Assessment (CISA): A Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine (IIV) Administered to Children 6 Through 47 Months of Age [NCT02212990]104 participants (Actual)Interventional2014-09-30Completed
A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus ULTRAM® (Tramadol HCl) Versus Placebo in Subjects With Pain Following Oral Surgery [NCT00236483]Phase 4456 participants (Actual)Interventional2002-11-30Completed
A Randomized, Double-Blind, Long-Term Comparative Study Evaluating the Safety and Efficacy of Acetaminophen (4000 mg/Day) and Naproxen (750 mg/Day) in the Treatment of Osteoarthritis of the Hip or Knee [NCT00240773]Phase 3581 participants (Actual)InterventionalCompleted
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) in the Treatment of Post-Race Muscle Aching and Pain (Soreness) [NCT00240851]Phase 4665 participants (Actual)InterventionalCompleted
A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery [NCT00245375]150 participants Interventional2005-01-31Completed
A Randomized Controlled Study of Transcranial Magnetic Stimulation for Postoperative Headache in Patients With Growth Hormone(GH) Pituitary Tumor [NCT04529356]200 participants (Anticipated)Interventional2020-09-01Not yet recruiting
Paracetamol Effect on Oxidative Stress and Renal Function in Severe Falciparum Malaria With Intravascular Haemolysis: A Randomised Controlled Clinical Trial [NCT01641289]62 participants (Actual)Interventional2012-07-10Completed
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL) [NCT02999633]Phase 214 participants (Actual)Interventional2017-03-08Terminated(stopped due to Due to an unsatisfactory benefit/risk ratio, as specified in & 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely)
An Evaluation of Hydrocodone/Acetaminophen for Pain Control in First Trimester Surgical Abortion [NCT01330459]Phase 4121 participants (Actual)Interventional2011-02-28Completed
A Randomized, Double-Blind, Parallel-Group Study Comparing the Safety and Effectiveness of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Ankle Sprains. [NCT00261560]Phase 4260 participants (Actual)InterventionalCompleted
A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis [NCT00298974]Phase 3873 participants (Actual)Interventional2006-02-28Completed
A Double-Blind, Double-Dummy, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10mg Co-Administered With Acetaminophen for the Treatment of Acute Migraine. [NCT00300924]Phase 3200 participants Interventional2006-03-31Completed
A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Acute Treatment of Migraine Headache Pain [NCT00297375]Phase 4375 participants (Actual)Interventional2003-04-30Completed
A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0974 Co-administered With Ibuprofen or Acetaminophen in Patients With Migraine With or Without Aura [NCT00758836]Phase 2683 participants (Actual)Interventional2008-12-03Completed
A Single-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Multiple Subcutaneous Injections of SHR20004 in Healthy Subjects on Gastric Emptying [NCT06137469]Phase 128 participants (Anticipated)Interventional2023-12-15Not yet recruiting
Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy [NCT00292214]Phase 430 participants Interventional2005-10-31Completed
A Randomized Controlled Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3® for the Treatment of Pain After Breast Surgery. [NCT00299039]Phase 3150 participants (Anticipated)Interventional2006-05-31Completed
Synergistic Effect Of Parenteral Diclofenac And Paracetamol In The Pain Management Of Acute Limb Injuries [NCT04199572]Phase 4162 participants (Actual)Interventional2022-10-16Completed
The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor [NCT03400267]Phase 4200 participants (Actual)Interventional2018-02-16Completed
A Phase III, International, Multicenter, Randomised Open Label Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Patients With Childhood Onset Idiopathic Nephrotic Syndrome [NCT05627557]Phase 380 participants (Anticipated)Interventional2023-03-29Recruiting
A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure [NCT05285813]Phase 242 participants (Anticipated)Interventional2022-05-06Recruiting
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus [NCT04963296]Phase 3300 participants (Anticipated)Interventional2021-10-26Recruiting
The Placebo Effect May Involve Modulating Drug Bioavailability [NCT01501747]162 participants (Actual)Interventional2012-02-29Completed
Pain Control in Elderly Hip Fracture Patients: Is Intravenous Acetaminophen Superior to Oral Administration? [NCT02774148]Phase 41 participants (Actual)Interventional2016-12-31Terminated(stopped due to Proved difficult to consent patient population due to comorbidities)
The Efficacy of Pain Management Protocol for Elderly Hip Fracture Patients After Surgery: A Prospective Cohort Study [NCT01630343]Phase 2400 participants (Actual)Interventional2010-01-31Completed
Absorption of Paracetamol, Talinolol and Amoxicillin After Oral Administration Using Non-caloric and Caloric Water [NCT01635608]Phase 112 participants (Actual)Interventional2011-04-30Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets (TV-46763) at Doses of 5.0 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 m [NCT02487108]Phase 3569 participants (Actual)Interventional2015-08-11Completed
Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair [NCT01637818]594 participants (Actual)Interventional1999-09-30Completed
The Effect on Knee Joint Loads of Instruction in Analgesic Use Compared With NEUROMUSCULAR Exercise in Patients With Knee Osteoarthritis - A Single Blind RCT [NCT01638962]93 participants (Actual)Interventional2012-08-31Completed
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management [NCT01381120]Phase 484 participants (Actual)Interventional2010-10-31Completed
THE EFFECT OF INTRAOPERATIVE PARACETAMOL ON CATHETER-RELATED BLADDER DISCOMFORT: A PROSPECTIVE, RANDOMISED, DOUBLE-BLIND STUDY [NCT01652183]Phase 464 participants (Actual)Interventional2008-10-31Completed
The Impact of Gall Bladder Emptying and Bile Acids on the Human GLP-1-secretion [NCT01656057]10 participants (Actual)Interventional2012-07-31Completed
Pharmacokinetic Study of a Fixed Dose Combination Nefopam Hydrochloride (30 mg) / Paracetamol (500 mg) and Individual Nefopam Hydrochloride and Paracetamol Taken Alone or Concomitantly After Oral Single Dose [NCT05129137]Phase 131 participants (Actual)Interventional2021-11-29Completed
Influence of Surgical Pleth Index-guided Analgesia Using Different Techniques on the Perioperative Outcomes in Patients Undergoing Vitreoretinal Surgery Under General Anaesthesia: Randomised, Controlled Trial [NCT02973581]176 participants (Actual)Interventional2016-02-29Completed
Prospective Randomized Equivalence Trial Comparing the Analgesic Efficacy of Ofirmev® Compared to a 1.5 Gram Dose of Oral Acetaminophen for Arthroscopic Rotator Cuff Repair [NCT01711229]Phase 4114 participants (Anticipated)Interventional2015-12-31Not yet recruiting
The Comparison of the Effectiveness of Intravenous Dexketoprofen and Paracetamol in the Treatment of Headache Caused by Acute Migraine Attack in Emergency Service [NCT01730326]Phase 4200 participants (Actual)Interventional2012-03-31Completed
Sublingual Analgesia for Acute Abdominal Pain in Children. Ketorolac Versus Tramadol Versus Paracetamol, a Randomized, Control Trial [NCT02465255]Phase 3210 participants (Actual)Interventional2015-03-31Completed
Comparison of Acetaminophen and Platelet-rich Plasma Therapy for the Treatment of Knee Osteoarthritis. [NCT01782885]543 participants (Actual)Interventional2013-05-31Completed
The Use of Ibuprofen and Acetaminophen for Acute Headache in the Post Concussive Youth: A Pilot Study. [NCT02268058]80 participants (Actual)Interventional2013-10-31Completed
Effect of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption and Pain After Video-assisted Thoracic Surgery: A Double-blind Randomized Controlled Trial [NCT05366777]96 participants (Actual)Interventional2022-10-03Completed
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? [NCT02307305]Phase 2168 participants (Anticipated)Interventional2014-08-31Recruiting
Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants [NCT01755728]Phase 319 participants (Actual)Interventional2013-01-01Completed
A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty [NCT01760330]Phase 20 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Unable to obtain funding)
CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study. [NCT01762891]22 participants (Actual)Interventional2003-03-31Completed
Pharmacokinetics of Intravenous Acetaminophen and Its Metabolites in Morbidly Obese Patients [NCT01764555]Phase 428 participants (Actual)Interventional2012-12-31Completed
A Pharmacokinetic Study to Evaluate the Rate and Extent of Absorption of Paracetamol From Two Formulations in an Indian Population. [NCT01767428]Phase 130 participants (Actual)Interventional2010-04-30Completed
Observational Study Assessing Cytochrome P450 Dependant Paracetamol Metabolites Following Liver Resection. [NCT01770041]42 participants (Actual)Observational2013-02-28Completed
Optimal Method of Pain Control After Minimally Invasive Coronary Artery Bypass Grafting [NCT01770236]Phase 441 participants (Actual)Interventional2013-01-31Terminated(stopped due to Study medication no longer available at institution)
A Single Center, Randomized, Open-Label Trial to Compare the Safety and Efficacy of Caldolor Used Singly and in Combination With Ofirmev in Total Knee or Hip Arthroplasty Surgery Patients [NCT01773005]Phase 478 participants (Actual)Interventional2012-12-31Completed
A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Low Back Pain Patients [NCT01776515]Phase 10 participants Interventional2012-01-31Completed
A Single Dose, Open-Label, Randomized, Two-Way Crossover Pivotal Study to Assess the Bioequivalence of a New ULTRACET ER Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition [NCT01778075]Phase 156 participants (Actual)Interventional2012-12-31Completed
Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of Post-Tonsillectomy Pain in Pediatric Patients [NCT04551196]Phase 347 participants (Actual)Interventional2020-09-28Completed
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair [NCT05122351]Early Phase 150 participants (Actual)Interventional2021-10-01Completed
Effect of Early Analgesic Treatment on Opioid Consumption [NCT03243006]1,500 participants (Actual)Interventional2016-01-01Completed
Clinical Predictors and Epigenetic Markers for Liver Fibrosis in Alpha-1 Antitrypsin Deficiency [NCT01810458]109 participants (Actual)Observational2013-10-31Completed
A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation [NCT02480114]Phase 379 participants (Actual)Interventional2015-07-31Completed
Oral Paracetamol as Preemptive Analgesia for Labor Pain [NCT01817829]Phase 3100 participants (Actual)Interventional2011-12-31Completed
A Single Centre Prospective Randomised Study to Investigate the Cerebrospinal Fluid (CSF) Pharmacokinetics of Intravenous Paracetamol in Humans [NCT01821872]Phase 430 participants (Actual)Interventional2011-05-31Completed
A Study Comparing Recurrent Use of Morphine Sulfate Immediate Release, Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at Discharge From the ED in Opioid-naïve Adult Patients With Moderate to Severe Pain. [NCT03529331]Phase 40 participants (Actual)Interventional2019-09-01Withdrawn(stopped due to The ED physicians no longer prescribe opioids at discharge; not feasible to conduct the study)
The Effects of Fascia Iliaca Compartment Block on Hip Fracture Patients [NCT04837924]Phase 480 participants (Actual)Interventional2021-04-21Completed
Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa [NCT02974348]Phase 3300 participants (Actual)Interventional2013-01-31Completed
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery [NCT02487303]148 participants (Actual)Interventional2015-03-17Completed
Single Blinded, Two-period, Two-treatment, Crossover, Randomized, Single Dose Bioequivalence Study of Two Oral Formulations With 500 mg of Paracetamol (Mejoral® 500 Tablets, Glaxosmithkline méxico s.a. De c.v. Vs. Tylenol® Caplets, Janssen Cilag de méxico [NCT02504775]28 participants (Actual)Interventional2015-08-01Completed
Can Acetaminophen PO Given 1-2 Hours Before Bilateral Myringotomy Tube (BMT) Placement Reduce Emergence Agitation (EA) in Children After General Sevoflurane Anesthesia? [NCT01737593]Phase 4108 participants (Actual)Interventional2012-11-30Terminated(stopped due to Interim analysis revealed a negative effect.)
The Efficacy of Intravenous Acetaminophen During The Perioperative Period Of Neurosurgical Patients Undergoing Craniotomies [NCT01739699]Phase 4140 participants (Actual)Interventional2012-01-31Completed
Randomized Clinical Trial of IV Acetaminophen as an Analgesic Adjunct to IV Hydromorphone in the Treatment of Acute Severe Pain in Elderly ED Patients [NCT02621619]Phase 4159 participants (Actual)Interventional2016-03-31Completed
Inhibition of Lipid Peroxidation During Cardiopulmonary Bypass [NCT01366976]67 participants (Actual)Interventional2011-07-31Completed
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy [NCT01267136]Phase 484 participants (Actual)Interventional2011-01-31Completed
A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies [NCT01332578]Phase 425 participants (Actual)Interventional2011-05-31Completed
The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants [NCT03008876]10 participants (Actual)Interventional2017-01-01Completed
Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery [NCT01852955]70 participants (Actual)Interventional2013-11-30Completed
The Copenhagen Analgesic Study [NCT04369222]600 participants (Anticipated)Observational2020-03-01Recruiting
An Open-label, Single Treatment, Single Period, Single Buccal Dose Pharmacokinetic Study of Paracetamol Uniflash (125 mg/ 1.25 mL) in Healthy, Adult, Human Subjects Under Fasting Conditions. [NCT05406752]Phase 132 participants (Actual)Interventional2022-07-22Completed
A Prospective, Double Blind, Randomized, Placebo Controlled Study to Compare the Effectiveness of Intravenous Acetaminophen and Intravenous Ibuprofen in Reducing Post Procedural Pain in the Uterine Fibroid Embolization Procedure [NCT02227316]Phase 440 participants (Actual)Interventional2014-08-31Completed
Analgesic Effect of Single Dose Intravenous Acetaminophen in Pediatric Patients Undergoing Tonsillectomy [NCT01691690]Phase 2250 participants (Actual)Interventional2012-10-31Completed
To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine [NCT02440399]200 participants (Actual)Interventional2015-07-31Completed
Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial [NCT03978767]Phase 2286 participants (Anticipated)Interventional2019-06-10Recruiting
A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy and Safety Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain [NCT03224403]Phase 3664 participants (Actual)Interventional2017-07-19Completed
Efficacy of Bromocriptine to Reduce Body Temperature in Febrile Critically-ill Adults With Acute Neurologic Disease: an Open-label, Blinded Endpoint, Randomized Controlled Trial [NCT03496545]Phase 1/Phase 247 participants (Actual)Interventional2018-11-30Completed
Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010 [NCT01374269]Phase 490 participants (Actual)Interventional2009-06-30Completed
A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache [NCT01755702]Phase 2/Phase 366 participants (Actual)Interventional2009-07-31Terminated(stopped due to Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.)
ZIH Study : Comparison of Oral Zaldiar (Combination of Paracetamol and Tramadol) With Intravenous Paracetamol and Tramadol for Postoperative Analgesia After Inguinal Hernia Repair [NCT02389361]Phase 451 participants (Actual)Interventional2011-04-30Completed
Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment [NCT02393339]Early Phase 1114 participants (Actual)Interventional2017-02-01Completed
A Randomized Controlled Trial on the Efficacy, Safety and Quality of Life Effects of Add-on Tramadol/Paracetamol Combination in Chronic Osteoarthritis [NCT01728246]Phase 4473 participants (Actual)Interventional2007-10-31Completed
IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy [NCT01798316]Phase 4105 participants (Actual)Interventional2013-03-31Terminated(stopped due to Principal Investigator left the institution)
Celecoxib for Pain Management After Tonsillectomy [NCT02934191]Phase 2172 participants (Actual)Interventional2016-06-30Completed
Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects [NCT03997851]Phase 1/Phase 217 participants (Actual)Interventional2019-07-22Completed
A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Repeated Dose, Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain in Combination With Patient-Controlled Analgesia With Morphine i [NCT02746263]Phase 41 participants (Actual)Interventional2016-04-27Terminated(stopped due to Business decision because enrollment was slower than expected)
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Sa [NCT05039619]Phase 240 participants (Anticipated)Interventional2022-05-12Recruiting
A Phase 4, Randomized, Open-Label Trial To Assess The Impact Of Prophylactic Antipyretic Medication On The Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine Given With Routine Pediatric Vaccinations In Healthy Infants [NCT01392378]Phase 4908 participants (Actual)Interventional2011-08-31Completed
Post-operative Morphine Consumption in Obese Patients Undergoing Laparoscopic Bariatric Surgery Following Ketamina and Lidocaine Perfusion [NCT05591105]60 participants (Actual)Observational2022-01-15Completed
KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Anti-PD-(L)1 Therapy [NCT04165096]Phase 2135 participants (Anticipated)Interventional2020-01-21Active, not recruiting
A Study of Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries: The No OUCH Trials [NCT03767933]Phase 2710 participants (Actual)Interventional2019-04-20Completed
A Multicenter, Open-label, Single-arm Study to Evaluate the Safety Administering Rituximab at a More Rapid Infusion Rate in Patients With Rheumatoid Arthritis [NCT01382940]Phase 4351 participants (Actual)Interventional2011-07-26Completed
Analgesia Efficacy of Repeated Doses of Intravenous Acetaminophen (Paracetamol) in the Pediatric Spinal Fusion Population [NCT01394718]Phase 367 participants (Actual)Interventional2011-07-31Completed
[NCT00382083]Phase 40 participants Interventional2006-03-31Completed
The Opioid-Sparing and Analgesic Effects of IV Acetaminophen in Craniotomy: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study [NCT01598701]Phase 4100 participants (Actual)Interventional2012-05-02Completed
Effects Of Native Collagen Type 2 Treatment In Knee Osteoarthritis : A Randomized Controlled Trial [NCT02237989]39 participants (Actual)Interventional2013-01-31Completed
Oral Ibuprofen Versus Oral Paracetamol in Pain Management During Screening for Retinopathy of Prematurity: A Prospective Observational Study [NCT04767178]44 participants (Actual)Observational2020-01-01Completed
Paracetamol and Setrons : Drug Interactions in the Management of Pain After Tonsillectomy in Children [NCT01432977]Phase 372 participants (Actual)Interventional2011-09-30Completed
Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features [NCT02911701]Phase 4100 participants (Actual)Interventional2016-09-30Completed
A Randomized, Double-Blind, Placebo-Controlled, Single Center Study of IV Acetaminophen for the Treatment of Post-Operative Pain After Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) [NCT01460667]85 participants (Anticipated)Interventional2011-10-31Recruiting
Impact of IV Acetaminophen on Post-operative Pain After Laparoscopic Appendectomy for Perforated Appendicitis: A Prospective Randomized Trial [NCT02881996]90 participants (Actual)Interventional2014-06-30Completed
Emergence Agitation and Pain Scores in Pediatric Patients Following Sevoflurane Anesthesia When Comparing Single-modal Versus Multi-modal Analgesia for Routine Ear-nose-throat (ENT) Surgery, a Multi-center Double-blinded Study [NCT03062488]Early Phase 1143 participants (Actual)Interventional2017-10-03Completed
Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery [NCT05564819]Phase 1220 participants (Anticipated)Interventional2022-09-14Recruiting
Dose-finding Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Knee Procedures of Short Duration [NCT03428230]Phase 260 participants (Actual)Interventional2018-08-06Completed
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction [NCT03105518]Phase 4100 participants (Actual)Interventional2011-03-01Active, not recruiting
The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy: A Randomized Control Trial [NCT03445390]Phase 427 participants (Actual)Interventional2014-05-01Completed
A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery [NCT01920386]Phase 3240 participants (Actual)Interventional2013-06-30Completed
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial [NCT03241030]Phase 2102 participants (Actual)Interventional2017-09-12Completed
Ibuprofen and Acetaminophen Versus Ibuprofen and Acetaminophen Plus Hydrocodone for Analgesia After Cesarean Section: A Prospective, Randomized Control Trial [NCT03372382]Phase 4170 participants (Actual)Interventional2017-12-13Completed
Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty [NCT03605914]Phase 4100 participants (Actual)Interventional2018-08-01Completed
Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis: A Randomized Double Blind Placebo-controlled Trial [NCT03035045]240 participants (Anticipated)Interventional2016-11-30Active, not recruiting
Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block [NCT03011905]Phase 353 participants (Actual)Interventional2017-01-31Completed
Multimodal Pain Management for Cesarean Delivery: A Randomized Control Trial [NCT02922985]Phase 4120 participants (Actual)Interventional2016-10-31Completed
Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Knee Osteoarthritis [NCT05398874]60 participants (Actual)Interventional2021-11-01Completed
Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial [NCT03145467]Phase 4200 participants (Actual)Interventional2016-01-31Completed
Analgesic Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain: A Randomized Double-blind Controlled Trial [NCT04066426]Phase 4200 participants (Actual)Interventional2018-03-01Completed
Onset of Action of a Fast Release Aspirin Tablet and Acetaminophen Caplet in Sore Throat Pain [NCT01453400]Phase 3177 participants (Actual)Interventional2011-09-27Completed
Effects of Different Local Anesthetic Concentrations With Epidural Tap Method for Labor Analgesia [NCT05499234]Phase 170 participants (Anticipated)Interventional2022-08-01Recruiting
Clinical, Pharmacological and Molecular Effects of Intravenous and Oral Acetaminophen in Adults With Aneurysmal Sub-Arachnoid Hemorrhage [NCT02549716]Phase 43 participants (Actual)Interventional2017-01-05Terminated(stopped due to Funding was stopped)
Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage [NCT01530880]Phase 435 participants (Actual)Interventional2012-10-31Terminated(stopped due to PI no longer at institution)
Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study [NCT02358850]Phase 427 participants (Actual)Interventional2016-01-31Terminated(stopped due to low enrollment)
Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples With an Electrochemical Indicator in Healthy Volunteers - a Validation Study for a Novel Technique [NCT04690673]12 participants (Actual)Interventional2021-01-15Completed
Active Temperature Management After Cardiac Surgery and Its Effect on Postoperative Cognitive Dysfunction [NCT03947671]Phase 2172 participants (Anticipated)Interventional2020-01-22Recruiting
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge [NCT01402375]Phase 3720 participants (Actual)Interventional2012-01-31Completed
Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up [NCT01410409]100 participants (Actual)Interventional2011-09-30Completed
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain [NCT01115673]Phase 3540 participants (Actual)Interventional2010-06-30Completed
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial [NCT01270659]Phase 360 participants (Actual)Interventional2011-05-31Completed
A Clinical Trial to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine [NCT03061734]Phase 292 participants (Actual)Interventional2017-02-18Completed
Effect of Preoperative Oral Tramadol on the Anaesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind, Controlled Study [NCT04961268]250 participants (Actual)Interventional2020-06-01Completed
A Randomized Controlled Clinical Trial on the Antipyretic Efficacy of Oral Paracetamol, Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever to Emergency Department [NCT01891435]434 participants (Actual)Interventional2010-01-31Completed
Evaluation of the Efficacy of a Homeopathic Protocol to Reduce the Onset or Aggravation of Joint Pain or Stiffness Following the Taking of Anti-aromatases (AI) in Patients With Non-metastatic Breast Cancer [NCT04408560]140 participants (Actual)Interventional2018-09-13Completed
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure [NCT05463367]Phase 280 participants (Anticipated)Interventional2021-01-01Recruiting
Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery: a Randomized, Split-mouth, Placebo-controller, Double-blind Clinical Trial [NCT03049878]Phase 432 participants (Actual)Interventional2013-02-21Completed
A Pilot Study to Assess Impact of Low Dose Melphalan on Disease Burden Measured by Next Generation Sequencing Before Autologous Hematopoietic Cell Transplant (AHCT) for Multiple Myeloma Patients [NCT05013437]Early Phase 120 participants (Anticipated)Interventional2023-03-31Recruiting
A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease [NCT00662818]Phase 3165 participants (Actual)Interventional2008-03-17Completed
Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain [NCT01420653]Phase 3408 participants (Actual)Interventional2013-04-30Completed
Pre-emptive Analgesics for Additional Pain Relief in Impacted Third Molar Surgery by depositing4% Articaine With 1:200000 Epinephrine Using Vazirani-Akinosi Closed Mouth Technique- A Randomized Clinical Trial [NCT04769557]Phase 460 participants (Actual)Interventional2017-03-04Completed
An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respirator [NCT01576809]Phase 351 participants (Actual)Interventional2012-03-31Completed
Inhibition of Lipid Peroxidation and Cerebral Vasospasm by an Acetaminophen-Based Regimen in Patients With Aneurysmal Subarachnoid Hemorrhage [NCT00585559]Phase 3120 participants (Anticipated)Interventional2007-04-30Active, not recruiting
The Use of Campath-1H, Tacrolimus, and Sirolimus Followed by Sirolimus Withdrawal in Renal Transplant Patients [NCT00078559]Phase 1/Phase 210 participants (Actual)Interventional2003-11-30Completed
A Single-dose, Open-label, Randomized, Two-treatment, Two-period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of the Newly Formulated Tylenol® Tablet (Acetaminophen) to the Tylenol® 8H ER Tablet (Acetaminophen) Under Fed Conditions [NCT04214691]Phase 130 participants (Actual)Interventional2019-12-17Completed
Oral Versus Intravenous Acetaminophen for the Treatment of Pain Secondary to Long Bone Fracture Requiring Surgery in Children [NCT05557344]Phase 420 participants (Anticipated)Interventional2021-04-21Recruiting
Postoperative Ibuprofen and the Risk of Bleeding After Tonsillectomy With or Without Adenoidectomy [NCT01605903]Phase 2741 participants (Actual)Interventional2012-05-03Completed
Regional Anesthesia for Breast Cancer Surgery, Effects on Postoperative Wellbeing and Disease Recurrence. [NCT03117894]200 participants (Actual)Interventional2017-05-23Completed
Effects of a Common Cold Treatment on Cognitive Function [NCT01466348]Phase 472 participants (Actual)Interventional2011-02-28Completed
Clinical Evaluation of Single-stage Advanced Versus Rotated Flaps in the Treatment of Gingival Recessions:Longitudinal, Controlled Clinical Trial. [NCT02433912]Phase 436 participants (Actual)Interventional2002-06-30Completed
Phase IIa Randomized Controlled Trial of Acetaminophen for the Reduction of Oxidative Stress in Severe Sepsis [NCT01739361]Phase 244 participants (Actual)Interventional2013-04-30Completed
The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of Primary Migraine in Childhood [NCT01756209]Phase 4160 participants (Actual)Interventional2010-01-31Completed
Pain Management in Head and Neck Surgery Patients [NCT03121963]Phase 40 participants (Actual)Interventional2017-11-10Withdrawn(stopped due to This protocol was difficult to enroll into, and changes to personnel have made it difficult to main this study. Data collection was not completed and therefore, no data analysis was performed. The PI has made the decision to close this study.)
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus [NCT00137969]Phase 2/Phase 3262 participants (Actual)Interventional2005-05-10Completed
A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and Various Formulations of SafeTynadol® in Healthy Volunteers [NCT05563961]Phase 136 participants (Anticipated)Interventional2022-10-28Recruiting
Randomized Controlled Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children With Suspected, Isolated Extremity Fractures in the Pediatric Emergency Department [NCT02521415]Phase 287 participants (Actual)Interventional2015-12-31Completed
Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy [NCT05547659]Phase 1/Phase 295 participants (Actual)Interventional2019-01-01Completed
Safety of Donor Alloantigen Reactive Tregs to Facilitate Minimization and/or Discontinuation of Immunosuppression in Adult Liver Transplant Recipients (CTOTC-12) [NCT02474199]Phase 1/Phase 215 participants (Actual)Interventional2016-06-06Completed
Protective Analgesia in Caesarean Section Using Intravenous Paracetamol: A Prospective Randomised Controlled Trial [NCT03060265]60 participants (Anticipated)Interventional2017-03-31Not yet recruiting
Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion [NCT04872283]Phase 3140 participants (Anticipated)Interventional2019-05-23Enrolling by invitation
A Comparative, Randomized, Double-blind, 3-arm Parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction [NCT04622735]Phase 3321 participants (Actual)Interventional2020-02-22Completed
A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth [NCT03041779]Phase 2909 participants (Actual)Interventional2015-10-31Completed
Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy: a Randomized Control Trial [NCT04360135]Phase 2/Phase 30 participants (Actual)Interventional2020-05-06Withdrawn(stopped due to "The study was closed on 3/8/2021 as per final progress report issued by the IRB on 3/12/2021. No subjects were enrolled in the study following approval. Status changed to Withdrawn (No Participants Enrolled) accordingly.")
Dexmedetomidine and IV Acetaminophen for the Prevention of Postoperative Delirium Following Cardiac Surgery in Adult Patients 60 Years of Age and Older [NCT02546765]Phase 4140 participants (Actual)Interventional2015-10-31Completed
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 1820237 Alone (Trial Parts 1+2) or Together With a Low Dose of Liraglutide (Trial Part 3) in Otherwise Healthy Male Subjects With Overweight/Obesity (Si [NCT04903509]Phase 195 participants (Actual)Interventional2021-06-08Completed
Assessment of Low-level Laser Therapy Versus Paracetamol-caffeine Efficacy in Controlling Pain During Fixed Orthodontic Treatment and Their Role in Enhancing Oral-health-related Quality of Life: A Randomized Controlled Trial [NCT03400111]60 participants (Actual)Interventional2017-09-15Completed
Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI [NCT01562704]Phase 121 participants (Actual)Interventional2012-01-31Completed
The Treatment of Post Operative Pain in Thyroid Surgery Patients: Perspective Study Acupuncture Versus Pharmacological Treatment [NCT01579786]121 participants (Actual)Interventional2011-05-31Active, not recruiting
A Pharmacokinetic Study Investigating the Rate and Extent of Absorption of Paracetamol and an Adjuvant From Two Different Paracetamol Formulations. [NCT01592227]Phase 130 participants (Actual)Interventional2009-12-31Completed
To Evaluate the Clinical Efficacy of Standardized Use of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia [NCT05691088]128 participants (Anticipated)Interventional2022-12-15Recruiting
Efficacy and Safety of Delta-9-tetrahydrocannabinol (∆9-THC) in Behavioural Disturbances and Pain in Dementia [NCT01608217]Phase 250 participants (Actual)Interventional2012-06-30Completed
Comparison of Local Anesthesia and Induced Hypotensive Anesthesia on Quality of External Dacryocystorhinostomy Operation Under General Anesthesia [NCT05241054]64 participants (Anticipated)Interventional2022-03-31Not yet recruiting
A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy [NCT04629248]Phase 3140 participants (Anticipated)Interventional2021-06-25Recruiting
Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results [NCT00324467]Phase 2150 participants (Actual)Interventional2006-08-31Active, not recruiting
A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain [NCT00325949]Phase 3770 participants (Actual)Interventional2006-05-31Completed
A Randomized, Multicenter, Single-blind, Placebo-controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects With Acute Pain Following Thi [NCT00935311]Phase 2122 participants (Actual)Interventional2009-06-30Completed
Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics [NCT00427206]Phase 4181 participants (Actual)Interventional2004-11-30Completed
The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures [NCT01328782]124 participants (Actual)Interventional2008-06-30Completed
Efficacy of Perioperative Intravenous Acetaminophen as an Adjunct Analgesic in Cardiac Surgery Patients [NCT01544062]Phase 468 participants (Actual)Interventional2012-07-31Completed
Comparison of Postoperative Analgesic Effects of Transversus Abdominis Plane Block and Quadratus Lumborum Block Type 2 [NCT03126084]Phase 490 participants (Actual)Interventional2017-05-02Completed
Assessing the Effect of Food Composition on Postprandial Insulin Secretion in KCNJ11 Neonatal Diabetes (FoND Study) [NCT02921906]16 participants (Actual)Interventional2016-06-30Completed
A Pilot Study: a Non-opioid Technique for Postoperative Adenoidectomy Pain Relief in Pediatric Patients [NCT03714919]Phase 210 participants (Actual)Interventional2019-08-02Completed
A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Advanced or Metastatic Solid Tumor Malignancies [NCT01607905]Phase 1192 participants (Actual)Interventional2012-06-18Completed
Randomized Controlled Trial of Infliximab (Remicade®) Induction Therapy for Deceased Donor Kidney Transplant Recipients (CTOT-19) [NCT02495077]Phase 2290 participants (Actual)Interventional2015-11-02Completed
Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial [NCT04939987]Phase 2/Phase 30 participants (Actual)Interventional2022-08-31Withdrawn(stopped due to PI left institution and study was not transferred to new PI)
An ED-based Randomized Trial of IV Acetaminophen Versus IV Hydromorphone for Elderly Adults With Acute Severe Pain [NCT03521102]Phase 2162 participants (Actual)Interventional2018-08-20Completed
Randomized, Controlled Cross-over Comparison of Cannabinoid to Oral Opioid for Postoperative Photorefractive Keratectomy Pain Control [NCT05477875]Phase 235 participants (Anticipated)Interventional2023-09-30Not yet recruiting
A Prospective, Randomized, Single-Blind Study to Evaluate the Efficacy of Transversus Abdominis Plane Versus Paravertebral Regional Blockade in Patients Undergoing Laparoscopic Colectomy [NCT02164929]17 participants (Actual)Interventional2013-12-31Terminated(stopped due to Poor recruitment)
Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Liver Transplantation (RTB-002) [NCT02188719]Phase 115 participants (Actual)Interventional2014-12-17Terminated(stopped due to The trial could not be completed within the grant timeline.)
Comparative Study Between the Prophylactic Intravenous Administrations of Acetaminophen vs Dexamethasone vs Pethidine Regarding the Incidence of Shivering Induced by Single Shot Spinal Anesthesia in the Orthopedic Surgeries of the Lower Limbs [NCT05284409]Phase 4108 participants (Anticipated)Interventional2022-07-01Active, not recruiting
Bone Marrow Transplantation and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance (ITN054ST) [NCT02029638]Phase 24 participants (Actual)Interventional2014-01-07Terminated(stopped due to Slow accrual)
A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department. [NCT01629329]Phase 493 participants (Actual)Interventional2010-11-30Terminated(stopped due to no difference found between two groups in a preliminary analysis)
Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection [NCT00000875]16 participants InterventionalTerminated
Effect of Steroids on Post-tonsillectomy Morbidities [NCT02401529]Phase 2100 participants (Actual)Interventional2013-01-31Completed
Evaluation of the Interaction Between Acetaminophen and Zidovudine [NCT00000731]10 participants InterventionalCompleted
A Multicenter, Phase IV, Interventional Study to Compare the Efficacy and Safety of NORSPAN to Tramadol/Acetaminophen in Patients With Prolonged Postoperative Pain After Spinal Surgery (PASSION) [NCT01983111]Phase 4136 participants (Actual)Interventional2013-10-31Completed
Analgesic Effects of Transversus Thoracic Plane (TTP) Block in Cardiac Surgery - Pilot Study [NCT03128346]100 participants (Anticipated)Interventional2017-10-01Not yet recruiting
Treatment Of Fever And Associated Symptoms In The Emergency Department: Which Drug To Choose? [NCT05814302]324 participants (Actual)Observational2021-06-01Completed
The Efficacy of Intraoperative Parecoxib Combined With Paracetamol for Reducing Opioid Consumption in Patients Undergoing Breast Cancer Surgery Under General Anesthesia: A Prospective Randomized Controlled Trial [NCT05757388]60 participants (Anticipated)Interventional2023-03-28Recruiting
Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting [NCT04744727]96 participants (Actual)Interventional2019-03-01Completed
Acetaminophen and Post Circumcision Pain Control [NCT02498483]Phase 411 participants (Actual)Interventional2015-09-30Terminated(stopped due to Understaffing)
Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting [NCT01827475]Phase 290 participants (Actual)Interventional2010-07-31Completed
Platelet-Rich Plasma and the Effects of NSAIDs on Pain and Functional Scores in Knee Osteoarthritis [NCT05742763]Phase 1/Phase 2300 participants (Anticipated)Interventional2023-04-03Not yet recruiting
Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management [NCT02605187]160 participants (Actual)Interventional2015-11-30Completed
ACL Repair and Multimodal Analgesia [NCT01868425]Phase 4112 participants (Actual)Interventional2013-04-30Completed
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial [NCT04931693]Phase 440 participants (Actual)Interventional2021-12-20Completed
Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group Undergoing Adenotonsillectomy: A Randomised Clinical Trial [NCT04949477]Phase 286 participants (Actual)Interventional2021-07-01Completed
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab (SAR650984) in Patients Awaiting Kidney Transplantation [NCT04294459]Phase 1/Phase 223 participants (Actual)Interventional2020-06-18Terminated(stopped due to Terminated due to non-safety reasons)
Supplementary Epidural Analgesia in Video-Assisted Thoracic Surgery (VATS) - The SEAVATS Study [NCT02359175]Phase 4161 participants (Actual)Interventional2015-02-28Completed
An Evaluation of Postoperative Pain Using Ibuprofen Versus Ibuprofen/Acetaminophen in Patients With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis [NCT03631433]Phase 4102 participants (Actual)Interventional2016-02-10Completed
Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy [NCT02519023]Phase 487 participants (Actual)Interventional2016-07-31Completed
Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients [NCT02432456]Phase 4153 participants (Actual)Interventional2015-09-30Completed
Post-Operative Pain Control Following Shoulder Surgery [NCT04622839]74 participants (Actual)Interventional2020-12-01Completed
Maxigesic IV Bunionectomy Study- A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group and Placebo-Controlled Study [NCT02689063]Phase 3276 participants (Actual)Interventional2016-10-26Completed
Liposomal Bupivacaine in Implant Based Breast Reconstruction [NCT02659501]24 participants (Actual)Interventional2015-07-31Terminated
Pilot Study of the Feasibility of n-of-1 Trials: the Individualisation of Treatments for Osteoarthritis [NCT00371696]Phase 210 participants Interventional2001-12-31Completed
NSAID Use in Postpartum Hypertensive Women [NCT02902172]Phase 436 participants (Actual)Interventional2017-03-15Terminated(stopped due to Unable to recruit necessary number of patients)
Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit: A Feasibility Randomized Controlled Trial [NCT05678244]Phase 460 participants (Anticipated)Interventional2023-04-17Recruiting
Role of Scheduled Intravenous Acetaminophen for Postoperative Pain Management in an Enhanced Recovery After Surgery (ERAS) Population: A Prospective, Randomized, Double-Blind and Placebo-Controlled Clinical Trial [NCT03198871]Phase 4180 participants (Actual)Interventional2018-05-24Completed
Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen [NCT03468920]Phase 4120 participants (Actual)Interventional2018-04-01Completed
Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment [NCT03523988]Phase 473 participants (Actual)Interventional2017-05-02Completed
A Single Dose, Open Label, Randomized Scintigraphic Study to Investigate the Gastrointestinal Behavior of 2 Triple Combination Products (Acetaminophen, Phenylephrine and Dextromethorphan) in Healthy Male Volunteers [NCT03415243]Phase 128 participants (Actual)Interventional2018-03-01Completed
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study Evaluating the Efficacy and Safety of VX-548 for Acute Pain After a Bunionectomy [NCT04977336]Phase 2274 participants (Actual)Interventional2021-07-19Completed
National Clinical Study, Phase III, Multicenter, Randomized, Double-blind, Controlled, Parallel, to Evaluate the Superiority of the Fixed Association (Orfenadrine 35mg, Acetaminophen 325mg, Caffeine 65mg and Diclofenac Sodium 50mg) Compared to the Drug Co [NCT02985671]Phase 3110 participants (Anticipated)Interventional2021-01-31Not yet recruiting
Evaluating the Renoprotective Effect of Paracetamol in Paediatric Severe Malaria: a Randomised Controlled Trial [NCT04251351]Phase 3460 participants (Anticipated)Interventional2021-12-13Recruiting
Comparison of Efficacy of Transversus Abdominis Plane Block and Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Inguinal Herniorraphy With Spinal Anesthesia [NCT02375100]90 participants (Actual)Interventional2015-02-28Completed
The Effect of Dexamethasone Versus Local Infiltration Technique on Postoperative Nausea and Vomiting After Tonsillectomy in Children: A Randomized Double-blind Clinical Trial [NCT02355678]129 participants (Actual)Interventional2015-01-31Completed
A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery [NCT03111186]Phase 240 participants (Actual)Interventional2017-04-24Completed
A Phase 4, Randomized, Blinded, Active-Controlled Study of HTX-011 in Subjects Undergoing Different Surgical Procedures [NCT05109312]Phase 490 participants (Anticipated)Interventional2021-10-12Active, not recruiting
An Efficacy and Safety Study of Sustained-release Paracetamol in Subjects With Osteoarthritis [NCT02311881]Phase 3960 participants (Actual)Interventional2015-01-31Completed
A Phase I Single-Arm Study of the Combination of Durvalumab (MEDI4736) and Vicineum (Oportuzumab Monatox, VB4-845) in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) [NCT03258593]Phase 115 participants (Actual)Interventional2018-06-07Completed
Effect of Paracetamol on Renal Function in Plasmodium Knowlesi Malaria: A Randomised Controlled Clinical Trial [NCT03056391]Phase 3360 participants (Actual)Interventional2016-10-31Completed
The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial [NCT02155738]Phase 4204 participants (Actual)Interventional2014-07-31Completed
Randomized, Double-Blind, Study to Assess Low-Dose Naltrexone and Acetaminophen Combination in the Prevention of Episodic Migraine in Adults [NCT03194555]Phase 212 participants (Actual)Interventional2017-08-25Completed
Continuous Infusion Versus Bolus Dosing for Pain Control After Pediatric Cardiothoracic Surgery [NCT02112448]78 participants (Actual)Interventional2014-06-30Completed
The Effect of Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized Clinical Trial [NCT03184649]Phase 1/Phase 252 participants (Anticipated)Interventional2017-05-01Enrolling by invitation
A Randomized, Double Blind, Two-period Cross-over Trial Investigating the Effect of Liraglutide as Add on to Intensive Insulin Treatment on the Endogenous Glucose Production in Subjects With C-peptide Positive Type 1 Diabetes Mellitus [NCT02408705]Phase 214 participants (Actual)Interventional2015-01-31Completed
Pre-Emptive Analgesia in Ano-Rectal Surgery [NCT02402543]90 participants (Actual)Interventional2014-06-30Completed
Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever [NCT04123717]Early Phase 1200 participants (Anticipated)Interventional2019-10-11Recruiting
Randomized, Double-Blind, and Placebo-Controlled Study to Assess a Single Dose of Low-Dose Naltrexone and Acetaminophen Combination Versus Sumatriptan in the Acute Treatment of Migraine With Nausea [NCT03185143]Phase 2/Phase 336 participants (Actual)Interventional2017-06-27Completed
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management [NCT02703259]Phase 4137 participants (Actual)Interventional2016-06-30Completed
Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice [NCT04765787]399 participants (Actual)Observational2020-11-25Completed
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial [NCT05842044]Phase 2110 participants (Anticipated)Interventional2023-09-15Recruiting
A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain [NCT01960114]Phase 2403 participants (Actual)Interventional2013-10-31Completed
Effect of Sleeve Gastroctomy on Pharmacokinetics of Paracetamol and Antiepileptic Drugs [NCT03161509]Phase 42 participants (Actual)Interventional2017-07-01Terminated(stopped due to publication of better study)
Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis, Especially of Pneumococcal Meningitis, in Angola. [NCT01540838]Phase 4375 participants (Actual)Interventional2012-02-29Completed
Does Oral Acetaminophen Lower Intraocular Pressure? [NCT02366065]Early Phase 111 participants (Actual)Interventional2015-01-31Completed
Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy [NCT05024825]Phase 417 participants (Actual)Interventional2017-08-04Terminated(stopped due to recruitment target not met.)
Administration of Rectal Acetaminophen During Oocyte Retrievals Reduces Post-Operative Opioid Utilization in Fertility Patients. [NCT05990868]78 participants (Anticipated)Interventional2023-08-31Not yet recruiting
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substud [NCT05319730]Phase 1/Phase 2200 participants (Anticipated)Interventional2023-05-16Recruiting
Paracetamol Vs Paracetamol-Caffeine Association Vs Paracetamol-Codeine Association in the Management of Post Traumatic Pain in Emergencies [NCT05229965]Phase 31,500 participants (Actual)Interventional2022-11-01Completed
Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus of Preterm Infants - Randomised, Placebo-controlled Multicentre Trial [NCT03648437]Phase 160 participants (Anticipated)Interventional2018-09-03Recruiting
A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate and Acetaminophen (a New Abuse Deterrent Tablet and a Marketed Tablet) Administered Under Fasted and Fed Condit [NCT03137017]Phase 10 participants (Actual)Interventional2017-09-30Withdrawn(stopped due to program discontinued)
A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congesti [NCT01448057]Phase 3341 participants (Actual)Interventional2013-07-31Completed
A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen [NCT04122443]Phase 4154 participants (Actual)Interventional2019-12-01Completed
A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With EU-approved MabThera® and US-licensed [NCT01390441]Phase 1100 participants (Actual)Interventional2011-07-31Terminated(stopped due to The study was terminated early by the Sponsor for business reasons.)
A Randomized, Open Label, Single Center, Single Dose, Two Period, Two Sequence, Crossover Bioequivalence Study of Paracetamol in a New Pediatric Paracetamol Oral Suspension Compared to a Marketed Paracetamol Oral Suspension (Panadol Baby & Infant) in Heal [NCT05022810]Phase 135 participants (Actual)Interventional2021-08-23Completed
[NCT01833728]16 participants (Actual)Interventional2013-04-30Completed
Ultrasound-guided Block of the Saphenous Nerve and Obturator Nerve, Posterior Branch, for Postoperative Pain Management After Ambulatory Knee Arthroscopy [NCT01837394]Phase 460 participants (Actual)Interventional2012-08-31Completed
The Effects of Hydromorphone on Responses to Verbal Tasks [NCT02205983]50 participants (Actual)Interventional2015-01-31Completed
Prospective, Double Blind, Placebo Control, Study of Acetaminophen iv on Hospital Length of Stay in Morbidly Obese Individuals Undergoing Elective Laparoscopic Sleeve Gastrectomy [NCT02452320]Phase 4136 participants (Actual)Interventional2016-02-29Completed
Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain [NCT02455518]Phase 4416 participants (Actual)Interventional2015-07-31Completed
Comparison Between Bupivacaine Extended-Release Liposome Injection (Exparel) Versus Bupivacaine With Dexamethasone in Transversus Abdominis Plane Block: A Prospective Randomized Controlled Trial [NCT02179892]Phase 49 participants (Actual)Interventional2014-07-31Terminated(stopped due to Inadequate patient population to complete enrollment)
Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants [NCT03024814]Phase 3300 participants (Anticipated)Interventional2016-10-31Recruiting
Effect of Paracetamol and Ibuprofen When Intravenously Given Combination or Alone in Reducing Morphine Requirements After Total Knee Arthroplasty [NCT04414995]Phase 2/Phase 336 participants (Actual)Interventional2020-06-05Completed
Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults: a Randomized Controlled Trial [NCT01869699]Phase 441 participants (Actual)Interventional2013-09-30Completed
Time of Intravenous Acetaminophen Administration for Total Hip Arthroplasty [NCT01699815]Phase 4126 participants (Actual)Interventional2012-10-31Completed
EVALUATION OF THE EFFICACY OF NOVEL IBUPROFEN ACETAMINOPHEN COMBINATION FORMULATIONS IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN [NCT01559259]Phase 2394 participants (Actual)Interventional2012-04-10Completed
Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery [NCT03088306]Early Phase 149 participants (Actual)Interventional2017-07-01Completed
A Randomized Controlled Trial on the Effect of Fever Suppression by Antipyretics on Influenza [NCT01891084]Phase 4300 participants (Actual)Interventional2013-07-31Completed
A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain [NCT02735122]Phase 3420 participants (Actual)Interventional2016-04-30Completed
To Study and Evaluate the Effectiveness of Treatment by Percutaneous Electrical NeuroStimulation (PENS) for Post-operative Pain in Cesarean Section Patients Using Primary Relief v 2.0 [NCT03829774]22 participants (Anticipated)Interventional2019-01-02Recruiting
Allogeneic Hematopoietic Cell Transplantation of Positively Selected CD34+ Cells and Defined Inoculum of T Cells From Related Haploidentical Donors for Older Patients With Indolent Hematologic Malignancies [NCT00185692]Phase 216 participants (Actual)Interventional2000-08-31Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery [NCT02197156]Phase 2241 participants (Actual)Interventional2002-08-31Completed
A Single-dose, Open-label, Randomized, Two-treatment, Two-period, Crossover Study in Healthy Subjects to Assess the Bioequivalence of the Newly Formulated Tylenol® Tablet (Acetaminophen) to the Tylenol® 8H ER Tablet (Acetaminophen) Under Fasting Condition [NCT04230252]Phase 130 participants (Actual)Interventional2020-01-07Completed
A Randomized, Single-blind, Parallel Group and Multiple - Dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and Various Formulations of SafeTynadol® in Healthy Volunteers [NCT03451487]28 participants (Actual)Interventional2022-05-19Completed
Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy [NCT03060434]Phase 467 participants (Actual)Interventional2018-06-01Active, not recruiting
Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen [NCT04459117]Phase 2/Phase 3824 participants (Anticipated)Interventional2020-10-29Recruiting
Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: A Randomized Controlled Trial [NCT04648540]Early Phase 160 participants (Actual)Interventional2020-12-01Completed
Erosive Osteoarthritis of the Hand: Efficacy of Prescription-grade Crystalline Glucosamine Sulfate as an add-on Therapy to Conventional Treatments [NCT05237596]123 participants (Actual)Observational2021-01-07Completed
A Double Blind, Randomized, Placebo-controlled Study to Investigate the Effectiveness of IV Acetominophen Administered During Functional Endoscopic Sinus Surgery in Reducing the Use of Opiates to Treat Postoperative Pain [NCT01608308]62 participants (Actual)Interventional2012-07-31Completed
The Clinical Efficacy and Safety Study of Tramadol Hydrochloride - Paracetamol Tablets in the Treatment of Moderate to Severe Acute Neck-shoulder Pain and Low Back Pain in Orthopaedics Outpatient or Emergency Setting [NCT01843660]Phase 41,059 participants (Actual)Interventional2007-09-30Completed
The Effect of NSAID Use in the Acute Phase of Skeletally Immature Bone Healing: A Prospective Study [NCT02076321]Phase 4102 participants (Actual)Interventional2014-01-31Completed
A Randomized, Active-Controlled, Parallel Group, Double-Blind Study to Compare the Efficacy and Safety of Tramadol HCl/Acetaminophen ER and IR in Subjects Who Complain of Moderate to Severe Postoperative Pain [NCT01814878]Phase 3320 participants (Actual)Interventional2009-11-30Completed
Efficacy of IV vs Oral Administration of Acetaminophen for Pain Control Following Tonsillectomy With or Without Adenoidectomy [NCT01721486]Phase 441 participants (Actual)Interventional2012-09-30Completed
Efficacy of Erector Spinae Plane Block and Pectoral Fascia Block in Patients Undergoing Mitral Valve Repair Through the Right Mini-thoracotomy [NCT03592485]Phase 433 participants (Actual)Interventional2018-06-28Completed
Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients: A Randomized Double-Blind Controlled Study [NCT06061575]Phase 484 participants (Anticipated)Interventional2023-10-31Not yet recruiting
Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis [NCT05556356]Phase 450 participants (Anticipated)Interventional2022-09-13Recruiting
Analysis of Hydrocodone Compared to Acetaminophen and Ibuprofen for Post-nail Procedure Analgesia [NCT05544734]Phase 420 participants (Actual)Interventional2022-11-10Completed
Clinically Integrated Opportunistic PK/PD Trial in Critically Ill Children [NCT05055830]2,000 participants (Anticipated)Observational2021-10-05Recruiting
Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery [NCT05246644]Phase 3900 participants (Anticipated)Interventional2022-03-01Not yet recruiting
A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis [NCT01943435]259 participants (Actual)Interventional2013-11-20Completed
Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment [NCT03830398]Phase 4225 participants (Anticipated)Interventional2018-11-20Recruiting
Close Kinetic Chain Exercise With Kinesio Taping in the Management of Patellofemoral Pain Syndrome. [NCT02241148]15 participants (Actual)Interventional2014-02-28Terminated(stopped due to Required number of participants were not able to be enrolled.)
Comparison of the Effect of Intravenous Paracetamol, Dexketoprofen and Ibuprofen on Visual Analogue Scale (VAS) in the Treatment of Acute Migraine Attack Headache in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial [NCT04372264]Phase 4210 participants (Actual)Interventional2018-10-15Active, not recruiting
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus [NCT04397913]500 participants (Anticipated)Observational2020-05-25Recruiting
A Comparison of Tramadol/Acetaminophen Tablets Maintenance Versus NSAID Maintenance After Tramadol/Acetaminophen and NSAID Combination Therapy in Knee Osteoarthritis Patients: Multicenter, Randomized, Open Comparative Study [NCT00635349]Phase 4143 participants (Actual)Interventional2007-05-31Completed
Impact of Loco-regional Anesthesia Techniques on Chronic Post-surgery in Breast Oncological Surgery: a Prospective Multicenter Observational Study [NCT05876390]1,500 participants (Anticipated)Observational2022-09-01Enrolling by invitation
An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double Refractory to a [NCT01985126]Phase 2124 participants (Actual)Interventional2013-09-27Completed
Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair [NCT04423107]Phase 3150 participants (Anticipated)Interventional2020-07-01Recruiting
A Randomised Control Clinical Trial Comparing Diclofenac / Acetaminophen /Codeine and Ibuprofen/Acetaminophen/Codeine Combination for Pain Management After Third Molars Surgery [NCT04874675]78 participants (Actual)Interventional2023-03-31Suspended(stopped due to Covid 19 lockdown)
Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering [NCT04682743]Early Phase 1120 participants (Actual)Interventional2021-01-06Completed
Single-Center, Randomized Controlled Trial of Intravenous v Oral Acetaminophen Administration in Perioperative Care of 1 and 2 Level XLIFs Supplemented With Bilateral Pedicle Screw Stabilization: a Comparative Effectiveness Study [NCT03020875]Phase 4166 participants (Anticipated)Interventional2017-01-31Enrolling by invitation
Validation of a Physiological Based Pharmacokinetic Model by the Study of Paracetamol Distribution in the Brain Compartments in Brain Injured Patients [NCT03223506]Phase 117 participants (Actual)Interventional2013-03-23Completed
Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial. [NCT03584373]Phase 3119 participants (Actual)Interventional2018-07-27Completed
A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture [NCT03759028]Phase 490 participants (Anticipated)Interventional2019-02-26Recruiting
A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain [NCT01364922]Phase 2168 participants (Actual)Interventional2011-06-30Completed
Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics [NCT00768716]Phase 495 participants (Actual)Interventional2008-12-31Completed
To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold. [NCT01277081]Phase 2200 participants (Actual)Interventional2010-10-31Completed
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone [NCT02029235]Phase 472 participants (Actual)Interventional2015-02-10Terminated(stopped due to Early termination due to slower than anticipated recruitment.)
An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection [NCT01586962]Phase 356 participants (Actual)Interventional2012-05-31Completed
The Effect of Decreased Opioid Prescribing on Pain Control and Patient Satisfaction Following Cesarean Section [NCT03355248]60 participants (Actual)Interventional2017-08-18Completed
Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children [NCT03352362]159 participants (Actual)Interventional2017-12-15Completed
[NCT02515188]98 participants (Actual)Interventional2015-08-07Completed
Effects of Two Doses of a Common Cold Treatment on Cognitive Function [NCT01686646]Phase 3240 participants (Actual)Interventional2011-11-30Completed
Oral Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Pain Reduction in Children [NCT04630834]Phase 4100 participants (Anticipated)Interventional2021-03-30Recruiting
A Randomized Double-blinded Study to Evaluate Preincisional Dextromethorphan in Patients Undergoing Total Knee Arthroplasty and Its Effect on Postoperative Opioid Use [NCT02987920]Phase 423 participants (Actual)Interventional2017-01-31Terminated(stopped due to The surgeon changed pain control protocol for all patients. Continued enrollment impossible under approved protocol.)
Acetaminophen vs. Ibuprofen in Children With Asthma [NCT01606319]Phase 3300 participants (Actual)Interventional2013-02-28Completed
[NCT01948505]Phase 4210 participants (Actual)Interventional2013-08-31Completed
The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Departement for Renal Colics. [NCT02304783]Phase 1/Phase 2500 participants (Anticipated)Interventional2014-01-31Recruiting
Comparison Between the Effect of Oral Paracetamol Versus Oral Ibuprofen in the Treatment of Patent Ductus Arteriosus in Preterm and Low Birth Weight Infants [NCT03265782]Phase 430 participants (Actual)Interventional2015-06-30Active, not recruiting
Tumescent Anesthesia Interest in Pain Management During a Dynamic Phototherapy (PTD) Session in Vertex Actinic Keratosis Treatment: a Single-center Prospective Randomized Study [NCT04779255]48 participants (Anticipated)Interventional2021-07-28Recruiting
Randomized Double-blind Controlled Study to Assess the Efficacy of Intravenous Acetaminophen Associated With Strong Opioids in the Management of Acute Pain in Adult Cancer Patients [NCT04779567]Phase 4112 participants (Actual)Interventional2019-06-10Completed
The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral Total Knee Arthroplasty: a Randomized Controlled Trial [NCT06112548]80 participants (Anticipated)Interventional2023-11-01Not yet recruiting
Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries [NCT04662125]63 participants (Actual)Interventional2020-12-10Completed
Determining the Efficacy of Intravenous Acetaminophen as a Non-Narcotic Postoperative Pain Management Technique Following Knee Arthroscopy [NCT02025634]Phase 4119 participants (Actual)Interventional2013-11-30Completed
Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer [NCT04726878]Phase 475 participants (Actual)Interventional2021-02-01Completed
The Impact of Tirzepatide on Gastric Emptying (GE) in Overweight/Obese Non-diabetic Subjects and in Overweight/Obese Subjects With Type 2 Diabetes Mellitus [NCT04407234]Phase 136 participants (Actual)Interventional2020-09-15Completed
Evaluation of Multimodal Preemptive Analgesia in Major Pediatric Abdominal Cancer Surgeries [NCT03580980]90 participants (Actual)Interventional2015-04-01Completed
Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome [NCT03521167]225 participants (Anticipated)Interventional2018-05-01Not yet recruiting
Efficacy of the Ultrasound-guidedTransversus Abdominis Plane (TAP) Block on Postoperative Pain Control in Open Aortic Abdominal Aneurysm Repair Surgery [NCT02292667]Phase 360 participants (Anticipated)Interventional2015-01-31Recruiting
Prospective Comparative Study of the Efficacy of Common Antipyretic Treatments in Febrile Children [NCT02294071]Phase 4120 participants (Anticipated)Interventional2014-12-31Not yet recruiting
Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial. [NCT02267057]Phase 4163 participants (Actual)Interventional2014-08-31Completed
Multimodal Analgesia Effect on Post Surgical Patient [NCT04240626]Phase 460 participants (Anticipated)Interventional2021-01-20Recruiting
A Double-blind, Randomized, Placebo-controlled Phase IV Clinical Study of the Efficacy and Safety of a New Formulation of Paracetamol for the Management of Fever of Infectious Origin [NCT02283203]Phase 480 participants (Actual)Interventional2015-02-28Completed
A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy And Safety of IV Paracetamol Versus Placebo in Subjects With Postoperative Pain After Total Hip Arthroplasty [NCT00344045]Phase 486 participants (Actual)Interventional2006-04-30Completed
A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents [NCT03475693]Early Phase 117 participants (Actual)Interventional2017-09-01Completed
Behavioral Consequences of Blunting Fear With Acetaminophen [NCT05396677]266 participants (Anticipated)Interventional2022-05-31Recruiting
A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval [NCT02418182]Phase 499 participants (Actual)Interventional2015-01-31Completed
A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a [NCT03424733]Phase 450 participants (Anticipated)Interventional2017-09-25Recruiting
Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery: Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial [NCT03437707]3 participants (Actual)Interventional2018-02-13Completed
Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial [NCT03428503]Phase 4200 participants (Actual)Interventional2015-12-31Completed
Influence of SPI-guided Analgesia With Preventive Different Peribulbar Blocks (PBB) on the Presence of OCR, Postoperative Pain, PONV in Patients Undergoing VRS Under General Anaesthesia: a Randomised, Controlled Trial [NCT03413371]175 participants (Anticipated)Interventional2018-04-26Recruiting
Postoperative Ibuprofen Use and Risk of Bleeding in Pediatric Tonsillectomy [NCT03385057]Phase 10 participants (Actual)Interventional2018-09-30Withdrawn(stopped due to Study design flaws; research design needed to be reconfigured)
PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS SARS-CoV2 (COVID-19) [NCT04416334]Phase 370 participants (Actual)Interventional2020-08-19Completed
A Randomized, Double-blind, Placebo- and Active-controlled Trial to Investigate the Single-dose Efficacy, Safety, and Pharmacokinetics of 250 and 1000 mg JNJ-10450232 in Postoperative Dental Pain [NCT02209181]Phase 2269 participants (Actual)Interventional2014-08-31Completed
Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial [NCT01822821]150 participants (Actual)Interventional2013-03-31Completed
A Study to Investigate the Gastrointestinal Safety of OTC Analgesics in Healthy Volunteers by Endoscopic Examination [NCT01822665]Phase 428 participants (Actual)Interventional2012-02-29Completed
Perioperative Tonsillectomy Protocol Development for Preoperative Acetaminophen and Intraoperative High Dose Dexamethasone: a Randomized Control Trial [NCT03323047]Phase 460 participants (Anticipated)Interventional2018-03-01Recruiting
Efficacy of IV Acetaminophen for Pain Management Following Major Gynecologic Surgery: Effect on Opioid Rescue, Return of Bowel Function, Cost and Length of Hospital Stay. [NCT02028715]Phase 468 participants (Actual)Interventional2013-12-24Completed
A Study to Assess Efficacy Over Placebo and Speed of Onset of Pain Relief of New Paracetamol and Caffeine Tablets as Compared to Ibuprofen in Episodic Tension Type Headache [NCT01842633]Phase 3365 participants (Actual)Interventional2013-04-01Terminated
Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies [NCT05965492]Phase 3100 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Paracetamol Metabolism Research in Postoperative Hepatic Surgery [NCT03297073]80 participants (Anticipated)Interventional2016-12-20Recruiting
Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial [NCT03375593]Phase 4250 participants (Anticipated)Interventional2019-08-01Recruiting
Estimation of Paracetamol in Urine to Assess the Diurnal Variation [NCT03122561]46 participants (Actual)Interventional2016-11-03Completed
Bioavailability of Paracetamol, Amoxicillin and Talinolol and Expression of Intestinal Drug Metabolizing Enzymes and Transport Proteins Before, Immediately and One Year After Proximal Roux-en-Y Gastric Bypass Operation in Patients With Morbid Adipositas [NCT02514941]Phase 112 participants (Actual)Interventional2007-06-30Completed
Simultaneous Versus Sequential Fractional CO2 Laser and Subcision Combination for Post-acne Atrophic Scars: A Split-face Comparative Study. [NCT05688202]34 participants (Actual)Interventional2022-10-24Completed
Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement [NCT02244619]Phase 4515 participants (Actual)Interventional2014-09-30Completed
Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief [NCT02046382]Phase 4132 participants (Actual)Interventional2014-01-31Completed
A Multicenter, Randomized, Parallel-group, Double-blind, Comparative Trial of the Superiority of Paracetamol 500mg/Fexofenadine 60mg/Phenylephrine 20mg Fixed-dose Combination Versus Placebo in the Symptomatic Treatment of Flu and Cold [NCT05118672]Phase 3478 participants (Anticipated)Interventional2024-08-30Not yet recruiting
Preemptive Paracetamol for Postoperative Pain: a Randomised, Double-blind, Two Way Crossover Trial [NCT02425254]Phase 450 participants (Anticipated)Interventional2016-01-31Not yet recruiting
Two-part Study of Intrathecal Paracetamol Administered Immediately Before Spinal Anaesthesia in Patients Scheduled for Hip Replacement Surgery [NCT02654860]Phase 1/Phase 269 participants (Actual)Interventional2016-11-30Completed
A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy [NCT01823224]67 participants (Actual)Interventional2013-02-28Completed
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI) [NCT02260934]Phase 243 participants (Actual)Interventional2015-07-09Completed
A Randomized Three-armed Comparative Effectiveness Study of Various Medications for Musculoskeletal Low Back Pain: Defining the Added Benefit of Muscle Relaxants and Opioids. [NCT01587274]Phase 4323 participants (Actual)Interventional2012-04-30Completed
Vital Capacity in Ultrasound Guided Serratus Plane Block in Emergency Department Patients With Multiple Rib Fractures: A Randomized Controlled Trial [NCT04530149]Phase 490 participants (Anticipated)Interventional2021-11-01Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00078559 (14) [back to overview]Number of Deaths Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status
NCT00078559 (14) [back to overview]Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study
NCT00078559 (14) [back to overview]Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period
NCT00078559 (14) [back to overview]Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated
NCT00078559 (14) [back to overview]Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Acute Rejections in All Enrolled Participants
NCT00078559 (14) [back to overview]Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal
NCT00078559 (14) [back to overview]Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status
NCT00078559 (14) [back to overview]Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status
NCT00078559 (14) [back to overview]Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status
NCT00137969 (8) [back to overview]Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period
NCT00137969 (8) [back to overview]Change in SLE Expanded Health Survey Physical Function Score From Baseline
NCT00137969 (8) [back to overview]Number of Participants Who Achieved a BILAG C or Better in All Domains
NCT00137969 (8) [back to overview]Time to First Moderate or Severe Flare
NCT00137969 (8) [back to overview]Number of Participants Who Achieved a PCR (Including MCR)
NCT00137969 (8) [back to overview]Number of Participants Who Achieved an MCR (Excluding PCR)
NCT00137969 (8) [back to overview]Number of Participants Who Achieved an MCR in The ITT Population
NCT00137969 (8) [back to overview]Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period
NCT00185692 (2) [back to overview]Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning
NCT00185692 (2) [back to overview]Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant
NCT00186628 (4) [back to overview]Incidence of Relapse
NCT00186628 (4) [back to overview]Chronic Graft-vs-Host Disease (cGvHD)
NCT00186628 (4) [back to overview]Mortality
NCT00186628 (4) [back to overview]Overall Survival
NCT00267293 (1) [back to overview]Child Temperature (Degrees C)Over 6 Hours
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52
NCT00282347 (9) [back to overview]Change From Baseline in C3 and C4 Complement Levels at Week 52
NCT00282347 (9) [back to overview]Time to Achieve a Complete Renal Response
NCT00282347 (9) [back to overview]Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52
NCT00282347 (9) [back to overview]Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52
NCT00282347 (9) [back to overview]Change From Baseline in Anti-double-stranded DNA at Week 52
NCT00282347 (9) [back to overview]British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks
NCT00282347 (9) [back to overview]Percentage of Participants Who Achieved a Complete Renal Response at Week 52
NCT00314340 (1) [back to overview]3 Scores on the Addiction Research Center Inventory (ARCI)
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84), BOCF"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
NCT00315445 (22) [back to overview]The Time to Discontinuation Due to Lack of Efficacy
NCT00315445 (22) [back to overview]Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
NCT00315445 (22) [back to overview]Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
NCT00315445 (22) [back to overview]Time to Stable Pain Management
NCT00315445 (22) [back to overview]"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"
NCT00315445 (22) [back to overview]Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
NCT00315445 (22) [back to overview]"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain on the Average Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
NCT00315445 (22) [back to overview]Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
NCT00324038 (1) [back to overview]Average Daily Pain Scores - BS11 Pain Scores.
NCT00325819 (8) [back to overview]Study Assignment Unblinded
NCT00325819 (8) [back to overview]Fever >=38C Within 32 Hours of Vaccination.
NCT00325819 (8) [back to overview]Fever >=39C Within 32 Hours of Vaccination.
NCT00325819 (8) [back to overview]Medical Utilization
NCT00325819 (8) [back to overview]Parent Time Lost From Work
NCT00325819 (8) [back to overview]Infant Fussiness
NCT00325819 (8) [back to overview]Parent Time Lost From Sleep
NCT00325819 (8) [back to overview]Infant Time Lost From Sleep
NCT00377364 (10) [back to overview]Hamilton Rating Scale for Depression (HRSD-17)
NCT00377364 (10) [back to overview]Young Mania Rating Scale (YMRS)
NCT00377364 (10) [back to overview]Young Mania Rating Scale (YMRS)
NCT00377364 (10) [back to overview]Rey Auditory Verbal Learning Test (RAVLT)
NCT00377364 (10) [back to overview]Rey Auditory Verbal Learning Task (RAVLT)
NCT00377364 (10) [back to overview]Internal State Scale - Activation (ISS-ACT)
NCT00377364 (10) [back to overview]Internal State Scale - Activation (ISS-ACT)
NCT00377364 (10) [back to overview]Hamilton Rating Scale for Depression (HRSD-17)
NCT00377364 (10) [back to overview]Asthma Control Questionnaire (ACQ)
NCT00377364 (10) [back to overview]Asthma Control Questionnaire
NCT00377403 (1) [back to overview]SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3
NCT00377832 (8) [back to overview]Rate of Diagnosis of Clinical Chorioamnionitis
NCT00377832 (8) [back to overview]Rate of Subsequent Development of Maternal Fever
NCT00377832 (8) [back to overview]Temperature Difference Before and After Treatment
NCT00377832 (8) [back to overview]Baseline Fetal Heart Rate (FHR) After Treatment
NCT00377832 (8) [back to overview]Maternal Body Temperature 90 Minutes After Randomization
NCT00377832 (8) [back to overview]Rate of Neonatal Sepsis
NCT00377832 (8) [back to overview]Rate of Determination of Non-reassuring Fetal Status
NCT00377832 (8) [back to overview]Rate of Cesarean Delivery
NCT00381810 (1) [back to overview]Percentage of Participants With at Least 1 Serious Adverse Event
NCT00385684 (2) [back to overview]Pain Assessment in Advanced Dementia (PAINAD)
NCT00385684 (2) [back to overview]Pain Assessment in Advanced Dementia (PAINAD)
NCT00399568 (4) [back to overview]Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
NCT00399568 (4) [back to overview]Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.
NCT00399568 (4) [back to overview]Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
NCT00399568 (4) [back to overview]Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
NCT00482053 (7) [back to overview]Overall Survival (OS)
NCT00482053 (7) [back to overview]Median Time to Neutrophil Engraftment After Allogeneic Transplant
NCT00482053 (7) [back to overview]Median Time to Neutrophil Engraftment After Autologous Transplant
NCT00482053 (7) [back to overview]Incidence of Chronic Graft vs Host Disease (GvHD)
NCT00482053 (7) [back to overview]Median Time to Platelet Engraftment After Autologous Transplant
NCT00482053 (7) [back to overview]Median Time to Platelet Engraftment After Allogeneic Transplant
NCT00482053 (7) [back to overview]Event-free Survival (EFS) Per Protocol
NCT00489424 (8) [back to overview]Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.
NCT00489424 (8) [back to overview]Number of Rescue Medication Tablets Taken
NCT00489424 (8) [back to overview]Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.
NCT00489424 (8) [back to overview]Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.
NCT00489424 (8) [back to overview]Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.
NCT00489424 (8) [back to overview]Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity
NCT00489424 (8) [back to overview]Proportion of Patients Who Used Rescue Medication.
NCT00489424 (8) [back to overview]Proportion of Patients Reporting Severe Questionnaire Symptoms.
NCT00490009 (3) [back to overview]Clinical Response Rate
NCT00490009 (3) [back to overview]Time to Progression (TTP)
NCT00490009 (3) [back to overview]Overall Survival (OS) Rate
NCT00493246 (6) [back to overview]Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen
NCT00493246 (6) [back to overview]Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen
NCT00493246 (6) [back to overview]Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)
NCT00493246 (6) [back to overview]Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen
NCT00493246 (6) [back to overview]Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen
NCT00493246 (6) [back to overview]Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)
NCT00493311 (5) [back to overview]Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever
NCT00493311 (5) [back to overview]Global Assessment of Treatment at T360 Minutes or Early Termination.
NCT00493311 (5) [back to overview]Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)
NCT00493311 (5) [back to overview]Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.
NCT00493311 (5) [back to overview]The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)
NCT00496015 (33) [back to overview]Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.
NCT00496015 (33) [back to overview]Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms
NCT00496015 (33) [back to overview]Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values
NCT00496015 (33) [back to overview]Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off
NCT00496015 (33) [back to overview]Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs
NCT00496015 (33) [back to overview]Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values
NCT00496015 (33) [back to overview]Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A
NCT00496015 (33) [back to overview]Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
NCT00496015 (33) [back to overview]rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group
NCT00496015 (33) [back to overview]Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.
NCT00496015 (33) [back to overview]Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
NCT00496015 (33) [back to overview]Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers
NCT00496015 (33) [back to overview]Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers
NCT00496015 (33) [back to overview]Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)
NCT00496015 (33) [back to overview]Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).
NCT00496015 (33) [back to overview]Concentrations of Antibodies Against Protein D (Anti-PD)
NCT00496015 (33) [back to overview]Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations
NCT00496015 (33) [back to overview]Number of Nasopharyngeal Swabs With H. Influenzae
NCT00496015 (33) [back to overview]Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae
NCT00496015 (33) [back to overview]Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
NCT00496015 (33) [back to overview]Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
NCT00496015 (33) [back to overview]Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group
NCT00496015 (33) [back to overview]Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations
NCT00496015 (33) [back to overview]Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group
NCT00496015 (33) [back to overview]Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off
NCT00496015 (33) [back to overview]Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off
NCT00496015 (33) [back to overview]Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.
NCT00496015 (33) [back to overview]Number of Subjects Reported With Serious Adverse Events (SAEs)
NCT00496015 (33) [back to overview]Number of Subjects Reported With Unsolicited Adverse Events (AEs)
NCT00496015 (33) [back to overview]Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)
NCT00496015 (33) [back to overview]Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)
NCT00496015 (33) [back to overview]Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)
NCT00496015 (33) [back to overview]Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.
NCT00564486 (4) [back to overview]Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
NCT00564486 (4) [back to overview]Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)
NCT00564486 (4) [back to overview]The Number of Subjects Reporting a Treatment Emergent Adverse Event
NCT00564486 (4) [back to overview]The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event
NCT00564629 (9) [back to overview]Maximum Temperature Reduction Observed From T0 to T360 Minutes
NCT00564629 (9) [back to overview]WSTD3
NCT00564629 (9) [back to overview]WSTD5
NCT00564629 (9) [back to overview]WSTD4
NCT00564629 (9) [back to overview]The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2)
NCT00564629 (9) [back to overview]Time to a Reduction in Temperature From T0 to T360 Minutes.
NCT00564629 (9) [back to overview]The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes
NCT00564629 (9) [back to overview]Subject's Global Evaluation of Study Medication at T360 Minutes
NCT00564629 (9) [back to overview]WSTD6
NCT00598559 (4) [back to overview]Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)
NCT00598559 (4) [back to overview]Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.
NCT00598559 (4) [back to overview]Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments
NCT00598559 (4) [back to overview]Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).
NCT00598702 (4) [back to overview]Subject's (Parent/Guardian) Global Evaluation of Study Treatment
NCT00598702 (4) [back to overview]Physician's Global Assessment of Study Treatment
NCT00598702 (4) [back to overview]Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)
NCT00598702 (4) [back to overview]Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
NCT00616018 (2) [back to overview]Alanine Aminotransferase (ALT)
NCT00616018 (2) [back to overview]Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts
NCT00634543 (6) [back to overview]Overall Assessment of Study Medication by Participants
NCT00634543 (6) [back to overview]Change From Baseline in Pain Intensity Score at Day 43
NCT00634543 (6) [back to overview]Change From Baseline in Short Form-36 (SF-36) Score at Day 43
NCT00634543 (6) [back to overview]Overall Assessment of Study Medication by Investigator
NCT00634543 (6) [back to overview]Percentage of Participants With Pain Relief
NCT00634543 (6) [back to overview]Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
NCT00635349 (7) [back to overview]Number of Participants With Categorical Swelling
NCT00635349 (7) [back to overview]Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85
NCT00635349 (7) [back to overview]Number of Participants With Overall Assessment on Study Drug by Investigator
NCT00635349 (7) [back to overview]Number of Participants With Categorical Tenderness
NCT00635349 (7) [back to overview]Change From Day 29 in Pain Intensity Score at Day 85
NCT00635349 (7) [back to overview]Number of Participants With Pain Relief
NCT00635349 (7) [back to overview]Number of Participants With Overall Assessment on Study Drug by Participants
NCT00646906 (2) [back to overview]Percent Change in Serum Thromboxane B2
NCT00646906 (2) [back to overview]Percent Change in Arachidonic Acid Induced Platelet Aggregation
NCT00652093 (12) [back to overview]Swiss Spinal Stenosis Score- Physical Function
NCT00652093 (12) [back to overview]Visual Analog Scale (VAS)
NCT00652093 (12) [back to overview]Total Distance
NCT00652093 (12) [back to overview]Area Under the Curve
NCT00652093 (12) [back to overview]Final Pain
NCT00652093 (12) [back to overview]Modified Brief Pain Inventory (mBPI)- Interference Score
NCT00652093 (12) [back to overview]Oswestry Disability Index (ODI) Score
NCT00652093 (12) [back to overview]Patient Global Assessment (PGA)
NCT00652093 (12) [back to overview]Recovery Time
NCT00652093 (12) [back to overview]Roland Morris Disability Questionnaire (RMDQ)
NCT00652093 (12) [back to overview]Swiss Spinal Stenosis Score- Symptom Severity
NCT00652093 (12) [back to overview]Time to First Symptoms (Tfirst) of Moderate Pain
NCT00662818 (9) [back to overview]Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
NCT00662818 (9) [back to overview]Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
NCT00662818 (9) [back to overview]Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
NCT00662818 (9) [back to overview]Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
NCT00662818 (9) [back to overview]Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
NCT00662818 (9) [back to overview]Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
NCT00662818 (9) [back to overview]Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
NCT00662818 (9) [back to overview]Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
NCT00662818 (9) [back to overview]Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
NCT00694369 (2) [back to overview]Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication
NCT00694369 (2) [back to overview]Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Standardised Quality of Life Scores (EORTC - QLQ-C30)
NCT00712712 (22) [back to overview]Standardised Quality of Life Scores (EORTC - QLQ-C30)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Total Intravenous Morphine Dose (mg)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
NCT00712712 (22) [back to overview]Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00712712 (22) [back to overview]Intensity of Pain (Minimum, Average, Maximum)
NCT00736853 (23) [back to overview]Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period
NCT00736853 (23) [back to overview]Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period
NCT00736853 (23) [back to overview]Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period
NCT00736853 (23) [back to overview]Mean PID During the Double-Blind Period
NCT00736853 (23) [back to overview]Mean PI Score During Double-Blind Period
NCT00736853 (23) [back to overview]Mean PAR Score During the Double-Blind Period
NCT00736853 (23) [back to overview]Mean Pain Relief (PAR) Score During the Open-Label Period
NCT00736853 (23) [back to overview]Mean Pain Intensity Difference (PID) During the Open-Label Period
NCT00736853 (23) [back to overview]Mean Pain Intensity (PI) Score During Open-Label Period
NCT00736853 (23) [back to overview]Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period
NCT00736853 (23) [back to overview]Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period
NCT00736853 (23) [back to overview]Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period
NCT00736853 (23) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period
NCT00736853 (23) [back to overview]Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period
NCT00736853 (23) [back to overview]Change From Baseline in SF-36 at Day 28 of Double-Blind Period
NCT00736853 (23) [back to overview]Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period
NCT00736853 (23) [back to overview]Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period
NCT00736853 (23) [back to overview]Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period
NCT00736853 (23) [back to overview]Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period
NCT00736853 (23) [back to overview]Total Pain Relief (TOTPAR) Score During the Open-Label Period
NCT00736853 (23) [back to overview]Total Pain Relief (TOTPAR) Score During the Double-Blind Period
NCT00736853 (23) [back to overview]Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period
NCT00736853 (23) [back to overview]Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period
NCT00736957 (7) [back to overview]Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4
NCT00736957 (7) [back to overview]Change From Baseline in VAS24 Score at Week 52
NCT00736957 (7) [back to overview]Change From Baseline in Short Form-36 (SF-36) Score
NCT00736957 (7) [back to overview]Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4
NCT00736957 (7) [back to overview]Number of Participants With Improvement From Baseline in VAS24 Score
NCT00736957 (7) [back to overview]Pain Intensity Difference (PID) at Week 4
NCT00736957 (7) [back to overview]Pain Relief (PAR) Score at Week 4
NCT00737048 (12) [back to overview]Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy
NCT00737048 (12) [back to overview]Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain
NCT00737048 (12) [back to overview]Sum of Pain Intensity Difference (SPID)
NCT00737048 (12) [back to overview]Number of Participants Treated With a Relief Analgesic
NCT00737048 (12) [back to overview]Percentage of Participants With Categorical Score for Patient Impressions
NCT00737048 (12) [back to overview]Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)
NCT00737048 (12) [back to overview]Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours
NCT00737048 (12) [back to overview]Total Pain Relief Based on Numerical Rating Scale (NRS) Score
NCT00737048 (12) [back to overview]Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment
NCT00737048 (12) [back to overview]Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment
NCT00737048 (12) [back to overview]Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment
NCT00737048 (12) [back to overview]Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment
NCT00743093 (2) [back to overview]The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.
NCT00743093 (2) [back to overview]The Proportion of Subjects With Detectable Serum Acetaminophen-cysteine Adduct (APAP-cys) Concentrations 1, 2, and 3 Days After Starting the Maximal Recommended Dosing of Acetaminophen (4 g/Day).
NCT00758836 (4) [back to overview]Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)
NCT00758836 (4) [back to overview]Percentage of Participants With Pain Freedom at Two Hours Post-dose
NCT00758836 (4) [back to overview]Percentage of Participants With Pain Relief at 2 Hours Post-dose.
NCT00758836 (4) [back to overview]Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)
NCT00761150 (2) [back to overview]Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
NCT00761150 (2) [back to overview]Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
NCT00763321 (2) [back to overview]Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
NCT00763321 (2) [back to overview]Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
NCT00766675 (10) [back to overview]Pain Visual Analog Scale Score at Day 28
NCT00766675 (10) [back to overview]Pain Visual Analog Scale Score at Day 14
NCT00766675 (10) [back to overview]Tender-Point Evaluation/ Myalgic Score
NCT00766675 (10) [back to overview]Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
NCT00766675 (10) [back to overview]Number of Participants With Subject's Global Assessment
NCT00766675 (10) [back to overview]Number of Participants With Physician Global Assessment
NCT00766675 (10) [back to overview]Number of Participants With Categorical Scores on Pain Relief Rating Scale
NCT00766675 (10) [back to overview]Pain Visual Analog Scale Score at Day 56
NCT00766675 (10) [back to overview]Participant Assessment Sleep Questionnaire Score
NCT00766675 (10) [back to overview]Total Fibromyalgia Impact Questionnaire (FIQ) Score
NCT00768716 (7) [back to overview]APAP Plasma Adduct Association With UGT2B15 Genotype
NCT00768716 (7) [back to overview]Acetaminophen Glucuronidation Partial Clearance Association With UGT2B15 Genotype
NCT00768716 (7) [back to overview]Acetaminophen Plasma Clearance Association With Race/Ethnicity
NCT00768716 (7) [back to overview]Acetaminophen Plasma Clearance Association With UGT2B15 Genotype
NCT00768716 (7) [back to overview]Acetaminophen Oxidation Partial Clearance Association With Race/Ethnicity
NCT00768716 (7) [back to overview]Acetaminophen Sulfation Partial Clearance Association With Race/Ethnicity
NCT00768716 (7) [back to overview]Acetaminophen Glucuronidation Partial Clearance Association With Race/Ethnicity
NCT00771875 (7) [back to overview]Incidence of Death
NCT00771875 (7) [back to overview]Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)
NCT00771875 (7) [back to overview]Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy
NCT00771875 (7) [back to overview]Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy
NCT00771875 (7) [back to overview]Renal Allograft Survival
NCT00771875 (7) [back to overview]Mean Serum Creatinine
NCT00771875 (7) [back to overview]Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection
NCT00784810 (2) [back to overview]Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)
NCT00784810 (2) [back to overview]Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.
NCT00899847 (8) [back to overview]Event-free Survival (EFS)
NCT00899847 (8) [back to overview]Complete Response Rate (CRR)
NCT00899847 (8) [back to overview]Partial Response Rate (PRR)
NCT00899847 (8) [back to overview]Median Time to Engraftment After Auto-PBSC Transplant
NCT00899847 (8) [back to overview]Median Time to Engraftment After Allo-PBSC Transplant
NCT00899847 (8) [back to overview]Overall Survival (OS)
NCT00899847 (8) [back to overview]Overall Response Rate (ORR)
NCT00899847 (8) [back to overview]Incidence of Graft Versus Host Disease (GvHD)
NCT00923910 (7) [back to overview]Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot)
NCT00923910 (7) [back to overview]Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)
NCT00923910 (7) [back to overview]Time to Immune Response
NCT00923910 (7) [back to overview]Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)
NCT00923910 (7) [back to overview]Toxicity
NCT00923910 (7) [back to overview]Number of Participants With Progressive Disease
NCT00923910 (7) [back to overview]Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3
NCT00935311 (4) [back to overview]Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
NCT00935311 (4) [back to overview]Time to First Rescue Medication
NCT00935311 (4) [back to overview]TOTPAR (Total Pain Relief)
NCT00935311 (4) [back to overview]Participants With Adverse Events (AEs)
NCT01002573 (7) [back to overview]Change From Baseline in Temperature After the First 30 Minutes of Treatment
NCT01002573 (7) [back to overview]Change From Baseline in Temperature After the First 60 Minutes of Treatment
NCT01002573 (7) [back to overview]Change From Baseline in Temperature After the First Four Hours of Treatment
NCT01002573 (7) [back to overview]Change in Temperature
NCT01002573 (7) [back to overview]Fever Reduction
NCT01002573 (7) [back to overview]Time to Afebrility (in Hours)
NCT01002573 (7) [back to overview]Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
NCT01003639 (4) [back to overview]Mean Change of Papilledema Grade on Fundus Photography
NCT01003639 (4) [back to overview]Visual Function Questionnaire (VFQ-25)
NCT01003639 (4) [back to overview]Visual Acuity (No. of Correct Letters)
NCT01003639 (4) [back to overview]Mean Change in Perimetric Mean Deviation
NCT01038609 (7) [back to overview]Time to Perceptible and Meaningful Pain Relief
NCT01038609 (7) [back to overview]Participants With Adverse Events (AEs)
NCT01038609 (7) [back to overview]Participant's Global Assessment of Study Drug
NCT01038609 (7) [back to overview]Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria
NCT01038609 (7) [back to overview]Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria
NCT01038609 (7) [back to overview]TOTPAR (Total Pain Relief)
NCT01038609 (7) [back to overview]Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)
NCT01048866 (19) [back to overview]Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline
NCT01048866 (19) [back to overview]Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
NCT01048866 (19) [back to overview]Change From Baseline in Body Temperature at End of Study
NCT01048866 (19) [back to overview]Change From Baseline in Body Temperature at 2 Hours Post Initial Dose
NCT01048866 (19) [back to overview]Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)
NCT01048866 (19) [back to overview]Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)
NCT01048866 (19) [back to overview]Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)
NCT01048866 (19) [back to overview]Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)
NCT01048866 (19) [back to overview]Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
NCT01048866 (19) [back to overview]Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
NCT01048866 (19) [back to overview]Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe
NCT01048866 (19) [back to overview]Time to First Rescue Pain Medication
NCT01048866 (19) [back to overview]Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
NCT01048866 (19) [back to overview]Percentage of Participants Who Took Rescue Pain Medication
NCT01048866 (19) [back to overview]Participant Satisfaction Score 24 Hours After Initial Dose
NCT01048866 (19) [back to overview]Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline
NCT01048866 (19) [back to overview]Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
NCT01048866 (19) [back to overview]Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline
NCT01048866 (19) [back to overview]Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline
NCT01053637 (3) [back to overview]Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale
NCT01053637 (3) [back to overview]Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group
NCT01053637 (3) [back to overview]Visual Analog Scale (VAS) Pain Score for Children > 7 Years.
NCT01075243 (15) [back to overview]SPID Scores at 4 Hours
NCT01075243 (15) [back to overview]SPID Scores at 6 Hours
NCT01075243 (15) [back to overview]SPRID at 2 Hours
NCT01075243 (15) [back to overview]SPRID at 4 Hours
NCT01075243 (15) [back to overview]Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
NCT01075243 (15) [back to overview]Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)
NCT01075243 (15) [back to overview]Time to Confirmed First Perceptible Relief
NCT01075243 (15) [back to overview]Time to Onset of Meaningful Pain Relief
NCT01075243 (15) [back to overview]Time to Start Using Rescue Medication
NCT01075243 (15) [back to overview]Total Pain Relief Score (TOTPAR) at 2 Hours
NCT01075243 (15) [back to overview]Percentage of Participants Who Took Rescue Medication at 6 Hours
NCT01075243 (15) [back to overview]TOTPAR at 4 Hours
NCT01075243 (15) [back to overview]Participants Global Assessment to Response to Treatment (PGART)
NCT01075243 (15) [back to overview]TOTPAR at 6 Hours
NCT01075243 (15) [back to overview]Percentage of Participants Who Took Rescue Medication at 2 Hours
NCT01082081 (15) [back to overview]TOTPAR at 6 Hours
NCT01082081 (15) [back to overview]TOTPAR at 4 Hours
NCT01082081 (15) [back to overview]Total Pain Relief (TOTPAR) at 2 Hours
NCT01082081 (15) [back to overview]Time to Start Using Rescue Medication
NCT01082081 (15) [back to overview]SPID Scores at 6 Hours
NCT01082081 (15) [back to overview]Participants Global Assessment to Response to Treatment (PGART)
NCT01082081 (15) [back to overview]Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours
NCT01082081 (15) [back to overview]SPID Scores at 4 Hours
NCT01082081 (15) [back to overview]SPRID at 4 Hours
NCT01082081 (15) [back to overview]SPRID at 2 Hours
NCT01082081 (15) [back to overview]Percentage of Participants Who Took Rescue Medication Within 2 Hours
NCT01082081 (15) [back to overview]Sum of Pain Intensity Difference (SPID) Scores at 2 Hours
NCT01082081 (15) [back to overview]Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)
NCT01082081 (15) [back to overview]Time to Confirmed First Perceptible Pain Relief
NCT01082081 (15) [back to overview]Time to Onset of Meaningful Pain Relief
NCT01086540 (19) [back to overview]Oxygen Saturation Levels at Week 24 and Week 48
NCT01086540 (19) [back to overview]Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)
NCT01086540 (19) [back to overview]Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score
NCT01086540 (19) [back to overview]Change in Carbon Monoxide Diffusing Capacity (DLCO)
NCT01086540 (19) [back to overview]Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score
NCT01086540 (19) [back to overview]Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization
NCT01086540 (19) [back to overview]Change in Severity of Raynaud's Phenomenon
NCT01086540 (19) [back to overview]Number of Infection-Related Adverse Events (AEs) Through Week 48
NCT01086540 (19) [back to overview]Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24
NCT01086540 (19) [back to overview]Change From Baseline in Distance Walked During a Six Minute Walk Test
NCT01086540 (19) [back to overview]All-Cause Mortality: From Treatment Initiation to Week 48
NCT01086540 (19) [back to overview]All-Cause Mortality: From Treatment Initiation to Week 104
NCT01086540 (19) [back to overview]Time to Clinical Worsening
NCT01086540 (19) [back to overview]Treatment-Related Mortality: From Treatment Initiation to Week 48
NCT01086540 (19) [back to overview]Number of New Digital Ulcers
NCT01086540 (19) [back to overview]Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48
NCT01086540 (19) [back to overview]Number of Infusion-Related Toxicities
NCT01086540 (19) [back to overview]Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48
NCT01086540 (19) [back to overview]Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications
NCT01105936 (7) [back to overview]Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]
NCT01105936 (7) [back to overview]Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]
NCT01105936 (7) [back to overview]Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]
NCT01105936 (7) [back to overview]Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]
NCT01105936 (7) [back to overview]Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]
NCT01105936 (7) [back to overview]Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]
NCT01105936 (7) [back to overview]BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]
NCT01112267 (7) [back to overview]Percentage of Participants With Reduction in Pain Intensity
NCT01112267 (7) [back to overview]Percentage of Participants With Pain Relief
NCT01112267 (7) [back to overview]Change From Baseline in Short Form (SF)-36 Score at Day 29
NCT01112267 (7) [back to overview]Change From Baseline in Pain Intensity at Day 29
NCT01112267 (7) [back to overview]Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29
NCT01112267 (7) [back to overview]Percentage of Participants With Investigator's Global Assessment on Investigational Product
NCT01112267 (7) [back to overview]Percentage of Participants With Participants' Global Assessment on Investigational Product
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 75 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
NCT01115673 (43) [back to overview]Rescue Rates Through Six Hours
NCT01115673 (43) [back to overview]Rescue Rates Through Four Hours
NCT01115673 (43) [back to overview]Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
NCT01115673 (43) [back to overview]Patient Global Evaluation
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference Over Six Hours (SPID6)
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 120 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 75 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 60 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 45 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 360 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 90 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 30 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 240 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
NCT01115673 (43) [back to overview]Duration of Analgesia - Time to Rescue
NCT01115673 (43) [back to overview]Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 300 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 180 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 15 Minutes
NCT01115673 (43) [back to overview]Pain Relief (PAR) Scores at 120 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 90 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 15 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 60 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
NCT01115673 (43) [back to overview]Time to Confirmed Perceptible Pain Relief
NCT01115673 (43) [back to overview]Time to Meaningful Pain Relief
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 45 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 360 Minutes
NCT01115673 (43) [back to overview]Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 300 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 30 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 240 Minutes
NCT01115673 (43) [back to overview]Pain Intensity Difference (PID) at 180 Minutes
NCT01216163 (15) [back to overview]Cumulative Percentage of Participants With Treatment Failure
NCT01216163 (15) [back to overview]Cumulative Percentage of Participants With Meaningful Relief
NCT01216163 (15) [back to overview]Cumulative Percentage of Participants With Confirmed First Perceptible Relief
NCT01216163 (15) [back to overview]Cumulative Percentage of Participants With Complete Relief
NCT01216163 (15) [back to overview]Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)
NCT01216163 (15) [back to overview]Time to Treatment Failure
NCT01216163 (15) [back to overview]Time to Onset of Meaningful Relief
NCT01216163 (15) [back to overview]Time to Confirmed First Perceptible Relief
NCT01216163 (15) [back to overview]Participant Global Evaluation of Study Medication
NCT01216163 (15) [back to overview]Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
NCT01216163 (15) [back to overview]Time-weighted Sum of Pain Relief Rating (TOTPAR)
NCT01216163 (15) [back to overview]Time-weighted Sum of Pain Intensity Difference (SPID)
NCT01216163 (15) [back to overview]Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
NCT01216163 (15) [back to overview]Pain Relief Rating (PRR)
NCT01216163 (15) [back to overview]Pain Intensity Difference (PID)
NCT01229449 (10) [back to overview]Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)
NCT01229449 (10) [back to overview]Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)
NCT01229449 (10) [back to overview]Individual Pain Intensity Differences Visual Analogue Scale (VAS)
NCT01229449 (10) [back to overview]Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
NCT01229449 (10) [back to overview]Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)
NCT01229449 (10) [back to overview]Change From Baseline in AUC (0-8h) of SPRID
NCT01229449 (10) [back to overview]Change From Baseline in AUC of Pain Relief Scores (TOTPAR)
NCT01229449 (10) [back to overview]Individual Pain Intensity Differences (Ordinal)
NCT01229449 (10) [back to overview]Change From Baseline in Peak Pain Relief (PR)
NCT01229449 (10) [back to overview]Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication
NCT01235949 (25) [back to overview]Antibody Concentrations Against Protein D (Anti-PD)
NCT01235949 (25) [back to overview]Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
NCT01235949 (25) [back to overview]Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)
NCT01235949 (25) [back to overview]Number of Subjects With Any Serious Adverse Events (SAEs)
NCT01235949 (25) [back to overview]Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A
NCT01235949 (25) [back to overview]Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
NCT01235949 (25) [back to overview]Number of Subjects With Any and Grade 3 Solicited Local Symptoms
NCT01235949 (25) [back to overview]Number of Subjects With Any Unsolicited Adverse Events (AEs)
NCT01235949 (25) [back to overview]Antibody Concentrations Against Vaccine Pneumococcal Serotypes
NCT01235949 (25) [back to overview]Number of Subjects With Any Unsolicited Adverse Events (AEs)
NCT01235949 (25) [back to overview]Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
NCT01235949 (25) [back to overview]Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes
NCT01235949 (25) [back to overview]Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
NCT01235949 (25) [back to overview]Antibody Concentrations Against Hepatitis B Surface Antigen
NCT01235949 (25) [back to overview]Number of Subjects With Any and Grade 3 Solicited Local Symptoms
NCT01235949 (25) [back to overview]Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off
NCT01235949 (25) [back to overview]Antibody Titers Against Poliovirus Type 1, 2 and 3
NCT01235949 (25) [back to overview]Antibody Titers Against Poliovirus Type 1, 2 and 3
NCT01235949 (25) [back to overview]Antibody Concentrations Against Vaccine Pneumococcal Serotypes
NCT01235949 (25) [back to overview]Antibody Concentrations Against Protein D (Anti-PD)
NCT01235949 (25) [back to overview]Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
NCT01235949 (25) [back to overview]Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)
NCT01235949 (25) [back to overview]Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids
NCT01235949 (25) [back to overview]Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids
NCT01235949 (25) [back to overview]Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)
NCT01246713 (1) [back to overview]Acetaminophen Metabolites
NCT01248468 (4) [back to overview]Percent of Subjects Who Are Free of Phonophobia at 2 Hours.
NCT01248468 (4) [back to overview]Percent of Subjects Who Are Pain Free at 2 Hours.
NCT01248468 (4) [back to overview]Percent of Subjects Who Are Free of Photophobia at 2 Hours.
NCT01248468 (4) [back to overview]Percent of Subjects Who Are Free of Nausea at 2 Hours.
NCT01267136 (2) [back to overview]Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
NCT01267136 (2) [back to overview]Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.
NCT01270659 (3) [back to overview]Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
NCT01270659 (3) [back to overview]Nausea Level
NCT01270659 (3) [back to overview]Number of Participants Experiencing Any Adverse Events
NCT01277081 (6) [back to overview]Cold Symptoms Score Post 60 Minutes
NCT01277081 (6) [back to overview]Overall Cold Symptoms Score
NCT01277081 (6) [back to overview]Cold Symptoms Score Post 15 Minutes
NCT01277081 (6) [back to overview]Breathing Scores Post 15 Minutes
NCT01277081 (6) [back to overview]Breathing Score Post 60 Minutes
NCT01277081 (6) [back to overview]Soothing Attribute Scores
NCT01298778 (8) [back to overview]Incidence of Persistent Pain
NCT01298778 (8) [back to overview]Incidence of Depression
NCT01298778 (8) [back to overview]Average Pain Over 24 Hours
NCT01298778 (8) [back to overview]Emetic Symptoms
NCT01298778 (8) [back to overview]Pruritus
NCT01298778 (8) [back to overview]Severity of Acute Pain
NCT01298778 (8) [back to overview]Analgesic Consumption
NCT01298778 (8) [back to overview]Pain
NCT01321710 (5) [back to overview]Change in Infant Sleep Quantity (Objective)
NCT01321710 (5) [back to overview]Maternal Sleep Disturbance (Subjective)
NCT01321710 (5) [back to overview]Maternal Sleep Quality (Objective)
NCT01321710 (5) [back to overview]Maternal Sleep Quantity (Objective)
NCT01321710 (5) [back to overview]Maternal Well-being
NCT01328782 (5) [back to overview]Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge
NCT01328782 (5) [back to overview]Need for IV Morphine of Fentanyl
NCT01328782 (5) [back to overview]The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).
NCT01328782 (5) [back to overview]Time (in Minutes) to First Narcotic Administration
NCT01328782 (5) [back to overview]Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting
NCT01330459 (5) [back to overview]Need for Additional Intraoperative and/or Postoperative Pain Medication
NCT01330459 (5) [back to overview]Postoperative Nausea
NCT01330459 (5) [back to overview]Satisfaction With Pain Control
NCT01330459 (5) [back to overview]Patient Perception of Pain During Cervical Dilation
NCT01330459 (5) [back to overview]Patient Perception of Pain
NCT01332578 (8) [back to overview]Time to Completion of Gastric Emptying
NCT01332578 (8) [back to overview]Time to Onset and Completion of Disintegration of Reference Tablets
NCT01332578 (8) [back to overview]AUC (0-60 Min)
NCT01332578 (8) [back to overview]Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)
NCT01332578 (8) [back to overview]Maximum Plasma Concentration (Cmax)
NCT01332578 (8) [back to overview]Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)
NCT01332578 (8) [back to overview]Time to Onset of Gastric Emptying
NCT01332578 (8) [back to overview]Time to Maximum Plasma Concentration (Tmax)
NCT01333722 (4) [back to overview]TOTPAR (Total Pain Relief)
NCT01333722 (4) [back to overview]Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
NCT01333722 (4) [back to overview]SPRID (Pain Relief and Pain Intensity Difference)
NCT01333722 (4) [back to overview]Time to Perceptible and Meaningful Pain Relief
NCT01364922 (3) [back to overview]Participant's Global Assessment of Back Pain Status at Final Evaluation
NCT01364922 (3) [back to overview]Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
NCT01364922 (3) [back to overview]Participant's Global Assessment of Study Drug at Final Evaluation
NCT01366976 (4) [back to overview]Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)
NCT01366976 (4) [back to overview]Serum Creatinine
NCT01366976 (4) [back to overview]Plasma Isofuran Concentrations
NCT01366976 (4) [back to overview]Plasma F2-isoprostane Concentrations
NCT01374269 (62) [back to overview]Oswestry Disability Index
NCT01374269 (62) [back to overview]Quality of Life, Bodily Pain
NCT01374269 (62) [back to overview]Quality of Life, Bodily Pain
NCT01374269 (62) [back to overview]Quality of Life, Change in Health
NCT01374269 (62) [back to overview]Quality of Life, Change in Health
NCT01374269 (62) [back to overview]Quality of Life, Change in Health
NCT01374269 (62) [back to overview]Quality of Life, Change in Health
NCT01374269 (62) [back to overview]Quality of Life, Emotional Performance.
NCT01374269 (62) [back to overview]Quality of Life, Emotional Performance.
NCT01374269 (62) [back to overview]Oswestry Disability Index
NCT01374269 (62) [back to overview]Oswestry Disability Index
NCT01374269 (62) [back to overview]Oswestry Disability Index
NCT01374269 (62) [back to overview]PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
NCT01374269 (62) [back to overview]PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
NCT01374269 (62) [back to overview]Relapses of Lumbar Pain
NCT01374269 (62) [back to overview]Roland-Morris Questionnaire
NCT01374269 (62) [back to overview]Roland-Morris Questionnaire
NCT01374269 (62) [back to overview]Roland-Morris Questionnaire
NCT01374269 (62) [back to overview]Quality of Life, General Health Perceptions.
NCT01374269 (62) [back to overview]Quality of Life, Mental Health.
NCT01374269 (62) [back to overview]Quality of Life, General Health Perceptions.
NCT01374269 (62) [back to overview]Quality of Life, General Health Perceptions.
NCT01374269 (62) [back to overview]Quality of Life, General Health Perceptions.
NCT01374269 (62) [back to overview]Roland-Morris Questionnaire
NCT01374269 (62) [back to overview]Quality of Life, Mental Health.
NCT01374269 (62) [back to overview]Treatments Associated With Low Back Pain at 6 Months
NCT01374269 (62) [back to overview]Visual Analogue Scale of Pain
NCT01374269 (62) [back to overview]Visual Analogue Scale of Pain
NCT01374269 (62) [back to overview]Visual Analogue Scale of Pain
NCT01374269 (62) [back to overview]Quality of Life, Mental Health.
NCT01374269 (62) [back to overview]Quality of Life, Mental Health.
NCT01374269 (62) [back to overview]Quality of Life, Physical Function.
NCT01374269 (62) [back to overview]Quality of Life, Physical Function.
NCT01374269 (62) [back to overview]Quality of Life, Physical Function.
NCT01374269 (62) [back to overview]Quality of Life, Physical Function.
NCT01374269 (62) [back to overview]Quality of Life, Physical Performance.
NCT01374269 (62) [back to overview]Quality of Life, Physical Performance.
NCT01374269 (62) [back to overview]Quality of Life, Physical Performance.
NCT01374269 (62) [back to overview]Quality of Life, Physical Performance.
NCT01374269 (62) [back to overview]Quality of Life, Social Function.
NCT01374269 (62) [back to overview]Visual Analogue Scale of Pain
NCT01374269 (62) [back to overview]Relapses of Lumbar Pain
NCT01374269 (62) [back to overview]Quality of Life, Vitality.
NCT01374269 (62) [back to overview]Quality of Life, Vitality.
NCT01374269 (62) [back to overview]Quality of Life, Emotional Performance.
NCT01374269 (62) [back to overview]Quality of Life, Social Function.
NCT01374269 (62) [back to overview]Quality of Life, Vitality.
NCT01374269 (62) [back to overview]Quality of Life, Social Function.
NCT01374269 (62) [back to overview]Quality of Life, Emotional Performance.
NCT01374269 (62) [back to overview]Quality of Life, Vitality.
NCT01374269 (62) [back to overview]Missing Workdays
NCT01374269 (62) [back to overview]Missing Workdays
NCT01374269 (62) [back to overview]Missing Workdays
NCT01374269 (62) [back to overview]Medical Consultations.
NCT01374269 (62) [back to overview]Quality of Life, Social Function.
NCT01374269 (62) [back to overview]Medical Consultations.
NCT01374269 (62) [back to overview]PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
NCT01374269 (62) [back to overview]PHQ-9 Patient Health Questionnaire (PHQ-9) Depression
NCT01374269 (62) [back to overview]Quality of Life, Bodily Pain
NCT01374269 (62) [back to overview]Missing Workdays
NCT01374269 (62) [back to overview]Quality of Life, Bodily Pain
NCT01374269 (62) [back to overview]Medical Consultations.
NCT01381120 (2) [back to overview]Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.
NCT01381120 (2) [back to overview]Change in Post-ureteroscopy Stent-induced Pain
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion
NCT01382940 (7) [back to overview]Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion
NCT01390441 (7) [back to overview]Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point
NCT01390441 (7) [back to overview]Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment
NCT01390441 (7) [back to overview]Number of Participants Who Experienced at Least One Adverse Event
NCT01390441 (7) [back to overview]Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24
NCT01390441 (7) [back to overview]Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment
NCT01390441 (7) [back to overview]Number of Participants Who Discontinued Study Drug Due to Adverse Events
NCT01390441 (7) [back to overview]Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24
NCT01392378 (24) [back to overview]Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
NCT01392378 (24) [back to overview]Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
NCT01392378 (24) [back to overview]Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
NCT01392378 (24) [back to overview]Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
NCT01392378 (24) [back to overview]Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
NCT01392378 (24) [back to overview]Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
NCT01392378 (24) [back to overview]Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
NCT01392378 (24) [back to overview]Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
NCT01392378 (24) [back to overview]Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
NCT01392378 (24) [back to overview]Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
NCT01392378 (24) [back to overview]Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
NCT01394718 (4) [back to overview]Average Nausea Score
NCT01394718 (4) [back to overview]Total Opiate Requirement
NCT01394718 (4) [back to overview]Average Pruritus Score
NCT01394718 (4) [back to overview]Average Pain Score
NCT01402375 (4) [back to overview]Overall Satisfaction With the Pain Medicine
NCT01402375 (4) [back to overview]Difference in Pain Intensity Score Before and After Last Dose.
NCT01402375 (4) [back to overview]Time to Follow up
NCT01402375 (4) [back to overview]50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score
NCT01410409 (8) [back to overview]Change in 20-meter Walk From Baseline
NCT01410409 (8) [back to overview]Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)
NCT01410409 (8) [back to overview]Proportion of Users of Pain Medication
NCT01410409 (8) [back to overview]Serious Adverse Events Related to the Index Knee
NCT01410409 (8) [back to overview]Weight Change in kg From Baseline
NCT01410409 (8) [back to overview]Change in EQ-5D From Baseline
NCT01410409 (8) [back to overview]Change in the Five Subscales of KOOS From Baseline
NCT01410409 (8) [back to overview]Change in Timed Up & Go (TUG) From Baseline
NCT01420653 (1) [back to overview]SPID (Summed Pain Intensity Differences)
NCT01448057 (2) [back to overview]Physician Global Evaluation of Effectiveness on Nasal Symptoms
NCT01448057 (2) [back to overview]Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms
NCT01462370 (14) [back to overview]Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose
NCT01462370 (14) [back to overview]Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose
NCT01462370 (14) [back to overview]Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)
NCT01462370 (14) [back to overview]PR at Up to 24 Hours Following the Initial Dose
NCT01462370 (14) [back to overview]Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)
NCT01462370 (14) [back to overview]Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)
NCT01462370 (14) [back to overview]Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose
NCT01462370 (14) [back to overview]Number of Participants Using Rescue Medication 24 Hours After the Initial Dose
NCT01462370 (14) [back to overview]Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose
NCT01462370 (14) [back to overview]Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose
NCT01462370 (14) [back to overview]Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose
NCT01462370 (14) [back to overview]PID at Up to 12 Hours Following the Initial Dose
NCT01462370 (14) [back to overview]PID at Up to 24 Hours Following the Initial Dose
NCT01462370 (14) [back to overview]PR at Up to 12 Hours Following the Initial Dose
NCT01466348 (11) [back to overview]Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test
NCT01466348 (11) [back to overview]Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test
NCT01466348 (11) [back to overview]Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test
NCT01466348 (11) [back to overview]Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test
NCT01466348 (11) [back to overview]Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test
NCT01466348 (11) [back to overview]Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test
NCT01466348 (11) [back to overview]Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test
NCT01466348 (11) [back to overview]Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test
NCT01466348 (11) [back to overview]Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test
NCT01466348 (11) [back to overview]Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test
NCT01466348 (11) [back to overview]Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test
NCT01535001 (8) [back to overview]Change From Baseline in EQ-5D
NCT01535001 (8) [back to overview]Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)
NCT01535001 (8) [back to overview]Change in the Five KOOS Subscale Scores From Baseline
NCT01535001 (8) [back to overview]Change From Baseline in Time From the Timed Up and Go
NCT01535001 (8) [back to overview]Weight Change in kg From Baseline
NCT01535001 (8) [back to overview]Proportion of Users of Pain Medication
NCT01535001 (8) [back to overview]Number of Serious Adverse Events Reported at Index Knee
NCT01535001 (8) [back to overview]Change From Baseline in 20-meter Walk
NCT01540838 (9) [back to overview]Death or Any Neurological Sequelae on Day 7
NCT01540838 (9) [back to overview]Death or Any Neurological Sequelae at Discharge From Hospital.
NCT01540838 (9) [back to overview]Day 7 Mortality
NCT01540838 (9) [back to overview]All Deaths During Hospital Stay
NCT01540838 (9) [back to overview]A Change in Hearing Threshold Compared to the First Test Result
NCT01540838 (9) [back to overview]Status on the Modified Glasgow Outcome Scale
NCT01540838 (9) [back to overview]Number of Participants With Deafness
NCT01540838 (9) [back to overview]Death or Severe Neurological Sequelae on Day 7
NCT01540838 (9) [back to overview]Death or Severe Neurological Sequelae at Discharge
NCT01544062 (21) [back to overview]24 Hour Dizziness
NCT01544062 (21) [back to overview]24 Hour Nausea
NCT01544062 (21) [back to overview]24 Hour Postoperative Opioid Consumption
NCT01544062 (21) [back to overview]48 Hour Sedation
NCT01544062 (21) [back to overview]48 Hour Respiratory Depression
NCT01544062 (21) [back to overview]48 Hour Postoperative Pain Scores With Movement
NCT01544062 (21) [back to overview]48 Hour Postoperative Pain Scores at Rest
NCT01544062 (21) [back to overview]24 Hour Wound Hyperalgesia
NCT01544062 (21) [back to overview]Length of Mechanical Ventilation
NCT01544062 (21) [back to overview]Length of ICU Stay
NCT01544062 (21) [back to overview]48 Hour Pruritus
NCT01544062 (21) [back to overview]24 Hour Postoperative Pain Scores at Rest
NCT01544062 (21) [back to overview]48 Hour Postoperative Opioid Consumption
NCT01544062 (21) [back to overview]48 Hour Patient Satisfaction
NCT01544062 (21) [back to overview]48 Hour Nausea
NCT01544062 (21) [back to overview]24 Hour Respiratory Depression
NCT01544062 (21) [back to overview]48 Hour Dizziness
NCT01544062 (21) [back to overview]24 Hour Sedation
NCT01544062 (21) [back to overview]48 Hour Wound Hyperalgesia
NCT01544062 (21) [back to overview]24 Hour Pruritus
NCT01544062 (21) [back to overview]24 Hour Postoperative Pain Scores With Movement
NCT01559259 (16) [back to overview]Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose
NCT01559259 (16) [back to overview]Time to Confirmed First Perceptible Relief
NCT01559259 (16) [back to overview]Cumulative Percentage of Participants With Treatment Failure
NCT01559259 (16) [back to overview]Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose
NCT01559259 (16) [back to overview]Time to Onset of Meaningful Pain Relief
NCT01559259 (16) [back to overview]Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose
NCT01559259 (16) [back to overview]Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
NCT01559259 (16) [back to overview]Pain Relief Rating Score (PRR)
NCT01559259 (16) [back to overview]Pain Intensity Difference on 4-Point Categorical Scale (PID4)
NCT01559259 (16) [back to overview]Cumulative Percentage of Participants With Meaningful Relief
NCT01559259 (16) [back to overview]Cumulative Percentage of Participants With Confirmed First Perceptible Relief
NCT01559259 (16) [back to overview]Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)
NCT01559259 (16) [back to overview]Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose
NCT01559259 (16) [back to overview]Participant Global Evaluation of Study Medication
NCT01559259 (16) [back to overview]Pain Intensity Difference on 11-Point Numerical Scale (PID11)
NCT01559259 (16) [back to overview]Time to Treatment Failure
NCT01576809 (3) [back to overview]Subject Acceptability of the Syrup
NCT01576809 (3) [back to overview]Safety and Tolerability of the Syrup
NCT01576809 (3) [back to overview]Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup
NCT01586962 (3) [back to overview]Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup
NCT01586962 (3) [back to overview]Subject Acceptability of the Syrup
NCT01586962 (3) [back to overview]Safety and Tolerability of the Syrup
NCT01587274 (1) [back to overview]Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire
NCT01588158 (9) [back to overview]Satisfaction With Pain Relief
NCT01588158 (9) [back to overview]Pain Patients Expect After Surgery
NCT01588158 (9) [back to overview]Expectation of Pain Relief
NCT01588158 (9) [back to overview]Pain Scale
NCT01588158 (9) [back to overview]QuickDASH
NCT01588158 (9) [back to overview]QuickDASH
NCT01588158 (9) [back to overview]PSEQ
NCT01588158 (9) [back to overview]PHQ-9
NCT01588158 (9) [back to overview]Pain Scale
NCT01598701 (5) [back to overview]Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria
NCT01598701 (5) [back to overview]Time to Extubation at Emergence From Anesthesia
NCT01598701 (5) [back to overview]Post-Operative Side Effects
NCT01598701 (5) [back to overview]Post-Operative Pain
NCT01598701 (5) [back to overview]Post-Operative Opioid Requirement
NCT01605903 (1) [back to overview]Number of Participants With Level 3 Postoperative Hemorrhage
NCT01606319 (4) [back to overview]Asthma Control Days
NCT01606319 (4) [back to overview]Health Care Utilization
NCT01606319 (4) [back to overview]Exacerbation Frequency
NCT01606319 (4) [back to overview]Asthma Rescue Medication Use
NCT01607905 (17) [back to overview]Number of Participants With Best Overall Response (BOR)
NCT01607905 (17) [back to overview]Number of Participants With Treatment-related Treatment-emergent Adverse Events
NCT01607905 (17) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Selinexor
NCT01607905 (17) [back to overview]Duration of Stable Disease (SD)
NCT01607905 (17) [back to overview]Area Under the Concentration Time Curve From the Time of Dosing to Time in Plasma (AUC0-t) of Selinexor
NCT01607905 (17) [back to overview]Area Under the Concentration Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Selinexor
NCT01607905 (17) [back to overview]Apparent Volume of Distribution of Selinexor (Vd/F)
NCT01607905 (17) [back to overview]Apparent Total Body Clearance (CL/F) of Selinexor
NCT01607905 (17) [back to overview]Elimination Half-Life (t1/2) of Selinexor
NCT01607905 (17) [back to overview]Overall Survival (OS)
NCT01607905 (17) [back to overview]Progression-free Survival (PFS)
NCT01607905 (17) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
NCT01607905 (17) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs) Greater Than or Equal to Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
NCT01607905 (17) [back to overview]Percentage of Participants With Objective Response
NCT01607905 (17) [back to overview]Number of Participants Who Experienced Dose Limiting Toxicity (DLT)
NCT01607905 (17) [back to overview]Recommended Phase 2 Dose (RP2D)
NCT01607905 (17) [back to overview]Time of Maximum Observed Concentration in Plasma (Tmax) of Selinexor
NCT01608308 (9) [back to overview]Postoperative Vital Sign (Respiratory Rate)
NCT01608308 (9) [back to overview]Postoperative Vital Sign (Systolic Blood Pressure)
NCT01608308 (9) [back to overview]Number of Participants Who Experienced Postoperative Morbidity (Nausea)
NCT01608308 (9) [back to overview]Total Doses of Postoperative Opiate (Morphine) Use
NCT01608308 (9) [back to overview]Postoperative Vital Sign (Diastolic Blood Pressure)
NCT01608308 (9) [back to overview]Postoperative Vital Sign (Pulse)
NCT01608308 (9) [back to overview]Number of Participants Who Received Intraoperative Supplemental Fentanyl
NCT01608308 (9) [back to overview]Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale
NCT01608308 (9) [back to overview]Postoperative Vital Sign (Temperature)
NCT01635101 (6) [back to overview]Summary of Pain Intensity Using the Leuven Neonatal Pain Scale (LNPS) in Neonates
NCT01635101 (6) [back to overview]Pain Intensity Using the FLACC Score in Older Infants
NCT01635101 (6) [back to overview]Pain Intensity Using the FLACC Score in Intermediate Aged Infants
NCT01635101 (6) [back to overview]Total Rescue Opioid Consumption
NCT01635101 (6) [back to overview]Time to First Rescue Medication
NCT01635101 (6) [back to overview]Summary of Pain Intensity Using the LNPS in Younger Infants
NCT01686646 (10) [back to overview]Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task
NCT01686646 (10) [back to overview]Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test
NCT01686646 (10) [back to overview]Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test
NCT01686646 (10) [back to overview]Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test
NCT01686646 (10) [back to overview]Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task
NCT01686646 (10) [back to overview]Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test
NCT01686646 (10) [back to overview]Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task
NCT01686646 (10) [back to overview]Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test
NCT01686646 (10) [back to overview]Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test
NCT01686646 (10) [back to overview]Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test
NCT01691690 (3) [back to overview]Time of First Opioid Analgesia in PACU
NCT01691690 (3) [back to overview]Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each
NCT01691690 (3) [back to overview]FLACC Pain Score Greater Than or Equal to 4
NCT01699815 (3) [back to overview]Average Length of Stay (LOS)
NCT01699815 (3) [back to overview]Pain Medication Consumption Rates
NCT01699815 (3) [back to overview]Changes in Postoperative Pain Scores
NCT01721486 (4) [back to overview]Incidence of Post-operative Vomiting
NCT01721486 (4) [back to overview]FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores
NCT01721486 (4) [back to overview]Parental Satisfaction With Pain Control.
NCT01721486 (4) [back to overview]Total Pain Medication
NCT01728246 (4) [back to overview]Change From Baseline in VAS-pain Score at Week 4
NCT01728246 (4) [back to overview]Percentage of Participants Who Discontinued Because of Rescue Medication
NCT01728246 (4) [back to overview]Change From Baseline in ODI Score at Week 4
NCT01728246 (4) [back to overview]Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2
NCT01737593 (8) [back to overview]Postanesthesia Pain Score
NCT01737593 (8) [back to overview]Postanesthesia Pain Score
NCT01737593 (8) [back to overview]Postanesthesia Emergence Agitation (EA) Score
NCT01737593 (8) [back to overview]Postanesthesia Pain Score
NCT01737593 (8) [back to overview]Postanesthesia Pain Score
NCT01737593 (8) [back to overview]Postanesthesia Pain Score
NCT01737593 (8) [back to overview]Postanesthesia Pain Score
NCT01737593 (8) [back to overview]Postanesthesia Pain Score
NCT01739361 (3) [back to overview]F2-isoprostanes After 72 Hours of Acetaminophen or Placebo
NCT01739361 (3) [back to overview]In-hospital Mortality
NCT01739361 (3) [back to overview]Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo
NCT01739699 (10) [back to overview]Opioid Requirement After Surgery
NCT01739699 (10) [back to overview]Time to Rescue Medication in Both Groups
NCT01739699 (10) [back to overview]# of Participants With Delirium Measured by a Positive CAM-ICU Every 8 Hours for 24 Hours in Both Groups-
NCT01739699 (10) [back to overview]Median Difference in ICU Length of Stay/Hospital Length of Stay Between Both Groups
NCT01739699 (10) [back to overview]Median Difference in Temperature Between Intervention and Placebo Groups
NCT01739699 (10) [back to overview]Number of Participants Who Had a Successful Neurologic Exams Between Intervention and Placebo Group as Determined by a Neurosurgical Provider by Answering Either Yes or No
NCT01739699 (10) [back to overview]Sedation Scores Measured by Richmand-Agitation-Sedation Scale (RASS) Every 8 Hours for 24 Hours in Both Groups
NCT01739699 (10) [back to overview]Median Satisfaction Scores on a Verbal Score From 1(Not Satisfied at All) to 100 (Very Satisfied)
NCT01739699 (10) [back to overview]Amount of Rescue Medication in PACU in Both Groups
NCT01739699 (10) [back to overview]Pain VAS Scores (1-100) Every 8 Hours for 24 Hours in Both Groups
NCT01755702 (9) [back to overview]Time to Rescue Medication
NCT01755702 (9) [back to overview]Number of Participants With Complete Headache Relief
NCT01755702 (9) [back to overview]Time to First Perceptible Headache Relief
NCT01755702 (9) [back to overview]Headache Severity
NCT01755702 (9) [back to overview]Headache Relief Scores
NCT01755702 (9) [back to overview]Total Pain Relief (TOTPAR)
NCT01755702 (9) [back to overview]Sum of TOTPAR and SPID (SPRID)
NCT01755702 (9) [back to overview]Sum of Pain Intensity Difference (SPID)
NCT01755702 (9) [back to overview]Patients Global Assessment in Response to Treatment
NCT01756209 (1) [back to overview]Pain-relief
NCT01782885 (9) [back to overview]Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
NCT01782885 (9) [back to overview]Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
NCT01782885 (9) [back to overview]Change in Visual Analog Scale (VAS)
NCT01782885 (9) [back to overview]Change in SF-12v2 Health Survey
NCT01782885 (9) [back to overview]Change in SF-12v2 Health Survey
NCT01782885 (9) [back to overview]Change in SF-12v2 Health Survey
NCT01782885 (9) [back to overview]Change in SF-12v2 Health Survey
NCT01782885 (9) [back to overview]Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
NCT01782885 (9) [back to overview]Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
NCT01783236 (5) [back to overview]VAS Pain Score 6 Hours Post-Operation
NCT01783236 (5) [back to overview]Total Number of PCA Requests in First 24 Hours Post-Operation
NCT01783236 (5) [back to overview]VAS Pain Score 2 Hours Post Operation
NCT01783236 (5) [back to overview]Total Morphine Consumption (mg)
NCT01783236 (5) [back to overview]VAS Score 24 Hours Post-Operation
NCT01798316 (7) [back to overview]Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
NCT01798316 (7) [back to overview]Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
NCT01798316 (7) [back to overview]Number of Participants With Postoperative Nausea and Vomiting (PONV).
NCT01798316 (7) [back to overview]Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
NCT01798316 (7) [back to overview]Narcotic Use During PACU Stay
NCT01798316 (7) [back to overview]Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
NCT01798316 (7) [back to overview]Patient Satisfaction on a 5 Point Likert Scale
NCT01814878 (8) [back to overview]Time to the First Rescue Medication Administered Because of Insufficient Pain Relief
NCT01814878 (8) [back to overview]Dosage of Rescue Medication Administered Because of Insufficient Pain Relief
NCT01814878 (8) [back to overview]Total Pain Relief (TOTPAR) Score
NCT01814878 (8) [back to overview]Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief
NCT01814878 (8) [back to overview]Patient Global Impression of Change (PGIC) Score
NCT01814878 (8) [back to overview]Sum of Pain Intensity Difference (SPID) at Hour 48
NCT01814878 (8) [back to overview]Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)
NCT01814878 (8) [back to overview]Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24
NCT01822665 (5) [back to overview]Duodenal Mucosal Damage (DMD) Scores
NCT01822665 (5) [back to overview]Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule
NCT01822665 (5) [back to overview]GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet
NCT01822665 (5) [back to overview]Incidence of Gastric and/or Duodenal Mucosal Injury
NCT01822665 (5) [back to overview]Incidence of Fecal Occult Blood
NCT01822821 (10) [back to overview]Total Bilirubin (mg/dL)
NCT01822821 (10) [back to overview]Cumulative Opioid Consumption
NCT01822821 (10) [back to overview]Duration of Mechanical Ventilation (Minutes)
NCT01822821 (10) [back to overview]Hospital Length of Stay
NCT01822821 (10) [back to overview]Intensive Care Unit (ICU) Length of Stay
NCT01822821 (10) [back to overview]Postoperative Nausea and Vomiting
NCT01822821 (10) [back to overview]Alanine Aminotransferase (ALT); U/L
NCT01822821 (10) [back to overview]Aspartate Aminotransferase (AST); U/L
NCT01822821 (10) [back to overview]Pain Intensity
NCT01822821 (10) [back to overview]Postoperative Sedation
NCT01823224 (2) [back to overview]Pain
NCT01823224 (2) [back to overview]Total Opioid Consumption From Time of First Waking to T24
NCT01827475 (2) [back to overview]Need for Rescue Pain Relief
NCT01827475 (2) [back to overview]Pain Severity
NCT01842633 (14) [back to overview]Rate of Rescue Medication
NCT01842633 (14) [back to overview]Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
NCT01842633 (14) [back to overview]Time to Perceptible Headache Relief
NCT01842633 (14) [back to overview]Time to the Use of Rescue Medication.
NCT01842633 (14) [back to overview]Change From Baseline in Headache Pain Intensity
NCT01842633 (14) [back to overview]Headache Relief
NCT01842633 (14) [back to overview]Number of Participants With Perceptible Pain Relief
NCT01842633 (14) [back to overview]Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours
NCT01842633 (14) [back to overview]Time to Meaningful Headache Relief
NCT01842633 (14) [back to overview]Total Pain Relief (TOTPAR)
NCT01842633 (14) [back to overview]Number of Pain Free Participants
NCT01842633 (14) [back to overview]Number of Participants With Meaningful Pain Relief
NCT01842633 (14) [back to overview]Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)
NCT01842633 (14) [back to overview]Global Evaluation of Response to Treatment
NCT01843660 (15) [back to overview]Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4
NCT01843660 (15) [back to overview]Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6
NCT01843660 (15) [back to overview]Number of Participants Who Required Additional Dosage Administration
NCT01843660 (15) [back to overview]Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5
NCT01843660 (15) [back to overview]Number of Participants With Overall Analgesic Satisfaction Score
NCT01843660 (15) [back to overview]Number of Participants With Analgesic Satisfaction Score
NCT01843660 (15) [back to overview]Number of Participants With Pain Relief Score at Hour 0.5
NCT01843660 (15) [back to overview]Number of Participants With Pain Relief Score at Hour 1
NCT01843660 (15) [back to overview]Number of Participants With Pain Relief Score at Hour 2
NCT01843660 (15) [back to overview]Number of Participants With Pain Relief Score at Hour 4
NCT01843660 (15) [back to overview]Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3
NCT01843660 (15) [back to overview]Number of Participants With Pain Relief Score at Hour 6
NCT01843660 (15) [back to overview]Number of Participants With Pain Relief Score at Hour 3
NCT01843660 (15) [back to overview]Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2
NCT01843660 (15) [back to overview]Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1
NCT01852955 (3) [back to overview]Postoperative Opioid Consumption
NCT01852955 (3) [back to overview]Quality of Recovery at 24 Hours(QoR-40 Instrument)
NCT01852955 (3) [back to overview]Postoperative Pain in the Post Anesthesia Care Unit
NCT01868425 (12) [back to overview]Sedation Scale
NCT01868425 (12) [back to overview]Intraoperative Medication Use: Ketorolac and Lidocaine
NCT01868425 (12) [back to overview]Intraoperative Medication Use: Fentanyl
NCT01868425 (12) [back to overview]Number of Participants With Complications From the Procedure
NCT01868425 (12) [back to overview]Post-Operative Incidence of Nausea
NCT01868425 (12) [back to overview]Opioid Consumption in the Immediate Postoperative Period
NCT01868425 (12) [back to overview]Incidence of Post-Operative Pruritus
NCT01868425 (12) [back to overview]Time to Discharge
NCT01868425 (12) [back to overview]Number of Participants Who Received Medication for Nausea
NCT01868425 (12) [back to overview]Pain Scores During Recovery
NCT01868425 (12) [back to overview]Post-Operative Nausea Scores
NCT01868425 (12) [back to overview]Post-Operative Pruritis Score
NCT01869699 (7) [back to overview]2-hour Change Over Time Core Temperature
NCT01869699 (7) [back to overview]2-hour Change Over Time Heart Rate
NCT01869699 (7) [back to overview]Respiratory Rate
NCT01869699 (7) [back to overview]Heart Rate
NCT01869699 (7) [back to overview]Core Body Temperature
NCT01869699 (7) [back to overview]Systolic Blood Pressure
NCT01869699 (7) [back to overview]2-hour Change Over Time Systolic Blood Pressure
NCT01943435 (3) [back to overview]Swiss Spinal Stenosis (SSS) Questionnaire Score
NCT01943435 (3) [back to overview]Sense Wear Armband
NCT01943435 (3) [back to overview]Self Paced Walking Test (SPWT)
NCT01948505 (1) [back to overview]Narcotic Requirement After Surgery
NCT01960114 (5) [back to overview]Time to Confirmed First Perceptible Pain Relief
NCT01960114 (5) [back to overview]Duration of Pain Relief
NCT01960114 (5) [back to overview]Time to Meaningful Pain Relief
NCT01960114 (5) [back to overview]Patient Global Evaluation
NCT01960114 (5) [back to overview]Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)
NCT01973205 (4) [back to overview]Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.
NCT01973205 (4) [back to overview]Number of Subjects Who Are Pain Free at the 2-hour Assessment
NCT01973205 (4) [back to overview]Number of Subjects Who Are Nausea Free at the 2-hour Assessment
NCT01973205 (4) [back to overview]Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.
NCT01983111 (6) [back to overview]Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration
NCT01983111 (6) [back to overview]Clinical Global Impression of Change(CGIC)
NCT01983111 (6) [back to overview]Patient Global Impressions of Change(PGIC)
NCT01983111 (6) [back to overview]Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.
NCT01983111 (6) [back to overview]Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose
NCT01983111 (6) [back to overview]Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)
NCT01985126 (7) [back to overview]Duration of Response
NCT01985126 (7) [back to overview]Overall Survival
NCT01985126 (7) [back to overview]Percentage of Participants With Overall Response
NCT01985126 (7) [back to overview]Time to Disease Progression
NCT01985126 (7) [back to overview]Percentage of Participants With Clinical Benefit
NCT01985126 (7) [back to overview]Progression Free Survival
NCT01985126 (7) [back to overview]Time to Response
NCT02025634 (3) [back to overview]Postoperative Opioid Consumption
NCT02025634 (3) [back to overview]"Total Time in Post Anesthesia Care Unit (PACU) (or Recovery Room)"
NCT02025634 (3) [back to overview]Postoperative Pain Levels
NCT02028715 (7) [back to overview]Opioid Rescue - 48 Hours
NCT02028715 (7) [back to overview]Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
NCT02028715 (7) [back to overview]Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
NCT02028715 (7) [back to overview]Return of Bowel Function
NCT02028715 (7) [back to overview]Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
NCT02028715 (7) [back to overview]Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
NCT02028715 (7) [back to overview]Length of Stay
NCT02029235 (2) [back to overview]Efficacy Comparison of Pain Intensity Level
NCT02029235 (2) [back to overview]Efficacy Comparison of Pain Relief
NCT02029638 (18) [back to overview]Duration in Days of Graft-versus-Host Disease in Transplanted Participants
NCT02029638 (18) [back to overview]Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology
NCT02029638 (18) [back to overview]Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery
NCT02029638 (18) [back to overview]Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy
NCT02029638 (18) [back to overview]Number of Days From Transplant to Platelet Count Recovery
NCT02029638 (18) [back to overview]Percent of Participants Who Achieved Operational Tolerance
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Engraftment Syndrome
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection
NCT02029638 (18) [back to overview]Number of Transplanted Participants With Acute Renal Allograft Rejection
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal
NCT02029638 (18) [back to overview]Number of Participants Free From Return to Immunosuppression for the Duration of the Study
NCT02029638 (18) [back to overview]Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant
NCT02029638 (18) [back to overview]Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment
NCT02029638 (18) [back to overview]Number of Transplanted Participants Who Died
NCT02043704 (13) [back to overview]Time to First Flatus/Bowel Movement
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Narcotic Associated Side Effects
NCT02043704 (13) [back to overview]Pain While Active - 18 hr
NCT02043704 (13) [back to overview]Time to Ambulation
NCT02043704 (13) [back to overview]Time to First Rescue Narcotic
NCT02046382 (4) [back to overview]Length of Stay
NCT02046382 (4) [back to overview]Number of Participants With Narcotic Associated Side Effects
NCT02046382 (4) [back to overview]Total Amount of Ibuprofen During Inpatient Stay
NCT02046382 (4) [back to overview]Total Oxycodone (mg)
NCT02061774 (4) [back to overview]Vital Signs
NCT02061774 (4) [back to overview]VAS
NCT02061774 (4) [back to overview]Total PCA Morphine
NCT02061774 (4) [back to overview]Level of 100% Sedation
NCT02069184 (6) [back to overview]Visual Analog Score (VAS) Pain Score
NCT02069184 (6) [back to overview]Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge
NCT02069184 (6) [back to overview]"Percentage of Patients With Adverse Events After the Surgery"
NCT02069184 (6) [back to overview]Opioid Requirements in Cesarean Section (C-section) Patient Population
NCT02069184 (6) [back to overview]Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section
NCT02069184 (6) [back to overview]Pain Medication Usage ( NSAIDS)
NCT02076321 (1) [back to overview]Compare the Time to Union of Fractures and Osteotomies in Skeletally Immature Patients Administered NSAIDs for Pain Control, Versus Those Administered Acetaminophen for Pain Control.
NCT02112448 (2) [back to overview]Total Morphine Dosage
NCT02112448 (2) [back to overview]Length of Stay
NCT02155738 (3) [back to overview]Cumulative Narcotic Consumption Over the First 24 Hours
NCT02155738 (3) [back to overview]Interference of Pain With Physical, Mental and Social Activities
NCT02155738 (3) [back to overview]Change From Baseline in Postoperative Pain
NCT02156154 (10) [back to overview]Incidence of Postoperative Nausea and Vomiting
NCT02156154 (10) [back to overview]Incidence of Low Respiratory Function Event
NCT02156154 (10) [back to overview]Duration of Hypoxemia
NCT02156154 (10) [back to overview]Time-weighted Pain Score During Initial 48 Postoperative Hours
NCT02156154 (10) [back to overview]Fatigue Score on Morning of Postoperative Day 1
NCT02156154 (10) [back to overview]Total Anesthetic Dose From Induction to Extubation
NCT02156154 (10) [back to overview]Time Weighted Pain Score in Post Anesthesia Care Unit
NCT02156154 (10) [back to overview]Time Spent in Sitting or Upright Position
NCT02156154 (10) [back to overview]Opioid Consumption - Intravenous Morphine Equivalents
NCT02156154 (10) [back to overview]Lowest RASS Score During Initial 48 Postoperative Hours
NCT02164929 (8) [back to overview]Pain Scores
NCT02164929 (8) [back to overview]Time to First Bowel Movement
NCT02164929 (8) [back to overview]Number of Epidural-related Side Effects
NCT02164929 (8) [back to overview]Quality of Recovery
NCT02164929 (8) [back to overview]Length of Stay
NCT02164929 (8) [back to overview]Opioid Related Side Effects
NCT02164929 (8) [back to overview]Time to First Ingestion of Solid Food
NCT02164929 (8) [back to overview]Postoperative Opioid Consumption
NCT02179892 (4) [back to overview]Mean Visual Analogue Scale (VAS) Pain Score at Rest
NCT02179892 (4) [back to overview]Mean Visual Analogue Scale (VAS) Pain Score With Movement
NCT02179892 (4) [back to overview]Mean Opioid Consumption
NCT02179892 (4) [back to overview]Mean Time of First Opioid Use
NCT02181387 (1) [back to overview]Neuraxial Analgesic Drug Consumption Per Hour
NCT02188719 (5) [back to overview]Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion
NCT02188719 (5) [back to overview]Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s)
NCT02188719 (5) [back to overview]Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia
NCT02188719 (5) [back to overview]Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection
NCT02188719 (5) [back to overview]Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s)
NCT02205983 (1) [back to overview]"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire"
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 3 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 24 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 2 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 16 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 15 Minutes Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 8 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 12 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 10 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 1.5 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 1 Hour Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 7 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 6 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 5 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 45 Minutes Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 4 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 30 Minutes Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose
NCT02209181 (39) [back to overview]Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
NCT02209181 (39) [back to overview]Duration of Pain Relief After Dosing (Time to Rescue Medication)
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 11 Hours Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose
NCT02209181 (39) [back to overview]Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose
NCT02209181 (39) [back to overview]Subject Global Evaluation
NCT02209181 (39) [back to overview]Pain Relief (PAR) Scores at 9 Hours Post Dose
NCT02227316 (6) [back to overview]Anti-Emetic Consumption
NCT02227316 (6) [back to overview]Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
NCT02227316 (6) [back to overview]Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen
NCT02227316 (6) [back to overview]Maximum Nausea Intensity
NCT02227316 (6) [back to overview]Opioid Consumption
NCT02227316 (6) [back to overview]Mean Nausea Intensity
NCT02236130 (2) [back to overview]Patient/Family Satisfaction With Pain Management
NCT02236130 (2) [back to overview]Total Hydrocodone Dose (mg/kg)
NCT02237989 (5) [back to overview]the Change From Baseline in 20 Meters Walking Time
NCT02237989 (5) [back to overview]the Change From Baseline in Coll2-1 Levels
NCT02237989 (5) [back to overview]the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)
NCT02237989 (5) [back to overview]the Change From Baseline in Short Form 36 / Bodily Pain Subgroup
NCT02237989 (5) [back to overview]the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
NCT02244619 (7) [back to overview]Hospital Length of Stay (LOS)
NCT02244619 (7) [back to overview]Time to First Rescue Opioid (PRN Order)
NCT02244619 (7) [back to overview]Time to First Ambulation - 10 Feet
NCT02244619 (7) [back to overview]Post-operative Nausea and Vomiting
NCT02244619 (7) [back to overview]Total Post-operative Use of Opioids
NCT02244619 (7) [back to overview]Post-Anesthesia Care Unit (PACU) Length of Stay, Hours
NCT02244619 (7) [back to overview]Patient-rated Pain in the Post-operative Period
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 24
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 48
NCT02260934 (15) [back to overview]Count of Participants: Frequency of Non-renal Flares by Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Event by Week 96
NCT02260934 (15) [back to overview]Frequency of Specific Adverse Events of Interest By Participant, By Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96
NCT02260934 (15) [back to overview]Percentage of Participants With a Sustained Complete Response
NCT02267772 (5) [back to overview]Number of Participants Who Received Rescue Medications
NCT02267772 (5) [back to overview]Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
NCT02267772 (5) [back to overview]Number of Participants With Fetal Heart Rate Changes
NCT02267772 (5) [back to overview]Number of Participants With Maternal Side Effects
NCT02267772 (5) [back to overview]Total Amount of Study Drug Administered
NCT02268058 (4) [back to overview]Number of Headache Days
NCT02268058 (4) [back to overview]Headache Intensity Per Day for One Week
NCT02268058 (4) [back to overview]Percentage of Study Participants That Returned to School at One Week Post Concussion
NCT02268058 (4) [back to overview]Number of Headaches a Day
NCT02280239 (5) [back to overview]Blood Pressure
NCT02280239 (5) [back to overview]Clinically Significant Hypotension
NCT02280239 (5) [back to overview]Fever Burden
NCT02280239 (5) [back to overview]Equivalent-volume Fluid Administered Post Intervention
NCT02280239 (5) [back to overview]Equivalent-dose of Vasoactive Medication Post Intervention
NCT02296840 (2) [back to overview]Faces Pain Score
NCT02296840 (2) [back to overview]Number of Participants With Post-operative Bleeding
NCT02305017 (4) [back to overview]Tmax - Time of Occurrence of Cmax
NCT02305017 (4) [back to overview]AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.
NCT02305017 (4) [back to overview]AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification
NCT02305017 (4) [back to overview]Cmax - Maximum Plasma Concentration
NCT02311881 (10) [back to overview]Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12
NCT02311881 (10) [back to overview]Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI)
NCT02311881 (10) [back to overview]Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment
NCT02311881 (10) [back to overview]Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment
NCT02311881 (10) [back to overview]Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment
NCT02311881 (10) [back to overview]Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment
NCT02311881 (10) [back to overview]Number of Participants Classified as Responder
NCT02311881 (10) [back to overview]Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks
NCT02311881 (10) [back to overview]Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA)
NCT02311881 (10) [back to overview]Patient Global Assessment of Response to Therapy (PGART)
NCT02313675 (2) [back to overview]Postoperative Pain (Pain Scores From 0-10 Scale)
NCT02313675 (2) [back to overview]Opioid Consumption (Number of Pills Taken)
NCT02357706 (9) [back to overview]Mixed Apnoea Index (MAI)
NCT02357706 (9) [back to overview]Mean Oxygen Desaturation Index (ODI)
NCT02357706 (9) [back to overview]Mean O2 Saturation
NCT02357706 (9) [back to overview]Mean Apnoea-Hypopnoea-Index (AHI)
NCT02357706 (9) [back to overview]Hypopnoea-Index HI
NCT02357706 (9) [back to overview]Central Apnoea Index (CAI)
NCT02357706 (9) [back to overview]Flow Limitation (%)
NCT02357706 (9) [back to overview]Respiratory Effort Related Arousals RERAs
NCT02357706 (9) [back to overview]Obstructive Apnoea Index (OAI)
NCT02359305 (3) [back to overview]PACU Time
NCT02359305 (3) [back to overview]Average FLACC Pain Score in the PACU
NCT02359305 (3) [back to overview]Acetaminophen Dosage
NCT02369211 (4) [back to overview]Opioid Use
NCT02369211 (4) [back to overview]Hospital Length of Stay
NCT02369211 (4) [back to overview]Post Anesthesia Care Unit Length of Stay
NCT02369211 (4) [back to overview]Pain Score
NCT02389361 (1) [back to overview]Acute Pain
NCT02400580 (6) [back to overview]Narcotic Medication Use
NCT02400580 (6) [back to overview]Nausea Before Surgery as Compared to After Surgery
NCT02400580 (6) [back to overview]Number of Participants Who Vomited Within 24 Hours of Operation
NCT02400580 (6) [back to overview]Readiness for Discharge
NCT02400580 (6) [back to overview]Postoperative Pain
NCT02400580 (6) [back to overview]Having a Feeling of General Well-being at One Month
NCT02401529 (10) [back to overview]Duration of Post-operative Nausea
NCT02401529 (10) [back to overview]Average Frequency of Meals Per Day
NCT02401529 (10) [back to overview]Average Amount of Meal Per Day
NCT02401529 (10) [back to overview]Occurence of Postoperative Vomiting
NCT02401529 (10) [back to overview]Onset of 1st Post-operative Oral Intake
NCT02401529 (10) [back to overview]Onset of Post-operative Nausea
NCT02401529 (10) [back to overview]Total Number of Post-operative Vomiting Episodes
NCT02401529 (10) [back to overview]Occurence of Post-operative Nausea
NCT02401529 (10) [back to overview]Maximum Severity of Post-operative Pain
NCT02401529 (10) [back to overview]Duration of Post-operative Pain
NCT02418182 (4) [back to overview]Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure
NCT02418182 (4) [back to overview]Median of Cumulative Pain Scores Up to 24 Hours Post Procedure
NCT02418182 (4) [back to overview]Number of Participants With Use of Analgesics in the First 24 Hours After Discharge
NCT02418182 (4) [back to overview]Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure
NCT02432456 (9) [back to overview]Oral Morphine Equivalent (Narcotic Usage)
NCT02432456 (9) [back to overview]Oral Morphine Equivalent (Narcotic Usage) in Severely Injured
NCT02432456 (9) [back to overview]Respiratory Failure
NCT02432456 (9) [back to overview]Visual Analog Numeric Pain Score
NCT02432456 (9) [back to overview]Visual Analog Numeric Pain Score
NCT02432456 (9) [back to overview]Regional Anesthesia Utilization
NCT02432456 (9) [back to overview]Length of Stay
NCT02432456 (9) [back to overview]Hallucination
NCT02432456 (9) [back to overview]Oral Morphine Equivalent (Narcotic Usage)
NCT02452320 (3) [back to overview]Length of Hospital Stay
NCT02452320 (3) [back to overview]Hospital Costs
NCT02452320 (3) [back to overview]Quality of Recovery-15 Patient Survey
NCT02455518 (2) [back to overview]Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
NCT02455518 (2) [back to overview]Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
NCT02474199 (8) [back to overview]Number of Participants Achieving Efficacy Status Post Receipt of a Single Intravenous (IV) Dose of Donor Alloantigen Reactive Regulatory T Cells (darTregs)
NCT02474199 (8) [back to overview]Number of Participants Who Experience at Least One Episode of Biopsy Proven Acute Rejection, Clinical Acute Rejection, or Chronic Rejection
NCT02474199 (8) [back to overview]Number of Participants Who Experienced Grade 3 or Higher Adverse Events (AEs) Deemed Attributable to darTreg Infusion
NCT02474199 (8) [back to overview]Count of Participants by Severity of Biopsy Proven Acute Rejection and/or Chronic Rejection
NCT02474199 (8) [back to overview]Proportion of Liver Transplant Recipients Who Are Able to Reduce Calcineurin Inhibitor Dosing by 75 Percent and Discontinue a Second Immunosuppression Drug (if Applicable) With Stable Liver Function Tests (LFTs) for ≥ 12 Weeks
NCT02474199 (8) [back to overview]Number of Participants With Study Defined Grade 3 or Higher Infections
NCT02474199 (8) [back to overview]Number of Participants With Any Malignancy
NCT02474199 (8) [back to overview]Number of Liver Transplant Recipients Who Experience the Composite Outcome
NCT02480114 (3) [back to overview]Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)
NCT02480114 (3) [back to overview]Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)
NCT02480114 (3) [back to overview]Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))
NCT02487108 (11) [back to overview]SPID Scores Over the Intervals During the First 36 Hours Following the First Dose of Study Drug
NCT02487108 (11) [back to overview]Total Rescue Medication Use (Number of Tablets Used)
NCT02487108 (11) [back to overview]Number of Participants With Adverse Events (AEs)
NCT02487108 (11) [back to overview]Summed Pain Intensity Difference (SPID) Score Calculated Over the First 48 Hours (SPID48) After the First Dose of Study Drug on an 11-Point Numerical Pain Rating Scale (NPRS-11)
NCT02487108 (11) [back to overview]Time to Onset of Meaningful Pain Relief (MPR)
NCT02487108 (11) [back to overview]Time to Onset of Perceptible Pain Relief (PPR)
NCT02487108 (11) [back to overview]Time to Peak PID
NCT02487108 (11) [back to overview]Number of Participants Taking Rescue Medication
NCT02487108 (11) [back to overview]Number of Participants With a 30% Reduction in Pain Intensity Measured Using NPRS-11 Scores
NCT02487108 (11) [back to overview]Number of Participants With a 50% Reduction in Pain Intensity Measured Using NPRS-11 Scores
NCT02487108 (11) [back to overview]Pain Intensity Difference (PID) Scores
NCT02487303 (4) [back to overview]Time Discharge
NCT02487303 (4) [back to overview]Time to First Opiate Rescue
NCT02487303 (4) [back to overview]VAS (Visual Analog Scale)
NCT02487303 (4) [back to overview]Cumulative Postoperative Opiate Consumption
NCT02495077 (44) [back to overview]The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.
NCT02495077 (44) [back to overview]Percent of Participants That Required at Least One Dialysis Treatment.
NCT02495077 (44) [back to overview]Percent of Participants With Only Graft Failure.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).
NCT02495077 (44) [back to overview]Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.
NCT02495077 (44) [back to overview]Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site
NCT02495077 (44) [back to overview]Percent of Participants With de Novo DSA.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR
NCT02495077 (44) [back to overview]Percent of Participants With Malignancy.
NCT02495077 (44) [back to overview]Percent of Participants With Mycobacterial or Fungal Infections
NCT02495077 (44) [back to overview]Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.
NCT02495077 (44) [back to overview]Percent of Participants With Death or Graft Failure.
NCT02495077 (44) [back to overview]The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.
NCT02495077 (44) [back to overview]The Percent of Participants Who Need Dialysis After Week 1.
NCT02495077 (44) [back to overview]Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)
NCT02495077 (44) [back to overview]Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.
NCT02495077 (44) [back to overview]Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.
NCT02495077 (44) [back to overview]The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.
NCT02495077 (44) [back to overview]Number of Dialysis Sessions.
NCT02495077 (44) [back to overview]eGFR Values as Measured by MDRD
NCT02495077 (44) [back to overview]eGFR Values as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.
NCT02495077 (44) [back to overview]Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)
NCT02495077 (44) [back to overview]Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.
NCT02495077 (44) [back to overview]Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery
NCT02495077 (44) [back to overview]Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Change in eGFR Between 6 Months and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]Change in eGFR Between 3 Months and 24 Months as Measured by MDRD
NCT02495077 (44) [back to overview]Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI
NCT02495077 (44) [back to overview]BANFF Grades of First AMR.
NCT02495077 (44) [back to overview]The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.
NCT02495077 (44) [back to overview]Change From Baseline (Immediately After Surgery) in Serum Creatinine.
NCT02495077 (44) [back to overview]eGFR Values as Measured by CKD-EPI
NCT02495077 (44) [back to overview]eGFR Values as Measured by MDRD
NCT02495077 (44) [back to overview]Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision
NCT02495077 (44) [back to overview]Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
NCT02495077 (44) [back to overview]Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.
NCT02498483 (5) [back to overview]Pulse Oximetry
NCT02498483 (5) [back to overview]Change in Salivary Cortisol Rise
NCT02498483 (5) [back to overview]Neonatal Infant Pain Scale (NIPS)
NCT02498483 (5) [back to overview]Heart Rate
NCT02498483 (5) [back to overview]Respiratory Rate
NCT02504775 (4) [back to overview]Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]
NCT02504775 (4) [back to overview]Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]
NCT02504775 (4) [back to overview]Maximum Plasma Concentration (Cmax)
NCT02504775 (4) [back to overview]Time to Reach Maximum Plasma Concentration (Tmax)
NCT02519023 (14) [back to overview]Number of Patients Admitted Post Operatively
NCT02519023 (14) [back to overview]Number of Participants With Nausea and Vomiting
NCT02519023 (14) [back to overview]Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
NCT02519023 (14) [back to overview]Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
NCT02519023 (14) [back to overview]Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
NCT02519023 (14) [back to overview]Length of Time in Phase 1 and Phase 2 of Recovery
NCT02519023 (14) [back to overview]Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
NCT02519023 (14) [back to overview]Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
NCT02519023 (14) [back to overview]Total Opioid Use for Pain Control
NCT02519023 (14) [back to overview]Quality of Recovery 15 (QoR15) Score
NCT02519023 (14) [back to overview]Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
NCT02519023 (14) [back to overview]Patient Satisfaction With Pain Management
NCT02519023 (14) [back to overview]Overall Benefit of Analgesia Score (OBAS)
NCT02519023 (14) [back to overview]Opioid Used From 24-48 Hours Post Surgery
NCT02521415 (2) [back to overview]Secondary Outcome: Total Dose of Opioid Pain Medication in Morphine Equivalents/kg/Hour
NCT02521415 (2) [back to overview]Exploratory Outcome: Reduction in Age Appropriate Pain Scale Scores
NCT02546765 (8) [back to overview]Duration of Delirium
NCT02546765 (8) [back to overview]ICU Length of Stay
NCT02546765 (8) [back to overview]Incidence of Delirium
NCT02546765 (8) [back to overview]Hospital Length of Stay
NCT02546765 (8) [back to overview]Montreal Cognitive Assessment (MoCA)
NCT02546765 (8) [back to overview]Postoperative Opioid Consumption in Morphine Equivalents
NCT02546765 (8) [back to overview]Severity of Delirium
NCT02546765 (8) [back to overview]Follow up Incidence of Cognitive Dysfunction
NCT02601027 (6) [back to overview]Post-operative Anti-emetic Usage
NCT02601027 (6) [back to overview]Quality of Life Measurement
NCT02601027 (6) [back to overview]Time to First Bowel Movement
NCT02601027 (6) [back to overview]Post-operative Narcotic Usage
NCT02601027 (6) [back to overview]Time to Ambulation
NCT02601027 (6) [back to overview]Post-operative Pain Score
NCT02605187 (12) [back to overview]Nausea Score Score at 24 and 48 After Delivery
NCT02605187 (12) [back to overview]Opioid Consumption in the 0-48 Hour Study Periods.
NCT02605187 (12) [back to overview]Pain Scores
NCT02605187 (12) [back to overview]Pruritus Score at 24 and 48 After Delivery
NCT02605187 (12) [back to overview]Patient Overall Satisfaction With Postoperative Analgesia
NCT02605187 (12) [back to overview]Counts of Participants With Presence of Nausea
NCT02605187 (12) [back to overview]Time to Discharge
NCT02605187 (12) [back to overview]Average Number of Vomiting Episodes After Delivery
NCT02605187 (12) [back to overview]Count of Participants Who Need Medical Treatment of Pruritus
NCT02605187 (12) [back to overview]Count of Participants Who Need Opioid Use
NCT02605187 (12) [back to overview]Count of Participants With Presence of Pruritus
NCT02605187 (12) [back to overview]Counts of Participants Who Need Medical Treatment for Nausea
NCT02613910 (11) [back to overview]Number of Participants With Vital Signs of Clinical Concern
NCT02613910 (11) [back to overview]Number of Participants Withdrawn Due to Treatment-related AEs
NCT02613910 (11) [back to overview]Number of Participants With Severe Adverse Events
NCT02613910 (11) [back to overview]Number of Participants With Post-injection Systemic Reactions
NCT02613910 (11) [back to overview]Number of Participants With Laboratory Results of Potential Clinical Concern
NCT02613910 (11) [back to overview]Number of Participants With Injection Site Reactions
NCT02613910 (11) [back to overview]Number of Participants With Infections
NCT02613910 (11) [back to overview]Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities
NCT02613910 (11) [back to overview]Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)
NCT02613910 (11) [back to overview]Number of Participants With Adverse Events Related to Ofatumumab SC
NCT02613910 (11) [back to overview]Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)
NCT02621619 (2) [back to overview]Change in Pain Intensity Over Time
NCT02621619 (2) [back to overview]Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused
NCT02643394 (2) [back to overview]Morphine Equivalents of Postoperative Opioid Usage
NCT02643394 (2) [back to overview]Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)
NCT02647788 (3) [back to overview]Quality of Recovery-9 (QoR-9).
NCT02647788 (3) [back to overview]Number of Pills Used
NCT02647788 (3) [back to overview]Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score
NCT02654860 (14) [back to overview]Phase 2: Vital Signs
NCT02654860 (14) [back to overview]Phase 1: Number of Participants With Adverse Events Related, Not Related and Serious Events Related to Paracetamol
NCT02654860 (14) [back to overview]Phase 2: SpO2
NCT02654860 (14) [back to overview]Phase 2: Time to Sensory Block
NCT02654860 (14) [back to overview]Phase 2: Time to Regression of Spinal Block
NCT02654860 (14) [back to overview]Phase 2: Time to Readiness for Surgery
NCT02654860 (14) [back to overview]Phase 2: Time to First Morphine Use
NCT02654860 (14) [back to overview]Phase 2: Number of Participants With Need for Supplemental Analgesia
NCT02654860 (14) [back to overview]Phase 2:Maximum Level of Sensory Block
NCT02654860 (14) [back to overview]Phase2: Concomitant Medications
NCT02654860 (14) [back to overview]Phase 2: Morphine-related Adverse Events
NCT02654860 (14) [back to overview]Phase 2: ECG
NCT02654860 (14) [back to overview]Phase 2: Pain Intensity
NCT02654860 (14) [back to overview]Phase 2: Morphine
NCT02659501 (5) [back to overview]The Effect of Liposomal Bupivacaine on Length of Hospital Stay
NCT02659501 (5) [back to overview]The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.
NCT02659501 (5) [back to overview]The Effect of Liposomal Bupivacaine on Antiemetic Consumption
NCT02659501 (5) [back to overview]The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption
NCT02659501 (5) [back to overview]The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption
NCT02678416 (2) [back to overview]Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
NCT02678416 (2) [back to overview]Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
NCT02689063 (14) [back to overview]Time to the Onset of Analgesia-Time to Onset of Analgesia (Measured as Time to Perceptible Pain Relief Confirmed by Meaningful Pain Relief) Using the Two-stopwatch Method
NCT02689063 (14) [back to overview]Time to the First Dose of Rescue Medication
NCT02689063 (14) [back to overview]Time to Peak Pain Relief
NCT02689063 (14) [back to overview]Percentage of Subjects Using Rescue Medication
NCT02689063 (14) [back to overview]Percentage of Participants With Complete Pain Relief
NCT02689063 (14) [back to overview]Percentage of Participants Who Obtained a Peak Pain Relief -Value of 3 ('A Lot of Relief') or 4 ('Complete Relief') Prior to the First Dose of Rescue
NCT02689063 (14) [back to overview]"VAS Pain Intensity Score-marking on a 100 mm VAS Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm). A High VAS Score Indicates a More Intensive Pain Level Experienced."
NCT02689063 (14) [back to overview]"VAS Pain Intensity Difference (PID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long VAS Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm)."
NCT02689063 (14) [back to overview]"The Percentage of Participants Who Evaluated Their Study Drug as Excellent on a 5-point Categorical Scale Global Evaluation of Study Drug"
NCT02689063 (14) [back to overview]"Summed Pain Intensity Difference (SPID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm)."
NCT02689063 (14) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT02689063 (14) [back to overview]TOTPAR-6, TOTPAR-12, TOTPAR-24, TOTPAR-48
NCT02689063 (14) [back to overview]Total Use of Rescue Medication
NCT02689063 (14) [back to overview]SPID-6, SPID-12, SPID-24-VAS SPID Over 0 to 6 Hours (SPID-6), Over 0 to 12 Hours (SPID-12), and Over 0 to 24 Hours (SPID-24) After Time 0 (=the First Dose)
NCT02691572 (1) [back to overview]Cumulative Fentanyl Dose
NCT02700451 (16) [back to overview]Veterans Rand - 12
NCT02700451 (16) [back to overview]Veterans Rand - 12
NCT02700451 (16) [back to overview]Veterans Rand - 12
NCT02700451 (16) [back to overview]Opioid Related Side Effects
NCT02700451 (16) [back to overview]Numerical Pain Rating Scale
NCT02700451 (16) [back to overview]Numerical Pain Rating Scale
NCT02700451 (16) [back to overview]Brief Pain Inventory
NCT02700451 (16) [back to overview]Oswestry Disability Index
NCT02700451 (16) [back to overview]Oswestry Disability Index
NCT02700451 (16) [back to overview]Oswestry Disability Index
NCT02700451 (16) [back to overview]Oswestry Disability Index
NCT02700451 (16) [back to overview]Perioperative Complications - Drain Output
NCT02700451 (16) [back to overview]Numerical Pain Rating Scale
NCT02700451 (16) [back to overview]Perioperative Opioid Use
NCT02700451 (16) [back to overview]Veterans Rand - 12
NCT02700451 (16) [back to overview]Length of Stay
NCT02703259 (6) [back to overview]Narcotic Use at 2 Weeks Postop
NCT02703259 (6) [back to overview]Narcotic Use at 24 Hours Postop
NCT02703259 (6) [back to overview]Subjective Pain at 2 Weeks Postop
NCT02703259 (6) [back to overview]Subjective Pain at 24 Hours Postoperative
NCT02703259 (6) [back to overview]Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
NCT02703259 (6) [back to overview]Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
NCT02761980 (6) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs)
NCT02761980 (6) [back to overview]Time to Rescue Medication
NCT02761980 (6) [back to overview]Time Weighted Sum of Temperature Difference From 6 to 8 Hours
NCT02761980 (6) [back to overview]Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6
NCT02761980 (6) [back to overview]Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours
NCT02761980 (6) [back to overview]Time to Return to Normal Body Temperature
NCT02777970 (6) [back to overview]% of Patients Achieving 50% of Max TOTPAR
NCT02777970 (6) [back to overview]% of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose
NCT02777970 (6) [back to overview]% of Patients Requiring RM (Rescue Medication)
NCT02777970 (6) [back to overview]PGE (Patient Global Evaluation)
NCT02777970 (6) [back to overview]TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)
NCT02777970 (6) [back to overview]Time to Confirmed FPPAR (First Perceptible Pain Relief)
NCT02797522 (2) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers
NCT02797522 (2) [back to overview]Number of Participants With TEAEs: CHB Participants
NCT02832687 (9) [back to overview]Number of Participants Requiring Additional Anti-emetics
NCT02832687 (9) [back to overview]The Level of C-reactive Protein
NCT02832687 (9) [back to overview]Readiness for Discharge
NCT02832687 (9) [back to overview]Plasma Stress Markers
NCT02832687 (9) [back to overview]Total Dosage of Post Operative Opioids
NCT02832687 (9) [back to overview]Time to Rescue Pain Medication
NCT02832687 (9) [back to overview]Post Operative Pain Scores
NCT02832687 (9) [back to overview]Patient Satisfaction Survey
NCT02832687 (9) [back to overview]Number of Participants With Post Operative Nausea and Vomiting
NCT02839876 (29) [back to overview]Subject Satisfaction at 48 Hours
NCT02839876 (29) [back to overview]Subject Satisfaction at 24 Hours
NCT02839876 (29) [back to overview]Straight Leg Raise
NCT02839876 (29) [back to overview]Self-paced Walk Test
NCT02839876 (29) [back to overview]Pharmacy-related Costs
NCT02839876 (29) [back to overview]Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
NCT02839876 (29) [back to overview]Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
NCT02839876 (29) [back to overview]Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)
NCT02839876 (29) [back to overview]Opioid Consumption (Other)
NCT02839876 (29) [back to overview]Number of Participants With Opioid-related Adverse Events
NCT02839876 (29) [back to overview]Number of Participants Able to Complete the Supine to Sit Test
NCT02839876 (29) [back to overview]Heel Slide Test
NCT02839876 (29) [back to overview]Costs Related to Opioid-related Adverse Events
NCT02839876 (29) [back to overview]Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events
NCT02839876 (29) [back to overview]Analgesic Consumption as Measured by Patient Diary
NCT02839876 (29) [back to overview]24 Hour Opioid Consumption
NCT02839876 (29) [back to overview]Overall Hospital Admission Costs
NCT02839876 (29) [back to overview]Hospital Length of Stay
NCT02839876 (29) [back to overview]Worst Pain (Day 30)
NCT02839876 (29) [back to overview]Subject Satisfaction at 48 Hours (48 Hours)
NCT02848729 (4) [back to overview]Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen
NCT02848729 (4) [back to overview]Maximum Concentration (Cmax) of Acetaminophen
NCT02848729 (4) [back to overview]Time to Maximum Concentration (Tmax) of Acetaminophen
NCT02848729 (4) [back to overview]Area Under the Plasma Concentration-time Curve Over 18 Hours (AUC18) for Acetaminophen After First Morphine Co-administration
NCT02881996 (2) [back to overview]Postoperative Duration of Hospital Stay
NCT02881996 (2) [back to overview]Time Until PCA Discontinued After the Operation
NCT02891174 (4) [back to overview]Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen
NCT02891174 (4) [back to overview]Mean Pain Score by Nursing Assessment
NCT02891174 (4) [back to overview]Change in Self-reported Pain Score 2 Hours After First Intervention
NCT02891174 (4) [back to overview]Difference in Systolic Blood Pressure (SBP)
NCT02902172 (2) [back to overview]Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
NCT02902172 (2) [back to overview]Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
NCT02910167 (5) [back to overview]Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima
NCT02910167 (5) [back to overview]Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N
NCT02910167 (5) [back to overview]Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment
NCT02910167 (5) [back to overview]Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.
NCT02910167 (5) [back to overview]Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients
NCT02911701 (14) [back to overview]Length of Hospitalization
NCT02911701 (14) [back to overview]Mean Arterial Pressure Over the Entire Postpartum Hospitalization
NCT02911701 (14) [back to overview]Mean Daily Pain Level, as Reported by Patient on Scale From 1-10, Stratified by Postpartum Day
NCT02911701 (14) [back to overview]Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg)
NCT02911701 (14) [back to overview]Need for Antihypertensives (Either Oral or Intravenous) for Acute Lowering of Blood Pressure
NCT02911701 (14) [back to overview]Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs
NCT02911701 (14) [back to overview]Proportion of Study Participants in Each Study Arm With Delayed Postpartum Hemorrhage
NCT02911701 (14) [back to overview]Proportion of Study Participants in Each Study Arm With New Onset Postpartum Acute Kidney Injury
NCT02911701 (14) [back to overview]Proportion of Study Participants in Each Study Arm With New Onset Postpartum Elevation of Liver Function Tests (AST, ALT) Above Twice the Normal Limit
NCT02911701 (14) [back to overview]Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge
NCT02911701 (14) [back to overview]The Proportion of Study Participants Requiring the Use of Intravenous Antihypertensives
NCT02911701 (14) [back to overview]Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day
NCT02911701 (14) [back to overview]Composite of Adverse Events
NCT02911701 (14) [back to overview]Duration of Severe-range Hypertension After Delivery
NCT02912650 (19) [back to overview]Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose
NCT02912650 (19) [back to overview]Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])
NCT02912650 (19) [back to overview]Cumulative Percentage of Participants With Confirmed First Perceptible Relief
NCT02912650 (19) [back to overview]Cumulative Percentage of Participants With Meaningful Relief
NCT02912650 (19) [back to overview]Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])
NCT02912650 (19) [back to overview]Participant's Global Evaluation of Study Medication
NCT02912650 (19) [back to overview]Cumulative Percentage of Participants With Treatment Failure
NCT02912650 (19) [back to overview]Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours
NCT02912650 (19) [back to overview]Pain Intensity Difference on 11-Point Numerical Scale (PID11)
NCT02912650 (19) [back to overview]Pain Intensity Difference on 4-Point Categorical Scale (PID4)
NCT02912650 (19) [back to overview]Pain Relief Rating (PRR) Score
NCT02912650 (19) [back to overview]Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)
NCT02912650 (19) [back to overview]Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose
NCT02912650 (19) [back to overview]Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose
NCT02912650 (19) [back to overview]Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose
NCT02912650 (19) [back to overview]Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose
NCT02912650 (19) [back to overview]Time to Treatment Failure
NCT02912650 (19) [back to overview]Time to Onset of Meaningful Pain Relief
NCT02912650 (19) [back to overview]Time to Confirmed Onset of First Perceptible Relief
NCT02922985 (10) [back to overview]NICU Admission
NCT02922985 (10) [back to overview]Need for Respiratory Support
NCT02922985 (10) [back to overview]Hospital Length of Stay
NCT02922985 (10) [back to overview]Apgar Score at 5 Minutes
NCT02922985 (10) [back to overview]Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)
NCT02922985 (10) [back to overview]Time to First Administration of Opioid Pain Medication Post Operatively
NCT02922985 (10) [back to overview]Pain Score at 6-12 Hours Post Operatively
NCT02922985 (10) [back to overview]Pain Score at 48 Hours Post-operatively
NCT02922985 (10) [back to overview]Pain Score at 24 Hours Post-operatively
NCT02922985 (10) [back to overview]Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.
NCT02932579 (2) [back to overview]Number of Participants That Did Not Need Opioid Analgesic Prescriptions
NCT02932579 (2) [back to overview]Mean Pain Score
NCT02934191 (2) [back to overview]Difference in Number of Days Requiring Rescue Pain Medication
NCT02934191 (2) [back to overview]Difference in Amount of Rescue Pain Medication Consumed
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)
NCT02974114 (12) [back to overview]Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)
NCT02994940 (4) [back to overview]Proportion of Patients With Severe Pain Score of 7 or Higher
NCT02994940 (4) [back to overview]Plasma Acetaminophen Level 1 - End of Surgery
NCT02994940 (4) [back to overview]Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration
NCT02994940 (4) [back to overview]Total Dose of Opioid
NCT02999633 (1) [back to overview]Percentage of Participants With Objective Response
NCT03020966 (3) [back to overview]Opioid Use
NCT03020966 (3) [back to overview]Opioid Side Effects
NCT03020966 (3) [back to overview]Pain With Physical Therapy on Post-operative Day 1
NCT03055507 (6) [back to overview]Pain Visual Analogue Scale
NCT03055507 (6) [back to overview]0-4 Bleeding Scale
NCT03055507 (6) [back to overview]Bleeding Visual Analogue Scale
NCT03055507 (6) [back to overview]Number of Opioid Pills
NCT03055507 (6) [back to overview]Pain Visual Analogue Scale (VAS)
NCT03055507 (6) [back to overview]Pain Visual Analogue Scale
NCT03062488 (3) [back to overview]Post Operative Fentanyl Consumption
NCT03062488 (3) [back to overview]Emergence Agitation (EA) as Measured by Standardized PAED Scale
NCT03062488 (3) [back to overview]Post Operative Pain
NCT03073980 (6) [back to overview]Oocyte Yield
NCT03073980 (6) [back to overview]Rescue Medication Required
NCT03073980 (6) [back to overview]Time to Discharge From the Post-operative Recovery Room
NCT03073980 (6) [back to overview]Post-operative Pain Score Difference 10 Mins From Pre-operative
NCT03073980 (6) [back to overview]Postoperative Nausea and Vomiting
NCT03073980 (6) [back to overview]Procedure Length
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion
NCT03080493 (6) [back to overview]Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion
NCT03084536 (5) [back to overview]Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
NCT03084536 (5) [back to overview]Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure
NCT03084536 (5) [back to overview]Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
NCT03084536 (5) [back to overview]Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure
NCT03084536 (5) [back to overview]Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year
NCT03088826 (1) [back to overview]Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)
NCT03104816 (1) [back to overview]Postoperative Opioid Use
NCT03105518 (2) [back to overview]Amount of Discomfort
NCT03105518 (2) [back to overview]Amount of Discomfort Following Discharge Until Embryo Transfer
NCT03131713 (7) [back to overview]Maximum Post-op Pain Score
NCT03131713 (7) [back to overview]Number of Participants Using Post-operative Analgesic
NCT03131713 (7) [back to overview]Anxiety
NCT03131713 (7) [back to overview]Thirst
NCT03131713 (7) [back to overview]Hunger
NCT03131713 (7) [back to overview]Maximum Pain Score
NCT03131713 (7) [back to overview]Fatigue
NCT03173456 (6) [back to overview]Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline
NCT03173456 (6) [back to overview]Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
NCT03173456 (6) [back to overview]Percentage of Patients Who Received Rescue Medication
NCT03173456 (6) [back to overview]Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain
NCT03173456 (6) [back to overview]Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication
NCT03173456 (6) [back to overview]Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication
NCT03198871 (13) [back to overview]Post-operative Emesis
NCT03198871 (13) [back to overview]Patient Satisfaction
NCT03198871 (13) [back to overview]Time to Oral Intake
NCT03198871 (13) [back to overview]Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)
NCT03198871 (13) [back to overview]Intensive Care Delirium Screening Checklist (ICDSC)
NCT03198871 (13) [back to overview]Time to Ambulation
NCT03198871 (13) [back to overview]Number of Participants With Readmission to the Hospital
NCT03198871 (13) [back to overview]Postoperative Pain Intensity
NCT03198871 (13) [back to overview]Time to Bowel Movement
NCT03198871 (13) [back to overview]Total Post-operative Narcotic Consumption
NCT03198871 (13) [back to overview]SF-12 Health Survey
NCT03198871 (13) [back to overview]Post-operative Nausea
NCT03198871 (13) [back to overview]Time to Hospital Discharge
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes
NCT03224403 (22) [back to overview]Time to Confirmed Perceptible Pain Relief
NCT03224403 (22) [back to overview]Time to Meaningful Pain Relief
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes
NCT03224403 (22) [back to overview]Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes
NCT03241030 (4) [back to overview]Number of Participants That Require Admission
NCT03241030 (4) [back to overview]Number of Participants With Unscheduled Visits
NCT03241030 (4) [back to overview]Oral Intake in ml/kg
NCT03241030 (4) [back to overview]Number of Participants That Require Intravenous Fluid Administration
NCT03258593 (11) [back to overview]Changes in the Immune Parameters Obtained From Blood Samples
NCT03258593 (11) [back to overview]Dose-Limiting Toxicity (DLT)
NCT03258593 (11) [back to overview]Number of Grades 1-5 Adverse Events
NCT03258593 (11) [back to overview]Disease Free Survival (DFS)
NCT03258593 (11) [back to overview]Maximum Tolerated Dose (MTD) of Durvalumab
NCT03258593 (11) [back to overview]Maximum Tolerated Dose (MTD) of Vicineum
NCT03258593 (11) [back to overview]Response Rate
NCT03258593 (11) [back to overview]Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
NCT03258593 (11) [back to overview]Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD)
NCT03258593 (11) [back to overview]Change in Programmed Death-ligand 1 (PD-L1) Levels Between Responders and Non-Responders
NCT03258593 (11) [back to overview]Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum
NCT03372382 (1) [back to overview]Pain Level
NCT03404518 (3) [back to overview]Ibuprofen Usage
NCT03404518 (3) [back to overview]Patient Pain Level
NCT03404518 (3) [back to overview]Narcotic Usage
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration
NCT03415243 (29) [back to overview]Small Intestine Transit Time
NCT03415243 (29) [back to overview]Total Area Under the Gastric Emptying Curve
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes
NCT03415243 (29) [back to overview]Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes
NCT03415243 (29) [back to overview]Gastric Emptying Half-Life
NCT03415243 (29) [back to overview]Mean Time for Gastric Emptying by Measuring 25 Percent Values
NCT03415243 (29) [back to overview]Mean Time for Gastric Emptying by Measuring 50 Percent Values
NCT03415243 (29) [back to overview]Mean Time for Gastric Emptying by Measuring 90 Percent Values
NCT03415243 (29) [back to overview]Mean Time to Complete Gastric Emptying
NCT03415243 (29) [back to overview]Mean Time to Onset of Gastric Emptying
NCT03415243 (29) [back to overview]Number of Participants With Clinically Significant Change in Laboratory Test Values
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration
NCT03415243 (29) [back to overview]Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration
NCT03428230 (21) [back to overview]Time to Ambulation
NCT03428230 (21) [back to overview]Time to Eligibility for Discharge
NCT03428230 (21) [back to overview]Time to First Urine
NCT03428230 (21) [back to overview]Time to Sensory Block
NCT03428230 (21) [back to overview]Time to Regression of Spinal Block
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia
NCT03428230 (21) [back to overview]Pain Intensity at Rest Evaluated Using a 0-100 mm VAS
NCT03428230 (21) [back to overview]Pain at Rest AUCt1-t2
NCT03428230 (21) [back to overview]Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)
NCT03428230 (21) [back to overview]Total Number of Partecipants Receiving Analgesic 2
NCT03428230 (21) [back to overview]Total Number of Partecipants Receiving Analgesic 1
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Rescue Anaesthesia
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge
NCT03428230 (21) [back to overview]Partecipants Received Level 2 Analgesia
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End
NCT03428230 (21) [back to overview]Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge
NCT03428230 (21) [back to overview]Partecipants to Received Level 1 Analgesia
NCT03428230 (21) [back to overview]Pain at Rest AUClast
NCT03428230 (21) [back to overview]Number of Participants With Neurological Complications Including TNS
NCT03435692 (6) [back to overview]Nausea
NCT03435692 (6) [back to overview]Maximum Pain Score
NCT03435692 (6) [back to overview]Hospital Length of Stay
NCT03435692 (6) [back to overview]Itching
NCT03435692 (6) [back to overview]Muscle Spasm
NCT03435692 (6) [back to overview]Total Perioperative Morphine Equivalents
NCT03445390 (3) [back to overview]Post-operative Opioid Consumption
NCT03445390 (3) [back to overview]Count of Participants Requiring Anti-emetic Administration
NCT03445390 (3) [back to overview]Post-operative Pain
NCT03447353 (2) [back to overview]Lane Departures
NCT03447353 (2) [back to overview]SDLP
NCT03448536 (10) [back to overview]TOTPAR 6-12 Hours
NCT03448536 (10) [back to overview]TOTPAR Over 0-6 Hours
NCT03448536 (10) [back to overview]Number of Participants by Global Evaluation Scores
NCT03448536 (10) [back to overview]SPID Over 0-6 Hours
NCT03448536 (10) [back to overview]Pain Intensity Difference (PID) Scores at Each Evaluation
NCT03448536 (10) [back to overview]Pain Relief Scores at Each Evaluation
NCT03448536 (10) [back to overview]Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours
NCT03448536 (10) [back to overview]Summed Pain Intensity Difference (SPID) Over 0-12 Hours
NCT03448536 (10) [back to overview]Time to First Intake of Rescue Medication
NCT03448536 (10) [back to overview]SPID Over 6-12 Hours
NCT03468920 (5) [back to overview]Patient Reported Pain
NCT03468920 (5) [back to overview]Number of Participants Who Experienced Postoperative Nausea and Vomiting
NCT03468920 (5) [back to overview]Length of Stay
NCT03468920 (5) [back to overview]Patient Satisfaction
NCT03468920 (5) [back to overview]Number of Participants Who Received Opioid Administration in PACU
NCT03472469 (10) [back to overview]Number of Intensive Care Unti (ICU) Days
NCT03472469 (10) [back to overview]Number of Participants Discharged From the Hospital With an Opioid Prescription
NCT03472469 (10) [back to overview]Number of Hospital Days
NCT03472469 (10) [back to overview]Number of Participants With Any Opioid-related Complications
NCT03472469 (10) [back to overview]Pharmacy Costs
NCT03472469 (10) [back to overview]Pain as Assessed by Score on the Numeric Rating Scale (NRS)
NCT03472469 (10) [back to overview]Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
NCT03472469 (10) [back to overview]Number of Ventilator Days
NCT03472469 (10) [back to overview]Opioid Use Per Day
NCT03472469 (10) [back to overview]Overall Costs
NCT03496545 (4) [back to overview]Total Time That Temperature is ≥ 38.3ºC
NCT03496545 (4) [back to overview]Total Time to First Temperature < 37.5ºC
NCT03496545 (4) [back to overview]Temperature Burden
NCT03496545 (4) [back to overview]Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache
NCT03510910 (5) [back to overview]Score on Visual Analog Scale (VAS) of Pain
NCT03510910 (5) [back to overview]Patient Satisfaction
NCT03510910 (5) [back to overview]Morphine-equivalent Consumption
NCT03510910 (5) [back to overview]Score on Visual Analog Scale (VAS) of Pain
NCT03510910 (5) [back to overview]Score on Visual Analog Scale (VAS) of Pain
NCT03521102 (3) [back to overview]Improvement in NPS Pain Score by >=50%
NCT03521102 (3) [back to overview]Need for Rescue Medication
NCT03521102 (3) [back to overview]Clinical Improvement in NRS Pain Score
NCT03523988 (3) [back to overview]Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
NCT03523988 (3) [back to overview]Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment
NCT03523988 (3) [back to overview]Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment
NCT03540030 (16) [back to overview]Simple Shoulder Test
NCT03540030 (16) [back to overview]Nausea
NCT03540030 (16) [back to overview]Simple Shoulder Test
NCT03540030 (16) [back to overview]Post Op Pain
NCT03540030 (16) [back to overview]Additional Post Op Pain
NCT03540030 (16) [back to overview]Falls
NCT03540030 (16) [back to overview]Morphine Use
NCT03540030 (16) [back to overview]ASES
NCT03540030 (16) [back to overview]Constipation
NCT03540030 (16) [back to overview]Constipation
NCT03540030 (16) [back to overview]Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
NCT03540030 (16) [back to overview]Pain Satisfaction
NCT03540030 (16) [back to overview]Pain Satisfaction
NCT03540030 (16) [back to overview]Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
NCT03540030 (16) [back to overview]Nausea
NCT03540030 (16) [back to overview]Falls
NCT03541980 (5) [back to overview]Inpatient Admission
NCT03541980 (5) [back to overview]Pain Scores
NCT03541980 (5) [back to overview]Adverse Effects
NCT03541980 (5) [back to overview]Cumulative Opioid Dosing
NCT03541980 (5) [back to overview]Percentage of the Patients Reporting Satisfaction
NCT03553498 (4) [back to overview]Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication
NCT03553498 (4) [back to overview]Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications
NCT03553498 (4) [back to overview]Percentage of Patients Who Want Additional Analgesics
NCT03553498 (4) [back to overview]Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment
NCT03554005 (3) [back to overview]Best Objective Response
NCT03554005 (3) [back to overview]Number of Participants Who Experienced an Adverse Event
NCT03554005 (3) [back to overview]Number of Participants Who Discontinued Treatment Due to an Adverse Event
NCT03554018 (3) [back to overview]Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
NCT03554018 (3) [back to overview]Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.
NCT03554018 (3) [back to overview]Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale
NCT03558555 (6) [back to overview]Patient Satisfaction.
NCT03558555 (6) [back to overview]Patient Reported Total Narcotic Use Post-discharge
NCT03558555 (6) [back to overview]PACU Length of Stay
NCT03558555 (6) [back to overview]Total MME Intraoperatively
NCT03558555 (6) [back to overview]PACU Visual Analogue Pain Scores
NCT03558555 (6) [back to overview]Total Narcotic Use in PACU.
NCT03570554 (3) [back to overview]Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4
NCT03570554 (3) [back to overview]Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period
NCT03570554 (3) [back to overview]Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point
NCT03584373 (7) [back to overview]Current Pain Intensity Level
NCT03584373 (7) [back to overview]Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery
NCT03584373 (7) [back to overview]Satisfaction With Pain Relief
NCT03584373 (7) [back to overview]Average Pain Intensity Level
NCT03584373 (7) [back to overview]Perception of an Acceptable Pain Intensity Level
NCT03584373 (7) [back to overview]Rates of Constipation
NCT03584373 (7) [back to overview]Peak Pain Intensity Level
NCT03588910 (5) [back to overview]Additional Contacts With Provider
NCT03588910 (5) [back to overview]Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery
NCT03588910 (5) [back to overview]Number of Oxycodone Tablets Used Day 1
NCT03588910 (5) [back to overview]Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)
NCT03588910 (5) [back to overview]Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)
NCT03599089 (3) [back to overview]Total Opioid Consumption (in Daily Morphine Equivalents)
NCT03599089 (3) [back to overview]Percentage of Subjects Opioid Free
NCT03599089 (3) [back to overview]Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)
NCT03605914 (5) [back to overview]Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
NCT03605914 (5) [back to overview]Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
NCT03605914 (5) [back to overview]Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
NCT03605914 (5) [back to overview]Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)
NCT03605914 (5) [back to overview]Number of Participants With Bleeding Complications
NCT03618823 (9) [back to overview]Average Pain Burden
NCT03618823 (9) [back to overview]Mean of Total Quantity of Pain Medications Taken
NCT03618823 (9) [back to overview]Average Dose of Each Analgesic Used
NCT03618823 (9) [back to overview]Overall Pain Relief Satisfaction
NCT03618823 (9) [back to overview]Number of Participants With Readmissions
NCT03618823 (9) [back to overview]Number of Participants With ED (Emergency Department) or Urgent Care Visits
NCT03618823 (9) [back to overview]Post-operative Nursing Phone Calls
NCT03618823 (9) [back to overview]Non-opioid Group Switching to Opioid Group
NCT03618823 (9) [back to overview]Duration of Each Analgesic Used
NCT03631433 (2) [back to overview]Number of Participants
NCT03631433 (2) [back to overview]Heft Parker Visual Analog Scale Pain Scale Pain Measurements
NCT03652818 (5) [back to overview]Sum Pain Intensity Difference Scores
NCT03652818 (5) [back to overview]Total Pain Relief Measure
NCT03652818 (5) [back to overview]Number of Participants With Differing Patient Global Evaluation Scores
NCT03652818 (5) [back to overview]Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2
NCT03652818 (5) [back to overview]Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2
NCT03657810 (9) [back to overview]Percentage of Patients With Any Nausea Over 48 Hours
NCT03657810 (9) [back to overview]Number of Doses of Study Medication Taken Over Days 3to7
NCT03657810 (9) [back to overview]Percentage of Participants With OINV Over 48 Hours
NCT03657810 (9) [back to overview]Percentage of Patients With Any Nausea or Vomiting Over 48 Hours
NCT03657810 (9) [back to overview]Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)
NCT03657810 (9) [back to overview]Number of Doses of Study Medication Taken Per Day Over Days 3to7
NCT03657810 (9) [back to overview]The Sum of Pain Intensity Differences (on PI-NRS) Over 48 Hours (SPID48)
NCT03657810 (9) [back to overview]Percentage of Patients With Complete Absence of OINV (no Nausea, no Vomiting, and no Use of Anti-emetic Medication) Over 48 Hours
NCT03657810 (9) [back to overview]Percentage of Patients With Any Vomiting Over 48 Hours
NCT03679013 (3) [back to overview]The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).
NCT03679013 (3) [back to overview]Average Pain Score at 24, 48 and 72 Hours Post-operatively
NCT03679013 (3) [back to overview]Number of Participants With Ileus During Hospitalization
NCT03695367 (5) [back to overview]Percentge of Subjects Receiving no Opioid Rescue
NCT03695367 (5) [back to overview]Percentage of Subjects Receiving no Opioid Rescue
NCT03695367 (5) [back to overview]Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.
NCT03695367 (5) [back to overview]Percentge of Subjects Receiving no Opioid Rescue
NCT03695367 (5) [back to overview]Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])
NCT03701074 (1) [back to overview]Ductus Arteriosus Closure/Constriction Rate
NCT03714919 (5) [back to overview]Average Pain Score
NCT03714919 (5) [back to overview]Extubation Time
NCT03714919 (5) [back to overview]Time in PACU
NCT03714919 (5) [back to overview]Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations
NCT03714919 (5) [back to overview]End of Surgery to Hospital Discharge
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Medication Log
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Pain Severity
NCT03789318 (5) [back to overview]Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)
NCT03789318 (5) [back to overview]Time to Opioid Cessation or Freedom
NCT03789318 (5) [back to overview]Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores
NCT03789318 (5) [back to overview]Total Opioid Consumption
NCT03789318 (5) [back to overview]Percent of Opioid Free Subjects
NCT03805932 (6) [back to overview]Number of Participants Who Are Minimal Residual Disease (MRD)-Free
NCT03805932 (6) [back to overview]Recommended Safe Dose of Rituximab/Ruxience
NCT03805932 (6) [back to overview]Recommended Safe Dose of Moxetumomab Pasudotox-tdfk
NCT03805932 (6) [back to overview]Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
NCT03805932 (6) [back to overview]Number of Participants With a Dose-limiting Toxicity (DLT)
NCT03805932 (6) [back to overview]Number of Participants Whose Cancer Shrinks or Disappears After Treatment
NCT03824938 (2) [back to overview]Time-to-exhaustion
NCT03824938 (2) [back to overview]Exercise-induced Body Temperature Change
NCT03879408 (9) [back to overview]Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)
NCT03879408 (9) [back to overview]Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)
NCT03879408 (9) [back to overview]Pain Relief (PAR) Scores at Individual Timepoints
NCT03879408 (9) [back to overview]Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation
NCT03879408 (9) [back to overview]Pain Intensity Difference (PID) Scores at Individual Time Points
NCT03879408 (9) [back to overview]Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)
NCT03879408 (9) [back to overview]Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
NCT03879408 (9) [back to overview]Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)
NCT03879408 (9) [back to overview]Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
NCT03885596 (5) [back to overview]Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)
NCT03885596 (5) [back to overview]Opioid Consumption
NCT03885596 (5) [back to overview]Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h
NCT03885596 (5) [back to overview]Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)
NCT03885596 (5) [back to overview]Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)
NCT03951649 (13) [back to overview]Duration of Headache Free Period at 7 Days
NCT03951649 (13) [back to overview]Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days
NCT03951649 (13) [back to overview]Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days
NCT03951649 (13) [back to overview]Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)
NCT03951649 (13) [back to overview]Number of Participants With Need for Crossover Treatment
NCT03951649 (13) [back to overview]Number of Participants With Need for Representation for Treatment of Headache With 28 Days
NCT03951649 (13) [back to overview]Number of Participants With Need for Second Line Treatment
NCT03951649 (13) [back to overview]Number of Participants With Response to Occipital Nerve Block in Pregnancy
NCT03951649 (13) [back to overview]Response to Cross Over Treatment at 60 Min
NCT03951649 (13) [back to overview]Response to Second Line Treatment at 60 Min
NCT03951649 (13) [back to overview]Response to Treatment Within 2 Hours
NCT03951649 (13) [back to overview]Number of Participants With Need for Admission for Treatment of Headache
NCT03951649 (13) [back to overview]Number of Participants With Need for Neurology Consult
NCT03974932 (19) [back to overview]1) Pain Control Based on Patient Global Assessment (PGA)."-NCT03974932">"Percentage of Subjects Achieving a Score of Good or Better (>1) Pain Control Based on Patient Global Assessment (PGA)."
NCT03974932 (19) [back to overview]Maximum Concentration (Cmax)
NCT03974932 (19) [back to overview]Mean Overall Benefit of Analgesia Score (OBAS).
NCT03974932 (19) [back to overview]Mean Total TSQM-9 Score
NCT03974932 (19) [back to overview]Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
NCT03974932 (19) [back to overview]Percentage of Subjects With Severe Pain.
NCT03974932 (19) [back to overview]Time of Occurrence of Maximum Concentration (Tmax)
NCT03974932 (19) [back to overview]Median Time to First Opioid Rescue Medication.
NCT03974932 (19) [back to overview]Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).
NCT03974932 (19) [back to overview]Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).
NCT03974932 (19) [back to overview]Mean AUC of VAS Scores.
NCT03974932 (19) [back to overview]Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).
NCT03974932 (19) [back to overview]Median Time to First Ambulation Postsurgery.
NCT03974932 (19) [back to overview]Percentage of Subjects Unable to Participate in Each Rehabilitation Session Because of Pain.
NCT03974932 (19) [back to overview]Percentage of Subjects Who Are Discharged Home vs to a Skilled Nursing Facility.
NCT03974932 (19) [back to overview]Percentage of Subjects Who Are Opioid-free
NCT03974932 (19) [back to overview]Percentage of Subjects Who Are Opioid-free Through 72 Hours Who Remain Opioid-free Through Day 11.
NCT03974932 (19) [back to overview]Percentage of Subjects Who do Not Receive an Opioid Prescription at Discharge.
NCT03974932 (19) [back to overview]Percentage of Subjects Who do Not Receive an Opioid Prescription Between Discharge and the Day 11 Visit.
NCT03994731 (6) [back to overview]Mean Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52
NCT03994731 (6) [back to overview]Percentage of Participants With Complete Resolution of ≥ 1 Tophi at Week 52
NCT03994731 (6) [back to overview]Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6
NCT03994731 (6) [back to overview]Percentage of sUA (sUA < 6 mg/dL) Responders During Month 12
NCT03994731 (6) [back to overview]Mean Change From Baseline HAQ Pain Score at Week 52
NCT03994731 (6) [back to overview]Mean Change From Baseline in HAQ Health Score at Week 52
NCT03997851 (3) [back to overview]Thermal Threshold Detection (Heat Pain)
NCT03997851 (3) [back to overview]Peak Itch Intensity Between the Vehicle and Active Treatments During Histaminergic Itch Induction
NCT03997851 (3) [back to overview]Peak Itch Intensity Between the Vehicle and Active Treatments During Non-histaminergic Itch Induction
NCT04018612 (18) [back to overview]Mean Change From Baseline to 24 Hours in Vital Signs (Diastolic Blood Pressure)
NCT04018612 (18) [back to overview]Half-life
NCT04018612 (18) [back to overview]Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
NCT04018612 (18) [back to overview]Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours After Dosing (AUC 0-24h)
NCT04018612 (18) [back to overview]Mean Change From Baseline to 24 Hours in Vital Signs (Respiratory Rate)
NCT04018612 (18) [back to overview]Time to Treatment Failure
NCT04018612 (18) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT04018612 (18) [back to overview]Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups
NCT04018612 (18) [back to overview]Time to Meaningful Perceptible Relief (MPR) Measure Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups
NCT04018612 (18) [back to overview]Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
NCT04018612 (18) [back to overview]Pain Intensity Rating at Different Timepoints After Dose 1 Administration
NCT04018612 (18) [back to overview]Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
NCT04018612 (18) [back to overview]Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale.
NCT04018612 (18) [back to overview]Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale
NCT04018612 (18) [back to overview]Patient Global Evaluation of the Study Medication
NCT04018612 (18) [back to overview]Mean Change From Baseline to 24 Hours in Vital Signs (Temperature)
NCT04018612 (18) [back to overview]Mean Change From Baseline to 24 Hours in Vital Signs (Systolic Blood Pressure)
NCT04018612 (18) [back to overview]Mean Change From Baseline to 24 Hours in Vital Signs (Pulse Rate)
NCT04066426 (4) [back to overview]Pain Evaluation
NCT04066426 (4) [back to overview]Pain Evaluation
NCT04066426 (4) [back to overview]Pain Evaluation
NCT04066426 (4) [back to overview]Pain Evaluation
NCT04149964 (8) [back to overview]Chronic Use of Pain Medication
NCT04149964 (8) [back to overview]Highest Subjective Pain Score
NCT04149964 (8) [back to overview]Lowest Subjective Pain Score
NCT04149964 (8) [back to overview]Participant Use of Acetaminophen as Needed
NCT04149964 (8) [back to overview]Participant Use of Additional Pain Medication
NCT04149964 (8) [back to overview]Participant Use of Scheduled Acetaminophen Around the Clock
NCT04149964 (8) [back to overview]Percentage of Time Participant Experienced Severe Pain
NCT04149964 (8) [back to overview]Number of Doses of Opiate (Narcotic) Pain Medication
NCT04175509 (8) [back to overview]Opioid Use
NCT04175509 (8) [back to overview]Operative Time
NCT04175509 (8) [back to overview]Estimated Blood Loss
NCT04175509 (8) [back to overview]Opioid Use
NCT04175509 (8) [back to overview]Opioid Use
NCT04175509 (8) [back to overview]Postoperative Pain: Standardized Pain Scale
NCT04175509 (8) [back to overview]Postoperative Pain: Standardized Pain Scale
NCT04175509 (8) [back to overview]Postoperative Pain: Standardized Pain Scale
NCT04194528 (1) [back to overview]Feasibility Determined by Accrual, Adherence and Patient Retention.
NCT04246541 (2) [back to overview]Pain Levels Recorded With a Visual Analogue Scale
NCT04246541 (2) [back to overview]Narcotic Medication Consumed
NCT04246554 (2) [back to overview]Narcotic Medication
NCT04246554 (2) [back to overview]Postoperative Visual Analogue Scale Scores
NCT04294459 (23) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
NCT04294459 (23) [back to overview]Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab
NCT04294459 (23) [back to overview]Duration for Achieving Target cPRA
NCT04294459 (23) [back to overview]Duration of Response (DOR)
NCT04294459 (23) [back to overview]Number of Kidney Transplant Offers
NCT04294459 (23) [back to overview]Number of Participants Achieving Target cPRA
NCT04294459 (23) [back to overview]Number of Participants With Graft Survival at 6 Months Post-Transplant
NCT04294459 (23) [back to overview]Percentage of Participants With Response
NCT04294459 (23) [back to overview]Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab
NCT04294459 (23) [back to overview]PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab
NCT04294459 (23) [back to overview]Time to First Transplant Offer
NCT04294459 (23) [back to overview]Time to Transplant
NCT04294459 (23) [back to overview]Number of Participants With Abnormal Electrolytes Parameters
NCT04294459 (23) [back to overview]Number of Participants With Abnormal Metabolism Parameters
NCT04294459 (23) [back to overview]Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction
NCT04294459 (23) [back to overview]Number of Participants With Hematological Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Liver Function Abnormalities
NCT04294459 (23) [back to overview]Number of Participants With Renal Function Abnormalities
NCT04307940 (9) [back to overview]Amount of Rescue Medication
NCT04307940 (9) [back to overview]Sum of Pain Intensity Difference Over 6 Hours (SPID 0-6)
NCT04307940 (9) [back to overview]Number of Participants Required or Did Not Reqiure Rescue Pain Medication
NCT04307940 (9) [back to overview]Total Pain Relief Over 6 Hours (TOTPAR 0-6)
NCT04307940 (9) [back to overview]Total Pain Relief Over 12 Hours (TOTPAR 0-12)
NCT04307940 (9) [back to overview]Time to First Use of Rescue Medication
NCT04307940 (9) [back to overview]Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12)
NCT04307940 (9) [back to overview]Duration of Pain at Least Half Gone Over 6 Hours
NCT04307940 (9) [back to overview]Duration of Pain at Least Half Gone Over 12 Hours
NCT04378114 (3) [back to overview]Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
NCT04378114 (3) [back to overview]Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
NCT04378114 (3) [back to overview]Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
NCT04399122 (2) [back to overview]Post-operative Uncorrected Visual Acuity Right and Left Eye
NCT04399122 (2) [back to overview]Post-operative Average Pain Score
NCT04429022 (8) [back to overview]Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required Through 3-24h Post op in MME
NCT04429022 (8) [back to overview]Estimated Blood Loss
NCT04429022 (8) [back to overview]Length of Stay in Hours
NCT04429022 (8) [back to overview]Operative Time
NCT04429022 (8) [back to overview]Pain Scores
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
NCT04429022 (8) [back to overview]Pain Scores
NCT04495283 (13) [back to overview]Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale From Hour 0 to Hour 12 (SPI0-12), Hour 12 to Hour 24 (SPI12-24), and Hour 24 to Hour 48 (SPI24-48).
NCT04495283 (13) [back to overview]Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time
NCT04495283 (13) [back to overview]Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours
NCT04495283 (13) [back to overview]Percentage of Participants Who Were Opioid Free Over Time
NCT04495283 (13) [back to overview]Maximum Observed Concentration for PGB and APAP
NCT04495283 (13) [back to overview]Total Consumption of Rescue Medication
NCT04495283 (13) [back to overview]Time to First Use of Rescue Medication From Hour 0
NCT04495283 (13) [back to overview]Summed Pain Intensity (SPI) Compared Between Group A and Group B
NCT04495283 (13) [back to overview]Summed Pain Intensity (SPI) Between Group A and Group C
NCT04495283 (13) [back to overview]Percentage of Participants Who Used Rescue Medication
NCT04495283 (13) [back to overview]Number of Participants With Treatment-Related Adverse Events (TRAE)
NCT04495283 (13) [back to overview]Minimum Observed Concentration for PGB and APAP
NCT04495283 (13) [back to overview]Maximum Observed Concentration for PGB and APAP
NCT04673214 (4) [back to overview]Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up
NCT04673214 (4) [back to overview]Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS
NCT04673214 (4) [back to overview]Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS
NCT04673214 (4) [back to overview]Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
NCT04766996 (2) [back to overview]Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
NCT04766996 (2) [back to overview]Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
NCT05544734 (2) [back to overview]Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale
NCT05544734 (2) [back to overview]Change in Health-related Quality of Life Scores on Postoperative Days 3 and 6, as Measured by an Adapted APS-POQ-R Questionnaire

Number of Deaths Stratified by Sirolimus Withdrawal Status

Participants who died during the study, all cause(s) (NCT00078559)
Timeframe: Transplantation to Death (up to four years post-transplant)

Interventiondeaths (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status

Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 - 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionmg/dL (Mean)
Alemtuzumab (Withdrawn From Sirolimus)-4.2
Alemtuzumab (Not Withdrawn From Sirolimus)-5.4

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Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study

"Acute rejections[1] between initiation of sirolimus withdrawal and end of study~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Initiation of sirolimus to end of study (up to four years post-transplant)

InterventionRejection Events (Number)
Alemtuzumab0

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Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period

"Time (days) to acute rejection[1] for participants occurring during the year following transplantation~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to one year post-transplant)

InterventionDays (Number)
Alemtuzumab274

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Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated

"Time (days) to acute rejection[1] for participants where sirolimus was not initiated~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)

InterventionDays (Number)
Alemtuzumab274

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Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)2

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Number of Acute Rejections in All Enrolled Participants

"Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)~Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Four years post-transplant

InterventionRejection Events (Number)
Alemtuzumab1

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Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status

"Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy~1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to acute rejection (up to four years post-transplantation)

Interventionparticipants (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal

"Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

InterventionRejection Events (Number)
Alemtuzumab0

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Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)8

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Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

(NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionadverse events (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)7

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Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status

Side effects of conventional immunosuppression include increased body weight and hypertension (NCT00078559)
Timeframe: Transplantation to end of study (up to four years post-transplant)

Interventionside effects (Number)
Alemtuzumab (Withdrawn From Sirolimus)2
Alemtuzumab (Not Withdrawn From Sirolimus)6

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Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status

"Participants who experienced severe acute rejections[1] during study~Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999" (NCT00078559)
Timeframe: Transplantation to severe acute rejection (up to four years post-transplantation)

InterventionRejection Events (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status

"Participants who experienced graft loss[1] during study~[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation" (NCT00078559)
Timeframe: Transplantation to Graft Loss (up to four years post-transplantation)

Interventionparticipants (Number)
Alemtuzumab (Withdrawn From Sirolimus)0
Alemtuzumab (Not Withdrawn From Sirolimus)0

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Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period

The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. (NCT00137969)
Timeframe: From baseline to 52 weeks

,
InterventionParticipants (Number)
MCR (excluding PCR)PCRNonclinical Response (NCR)
Placebo + Prednisone141163
Rituximab 1000 mg + Prednisone2129119

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Change in SLE Expanded Health Survey Physical Function Score From Baseline

Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved. (NCT00137969)
Timeframe: From baseline to 52 weeks

Interventionscore on a scale (Mean)
Rituximab 1000 mg + Prednisone8.2
Placebo + Prednisone4.1

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Number of Participants Who Achieved a BILAG C or Better in All Domains

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. (NCT00137969)
Timeframe: 24 weeks

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone42
Placebo + Prednisone24

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Time to First Moderate or Severe Flare

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state. (NCT00137969)
Timeframe: 52 weeks

Interventiondays (Median)
Rituximab 1000 mg + Prednisone112.0
Placebo + Prednisone126.0

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Number of Participants Who Achieved a PCR (Including MCR)

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. (NCT00137969)
Timeframe: From baseline to 52 Weeks

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone50
Placebo + Prednisone25

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Number of Participants Who Achieved an MCR (Excluding PCR)

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+>=2Bs, or>=2 As, or>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. (NCT00137969)
Timeframe: From baseline to 52 weeks

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone21
Placebo + Prednisone14

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Number of Participants Who Achieved an MCR in The ITT Population

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. (NCT00137969)
Timeframe: From Weeks 24 to 52

Interventionparticipants (Number)
Rituximab 1000 mg + Prednisone14
Placebo + Prednisone9

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Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period

The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as: 1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks. 2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study. 3. Minus the Time-Adjusted AUC by the baseline BILAG global score (NCT00137969)
Timeframe: From baseline to 52 weeks

InterventionBILAG score unit (Mean)
Rituximab 1000 mg + Prednisone-5.8
Placebo + Prednisone-5.9

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Engraftment of Haploidentical CD34+ Selected Blood Stem Cells in Older Patients or Those With Medical Co-morbidities Following Total Lymphoid Irradiation and Antithymocyte Globulin Transplant Conditioning

number achieving donor cell engraftment (>95%) by day 90 after transplant. (NCT00185692)
Timeframe: 100 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells4

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Acute Graft-versus-Host Disease (GVHD) Grade 2-4 Risk From Time of Transplant Until Day 90 Post-transplant

GVHD grading system goes from 0-4 where grade 4 is the most severe. Grade 0 and 1 do not require systemic treatment, Grade 2-4 require treatment. This trial evaluated the risk of developing acute GVHD grades 2-4 within 90 days of transplant. (NCT00185692)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Transplantation of CD34+ Cells1

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Incidence of Relapse

Subjects who Relapsed following after Allogeneic HSCT (NCT00186628)
Timeframe: 4 years

InterventionParticipants (Count of Participants)
Prophylactic Rituximab18

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Chronic Graft-vs-Host Disease (cGvHD)

The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955) (NCT00186628)
Timeframe: 4 years

Interventionpercentage of participants (Number)
Prophylactic Rituximab20

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Mortality

Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse. (NCT00186628)
Timeframe: Day 100 and 1 year

InterventionParticipants (Number)
Mortality within 100 days, all causesNonrelapse mortality within 1 yearRelapse + mortality within 1 year
Prophylactic Rituximab012

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Overall Survival

(NCT00186628)
Timeframe: 4 years

InterventionPercentage of participants by disease (Number)
Prophylactic Rituximab (CLL Patients)73
Prophylactic Rituximab (MCL Patients)69

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Child Temperature (Degrees C)Over 6 Hours

Temperature was measured hourly using a temporal thermometer to monitor the child's temperature in degrees C. Temperature of 38 degrees C or higher was considered febrile. (NCT00267293)
Timeframe: 6 hours

Interventiondegrees Celcius (Mean)
Group A: Ibuprofen Alone38.5
Group B: Ibuprofen and Acetaminophen37.2
Group C: Ibuprofen Then Acetaminophen36.9

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Percentage of Participants Who Achieved a Complete Renal Response (CRR), a Partial Renal Response (PRR), or no Renal Response (NRR) at Week 52

A participant had a CRR if they met the following 3 criteria: (1) Normalization of serum creatinine (SC) as evidenced by a SC level ≤ the upper limit of the normal range of central laboratory values or a SC level ≤ 15% greater than Baseline, if Baseline SC was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field (RBCs/HPF) and absence of red cell casts; (3) Urinary protein (UP) to creatinine ratio (CR) < 0.5. A participant had a PRR if they met the following 3 criteria: (1) A SC level ≤ 15% above Baseline; (2) RBCs/HPF ≤ 50% above Baseline and no RBC casts; (3) 50% improvement in the UP to CR, with 1 of the following conditions met: If the Baseline UP to CR was ≤ 3.0, then a UP to CR of < 1.0 or if the Baseline UP to CR was > 3.0, then a UP to CR of ≤ 3.0. A participant had a NRR if they did not achieve either a CRR or PRR. (NCT00282347)
Timeframe: Week 52

,
InterventionPercentage of participants (Number)
CRRPRRNRR
Placebo30.615.354.2
Rituximab26.430.643.1

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Change From Baseline in C3 and C4 Complement Levels at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

,
Interventionmg/dL (Mean)
C3 ComplementC4 Complement
Placebo25.96.6
Rituximab37.59.9

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Time to Achieve a Complete Renal Response

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionWeeks (Median)
Rituximab11.99
Placebo12.12

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Percentage of Participants With a Baseline Urine Protein to Creatinine Ratio of > 3.0 Who Achieved a Urine Protein to Creatinine Ratio of < 1.0 at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionPercentage of participants (Number)
Rituximab47.4
Placebo53.7

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Percentage of Participants Who Achieved a Complete Renal Response at Week 24 and Maintained it to Week 52

A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 24 to Week 52

InterventionPercentage of participants (Number)
Rituximab1.4
Placebo6.9

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Change From Baseline in the Systemic Lupus Erythematosus Expanded Health Survey Physical Function Score at Week 52

The systemic lupus erythematosus Expanded Health Survey is based on the Short Form 36 Health survey with additional questions specific to lupus. The physical function component score of the survey can range from 0-100. A higher score indicates better health. A positive change score indicates improvement. (NCT00282347)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Rituximab4.8
Placebo5.7

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Change From Baseline in Anti-double-stranded DNA at Week 52

(NCT00282347)
Timeframe: Baseline to Week 52

InterventionIU/mL (Mean)
Rituximab0.45
Placebo1.06

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British Isles Lupus Assessment Group (BILAG) Index Score Over 52 Weeks

The BILAG Index assesses 86 clinical signs and symptoms and laboratory measures of systemic lupus erythematosus in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic. Most of the 86 items are rated on the following scale: 0=Not present, 1=Improving, 2=Same, 3=Worse, 4=New. Some items are rated as either Yes or No. A single alphabetic score of A (very active) through E (not or never active) for each of the 8 domains is determined from the rating of the individual items in each domain. The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. To calculate a BILAG score over the 52 week treatment period of the study, the area under the response-time curve of BILAG scores assessed every 4 weeks was divided by the number of days in the time curve minus the Baseline BILAG score. (NCT00282347)
Timeframe: Baseline to Week 52

InterventionUnits on a scale (Mean)
Rituximab-8.49
Placebo-8.58

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Percentage of Participants Who Achieved a Complete Renal Response at Week 52

A participant had a complete renal response if they met the following 3 criteria: (1) Normalization of serum creatinine as evidenced by a serum creatinine level ≤ the upper limit of the normal range of central laboratory values or a serum creatinine level ≤ 15% greater than Baseline, if Baseline serum creatinine was within the normal range of the central laboratory values; (2) Inactive urinary sediment (as evidenced by < 5 red blood cells/high-power field and absence of red cell casts; (3) Urinary protein to creatinine ratio < 0.5. (NCT00282347)
Timeframe: Week 52

InterventionPercentage of participants (Number)
Rituximab26.4
Placebo30.6

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3 Scores on the Addiction Research Center Inventory (ARCI)

The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine-Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital-Chorpromazine-Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria. (NCT00314340)
Timeframe: 0, 60, 120, 180, 240, or 300 minutes

,,
Interventionscores on a scale (Mean)
trough sedationpeak euphoriatrough agitation
ER Morphine Tablets, 45mg7.63.34.7
Hydrocodone 30 mg Plus N-acetyl-para-aminophenol 975 mg5.44.64.2
Placebo5.23.53.6

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"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"

"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)." (NCT00315445)
Timeframe: Baseline to days 21-84

InterventionUnits on a scale (Least Squares Mean)
Placebo-0.78
OXY/APAP-1.60
BTDS-1.59

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"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84), BOCF"

"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it. Primary back pain was measured." (NCT00315445)
Timeframe: Baseline to days 21-84

InterventionUnits on a scale (Least Squares Mean)
Placebo-0.53
OXY/APAP-1.46
BTDS-1.64

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"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"

"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd from study due to AE, the baseline observation was carried forward (BOCF). If subject D/C'd from study other than for AE, the last missing data prior to D/C of study drug was carried forward (LOCF)." (NCT00315445)
Timeframe: Baseline to day 84

InterventionUnits on a scale (Least Squares Mean)
Placebo-1.30
OXY/APAP-1.56
BTDS-1.50

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"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"

"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Social Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo53.3
OXY/APAP59.5
BTDS65.2

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"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"

"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Vitality is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo39.0
OXY/APAP42.9
BTDS41.2

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Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)

"The subject assessed satisfaction with study drug. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = No response to 3 = Marked response." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo2.2
OXY/APAP1.8
BTDS1.7

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The Time to Discontinuation Due to Lack of Efficacy

Dropouts due to various reasons were summarized by counts and percentage. Cox proportional hazards regression was used to assess the treatment differences in time to dropout due to lack of efficacy. Clinically important covariates (including gender, age, race, weight, baseline pain, and previous opioid use) were incorporated into the model when statistically significant at P< .10, using a backward elimination procedure. (NCT00315445)
Timeframe: Time after dosing to dropout due to lack of efficacy

InterventionDays (Median)
PlaceboNA
OXY/APAPNA
BTDSNA

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Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)

"The therapeutic response was rated by the investigator. The assessment was completed by the investigator using a 0-3 ordinal scale from 0 = No response to 3 = Marked response." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo1.1
OXY/APAP2.0
BTDS1.9

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Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)

"The therapeutic response was rated by the subject. The assessment was completed by the subject using a 0-3 ordinal scale from 0 = No response to 3 = Marked response." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo1.1
OXY/APAP2.1
BTDS2.0

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Time to Stable Pain Management

"For each subject, time to stable pain management is defined as the first (post-baseline) time during the titration period when his/her diary pain was 4 or less (or at least 2 points lower than baseline) for 3 consecutive daily records or the pain on the average (at the day 7 or day 21 visit) was 4 or less (or at least 2 points lower than baseline)." (NCT00315445)
Timeframe: Start of study to day 21.

InterventionDays (Median)
Placebo14
OXY/APAP7
BTDS7

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"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"

"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Bodily Pain is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo35.3
OXY/APAP39.0
BTDS41.9

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"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"

"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. General Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo52.4
OXY/APAP52.5
BTDS57.7

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"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"

"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Mental Health is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo67.4
OXY/APAP68.8
BTDS67.8

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"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"

"The Medical Outcomes Survey (MOS) Short-Form-36 Health Survey (SF-36) assesses 8 categories of functionality through 36 individual questions. Physical Functioning is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84, or, if applicable, at early termination

InterventionUnits on a scale (Mean)
Placebo46.4
OXY/APAP44.5
BTDS46.5

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"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"

"The MOS Short-Form Health Survey assesses 8 categories of functionality through 36 individual questions. Emotional Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo55.3
OXY/APAP56.3
BTDS63.0

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"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"

"The Medical Outcomes Survey Short-Form-36 health survey assesses 8 categories of functionality through 36 individual questions. Physical Role is 1 of the 8 categories. Its transformed score, scaled from 0% to 100%, is used. A higher score represents a better subject condition. The survey was completed by the subject at the clinic. The mean scores were analyzed." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo18.9
OXY/APAP24.4
BTDS33.9

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Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)

"The subject compared study drug treatment to prestudy analgesic. The assessment was completed by the subject using a 0-2 ordinal scale from 0 = Worse than prestudy medicine to 2 = Better than prestudy medicine." (NCT00315445)
Timeframe: Day 84

InterventionUnits on a scale (Mean)
Placebo0.9
OXY/APAP1.4
BTDS1.4

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"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"

"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)." (NCT00315445)
Timeframe: Baseline to days 21-84

InterventionUnits on a scale (Least Squares Mean)
Placebo-0.91
OXY/APAP-1.77
BTDS-1.86

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"Sensitivity Analysis: Pain on the Average Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)"

"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it." (NCT00315445)
Timeframe: Baseline to days 21 - 84

InterventionUnits on a scale (Least Squares Mean)
Placebo-0.77
OXY/APAP-1.70
BTDS-1.74

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"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"

"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it.~This is a multiple imputation method that requires imputed changes from baseline to be stratified by discontinuation (D/C) reason. If subject D/C'd due to AE, the baseline observation was carried forward (ie, BOCF method of imputation). If subject D/C'd other than for an AE, the last missing data prior to D/C of study drug was carried forward (ie, LOCF method of imputation)." (NCT00315445)
Timeframe: Baseline to day 84

InterventionUnits on a scale (Least Squares Mean)
Placebo-1.44
OXY/APAP-1.47
BTDS-1.70

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Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])

"Subjects were asked, Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit. 0 = no pain and 10 = pain as bad as you can imagine it." (NCT00315445)
Timeframe: On baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

InterventionUnits on a scale (Least Squares Mean)
Placebo-1.01
OXY/APAP-1.82
BTDS-1.92

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Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)

"Subjects were asked, Please rate your pain by circling the one number (0-10) that tells how much pain you have right now. Subjects rated their answers on a 0-10 ordinal scale from 0 = No pain to 10 = Pain as bad as you can imagine it. Pain right now is presented as the LSmean [change from baseline] (SE)." (NCT00315445)
Timeframe: Assessed at baseline day 1 and days 21, 30, 45, 60, 75, and 84, and, if applicable, at early termination.

InterventionUnits on a scale (Least Squares Mean)
Placebo-0.80
OXY/APAP-1.53
BTDS-1.66

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Average Daily Pain Scores - BS11 Pain Scores.

The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain. (NCT00324038)
Timeframe: every day over a 12 week study duration.

InterventionBox Scale 11 boxes (Mean)
Buprenorphine Transdermal System3
Co-codamol Tablets3

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Study Assignment Unblinded

The need for unblinding at any time during the study (NCT00325819)
Timeframe: At any time during participation in the study

Interventionpercentage of participants (Number)
Acetaminophen3
Placebo9

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Fever >=38C Within 32 Hours of Vaccination.

Fever, defined as rectal temperature >=38C within 32 hours of vaccination. (NCT00325819)
Timeframe: Fever within 32 hours following vaccination

Interventionpercentage of participants (Number)
Acetaminophen14
Placebo22

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Fever >=39C Within 32 Hours of Vaccination.

Fever, defined as rectal temperature >=39C within 32 hours of vaccination. (NCT00325819)
Timeframe: Fever within 32 hours following vaccination

Interventionpercentage of participants (Number)
Acetaminophen0
Placebo2

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Medical Utilization

Telephone calls to the consulting nurse or the child's physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination. (NCT00325819)
Timeframe: Within 32 hours of vaccination.

Interventionpercentage of participants (Number)
Acetaminophen3
Placebo6

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Parent Time Lost From Work

Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days. (NCT00325819)
Timeframe: Through the day after vaccination

Interventionpercentage of participants (Number)
Acetaminophen4
Placebo1

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Infant Fussiness

Parents were asked to record level of fussiness (compared with the child's usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual. (NCT00325819)
Timeframe: Within 32 hours of vaccination

,
Interventionpercentage of participants (Number)
Infant fussiness - About usual or less than usualInfant fussiness-More than or much more than usualInfant fussiness-Much more than usual
Acetaminophen425810
Placebo386224

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Parent Time Lost From Sleep

Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night. (NCT00325819)
Timeframe: On the night following vaccinations

,
Interventionpercentage of participants (Number)
Parent sleep - About usual or more than usualParent sleep - Less than or much less than usualParent sleep - Much less than usual
Acetaminophen73273
Placebo77235

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Infant Time Lost From Sleep

Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night. (NCT00325819)
Timeframe: On the night following vaccinations

,
Interventionpercentage of participants (Number)
Infant sleep - About usual or more than usualInfant sleep - Less than or much less than usualInfant sleep - Much less than usual
Acetaminophen78222
Placebo81192

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Hamilton Rating Scale for Depression (HRSD-17)

The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+). (NCT00377364)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Acetaminophen11.3
Placebo13.4

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Young Mania Rating Scale (YMRS)

This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). (NCT00377364)
Timeframe: Exit (Day 3 or Day 7)

Interventionunits on a scale (Mean)
Acetaminophen5.9
Placebo5.6

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Young Mania Rating Scale (YMRS)

This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe). (NCT00377364)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Acetaminophen5.8
Placebo6.1

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Rey Auditory Verbal Learning Test (RAVLT)

This is a measure of declarative memory (associated with the hippocampus). The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy. (NCT00377364)
Timeframe: Baseline

Interventionwords (Mean)
Acetaminophen44.8
Placebo44.1

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Rey Auditory Verbal Learning Task (RAVLT)

This is a measure of declarative memory (associated with the hippocampus), using the mean number of words (0-75) recalled from Trials I-V of the RAVLT ± the standard deviation. The assessement was conducted using the same procedures as at baseline. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy. (NCT00377364)
Timeframe: Exit (Day 3 or Day 7)

Interventionwords (Mean)
Acetaminophen44.9
Placebo44.9

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Internal State Scale - Activation (ISS-ACT)

Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology. (NCT00377364)
Timeframe: Exit (Day 3 or Day 7)

Interventionunits on a scale (Mean)
Acetaminophen93.5
Placebo107.8

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Internal State Scale - Activation (ISS-ACT)

Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology. (NCT00377364)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Acetaminophen58.0
Placebo109.6

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Hamilton Rating Scale for Depression (HRSD-17)

The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+). (NCT00377364)
Timeframe: Exit (Day 3 or Day 7)

Interventionunits on a scale (Mean)
Acetaminophen8.3
Placebo10.3

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Asthma Control Questionnaire (ACQ)

This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled). (NCT00377364)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Acetaminophen3.1
Placebo3.3

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Asthma Control Questionnaire

This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled). (NCT00377364)
Timeframe: Exit (Day 3 or Day 7)

Interventionunits on a scale (Mean)
Acetaminophen1.9
Placebo1.7

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SNOT-16 Score (Sino-Nasal Outcomes Test) at Day 3

The Sino-Nasal Outcomes Test (SNOT-16) assesses disease-specific quality of life for acute and chronic rhinosinusitis. This brief instrument assesses 16 sinus-related symptoms and was administered by phone. The respondent reported how much they were bothered by each item considering both its severity and frequency. Response options include no problem (0), mild or slight problem (1), moderate problem (2), severe problem (3). The SNOT-16 score is the mean score from all 16 items and ranges from 0 (minimal impact) to 3 (significant impact). (NCT00377403)
Timeframe: 4 days

InterventionUnits on a scale (Mean)
Intervention Arm1.12
Symptomatic Treatments Only1.14

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Rate of Diagnosis of Clinical Chorioamnionitis

Rate of diagnosis of clinical chorioamnionitis, i.e., the number of participants who developed chorioamnionitis. (NCT00377832)
Timeframe: Labor--up to 24 hours

Interventionparticipants (Number)
In Labor With a Fever Will Get no Medication1
In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce0

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Rate of Subsequent Development of Maternal Fever

Rate of subsequent development of maternal fever, i.e., the number of participants who developed fever. (NCT00377832)
Timeframe: Labor--up to 24 hours

Interventionparticipants (Number)
In Labor With a Fever Will Give no Medication6
In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce2

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Temperature Difference Before and After Treatment

Maternal temperature difference before randomization and 90 minutes after randomization in degrees Centigrade (NCT00377832)
Timeframe: 90 minutes

Interventiondegrees Centigrade (Median)
In Labor With a Fever Will Give no Medication0.3
In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce-0.15

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Baseline Fetal Heart Rate (FHR) After Treatment

(NCT00377832)
Timeframe: 90 minutes

Interventionbeats per minute (Mean)
No Medication167.6
Acetaminophen 975 mg Once152.5

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Maternal Body Temperature 90 Minutes After Randomization

Fever in labor is identified,consenting and randomization occurs, either acetaminophen is given or no medication is given, then 90 minutes later maternal temperature is recorded. (NCT00377832)
Timeframe: 90 minutes

Interventiondegrees centigrade (Median)
In Labor With a Fever Will Give no Medication38
In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce37.4

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Rate of Neonatal Sepsis

the number of participants who developed neonatal sepsis (NCT00377832)
Timeframe: 7 days

Interventionparticipants (Number)
In Labor With a Fever Will Give no Medication0
In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce0

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Rate of Determination of Non-reassuring Fetal Status

Non-reassuring fetal status is when cesarean delivery or operative vaginal delivery (forceps or vacuum) are performed for fetal heart rate abnormalities. (NCT00377832)
Timeframe: Labor--up to 24 hours

Interventionparticipants (Number)
In Labor With a Fever Will Give no Medication1
In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce2

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Rate of Cesarean Delivery

Rate of cesarean delivery (NCT00377832)
Timeframe: Labor--up to 24 hours

Interventionparticipants (Number)
In Labor With a Fever Will Give no Medication1
In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce2

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Percentage of Participants With at Least 1 Serious Adverse Event

A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator. (NCT00381810)
Timeframe: Baseline to the end of the study (up to 52 weeks)

InterventionPercentage of participants (Number)
Rituximab 1000 mg35.5

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Pain Assessment in Advanced Dementia (PAINAD)

Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. Scale range is 0-10. (NCT00385684)
Timeframe: Two (2) weeks

Interventionunits on a scale (Mean)
Experimental: A12.20
Placebo Comparator: A22.56

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Pain Assessment in Advanced Dementia (PAINAD)

Pain intensity observational assessment for persons with severe dementia. Higher scores indicate more pain/discomfort. (NCT00385684)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Phase B: Open Label1.93

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Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.

"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-2400 mm for 24 hours." (NCT00399568)
Timeframe: Baseline (just prior to the first dose) through 24 hours

Interventionunits on a scale (in millimeters) (Mean)
IV Acetaminophen 1 g/100 ml Solution1793.3
IV Placebo 100 ml Solution1845.3

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Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.

"Number of subjects who reported SAEs during the study.~A serious Adverse event (SAE) is defined as any untoward medical occurence at any dose of study medication that:~Results in Death, Is Life Threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, or Is an important medical event" (NCT00399568)
Timeframe: 32 days following first dose of study medication.

InterventionSubjects (Number)
IV Acetaminophen 1 g/100 ml Solution11
IV Placebo 100 ml Solution14

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Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)

Number of subjects who experienced at least one treatment emergent adverse event (TEAE) A TEAE is an adverse event that occurs on or after administration of the first dose of study medication (T0) (NCT00399568)
Timeframe: First dose through 7 day follow up

InterventionSubjects (Number)
IV Acetaminophen 1g/100 ml Solution141
IV Placebo 100 ml Solution149

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Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo

"The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale No Pain and the right terminus (100 mm) with Worst Pain Imaginable. The range of measurement is 0-4800 mm for 48 hours." (NCT00399568)
Timeframe: Baseline (just prior to the first dose) through 48 hours

Interventionunits on a scale (in millimeters) (Mean)
IV Acetaminophen 1 g/100 ml Solution3612.4
IV Placebo 100 ml Solution3718.2

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Overall Survival (OS)

To evaluate the overall and transplant related mortality rate, reported as the number of subjects remaining alive 3 years after transplant. (NCT00482053)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL2

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Median Time to Neutrophil Engraftment After Allogeneic Transplant

Reported as neutrophil engraftment after allogeneic transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL10.5

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Median Time to Neutrophil Engraftment After Autologous Transplant

Reported as neutrophil engraftment after autologous transplant, defined as absolute neutrophil count (ANC) > 500/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL11

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Incidence of Chronic Graft vs Host Disease (GvHD)

The incidence of chronic graft vs host disease (GvHD) is reported as any events within 3 years. Note that GvHD was assessed per investigator judgement. There was no protocol-specified criteria of GvHD. (NCT00482053)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL0

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Median Time to Platelet Engraftment After Autologous Transplant

Reported as platelet engraftment after autologous transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL19

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Median Time to Platelet Engraftment After Allogeneic Transplant

Reported as platelet engraftment after allogeneic transplant, defined as platelet count > 20,000/µL, counting from the day of transplant. (NCT00482053)
Timeframe: within 1 month

InterventionDays (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL10

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Event-free Survival (EFS) Per Protocol

Event-free survival (EFS) through 4 years, as assessed in participants with poor-risk recurrent or primary refractory DLBCL treated with TLI and ATG followed by matched allogeneic hematopoietic cell transplantation as a consolidation to HCT. Event is defined as tumor progression or death. (NCT00482053)
Timeframe: 48 months

Interventionmonths (Median)
Auto-HCT Followed by Allo-HCT for Poor-risk DLBCL48

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Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.

Clinically significant increase in oral body temperature or used rescue medication ibuprofen >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period. (NCT00489424)
Timeframe: 0 - 3 days

,,
Interventionproportion of patients (Number)
Increase in oral body temperature:YesIncrease in oral body temperature:No
Acetaminophen0.3980.602
Fluvastatin0.6180.382
Placebo0.6070.39

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Number of Rescue Medication Tablets Taken

Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication. (NCT00489424)
Timeframe: 0 - 3 days

Interventiontablets (Mean)
Placebo6.3
Acetaminophen5.7
Fluvastatin6.5

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Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.

Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication. (NCT00489424)
Timeframe: 0 - 3 days

Interventionhours (Mean)
Placebo21.9
Acetaminophen28.2
Fluvastatin19.9

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Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.

A major increase (worsening) in severity was defined as an increase in severity of 2 units or more from baseline at least once during the 3 days immediately following i.v. infusion of zoledronic acid 5 mg. The severity of the symptom was evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). (NCT00489424)
Timeframe: 0 - 3 days

,,
Interventionproportion of patients (Number)
Feeling feverishHeadacheAches and pains of muscles/joints
Acetaminophen0.2350.2540.337
Fluvastatin0.3970.4390.462
Placebo0.3950.3910.477

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Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.

Clinically significant increase in oral body temperature >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period. (NCT00489424)
Timeframe: 0 - 3 days

,,
Interventionproportion of patients (Number)
Increase in oral body temperature: YesIncrease in oral body temperature: No
Acetaminophen0.0490.951
Fluvastatin0.1150.885
Placebo0.1050.891

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Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity

Effect on severity of symptoms following i.v. infusion of zoledronic acid 5 mg. The VAS is a 100-mm linear visual analog scale (0 = no symptoms to 100 = severe symptoms). The baseline VAS measurement was defined as the VAS measurement recorded prior to the infusion. (NCT00489424)
Timeframe: 0 - 3 days

,,
Interventionunits on a scale (Mean)
Change from baseline to Day 1 - late eveningChange from baseline to Day 2 - late eveningChange from baseline to Day 3 - late evening
Acetaminophen4.411.83.9
Fluvastatin6.020.86.6
Placebo7.618.96.2

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Proportion of Patients Who Used Rescue Medication.

Patients that took rescue medication >= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. Patients who experienced severe discomfort after their first home measurements and self-administration of study medication were allowed to take ibuprofen (200 mg tablets every 4-6 hours as needed) as rescue medication while continuing to take their study medication. (NCT00489424)
Timeframe: 0 - 3 days

,,
Interventionproportion of patients (Number)
Took rescue medication >= 1 time: YesTook rescue medication >= 1 time: No
Acetaminophen0.3860.614
Fluvastatin0.5950.405
Placebo0.5730.423

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Proportion of Patients Reporting Severe Questionnaire Symptoms.

A severe questionnaire symptom was defined as experiencing a severe specified symptom (feeling feverish, experiencing headaches, having aches and pains of muscles and joints) at least once post-baseline. (NCT00489424)
Timeframe: 0 - 3 days

,,
Interventionproportion of patients (Number)
Feeling feverishHeadacheAches and pains of muscles/joints
Acetaminophen0.0760.0680.212
Fluvastatin0.1450.1600.302
Placebo0.1350.1570.303

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Clinical Response Rate

Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response. (NCT00490009)
Timeframe: 6 years

Interventionparticipants (Number)
Clinical ResponseComplete Response (CR)Functional CRPRSDPD
Bexxar201161

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Time to Progression (TTP)

Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression. (NCT00490009)
Timeframe: 1.5 months; 3 months; 6 months; or Not Progressed

Interventionparticipants (Number)
1.5 months3 months6 monthsNot Progressed
Bexxar1223

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Overall Survival (OS) Rate

Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years. (NCT00490009)
Timeframe: 6 years

Interventionpercentage of participants (Number)
Bexxar37.5

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Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen

Tmax: Time to reach maximum plasma concentration (Cmax) (NCT00493246)
Timeframe: Time Zero (just prior to first dose) to 24 hours post first dose

InterventionHour (Median)
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen0.450
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen0.333
Infants: 12.5 mg/kg q4h IV Acetaminophen0.267
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen0.267
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen0.250
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen0.250
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen0.250
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen0.267

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Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen

Cmax: Maximum Plasma Concentration (NCT00493246)
Timeframe: Time Zero (just prior to first dose) to 24 hours post first dose

Interventionmicrograms per milliliter (µg/mL) (Median)
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen40.1
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen20.1
Infants: 12.5 mg/kg q4h IV Acetaminophen16.7
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen19.3
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen18.2
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen21.6
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen15.9
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen25.5

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Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)

A TEAE is defined as an adverse event that starts on or after the start of study medication (NCT00493246)
Timeframe: First dose of study medication to 30 days after the last dose of study medication

InterventionParticipants (Number)
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen2
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen1
Infants: 12.5 mg/kg q4h IV Acetaminophen10
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen9
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen2
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen11
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen10
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen6

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Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen

t1/2: Terminal elimination half-life (NCT00493246)
Timeframe: 48hrs

InterventionHours (Median)
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen3.88
Infants: 12.5 mg/kg q4h IV Acetaminophen2.37
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen2.79
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen2.64
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen2.77
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen3.37
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen4.10

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Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen

AUC 0-t (µg*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state. (NCT00493246)
Timeframe: Time Zero (just prior to first dose) to 48 hours post first dose

Interventionµg*h/ml (Median)
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen65.6
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen105
Infants: 12.5 mg/kg q4h IV Acetaminophen43.3
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen51.9
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen37.8
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen48.0
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen47.7
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen64.0

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Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)

A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV acetaminophen that; Results in Death, Is life-threatening, Requires inpatient hospitalization or causes prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Is a congenital anomaly/birth defect, Is an important medical event (NCT00493246)
Timeframe: First dose to 30 days following last dose of study medication

InterventionParticipants (Number)
Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen0
Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen0
Infants: 12.5 mg/kg q4h IV Acetaminophen0
Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen1
Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen1
Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen2
Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen1
Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen1

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Weighted Sum of Temperature Differences Over 6 Hours (WSTD6) Assessment of the Antipyretic Effect Over 6 h of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever

The primary efficacy endpoint was WSTD6 defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through 6 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints. (NCT00493311)
Timeframe: Baseline (T0) to 6 hours post study drug administration

InterventionDegrees Celsius (Mean)
Intravenous (IV) Placebo-0.7
Intravenous (IV) Acetaminophen 1 g-3.7

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Global Assessment of Treatment at T360 Minutes or Early Termination.

"Subject Global Evaluation was assessed by subject using a 4 point categorical scale in response to the following question:Overall, how would you rate the study treatments? 0 = Poor~= Fair~= Good~= Excellent" (NCT00493311)
Timeframe: Baseline (T0) to 6 hours

,
Interventionparticipants (Number)
Rate treatment as 'poor'Rate treatment as 'fair'Rate treatment as 'good'Rate treatment as 'excellent'
Intravenous (IV) Acetaminophen 1 g15169
Intravenous (IV) Placebo29108

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Maximum Temperature Change During the Period From T0 to T360 Minutes (6 Hours After Study Drug Administration)

(NCT00493311)
Timeframe: Baseline (T0) to 360 minutes (6 hours) post study drug administration

InterventionDegrees celsius (Mean)
Intravenous (IV) Placebo-0.9
Intravenous (IV) Acetaminophen 1 g-1.3

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Weighted Sum of Temperature Differences Over 3 Hours (WSTD3) Assessment of the Antipyretic Effect Over 3 Hours of a Single Dose of IV APAP vs. Placebo for Treatment of Endotoxin-induced Fever.

WSTD3 is defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through the first 3 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints. (NCT00493311)
Timeframe: Baseline (T0) to 3 hours

InterventionDegrees Celsius (Mean)
Intravenous (IV) Placebo0.7
Intravenous (IV) Acetaminophen 1 g-0.9

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The Percentage of Subjects With Temperature Less Than 38 Degrees Celsius at Any Timepoint During the Time From T0 to T360 Minutes (6 Hours After Study Drug Administration)

(NCT00493311)
Timeframe: 360 minutes (6 hours after study drug administration)

InterventionPercentage of participants (Number)
Intravenous (IV) Placebo3
Intravenous (IV) Acetaminophen 1 g13

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Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters (mm) from injection site. (NCT00496015)
Timeframe: During the 4-day (Days 0-3) post-primary vaccination period

,,,,
InterventionParticipants (Count of Participants)
Any PainGrade 3 PainAny RednessGrade 3 RednessAny SwellingGrade 3 Swelling
Mencevax + Infanrix Hexa Group1144146167112
Synflorix I Group542897522
Synflorix II Group1029181
Synflorix POST Group193121133
Synflorix PRE Group79107414509

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Number of Subjects With Anti-polysaccharide N (Anti-PS) Concentrations ≥ the Cut-off Values

Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). (NCT00496015)
Timeframe: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination

InterventionParticipants (Count of Participants)
ANTI-PSA PRE ≥ 0.3 μg/mLANTI-PSA PRE ≥ 2.0 μg/mLANTI-PSA M1≥ 0.3 μg/mLANTI-PSA M1 ≥ 2.0 μg/mLANTI-PSA M12 ≥ 0.3 μg/mLANTI-PSA M12 ≥ 2.0 μg/mLANTI-PSC PRE ≥ 0.3 μg/mLANTI-PSC PRE ≥ 2.0 μg/mLANTI-PSC M1 ≥ 0.3 μg/mLANTI-PSC M1≥ 2.0 μg/mLANTI-PSC M12 ≥ 0.3 μg/mLANTI-PSC M12 ≥ 2.0 μg/mLANTI-PSW-135 PRE ≥ 0.3 μg/mLANTI-PSW-135 PRE ≥ 2.0 μg/mLANTI-PSW-135 M1 ≥ 0.3 μg/mLANTI-PSW-135 M1 ≥ 2.0 μg/mLANTI-PSW-135 M12 ≥ 0.3 μg/mLANTI-PSW-135 M12 ≥ 2.0 μg/mLANTI-PSY PRE ≥ 0.3 μg/mLANTI-PSY PRE ≥ 2.0 μg/mLANTI-PSY M1 ≥ 0.3 μg/mLANTI-PSY M1 ≥ 2.0 μg/mLANTI-PSY M12 ≥ 0.3 μg/mLANTI-PSY M12 ≥ 2.0 μg/mL
Mencevax + Infanrix Hexa Group121271271133473027827794910258234117453026124913159

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Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off

"Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).~The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL)." (NCT00496015)
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

,,,,
InterventionParticipants (Count of Participants)
ANTI-1 PREANTI-1 M1ANTI-1 M12ANTI-4 PREANTI-4 M1ANTI-4 M12ANTI-5 PREANTI-5 M1ANTI-5 M12ANTI-6B PREANTI-6B M1ANTI-6B M12ANTI-7F PREANTI-7F M1ANTI-7F M12ANTI-9V PREANTI-9V M1ANTI-9V M12ANTI-14 PREANTI-14 M1ANTI-14 M12ANTI-18C PREANTI-18C M1ANTI-18C M12ANTI-19F PREANTI-19F M1ANTI-19F M12ANTI-23F PREANTI-23F M1ANTI-23F M12
Mencevax + Infanrix Hexa Group6511662061031112159205103025296389291724902424
Synflorix I Group741408912314110310214011311013497130140132117141129131140131118141113128138135103135115
Synflorix II Group142411152414152318132118212521202420222421142518212522142116
Synflorix POST Group273630313727303630323530343736343735353634293735363736303633
Synflorix PRE Group115167122147167147142167159143166148156167165152167166159166166154167157163165165132163154

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Number of Subjects With New Acquisition Associated to S. Pneumoniae Detected in Nasopharyngeal Swabs

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. (NCT00496015)
Timeframe: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

,
InterventionParticipants (Count of Participants)
M1M3M7M12Overall
Mencevax + Infanrix Hexa Group43637065161
Pooled Synflorix Group56767370195

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Number of Subjects With Serum Bactericidal Antibodies, Using Baby Rabbit Complement for Assay (rSBA) Titres ≥ the Cut-off Values

"The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY).~Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group)." (NCT00496015)
Timeframe: Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination

InterventionParticipants (Count of Participants)
rSBA-MenA,Pre, ≥ 1:8rSBA-MenA, Pre, ≥ 1:128rSBA-MenA, M1, ≥ 1:8rSBA-MenA, M1, ≥ 1:128rSBA-MenA, M12, ≥ 1:8rSBA-MenA, M12, ≥ 1:128rSBA-MenC,Pre, ≥ 1:8rSBA-MenC, Pre, ≥ 1:128rSBA-MenC, M1, ≥ 1:8rSBA-MenC, M1, ≥ 1:128rSBA-MenC, M12, ≥ 1:8rSBA-MenC, M12, ≥ 1:128rSBA-MenW-135,Pre, ≥ 1:8rSBA-MenW-135, Pre, ≥ 1:128rSBA-MenW-135, M1, ≥ 1:8rSBA-MenW-135, M1, ≥ 1:128rSBA-MenW-135, M12, ≥ 1:8rSBA-MenW-135, M12, ≥ 1:128rSBA-MenY,Pre, ≥ 1:8rSBA-MenY, Pre, ≥ 1:128rSBA-MenY, M1, ≥ 1:8rSBA-MenY, M1, ≥ 1:128rSBA-MenY, M12, ≥ 1:8rSBA-MenY, M12, ≥ 1:128
Mencevax + Infanrix Hexa Group694429829813613450173002941541051145930130113812916793300300137127

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Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A

OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. (NCT00496015)
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

,,,,
InterventionTiters (Geometric Mean)
OPSONO-6A-PREOPSONO-6A-M1OPSONO-6A-M12OPSONO-19A-PREOPSONO-19A-M1OPSONO-19A-M12
Mencevax + Infanrix Hexa Group9.716.117.1444.7
Synflorix I Group72.4251.559.4539.27
Synflorix II Group35.6105.1234.939.74.8
Synflorix POST Group66403.737.2599.69.5
Synflorix PRE Group65.4401.752.14.889.78.9

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Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F

OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. (NCT00496015)
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

,,,,
InterventionTiters (Geometric Mean)
OPSONO-1 PREOPSONO-1 M1OPSONO-1 M12OPSONO-4 PREOPSONO-4 M1OPSONO-4 M12OPSONO-5 PREOPSONO-5 M1OPSONO-5 M12OPSONO-6B PREOPSONO-6B M1OPSONO-6B M12OPSONO-7F PREOPSONO-7F M1OPSONO-7F M12OPSONO-9V PREOPSONO-9V M1OPSONO-9V M12OPSONO-14 PREOPSONO-14 M1OPSONO-14 M12OPSONO-18C PREOPSONO-18C M1OPSONO-18C M12OPSONO-19F PREOPSONO-19F M1OPSONO-19F M12OPSONO-23F PREOPSONO-23F M1OPSONO-23F M12
Mencevax + Infanrix Hexa Group4.95.14.75.97.86.84.24.349.920.919.190267.3681.169.287.4127.211.5158287.84.544.65.34.56.420.2261.8147.1
Synflorix I Group6.1144.612.823.81547.919.98.5134.310.332.5496.746.9413.64025.81503.3420.72234.8791.6189.71581.7434.56.1652.911.921.2629.464.3288.72335.7386.4
Synflorix II Group5.6193.412.58.8971.614.910.410510.515.9148.397.7221.417491606.4472.9752.9552.2150.21515438.46269.724.717.4372.939.4310.11223.1433.8
Synflorix POST Group632520.529.71303.272.515.1227.715.449.7718.329.4258.42212.21738.3365.71155.5716.8227.41964.55589.5537.623.536.41198.8121.3305.31808.7670.2
Synflorix PRE Group8.141723.144.9229751.216.6289.323.745.2985.753.9584.74674.71285.7407.72403.7906.7293.21865.2447.511.7737.827.735.11062.2101.34083154857.5

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rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers in the Mencevax + Infanrix Hexa Group

Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). (NCT00496015)
Timeframe: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

InterventionTiters (Geometric Mean)
rSBA-MenA,PrerSBA-MenA, M1rSBA-MenA, M12rSBA-MenC,PrerSBA-MenC, M1rSBA-MenC, M12rSBA-MenW-135,PrerSBA-MenW-135, M1rSBA-MenW-135, M12rSBA-MenY,PrerSBA-MenY, M1rSBA-MenY, M12
Mencevax + Infanrix Hexa Group11.52151.3677.66.9811.2191.116.35393.6573.130.22863.7665.2

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Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off.

"Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).~Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).~Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL)." (NCT00496015)
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

,,,,
Interventionμg/mL (Geometric Mean)
ANTI-1 PREANTI-1 M1ANTI-1 M12ANTI-4 PREANTI-4 M1ANTI-4 M12ANTI-5 PREANTI-5 M1ANTI-5 M12ANTI-6B PREANTI-6B M1ANTI-6B M12ANTI-7F PREANTI-7F M1ANTI-7F M12ANTI-9V PREANTI-9V M1ANTI-9V M12ANTI-14 PREANTI-14 M1ANTI-14 M12ANTI-18C PREANTI-18C M1ANTI-18C M12ANTI-19F PREANTI-19F M1ANTI-19F M12ANTI-23F PREANTI-23F M1ANTI-23F M12
Mencevax + Infanrix Hexa Group0.030.030.040.030.030.040.040.040.060.030.030.040.030.030.040.030.030.040.040.050.110.030.030.040.030.050.120.030.030.04
Synflorix I Group0.221.670.260.43.010.340.362.30.420.351.350.40.742.90.680.612.860.670.824.580.890.474.960.560.9861.460.381.990.46
Synflorix II Group0.181.640.180.242.840.210.3120.350.180.890.360.552.370.450.592.570.550.524.370.940.293.460.440.634.840.820.31.330.29
Synflorix POST Group0.262.970.410.453.950.550.533.030.580.52.250.540.874.380.960.994.350.861.275.861.250.546.130.921.48.772.040.453.860.98
Synflorix PRE Group0.312.620.390.64.210.50.593.680.720.552.450.561.054.130.9114.390.971.575.951.540.7871.051.487.551.80.542.920.8

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Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL). (NCT00496015)
Timeframe: 1 month post-vaccination (M1)

,,,,
InterventionEL.U/mL (Number)
Anti-PT, M1Anti-FHA, M1Anti-PRN, M1
Mencevax + Infanrix Hexa Group163.1580.8350.7
Synflorix I Group83.3467.9222.8
Synflorix II Group81.6431.1153.4
Synflorix POST Group76.7400.4220.4
Synflorix PRE Group82453.8254.9

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Anti-poliovirus (Anti-Polio) Type 1, 2 and 3 Titers

The seroprotection cut-off for the assay was ≥ 8. (NCT00496015)
Timeframe: 12 month post-vaccination (M12)

,,,,
InterventionTiters (Geometric Mean)
Anti-Polio 1, M12Anti-Polio 2, M12Anti-Polio 3, M12
Mencevax + Infanrix Hexa Group335.4322.7203.3
Synflorix I Group208.2311.2431.3
Synflorix II Group150.4212.4301
Synflorix POST Group220.8400672.2
Synflorix PRE Group234.5310.6506.3

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Anti-poliovirus (Anti-Polio) Types 1, 2 and 3 Titers

The seroprotection cut-off for the assay was ≥ 8. (NCT00496015)
Timeframe: 1 month post-vaccination (M1)

,,,,
InterventionTiters (Geometric Mean)
Anti-Polio 1, M1Anti-Polio 2, M1Anti-Polio 3, M1
Mencevax + Infanrix Hexa Group409681928192
Synflorix I Group11931354.12354.2
Synflorix II Group1534.22047.92233.3
Synflorix POST Group1208.62215.83576.5
Synflorix PRE Group1058.71413.22647.5

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Antibody Concentrations Against Pneumococcal Serotypes 6A and 19A (Anti-6A and 19A)

Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). (NCT00496015)
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

,,,,
Interventionμg/mL (Geometric Mean)
Anti-6A-PREAnti-6A-M1Anti-6A-M12Anti-19A-PREAnti-19A-M1Anti-19A-M12
Mencevax + Infanrix Hexa Group0.030.030.040.030.040.06
Synflorix I Group0.120.40.140.150.840.22
Synflorix II Group0.080.290.10.120.560.13
Synflorix POST Group0.190.750.20.21.540.41
Synflorix PRE Group0.210.860.240.231.340.36

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Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T).

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL). (NCT00496015)
Timeframe: 1 month post-vaccination (M1)

,,,,
InterventionIU/mL (Geometric Mean)
Anti-D, M1Anti-T, M1
Mencevax + Infanrix Hexa Group7.29111.79
Synflorix I Group10.1127.382
Synflorix II Group9.8398.684
Synflorix POST Group118.196
Synflorix PRE Group12.2859.583

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Concentrations of Antibodies Against Protein D (Anti-PD)

The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL). (NCT00496015)
Timeframe: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination

,,,,
InterventionEL.U/mL (Geometric Mean)
Anti-PD-PREAnti-PD-M1Anti-PD-M12
Mencevax + Infanrix Hexa Group65.664.674.4
Synflorix I Group365.11654468.1
Synflorix II Group356.51813.5418
Synflorix POST Group584.32612.3713.4
Synflorix PRE Group685.53134.2834.6

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Geometric Mean Antibody Concentration (GMCs) for Anti-polysaccharide N (Anti-PS) Antibody Concentrations

Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). (NCT00496015)
Timeframe: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination.

Interventionμg/mL (Geometric Mean)
Anti-PSA, PreAnti-PSA, M1Anti-PSA, M12Anti-PSC, PreAnti-PSC, M1Anti-PSC, M12Anti-PSW-135, PreAnti-PSW-135, M1Anti-PSW-135, M12Anti-PSY, PreAnti-PSY, M1Anti-PSY, M12
Mencevax + Infanrix Hexa Group0.1636.280.990.1514.120.420.156.111.210.158.031.81

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Number of Nasopharyngeal Swabs With H. Influenzae

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. (NCT00496015)
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

,
InterventionSwabs (Number)
PreM1M3M7M12Overall
Mencevax + Infanrix Hexa Group4139344957124
Pooled Synflorix Group4856626446160

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Number of Nasopharyngeal Swabs With S. Pneumoniae and H. Influenzae

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. (NCT00496015)
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

,
InterventionSwabs (Number)
PreM1M3M7M12Overall
Mencevax + Infanrix Hexa Group192017222261
Pooled Synflorix Group213031281986

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Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 10 mIU/mL. (NCT00496015)
Timeframe: 1 month post-vaccination (M1)

InterventionmIU/mL (Geometric Mean)
Synflorix I Group1883.9
Synflorix II Group1460.6
Synflorix PRE Group2133
Synflorix POST Group1818.5
Mencevax + Infanrix Hexa Group20610

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Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 10 mIU/mL. (NCT00496015)
Timeframe: 12 month post-vaccination (M12)

InterventionmIU/mL (Geometric Mean)
Synflorix I Group219.3
Synflorix II Group147.3
Synflorix PRE Group231.2
Synflorix POST Group139.2
Mencevax + Infanrix Hexa Group535.1

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Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1. (NCT00496015)
Timeframe: Prior to vaccination (Pre)

InterventionmIU/mL (Geometric Mean)
Mencevax + Infanrix Hexa Group1336.1

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Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations

The seroprotection cut-off for the assay was ≥ 0.15 μg/mL. (NCT00496015)
Timeframe: 1 month post-vaccination (M1)

Interventionμg/mL (Geometric Mean)
Synflorix I Group23.066
Synflorix II Group26.006
Synflorix PRE Group27.373
Synflorix POST Group22.011
Mencevax + Infanrix Hexa Group20.985

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Anti-tetanus Toxoids (Anti-T) Antibody Concentrations in the Mencevax + Infanrix Hexa Group

The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL). (NCT00496015)
Timeframe: Prior to vaccination (Pre)

InterventionIU/mL (Geometric Mean)
Mencevax + Infanrix Hexa Group0.512

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Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off

The cut-off value for core fever (rectal temperature) was 39.0ºC. (NCT00496015)
Timeframe: Within 4 days (Day 0-3) after primary vaccination dose

InterventionParticipants (Count of Participants)
Synflorix I Group4
Synflorix II Group0
Synflorix PRE Group14
Synflorix POST Group1
Mencevax + Infanrix Hexa Group16

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Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off

The cut-off for core fever was 38.0 degrees Celsius (ºC). (NCT00496015)
Timeframe: Within 4 days (Day 0-3) after primary vaccine dose.

InterventionParticipants (Count of Participants)
Synflorix I Group64
Synflorix II Group14
Synflorix PRE Group100
Synflorix POST Group16
Mencevax + Infanrix Hexa Group146

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Number of Subjects With New Acquisition Associated to H. Influentzae Detected in Nasopharyngeal Swabs.

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. (NCT00496015)
Timeframe: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

,
InterventionParticipants (Count of Participants)
M1M3M7M12Overall
Mencevax + Infanrix Hexa Group21223739104
Pooled Synflorix Group32404235129

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Number of Subjects Reported With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. (NCT00496015)
Timeframe: Throughout the entire study period (Month 0-Month 12)

InterventionParticipants (Count of Participants)
Synflorix I Group13
Synflorix II Group5
Synflorix PRE Group13
Synflorix POST Group4
Mencevax + Infanrix Hexa Group30

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Number of Subjects Reported With Unsolicited Adverse Events (AEs)

"The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group.~An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination." (NCT00496015)
Timeframe: Within 31 days (Days 0-30) after primary vaccine dose.

InterventionParticipants (Count of Participants)
Synflorix I Group22
Synflorix II Group3
Mencevax + Infanrix Hexa Group64
Pooled Synflorix PRE and POST Group30

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Number of Nasopharyngeal Swabs With S.Pneumoniae (Cross-reactive Serotypes)

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group. (NCT00496015)
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

,
InterventionSwabs (Number)
PreM1M3M7M12Overall
Mencevax + Infanrix Hexa Group131921191955
Pooled Synflorix Group152227211859

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Number of Nasopharyngeal Swabs With S.Pneumoniae (Non-vaccine and Non-cross-reactive Serotypes)

Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group. (NCT00496015)
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

,
InterventionSwabs (Number)
PreM1M3M7M12Overall
Mencevax + Infanrix Hexa Group263032292282
Pooled Synflorix Group2742454239111

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Number of Nasopharyngeal Swabs With S.Pneumoniae (Vaccine Serotypes)

Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group. (NCT00496015)
Timeframe: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall)

,
InterventionSwabs (Number)
PreM1M3M7M12Overall
Mencevax + Infanrix Hexa Group5347555043115
Pooled Synflorix Group4345494234111

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Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits.

Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol. (NCT00496015)
Timeframe: Up to 6 months after vaccination with Mencevax™

InterventionParticipants (Count of Participants)
Subject(s) with any rash(es)Subject(s) with any NOCI(s)Subject(s) with any ER visit(s)Subject(s) with any visit(s) at physician office
Mencevax + Infanrix Hexa Group71053

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Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 1 g IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)

"Pain Intensity (PI) as measured by a 100 millimeter (mm) long Visual Analogue Scale (VAS) over 24 hours after treatment minus the Baseline VAS score. The 100 mm VAS was drawn on a pain ruler and labeled at its left end with '0 = No Pain' and with 100 = Worst Pain Imaginable' at its right end. Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI at baseline was compared to the PI at each timepoint and differences were summed over the 24 hour time period." (NCT00564486)
Timeframe: Baseline to 24 hrs

InterventionUnits on a scale (Mean)
IV Placebo-45.2
IV Acetaminophen 1 gm-194.1

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Sum Pain Intensity Difference - Baseline to 24 Hours (SPID24), 650 mg IV Acetaminophen vs. Placebo (PI Was Measured at the Timepoints of T0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 18, 20, and 24 Hours.)

"Sum of Pain Intensity (PI) as measured by the 100 mm long Visual Analogue Scale (VAS) over 24 hours after treatment subtracting the Baseline VAS score.The 100 mm VAS was drawn on a pain ruler and labeled at it's left end with 0 = No Pain' and its right end with '100 = Worst Pain Imaginable.' Subjects placed a mark on the scale to represent their perceived pain. The score was the distance in mm from the left end of the VAS to the point where the subject's mark crossed the line. PI difference from baseline was calculated at each assessment over a 24 hour period." (NCT00564486)
Timeframe: Baseline to 24 hrs

InterventionUnits on a scale (Mean)
IV Placebo-45.2
IV Acetaminophen 650 mg-323.1

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The Number of Subjects Reporting a Treatment Emergent Adverse Event

"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)." (NCT00564486)
Timeframe: First dose through 7 day follow up

InterventionSubjects (Number)
IV Placebo68
IV Acetaminophen 1000 mg65
IV Acetaminophen 650 mg28

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The Number of Subjects Reporting a Treatment Emergent Serious Adverse Event

"The number of subjects who reported at least one treatment emergent SAE during the study.~A Serious Adverse Event is defined as any untoward medical occurrence at any dose of blinded study medication that:~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event" (NCT00564486)
Timeframe: First dose to 30 days after last dose of study medication.

InterventionSubjects (Number)
IV Placebo2
IV Acetaminophen 1 gm1
IV Acetaminophen 650 mg3

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Maximum Temperature Reduction Observed From T0 to T360 Minutes

This outcome measures the maximum core temperature reduction observed from T0 to T360 minutes. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. (NCT00564629)
Timeframe: T0-T360 minutes

InterventionDegrees Celsius (Mean)
IV APAP 1 g / 100 ml Solution-0.8
PO APAP 1 g-1.1

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WSTD3

This outcome measure is a statistical analysis of WSTD3, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 3 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. (NCT00564629)
Timeframe: 0-3 hours

Interventiondegrees Celsius (Mean)
IV APAP 1 g / 100 ml Solution0.2
PO APAP 1 g0.5

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WSTD5

This outcome measure is a statistical analysis of WSTD5, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 5 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. (NCT00564629)
Timeframe: 0-5 hours

Interventiondegrees Celsius (Mean)
IV APAP 1 g / 100 ml Solution-0.7
PO APAP 1 g-0.7

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WSTD4

This outcome measure is a statistical analysis of WSTD4, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 4 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. (NCT00564629)
Timeframe: 0-4 hours

Interventiondegrees Celsius (Mean)
IV APAP 1 g / 100 ml Solution-0.20
PO APAP 1 g-0.02

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The Rapidity of Onset of Antipyretic Effect at 2 Hours (Measured as Weighted Sum of Temperature Differences Over 2 Hours, WSTD2)

This outcome measures when the antipyretic effect begins by statistical analysis of WSTD2, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 2 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. (NCT00564629)
Timeframe: 0-2 hours

InterventionDegrees Celsius (Mean)
IV APAP 1 g / 100 ml Solution0.3
PO APAP 1 g0.6

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Time to a Reduction in Temperature From T0 to T360 Minutes.

This outcome measures how much time it took to observe a decrease in subjects' core body temperature by 0.8 ºC, 1.0 ºC, and 1.5 ºC from the temperature at T0 and from the temperature at the peak after T0 through T360 (6 hours). The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. (NCT00564629)
Timeframe: 6 hours

,
InterventionHours (Mean)
reduction in temperature of 0.8 ºC from T0 tempreduction in temp of 0.8 ºC from the peak T0-T360reduction in temperature of 1.0 ºC from T0 tempreduction in temp of 1.0 ºC from the peak T0-T360reduction in temperature of 1.5 ºC from T0 tempreduction in temp of 1.5 ºC from the peak T0-T360
IV APAP 1 g / 100 ml Solution4.83.55.13.85.75.1
PO APAP 1 g4.72.45.02.95.64.2

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The Percentage of Subjects With Temperature < 38 ºC and < 38.5 ºC at Any Timepoint During the Time From T0 to T360 Minutes

This outcome measures what percentage of total subjects had a temperature < 38 ºC and < 38.5 ºC at any timepoint during the time from T0 to T360 minutes. (NCT00564629)
Timeframe: T0 to T360 minutes

,
Interventionpercentage of participants (Number)
temperature < 38 ºCtemperature < 38.5 ºC
IV APAP 1 g / 100 ml Solution4084
PO APAP 1 g6792

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Subject's Global Evaluation of Study Medication at T360 Minutes

"This outcome measures how satisfied the subject was with the study treatment. The subject was asked to answer Overall, how would you rate study treatments? at T360 minutes using a 4-point categorical scale (0=poor, 1=fair, 2=good, 3=excellent)." (NCT00564629)
Timeframe: T360 minutes

,
Interventionparticipants (Number)
Poor (0)Fair (1)Good (2)Excellent (3)
IV APAP 1 g / 100 ml Solution071820
PO APAP 1 g221121

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WSTD6

This outcome measure is a statistical analysis of WSTD6, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 6 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder. (NCT00564629)
Timeframe: 0-6 hours

Interventiondegrees Celsius (Mean)
IV APAP 1 g / 100 ml Solution-1.4
PO APAP 1 g-1.7

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Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)

"Serious TEAE is any untoward medical occurrences at any dose of study medication that:~results in death~is life threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event" (NCT00598559)
Timeframe: First dose (T0) to within 30 days of the last dose of study medication.

InterventionParticipants (Number)
IV Acetaminophen 1 g q6h14
IV Acetaminophen 650 mg q4h11
Standard of Care (SOC)3

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Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.

Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7. (NCT00598559)
Timeframe: Study period lookback at Day 7

InterventionUnits on a scale (Mean)
IV Acetaminophen 1 g q6h2.4
IV Acetaminophen 650 mg q4h2.3
Standard of Care (SOC)2.2

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Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).

"Number of subjects who experienced at least one treatment emergent adverse event (TEAE).~A TEAE is an adverse event that occurs on or after the first dose of study medication (T0)." (NCT00598559)
Timeframe: T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up

InterventionParticipants (Number)
IV Acetaminophen 1 g q6h77
IV Acetaminophen 650 mg q4h86
Standard of Care (SOC)26

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Subject's (Parent/Guardian) Global Evaluation of Study Treatment

Subject's (parent/guardian) was asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair, 2=good, 3= excellent). (NCT00598702)
Timeframe: Day 0 to Day 5, Day 7 or Early Termination from study

,,,,,,,
Interventionparticipants (Number)
PoorFairGoodExcellentMissing
Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h0217230
Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h01350
Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h0011175
Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h00160
Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h00121
Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h00010
Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h00300
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h00010

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Physician's Global Assessment of Study Treatment

Physicians were asked to evaluate the overall study treatment using a 4-point categorical evaluation scale (0= poor, 1= fair,2=good, 3= excellent). (NCT00598702)
Timeframe: End of study or Early Termination

,,,,,,,
Interventionparticipants (Number)
PoorFairGoodExcellentMissing
Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h0116250
Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h00450
Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h0015135
Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h00160
Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h00121
Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h00010
Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h00210
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h00010

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Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)

A TEAE is defined as an adverse event that starts on or after the start of study medication. (NCT00598702)
Timeframe: First dose to end of treatment period

InterventionSubjects (Number)
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h1
Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h1
Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h5
Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h25
Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h9
Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h35
Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h0
Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h2

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Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event

"A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that;~results in death~is life-threatening~requires inpatient hospitalization or causes prolongation of existing hospitalization~results in persistent or significant disability/incapacity~is a congenital anomaly/birth defect~is an important medical event" (NCT00598702)
Timeframe: First dose to 30 days after last dose

InterventionSubjects (Number)
Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h1
Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h1
Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h0
Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h13
Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h2
Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h3
Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h0
Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h1

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Alanine Aminotransferase (ALT)

ALT was measured at Day 0, 4, 7, 9, 11, and 14. (NCT00616018)
Timeframe: Day 0, 4, 7, 9, 11, and 14.

InterventionIU/L (Mean)
Day 0Day 4Day 7Day 9Day 11Day 14
Acetaminophen24.025.941.341.341.836.1

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Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts

Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum. (NCT00616018)
Timeframe: Day 0, 4, 7, 9, 11, and 14.

Interventionnmol/mL (Mean)
Day 0Day 4Day 7Day 9Day 11Day 14
Acetaminophen0.00.30.30.40.40.2

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Overall Assessment of Study Medication by Participants

Overall assessment of study medication was done by participants. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good. (NCT00634543)
Timeframe: Day 43

,
InterventionPercentage of participants (Number)
BadNo changeGoodVery good
Gabapentin12.529.241.716.7
Tramadol Hydrochloride/ Acetaminophen4.529.950.814.9

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Change From Baseline in Pain Intensity Score at Day 43

Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine. (NCT00634543)
Timeframe: Baseline and Day 43

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 43
Gabapentin6.302.76
Tramadol Hydrochloride/ Acetaminophen6.653.15

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Change From Baseline in Short Form-36 (SF-36) Score at Day 43

The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health and mental health. Physical health includes physical functioning, role limitations due to physical health, pain and general health. Mantal health includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. (NCT00634543)
Timeframe: Baseline and Day 43

,
InterventionUnits on a scale (Mean)
Baseline: Phiysical functioning (n=71,76)Change at Day 43: Physical functioning (n=63, 68))Baseline: Physical role limitation (n=71,76)Change at Day 43:Physical role limitation(n=62,68)Baseline: Pain (n=71,76)Change at Day 43: Pain (n=63, 68)Baseline: General health (n=71,76)Change at Day 43: General health (n=63, 68)Baseline: Emotional role limitation (n=71,76)Change at Day43:Emotional role limitation(n=63,68)Baseline: Energy/Fatigue (n=71,76)Change at Day 43: Energy/Fatigue (n=63, 68)Baseline: Emotional well-being (n=71,76)Change at Day 43: Emotional well being (n=63, 68)Baseline: Social functioning (n=71,76)Change at Dya 43: Social functioning (n=63, 68)
Gabapentin60.63.249.310.750.810.440.34.450.418.142.610.061.47.072.25.5
Tramadol Hydrochloride/ Acetaminophen56.33.242.313.749.315.638.04.646.912.739.45.757.25.368.39.9

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Overall Assessment of Study Medication by Investigator

Overall assessment of study medication was done by Investigator. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good. (NCT00634543)
Timeframe: Day 43

,
InterventionPercentage of participants (Number)
BadNo changeGoodVery good
Gabapentin2.830.651.415.3
Tramadol Hydrochloride/ Acetaminophen031.350.817.9

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Percentage of Participants With Pain Relief

Pain relief was assessed on a scale ranging from -1 to 4, where -1=became worse, 0=no change, 1=relieved a little, 2=relieved moderately, 3=relieved a lot and 4=completely resolved. (NCT00634543)
Timeframe: Day 15, Day 29 and Day 43

,
InterventionPercentage of Participants (Number)
Day 15: Became worseDay 15: No changeDay 15: Relieved a littleDay 15: Relieved moderatelyDay 15: Relieved a lotDay 15: Completely resolvedDay 29: Became worseDay 29: No changeDay 29: Relieved a littleDay 29: Relieved moderatelyDay 29: Relieved a lotDay 29: Completely resolvedDay 43: Became worseDay 43: No changeDay 43: Relieved a littleDay 43: Relieved moderatelyDay 43: Relieved a lotDay 43: Completely resolved
Gabapentin4.014.534.221.126.30.01.310.529.014.544.70.01.311.825.015.842.14.0
Tramadol Hydrochloride/ Acetaminophen1.412.731.026.826.81.44.29.925.421.138.01.42.87.022.519.746.51.4

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Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43

The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Pain severity score is caculated by sum of all severity items (pain worst, pain least, pain average and pain now) divided by pain now. Total score for pain severity ranges from 0=no pain to 10=extreme pain. Pain interference score was calculated by sum of all interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) score. Total score for pain interference ranges from 0=no interference to 70= interferes completely. (NCT00634543)
Timeframe: Baseline and Day 43

,
InterventionUnits on a scale (Mean)
Baseline: Pain severity score (n=68, 73)Change at Day 43: Pain severity score (n=60, 60)Baseline: Pain interference score (n=71, 76)Change at Day 43:Pain interference score(n=63, 68)
Gabapentin4.90.129.8-8.8
Tramadol Hydrochloride/ Acetaminophen4.50.130.2-11.0

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Number of Participants With Categorical Swelling

Swelling was assessed by using a 4-point scale ranging from 0 to 3 where, 0=no swelling, 1=presence of cross fluctuation of fluid (PCFF), 2=patellar ballotment, and 3=swelling that distort the joint contours (SDJC). (NCT00635349)
Timeframe: Day 29, Day 57 and Day 85

,
Interventionparticipants (Number)
Day 29; No swelling (n=56, 52)Day 29; PCFF (n=56, 52)Day 57; No swelling (n=47, 41)Day 57; PCFF (n=47, 41)Day 85; No swelling (n=55, 56)Day 85; PCFF (n=55, 56)Day 85; Patellar ballotment (n=55, 56)
Non-steroidal Anti-inflammatory Drugs (NSAIDs)5244345311
Tramadol Hydrochloride Plus Acetaminophen4573834691

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Change From Day 29 in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total Score at Day 85

The WOMAC is a self-administered and health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a visual analog scale (VAS) of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best. (NCT00635349)
Timeframe: Day 29 and Day 85

,
Interventionunits on a scale (Mean)
Day 29Change at Day 85
Non-steroidal Anti-inflammatory Drugs (NSAIDs)33.54-1.88
Tramadol Hydrochloride Plus Acetaminophen39.44-0.07

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Number of Participants With Overall Assessment on Study Drug by Investigator

Investigator was completed overall assessment on study drug by using a 5-point scale (-2 to 2; where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good). Study drug refers specifically to the randomized treatment received from Day 29 to Day 85. (NCT00635349)
Timeframe: Day 85

,
Interventionparticipants (Number)
Very badBadModerateGoodVery good
Non-steroidal Anti-inflammatory Drugs (NSAIDs)1121313
Tramadol Hydrochloride Plus Acetaminophen0625242

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Number of Participants With Categorical Tenderness

Tenderness was assessed by using a 4-point scale 0 to 3 where, 0= no tenderness, 1= complaint of tenderness, 2=complaint of tenderness with wincing (CTW), and 3=wincing and attempt to withdraw. (NCT00635349)
Timeframe: Day 29, Day 57 and Day 85

,
Interventionparticipants (Number)
Day 29; No tenderness(n=56, 52)Day 29; Complaint of tenderness (n=56, 52)Day 29; CTW (n=56, 52)Day 29; Wincing and attempt to withdraw (n=56, 52)Day 57; No tenderness(n=47, 41)Day 57; Complaint of tenderness (n=47, 41)Day 57; CTW (n=47, 41)Day 57; wincing and attempt to withdraw(n=47, 41)Day 85; No tenderness(n=55, 56)Day 85; Complaint of tenderness (n=55, 56)Day 85; CTW (n=55, 56)Day 85; Wincing and attempt to withdraw(n=55, 56)
Non-steroidal Anti-inflammatory Drugs (NSAIDs)332201331400391501
Tramadol Hydrochloride Plus Acetaminophen371410301010441020

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Change From Day 29 in Pain Intensity Score at Day 85

Pain intensity was evaluated by 11- point numeric rating scale ranging from 0 to 10 where, 0=no pain and 10=pain as bad as you can imagine. (NCT00635349)
Timeframe: Day 29 and Day 85

,
Interventionunits on a scale (Mean)
Day 29Change at Day 85
Non-steroidal Anti-inflammatory Drugs (NSAIDs)3.820.14
Tramadol Hydrochloride Plus Acetaminophen3.810.83

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Number of Participants With Pain Relief

Pain relief was assessed by using a 6-point scale ranging from -1 to 4 where, -1=pain aggravated, 0=no change, 1=slightly relieved, 2=moderately relieved, 3=considerably relieved, and 4=pain completely disappeared. Participants with pain slightly relieved, moderately relieved and completely disappeared were considered as pain relieved. (NCT00635349)
Timeframe: Day 29, Day 57 and Day 85

,
Interventionparticipants (Number)
Day 29; Pain relieved (n=56, 52)Day 57; Pain relieved (n=47, 41)Day 85; Pain relieved (n=55, 56)
Non-steroidal Anti-inflammatory Drugs (NSAIDs)493242
Tramadol Hydrochloride Plus Acetaminophen422835

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Number of Participants With Overall Assessment on Study Drug by Participants

Participants' overall assessment on study drug was done by using a 5-point scale ranging from -2 to 2 where, -2= very bad, 1= bad, 0=moderate, 1=good and 2=very good. Study drug refers specifically to the randomized treatment received from Day 29 to Day 85. (NCT00635349)
Timeframe: Day 85

,
Interventionparticipants (Number)
Very badBadModerateGoodVery good
Non-steroidal Anti-inflammatory Drugs (NSAIDs)1221294
Tramadol Hydrochloride Plus Acetaminophen11122212

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Percent Change in Serum Thromboxane B2

Thromboxan B2 is a stable metabolite of thromboxane A2. Thromboxane B2 formation during clotting of whole blood (37 degrees Celsius, 1 hour) is reflective of the capacity of platelets to form thromboxane A2. Serum Thromboxane B2 was measured by radio-immuno assay. The quantity of interest was percent change from start (8:00 am on day 1) to finish (8:00 am on last day) of each crossover period in serum thromboxane B2. This was calculated as: 100%*(value at start of period minus value at end of period)/value at start of period. (NCT00646906)
Timeframe: 7 days (Phase 1a and 1b), 4 days (Phase 2)

InterventionPercent inhibition of baseline (Mean)
Phase 1a: Acetaminophen 1000 mg / Aspirin First97.0
Phase 1a: Acetaminophen 1000 mg / Aspirin Last97.4
Phase 1a: Acetaminophen 2000 mg / Aspirin First98.3
Phase 1a: Acetaminophen 2000 mg / Aspirin Last96.7
Phase 1b: Acetaminophen 1000 mg/d-6.5
Phase 2: Acetaminophen 4000 mg/d21.9
Phase 2: Ibuprofen 800 mg/d62.6

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Percent Change in Arachidonic Acid Induced Platelet Aggregation

Platelet aggregation was induced by 500 micro molar arachidonic acid using a Chronolog aggregometer. The quantity of interest was percent change from start (8:00 am on day 1) to finish (8:00 am on last day) of each crossover period in platelet aggregation. This was calculated as: 100%*(value at start of period minus value at end of period)/value at start of period. (NCT00646906)
Timeframe: 7 days (only Phase 1a)

InterventionPercent inhibition of baseline (Mean)
Phase 1a: Acetaminophen 1000 mg / Aspirin First93
Phase 1a: Acetaminophen 1000 mg / Aspirin Last93
Phase 1a: Acetaminophen 2000 mg / Aspirin First95
Phase 1a: Acetaminophen 2000 mg / Aspirin Last90

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Swiss Spinal Stenosis Score- Physical Function

The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo2.5
Opana Then Placebo Then Darvocet2.5
Placebo Then Opana Then Darvocet2.6
Placebo Then Darvocet Then Opana2.6
Darvocet Then Opana Then Placebo2.6
Darvocet Then Placebo Then Opana2.2

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Visual Analog Scale (VAS)

The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo51.3
Opana Then Placebo Then Darvocet57.9
Placebo Then Opana Then Darvocet56.2
Placebo Then Darvocet Then Opana46.7
Darvocet Then Opana Then Placebo63.3
Darvocet Then Placebo Then Opana55.1

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Total Distance

Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill. (NCT00652093)
Timeframe: study visit

Interventionmeters (Mean)
Opana Then Darvocet Then Placebo266.6
Opana Then Placebo Then Darvocet249.5
Placebo Then Opana Then Darvocet177.9
Placebo Then Darvocet Then Opana290.1
Darvocet Then Opana Then Placebo160.8
Darvocet Then Placebo Then Opana294.8

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Area Under the Curve

Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale * minutes (Mean)
Opana Then Darvocet Then Placebo76.0
Opana Then Placebo Then Darvocet95.7
Placebo Then Opana Then Darvocet95.0
Placebo Then Darvocet Then Opana86.4
Darvocet Then Opana Then Placebo123.3
Darvocet Then Placebo Then Opana79.6

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Final Pain

Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo4.6
Opana Then Placebo Then Darvocet6.6
Placebo Then Opana Then Darvocet6.2
Placebo Then Darvocet Then Opana6.7
Darvocet Then Opana Then Placebo8.0
Darvocet Then Placebo Then Opana7.1

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Modified Brief Pain Inventory (mBPI)- Interference Score

The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo3.7
Opana Then Placebo Then Darvocet4.2
Placebo Then Opana Then Darvocet2.7
Placebo Then Darvocet Then Opana4.3
Darvocet Then Opana Then Placebo6.2
Darvocet Then Placebo Then Opana2.8

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Oswestry Disability Index (ODI) Score

The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo37.9
Opana Then Placebo Then Darvocet98.4
Placebo Then Opana Then Darvocet38.0
Placebo Then Darvocet Then Opana44.1
Darvocet Then Opana Then Placebo37.0
Darvocet Then Placebo Then Opana29.7

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Patient Global Assessment (PGA)

Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo2.8
Opana Then Placebo Then Darvocet2.8
Placebo Then Opana Then Darvocet3.1
Placebo Then Darvocet Then Opana2.6
Darvocet Then Opana Then Placebo3.3
Darvocet Then Placebo Then Opana2.6

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Recovery Time

After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes. (NCT00652093)
Timeframe: study visit

Interventionminutes (Mean)
Opana Then Darvocet Then Placebo1.10
Opana Then Placebo Then Darvocet1.50
Placebo Then Opana Then Darvocet2.02
Placebo Then Darvocet Then Opana1.58
Darvocet Then Opana Then Placebo2.15
Darvocet Then Placebo Then Opana1.57

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Roland Morris Disability Questionnaire (RMDQ)

The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled). (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo12.8
Opana Then Placebo Then Darvocet15.3
Placebo Then Opana Then Darvocet13.2
Placebo Then Darvocet Then Opana15.2
Darvocet Then Opana Then Placebo13.7
Darvocet Then Placebo Then Opana7.4

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Swiss Spinal Stenosis Score- Symptom Severity

The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity. (NCT00652093)
Timeframe: study visit

Interventionunits on a scale (Mean)
Opana Then Darvocet Then Placebo2.6
Opana Then Placebo Then Darvocet2.9
Placebo Then Opana Then Darvocet3.2
Placebo Then Darvocet Then Opana3.2
Darvocet Then Opana Then Placebo3.6
Darvocet Then Placebo Then Opana2.9

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Time to First Symptoms (Tfirst) of Moderate Pain

Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10. (NCT00652093)
Timeframe: study visit

Interventionminutes (Mean)
Opana Then Darvocet Then Placebo1.73
Opana Then Placebo Then Darvocet3.02
Placebo Then Opana Then Darvocet3.93
Placebo Then Darvocet Then Opana2.65
Darvocet Then Opana Then Placebo0.83
Darvocet Then Placebo Then Opana5.43

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Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT00662818)
Timeframe: Up to 48 hours post-dose (Up to 14 weeks)

InterventionParticipants (Number)
Telcagepant 300 mg0
APAP0

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Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose

SPF from 2 to 24 hours post-dose is defined as PF at 2 hours, with no administration of either rescue medication or the optional second dose and with no occurrence thereafter of a mild/moderate/severe headache during the 2 to 24 hours after dosing with the study medication. (NCT00662818)
Timeframe: Up to 24 hours post-dose (Up to 14 weeks)

InterventionPercentage of Participants (Number)
Telcagepant 300 mg19.2
Placebo15.4

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Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)

Pain Relief (PR) at 2 hours post-dose (first migraine attack), with pain relief defined as a reduction in headache severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-dose. Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. (NCT00662818)
Timeframe: 2 hours post-dose (Up to 6 weeks)

InterventionPercentage of Participants (Number)
Telcagepant 300 mg63.5
Placebo56.6

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Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)

Pain Freedom (PF) at 2 hours post-dose (Period 1, Attack 1) defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at baseline to no pain (Grade 0). Headache severity was subjectively rated by the participant at predefined time points on a scale of Grade 0 to Grade 3: Grade 0 - No pain; Grade 1 - Mild pain; Grade 2 - Moderate Pain; and Grade 3 - Severe Pain. (NCT00662818)
Timeframe: 2 hours post-dose (Up to 6 weeks)

InterventionPercentage of participants (Number)
Telcagepant 300 mg25.0
Placebo18.9

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Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)

The participant recorded whether photophobia (sensitivity to light) was present or absent at each of the predefined time points. (NCT00662818)
Timeframe: 2 Hours post-dose (Up to 6 weeks)

InterventionPercentage of Participants (Number)
Telcagepant 300 mg53.8
Placebo58.5

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Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)

The participant recorded whether phonophobia (sensitivity to sound) was present or absent at each of the predefined time points. (NCT00662818)
Timeframe: 2 hours post-dose (Up to 6 weeks)

InterventionPercentage of participants (Number)
Telcagepant 300 mg65.4
Placebo58.5

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Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)

The participant recorded whether nausea was present or absent at each of the predefined time points. (NCT00662818)
Timeframe: 2 hours post-dose (Up to 6 weeks)

InterventionPercentage of Participants (Number)
Telcagepant 300 mg80.8
Placebo69.8

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Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose

Confirmed Vascular Event included cardiac events, cerebrovascular events, and peripheral vascular events. (NCT00662818)
Timeframe: Up to 48 hours after the dose of any study medication (Up to 14 weeks)

InterventionParticipants (Number)
Telcagepant 300 mg0
APAP0

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Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT00662818)
Timeframe: Within 14 days of any dose of study medication (Up to 16 weeks)

InterventionParticipants (Number)
Telcagepant 300 mg21
Acetaminophen/Paracetamol (APAP)14

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Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication

Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain. (NCT00694369)
Timeframe: At 24 hours post the initial Day 1 dose of the study medication

,,,,
InterventionParticipants (Number)
PoorFairGoodVery GoodExcellent
Acetaminophen 2400 mg/Codeine 240 mg11315187
Etoricoxib 120 mg75202628
Etoricoxib 90 mg1212436651
Ibuprofen 2400 mg624427335
Placebo1912553

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Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)

TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24. (NCT00694369)
Timeframe: Over the first 6 hours post the initial Day 1 dose of the study medication

InterventionUnits on a Scale (Least Squares Mean)
Placebo5.08
Etoricoxib 90 mg16.10
Etoricoxib 120 mg15.73
Ibuprofen 2400 mg15.67
Acetaminophen 2400 mg/Codeine 240 mg11.83

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected one day before radiofrequency (J-1)." (NCT00712712)
Timeframe: Algology assessment one day before radiofrequency (J-1)

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases2.05.07.0

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Standardised Quality of Life Scores (EORTC - QLQ-C30)

"Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions :~5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties;~1 global health dimension: Global health status/QoL~Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health." (NCT00712712)
Timeframe: 2 months after radiofrequency

Interventionscore on a scale (Median)
Physical functioningRole functioningEmotional functioningCognitive functioningSocial functioningGlobal health status/QoLFatigueNausea and vomitingPainDyspnoeaInsomniaAppetite lossConstipationDiarrhoeaFinancial difficulties
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.050.062.550.050.050.055.60.050.033.333.333.333.30.00.0

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Standardised Quality of Life Scores (EORTC - QLQ-C30)

"Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions :~5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties;~1 global health dimension: Global health status/QoL~Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health." (NCT00712712)
Timeframe: Inclusion

Interventionscore on a scale (Median)
Physical functioningRole functioningEmotional functioningCognitive functioningSocial functioningGlobal health status/QoLFatigueNausea and vomitingPainDyspnoeaInsomniaAppetite lossConstipationDiarrhoeaFinancial difficulties
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases46.733.358.366.733.341.766.716.783.333.333.30.033.30.00.0

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected at the discharge from hospital visit." (NCT00712712)
Timeframe: Algology assessment at the discharge from hospital visit

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases0.02.03.0

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.0

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Total Intravenous Morphine Dose (mg)

"Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay.~As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA)." (NCT00712712)
Timeframe: 24 hours after radiofrequency

Interventionmg (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases3.0

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected 1 month after radiofrequency." (NCT00712712)
Timeframe: Algology assessment 1 month after radiofrequency

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases0.02.03.0

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: J-1 (One day before radiofrequency)

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.0

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: Inclusion: Second algology visit (One week after the first algology visit)

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.0

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: Discharge from hospital

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.0

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: 7 days after discharge

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.0

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: 3 months after radiofrequency

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases50.0

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Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)

"Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale~Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation.~This rate is calculated for the evaluable population for the principal outcome measure.~This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population.~The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III." (NCT00712712)
Timeframe: 2 months after radiofrequency ablation (RFA)

Interventionpercentage of participants (Number)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases83.6

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: 2 months after radiofrequency

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.0

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Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day

"Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned.~In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day.~This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency." (NCT00712712)
Timeframe: 1 month after radiofrequency

Interventionmg morphine equivalents/day (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases60.0

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Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)

As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA). (NCT00712712)
Timeframe: 24 hours after radiofrequency

Interventionmg (Median)
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases1.0

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected 2 months after radiofrequency." (NCT00712712)
Timeframe: Algology assessment 2 months after radiofrequency

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases0.02.03.0

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected 3 months after radiofrequency." (NCT00712712)
Timeframe: Algology assessment 3 months after radiofrequency

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases0.01.02.5

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected 7 days after discharge from hospital." (NCT00712712)
Timeframe: Algology assessment 7 days after discharge from hospital

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases0.02.06.0

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected at the inclusion visit." (NCT00712712)
Timeframe: Second algology assessment at inclusion visit

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases2.05.08.0

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected at the pre-selection visit." (NCT00712712)
Timeframe: First algology assessment at pre-selection visit

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases0.55.08.0

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Intensity of Pain (Minimum, Average, Maximum)

"According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency.~Assessment of intensity of pain has been done in this order at:~Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation,~Inclusion visit: Second algology assessment (One week after the first algology assessment)~J-1: one day before radiofrequency~J+1: One day after radiofrequency~Discharge from hospital~7 days after discharge from hospital~1 month after radiofrequency~2 months after radiofrequency~3 months after radiofrequency~Here, are presented only data collected one day after radiofrequency (J+1)." (NCT00712712)
Timeframe: Algology assessment one day after radiofrequency: J+1

Interventionscore on a scale (Median)
Minimal painAverage painMaximum pain
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases0.02.04.0

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Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period

The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. (NCT00736853)
Timeframe: Day 1, and Day 8 of open-label period

Interventionunits on a scale (Mean)
Day 1 (n=274)Day 8 (n=219)
Tramadol Hydrochloride and Acetaminophen (Open-Label)0.90.5

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Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period

The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. (NCT00736853)
Timeframe: Day 1, 8, 15, 22 and 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1 (n=84, 89)Day 8 (n=74, 48)Day 15 (n=67, 41)Day 22 (n=63, 40)Day 28 (n=72, 47)
Placebo (Double-Blind)0.10.30.40.50.4
Tramadol Hydrochloride and Acetaminophen (Double-Blind)0.40.50.40.40.4

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Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period

The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. (NCT00736853)
Timeframe: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period

Interventionunits on a scale (Mean)
Day 1; 2 hours after dosing (n=274)Day 1; 4 hours after dosing (n=274)Day 8; 2 hours after dosing (n=219)Day 8; 4 hours after dosing (n=219)
Tramadol Hydrochloride and Acetaminophen (Open-Label)1.61.91.92.2

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Mean PID During the Double-Blind Period

The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. (NCT00736853)
Timeframe: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1; 2 hours after dosing (n=84, 89)Day 1; 4 hours after dosing (n=84, 89)Day 8; 2 hours after dosing (n=74, 48)Day 8; 4 hours after dosing (n=74, 48)Day 15; 2 hours after dosing (n=67, 41)Day 15; 4 hours after dosing (n=67, 41)Day 22; 2 hours after dosing (n=63, 40)Day 22; 4 hours after dosing (n=63, 40)Day 28; 2 hours after dosing (n=72, 47)Day 28; 4 hours after dosing (n=72, 47)
Placebo (Double-Blind)0.10.10.10.20.20.20.20.20.20.2
Tramadol Hydrochloride and Acetaminophen (Double-Blind)0.20.20.20.30.10.30.10.20.20.3

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Mean PI Score During Double-Blind Period

The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. (NCT00736853)
Timeframe: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1; Pre-dose (n=84, 89)Day 1; 2 hours after dosing (n=84, 89)Day 1; 4 hours after dosing (n=84, 89)Day 8; Pre-dose (n=74, 48)Day 8; 2 hours after dosing (n=74, 48)Day 8; 4 hours after dosing (n=74, 48)Day 15; Pre-dose (n=67, 41)Day 15; 2 hours after dosing (n=67, 41)Day 15; 4 hours after dosing (n=67, 41)Day 22; Pre-dose (n=63, 40)Day 22, 2 hours after dosing (n=63, 40)Day 22; 4 hours after dosing (n=63, 40)Day 28; Pre-dose (n=72, 47)Day 28; 2 hours after dosing (n=72, 47)Day 28; 4 hours after dosing (n=72, 47)
Placebo (Double-Blind)1.21.11.11.21.11.11.11.00.91.21.01.01.21.01.0
Tramadol Hydrochloride and Acetaminophen (Double-Blind)1.21.01.01.21.00.91.11.00.81.11.00.91.11.00.9

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Mean PAR Score During the Double-Blind Period

PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. (NCT00736853)
Timeframe: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1; 2 hours after dosing (n=84, 89)Day 1; 4 hours after dosing (n=84, 89)Day 8; 2 hours after dosing (n=74, 48)Day 8; 4 hours after dosing (n=74, 48)Day 15; 2 hours after dosing (n=67, 41)Day 15; 4 hours after dosing (n=67, 41)Day 22; 2 hours after dosing (n=63, 40)Day 22; 4 hours after dosing (n=63, 40)Day 28; 2 hours after dosing (n=72, 47)Day 28; 4 hours after dosing (n=72, 47)
Placebo (Double-Blind)1.11.21.21.41.71.71.81.81.61.7
Tramadol Hydrochloride and Acetaminophen (Double-Blind)1.71.81.91.92.12.12.12.22.12.1

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Mean Pain Relief (PAR) Score During the Open-Label Period

PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. (NCT00736853)
Timeframe: 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period

Interventionunits on a scale (Mean)
Day 1; 2 hours after dosing (n=274)Day 1; 4 hours after dosing (n=274)Day 8; 2 hours after dosing (n=219)Day 8; 4 hours after dosing (n=219)
Tramadol Hydrochloride and Acetaminophen (Open-Label)1.21.41.71.8

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Mean Pain Intensity Difference (PID) During the Open-Label Period

The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. (NCT00736853)
Timeframe: Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period

Interventionunits on a scale (Mean)
Day 1; 2 hours after dosing (n=274)Day 1; 4 hours after dosing (n=274)Day 8; 2 hours after dosing (n=219)Day 8; 4 hours after dosing (n=219)
Tramadol Hydrochloride and Acetaminophen (Open-Label)0.40.50.20.3

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Mean Pain Intensity (PI) Score During Open-Label Period

PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. (NCT00736853)
Timeframe: Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period

Interventionunits on a scale (Mean)
Day 1; Pre-dose (n=275)Day 1; 2 hours after dosing (n=274)Day 1; 4 hours after dosing (n=274)Day 8; Pre-dose (n=219)Day 8; 2 hours after dosing (n=219)Day 8; 4 hours after dosing (n=219)
Tramadol Hydrochloride and Acetaminophen (Open-Label)1.71.21.11.21.00.9

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Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period

Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. (NCT00736853)
Timeframe: Day 1 of open-label period and Day 1 of double-blind period

Interventionmm (Mean)
Day 1 of open-label periodChange at Day 1 of double-blind period
Tramadol Hydrochloride and Acetaminophen (Open-Label)66.27-28.17

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Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period

Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. (NCT00736853)
Timeframe: Day 1 and Day 28 of double-blind period

,
Interventionmm (Mean)
Day 1Change at Day 28
Placebo (Double-Blind)31.186.21
Tramadol Hydrochloride and Acetaminophen (Double-Blind)30.33-0.67

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Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period

The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. (NCT00736853)
Timeframe: Day 1 and Day 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1; Pain (n=39, 36)Change at Day 28; Pain (n=39, 36)Day 1; Stiffness (n=39, 36)Change at Day 28; Stiffness (n=39, 36)Day 1; EODA (n=39, 36)Change at Day 28; EODA (n=39, 36)Day 1; General index (n=39, 36)Change at Day 28; General index (n=39, 36)
Placebo (Double-Blind)2.20.52.40.21.90.42.20.4
Tramadol Hydrochloride and Acetaminophen (Double-Blind)2.6-0.32.7-0.22.3-0.52.5-0.4

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period

The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. (NCT00736853)
Timeframe: Day 1 and Day 14 of open-label period

Interventionunits on a scale (Mean)
Day 1; Pain (n=117)Change at Day 14; Pain (n=90)Day 1; Stiffness (n=117)Change at Day 14; Stiffness (n=90)Day 1; EODA (n=117)Change at Day 14; EODA (n=90)Day 1; General index (n=117)Change at Day 14; General index (n=90)
Tramadol Hydrochloride and Acetaminophen (Open-Label)4.4-1.94.2-1.53.7-1.54.1-1.7

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Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period

The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. (NCT00736853)
Timeframe: Day 1 and Day 14 of open-label period

Interventionunits on a scale (Mean)
Day 1; Physical functioning (n=277)Change at Day 14; Physical functioning (n=216)Day 1; Role-physical (n=216)Change at Day 14; Role-physical (n=216)Day 1; Bodily pain (n=277)Change at Day 14; Bodily pain (n=216)Day 1; General health (n=277)Change at Day 14; General health (n=216)Day 1; Vitality (n=277)Change at Day 14; Vitality (n=216)Day 1; Social functioning (n=277)Change at Day 14; Social functioning (n=277)Day 1; Role-emotional (n=277)Change at Day 14; Role-emotional (n=216)Day 1; Mental health (n=277)Change at Day 14; Mental health (n=216)
Tramadol Hydrochloride and Acetaminophen (Open-Label)34.33.937.04.334.85.445.42.745.12.343.52.043.22.546.82.8

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Change From Baseline in SF-36 at Day 28 of Double-Blind Period

The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. (NCT00736853)
Timeframe: Day 1 and Day 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1; Physical functioning (n=94,93)Change at Day 28; Physical functioning (n=94,93)Day 1; Role-physical (n=94,93)Change at Day 28; Role-physical (n=94,93)Day 1; Bodily pain (n=94,93)Change at Day 28; Bodily pain (n=94,93)Day 1; General health (n=94,93)Change at Day 28; General health (n=94,93)Day 1; Vitality (n=94,93)Change at Day 28; Vitality (n=94,93)Day 1; Social functioning (n=94,93)Change at Day 28; Social functioning (n=94,93)Day 1; Role-emotional (n=94,93)Change at Day 28; Role-emotional (n=94,93)Day 1; Mental health (n=94,93)Change at Day 28; Mental health (n=94,93)
Placebo (Double-Blind)39.7-1.641.8-0.639.30.348.0-1.247.40.145.70.445.8-1.049.6-0.7
Tramadol Hydrochloride and Acetaminophen (Double-Blind)39.01.140.50.841.02.449.10.447.33.146.41.646.70.050.42.2

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Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period

The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. (NCT00736853)
Timeframe: Day 1 and Day 14 of open-label period

Interventionunits on a scale (Mean)
Day 1 (n=160)Change at Day 14 (n=126)
Tramadol Hydrochloride and Acetaminophen (Open-Label)9.1-2.6

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Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period

The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. (NCT00736853)
Timeframe: Day 1 and Day 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1 (n=55, 57)Change at Day 28 (n=55, 57)
Placebo (Double-Blind)6.00.8
Tramadol Hydrochloride and Acetaminophen (Double-Blind)6.5-0.5

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Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period

The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief. (NCT00736853)
Timeframe: Day 28 of double-blind period

Interventionnumber of participants (Number)
Tramadol Hydrochloride and Acetaminophen (Double-Blind)20
Placebo (Double-Blind)43

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Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period

The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. (NCT00736853)
Timeframe: 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1; 2 hours after dosing (n=84, 89)Day 1; 4 hours after dosing (n=84, 89)Day 8; 2 hours after dosing (n=74, 48)Day 8; 4 hours after dosing (n=74, 48)Day 15; 2 hours after dosing (n=67, 41)Day 15; 4 hours after dosing (n=67, 41)Day 22; 2 hours after dosing (n=63, 40)Day 22; 4 hours after dosing (n=63, 40)Day 28; 2 hours after dosing (n=72, 47)Day 28; 4 hours after dosing (n=72, 47)
Placebo (Double-Blind)1.21.21.41.61.81.92.02.11.81.9
Tramadol Hydrochloride and Acetaminophen (Double-Blind)1.92.02.12.32.22.42.32.42.22.4

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Total Pain Relief (TOTPAR) Score During the Open-Label Period

The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. (NCT00736853)
Timeframe: Day 1 and Day 8 of open-label period

Interventionunits on a scale (Mean)
Day 1 (n=274)Day 8 (n=219)
Tramadol Hydrochloride and Acetaminophen (Open-Label)2.63.5

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Total Pain Relief (TOTPAR) Score During the Double-Blind Period

The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. (NCT00736853)
Timeframe: Day 1, 8, 15, 22 and 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1 (n=84, 89)Day 8 (n=74, 48)Day 15 (n=67, 41)Day 22 (n=63, 40)Day 28 (n=72, 47)
Placebo (Double-Blind)2.32.63.33.63.3
Tramadol Hydrochloride and Acetaminophen (Double-Blind)3.53.84.14.34.2

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Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period

The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief. (NCT00736853)
Timeframe: Day 1, and Day 8 of open-label period

Interventionunits on a scale (Mean)
Day 1 (n=274)Day 8 (n=219)
Tramadol Hydrochloride and Acetaminophen (Open-Label)3.54.1

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Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period

The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. (NCT00736853)
Timeframe: Day 1, 8, 15, 22 and 28 of double-blind period

,
Interventionunits on a scale (Mean)
Day 1 (n=84, 89)Day 8 (n=74, 48)Day 15 (n=67, 41)Day 22 (n=63, 40)Day 28 (n=72, 47)
Placebo (Double-Blind)2.43.03.74.03.7
Tramadol Hydrochloride and Acetaminophen (Double-Blind)3.94.34.64.74.6

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Pain Relief Combined With Pain Intensity Difference (PRID) at Week 4

PRID was sum of the PID and PAR for each participant at each evaluation time point (2 hours after dosing, 4 hours after dosing). Pain Intensity was evaluated on a 4-stage scale ranges from 3=severe pain to 0=no pain and PID ranges from -3 (the worst) to +3 (the most improved). PAR ranges from 0 (no improved) to +4 (the most improved). PRID ranges from -3 (the worst) to +7 (the most improved). (NCT00736957)
Timeframe: Week 4

Interventionunits on scale (Mean)
2 hours after dosing at Week 44 hours after dosing at Week 4
Tramadol Hydrochloride Plus Acetaminophen (JNS013)1.31.4

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Change From Baseline in VAS24 Score at Week 52

Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement. (NCT00736957)
Timeframe: Baseline and Week 52

Interventionmillimeter (Mean)
BaselineChange at Week 52
Tramadol Hydrochloride Plus Acetaminophen (JNS013)65.80-36.54

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Change From Baseline in Short Form-36 (SF-36) Score

SF-36 is a metric for general health and Quality of Life (QOL), consists of 8 sub-scale indices related to health and QOL (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each of the sub-scale scores ranged from 0 to 100, where higher values indicate a better health status or a better mental status. (NCT00736957)
Timeframe: Baseline, Week 4 and 52

Interventionunits on a scale (Mean)
Physical functioning:BaselinePhysical functioning:Change at Week 4 (n=150)Physical functioning:Change at Week 52 (n=96)Role-physical:BaselineRole-physical:Change at Week 4 (n=150)Role-physical:Change at Week 52 (n=96)Bodily pain:BaselineBodily pain:Change at Week 4 (n=150)Bodily pain:Change at Week 52 (n=96)General health:BaselineGeneral health:Change at Week 4 (n=150)General health:Change at Week 52 (n=96)Vitality:BaselineVitality:Change at Week 4 (n=150)Vitality:Change at Week 52 (n=96)Social functioning:BaselineSocial functioning:Change at Week 4 (n=150)Social functioning:Change at Week 52 (n=96)Role-emotional:BaselineRole-emotional:Change at Week 4 (n=150)Role-emotional:Change at Week 52 (n=96)Mental health:BaselineMental health:Change at Week 4 (n=150)Mental health:Change at Week 52 (n=96)
Tramadol Hydrochloride Plus Acetaminophen (JNS013)33.72.94.135.03.26.033.75.59.042.11.53.944.02.14.941.02.76.039.42.65.243.92.55.5

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Change From Baseline in Visual Analogue Scale (VAS24) Score at Week 4

Pain over the last 24 hours was assessed by using VAS score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement. (NCT00736957)
Timeframe: Baseline and Week 4

Interventionmillimeter (Mean)
BaselineChange at Week 4
Tramadol Hydrochloride Plus Acetaminophen (JNS013)65.80-22.28

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Number of Participants With Improvement From Baseline in VAS24 Score

Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from baseline represented disease progression and decrease represented improvement. (NCT00736957)
Timeframe: Week 4 and 52

Interventionparticipants (Number)
Improvement of 30 percent or more at Week 4Improvement of 50 percent or more at Week 4Improvement of 30 percent or more at Week 52Improvement of 50 percent or more at Week 52
Tramadol Hydrochloride Plus Acetaminophen (JNS013)765111077

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Pain Intensity Difference (PID) at Week 4

PID is defined as the amount of change in the pain intensity at each evaluation time point (at 2 and 4 hours after the study drug dosing) from the baseline for each participant. Pain Intensity was evaluated on a 4-stage scale ranging from 3=severe pain to 0=no pain. PID ranges from -3 (the worst) to +3 (the most improved). (NCT00736957)
Timeframe: Week 4

Interventionunits on a scale (Mean)
2 hours after dosing at Week 44 hours after dosing at Week 4
Tramadol Hydrochloride Plus Acetaminophen (JNS013)0.10.1

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Pain Relief (PAR) Score at Week 4

Pain relief was evaluated based on a 5-stage scale from 4 (complete relief) to 0 (no relief). An increase in score represented improvement and decrease represented disease progression (NCT00736957)
Timeframe: Week 4

Interventionunits on a scale (Mean)
2 hours after dosing at Week 44 hours after dosing at Week 4
Tramadol Hydrochloride Plus Acetaminophen (JNS013)1.31.3

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Time to Reach the Onset of Drug Efficacy and Time to Recurrence of Pain After the Onset of Drug Efficacy

Time to reach the onset of drug efficacy (TOE) means time took by participants for the onset of relief from pain after tooth-extraction and time to recurrence of pain (TOR) after the onset of drug efficacy (that is, duration of drug efficacy) were assessed after study drug treatment. (NCT00737048)
Timeframe: Baseline up to 8 hours post-administration of study treatment

,,
InterventionMinutes (Mean)
TOE (n=102, 36, 104)TOR (n=41, 14, 53)
Acetaminophen and Placebo53.5198.2
Tramadol Hydrochloride and Placebo82.8207.9
Tramadol Hydrochloride Plus Acetaminophen and Placebo47.6252.5

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Percentage of Participants With Treatment Response Based on Evaluation Criteria for Efficacy of Analgesics in Post-Tooth-Extraction Pain

"Percentage of participants were assessed with treatment response based on evaluation criteria for efficacy of analgesics in post-tooth-extraction pain for the efficacy of analgesics used to treat pain following tooth extraction. Participants were assessed as very effective, effective, somewhat effective and ineffective for the following categories: Pain suppression (PS), speed of pain relief (SPR), duration of pain relief (DPR), general effectiveness (GE). Participants judged the treatment as extremely useful, useful, not useful & could not be assessed for overall evaluation (OE)." (NCT00737048)
Timeframe: Baseline up to 8 hours post-administration of study treatment

,,
InterventionPercentage of participants (Number)
PS:very effective (n=107, 46, 113)PS:effective (n=107, 46, 113)PS:somewhat effective (n=107, 46, 113)PS:ineffective (n=107, 46, 113)SPR:very effective (n=107, 46, 113)SPR:effective (n=107, 46, 113)SPR:somewhat effective (n=107, 46, 113)SPR:ineffective (n=107, 46, 113)DPR:very effective (n=41, 14, 53)DPR:effective (n=41, 14, 53)DPR:somewhat effective (n=41, 14, 53)DPR:ineffective (n=41, 14, 53)GE:very effective (n=107, 46, 113)GE:effective (n=107, 46, 113)GE:somewhat effective (n=107, 46, 113)GE:ineffective (n=107, 46, 113)OE:Extremely useful (n=107, 46, 113)OE:useful (n=107, 46, 113)OE:not useful (n=107, 46, 113)OE:could not be assessed (n=107, 46, 113)
Acetaminophen and Placebo9.6067.522.844.828.410.316.424.528.320.826.4023.353.423.3017.282.80
Tramadol Hydrochloride and Placebo8.2042.949.021.621.615.741.228.635.77.128.6013.731.454.903.996.10
Tramadol Hydrochloride Plus Acetaminophen and Placebo19.42.863.913.956.926.67.39.239.026.817.117.12.833.946.816.50.911.987.20

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Sum of Pain Intensity Difference (SPID)

Pain Intensity (PI) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and 8 hours post-administration of study treatments.Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score). (NCT00737048)
Timeframe: Baseline up to 8 hours post-administration of study treatment

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride Plus Acetaminophen and Placebo6.4
Tramadol Hydrochloride and Placebo2.9
Acetaminophen and Placebo4.1

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Number of Participants Treated With a Relief Analgesic

Participants who were treated with a relief analgesic were assessed. Analgesics are the compounds capable of relieving pain without the loss of consciousness. (NCT00737048)
Timeframe: Baseline up to 8 hours post-administration of study treatment

InterventionParticipants (Number)
Tramadol Hydrochloride Plus Acetaminophen and Placebo37
Tramadol Hydrochloride and Placebo25
Acetaminophen and Placebo54

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Percentage of Participants With Categorical Score for Patient Impressions

Percentage of participants with patient impressions were assessed on categories, that are: worked well; worked; worked a little; and didn't work. (NCT00737048)
Timeframe: Baseline up to 8 hours post-administration of study treatment

,,
InterventionPercentage of participants (Number)
Worked wellWorkedWorked a littleDidn't work
Acetaminophen and Placebo15.753.522.87.9
Tramadol Hydrochloride and Placebo16.444.324.614.8
Tramadol Hydrochloride Plus Acetaminophen and Placebo28.755.813.22.3

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Sum of Pain Relief Combined With Pain Intensity Difference (SPRID)

The SPRID is the sum of pain relief scores combined with pain intensity difference, score ranging from from (-) 24 (the worst) through 56 (the most improved). Higher score indicates treatment response. Pain Intensity (PI) and Pain relief (PAR) were assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Scores were measured at Baseline (that is, 0 hours after tooth extraction) and at 8 hours post-administration of study treatments. Pain intensity difference (PID) was calculated (that is, for 0-8 hours, time point [8 hour] score minus baseline [0 hour] score). (NCT00737048)
Timeframe: Baseline up to 8 hours post-administration of study treatment

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride Plus Acetaminophen and Placebo24.0
Tramadol Hydrochloride and Placebo15.3
Acetaminophen and Placebo17.4

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Total Pain Relief Based on Numerical Rating Scale (NRS) Score Every 4 Hours up to 8 Hours

Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. (NCT00737048)
Timeframe: Baseline up to 8 hours post-administration of study treatment

,,
InterventionUnits on a scale (Mean)
0-4 hours4-8 hours
Acetaminophen and Placebo7.45.9
Tramadol Hydrochloride and Placebo6.36.1
Tramadol Hydrochloride Plus Acetaminophen and Placebo9.68.0

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Total Pain Relief Based on Numerical Rating Scale (NRS) Score

Total pain relief was evaluated using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. (NCT00737048)
Timeframe: 8 hours

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride Plus Acetaminophen and Placebo17.7
Tramadol Hydrochloride and Placebo12.4
Acetaminophen and Placebo13.3

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Change From Baseline in Visual Analog Scale (VAS) Score at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment

Pain was assessed by using Visual Analogue Scale (VAS) score ranges from 0 millimeter (mm)=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented treatment response. (NCT00737048)
Timeframe: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

,,
InterventionUnits on a scale (Mean)
Change at Hour 0.5Change at Hour 1Change at Hour 2Change at Hour 3Change at Hour 4Change at Hour 5Change at Hour 6Change at Hour 7Change at Hour 8
Acetaminophen and Placebo-15.50-26.68-28.43-28.40-24.83-21.48-17.51-15.62-14.48
Tramadol Hydrochloride and Placebo-4.28-12.82-20.94-25.75-21.75-17.56-15.70-13.18-13.03
Tramadol Hydrochloride Plus Acetaminophen and Placebo-22.11-36.79-42.71-41.40-37.70-34.78-30.20-26.37-22.85

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Mean Change Over Time for Pain Intensity Difference (PID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-Administration of Study Treatment

The PID is defined as difference between current pain intensity (PI) and Baseline PI, PI was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. (NCT00737048)
Timeframe: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

,,
InterventionUnits on a scale (Mean)
PID:Change at Hour 0.5PID:Change at Hour 1PID:Change at Hour 2PID:Change at Hour 3PID:Change at Hour 4PID:Change at Hour 5PID:Change at Hour 6PID:Change at Hour 7PID:Change at Hour 8
Acetaminophen and Placebo0.50.70.80.70.60.50.40.30.3
Tramadol Hydrochloride and Placebo0.10.40.50.50.40.30.40.20.2
Tramadol Hydrochloride Plus Acetaminophen and Placebo0.60.91.11.10.90.80.70.60.5

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Mean Change Over Time for Pain Relief (PAR) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment

Pain Relief (PAR) was assessed using numerical rating scale score ranging from 0 to 32, wherein 0 indicates no treatment response and 32 indicates the most improved. Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. (NCT00737048)
Timeframe: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

,,
InterventionUnits on a scale (Mean)
PAR:Change at Hour 0.5PAR:Change at Hour 1PAR:Change at Hour 2PAR:Change at Hour 3PAR:Change at Hour 4PAR:Change at Hour 5PAR:Change at Hour 6PAR:Change at Hour 7PAR:Change at Hour 8
Acetaminophen and Placebo1.32.02.02.01.81.61.51.41.4
Tramadol Hydrochloride and Placebo0.71.41.71.91.71.61.61.51.5
Tramadol Hydrochloride Plus Acetaminophen and Placebo1.52.32.72.62.42.22.11.91.8

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Mean Change Over Time for Pain Relief Combined With Pain Intensity Difference (PRID) at 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 Hours Post-administration of Study Treatment

Pain Relief combined with pain Intensity Difference (PRID) represented pain relief scores combined with Pain Intensity difference (PID) scores. PRID score ranges from -3 (the worst) through +7 (the most improved). Higher score indicates treatment response. Mean change from Baseline (that is, 0 hours after tooth extraction) at specified end time points were evaluated. (NCT00737048)
Timeframe: 0.5, 1, 2, 3, 4, 5, 6, 7 and 8 hours post-administration of study treatment

,,
InterventionUnits on a scale (Mean)
PRID:Change at Hour 0.5PRID:Change at Hour 1PRID:Change at Hour 2PRID:Change at Hour 3PRID:Change at Hour 4PRID:Change at Hour 5PRID:Change at Hour 6PRID:Change at Hour 7PRID:Change at Hour 8
Acetaminophen and Placebo1.82.72.82.72.42.11.81.81.6
Tramadol Hydrochloride and Placebo0.81.82.22.42.11.91.91.71.7
Tramadol Hydrochloride Plus Acetaminophen and Placebo2.13.23.83.73.33.02.82.52.3

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The Proportion of Subjects Treated With Long-term Acetaminophen (4 g/Day) That Develops Persistent ALT Elevations.

ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40. (NCT00743093)
Timeframe: serial samples for 16-40 days

,
Interventionparticipants (Number)
Subjects without persisitent ALT elevationSubjects with persistent ALT elevation
Acetaminophen Arm2041
Placebo Arm470

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Number of Participants Experiencing Adverse Events Within 14 Days Post-dose (Count ≥4 in One or More Treatment Groups)

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00758836)
Timeframe: Up to 14 days post-dose

Interventionparticipants (Number)
Placebo31
Telcagepant 280 mg +Ibuprofen 400 mg46
Telcagepant 280 mg +APAP 1000 mg46
Telcagepant 280 mg37

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Percentage of Participants With Pain Freedom at Two Hours Post-dose

Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain freedom was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to no pain (Grade 0). (NCT00758836)
Timeframe: 2 hours post-dose

InterventionPercentage of Participants (Number)
Placebo10.9
Telcagepant 280 mg +Ibuprofen 400 mg35.2
Telcagepant 280 mg +APAP 1000 mg38.3
Telcagepant 280 mg31.2

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Percentage of Participants With Pain Relief at 2 Hours Post-dose.

Pain severity was rated by the participants in a paper diary by grade; Grade 0 (no pain), Grade 1 (mild pain), Grade 2 (moderate pain), and Grade 3 (severe pain). Pain relief was defined as a reduction in pain severity from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0). (NCT00758836)
Timeframe: 2 hours post-dose

InterventionPercentage of Participants (Number)
Placebo30.6
Telcagepant 280 mg +Ibuprofen 400 mg71.0
Telcagepant 280 mg +APAP 1000 mg69.9
Telcagepant 280 mg65.2

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Number of Participants Experiencing Adverse Events Within 48 Hours Post-dose (Count ≥4 in One or More Treatment Groups)

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. (NCT00758836)
Timeframe: Up to 48 hours post-dose

InterventionParticipants (Number)
Placebo27
Telcagepant 280 mg +Ibuprofen 400 mg44
Telcagepant 280 mg +APAP 1000 mg42
Telcagepant 280 mg34

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Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)

The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction. (NCT00761150)
Timeframe: Double-blind baseline to 4 weeks

,
Interventionscores on a scale (Least Squares Mean)
Trouble Falling AsleepNeeded Sleeping MedicationAwakened by Pain During the NightAwakened by Pain in the MorningQuality of Sleep
Double-blind ABT-712-4.8-1.6-0.50.30.1
Double-blind Placebo13.18.415.113.0-13.9

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Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)

The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction. (NCT00761150)
Timeframe: Double-blind baseline to 4 weeks

Interventionscores on a scale (Least Squares Mean)
Double-blind ABT-7121.1
Double-blind Placebo18.0

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Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)

The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction. (NCT00763321)
Timeframe: Double-blind baseline to 4 weeks

,
Interventionscores on a scale (Least Squares Mean)
Trouble Falling AsleepNeeded Sleeping MedicationAwakened by Pain During the NightAwakened by Pain in the MorningQuality of Sleep
Double-blind ABT-712-3.7-1.2-5.0-4.5-0.4
Double-blind Placebo18.713.519.520.1-23.2

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Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)

The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from 2-way ANCOVA model without interaction. (NCT00763321)
Timeframe: Double-blind baseline to 4 weeks

Interventionscores on a scale (Least Squares Mean)
Double-blind ABT-7121.2
Double-blind Placebo23.0

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Pain Visual Analog Scale Score at Day 28

"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)." (NCT00766675)
Timeframe: Day 28

InterventionMillimeter (mm) (Mean)
Tramadol Hydrochloride/Acetaminophen49.6

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Pain Visual Analog Scale Score at Day 14

"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)." (NCT00766675)
Timeframe: Day 14

InterventionMillimeter (mm) (Mean)
Tramadol Hydrochloride/Acetaminophen53.0

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Tender-Point Evaluation/ Myalgic Score

Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site. The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched). Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54. Higher score indicates worsening. (NCT00766675)
Timeframe: Baseline and Day 56

InterventionUnits on a scale (Mean)
Tender-Point Evaluation (right side):BaselineMyalgic Score (right side):BaselineTender-Point Evaluation (left side):BaselineMyalgic Score (left side):BaselineTender-Point Evaluation (right side):Day 56Myalgic Score (right side):Day 56Tender-Point Evaluation (left side):Day 56Myalgic Score (left side):Day 56
Tramadol Hydrochloride/Acetaminophen7.913.67.813.14.97.05.17.2

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Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept

"The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant's sleep habits out of which Q1 was How long did it usually take for participant to fall asleep during the past 4 weeks and Q2 was On the average, how many hours did participant sleep each night during the past 4 weeks." (NCT00766675)
Timeframe: Baseline and Day 56

InterventionHours (Mean)
Question 1: BaselineQuestion 2: BaselineQuestion 1: Day 56Question 2: Day 56
Tramadol Hydrochloride/Acetaminophen3.25.42.26.4

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Number of Participants With Subject's Global Assessment

Participants indicated their condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor. (NCT00766675)
Timeframe: Day 14, 28 and 56

InterventionParticipants (Number)
Q1: Very good (Day 14)Q1: Good (Day 14)Q1: Moderate (Day 14)Q1: Poor (Day 14)Q1: Very poor (Day 14)Q1: Missing (Day 14)Q2: Very good (Day 14)Q2: Good (Day 14)Q2: Moderate (Day 14)Q2: Poor (Day 14)Q2: Very poor (Day 14)Q2: Missing (Day 14)Q3: Very good (Day 14)Q3: Good (Day 14)Q3: Moderate (Day 14)Q3: Poor (Day 14)Q3: Very poor (Day 14)Q3: Missing (Day 14)Q1: Very good (Day 28)Q1: Good (Day 28)Q1: Moderate (Day 28)Q1: Poor (Day 28)Q1: Very poor (Day 28)Q1: Missing (Day 28)Q2: Very good (Day 28)Q2: Good (Day 28)Q2: Moderate (Day 28)Q2: Poor (Day 28)Q2: Very poor (Day 28)Q2: Missing (Day 28)Q3: Very good (Day 28)Q3: Good (Day 28)Q3: Moderate (Day 28)Q3: Poor (Day 28)Q3: Very poor (Day 28)Q3: Missing (Day 28)Q1: Very good (Day 56)Q1: Good (Day 56)Q1: Moderate (Day 56)Q1: Poor (Day 56)Q1: Very poor (Day 56)Q1: Missing (Day 56)Q2: Very good (Day 56)Q2: Good (Day 56)Q2: Moderate (Day 56)Q2: Poor (Day 56)Q2: Very poor (Day 56)Q2: Missing (Day 56)Q3: Very good (Day 56)Q3: Good (Day 56)Q3: Moderate (Day 56)Q3: Poor (Day 56)Q3: Very poor (Day 56)Q3: Missing (Day 56)
Tramadol Hydrochloride/Acetaminophen583215218162119331838381301831521733116161340313172180314181910128142194428416257028

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Number of Participants With Physician Global Assessment

The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit. The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor. (NCT00766675)
Timeframe: Day 14, 28 and 56

InterventionParticipants (Number)
Q1: Very good (Day 14)Q1: Good (Day 14)Q1: Moderate (Day 14)Q1: Poor (Day 14)Q1: Very poor (Day 14)Q1: Missing (Day 14)Q2: Very good (Day 14)Q2: Good (Day 14)Q2: Moderate (Day 14)Q2: Poor (Day 14)Q2: Very poor (Day 14)Q2: Missing (Day 14)Q3: Very good (Day 14)Q3: Good (Day 14)Q3: Moderate (Day 14)Q3: Poor (Day 14)Q3: Very poor (Day 14)Q3: Missing (Day 14)Q1: Very good (Day 28)Q1: Good (Day 28)Q1: Moderate (Day 28)Q1: Poor (Day 28)Q1: Very poor (Day 28)Q1: Missing (Day 28)Q2: Very good (Day 28)Q2: Good (Day 28)Q2: Moderate (Day 28)Q2: Poor (Day 28)Q2: Very poor (Day 28)Q2: Missing (Day 28)Q3: Very good (Day 28)Q3: Good (Day 28)Q3: Moderate (Day 28)Q3: Poor (Day 28)Q3: Very poor (Day 28)Q3: Missing (Day 28)Q1: Very good (Day 56)Q1: Good (Day 56)Q1: Moderate (Day 56)Q1: Poor (Day 56)Q1: Very poor (Day 56)Q1: Missing (Day 56)Q2: Very good (Day 56)Q2: Good (Day 56)Q2: Moderate (Day 56)Q2: Poor (Day 56)Q2: Very poor (Day 56)Q2: Missing (Day 56)Q3: Very good (Day 56)Q3: Good (Day 56)Q3: Moderate (Day 56)Q3: Poor (Day 56)Q3: Very poor (Day 56)Q3: Missing (Day 56)
Tramadol Hydrochloride/Acetaminophen21830102181923144218314341011832019703114221120313231760315201881281322132228426156128

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Number of Participants With Categorical Scores on Pain Relief Rating Scale

Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete. (NCT00766675)
Timeframe: Day 14, 28 and 56

InterventionParticipants (Number)
A lot:Day 14Moderate:Day 14Slight:Day 14None:Day 14Worse:Day 14Missing:Day 14A lot:Day 28Moderate:Day 28Slight:Day 28None:Day 28Worse:Day 28Missing:Day 28A lot:Day 56Moderate:Day 56Slight:Day 56None:Day 56Worse:Day 56Missing:Day 56
Tramadol Hydrochloride/Acetaminophen121924421917231453182513189312

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Pain Visual Analog Scale Score at Day 56

"Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from no pain (0 mm) to worst possible pain (100 mm)." (NCT00766675)
Timeframe: Day 56

InterventionMillimeter (mm) (Mean)
Tramadol Hydrochloride/Acetaminophen44.9

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Participant Assessment Sleep Questionnaire Score

"Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to How often during past 4 weeks did participant felt and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed. Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement." (NCT00766675)
Timeframe: Baseline and Day 56

InterventionUnits on a scale (Mean)
Question 3: BaselineQuestion 4: BaselineQuestion 5: BaselineQuestion 6: BaselineQuestion 7: BaselineQuestion 8: BaselineQuestion 9: BaselineQuestion 10: BaselineQuestion 11: BaselineQuestion 12: BaselineQuestion 3: Day 56Question 4: Day 56Question 5: Day 56Question 6: Day 56Question 7: Day 56Question 8: Day 56Question 9: Day 56Question 10: Day 56Question 11: Day 56Question 12: Day 56
Tramadol Hydrochloride/Acetaminophen2.54.53.82.92.92.93.53.43.34.73.83.54.94.34.24.44.44.64.23.8

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Total Fibromyalgia Impact Questionnaire (FIQ) Score

The FIQ was 19-item questionnaire which measured participant status, progress and outcomes. First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never). Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days). Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very). Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening. (NCT00766675)
Timeframe: Baseline and Day 56

InterventionUnits on a scale (Mean)
Baseline (n=73)Day 56 (n=51)
Tramadol Hydrochloride/Acetaminophen6.14.0

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APAP Plasma Adduct Association With UGT2B15 Genotype

The association of UGT2B15 genotype with APAP plasma adduct concentrations (NCT00768716)
Timeframe: 2 days

InterventionmL/min/kg (Median)
UGT2B15*1/*116
UGT2B15*1/*219
UGT2B15*2/*227

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Acetaminophen Glucuronidation Partial Clearance Association With UGT2B15 Genotype

The association of acetaminophen glucuronidation partial clearance with UGT2B15 genotype (NCT00768716)
Timeframe: 2 days

InterventionmL/min/kg (Median)
UGT2B15*1/*13.8
UGT2B15*1/*22.8
UGT2B15*2/*22.1

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Acetaminophen Plasma Clearance Association With Race/Ethnicity

Plasma total clearance of acetaminophen in plasma measured by HPLC (NCT00768716)
Timeframe: 2 days

InterventionmL/min/kg (Median)
White Subjects5.3
Black Subjects5.9

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Acetaminophen Plasma Clearance Association With UGT2B15 Genotype

The association of UGT2B15 genotype with acetaminophen total clearance (NCT00768716)
Timeframe: 2 days

InterventionmL/min/kg (Median)
UGT2B15*1/*16.4
UGT2B15*1/*25.5
UGT2B15*2/*24.7

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Acetaminophen Oxidation Partial Clearance Association With Race/Ethnicity

Acetaminophen oxidation partial clearance determined from plasma clearance and urinary metabolite excretion (NCT00768716)
Timeframe: 2 days

InterventionmL/min/kg (Median)
White Subjects0.9
Black Subjects0.57

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Acetaminophen Sulfation Partial Clearance Association With Race/Ethnicity

Acetaminophen sulfation partial clearance determined from plasma clearance and urinary metabolite excretion (NCT00768716)
Timeframe: 2 days

InterventionmL/min/kg (Median)
White Subjects1.4
Black Subjects1.7

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Acetaminophen Glucuronidation Partial Clearance Association With Race/Ethnicity

Acetaminophen glucuronidation partial clearance determined from plasma clearance and urinary metabolite excretion (NCT00768716)
Timeframe: 2 days

InterventionmL/min/kg (Median)
White Subjects2.9
Black Subjects3.3

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Incidence of Death

(NCT00771875)
Timeframe: 90 days

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)0
RATG/Rituximab0
RATG/Bortezomib0

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Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)

(NCT00771875)
Timeframe: 1 year

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)0
RATG/Rituximab0
RATG/Bortezomib0

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Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy

(NCT00771875)
Timeframe: 90 days

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)3
RATG/Rituximab3
RATG/Bortezomib5

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Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy

(NCT00771875)
Timeframe: Day 1

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)2
RATG/Rituximab2
RATG/Bortezomib4

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Renal Allograft Survival

(NCT00771875)
Timeframe: 1 year after rejection treatment

Interventionparticipants (Number)
Rabbit Antithymocyte Globulin (RATG)7
RATG/Rituximab7
RATG/Bortezomib10

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Mean Serum Creatinine

Renal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation (NCT00771875)
Timeframe: 7, 14, 28, 60, 90 days and 1 year post therapy initiation

,,
Interventionmg/dL (Mean)
7 days14 days28 days60 days90 days1 year
Rabbit Antithymocyte Globulin (RATG)3.043.252.92.622.482.19
RATG/Bortezomib2.312.202.182.382.132.87
RATG/Rituximab2.322.352.352.322.122.07

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Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection

"Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment.~Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal." (NCT00771875)
Timeframe: 1 year

,,
Interventionparticipants (Number)
Rejection RecurrenceRejection Reversal
Rabbit Antithymocyte Globulin (RATG)02
RATG/Bortezomib01
RATG/Rituximab01

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Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)

The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours) (NCT00784810)
Timeframe: Average daily pain over last 24 hours (at Week 12)

InterventionUnits on a BS-11 scale at Week 12 (Mean)
Oxycodone/Naloxone Tablets (OXN)4.2
Codeine/Paracetamol Tablets4.64

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Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.

"To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the number of intakes of rescue medication for this period (ie between Visit 8 and Visit 9)." (NCT00784810)
Timeframe: Between visit 8 and 9

InterventionNumber of rescue medication intakes (Mean)
Oxycodone/Naloxone Tablets (OXN)13.2
Codeine/Paracetamol Tablets9.4

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Event-free Survival (EFS)

To evaluate the graft versus myeloma effect by monitoring rate of event-free survival (EFS) (NCT00899847)
Timeframe: 2 years after the last participant is enrolled

Interventionpercentage of participants (Number)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant44

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Complete Response Rate (CRR)

"Complete response rate (CRR) was assessed as all of:~Negative immunoflixation on the serum and urine~Disappearance of any soft tissue plasmacytomas~< 5% plasma cells in bone marrow" (NCT00899847)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant3

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Partial Response Rate (PRR)

"Partial response rate (PRR) was assessed as~> 50% reduction in serum M-protein plus urine M-protein reduction by 90% or < 200 mg/24 hr~If serum M-protein is not measurable, then > 50% reduction in the involved serum free light chain~If involved serum free light chain is not measurable, then > 50% reduction in the bone marrow plasma cell percentage + > 50% reduction in the size of any soft tissue plasmacytoma." (NCT00899847)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Peripheral Blood Stem Cell Transplant4

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Median Time to Engraftment After Auto-PBSC Transplant

"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia" (NCT00899847)
Timeframe: 1 month

InterventionDays (Median)
Neutrophil EngraftmentPlatelet Engraftment
Autologous-Allogeneic Hematopoietic Stem Cell Transplant1115

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Median Time to Engraftment After Allo-PBSC Transplant

"Engraftment is assessed as:~Neutrophil engraftment is > 0.5 x 10⁹/L after cytopenia~Platelet engraftment is > 20 x 10⁹/L after cytopenia" (NCT00899847)
Timeframe: 1 month

InterventionDays (Median)
Neutrophil EngraftmentPlatelet Engraftment
Autologous-Allogeneic Hematopoietic Stem Cell Transplant2410

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Overall Survival (OS)

To evaluate the graft versus myeloma effect by monitoring rate of overall survival (OS) (NCT00899847)
Timeframe: 2 years after the last participant is enrolled

Interventionpercentage of participants (Number)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant67

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Overall Response Rate (ORR)

Overall response rate (ORR) = Complete Response Rate (CRR) + Partial Response Rate (PRR) (NCT00899847)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Peripheral Blood Stem Cell Transplant7

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Incidence of Graft Versus Host Disease (GvHD)

To evaluate the incidence acute GvHD of this tandem autologous/allogeneic transplant setting (NCT00899847)
Timeframe: 2 years after the last participant is enrolled.

InterventionParticipants (Count of Participants)
Autologous-Allogeneic Hematopoietic Stem Cell Transplant1

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Wilm's Tumor 1 (WT1) Enzyme-Linked Immunospot (ELISpot)

WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control. (NCT00923910)
Timeframe: 48 to 72 hours after placement

Interventionparticipants (Number)
PositiveNegative
Recipients32

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Wilm's Tumor (WT1) Delayed-type Hypersensitivity (DTH)

WT1 expression of the hematologic malignancy was confirmed by either having greater than 15% of malignant cells react with anti-WT1 by immunohistochemistry or by having a positive quantitative reverse transcription polymerase chain reaction (RT-PCR) of WT1 compared with a negative control. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement. (NCT00923910)
Timeframe: 48 to 72 hours after placement

Interventionparticipants (Number)
PositiveNegativeNA (Not available)
Recipients221

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Time to Immune Response

Immune response was monitored by use of interferon gamma Enzyme-Linked Immunospot (ELISpot) and by delayed-type hypersensitivity (DTH) testing. (NCT00923910)
Timeframe: 4 to 12 weeks

InterventionWeeks (Number)
Patient 1Patient 2Patient 3Patient 4Patient 5
Recipients12NA843

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Keyhole Limpet Hemocyanin (KLH) Delayed-type Hypersensitivity (DTH)

KLH is a neoantigen known to induce helper response was used concurrently as a vaccine adjuvant and control antigen. DTH skin testing was performed using KLH and with a cocktail of WT1 peptides as 2 separate injections. Enzyme-Linked Immunospot (ELISpot) was performed against each peptide and was considered positive if results were at least 10 spots above background on at least 2 measurements. DTH was considered positive if there was at least .5cm induration 48 to 72 hours after placement. (NCT00923910)
Timeframe: 48 to 72 hours after placement

Interventionparticipants (Number)
PositiveNegativeNA (Not available)
Recipients311

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Toxicity

Here is the number of participants with adverse events. For details of the adverse events, see the adverse event module. (NCT00923910)
Timeframe: 21 months

Interventionparticipants (Number)
Recipients5

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Number of Participants With Progressive Disease

Progressive disease is at least a 20% increase in the sum of the longest diameter of all target lesions (i.e. tumor response). Response criteria for acute leukemia's is worse marrow classification (i.e., M status) with at least a 50% increase in the percentage of marrow blasts, or no change in marrow classification (i.e., M status), but a 50% or greater increase in absolute peripheral blast count or extent of medullary disease (NCT00923910)
Timeframe: 4 to12 weeks

Interventionparticipants (Number)
Recipients5

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Number of Participants With Graft Versus Host Disease (GVHD) Greater Than or Equal to Grade 3

Acute Graft versus Host Disease (GVHD) was graded by the modified Glucksberg scale. 0 = no GVHD normal, 4 = severe GVHD. (NCT00923910)
Timeframe: 28 days following completion of last vaccine and/or DLI (donor lymphocyte infusion) administration

Interventionparticipants (Number)
Recipients0

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Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)

"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule." (NCT00935311)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
ABT-712268.8
Hydrocodone/Acetaminophen230.9
Placebo54.8

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Time to First Rescue Medication

The median time (minutes) from first dose of study drug to first use of analgesic rescue medication. (NCT00935311)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionminutes (Median)
ABT-712442.0
Hydrocodone/Acetaminophen205.0
Placebo123.5

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TOTPAR (Total Pain Relief)

TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. (NCT00935311)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
ABT-71218.0
Hydrocodone/Acetaminophen15.9
Placebo10.5

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Participants With Adverse Events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details. (NCT00935311)
Timeframe: AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).

,,
Interventionparticipants (Number)
Any AE"Any AE at least possibly drug related""Any AE at least probably not drug related""Any severe AE"Any SAEAny AE leading to discontinuation of study drugAny AE leading to deathDeath
ABT-712145910000
Hydrocodone/Acetaminophen128400000
Placebo1441020000

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Change From Baseline in Temperature After the First 30 Minutes of Treatment

Change in temperature in patients receiving intravenous ibuprofen and acetaminophen (APAP) after the first 30 minutes of treatment. (NCT01002573)
Timeframe: 30 minutes following treatment

InterventionCelsius (Mean)
Ibuprofen-0.5
Acetaminophen-0.3

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Change From Baseline in Temperature After the First 60 Minutes of Treatment

Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 60 minutes of treatment. (NCT01002573)
Timeframe: 60 minutes following treatment

InterventionCelsius (Mean)
Ibuprofen-0.9
Acetaminophen-0.5

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Change From Baseline in Temperature After the First Four Hours of Treatment

Change in temperature during the first 4 hours of treatment by assessing the area under the change in temperature versus time curve during the first four hours of treatment (AUC0-4) (NCT01002573)
Timeframe: 0 to 4 hours post-dose

Interventiondegree Celsius*Time (Mean)
Ibuprofen-4.4
Acetaminophen-2.6

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Change in Temperature

Change in temperature in patients receiving intravenous ibuprofen and APAP after the first 4 hours of treatment. (NCT01002573)
Timeframe: 4 hours following treatment

InterventionCelsius (Mean)
Ibuprofen-1.5
Acetaminophen-0.9

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Fever Reduction

Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2) (NCT01002573)
Timeframe: 0 to 2 hours post-dose

Interventiondegree Celsius*Time (Mean)
Ibuprofen-1.5
Acetaminophen-0.9

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Time to Afebrility (in Hours)

Tme to afebrility (temperature less than 100.4 ºF [38 ºC]) in patients receiving intravenous ibuprofen and APAP. (NCT01002573)
Timeframe: 4 Hour post treatment

InterventionHours (Mean)
Ibuprofen2.2
Acetaminophen3.3

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Number of Afebrile and Febrile Subject at 4 Hours Post-Dose

Number of Afebrile and Febrile Subject at 4 Hours Following Treatment (NCT01002573)
Timeframe: 4 Hours Post-Dose

,
Interventionparticipants (Number)
Afebrile Subjects at 4 hoursFebrile at 4 Hours
Acetaminophen4011
Ibuprofen433

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Mean Change of Papilledema Grade on Fundus Photography

Mean change at month 6 as compared to baseline. Frisén papilledema grade is an ordinal scale that uses ocular fundus features to rate the severity of papilledema; grade 0 indicates no features of papilledema and grade 5 indicates severe papilledema. (NCT01003639)
Timeframe: Baseline and 6 Months

,
Interventionunits on a scale (Mean)
Study eyeFellow eye
Acetazolamide-1.31-1.14
Sugar Pill-0.61-0.52

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Visual Function Questionnaire (VFQ-25)

Visual Function Questionnaire (VFQ-25) total score, VFQ-25 10-item neuro-ophthalmic supplement total score: 0-100 (higher scores indicate better quality of life) (NCT01003639)
Timeframe: baseline

,
Interventionunits on a scale (Mean)
Total score10-item neuro-ophthalmic supplement
Acetazolamide83.875.8
Sugar Pill82.175.0

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Visual Acuity (No. of Correct Letters)

(NCT01003639)
Timeframe: Baseline

,
Interventioncorrect letters (Mean)
Study EyeFellow Eye
Acetazolamide56.858.3
Sugar Pill55.656.2

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Mean Change in Perimetric Mean Deviation

Treatment Effects on the Primary Outcome Variable, Mean change From Baseline to Month 6 in Perimetric Mean Deviation (PMD) in the Study Eye. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss. (NCT01003639)
Timeframe: base line and 6 months

InterventiondB (Mean)
Acetazolamide1.43
Sugar Pill0.71

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Time to Perceptible and Meaningful Pain Relief

The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief. (NCT01038609)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

,,,,
Interventionminutes (Median)
Time to Onset of Perceptible Pain ReliefTime to Onset of Meaningful Pain Relief
Acetaminophen25.562.5
Hydrocodone/Acetaminophen Extended Release22.560.5
Morphine Extended Release32.0142.0
Morphine Extended Release / Acetaminophen31.0101.0
Placebo23.0220.0

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Participants With Adverse Events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details. (NCT01038609)
Timeframe: AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).

,,,,
Interventionparticipants (Number)
Any AE"Any AE at least possibly drug related""Any severe AE"Any SAEAny AE leading to discontinuation of study drugAny AE leading to deathDeath
Acetaminophen282310000
Hydrocodone/Acetaminophen Extended Release332450000
Morphine Extended Release292310000
Morphine Extended Release / Acetaminophen282320100
Placebo281910000

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Participant's Global Assessment of Study Drug

The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor. (NCT01038609)
Timeframe: From time of first study drug administration to 48 hours following first study drug administration

,,,,
Interventionparticipants (Number)
ExcellentVery GoodGoodFairPoor
Acetaminophen91516100
Hydrocodone/Acetaminophen Extended Release7201542
Morphine Extended Release81614311
Morphine Extended Release / Acetaminophen41912113
Placebo31712154

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Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria

Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate <10 respirations per minute (rpm) (low) or >24 rpm (high). (NCT01038609)
Timeframe: At specified intervals from Screening through 7 days after first dose of study drug

,,,,
Interventionparticipants (Number)
Systolic BP decreaseSystolic BP increaseDiastolic BP decreaseDiastolic BP increaseHeart rate decreaseHeart rate increaseRespiratory rate < 10 rpmRespiratory rate > 24 rpm
Acetaminophen31203100
Hydrocodone/Acetaminophen Extended Release20502100
Morphine Extended Release60501000
Morphine Extended Release / Acetaminophen80620000
Placebo51200000

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Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria

Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L. (NCT01038609)
Timeframe: At specified intervals from Screening through 7 days after first dose of study drug

,,,,
Interventionparticipants (Number)
ALT >= 3 * ULNAST >= 3 * ULNCalcium <= 1.8 mmol/L
Acetaminophen110
Hydrocodone/Acetaminophen Extended Release000
Morphine Extended Release220
Morphine Extended Release / Acetaminophen331
Placebo002

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TOTPAR (Total Pain Relief)

TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. (NCT01038609)
Timeframe: From time of first study drug administration to 48 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
Acetaminophen65.9
Morphine Extended Release42.7
Morphine Extended Release / Acetaminophen49.5
Hydrocodone/Acetaminophen Extended Release56.3
Placebo32.9

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Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)

"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule." (NCT01038609)
Timeframe: From time of first study drug administration to 48 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
Acetaminophen720.5
Morphine Extended Release239.9
Morphine Extended Release / Acetaminophen614.4
Hydrocodone/Acetaminophen Extended Release450.8
Placebo-57.6

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Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline

"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.~The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -100320 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31680 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS. Negative values for differences indicate improvement." (NCT01048866)
Timeframe: Baseline (pre-dose), hourly readings to 24 hours post-dose

Interventionunits on a scale (Mean)
Flurbiprofen 8.75 mg Lozenge-542.4
Placebo Lozenge-377.4

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Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing

"Participants graded the relief of his/her sore throat at 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.~The patient was instructed to swallow and:~Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now. Responses following each lozenge were no relief, slight, mild, moderate, considerable, and complete relief. Results summarize responses 2 hours after taking each lozenge." (NCT01048866)
Timeframe: Days 2-7

,
Interventionpercentage of doses (Number)
No reliefSlight reliefMild reliefModerate reliefConsiderable reliefComplete relief
Flurbiprofen 8.75 mg Lozenge9.721.725.216.518.98.0
Placebo Lozenge23.024.819.013.714.74.9

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Change From Baseline in Body Temperature at End of Study

(NCT01048866)
Timeframe: baseline (pre-dose), up to Day 7

Interventiondegrees Fahrenheit (Mean)
Flurbiprofen 8.75 mg Lozenge-0.4
Placebo Lozenge-0.3

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Change From Baseline in Body Temperature at 2 Hours Post Initial Dose

(NCT01048866)
Timeframe: baseline (pre-dose), 2 hours post-dose

Interventiondegrees Fahrenheit (Mean)
Flurbiprofen 8.75 mg Lozenge-0.2
Placebo Lozenge-0.0

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Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)

"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.~To measure the functional effect on pharyngitis, the participant was asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose. The participant was instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data for multiple doses/days were averaged to obtain the values used for calculating DSS2. The full range for differences was -5626 to 6374 with negative values indicating improvement in pain intensity.~Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants." (NCT01048866)
Timeframe: Days 2-7

Interventionunits on a scale (Least Squares Mean)
Flurbiprofen 8.75 mg Lozenge-21.0
Placebo Lozenge-15.5

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Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)

"The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline.~The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose.~The patient was instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. Data for multiple doses/days were averaged to obtain the values used for calculating SWoTS2. The full range for differences was -5396 to 6604 with negative values indicating improvement in pain intensity.~Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants." (NCT01048866)
Timeframe: Days 2-7

Interventionunits on a scale (Least Squares Mean)
Flurbiprofen 8.75 mg Lozenge-19.5
Placebo Lozenge-13.4

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Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)

"The time weighted summed differences over 2 hours after taking a lozenge after the initial 24-hours post-baseline.~STPIS is a validated 100-mm visual analog scale completed by participants that measures pain on swallowing (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from a measurement taken prior to taking a lozenge and at hours 1 + 2 after taking the lozenge during Days 2-7. Data for multiple doses/days were averaged to obtain the values used for calculating SPID2. The full range for SPID2 was -5843 to 6157 with negative values indicating improvement in pain intensity. Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants." (NCT01048866)
Timeframe: Days 2-7

Interventionunits on a scale (Least Squares Mean)
Flurbiprofen 8.75 mg Lozenge-22.7
Placebo Lozenge-16.8

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Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)

"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9492 (complete pain relief within one hour of dosing that lasts 2 hours) to 2508 (maximum pain within 1 hour lasting 2 hours) using the mean baseline STPIS.~If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose." (NCT01048866)
Timeframe: baseline (pre-dose), post-dose: 1 hour, 2 hours

Interventionunits on a scale (Mean)
Flurbiprofen 8.75 mg Lozenge-37.1
Placebo Lozenge-17.9

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Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)

"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS.~Participants with a last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose." (NCT01048866)
Timeframe: baseline (pre-dose), post-dose - hourly up to 24 hours

Interventionunits on a scale (Mean)
Flurbiprofen 8.75 mg Lozenge-522.9
Placebo Lozenge-326.5

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Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)

"Investigators assessed the effectiveness of study medication on the patient's sore throat at the end of study by answering the following question: Considering the patient's response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent." (NCT01048866)
Timeframe: Day 7 (end of study)

,
Interventionpercentage of participants (Number)
PoorFairGoodVery GoodExcellent
Flurbiprofen 8.75 mg Lozenge19.822.924.026.07.3
Placebo Lozenge25.026.120.722.85.4

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Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe

"STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -115695 (no pain at any post-dose time (0) - average baseline) to 28505 (maximum possible pain (100) - average baseline).~Participants with their last recorded time point <21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imput" (NCT01048866)
Timeframe: baseline (pre-dose), 24 hours post dose (measured each hour post dose)

Interventionunits on a scale (Mean)
Flurbiprofen 8.75 mg Lozenge-476.9
Placebo Lozenge-351.3

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Time to First Rescue Pain Medication

Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment during the study. Time from initial dose to first rescue medication is summarized by time categories. (NCT01048866)
Timeframe: Days 1-7

,
Interventionpercentage of participants (Number)
2 - <4 hours4 - <6 hours6 - <24 hours24 - <72 hours72 - 168 hoursDid not rescue
Flurbiprofen 8.75 mg Lozenge2.02.05.93.01.086.1
Placebo Lozenge6.22.113.43.11.074.2

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Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose

"Participants graded the relief of his/her sore throat at 2 hours post initial dose using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.~The patient was instructed to swallow and asked:~Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now. Responses were no relief, slight, mild, moderate, considerable, and complete relief." (NCT01048866)
Timeframe: 2 hours

,
Interventionpercentage of participants (Number)
No reliefSlight reliefMild reliefModerate reliefConsiderable relief
Flurbiprofen 8.75 mg Lozenge9.928.727.717.815.8
Placebo Lozenge38.122.717.518.63.1

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Percentage of Participants Who Took Rescue Pain Medication

Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study. (NCT01048866)
Timeframe: Days 1-7

,
Interventionpercentage of participants (Number)
YesNo
Flurbiprofen 8.75 mg Lozenge13.986.1
Placebo Lozenge25.874.2

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Participant Satisfaction Score 24 Hours After Initial Dose

After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied. (NCT01048866)
Timeframe: 24 hours

,
Interventionpercentage of participants (Number)
Extremely dissatisfiedVery dissatisfiedDissatisfiedSomewhat satisfiedSatisfiedVery satisifiedExtremely satisfied
Flurbiprofen 8.75 mg Lozenge4.04.010.927.723.824.85.0
Placebo Lozenge5.29.414.632.326.07.35.2

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Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline

"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.~Data are reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9360 (no difficulty swallowing within 1 hour of dosing that lasts 2 hours) to 2640 (maximum difficulty swallowing within 1 hour of dosing lasting 2 hours) using the baseline DSS value.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation." (NCT01048866)
Timeframe: Baseline (pre-dose), Hours 1 and 2 post-dose

Interventionunits on a scale (Mean)
Flurbiprofen 8.75 mg Lozenge-37.1
Placebo Lozenge-18.1

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Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose

"Investigators assessed the effectiveness of study medication on the patient's sore throat at 24 hours following initial dose by answering the following question: Considering the patient's response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat? Responses were poor, fair, good, very good or excellent." (NCT01048866)
Timeframe: 24 hours

,
Interventionpercentage of participants (Number)
PoorFairGoodVery GoodExcellent
Flurbiprofen 8.75 mg Lozenge25.027.026.014.08.0
Placebo Lozenge25.329.524.212.68.4

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Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline

"DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how difficult it is to swallow now. A mark at 0-mm indicated not difficult and 100-mm indicated very difficult.~Data are reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -102960 (no difficulty swallowing within 1 hour of dosing that lasts 24 hours) to 29040 (maximum difficulty swallowing within 1 hour of dosing lasting 24 hours) using the baseline DSS value. Negative values indicate improvement in difficulty swallowing.~Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation." (NCT01048866)
Timeframe: Baseline (pre-dose), hourly readings to 24 hours post-dose

Interventionunits on a scale (Mean)
Flurbiprofen 8.75 mg Lozenge-555.5
Placebo Lozenge-379.4

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Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline

"SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and Place a line on the scale that best characterizes how swollen your throat feels now. A mark at 0-mm indicated not swollen and 100-mm indicated very swollen.~The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9120 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2880 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS.~Negative values for the differences indicate improvement. Missing values of SwoTS with non-missing values at assessments before and after were calculated using linear interpolation." (NCT01048866)
Timeframe: Baseline (pre-dose), hourly readings to 2 hours post-dose

Interventionunits on a scale (Mean)
Flurbiprofen 8.75 mg Lozenge-35.5
Placebo Lozenge-16.9

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Statistical Difference in State-Trait Anxiety Inventory for Children (STAIC) Scores for Children Aged 8-17 Years During Laceration Repair and VAS Pain Scale

"State-Trait Anxiety Inventory for Children - 20 questions with 3 answer options for each question.~Scores range from 20 to 60 for state and 20 to 60 for trait with 60 being the higher (more or worse) anxiety on self-assessment. The VAS pain Scale from 0-10 was included in this older population as well." (NCT01053637)
Timeframe: 1 hour approximately (survey was given pre and post procedure so from 15 minutes to 1 hour after initial survey (or 5 minutes to 45 minutes after the procedure).

,
Interventionunits on a scale (Median)
State Anxiety Pre-TestState Anxiety Post-TestVAS Pain Score at 5 minutes
Hydrocodone/Acetaminophen34.526.00.1
Sugar Water38.029.00.5

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Statistical Difference in Pain Scores in Children During Laceration Repair Between Study and Placebo Group

Children's Hospital of Eastern Ontario Pain Scale, for children 2-7 years. This score ranks 6 categories: Cry, Facial expression, Verbal Response, Torso movement, Touch, and Leg movement. The scale varies by each category from 0-2 or 1-2 or 1-3; such that a minimum score is 4 (no pain) and a maximum score is 13 signifying greatest pain. This results in a 10 point scale of possible results, and is rated by an objective observer; the child life specialist at the bedside during the laceration repair. If the procedure was completed, there were no scores recorded at that time point. (NCT01053637)
Timeframe: 5 minutes

Interventionunits on a scale (Median)
Hydrocodone/Acetaminophen5
Sugar Water7

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Visual Analog Scale (VAS) Pain Score for Children > 7 Years.

"Visual Analog Scale from 0-10 as marked on a 10 cm line. 0 no pain, 10 worst pain.~A child >7 group marks their pain on the line, and a mm measurement is made. Power based on a change in the Visual Analog Scale (VAS) for children > 7 years. A change in pain score of 10 mm (95% Confidence Interval 7-12 mm) was considered to be clinically significant based upon a previous study." (NCT01053637)
Timeframe: 30 minutes

,
Interventionscore on a scale (Median)
Baseline5 minutes10 minutes15 minutesProcedure Finish
Hydrocodone/Acetaminophen0.50.10.00.00.0
Sugar Water0.850.50.00.00.0

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SPID Scores at 4 Hours

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01075243)
Timeframe: Every two hours from baseline to 4 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg3.88
Paracetamol Caplet 650 mg2.81
Placebo Caplet0.20

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SPID Scores at 6 Hours

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01075243)
Timeframe: Every two hours from baseline to 6 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg5.02
Paracetamol Caplet 650 mg3.59
Placebo Caplet0.34

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SPRID at 2 Hours

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief (NCT01075243)
Timeframe: Every two hours from baseline to 2 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg6.49
Paracetamol Caplet 650 mg5.57
Placebo Caplet1.55

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SPRID at 4 Hours

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief (NCT01075243)
Timeframe: Every two hours from baseline to 4 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg12.09
Paracetamol Caplet 650 mg9.45
Placebo Caplet3.00

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Sum of Pain Intensity Difference (SPID) Scores at 2 Hours

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01075243)
Timeframe: Every two hours from baseline to 2 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg2.17
Paracetamol Caplet 650 mg1.77
Placebo Caplet0.19

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Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01075243)
Timeframe: Every two hours from Baseline to 6 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg16.08
Paracetamol Caplet 650 mg12.42
Placebo Caplet4.63

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Time to Confirmed First Perceptible Relief

Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

Interventionminutes (Mean)
Paracetamol Caplet 1000mg54.72
Paracetamol Caplet 650 mg69.67
Placebo Caplet225.70

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Time to Onset of Meaningful Pain Relief

Participants recorded the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

Interventionminutes (Mean)
Paracetamol Caplet 1000mg70.53
Paracetamol Caplet 650 mg88.16
Placebo Caplet247.14

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Time to Start Using Rescue Medication

Median time of use of rescue medication by participants. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

Interventionminutes (Median)
Paracetamol Caplet 1000 mg360.00
Paracetamol Caplet 650 mg314.00
Placebo Caplet131.00

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Total Pain Relief Score (TOTPAR) at 2 Hours

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01075243)
Timeframe: Every two hours from baseline to 2 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg4.31
Paracetamol Caplet 650 mg3.80
Placebo Caplet1.36

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Percentage of Participants Who Took Rescue Medication at 6 Hours

Percentage of participants who received rescue medication at different time points post dose. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

InterventionPercentage of participants (Number)
Paracetamol Caplet 1000mg44.20
Paracetamol Caplet 650 mg51.90
Placebo Caplet70.00

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TOTPAR at 4 Hours

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01075243)
Timeframe: Every two hours from baseline to 4 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg8.21
Paracetamol Caplet 650 mg6.64
Placebo Caplet2.79

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Participants Global Assessment to Response to Treatment (PGART)

PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent. (NCT01075243)
Timeframe: Baseline to 6 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg2.20
Paracetamol Caplet 650 mg1.80
Placebo Caplet0.80

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TOTPAR at 6 Hours

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01075243)
Timeframe: Every two hours from baseline to 6 hours post dose

InterventionScore on a scale (Mean)
Paracetamol Caplet 1000mg11.06
Paracetamol Caplet 650 mg8.83
Placebo Caplet4.29

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Percentage of Participants Who Took Rescue Medication at 2 Hours

Percentage of participants who received rescue medication at different time points post dose. (NCT01075243)
Timeframe: Baseline to 2 hours post dose

InterventionPercentage of participants (Number)
Paracetamol Caplet 1000mg0.00
Paracetamol Caplet 650 mg0.00
Placebo Caplet1.30

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TOTPAR at 6 Hours

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01082081)
Timeframe: Every two hours from baseline to 6 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg8.05
Paracetamol Caplet 500 mg5.18
Placebo Caplet4.10

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TOTPAR at 4 Hours

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01082081)
Timeframe: Every two hours from baseline to 4 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg5.82
Paracetamol Caplet 500 mg3.73
Placebo Caplet2.55

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Total Pain Relief (TOTPAR) at 2 Hours

"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (timet - timet-1).~PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]." (NCT01082081)
Timeframe: Every two hours from baseline to 2 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg3.33
Paracetamol Caplet 500 mg2.46
Placebo Caplet1.47

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Time to Start Using Rescue Medication

Median time of use of rescue medication by participants was calculated. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

Interventionminutes (Median)
Paracetamol Caplet 1000 mg242.00
Paracetamol Caplet 500 mg189.00
Placebo Caplet148.00

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SPID Scores at 6 Hours

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01082081)
Timeframe: Every two hours from baseline to 6 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg2.6
Paracetamol Caplet 500 mg0.7
Placebo Caplet-0.8

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Participants Global Assessment to Response to Treatment (PGART)

PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg1.54
Paracetamol Caplet 500 mg1.24
Placebo Caplet0.63

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Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours

Percentage of participants who took rescue medication during 2 to 6 hours (NCT01082081)
Timeframe: Within 2 to 6 hours post dose

InterventionPercentage of participants (Number)
Paracetamol Caplet 1000 mg57.9
Paracetamol Caplet 500 mg55.5
Placebo Caplet53.3

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SPID Scores at 4 Hours

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01082081)
Timeframe: Every two hours from baseline to 4 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg2.0
Paracetamol Caplet 500 mg0.7
Placebo Caplet-0.5

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SPRID at 4 Hours

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01082081)
Timeframe: Every two hours from baseline to 4 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg7.82
Paracetamol Caplet 500 mg4.42
Placebo Caplet2.07

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SPRID at 2 Hours

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01082081)
Timeframe: Every two hours from baseline to 2 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg4.62
Paracetamol Caplet 500 mg3.26
Placebo Caplet1.49

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Percentage of Participants Who Took Rescue Medication Within 2 Hours

Percentage of participants who received rescue medication within 2 hours (NCT01082081)
Timeframe: Baseline to 2 hours post dose

InterventionPercentage of participants (Number)
Paracetamol Caplet 1000 mg5.00
Paracetamol Caplet 500 mg11.80
Placebo Caplet18.30

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Sum of Pain Intensity Difference (SPID) Scores at 2 Hours

"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.~SPIDt = ∑PID x (timet - timet-1)~Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.~If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline." (NCT01082081)
Timeframe: Every two hours from baseline to 2 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg1.3
Paracetamol Caplet 500 mg0.8
Placebo Caplet0.0

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Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)

SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief] (NCT01082081)
Timeframe: Every two hours from baseline to 6 hours post dose

InterventionUnits on a scale (Mean)
Paracetamol Caplet 1000 mg10.60
Paracetamol Caplet 500 mg5.87
Placebo Caplet3.35

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Time to Confirmed First Perceptible Pain Relief

Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

Interventionminutes (Mean)
Paracetamol Caplet 1000 mg80.63
Paracetamol Caplet 500 mg119.10
Placebo Caplet189.53

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Time to Onset of Meaningful Pain Relief

Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief. (NCT01082081)
Timeframe: Baseline to 6 hours post dose

Interventionminutes (Mean)
Paracetamol Caplet 1000 mg96.44
Paracetamol Caplet 500 mg129.75
Placebo Caplet207.67

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Oxygen Saturation Levels at Week 24 and Week 48

Oxygen saturation is the amount of oxygen that is in your bloodstream and is measured as the percentage of blood hemoglobin that is carrying oxygen. Normal oxygen saturation levels are considered to be 95-100 percent; low oxygen saturation values indicate worse disease. Room air oxygen saturation by pulse oximetry and/or amount of supplemental oxygen used, if saturation <90%, were recorded. (NCT01086540)
Timeframe: Week 24 , Week 48

,
InterventionPercent Oxygen Saturation (Mean)
O2 Sat Level: Week 24O2 Sat Level: Week 48
Placebo96.196.2
Rituximab96.597.7

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Change in Quality of Life as Measured by the Disability Index of the Scleroderma Health Assessment Questionnaire (HAQ-DI)

The HAQ-DI is a self-reported questionnaire of functionality that includes questions in 8 domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities) and addresses scleroderma related manifestations that contribute to disability. The final score ranges from 0 to 3, where a higher HAQ-DI score indicates a worse outcome. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.00.0
Rituximab0.00.0

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Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Mental Component Summary Score

The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Mental Health component summary score is comprised of the Vitality Scale, the Social Functioning Scale, the Role-Emotional Scale, and the Mental Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.40.9
Rituximab0.10.2

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Change in Carbon Monoxide Diffusing Capacity (DLCO)

"Carbon Monoxide Diffusing Capacity (DLCO) is a measure of lung function. Predicted values for DLCO were computed according to the Global Lung Function Initiative (GLI) all-age reference values and corrected for hemoglobin. Lower DLCO values indicate worse disease activity.~DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)" (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionPercent Predicted Value (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.40.7
Rituximab-0.3-0.5

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Change From Baseline in Quality of Life as Measured by the Short Form Health Survey (SF-36): Physical Component Summary Score

The SF-36 measures health-related quality of life. It has 36 items and 2 component scores, the Physical Component Score and the Mental Component Score. The SF-36 Physical component summary score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 is equivalent to no disability. A negative value indicates a decrease in quality of life from Baseline. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

,
InterventionUnits on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo1.73.5
Rituximab0.61.3

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Percent Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization

"During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. Pulmonary vascular resistance (PVR) is measured in Woods Units. Higher PVR values indicate worse disease status.~Change in PVR is determined by Baseline value minus (-) Week 24 value." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionPercent Change (Least Squares Mean)
Rituximab-4.6
Placebo3.2

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Change in Severity of Raynaud's Phenomenon

"Severity of Raynaud's phenomenon was measured by a Visual Analog Scale (VAS) of the Scleroderma Health Assessment Questionnaire (SHAQ). The SHAQ VAS includes a question asking, In the past week, how much has your Raynaud's Phenomenon interfered with your activities? Participants were asked to place a mark on a 15 cm line, scaled from 0 (does not interfere) to 100 (very severe limitation), to describe the severity of their Raynaud's phenomenon in the past week. The distance from the left edge of the line to the vertical line placed by the participant was measured in centimeters; VAS scores were converted to a 0 to 100 scale." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionScore on a Scale (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.10.1
Rituximab-2.2-4.4

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Change From Baseline in Pulmonary Vascular Resistance Measured by Right Heart Catheterization at Week 24

During a right heart catheterization, a catheter is guided to the right side of the heart and then into the pulmonary artery; blood flow through the heart is observed and is used to measure pressures in a participant's heart and lungs. The calculation of Pulmonary Vascular Resistance (PVR) is measured in Woods Units. Change is derived by measuring the difference between Baseline and Week 24 PVR (Week 24 minus Baseline). Higher PVR values indicate worse disease status. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionWoods Units (Least Squares Mean)
Rituximab-0.5
Placebo0.1

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Change From Baseline in Distance Walked During a Six Minute Walk Test

The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24

InterventionMeters (Least Squares Mean)
Rituximab23.6
Placebo0.5

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All-Cause Mortality: From Treatment Initiation to Week 48

Death from any cause occurring after randomization and ≤ Week 48. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 48

InterventionParticipants (Count of Participants)
Rituximab4
Placebo1

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All-Cause Mortality: From Treatment Initiation to Week 104

Death from any cause occurring after randomization and ≤ Week 104. (NCT01086540)
Timeframe: Day 0 (Treatment Randomization) to Week 104

InterventionParticipants (Count of Participants)
Rituximab8
Placebo5

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Time to Clinical Worsening

"Assessment of time to clinical worsening, censored at Week 48, defined as the first occurrence of any of the following:~death,~hospitalization for Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH),~lung transplantation,~atrial septostomy,~addition of other Pulmonary Arterial Hypertension (PAH) therapeutic agents, or~worsening of the six minute walk distance by > 20% and an increase in New York Heart Association functional class.~Time to clinical worsening was defined as the first date that met any of the above criteria and was calculated in study days as: date of first event minus (-) date of treatment randomization. If a participant did not experience any of the referenced events by Week 48 or, if the date of death was after the 48 week follow-up period, time to clinical worsening was equal to the participant's duration of follow-up in the study." (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

InterventionWeeks (Mean)
Rituximab21.2
Placebo26.2

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Number of New Digital Ulcers

The total number of digital ulcers present on the dorsal and palmar surfaces for both the left and right fingers were captured at the Baseline study visit. The number of new digital ulcers since the last study visit (including any ulcers that had appeared and healed since the last study visit) on the dorsal and palmar surfaces for both the left and right fingers were captured at the post-Baseline study visits. The total number of digital ulcers on both hands was summed from the number present on the dorsal and palmar surfaces for both the left and right fingers. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionNew Ulcers (Mean)
Total Ulcer Count at BaselineNew Ulcers at Week 24New Ulcers at Week 48
Placebo0.40.10.2
Rituximab0.60.00.1

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Change From Baseline in Distance Walked During a Six Minute Walk Test at Week 24 and Week 48

The six minute walk test measures the distance a participant is able to walk over a total of six minutes on a hard, flat surface. The goal is for the participant to walk as far as possible in six minutes. The participant is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The total distance walked, in meters, was recorded for each participant. Longer distances indicate better outcomes. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 24 and Week 48

,
InterventionMeters (Least Squares Mean)
Change from Baseline to Week 24Change from Baseline to Week 48
Placebo0.4-7.0
Rituximab25.59.5

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Number of Grade 3 or Higher Adverse Events (AEs) Through Week 48

Total number of Grade 3, 4, and 5 AEs. Ref: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

,
InterventionEvents (Number)
Grade 3 AEsGrade 4 AEsGrade 5 AEs
Placebo1921
Rituximab2863

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Time to the Change or Addition of New Pulmonary Arterial Hypertension (PAH) Therapeutic Medications

Per protocol, from the time of study entry, participants were to remain on background PAH medical therapy with either a single agent or a combination of prostanoid, endothelin receptor antagonist, PDE-5 inhibitor, and/or guanylate cyclase stimulators as per the entry criteria. Doses should have remained stable through the Week 24 primary outcome/endpoint visit. If a dose of a background PAH medication was changed or a new PAH medication was added during the course of the trial, the date of the first dose change or additional medication was recorded. Time to the addition or modification of PAH medications was defined in study days as: date of the first time a PAH medication was modified or added minus (-) date of randomization. (NCT01086540)
Timeframe: Baseline (Pre Treatment Initiation) to Week 48

InterventionWeeks (Mean)
Rituximab21.2
Placebo26.7

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Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation Prior the fMRI Scan: [NRS (T-f Pre-scan)]

"Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on tibio-femoral joint. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine." (NCT01105936)
Timeframe: Baseline and post-dose pre-scan after stimulus

InterventionScore on a Scale (Mean)
Paracetamol 665 mg0.55
Placebo0.17
No Treatment0.00

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Blood Oxygen Level-Dependent (BOLD) Response in the Tibio-femoral Joint of Knee Osteoarthritis (OA): [BOLD (T-f)]

BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution. (NCT01105936)
Timeframe: Baseline to 2-5 hours post last dose administration

InterventionZ-score (Mean)
Paracetamol 665 mgNA
PlaceboNA
No TreatmentNA

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Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation After the fMRI Scan: [NRS (P-f Post-scan)]

"Subjective NRS response for each participant for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine." (NCT01105936)
Timeframe: Baseline and post-dose post-scan after stimulus

InterventionScore on a Scale (Mean)
Paracetamol 665 mg0.30
Placebo-0.48
No Treatment-0.39

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Subjective NRS Response for Treatment Effect on Patello-femoral Stimulation Prior the fMRI Scan: [NRS (P-f Pre-scan)]

"Subjective NRS response was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment pre-scan pain assessment after stimulus on patello-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine." (NCT01105936)
Timeframe: Baseline and post-dose pre-scan after stimulus

InterventionScore on a Scale (Mean)
Paracetamol 665 mg0.60
Placebo0.43
No Treatment0.00

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Subjective NRS Response for Treatment Effect on Tibio-femoral Stimulation After the fMRI Scan: [NRS (T-f Post-scan)]

"Subjective NRS response for treatment effect on tibio-femoral stimulus after the fMRI scan was calculated for each participant as difference of pre-treatment pain assessment after stimulus and post-treatment post-scan pain assessment after stimulus on tibio-femoral. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine." (NCT01105936)
Timeframe: Baseline and post-dose post-scan after stimulus

InterventionScore on a Scale (Mean)
Paracetamol 665 mg0.15
Placebo0.09
No Treatment-0.13

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Subjective Numerical Rating Scale (NRS) Response for Treatment Effect on OA Knee Before Stimulation: [NRS (TRT)]

"Subjective NRS response for each participant was calculated as difference of pre-treatment NRS pain assessment before stimulus and post-treatment NRS pain assessment before stimulus. NRS responses was based on an 11 scale rating (0-10), with 0 corresponding to No Pain and 10 corresponding to Extreme Pain or Pain as bad as you can imagine." (NCT01105936)
Timeframe: Baseline and post-dose before stimulus

InterventionScore on a Scale (Mean)
Paracetamol 665 Milligram (mg)0.95
Placebo-0.52
No Treatment0.48

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BOLD Response in the Patello-femoral Joint of Knee Osteoarthritis: [BOLD (P-f)]

BOLD response to painful pressure stimuli was evaluated using fMRI. Voxel-wise BOLD scores were reported on a Z-scale (Gaussian,mean=0,SD=1); range -3 (worst score, lowest connectivity) to +3 (best score, highest connectivity). The software derived scores compared the intensity reading in the region to a template, specifically the Montreal Neurological Institute (MNI) Echo-Planar Image (EPI) template. The template provides, for each region, expected (mean/median) intensity for that region, along with expected variation. The BOLD score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution (NCT01105936)
Timeframe: Baseline to 2-5 hours post last dose administration

,,
InterventionZ-score (Mean)
BOLD - Sensory Cortex (a)BOLD - Supramarginal GyrusBOLD - ThalamusBOLD - Subgenu PrefrontalBOLD - Frontal CortexBOLD - InsulaBOLD - Sensory Cortex (b)
No Treatment0.480.76NA0.190.260.620.44
Paracetamol 665 mg0.160.460.48NANANANA
PlaceboNANA-0.68-0.27-0.040.12-0.11

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Percentage of Participants With Reduction in Pain Intensity

The percentage of participants with extent of reduction in pain intensity greater than or equal to 30 percent was reported. Pain intensity change rate was calculated by Visual Analog Scale (VAS) score at baseline minus VAS score at Day 29 divided by VAS score at Baseline. VAS is a 10 centimeter (cm) scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain. (NCT01112267)
Timeframe: Baseline up to Day 29

InterventionPercentage of Participants (Number)
Tramadol HCl/Acetaminophen57.65
Placebo41.11

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Percentage of Participants With Pain Relief

Pain relief was measured in 6 stages to assess the participant's pain relief. Extent of pain relief was measured on a scale ranging from 4 to -1, where 4=complete disappearance, 3=fair relief, 2=moderate relief, 1=slight relief, 0=no change and -1=pain worsening. Relief more than 'slight relief (1)' was considered as pain relief success. (NCT01112267)
Timeframe: Day 8, Day 15 and Day 29

,
InterventionPercentage of participants (Number)
Day 8: Slight relief (n=82,88)Day 15: Slight relief (n=85,89)Day 29, Slight relief (85,89)
Placebo53.4165.1777.53
Tramadol HCl/Acetaminophen70.7382.3581.18

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Change From Baseline in Short Form (SF)-36 Score at Day 29

"The quality of life of participants was evaluated by SF-36 Korean version questionnaire. It is composed of 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Participants answered to the questionnaire of 36 questions; and physical, social, and psychological health status were assessed. It ranges 0 to 100, and higher score indicates better quality of life, But in Reported (Rptd.) Health Transition domain higher score indicates worse quality of life." (NCT01112267)
Timeframe: Baseline and Day 29

,
InterventionUnit on a scale (Mean)
Baseline: Physical functioningChange at Day 29: Physical functioning (n=83,87)Baseline: Role physicalChange at Day 29: Role Physical (n=83,87)Baseline: Bodily painChange at Day 29: Bodily pain (n=83,87)Baseline: General healthChange at Day 29: General health (n=83,87)Baseline: VitalityChange at Day 29: Vitality (n=83,87)Baseline: Social functioningChange at Day 29: Social functioning (n=83,87)Baseline: Role emotionalChange at Day 29: Role emotional (n=83,87)Baseline: Mental HealthChange at Day 29: Mental Health (n=83,87)Baseline: Rptd. health transitionChange at Day 29: Rptd. health transition(n=83,87)
Placebo47.946.6749.518.6935.9917.6948.112.7742.715.8264.586.6161.577.4760.5618.3963.61-6.90
Tramadol HCl/Acetaminophen46.719.8244.9316.0434.6619.3943.567.3638.8211.1464.2611.7561.768.1361.0620.4865.00-18.07

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Change From Baseline in Pain Intensity at Day 29

Change in pain intensity experienced by participants over the last 48 hours was measured on Day 29 against Baseline with VAS. VAS is a 10 cm scale. Intensity of pain range: 0 cm=no pain to 10 cm=worst possible pain. (NCT01112267)
Timeframe: Baseline and Day 29

,
InterventionUnit on a scale (Mean)
BaselineChange at Day 29
Placebo6.0001.549
Tramadol HCl/Acetaminophen6.3342.299

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Change From Baseline in Oswestry Disability Index (ODI) Korean Version Score at Day 29

The ODI Korean version was used to assess the participant's functionality. The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). Total score is the sum of score obtained in each section and ranges from 0 to 50. A higher score represents greater disability. (NCT01112267)
Timeframe: Baseline and Day 29

,
InterventionUnit on a scale (Mean)
BaselineChange at Day 29 (n=87,83)
Placebo38.1267.178
Tramadol HCl/Acetaminophen39.62611.216

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Percentage of Participants With Investigator's Global Assessment on Investigational Product

"Global assessment on investigational product was done by investigator on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here." (NCT01112267)
Timeframe: Day 29

InterventionPercentage of participants (Number)
Tramadol HCl/Acetaminophen81.25
Placebo69.88

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Percentage of Participants With Participants' Global Assessment on Investigational Product

"Global assessment on investigational product was done by participants on how well the investigational product controlled chronic (lasting a long time) low back pain. Assessment was done by categories 'Very bad (-2)' 'Bad (-1)' 'Not changed (0) 'Good (1)' and 'Very good (2)'. Assessment better than Good was considered as pain improvement success. Percentage of participants with pain improvement success is reported here." (NCT01112267)
Timeframe: Day 29

InterventionPercentage of participants (Number)
Tramadol HCl/Acetaminophen76.25
Placebo72.29

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Pain Intensity Difference (PID) at 75 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 75 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100043.1
ACE-65037.6
ACE-0-0.9

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 300 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100090.1
ACE-65067.6
ACE-013.7

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 360 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100081.4
ACE-65060.4
ACE-015.0

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 45 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100080.0
ACE-65077.6
ACE-08.1

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 60 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100094.9
ACE-65086.7
ACE-08.2

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 75 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-1000101.1
ACE-65089.6
ACE-07.4

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 90 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-1000104.2
ACE-65091.2
ACE-09.4

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Rescue Rates Through Six Hours

Percentage of subjects using rescue medication. (NCT01115673)
Timeframe: through 6 Hours

InterventionPercentage of Participants (Number)
ACE-100029.3
ACE-65045.6
ACE-080.0

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Rescue Rates Through Four Hours

Percentage of subjects using rescue medication. (NCT01115673)
Timeframe: through 4 Hours

InterventionPercentage of Participants (Number)
ACE-100020.1
ACE-65032.4
ACE-080.0

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Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score

Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600 (NCT01115673)
Timeframe: 6 Hours

InterventionPercentage of Participants (Number)
ACE-100056.9
ACE-65044.4
ACE-06.7

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Patient Global Evaluation

Patient Assessment of the Pain Medication - Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent (NCT01115673)
Timeframe: 6 Hours

InterventionUnits on a scale (Least Squares Mean)
ACE-10002.28
ACE-6501.95
ACE-00.60

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Sum of Pain Intensity Difference Over Six Hours (SPID6)

Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point. (NCT01115673)
Timeframe: 6 Hours

Interventionunits on a scale (Least Squares Mean)
ACE-1000222.5
ACE-650174.3
ACE-0-4.2

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Pain Intensity Difference (PID) at 120 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 120 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100044.8
ACE-65035.7
ACE-0-2.7

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Pain Relief (PAR) Scores at 75 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 75 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100058.0
ACE-65052.0
ACE-08.4

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Sum of Pain Relief Scores Over Six Hours (TOTPAR6)

Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point. (NCT01115673)
Timeframe: 6 Hours

Interventionunits on a scale (Least Squares Mean)
ACE-1000306.9
ACE-650253.0
ACE-064.3

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Pain Relief (PAR) Scores at 60 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 60 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100054.4
ACE-65050.1
ACE-08.3

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Pain Relief (PAR) Scores at 45 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 45 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100046.1
ACE-65044.8
ACE-07.9

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Pain Relief (PAR) Scores at 360 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 360 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100048.0
ACE-65036.6
ACE-014.0

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Pain Relief (PAR) Scores at 90 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 90 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100059.9
ACE-65053.1
ACE-010.1

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Pain Relief (PAR) Scores at 30 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 30 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100029.6
ACE-65029.9
ACE-04.8

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Pain Relief (PAR) Scores at 240 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 240 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100056.2
ACE-65044.3
ACE-012.3

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 240 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100097.0
ACE-65074.6
ACE-011.2

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Duration of Analgesia - Time to Rescue

Minutes until rescue medication was given. (NCT01115673)
Timeframe: within 6 Hours

InterventionMinutes (Median)
ACE-1000NA
ACE-650NA
ACE-099.5

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Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)

Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point. (NCT01115673)
Timeframe: 6 Hours

Interventionunits on a scale (Least Squares Mean)
ACE-1000529.4
ACE-650427.3
ACE-060.0

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Pain Relief (PAR) Scores at 300 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 300 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100052.2
ACE-65040.5
ACE-013.8

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Pain Relief (PAR) Scores at 180 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 180 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100056.3
ACE-65046.3
ACE-09.5

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Pain Relief (PAR) Scores at 15 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 15 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-10008.3
ACE-6509.4
ACE-03.0

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Pain Relief (PAR) Scores at 120 Minutes

Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100 (NCT01115673)
Timeframe: 120 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100060.3
ACE-65050.8
ACE-08.0

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Pain Intensity Difference (PID) at 90 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 90 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100044.4
ACE-65038.0
ACE-0-0.6

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Pain Intensity Difference (PID) at 15 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 15 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-10005.6
ACE-6506.9
ACE-01.3

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Pain Intensity Difference (PID) at 60 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 60 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100040.4
ACE-65036.6
ACE-0-0.1

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 180 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100097.1
ACE-65078.2
ACE-06.9

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Time to Confirmed Perceptible Pain Relief

Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain. (NCT01115673)
Timeframe: within 6 Hours

InterventionMinutes (Median)
ACE-100022.2
ACE-65022.2
ACE-0NA

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Time to Meaningful Pain Relief

Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them. (NCT01115673)
Timeframe: within 6 Hours

InterventionMinutes (Median)
ACE-100053.7
ACE-65056.1
ACE-0NA

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 30 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100050.9
ACE-65051.3
ACE-05.2

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 120 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-1000105.1
ACE-65086.5
ACE-05.3

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Pain Intensity Difference (PID) at 45 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 45 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100033.9
ACE-65032.8
ACE-00.2

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Pain Intensity Difference (PID) at 360 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 360 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100033.4
ACE-65023.8
ACE-01.0

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Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes

Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief (NCT01115673)
Timeframe: 15 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100013.9
ACE-65016.4
ACE-04.2

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Pain Intensity Difference (PID) at 300 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 300 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100037.9
ACE-65027.1
ACE-0-0.1

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Pain Intensity Difference (PID) at 30 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 30 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100021.3
ACE-65021.5
ACE-00.5

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Pain Intensity Difference (PID) at 240 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 240 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100040.8
ACE-65030.3
ACE-0-1.1

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Pain Intensity Difference (PID) at 180 Minutes

Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point. (NCT01115673)
Timeframe: 180 Minutes

Interventionunits on a scale (Least Squares Mean)
ACE-100040.8
ACE-65031.9
ACE-0-2.6

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Cumulative Percentage of Participants With Treatment Failure

Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

,,
Interventionpercentage of participants (Number)
0.25 hours0.5 hours1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours
Acetaminophen0.00.00.02.412.921.227.132.935.3
Ibuprofen Sodium0.00.00.02.35.711.415.925.029.5
Placebo0.00.00.042.268.982.282.282.282.2

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Cumulative Percentage of Participants With Meaningful Relief

Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment participant first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

,,
Interventionpercentage of participants (Number)
0.25 hours0.5 hours1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours
Acetaminophen0.020.056.564.770.671.874.174.174.1
Ibuprofen Sodium0.021.653.472.775.077.378.479.579.5
Placebo0.00.00.02.28.911.113.313.313.3

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Cumulative Percentage of Participants With Confirmed First Perceptible Relief

Percentage of participants with first perceptible relief evaluated by stopping the stopwatch labeled 'first perceptible relief' at the moment participant first began to experience any relief. First perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

,,
Interventionpercentage of participants (Number)
0.25 hours0.5 hours1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours
Acetaminophen24.762.472.974.174.174.174.174.174.1
Ibuprofen Sodium28.464.878.479.579.579.579.579.579.5
Placebo2.24.411.111.113.313.313.313.313.3

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Cumulative Percentage of Participants With Complete Relief

Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

,,
Interventionpercentage of participants (Number)
0.25 hours0.5 hours1 hours1.5 hours2 hours3 hours4 hours5 hours6 hours
Acetaminophen1.24.715.324.729.432.935.335.335.3
Ibuprofen Sodium0.06.823.929.536.442.045.545.546.6
Placebo0.00.00.00.04.44.46.78.98.9

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Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)

SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01216163)
Timeframe: 0 to 6 hours

Interventionunits on a scale (Mean)
Placebo2.8
Ibuprofen Sodium20.0
Acetaminophen17.1

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Time to Treatment Failure

Median time of dropping out of the participants from the study due to lack of efficacy or use of rescue medication, whichever comes first. (NCT01216163)
Timeframe: 0 to 6 hours

Interventionhours (Median)
Placebo1.6
Ibuprofen SodiumNA
AcetaminophenNA

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Time to Onset of Meaningful Relief

Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. (NCT01216163)
Timeframe: 0 to 6 hours

Interventionminutes (Median)
PlaceboNA
Ibuprofen Sodium58.0
Acetaminophen53.4

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Time to Confirmed First Perceptible Relief

Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered. The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief. (NCT01216163)
Timeframe: 0 to 6 hours

Interventionminutes (Median)
PlaceboNA
Ibuprofen Sodium16.0
Acetaminophen23.7

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Participant Global Evaluation of Study Medication

Participant global evaluation of study medication was performed at the 6-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent. (NCT01216163)
Timeframe: 6 hours

Interventionunits on a scale (Mean)
Placebo0.9
Ibuprofen Sodium3.5
Acetaminophen3.0

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Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)

SPRID: time-weighted sum of PRID over 2 and 3 hours. Total score range: -2 (worst) to 14 (best) for SPRID 0-2, and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief). (NCT01216163)
Timeframe: 0 to 2, 0 to 3 hours

,,
Interventionunits on a scale (Mean)
SPRID 0-2SPRID 0-3
Acetaminophen6.09.1
Ibuprofen Sodium6.910.6
Placebo0.91.3

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Time-weighted Sum of Pain Relief Rating (TOTPAR)

TOTPAR: time-weighted sum of PRR over 2, 3, and 6 hours. Total score range: 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, and 0 (worst) to 24 (best) for TOTPAR 0-6. PRR was evaluated at different time points during the study up to 6 hours, and immediately after taking rescue medication (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01216163)
Timeframe: 0 to 2, 0 to 3, 0 to 6 hours

,,
Interventionunits on a scale (Mean)
TOTPAR 0-2TOTPAR 0-3TOTPAR 0-6
Acetaminophen4.26.412.0
Ibuprofen Sodium4.77.213.6
Placebo0.91.42.9

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Time-weighted Sum of Pain Intensity Difference (SPID)

SPID: time-weighted sum of PID over 2, 3 and 6 hours. Total score range: -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, and -6 (worst) to 18 (best) for SPID 0-6. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). (NCT01216163)
Timeframe: 0 to 2, 0 to 3, 0 to 6 hours

,,
Interventionunits on a scale (Mean)
SPID 0-2SPID 0-3SPID 0-6
Acetaminophen1.82.85.1
Ibuprofen Sodium2.23.46.3
Placebo-0.1-0.1-0.1

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Sum of Pain Relief Rating and Pain Intensity Difference (PRID)

PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief). (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

,,
Interventionunits on a scale (Mean)
0.25 hours0.5 hours1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours
Acetaminophen0.62.03.43.73.63.13.02.72.3
Ibuprofen Sodium0.92.53.94.14.13.73.62.92.8
Placebo0.10.20.60.50.50.40.50.50.5

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Pain Relief Rating (PRR)

PRR was evaluated at different time points during the study up to 6 hours after taking the study medication, and immediately before rescue medication was taken (if necessary). PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief. (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

,,
Interventionunits on a scale (Mean)
0.25 hours0.5 hours1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours
Acetaminophen0.41.52.42.52.52.22.11.91.7
Ibuprofen Sodium0.71.82.62.82.82.52.42.02.0
Placebo0.10.30.60.50.50.50.50.50.5

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Pain Intensity Difference (PID)

PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best). (NCT01216163)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

,,
Interventionunits on a scale (Mean)
0.25 hours0.5 hours1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours
Acetaminophen0.20.51.01.11.10.90.90.80.6
Ibuprofen Sodium0.30.81.31.31.31.21.10.90.9
Placebo-0.1-0.10.0-0.0-0.0-0.0-0.00.0-0.0

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Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)

"SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.~Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'~Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'" (NCT01229449)
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours

,,,,
Interventionunits on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours11 hours12 hours
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)1.122.493.203.714.124.284.184.083.773.062.562.091.571.210.900.69
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)1.292.793.524.044.444.514.534.464.363.983.512.792.532.041.631.34
Nurofen Plus®0.782.082.923.493.924.174.023.783.522.982.542.081.681.301.120.96
Panadeine® Extra1.012.623.393.813.963.913.312.792.231.701.311.020.910.810.760.74
Placebo0.290.580.650.710.600.671.660.640.600.530.450.400.470.490.490.49

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Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)

"Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'~PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain." (NCT01229449)
Timeframe: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose

Interventionunits on a scale (Mean)
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)1.78
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)1.93
Nurofen Plus®1.74
Panadeine® Extra1.63
Placebo0.60

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Individual Pain Intensity Differences Visual Analogue Scale (VAS)

Pain Intensity (PI) VAS was measured using a horizontal 100-mm VAS ranging 0 mm = 'No Pain' as the left anchor and 100 mm = 'Worst Pain' as the right anchor, labelled by the subject marking the VAS line in the pain assessment questionnaire in response to the instruction 'Please indicate with a line on the scale below your pain at this time.' (NCT01229449)
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours

,,,,
Interventionunits on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours11 hours12 hours
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)9.022.832.540.348.350.651.050.245.436.630.925.017.714.19.48.0
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)10.526.237.546.352.554.955.955.552.847.941.033.829.623.718.715.1
Nurofen Plus®4.517.728.336.643.747.348.045.642.535.629.724.418.414.912.811.0
Panadeine® Extra8.723.934.341.544.645.238.932.925.918.415.411.710.89.79.89.3
Placebo0.42.20.91.80.95.06.17.27.26.55.85.15.66.26.26.4

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Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)

"SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.~Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'~Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'" (NCT01229449)
Timeframe: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose

Interventionunits on a scale*hour (Mean)
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)2.68
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)3.30
Nurofen Plus®2.62
Panadeine® Extra1.93
Placebo0.54

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Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)

Sum of Pain Intensity Difference (SPID) was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Score range: 0mm = No pain and 100mm = Worst pain. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' (NCT01229449)
Timeframe: 0-4, 0-6, 0-8 and 0-12 hours

,,,,
Interventionunits on a scale*hour (Mean)
0-4h0-6h0-8h0-12h
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)1.321.321.210.94
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)1.461.501.431.18
Nurofen Plus®1.231.231.140.91
Panadeine® Extra1.131.010.870.67
Placebo0.180.190.190.19

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Change From Baseline in AUC (0-8h) of SPRID

"SPRID 0-8h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0 mm = No pain and 100 mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero.~Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?'~Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'" (NCT01229449)
Timeframe: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose

,,,,
Interventionunits on a scale*hour (Mean)
0-4h0-6h0-8h
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)3.653.663.39
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)3.954.063.91
Nurofen Plus®3.443.453.22
Panadeine® Extra3.192.862.48
Placebo0.610.600.57

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Change From Baseline in AUC of Pain Relief Scores (TOTPAR)

"Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'~Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete." (NCT01229449)
Timeframe: 0-4, 0-6, 0-8 and 0-12 hours

,,,,
Interventionunits on a scale*hour (Mean)
0-4h0-6h0-8h0-12h
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)2.332.342.181.73
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)2.482.562.482.12
Nurofen Plus®2.202.222.081.70
Panadeine® Extra2.051.851.611.27
Placebo0.420.410.380.34

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Individual Pain Intensity Differences (Ordinal)

"Pain intensity (PI) was measured by pain assessment questionnaire where subject tick the appropriate box in response to the question 'What is your pain level at this time?'~PI measured using a 4-point ordinal scale: 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain." (NCT01229449)
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours

,,,,
Interventionunits on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours11 hours12 hours
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)0.400.941.141.311.491.541.541.491.351.070.890.710.530.400.270.21
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)0.461.031.271.481.611.691.701.681.601.441.220.960.860.670.520.42
Nurofen Plus®0.230.731.041.241.401.521.461.361.241.040.880.720.550.430.360.30
Panadeine® Extra0.310.951.191.351.421.411.190.960.790.580.440.330.290.270.240.25
Placebo0.090.150.160.220.110.240.220.240.220.200.180.160.200.200.200.20

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Change From Baseline in Peak Pain Relief (PR)

"Total pain relief (TOTPAR) was measured using pain assessment diary where subject tick the appropriate box in response to the question 'How much relief have you had from your starting pain?'~Pain Relief (PR) was rated on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete." (NCT01229449)
Timeframe: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose

Interventionunits on a scale (Mean)
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)3.06
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)3.25
Nurofen Plus®2.98
Panadeine® Extra2.88
Placebo0.96

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Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication

"Subject's Overall Assessment measured by subject ticking the appropriate box in response to the question 'How effective do you think the study medication is as a treatment for pain?'~Subject's Overall Assessment rated on a five-point ordinal scale: 1 = Poor, 2 = Fair, 3 = Good, 4 = Very good, and 5 = Excellent." (NCT01229449)
Timeframe: At 12 hours

,,,,
InterventionParticipants (Count of Participants)
1 Poor2 Fair3 Good4 Very good5 Excellent
Ibuprofen 200mg + Paracetamol 500mg (Lower Dose)1516437223
Ibuprofen 400mg + Paracetamol 1000mg (Higher Dose)912326939
Nurofen Plus®1522406426
Panadeine® Extra121941347
Placebo436231

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Antibody Concentrations Against Protein D (Anti-PD)

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)

InterventionEL.U/mL (Geometric Mean)
IIBU Group1461.3
DIBU Group1353.1
NIBU Group1557.7
IPARA Group1109.6
DPARA Group1348.6
NPARA Group1667.9

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Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)

Interventionµg/mL (Geometric Mean)
IIBU Group3.994
DIBU Group3.66
NIBU Group4.51
IPARA Group3.29
DPARA Group4.23
NPARA Group5.007

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Antibody Concentrations Against Hepatitis B Surface Antigen (HBs)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)

InterventionmIU/mL (Geometric Mean)
IIBU Group911.85
DIBU Group1139.1
NIBU Group1245.07
IPARA Group934.65
DPARA Group674.25
NPARA Group1027.79

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Number of Subjects With Any Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity. (NCT01235949)
Timeframe: During the entire study period (Month 0 to 10)

InterventionParticipants (Count of Participants)
IIBU Group4
DIBU Group4
NIBU Group2
IPARA Group4
DPARA Group1
NPARA Group0

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Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A

Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)

,,,,,
Interventionμg/mL (Geometric Mean)
Anti-6AAnti-19A
DIBU Group0.180.2
DPARA Group0.120.17
IIBU Group0.170.23
IPARA Group0.110.15
NIBU Group0.150.16
NPARA Group0.190.25

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Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). (NCT01235949)
Timeframe: Within the 4-day (Days 0-3) period following booster vaccination

,,,,,,,,,,,
InterventionParticipants (Count of Participants)
Any PainGrade 3 PainAny RednessGrade 3 RednessAny SwellingGrade 3 Swelling
DIBU-DIBU Group16115161
DIBU-IIBU Group222230160
DIBU-NIBU Group252220110
DPARA-IPARA Group244230120
IIBU-DIBU Group223251160
IIBU-IIBU Group250270160
IIBU-NIBU Group15017090
IPARA-NPARA Group234230170
NIBU-DIBU Group321255182
NIBU-IIBU Group284233160
NIBU-NIBU Group284230150
NPARA-IPARA Group241232160

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Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. (NCT01235949)
Timeframe: Within 31-days (Day 0-30) following booster vaccination

InterventionSubjects (Number)
IIBU-IIBU Group6
IIBU-DIBU Group6
IIBU-NIBU Group2
DIBU-IIBU Group3
DIBU-DIBU Group3
DIBU-NIBU Group4
NIBU-IIBU Group6
NIBU-DIBU Group6
NIBU-NIBU Group3
IPARA-NPARA Group4
DPARA-IPARA Group0
NPARA-IPARA Group2

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Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
Interventionμg/mL (Geometric Mean)
Anti-1, M9Anti-1, M10Anti-4, M9Anti-4, M10Anti-5, M9Anti-5, M10Anti-6B, M9Anti-6B M10Anti-7F, M9Anti-7F M10Anti-9V, M9Anti-9V M10Anti-14, M9Anti-14 M10Anti-18C M9Anti-18C M10Anti-19F M9Anti-19F M10Anti-23F M9Anti-23F M10Anti-6A, M9Anti-6A M10Anti-19A M9Anti-19A M10
IIBU-NIBU Group0.272.390.553.220.764.110.542.430.894.20.833.941.065.160.967.781.726.910.412.590.251.140.221.05
IPARA-NPARA Group0.311.760.523.270.592.620.431.740.843.890.743.111.184.720.916.181.565.940.472.50.190.810.210.74
NIBU-DIBU Group0.383.040.734.080.843.920.582.321.315.550.923.881.936.561.3911.291.77.260.693.170.280.990.20.93
NIBU-IIBU Group0.442.840.724.040.834.210.562.161.075.431.094.071.66.031.127.151.255.240.613.120.261.030.150.67
NIBU-NIBU Group0.432.840.624.070.964.480.672.511.114.931.094.051.956.31.238.681.97.340.583.330.341.40.280.97
NPARA-IPARA Group0.452.840.844.280.854.330.612.290.974.520.973.91.865.621.318.171.726.660.523.150.240.980.241.11
DIBU-DIBU Group0.422.440.723.630.763.330.622.181.14.361.033.161.75.081.17.161.545.270.52.160.321.090.20.66
DIBU-IIBU Group0.382.690.634.050.783.420.552.131.084.961.033.471.314.541.088.231.585.350.552.930.260.890.240.75
DIBU-NIBU Group0.341.870.643.410.73.370.61.521.093.930.933.071.734.611.037.11.385.570.652.740.320.740.240.95
DPARA-IPARA Group0.32.140.63.310.723.580.431.840.984.630.933.491.535.521.148.661.515.540.432.530.220.870.190.63
IIBU-DIBU Group0.362.230.633.650.833.90.441.970.964.20.833.31.745.621.038.061.666.640.643.080.180.860.231.1
IIBU-IIBU Group0.412.870.714.090.984.50.632.751.335.751.074.461.766.021.139.351.946.90.653.720.311.360.281.11

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Number of Subjects With Any Unsolicited Adverse Events (AEs)

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. (NCT01235949)
Timeframe: Within 31-days (Day 0-30) following each primary vaccination dose

InterventionParticipants (Count of Participants)
IIBU Group28
DIBU Group33
NIBU Group35
IPARA Group16
DPARA Group4
NPARA Group13

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Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)

,,,,,
InterventionTiters (Geometric Mean)
OPSONO-1OPSONO-4OPSONO-5OPSONO-6BOPSONO-7FOPSONO-9VOPSONO-14OPSONO-18COPSONO-19FOPSONO-23FOPSONO-6AOPSONO-19A
DIBU Group67.91172.352.4882.44977.94040.41219.7167.6514.81105.5151.146.1
DPARA Group941712.470.7140.37306.43777.11780.5382.7254.272334.239.7
IIBU Group69.4131186.67238827.73429.21346.3186.9536.2989.87916.6
IPARA Group23684.838.7739.98362.75520.1591.591.6501.11188.4100.711.2
NIBU Group75.91027.774.3361.36444.82744.21417.9135.9267.9129626.420.4
NPARA Group64.4777.280.8237.16286.12273.21460.1106272.1838.444.511.4

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Opsonophagocytic Activity (OPA) Titers Against Vaccine Pneumococcal Serotypes

"OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value 99999.9 has been entered when value to be entered in the system was greater than (>) 1.0 E10." (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
InterventionTiters (Geometric Mean)
OPSONO-1, M9OPSONO-1, M10OPSONO-4, M9OPSONO-4, M10OPSONO-5, M9OPSONO-5, M10OPSONO-6B, M9OPSONO-6B, M10OPSONO-7F, M9OPSONO-7F, M10OPSONO-9V, M9OPSONO-9V, M10OPSONO-14, M9OPSONO-14, M10OPSONO-18C, M9OPSONO-18C, M10OPSONO-19F, M9OPSONO-19F, M10OPSONO-23F, M9OPSONO-23F, M10OPSONO-6A, M9OPSONO-6A, M10OPSONO-19A, M9OPSONO-19A, M10
IPARA-NPARA Group6120.625.9548.35.742.2127.7431.51290.911414.1567.4856.698.3557.56.5149.911163.389.429746.7154444.3
NIBU-DIBU Group40.2546.252.41149.812.7128.913.7173.111523565.8282.12919.8255.9935.39.4707.924.2273.930.53682.734.1106.94253
NIBU-IIBU Group7.3388.298.11953.47.699.516.4237.6256314362.41075.24218.92951498.131.9428.615572.7499.74249.123.398.14125.7
NIBU-NIBU Group10.762715.21414.19.8184.6182.51047.81263.55829.11571.38601.7382.638175.5481.353.2250.615.61464.158.3120412.8
NPARA-IPARA Group15.7887.6161.8854.422.2149.7239376.51744.77567.3738.71340.1195.4587.514242.748.451137.7875.224.578.54541.6
IIBU-NIBU Group4316.442213.48.2241.784.3769.11762.512162.6649.44756.147.24426.642394.788.52575.222.22792.913.4318.4421.2
DIBU-DIBU Group50.6248407.61037.517.5114.1289.4553.15343.29941.81423.63772.9791.7200221.9650.617.71040.71342096.1224.874.57.429.8
DIBU-IIBU Group50.315892096.7197913.3694.21729.9117411302.74190.8737.11507.611.5397.39.7637.129.72977.7239.5581.1428
DIBU-NIBU Group9.9344.474.21096.710.8165.8208.91021.63522.85744.51081.94970.9539.21312.410.9298.167.81575396.63530.199169.24325.4
DPARA-IPARA Group12.2736.356.31885.97.4125.3105.6904.32256.221670480.97262.2260.7228819.1888.942.31215.3274.51436.284159.19.1416.5
IIBU-DIBU Group4296.380.2865.89.293.3237.2606.21777.34591.41283.87041.7255.1671.47.2207.332.1330.5132.42381.545.1125.444
IIBU-IIBU Group5.8346.234928.112.9131.896.1745.6207616259.98304969149.21592.97.2912.9631112.927.958139.8183.74363.7

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Antibody Concentrations Against Hepatitis B Surface Antigen

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
InterventionmIU/mL (Geometric Mean)
Anti-HBs, M9Anti-HBs, M10
DIBU-DIBU Group225.012492.42
DIBU-IIBU Group136.531685.87
DIBU-NIBU Group194.512107.75
DPARA-IPARA Group199.572003.09
IIBU-DIBU Group210.321898.54
IIBU-IIBU Group197.461949.42
IIBU-NIBU Group164.331970.6
IPARA-NPARA Group128.122078.63
NIBU-DIBU Group244.522579.59
NIBU-IIBU Group226.11851.22
NIBU-NIBU Group159.793244.33
NPARA-IPARA Group209.272218.23

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Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). (NCT01235949)
Timeframe: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

,,,,,
InterventionParticipants (Count of Participants)
Any Pain, Dose 1Grade 3 Pain, Dose 1Any Redness, Dose 1Grade 3 Redness, Dose 1Any Swelling, Dose 1Grade 3 Swelling, Dose 1Any Pain, Dose 2Grade 3 Pain, Dose 2Any Redness, Dose 2Grade 3 Redness, Dose 2Any Swelling, Dose 2Grade 3 Swelling, Dose 2Any Pain, Dose 3Grade 3 Pain, Dose 3Any Redness, Dose 3Grade 3 Redness, Dose 3Any Swelling, Dose 3Grade 3 Swelling, Dose 3Any Pain, Across dosesGrade 3 Pain, Across dosesAny Redness, Across dosesGrade 3 Redness, Across dosesAny Swelling, Across dosesGrade 3 Swelling, Across doses
DIBU Group482520220492590330483630320767890510
DPARA Group28219071220230111211252120373352171
IIBU Group4437412916017313115027023619251084613
IPARA Group212240100192240101181280160305360201
NIBU Group788771280676720310524560300107151051570
NPARA Group337320110251312122221272132447462192

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Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off

Antibodies against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL). (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)

,,,,,
InterventionParticipants (Count of Participants)
Anti-1Anti-4Anti-5Anti-6BAnti-7FAnti-9VAnti-14Anti-18CAnti-19FAnti-23F
DIBU Group155155154135157153153153152141
DPARA Group50515037555050505043
IIBU Group144145143121153144144143145136
IPARA Group52535342555353525347
NIBU Group160158156133164155154155157149
NPARA Group55565448565353545450

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Antibody Titers Against Poliovirus Type 1, 2 and 3

Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
InterventionTiters (Geometric Mean)
Anti-Polio 1, M9Anti-Polio 1, M10Anti-Polio 2, M9Anti-Polio 2, M10Anti-Polio 3, M9Anti-Polio 3, M10
DIBU-DIBU Group45.438841.7512.545.3588.1
DIBU-IIBU Group145.71824.5292.12151.9205.43649.1
DIBU-NIBU Group32.1543.98542.445.21152.5
DPARA-IPARA Group128.31448.1139.61625.4108.11625.4
IIBU-DIBU Group85.9790.760.81217.7861724.5
IIBU-IIBU Group561378.2120.8194972861
IIBU-NIBU Group80.9429.948.3548.7127.8359.5
IPARA-NPARA Group53.81290.129.72047.996.52195
NIBU-DIBU Group53.74119.6434.1139.6724.1
NIBU-IIBU Group67.11217.7134.81217.770558.3
NIBU-NIBU Group141.21075.9156.11393.41282233.3
NPARA-IPARA Group117.4861.1168.91116.669.72048

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Antibody Titers Against Poliovirus Type 1, 2 and 3

Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)

,,,,,
InterventionTiters (Geometric Mean)
Anti-Polio 1Anti-Polio 2Anti-Polio 3
DIBU Group252.5327.4351.3
DPARA Group166394.8394.8
IIBU Group283.4362423.2
IPARA Group225.6240.7284
NIBU Group337378624.1
NPARA Group449.3335.2438.6

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Antibody Concentrations Against Vaccine Pneumococcal Serotypes

Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. (NCT01235949)
Timeframe: One month after primary immunization (At Month 3)

,,,,,
Interventionµg/mL (Geometric Mean)
Anti-1Anti-4Anti-5Anti-6BAnti-7FAnti-9VAnti-14Anti-18CAnti-19FAnti-23F
DIBU Group1.712.212.390.762.832.014.523.85.040.92
DPARA Group1.381.952.360.422.451.824.124.085.20.74
IIBU Group1.822.252.930.672.872.14.763.856.111.04
IPARA Group1.321.571.950.492.181.673.443.084.950.77
NIBU Group1.92.212.770.62.772.184.774.344.961.07
NPARA Group1.952.593.050.722.952.45.174.966.981

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Antibody Concentrations Against Protein D (Anti-PD)

Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
InterventionEL.U/mL (Geometric Mean)
Anti-PD, M9Anti-PD M10
DIBU-DIBU Group5901664.8
DIBU-IIBU Group622.91888.7
DIBU-NIBU Group5021540.7
DPARA-IPARA Group525.41517.3
IIBU-DIBU Group660.41980.1
IIBU-IIBU Group661.62069
IIBU-NIBU Group588.31907.5
IPARA-NPARA Group446.11482.7
NIBU-DIBU Group555.11953.1
NIBU-IIBU Group752.12319.7
NIBU-NIBU Group777.22285.5
NPARA-IPARA Group691.32082.5

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Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)

,,,,,
InterventionEL.U/mL (Geometric Mean)
Anti-PTAnti-FHAAnti-PRN
DIBU Group64.2171.6114.3
DPARA Group63.1196.5106.2
IIBU Group59.1163.1103.9
IPARA Group60.417197.1
NIBU Group65191.1118.1
NPARA Group61.5168.9114

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Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA) and Pertactin (Anti-PRN)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
InterventionEL.U/mL (Geometric Mean)
Anti-PT, M9Anti-PT, M10Anti-FHA, M9Anti-FHA, M10Anti-PRN, M9Anti-PRN, M10
DIBU-DIBU Group14.275.559.3322.925.1246.2
DIBU-IIBU Group14.772.353.8359.822.4262.9
DIBU-NIBU Group13.674.857.7332.716184.3
DPARA-IPARA Group10.866.848.5332.919.7214.2
IIBU-DIBU Group12.864.442.6252.716173.5
IIBU-IIBU Group13.373.846.1308.815.7218.6
IIBU-NIBU Group10.556.642.6327.218.3225.9
IPARA-NPARA Group1359.450.832120.1205.1
NIBU-DIBU Group1274.945.7338.618.8255.7
NIBU-IIBU Group12.863.457.9312.319.4226.7
NIBU-NIBU Group15.297.659.1442.827.3330.4
NPARA-IPARA Group14.25752.9294.220.3213.6

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Antibody Concentrations Against Diphteria (D) and Tetanus (T) Toxoids

Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
InterventionIU/mL (Geometric Mean)
Anti-D, M9Anti-D, M10Anti-T, M9Anti-T, M10
DIBU-DIBU Group0.5815.8310.8687.269
DIBU-IIBU Group0.555.9260.6817.092
DIBU-NIBU Group0.6286.4860.6926.522
DPARA-IPARA Group0.5466.4770.6987.431
IIBU-DIBU Group0.5935.2570.7356.887
IIBU-IIBU Group0.7367.4920.8388.03
IIBU-NIBU Group0.6167.570.667.283
IPARA-NPARA Group0.6657.2380.6666.491
NIBU-DIBU Group0.6277.2260.88310.8
NIBU-IIBU Group0.7147.0590.8437.095
NIBU-NIBU Group0.6568.2060.8589.045
NPARA-IPARA Group0.6426.7490.97.423

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Antibody Concentrations Against Diphtheria (D) and Tetanus (T) Toxoids

Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL. (NCT01235949)
Timeframe: One month after primary immunization (Month 3)

,,,,,
InterventionIU/mL (Geometric Mean)
Anti-DAnti-T
DIBU Group2.9383.373
DPARA Group2.8913.058
IIBU Group3.3263.746
IPARA Group3.0622.943
NIBU Group3.1323.961
NPARA Group3.4573.762

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Antibody Concentrations Against Polyribosyl-ribitol-phosphate (PRP)

Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL. (NCT01235949)
Timeframe: Prior to (Month 9) and one month after booster vaccination (Month 10)

,,,,,,,,,,,
Interventionµg/mL (Geometric Mean)
Anti-PRP, M9Anti-PRP, M10
DIBU-DIBU Group0.84718.987
DIBU-IIBU Group0.82420.28
DIBU-NIBU Group0.76317.544
DPARA-IPARA Group0.65121.602
IIBU-DIBU Group0.68417.484
IIBU-IIBU Group0.87821.964
IIBU-NIBU Group0.67821.277
IPARA-NPARA Group0.69616.682
NIBU-DIBU Group0.7233.45
NIBU-IIBU Group0.79820.659
NIBU-NIBU Group1.01322.083
NPARA-IPARA Group0.95323.277

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Acetaminophen Metabolites

Area-under-curve from time zero to 8 hours for APAP-cysteinate metabolite. Serum was collected just prior to and at hours 1, 2, 4, 6, and 8 after administration of the APAP dose. (NCT01246713)
Timeframe: 8 hours

Interventionmcg.hr/ml (Mean)
Acetaminophen Solid Formulation2.411
Acetaminophen Liquid Formulation2.009

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Percent of Subjects Who Are Free of Phonophobia at 2 Hours.

Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours (NCT01248468)
Timeframe: 2 hours

InterventionPercent of participants (Number)
Aspirin, Acetaminophen, and Caffeine53.4
Sumatriptan (100 mg)60.9
Placebo46.2

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Percent of Subjects Who Are Pain Free at 2 Hours.

Subjects assessed severity of pain on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours (NCT01248468)
Timeframe: 2 hours

InterventionPercent of participants (Number)
Aspirin, Acetaminophen, and Caffeine34.7
Sumatriptan (100 mg)44.9
Placebo26.4

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Percent of Subjects Who Are Free of Photophobia at 2 Hours.

Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours (NCT01248468)
Timeframe: 2 hours

InterventionPercent of participants (Number)
Aspirin, Acetaminophen, and Caffeine48.6
Sumatriptan (100 mg)52.3
Placebo40.8

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Percent of Subjects Who Are Free of Nausea at 2 Hours.

Subjects assessed severity of relevant symptom on a 4 point scale (0=none, …, 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours (NCT01248468)
Timeframe: 2 hours

Interventionpercent of participants (Number)
Aspirin, Acetaminophen, and Caffeine70.6
Sumatriptan (100 mg)72.2
Placebo66.4

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Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.

Parent-reported side effects entered in 10-day diary. (NCT01267136)
Timeframe: Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.

,
Interventionparticipants (Number)
NauseaVomitingFeverItchingRashSweatingDizzinessHeadacheConstipationOversedationTonsil bleed
Capital® With Codeine Suspension202111519151221143
Tramadol Suspension201810121717172180

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Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.

Average number of post-operative days with pain score >4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001). (NCT01267136)
Timeframe: Efficacy was assessed daily during the 10-day postoperative recovery period.

Interventiondays (Median)
Capital® With Codeine Suspension1.5
Tramadol Suspension1

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Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)

Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever). (NCT01270659)
Timeframe: 60 minutes

Interventionminutes (Median)
Low-FBT15.0
High-FBT20.0
Low Control15.0
High Control15.0

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Nausea Level

"Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.~Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).~At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132)." (NCT01270659)
Timeframe: every 5 minutes for the first 60 minutes

InterventionParticipants (Count of Participants)
Low-FBT0
High-FBT0
Low Control0
High Control0

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Number of Participants Experiencing Any Adverse Events

Occurrence of any adverse event. (NCT01270659)
Timeframe: Full 2 hours of the study period

InterventionParticipants (Count of Participants)
Low-FBT1
High-FBT9
Low Control3
High Control10

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Cold Symptoms Score Post 60 Minutes

"A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered." (NCT01277081)
Timeframe: Baseline to 60 minutes

InterventionScore on a scale (Mean)
Mentholated Paracetamol Hot Drink0.87
Paracetamol Tablet0.35

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Overall Cold Symptoms Score

"Overall cold symptom score was assessed by asking the question my cold symptoms are improved only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'." (NCT01277081)
Timeframe: Baseline to 15 and 60 minutes

,
InterventionScore on a scale (Mean)
Average effect over first 15 minutesAverage effect over 60 minutes
Mentholated Paracetamol Hot Drink1.82.1
Paracetamol Tablet0.91.3

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Cold Symptoms Score Post 15 Minutes

"A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. My head feels clear, I feel soothing in my throat and I feel my cough is being soothed. The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered." (NCT01277081)
Timeframe: Baseline to 15 minutes

InterventionScore on a scale (Mean)
Mentholated Paracetamol Hot Drink0.64
Paracetamol Tablet0.13

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Breathing Scores Post 15 Minutes

"A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered." (NCT01277081)
Timeframe: Baseline to 15 minutes

InterventionScore on a Scale (Mean)
Mentholated Paracetamol Hot Drink0.83
Paracetamol Tablet0.11

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Breathing Score Post 60 Minutes

"A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. my breathing feels easy, I feel airways are open, I feel a cooling sensation in my throat, I can feel the air flowing to my lungs easily, My nose feels less blocked and I feel my breathing is comfortable. The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered." (NCT01277081)
Timeframe: Baseline to 60 minutes

InterventionScore on a scale (Mean)
Mentholated Paracetamol Hot Drink0.92
Paracetamol Tablet0.34

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Soothing Attribute Scores

"Soothing attribute of test treatment was assessed by asking the question if the hot drink is soothing at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'." (NCT01277081)
Timeframe: Baseline to 15 and 60 minutes

,
InterventionScore on a scale (Mean)
Average effect over first 15 minutesAverage effect over 60 minutes
Mentholated Paracetamol Hot Drink2.32.4
Paracetamol Tablet1.21.3

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Incidence of Persistent Pain

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces persistent pain up to 2 months post delivery. (NCT01298778)
Timeframe: 2 months

Interventionpercentage of participants (Number)
Standard of Care13
Acetaminophen and Increased Dose of Duramorph10

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Incidence of Depression

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces postpartum depression up to 2 months post delivery. (NCT01298778)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Standard of Care3
Acetaminophen and Increased Dose of Duramorph4

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Average Pain Over 24 Hours

(NCT01298778)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Standard of Care37
Acetaminophen and Increased Dose of Duramorph23

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Emetic Symptoms

side effect potential with the increased dose of duramorph-percentage experiencing such symptoms (NCT01298778)
Timeframe: 24hours

InterventionParticipants (Count of Participants)
Standard of Care16
Acetaminophen and Increased Dose of Duramorph18

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Pruritus

side effects-percentage of subjects requiring treatment (NCT01298778)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Standard of Care15
Acetaminophen and Increased Dose of Duramorph21

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Severity of Acute Pain

to determine whether an intervention in women predicted to experience severe pain after cesarean delivery reduces acute post-delivery pain (24 hour evoked pain post delivery). The scale utilized was a 100mm sliding VAS, where 0mm=no pain up to 100mm-worst pain imaginable. (NCT01298778)
Timeframe: 24 hour

Interventionmm (Mean)
Standard of Care46
Acetaminophen and Increased Dose of Duramorph31

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Analgesic Consumption

total amount of analgesic consumption (NCT01298778)
Timeframe: 24 hour

,
Interventionmg (Median)
IV PCA morphinetotal 24 hr opioid use
Acetaminophen and Increased Dose of Duramorph1515
Standard of Care1521

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Pain

resting pain, worst pain (NCT01298778)
Timeframe: 24 hour

,
Interventionunits on a scale, 0 -none, 100-worst (Median)
resting pain score over 24 hrsworst pain score over 24 hrs
Acetaminophen and Increased Dose of Duramorph462
Standard of Care1969

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Change in Infant Sleep Quantity (Objective)

Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy. (NCT01321710)
Timeframe: 24 hours before and 24 hours after immunizations at approximately 2 months of age

Interventionminutes (Mean)
Standard Immunization Care47.4
Prophylactic Acetaminophen73.1

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Maternal Sleep Disturbance (Subjective)

Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance. (NCT01321710)
Timeframe: 1 month postpartum (approximately)

InterventionScores on a scale (Mean)
Dietary Information49.9
Sleep Hygiene49.4

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Maternal Sleep Quality (Objective)

Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy. (NCT01321710)
Timeframe: 1 month postpartum (approximately)

Interventionpercentage of sleep per time in bed (Mean)
Dietary Information68
Sleep Hygiene71

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Maternal Sleep Quantity (Objective)

Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights. (NCT01321710)
Timeframe: 1-month postpartum (approximately)

Interventionhours (Mean)
Dietary Information6.1
Sleep Hygiene6.6

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Maternal Well-being

Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression. (NCT01321710)
Timeframe: 1 month postpartum (approximately)

InterventionScores on a scale (Mean)
Dietary Information13.3
Sleep Hygiene13.0

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Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge

(NCT01328782)
Timeframe: Analgesic data collected during first four hours following the end of surgery (surgery close)

InterventionMorphine (po) equivalents [mg*kg-1] (Mean)
Oral Narcotic Group0.09
Bupivacaine Group0.05
Ropivacaine Group0.08

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Need for IV Morphine of Fentanyl

Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl. (NCT01328782)
Timeframe: First 120 minutes after the end of surgery (surgery close time)

Interventionparticipants (Number)
Oral Narcotic Group19
Bupivacaine Group4
Ropivacaine Group15

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The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).

The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. (NCT01328782)
Timeframe: Will be obtained 30 - 60 minutes after arrival to the recovery room

InterventionScores on a scale (Mean)
Oral Narcotic Group4.14
Bupivacaine Group2.73
Ropivacaine Group3.66

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Time (in Minutes) to First Narcotic Administration

(NCT01328782)
Timeframe: first 72 hours after surgery close time

InterventionMinutes (Median)
Oral Narcotic Group30
Bupivacaine Group50.5
Ropivacaine Group34

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Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting

Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain. (NCT01328782)
Timeframe: Will be obtained from parent(s) 120 minutes after arrival to the recovery room

InterventionScores on a scale (Mean)
Oral Narcotic Group4.58
Bupivacaine Group2.73
Ropivacaine Group4.32

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Need for Additional Intraoperative and/or Postoperative Pain Medication

To assess need for additional intraoperative and/or postoperative pain medication (NCT01330459)
Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

InterventionParticipants (Count of Participants)
Hydrocodone/Acetaminophen0
Placebo0

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Postoperative Nausea

To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable. (NCT01330459)
Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Interventionmm (Mean)
Hydrocodone/Acetaminophen19.4
Placebo11.4

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Satisfaction With Pain Control

Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure. (NCT01330459)
Timeframe: 30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)

Interventionmm (Mean)
Hydrocodone/Acetaminophen74.8
Placebo67.3

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Patient Perception of Pain During Cervical Dilation

Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation (NCT01330459)
Timeframe: During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)

Interventionmm (Mean)
Hydrocodone/Acetaminophen47.2
Placebo43.9

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Patient Perception of Pain

To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable. (NCT01330459)
Timeframe: At time of uterine aspiration (baseline)

Interventionmm (Mean)
Hydrocodone/Acetaminophen65.7
Placebo63.1

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Time to Completion of Gastric Emptying

Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity. (NCT01332578)
Timeframe: Baseline to 10 hours

Interventionminutes (Least Squares Mean)
Hot Drink Remedy202.59
Standard Paracetamol Tablets168.38

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Time to Onset and Completion of Disintegration of Reference Tablets

Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program. (NCT01332578)
Timeframe: Baseline to 10 hours post dose

Interventionminutes (Mean)
Onset Time of DisintegrationCompletion Time of Disintegration
Standard Paracetamol Tablets42.5062.88

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AUC (0-60 Min)

AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method. (NCT01332578)
Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Interventionng*h/mL (Mean)
Hot Drink Remedy5007.11
Standard Paracetamol Tablets1874.22

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Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)

AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule. (NCT01332578)
Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Interventionnanograms (ng)*hours (h)/mL (Mean)
Hot Drink Remedy1535.80
Standard Paracetamol Tablets387.28

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Maximum Plasma Concentration (Cmax)

Cmax was determined using plasma paracetamol concentration time profile. (NCT01332578)
Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Interventionng/mL (Mean)
Hot Drink Remedy8309.58
Standard Paracetamol Tablets9225.20

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Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)

Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles. (NCT01332578)
Timeframe: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Interventionminutes (Median)
Hot Drink Remedy4.59
Standard Paracetamol Tablets23.14

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Time to Onset of Gastric Emptying

The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets. (NCT01332578)
Timeframe: Baseline to 10 hours

Interventionminutes (Least Squares Mean)
Hot Drink Remedy7.86
Standard Paracetamol Tablets54.23

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Time to Maximum Plasma Concentration (Tmax)

Time after administration when the maximum plasma concentration was reached. (NCT01332578)
Timeframe: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Interventionhours (Median)
Hot Drink Remedy1.50
Standard Paracetamol Tablets1.99

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TOTPAR (Total Pain Relief)

TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. (NCT01333722)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
Hydrocodone/Acetaminophen Extended Release15.4
Placebo5.3

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Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)

"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule." (NCT01333722)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
Hydrocodone/Acetaminophen Extended Release259.0
Placebo39.4

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SPRID (Pain Relief and Pain Intensity Difference)

"SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule." (NCT01333722)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
Hydrocodone/Acetaminophen Extended Release23.4
Placebo7.2

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Time to Perceptible and Meaningful Pain Relief

The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief. (NCT01333722)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

,
Interventionminutes (Median)
Time to Onset of Perceptible Pain ReliefTime to Onset of Meaningful Pain Relief
Hydrocodone/Acetaminophen Extended Release34.0119.0
Placebo56.0NA

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Participant's Global Assessment of Back Pain Status at Final Evaluation

"The participant's overall impression of their back pain status was obtained by having the participant answer the question Considering all the ways your chronic low back pain affects you, how are you doing today? on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)." (NCT01364922)
Timeframe: Double-blind baseline to Day 29

,
Interventionparticipants (Number)
Very GoodGoodFairPoorVery Poor
Double-blind Hydrocodone/Acetaminophen Extended Release134725100
Double-blind Placebo2161990

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Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)

The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model. (NCT01364922)
Timeframe: Double-blind baseline to Day 29

Interventionscores on a scale (Least Squares Mean)
Double-blind Hydrocodone/Acetaminophen Extended Release10.9
Double-blind Placebo19.9

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Participant's Global Assessment of Study Drug at Final Evaluation

"The participant's overall impression of the study drug was obtained by having the participant answer the question How would you rate your overall response to the study medication? on a 5-point categorical scale: excellent; very good; good; fair; poor." (NCT01364922)
Timeframe: Double-blind baseline to Day 29

,
Interventionparticipants (Number)
ExcellentVery GoodGoodFairPoor
Double-blind Hydrocodone/Acetaminophen Extended Release211363113
Double-blind Placebo7419115

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Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)

Changes in urinary NGAL (neutrophil gelatinase-associated lipocalin) as marker of acute kidney injury (NCT01366976)
Timeframe: 24 hours

,
Interventionng/mL (Mean)
baselinepos-bypasspostoperative day 1
Acetaminophen19.21145.846.04
Placebo23.2138.416.8

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Serum Creatinine

Serum creatinine measured over a 72 hour period (NCT01366976)
Timeframe: 72 hours

,
Interventionmg/dL (Mean)
baselinepostoperative day 1postoperative day 2postoperative day 3
Acetaminophen0.980.890.960.93
Placebo0.940.900.960.88

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Plasma Isofuran Concentrations

Plasma isofuran concentrations as a measure of lipid peroxidation (NCT01366976)
Timeframe: 24 hours

,
Interventionpg/mL (Mean)
baseline30min of bypass60min of bypasspost-bypassICUpostoperative day 1
Acetaminophen61.572.183.482.985.370.4
Placebo67.782.7110.896.188.068.5

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Plasma F2-isoprostane Concentrations

Plasma F2-isoprostane concentrations as a measure of lipid peroxidation (NCT01366976)
Timeframe: 24 hours

,
Interventionpg/mL (Mean)
baseline30min of bypass60min of bypasspost-bypassICUpostoperative day 1
Acetaminophen27.845.852.03432.026.5
Placebo30.649.152.848.447.526.0

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Oswestry Disability Index

Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise16.6
NSAID19.4

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Quality of Life, Bodily Pain

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise57.8
NSAID54.0

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Quality of Life, Bodily Pain

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise39.5
NSAID39.2

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Quality of Life, Change in Health

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise73.3
NSAID67.0

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Quality of Life, Change in Health

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise78.0
NSAID70.7

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Quality of Life, Change in Health

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise60.4
NSAID61.3

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Quality of Life, Change in Health

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise52.6
NSAID54.5

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Quality of Life, Emotional Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise94.1
NSAID93.9

[back to top]

Quality of Life, Emotional Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise82.5
NSAID84.7

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Oswestry Disability Index

Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise13.8
NSAID17.2

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Oswestry Disability Index

Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise21.9
NSAID26.6

[back to top]

Oswestry Disability Index

Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise28.9
NSAID29.4

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PHQ-9 Patient Health Questionnaire (PHQ-9) Depression

Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression). (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise3.0
NSAID3.2

[back to top]

PHQ-9 Patient Health Questionnaire (PHQ-9) Depression

Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression). (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise2.3
NSAID3.1

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Relapses of Lumbar Pain

The percentage of patients with relapsed of low back pain was measured. (NCT01374269)
Timeframe: 24 weeks

Interventionpercentage of participants (Number)
Excercise5.0
NSAID20.5

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Roland-Morris Questionnaire

Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise2.6
NSAID3.2

[back to top]

Roland-Morris Questionnaire

Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise2.3
NSAID2.5

[back to top]

Roland-Morris Questionnaire

Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise4.2
NSAID4.6

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Quality of Life, General Health Perceptions.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise72.0
NSAID69.2

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Quality of Life, Mental Health.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise76.4
NSAID75.6

[back to top]

Quality of Life, General Health Perceptions.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise73.4
NSAID69.3

[back to top]

Quality of Life, General Health Perceptions.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise66.3
NSAID67.1

[back to top]

Quality of Life, General Health Perceptions.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise64.3
NSAID64.7

[back to top]

Roland-Morris Questionnaire

Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise6.9
NSAID7.7

[back to top]

Quality of Life, Mental Health.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise78.5
NSAID76.9

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Treatments Associated With Low Back Pain at 6 Months

we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study. (NCT01374269)
Timeframe: 6 months

Interventionparticipants (Number)
Excercise3
NSAID14

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Visual Analogue Scale of Pain

In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise21.0
NSAID20.6

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Visual Analogue Scale of Pain

In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise28.8
NSAID34.9

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Visual Analogue Scale of Pain

In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise47.3
NSAID45.2

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Quality of Life, Mental Health.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise71.4
NSAID74.6

[back to top]

Quality of Life, Mental Health.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise66.4
NSAID67.0

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Quality of Life, Physical Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise81.6
NSAID77.2

[back to top]

Quality of Life, Physical Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise84.1
NSAID82.6

[back to top]

Quality of Life, Physical Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise75.8
NSAID70.3

[back to top]

Quality of Life, Physical Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise64.6
NSAID66.5

[back to top]

Quality of Life, Physical Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise77.3
NSAID72.5

[back to top]

Quality of Life, Physical Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise58.1
NSAID55.1

[back to top]

Quality of Life, Physical Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise30.5
NSAID36.0

[back to top]

Quality of Life, Physical Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise84.3
NSAID85.2

[back to top]

Quality of Life, Social Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise87.3
NSAID80.4

[back to top]

Visual Analogue Scale of Pain

The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise17.8
NSAID17.5

[back to top]

Relapses of Lumbar Pain

The percentage of patients with relapsed of low back pain was measured. (NCT01374269)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Excercise7.1
NSAID25

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Quality of Life, Vitality.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise61.3
NSAID64.0

[back to top]

Quality of Life, Vitality.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise70.3
NSAID62.8

[back to top]

Quality of Life, Emotional Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise91.2
NSAID82.4

[back to top]

Quality of Life, Social Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise88.6
NSAID86

[back to top]

Quality of Life, Vitality.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise67.5
NSAID66.6

[back to top]

Quality of Life, Social Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function. (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise80.7
NSAID74.8

[back to top]

Quality of Life, Emotional Performance.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise67.2
NSAID63.4

[back to top]

Quality of Life, Vitality.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise55.5
NSAID55.3

[back to top]

Missing Workdays

This result shows the average of the number of missed work days. (NCT01374269)
Timeframe: 4 weeks

InterventionDays (Mean)
Excercise0.0
NSAID0.3

[back to top]

Missing Workdays

This result shows the average of the number of missed work days. (NCT01374269)
Timeframe: 24 weeks

InterventionDays (Mean)
Excercise0.2
NSAID0.2

[back to top]

Missing Workdays

This result shows the average of the number of missed work days. (NCT01374269)
Timeframe: 12 weeks

InterventionDays (Mean)
Excercise0.0
NSAID0.1

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Medical Consultations.

This result shows, the total number of participants received additional medical consultations. (NCT01374269)
Timeframe: 4 weeks

Interventionparticipants (Number)
Excercise4
NSAID6

[back to top]

Quality of Life, Social Function.

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function. (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise71.3
NSAID65.9

[back to top]

Medical Consultations.

This result shows, the total number of participants received additional medical consultations. (NCT01374269)
Timeframe: 12 weeks

Interventionparticipants (Number)
Excercise1
NSAID6

[back to top]

PHQ-9 Patient Health Questionnaire (PHQ-9) Depression

Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression). (NCT01374269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Excercise3.9
NSAID3.4

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PHQ-9 Patient Health Questionnaire (PHQ-9) Depression

Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression). (NCT01374269)
Timeframe: At the beginning

Interventionunits on a scale (Mean)
Excercise5.7
NSAID5.1

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Quality of Life, Bodily Pain

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain. (NCT01374269)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Excercise67.6
NSAID58.7

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Missing Workdays

This result shows the average of the number of missed work days. (NCT01374269)
Timeframe: 6 weeks before starting

InterventionDays (Mean)
Excercise1.0
NSAID1.7

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Quality of Life, Bodily Pain

Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain. (NCT01374269)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Excercise74.1
NSAID68

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Medical Consultations.

This result shows, the total number of participants received additional medical consultations. (NCT01374269)
Timeframe: 24 weeks

Interventionparticipants (Number)
Excercise4
NSAID4

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Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.

Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and three months.

Interventionunits on a scale (Mean)
VESIcare + Narcotic Painkiller1.90
Narcotic Painkiller1.13

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Change in Post-ureteroscopy Stent-induced Pain

Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and 3 months.

Interventionunits on a scale (Mean)
VESIcare + Narcotic Painkiller4.61
Narcotic Painkiller3.11

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Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion

A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 15

Interventionpercentage of participants (Number)
Rituximab0.0

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Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion

"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows: - Grade 3 means Severe, indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible. - Grade 4 means Life-threatening, Disabling, based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable." (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 15

Interventionpercentage of participants (Number)
Rituximab0.6

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Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion

"The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 (Mild) to Grade 5 (Death). Grade 3 AEs are Severe and Grade 4 AEs are Life-threatening, Disabling." (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 168

Interventionpercentage of participants (Number)
Rituximab0.0

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Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion

"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - Moderate means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study." (NCT01382940)
Timeframe: During the infusion (a 2-hour period) on Day 15

Interventionpercentage of participants (Number)
Rituximab3.9

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Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion

"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - Moderate means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study." (NCT01382940)
Timeframe: During the infusion (a 2-hour period) on Day 168

Interventionpercentage of participants (Number)
Rituximab6.6

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Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion

IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution. (NCT01382940)
Timeframe: Within 24 hours of beginning infusion on Day 168

Interventionpercentage of participants (Number)
Any IRRAny SIRR
Rituximab5.90.0

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Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point

The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP. (NCT01390441)
Timeframe: Baseline, Week 6, Week 12

,
InterventionScore (Mean)
Week 6 (n=22, n=20)Week 12 (n=21, n=21)
Part A: MabThera® 500 mg/m^2-1.16-2.04
Part A: MK-8808 500 mg/m^2-1.39-1.68

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Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment

Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3. (NCT01390441)
Timeframe: Day 15

Interventionng/mL (Geometric Mean)
Part A: MK-8808 500 mg/m^2326.49
Part A: MabThera® 500 mg/m^2332.39

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Number of Participants Who Experienced at Least One Adverse Event

An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. (NCT01390441)
Timeframe: Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks

InterventionParticipants (Number)
Part A: MK-8808 500 mg/m^218
Part A: MabThera 500 mg/m^221
Part B: MK-8808 1000 mg12
Part B: MabThera 1000 mg16
Part B: Rituxan 1000 mg13
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg2
Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg2
Extension B: MK-8808 1000 mg /MK-8808 1000 mg0
Extension B: MabThera 1000 mg /MK-8808 1000 mg0
Extension B: Rituxan1000 mg/MK-8808 1000 mg0

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Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24

"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do" (NCT01390441)
Timeframe: Week 24

,,
InterventionParticipants (Number)
ACR20ACR50ACR70
Part B: MabThera® 1000 mg17121
Part B: MK-8808 1000 mg16122
Part B: Rituxan® 1000 mg15131

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Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment

AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6. (NCT01390441)
Timeframe: Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85

Interventionhr*mg/mL (Geometric Mean)
Part A: MK-8808 500 mg/m^2110.56
Part A: MabThera® 500 mg/m^2110.12

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Number of Participants Who Discontinued Study Drug Due to Adverse Events

Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. (NCT01390441)
Timeframe: Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks

InterventionParticipants (Number)
Part A: MK-8808 500 mg/m^22
Part A: MabThera® 500 mg/m^22
Part B: MK-8808 1000 mg1
Part B: MabThera® 1000 mg1
Part B: Rituxan® 1000 mg2
Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg0
Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg0
Extension B: MK-8808 1000 mg /MK-8808 1000 mg0
Extension B: MabThera® 1000 mg /MK-8808 1000 mg0
Extension B: Rituxan® 1000 mg/MK-8808 1000 mg0

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Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24

"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do" (NCT01390441)
Timeframe: Week 24

,
InterventionParticipants (Number)
ACR20ACR50ACR70
Part A: MabThera® 500 mg/m^220154
Part A: MK-8808 500 mg/m^223164

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Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series

An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment). (NCT01392378)
Timeframe: Baseline up to 1 Month (28 to 42 days) after infant series

,,,,
Interventionparticipants (Number)
Non-SAEsSAEs
13vPnC + INFANRIX Hexa8010
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily728
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily713
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily6711
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily577

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Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series

An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment). (NCT01392378)
Timeframe: 1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose

,,,,
Interventionparticipants (Number)
Non-SAEsSAEs
13vPnC + INFANRIX Hexa89
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily411
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily614
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily310
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily36

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Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series

Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
Interventiontiter (Geometric Mean)
4 (n = 37, 46, 42, 41, 61)6B (n = 36, 45, 43, 40, 62)9V (n = 37, 48, 42, 41, 65)14 (n = 38, 48, 41, 41, 64)18C (n = 37, 47, 41, 41, 62)19F (n = 37, 46, 41, 42, 63)23F (n = 38, 45, 42, 42, 63)1 (n = 42, 42, 43, 44, 74)3 (n = 41, 41, 39, 39, 69)5 (n = 42, 43, 44, 42, 73)6A (n = 46, 42, 39, 39, 76)7F (n = 46, 42, 40, 39, 76)19A (n = 42, 44, 41, 42, 74)
13vPnC + INFANRIX Hexa1086748241951109227936612877614622125240
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily136166328599110312943218629912811584159
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily113565516662285322144111769616811907257
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily1240470936508771653328565412281747163
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily1269794120435109434634212728610601766185

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Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series

Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies. (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
InterventionEU/mL (Geometric Mean)
Pertussis PTPertussis FHAPertussis PRN
13vPnC + INFANRIX Hexa44.8548.4284.57
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily39.2635.5568.53
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily43.5140.6571.26
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily40.2741.3265.82
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily40.8646.2972.90

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Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series

Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies. (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
Interventiontiter (Geometric Mean)
Poliomyelitis Type 1Poliomyelitis Type 2Poliomyelitis Type 3
13vPnC + INFANRIX Hexa72.0267.37231.02
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily70.6655.17218.85
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily66.5973.52184.03
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily67.4362.12257.92
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily68.1179.60246.22

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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose

Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively. (NCT01392378)
Timeframe: 1 month after the toddler dose

,,,,
Interventionmcg/mL (Geometric Mean)
4 (n = 130, 144, 143, 139, 206)6B (n = 130, 144, 143, 139, 206)9V (n = 130, 144, 143, 139, 206)14 (n = 130, 144, 143, 139, 206)18C (n = 130, 144, 143, 139, 206)19F (n = 130, 144, 143, 139, 206)23F (n = 130, 144, 142, 139, 206)1 (n = 130, 144, 143, 139, 206)3 (n = 129, 144, 143, 138, 203)5 (n = 130, 144, 143, 139, 206)6A (n = 130, 144, 143, 139, 206)7F (n = 130, 144, 142, 139, 206)19A (n = 129, 144, 142, 139, 206)
13vPnC + INFANRIX Hexa3.107.082.169.101.597.952.753.040.542.845.523.987.71
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily3.437.302.129.121.638.022.863.120.492.625.363.977.35
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily3.438.012.238.401.688.992.963.220.542.755.733.897.99
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily2.976.382.177.951.367.532.372.660.462.405.273.567.31
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily3.076.702.158.101.358.412.342.800.462.335.123.797.11

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Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series

Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
Interventionmicrogram per milliliter (mcg/mL) (Geometric Mean)
4 (n = 137, 155, 148, 146, 210)6B (n = 136, 155, 148, 146, 210)9V (n = 138, 155, 148, 147, 210)14 (n = 138, 155, 148, 147, 210)18C (n = 138, 155, 148, 147, 210)19F (n = 138, 155, 148, 147, 210)23F (n= 137, 155, 148, 146, 210)1 (n = 138, 155, 148, 147, 210)3 (n = 138, 155, 148, 147, 210)5 (n = 137, 155, 148, 146, 210)6A (n = 138, 155, 148, 146, 210)7F (n = 138, 155, 148, 146, 210)19A (n = 137, 155, 148, 146, 210)
13vPnC + INFANRIX Hexa2.020.811.315.381.541.991.041.250.880.811.102.153.02
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily2.070.901.405.261.752.041.071.290.840.901.222.283.14
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily1.990.911.454.731.732.301.191.500.830.981.252.223.39
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily1.480.561.174.751.251.590.731.020.570.630.851.832.53
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily1.640.681.134.451.471.780.851.120.710.790.971.942.70

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Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series

Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies. (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
InterventionIU/mL (Geometric Mean)
TetanusDiphtheria
13vPnC + INFANRIX Hexa0.820.65
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily0.600.65
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily0.700.68
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily0.690.61
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily0.730.62

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Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose

Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies. (NCT01392378)
Timeframe: 1 month after the toddler dose

,,,,
InterventionIU/mL (Geometric Mean)
TetanusDiphtheria
13vPnC + INFANRIX Hexa2.661.90
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily2.291.87
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily2.501.94
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily2.601.69
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily2.541.64

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Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose

Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies. (NCT01392378)
Timeframe: 1 month after the toddler dose

,,,,
InterventionEU/mL (Geometric Mean)
Pertussis PTPertussis FHAPertussis PRN
13vPnC + INFANRIX Hexa74.01117.01172.80
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily73.38108.11158.71
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily76.93117.87156.98
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily73.72123.56160.96
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily77.43115.55158.28

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Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose

Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody. (NCT01392378)
Timeframe: 1 month after the toddler dose

InterventionmIU/mL (Geometric Mean)
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily4868.61
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily4148.04
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily4250.41
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily4263.28
13vPnC + INFANRIX Hexa3866.37

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Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series

Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody. (NCT01392378)
Timeframe: 1 month after the infant series

InterventionmIU/mL (Geometric Mean)
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily756.42
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily770.93
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily689.34
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily599.12
13vPnC + INFANRIX Hexa733.29

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Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose

Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody. (NCT01392378)
Timeframe: 1 month after the toddler dose

Interventionmcg/mL (Geometric Mean)
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily9.65
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily9.35
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily8.25
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily7.84
13vPnC + INFANRIX Hexa8.96

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Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3

Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error. (NCT01392378)
Timeframe: Within 4 days after infant series Dose 3

,,,,
Interventionpercentage of participants (Number)
Fever >=38, <=39 degree C (n= 136,146,135,141,175)Fever >39, <=40 degree C (n = 129,137,125,136,167)Fever >40 degree C (n = 128,136,126,135,166)
13vPnC + INFANRIX Hexa29.71.80.0
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily33.31.50.0
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily30.82.90.0
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily17.00.80.8
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily22.11.60.0

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Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1

Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C. (NCT01392378)
Timeframe: Within 4 days after infant series Dose 1

,,,,
Interventionpercentage of participants (Number)
Fever >=38, <=39 degree C (n= 149,157,147,155,187)Fever >39, <=40 degree C (n = 138,145,137,146,170)Fever >40 degree C (n = 138,145,137,146,170)
13vPnC + INFANRIX Hexa41.71.20.0
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily34.20.70.0
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily45.21.40.0
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily18.40.70.0
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily32.91.40.0

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Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series

Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13. (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
Interventionpercentage of participants (Number)
4 (n = 37, 46, 42, 41, 61)6B (n = 36, 45, 43, 40, 62)9V (n = 37, 48, 42, 41, 65)14 (n = 38, 48, 41, 41, 64)18C (n = 37, 47, 41, 41, 62)19F (n = 37, 46, 41, 42, 63)23F (n = 38, 45, 42, 42, 63)1 (n = 42, 42, 43, 44, 74)3 (n = 41, 41, 39, 39, 69)5 (n = 42, 43, 44, 42, 73)6A (n = 46, 42, 39, 39, 76)7F (n = 46, 42, 40, 39, 76)19A (n = 42, 44, 41, 42, 74)
13vPnC + INFANRIX Hexa100.096.875.496.9100.095.293.745.9100.086.398.7100.097.3
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily100.092.580.597.697.692.990.529.594.992.9100.097.488.1
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily100.088.966.797.995.787.097.842.997.690.7100.0100.0100.0
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily100.088.459.5100.0100.090.292.930.297.486.4100.0100.090.2
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily100.094.462.289.5100.097.392.147.697.692.993.5100.092.9

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Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series

Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
Interventionpercentage of participants (Number)
4 (n = 137, 155, 148, 146, 210)6B (n = 136, 155, 148, 146, 210)9V (n = 138, 155, 148, 147, 210)14 (n = 138, 155, 148, 147, 210)18C (n = 138, 155, 148, 147, 210)19F (n = 138, 155, 148, 147, 210)23F (n = 137, 155, 148, 146, 210)1 (n = 138, 155, 148, 147, 210)3 (n = 138, 155, 148, 147, 210)5 (n = 137, 155, 148, 146, 210)6A (n = 138, 155, 148, 146, 210)7F (n = 138, 155, 148, 146, 210)19A (n = 137, 155, 148, 146, 210)
13vPnC + INFANRIX Hexa98.177.696.299.596.797.688.194.391.084.391.999.5100.0
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily97.379.595.998.695.996.688.494.688.489.791.8100.099.3
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily97.480.099.498.797.499.490.397.489.791.092.399.499.4
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily96.661.595.999.395.395.374.390.581.176.483.197.398.0
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily96.472.894.2100.096.497.186.194.283.384.786.2100.098.5

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Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose

An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment). (NCT01392378)
Timeframe: Toddler dose up to 1 Month (28 to 42 days) after toddler dose

,,,,
Interventionparticipants (Number)
Non-SAEsSAEs
13vPnC + INFANRIX Hexa501
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily761
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily572
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily521
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily473

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Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2

Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. (NCT01392378)
Timeframe: Within 4 days after infant series Dose 2

,,,,
Interventionpercentage of participants (Number)
Fever >=38, <=39 degree C (n= 141,152,140,159,181)Fever >39, <=40 degree C (n = 133,140,134,145,164)Fever >40 degree C (n = 131,140,133,144,164)
13vPnC + INFANRIX Hexa39.83.70.0
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily44.01.40.0
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily42.80.70.0
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily21.41.50.0
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily26.21.50.0

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Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose

Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group. (NCT01392378)
Timeframe: 1 month after the toddler dose

,,,,
Interventionpercentage of participants (Number)
Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202)Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202)Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199)Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199)Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199)Tetanus >=0.1 IU/mL (n = 123,137,141,136,199)Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199)HBV >= 10 mIU/mL (n = 119,131,133,133,191)Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201)Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201)Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201)
13vPnC + INFANRIX Hexa100.095.095.595.595.5100.0100.099.599.5100.0100.0
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily100.095.7100.092.694.1100.0100.0100.0100.0100.0100.0
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily99.396.399.394.994.9100.0100.098.5100.0100.0100.0
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily100.095.798.693.694.3100.0100.0100.0100.0100.0100.0
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily100.095.297.691.191.9100.0100.0100.099.2100.0100.0

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Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose

Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies. (NCT01392378)
Timeframe: 1 month after the toddler dose

,,,,
Interventiontiter (Geometric Mean)
Poliomyelitis Type 1Poliomyelitis Type 2Poliomyelitis Type 3
13vPnC + INFANRIX Hexa406.37621.071237.86
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily415.45605.781187.11
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily426.63586.301045.57
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily443.97587.561210.29
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily399.56613.181205.80

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Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose

Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. (NCT01392378)
Timeframe: Within 4 days after toddler dose

,,,,
Interventionpercentage of participants (Number)
Fever >=38, <=39 degree C (n= 133,140,134,144,162)Fever >39, <=40 degree C (n = 128,127,118,123,150)Fever >40 degree C (n = 123,125,117,122,150)
13vPnC + INFANRIX Hexa30.22.00.0
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily50.05.70.0
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily37.17.10.0
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily37.34.20.0
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily31.65.50.0

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Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series

Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group. (NCT01392378)
Timeframe: 1 month after the infant series

,,,,
Interventionpercentage of participants (Number)
Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198)Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198)Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193)Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193)Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193)Tetanus >=0.1 IU/mL (n = 132,143,141,131,193)Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193)HBV >= 10mIU/mL (n = 105,116,120,112,156)PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135)PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135)PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135)
13vPnC + INFANRIX Hexa87.933.895.395.395.399.599.598.799.395.699.3
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily85.628.190.888.589.398.597.799.1100.096.498.8
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily84.237.097.292.387.4100.098.699.198.198.1100.0
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily86.127.191.593.688.7100.099.399.297.895.798.9
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily87.533.893.296.290.9100.0100.0100.097.895.5100.0

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Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series

Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody. (NCT01392378)
Timeframe: 1 month after the infant series

Interventionmcg/mL (Geometric Mean)
13vPnC + INFANRIX Hexa + Paracetamol Twice Daily0.54
13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily0.59
13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily0.49
13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily0.51
13vPnC + INFANRIX Hexa0.58

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Average Nausea Score

Nausea scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Nausea Scores range from 1 (none) to 4 (severe). (NCT01394718)
Timeframe: 24 hours

Interventionunits on a scale (Median)
Saline Placebo1.2
Intravenous Acetaminophen1.0

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Total Opiate Requirement

Total opiate requirement was monitored 24 hours post-operatively. Morphine and hydromorphone measurements were totaled and recorded in mg/kg/day of morphine equivalents. (NCT01394718)
Timeframe: 24 hours

Interventionmg/kg (Mean)
Saline Placebo1.19
Intravenous Acetaminophen1.01

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Average Pruritus Score

Pruritus scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Pruritus scores range from 1 (none) to 3 (intolerable). (NCT01394718)
Timeframe: 24 hours

Interventionunits on a scale (Median)
Saline Placebo1.0
Intravenous Acetaminophen1

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Average Pain Score

Pain Scores were monitored using the numeric pain assessment scale in both treatment arms of the study and recorded and averaged for the first 24 hours after initial intra-operative dose of study drug. The numeric pain assessment scale is a verbal self-reported pain assessment that ranges between 1 (no pain) to 10 (worst pain imaginable). (NCT01394718)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Saline Placebo4.53
Intravenous Acetaminophen4.62

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Overall Satisfaction With the Pain Medicine

Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication. (NCT01402375)
Timeframe: 24 hrs

,,,,,
InterventionParticipants (Count of Participants)
Number of participants satisfied with analgesicparticipants would want the same analgesic again
Codeine (First Trial)6666
Codeine (for Second Trial)9185
Hydrocodone (First Trial)7259
Hydrocodone (Third Trial)9790
Oxycodone (for Second Trial)9991
Oxycodone (Third Trial)9386

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Difference in Pain Intensity Score Before and After Last Dose.

"Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken." (NCT01402375)
Timeframe: 2 hrs

,,,,,
Interventionunits on a scale (Mean)
before most recent dose2 hours after most recent dosechange in NRS before to after most recent dose
Codeine (First Trial)7.64.13.5
Codeine (for Second Trial)7.93.64.2
Hydrocodone (First Trial)7.63.63.9
Hydrocodone (Third Trial)7.63.64.0
Oxycodone (for Second Trial)7.93.44.5
Oxycodone (Third Trial)7.83.34.4

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Time to Follow up

Median time to contact patients for data collection, measured from discharge to time contacted (NCT01402375)
Timeframe: up to 48 hours

Interventionhours (Median)
Hydrocodone (First Trial)27
Codeine (First Trial)25
Oxycodone (for Second Trial)26
Codeine (for Second Trial)28
Oxycodone (Third Trial)27
Hydrocodone (Third Trial)28

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50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score

(NCT01402375)
Timeframe: 2 hours

InterventionParticipants (Count of Participants)
Hydrocodone (First Trial)50
Codeine (First Trial)45
Oxycodone (for Second Trial)73
Codeine (for Second Trial)64
Oxycodone (Third Trial)68
Hydrocodone (Third Trial)66

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Change in 20-meter Walk From Baseline

(NCT01410409)
Timeframe: Primary: 12months.

Interventionsec (Mean)
MEDIC-1.0
MEDIC + TKR-2.9

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Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)

The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority. (NCT01410409)
Timeframe: Primary: 12months.

Interventionunits on a scale (Mean)
MEDIC16.0
MEDIC + TKR32.5

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Proportion of Users of Pain Medication

With possible answers being yes and no (NCT01410409)
Timeframe: Baseline and 12months.

,
Interventionproportion of participants (Number)
Baseline12months
MEDIC0.580.41
MEDIC + TKR0.670.26

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Weight Change in kg From Baseline

Weight change in kg measured without shoes at the same time of day and on the same scale (NCT01410409)
Timeframe: Primary: 12months.

Interventionkg (Mean)
MEDIC-2.6
MEDIC + TKR0.1

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Change in EQ-5D From Baseline

"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description (Links)~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)." (NCT01410409)
Timeframe: Primary: 12months.

,
Interventionunits on a scale (Mean)
Descriptive indexVisual-analogue scale
MEDIC0.11510.2
MEDIC + TKR0.20615.0

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Change in the Five Subscales of KOOS From Baseline

All subscales going from 0 to 100 (worst to best) (NCT01410409)
Timeframe: Primary: 12months.

,
Interventionunits on a scale (Mean)
PainSymptomsActivities of Daily LivingQuality of LifeSports and recreation
MEDIC17.211.417.617.819.3
MEDIC + TKR34.826.430.038.234.5

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Change in Timed Up & Go (TUG) From Baseline

(NCT01410409)
Timeframe: Primary: 12months.

Interventionsec (Mean)
MEDIC-1.2
MEDIC + TKR-2.4

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SPID (Summed Pain Intensity Differences)

"The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication.~This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference." (NCT01420653)
Timeframe: 48 hours afte the first dose

Interventionscore on a scale (Mean)
Maxigesic 32531.56
Acetaminophen17.71
Ibuprofen23.18
Placebo14.86

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Physician Global Evaluation of Effectiveness on Nasal Symptoms

"The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.~Range from 1 to 5 where 1 is excellent and 5 is bad :~1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms" (NCT01448057)
Timeframe: Day 2

Interventionscore on a scale (Mean)
Arm A1.9
Arm B2.1

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Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms

Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms (NCT01448057)
Timeframe: Day 3

Interventionmm (Mean)
Arm A169.2
Arm B225.3

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Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose

Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect. (NCT01462370)
Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg2.2
Ibuprofen up to 2400 mg2.1

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Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose

TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief. (NCT01462370)
Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg17.38
Ibuprofen up to 2400 mg16.49

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Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)

The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18. (NCT01462370)
Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg9.48
Ibuprofen up to 2400 mg9.27

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PR at Up to 24 Hours Following the Initial Dose

PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. (NCT01462370)
Timeframe: Up to 24 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg3.88
Ibuprofen up to 2400 mg3.62

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Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)

The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief. (NCT01462370)
Timeframe: 24 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg2.65
Ibuprofen up to 2400 mg2.29

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Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)

The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief. (NCT01462370)
Timeframe: 6 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg2.50
Ibuprofen up to 2400 mg2.24

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Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose

The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect. (NCT01462370)
Timeframe: Baseline and 6 hours

InterventionHours (Mean)
Etoricoxib 120 mg1.0
Ibuprofen up to 2400 mg1.5

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Number of Participants Using Rescue Medication 24 Hours After the Initial Dose

Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes. (NCT01462370)
Timeframe: 24 Hours

InterventionParticipants (Number)
Etoricoxib 120 mg1
Ibuprofen up to 2400 mg4

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Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose

At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed. (NCT01462370)
Timeframe: 24 Hours

InterventionParticipants (Number)
Etoricoxib 120 mg113
Ibuprofen up to 2400 mg101

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Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose

At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed. (NCT01462370)
Timeframe: 6 hours

InterventionParticipants (Number)
Etoricoxib 120 mg111
Ibuprofen up to 2400 mg103

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Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose

"Peak PR during the 6 hours post initial dose is defined as the maximum PR score~recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief." (NCT01462370)
Timeframe: Up to 6 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg3.70
Ibuprofen up to 2400 mg3.52

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PID at Up to 12 Hours Following the Initial Dose

PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain. (NCT01462370)
Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg2.28
Ibuprofen up to 2400 mg2.07

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PID at Up to 24 Hours Following the Initial Dose

PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain. (NCT01462370)
Timeframe: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg2.36
Ibuprofen up to 2400 mg2.25

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PR at Up to 12 Hours Following the Initial Dose

PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. (NCT01462370)
Timeframe: Up to 12 hours

InterventionScore on a Scale (Least Squares Mean)
Etoricoxib 120 mg3.73
Ibuprofen up to 2400 mg3.45

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Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test

Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
InterventionValid responses (Mean)
30 minutes60 minutes
Paracetamol Powder-0.5-0.7
Paracetamol/ Caffeine Tablet1.81.5

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Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
Interventionmilliseconds (msec) (Mean)
30 minutes60 minutes
Paracetamol Powder1.88-4.85
Paracetamol/ Caffeine Tablet6.000.08

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Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test

For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
InterventionValid responses (Mean)
30 minutes60 minutes
Paracetamol Powder2.01.9
Paracetamol/ Caffeine Tablet6.87.4

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Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. (NCT01466348)
Timeframe: Baseline to 30 minutes post treatment administration

InterventionValid responses (Mean)
Paracetamol/ Caffeine Tablet4.8
Paracetamol Powder1.3

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Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. (NCT01466348)
Timeframe: Baseline to 60 minutes post treatment administration

InterventionValid responses (Mean)
Paracetamol/ Caffeine Tablet7.1
Paracetamol Powder0.6

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Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test

Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with 'not at all' and the right hand end with 'extremely'. For each question, '9' represented the 'best' score and '1' represented the 'worst' score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
InterventionScore on a scale (Mean)
Alertness at 30 minutesAlertness at 60 minutesAnxiety at 30 minutesAnxiety at 60 minutesHeadache at 30 minutesHeadache at 60 minutes
Paracetamol Powder0.20.10.20.40.40.6
Paracetamol/Caffeine Tablet0.80.70.20.30.40.6

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Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test

For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
Interventionmsec (Mean)
30 Minutes60 minutes
Paracetamol Powder-7.42-12.39
Paracetamol/ Caffeine Tablet1.65-5.49

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Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test

Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
Interventionmsec (Mean)
30 minutes60 minutes
Paracetamol Powder-6.18-9.45
Paracetamol/ Caffeine Tablet-6.49-10.69

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Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test

For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
InterventionResponses (Mean)
Incorrect responses at 30 minutesIncorrect responses at 60 minutesMissed responses at 30 minutesMissed responses at 60 minutes
Paracetamol Powder-1.4-0.2-2.0-1.9
Paracetamol/Caffeine Tablet-5.4-5.2-6.7-7.4

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Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
InterventionResponses (Mean)
Incorrect responses at 30 minutesIncorrect responses at 60 minutesMissed responses at 30 minutesMissed responses at 60 minutes
Paracetamol Powder-2.7-2.7-1.3-0.6
Paracetamol/ Caffeine Tablet-2.3-1.7-4.8-7.1

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Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test

Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated. (NCT01466348)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,
InterventionResponses (Mean)
Incorrect responses at 30 minutesIncorrect responses at 60 minutesMissed responses at 30 minutesMissed responses at 60 minutes
Paracetamol Powder0.10.60.50.7
Paracetamol/Caffeine Tablet-2.3-3.6-1.8-1.5

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Change From Baseline in EQ-5D

"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See statistical analysis plan for further description (available under Links).~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)." (NCT01535001)
Timeframe: Primary: 12months.

,
Interventionunits on a scale (Mean)
Descriptive indexEQ VAS
MEDIC0.1405.3
Standard Treatment0.0757.2

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Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)

"The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best).~Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority." (NCT01535001)
Timeframe: Primary: 12months.

Interventionunits on a scale (Mean)
MEDIC18.2
Standard Treatment7.1

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Change in the Five KOOS Subscale Scores From Baseline

Range of all subscales are 0 to 100 (worst to best). (NCT01535001)
Timeframe: Primary: 12 months.

,
Interventionunits on a scale (Number)
PainSymptomsActivities of Daily LivingSports and recreationQuality of Life
MEDIC18.716.318.716.019.0
Standard Treatment9.37.75.912.05.5

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Change From Baseline in Time From the Timed Up and Go

(NCT01535001)
Timeframe: Primary: 12 months.

Interventionsec (Mean)
MEDIC-1.4
Standard Treatment-1.1

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Weight Change in kg From Baseline

Weight change in kg measured without shoes at the same time of day and on the same scale (NCT01535001)
Timeframe: Primary: 12months.

Interventionkg (Mean)
MEDIC-2.4
Standard Treatment-2.4

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Proportion of Users of Pain Medication

With possible answers being yes and no (NCT01535001)
Timeframe: Baseline and 12months.

,
Interventionproportion of participants (Number)
Baseline12months
MEDIC0.640.39
Standard Treatment0.560.57

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Number of Serious Adverse Events Reported at Index Knee

Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants. (NCT01535001)
Timeframe: Primary: 12months.

InterventionSerious adverse events related to knee (Number)
MEDIC13
Standard Treatment24

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Change From Baseline in 20-meter Walk

(NCT01535001)
Timeframe: Primary: 12months.

Interventionsec (Mean)
MEDIC-1.2
Standard Treatment-0.6

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Death or Any Neurological Sequelae on Day 7

Defined as death or any severe neurological sequelae, or hemi- or monoparesis, or ataxia, or psychomotor retardation of any degree. (NCT01540838)
Timeframe: Examined on day 7 since institution of treatment.

InterventionParticipants (Count of Participants)
Infusion With Paracetamol96
Bolus With Placebo86

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Death or Any Neurological Sequelae at Discharge From Hospital.

Defined as death or any severe neurological sequelae, or hemi- or monoparesis, or ataxia, or psychomotor retardation of any degree. (NCT01540838)
Timeframe: Examined at discharge from hospital. The longest hospital stay was 84 days.

InterventionParticipants (Count of Participants)
Infusion With Paracetamol104
Bolus With Placebo89

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Day 7 Mortality

All patients who had received at least one dose of treatment and were dead on day 7 from the institution of treatment on day 1. (NCT01540838)
Timeframe: On day 7 from the institution of treatment

InterventionParticipants (Count of Participants)
Infusion With Paracetamol61
Bolus With Placebo64

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All Deaths During Hospital Stay

All patients who had received at least one dose of treatment and died during the hospital stay. (NCT01540838)
Timeframe: The outcome was assessed each day until the patient was discharged from the hospital. The longest hospital stay was 84 days, while the last death occurred 39 days after treatment initiation.

InterventionParticipants (Count of Participants)
Infusion With Paracetamol71
Bolus With Placebo75

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A Change in Hearing Threshold Compared to the First Test Result

Hearing thresholds (in decibel, dB) were determined by brainstem evoked response audiometry (BERA), for each ear separately. The better ear's hearing threshold, obtained on admission or shortly thereafter, was compared with the better ear's hearing threshold obtained at earliest after one week of treatment. (NCT01540838)
Timeframe: Hearing thresholds obtained during any of the first three days after hospital admission were compared with hearing thresholds obtained on day seven or later, during the hospital stay. The longest hospital stay was 84 days.

InterventiondB (Median)
Infusion With Paracetamol0
Bolus With Placebo0

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Status on the Modified Glasgow Outcome Scale

"Scores on the modified Glasgow Outcome Scale which range from a maximum of 5 (best) to a minimum of 1 (worst) points.~The Glasgow Outcome Scale categorizes the outcome after brain injury into five categories, based on the level and severeness of disability. As hearing impairment is one of the most common sequelae of bacterial meningitis, an assessment of hearing should be included when estimating the grade of disability.~Hearing thresholds (in decibel, dB) were determined by brainstem evoked response audiometry (BERA), for each ear separately." (NCT01540838)
Timeframe: Examined at discharge from hospital, except for hearing evaluations which were performed at earliest seven days since the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.

Interventionscore on a scale (Median)
Infusion With Paracetamol5
Bolus With Placebo5

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Number of Participants With Deafness

Hearing thresholds (in decibel, dB) were determined by brainstem evoked response audiometry (BERA), for each ear separately. Deafness was defined as a hearing threshold >80 dB in the better ear. (NCT01540838)
Timeframe: This outcome includes hearing thresholds determined at earliest seven days after the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.

InterventionParticipants (Count of Participants)
Infusion With Paracetamol3
Bolus With Placebo1

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Death or Severe Neurological Sequelae on Day 7

Death or severe neurological sequelae, defined as blindness, tetraplegia/paresis, hydrocephalus requiring a shunt and severe psychomotor retardation (NCT01540838)
Timeframe: Examined on day 7 since institution of treatment

InterventionParticipants (Count of Participants)
Infusion With Paracetamol80
Bolus With Placebo75

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Death or Severe Neurological Sequelae at Discharge

Death or severe neurological sequelae, defined as blindness, tetraplegia/paresis, hydrocephalus requiring a shunt and severe psychomotor retardation (NCT01540838)
Timeframe: Examined at discharge from hospital. The longest hospital stay was 84 days.

InterventionParticipants (Count of Participants)
Infusion With Paracetamol90
Bolus With Placebo85

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24 Hour Dizziness

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline20
IV Acetaminophen17

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24 Hour Nausea

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline25
IV Acetaminophen26

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24 Hour Postoperative Opioid Consumption

The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents. (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionmg (Mean)
Normal Saline62.3
IV Acetaminophen45.6

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48 Hour Sedation

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline6
IV Acetaminophen3

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48 Hour Respiratory Depression

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline1
IV Acetaminophen0

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48 Hour Postoperative Pain Scores With Movement

Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionunits on a scale (Mean)
Normal Saline5.1
IV Acetaminophen4.6

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48 Hour Postoperative Pain Scores at Rest

Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionunits on a scale (Mean)
Normal Saline2.4
IV Acetaminophen2.0

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24 Hour Wound Hyperalgesia

Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventioncm (Mean)
Normal Saline4.8
IV Acetaminophen4.5

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Length of Mechanical Ventilation

"The length of mechanical ventilation will be determined based on the Extubation Criteria checklist that will be completed by nursing staff every 2 hours until extubation." (NCT01544062)
Timeframe: From the time of arrival in ICU until extubation

Interventionminutes (Mean)
Normal Saline407
IV Acetaminophen360

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Length of ICU Stay

"The length of ICU stay will be determined based on the ICU Discharge Criteria checklist that will be completed by nursing staff every 4 hours until ICU discharge." (NCT01544062)
Timeframe: From the time of arrival in ICU until ICU discharge

Interventionhours (Mean)
Normal Saline67
IV Acetaminophen61

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48 Hour Pruritus

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline4
IV Acetaminophen7

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24 Hour Postoperative Pain Scores at Rest

Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionunits on a scale (Mean)
Normal Saline3.9
IV Acetaminophen3.7

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48 Hour Postoperative Opioid Consumption

48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents. (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionmg (Mean)
Normal Saline105.1
IV Acetaminophen85.1

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48 Hour Patient Satisfaction

"The extent to which subjects overall pain experience met their expectations question responses were converted to the Likert scale with the following values: not at all (1), a little (2), a fair amount (3), very much (4) and extremely well (5)." (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionunits on a scale (Mean)
Normal Saline2.3
IV Acetaminophen2.8

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48 Hour Nausea

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline12
IV Acetaminophen14

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24 Hour Respiratory Depression

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline2
IV Acetaminophen2

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48 Hour Dizziness

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline9
IV Acetaminophen10

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24 Hour Sedation

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline8
IV Acetaminophen8

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48 Hour Wound Hyperalgesia

Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45). (NCT01544062)
Timeframe: 48 hours after arriving in ICU

Interventioncm (Mean)
Normal Saline4.6
IV Acetaminophen5.0

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24 Hour Pruritus

Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionparticipants (Number)
Normal Saline4
IV Acetaminophen7

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24 Hour Postoperative Pain Scores With Movement

Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable). (NCT01544062)
Timeframe: 24 hours after arriving in ICU

Interventionunits on a scale (Mean)
Normal Saline6.3
IV Acetaminophen6.0

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Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (SPRID4) Over 2, 6 and 12 Hours Post Dose

SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6 and -12 (worst score) to 84 (best score) for SPRID 0-12. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief. (NCT01559259)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 12 hours
Ibuprofen 200 mg + Acetaminophen 500 mg7.424.837.2
Ibuprofen 250 mg + Acetaminophen 500 mg6.723.336.3
Ibuprofen 300 mg + Acetaminophen 500 mg7.425.339.9
Ibuprofen 400 mg6.222.536.9
Placebo0.93.58.4

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Time to Confirmed First Perceptible Relief

Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure (defined as participant taking rescue medication, or discontinuing due to lack of efficacy) prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). (NCT01559259)
Timeframe: From 0 hour up to 12 hours post-dose

Interventionminutes (Median)
PlaceboNA
Ibuprofen 200 mg + Acetaminophen 500 mg18.5
Ibuprofen 250 mg + Acetaminophen 500 mg22.8
Ibuprofen 300 mg + Acetaminophen 500 mg18.5
Ibuprofen 400 mg24.9

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Cumulative Percentage of Participants With Treatment Failure

Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported. (NCT01559259)
Timeframe: 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,,
Interventionpercentage of participants (Number)
1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Ibuprofen 200 mg + Acetaminophen 500 mg2.22.22.23.34.48.917.828.940.051.157.864.4
Ibuprofen 250 mg + Acetaminophen 500 mg2.26.58.69.714.018.320.423.733.346.253.857.0
Ibuprofen 300 mg + Acetaminophen 500 mg4.55.66.77.910.114.615.725.836.042.748.350.6
Ibuprofen 400 mg5.410.913.015.215.220.727.232.635.945.753.355.4
Placebo43.373.380.080.080.080.080.080.080.080.080.080.0

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Time-weighted Sum of Pain Relief Rating (TOTPAR) Over 2, 6, 8, 12 Hours Post-Dose

TOTPAR: time-weighted sum of PRR scores over 2, 6, 8 and 12 hours. TOTPAR score range was 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale where 0= No relief to 4= Complete relief. (NCT01559259)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 8 hours0 to 12 hours
Ibuprofen 200 mg + Acetaminophen 500 mg4.715.719.623.9
Ibuprofen 250 mg + Acetaminophen 500 mg4.314.818.923.4
Ibuprofen 300 mg + Acetaminophen 500 mg4.716.020.225.8
Ibuprofen 400 mg4.014.318.423.9
Placebo0.72.84.06.4

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Time to Onset of Meaningful Pain Relief

"Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy." (NCT01559259)
Timeframe: From 0 hour up to 12 hours post-dose

Interventionminutes (Median)
PlaceboNA
Ibuprofen 200 mg + Acetaminophen 500 mg44.5
Ibuprofen 250 mg + Acetaminophen 500 mg54.1
Ibuprofen 300 mg + Acetaminophen 500 mg45.9
Ibuprofen 400 mg56.2

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Time-weighted Sum of Pain Intensity Difference on 11-Point Numerical Scale (SPID11) Over 2, 6, 8 and 12 Hours Post-Dose

Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -40 (worst score) to 80 (best score) for SPID 0-8, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). (NCT01559259)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 8 hours0 to12 hours
Ibuprofen 200 mg + Acetaminophen 500 mg8.829.936.944.0
Ibuprofen 250 mg + Acetaminophen 500 mg8.028.836.544.5
Ibuprofen 300 mg + Acetaminophen 500 mg8.630.137.646.5
Ibuprofen 400 mg7.226.834.243.7
Placebo0.11.11.84.1

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Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)

PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief. (NCT01559259)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Ibuprofen 200 mg + Acetaminophen 500 mg1.02.64.04.54.64.64.54.33.83.32.72.21.71.41.1
Ibuprofen 250 mg + Acetaminophen 500 mg0.72.23.64.14.34.44.34.13.93.42.92.21.71.51.2
Ibuprofen 300 mg + Acetaminophen 500 mg1.02.43.94.54.74.74.64.44.23.62.82.52.21.91.6
Ibuprofen 400 mg0.61.63.23.94.24.34.24.13.73.33.02.52.11.91.7
Placebo0.30.30.50.50.40.60.70.60.80.70.70.80.80.90.9

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Pain Relief Rating Score (PRR)

"Participants answered a question: how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief." (NCT01559259)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Ibuprofen 200 mg + Acetaminophen 500 mg0.61.72.52.82.92.92.92.72.52.11.71.41.20.90.8
Ibuprofen 250 mg + Acetaminophen 500 mg0.51.52.32.62.72.82.72.62.42.21.91.51.21.00.9
Ibuprofen 300 mg + Acetaminophen 500 mg0.71.62.52.82.93.02.92.82.72.31.91.71.51.31.1
Ibuprofen 400 mg0.41.12.12.52.62.72.72.62.42.11.91.71.41.31.2
Placebo0.20.30.40.40.40.50.50.50.60.60.60.60.60.60.6

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Pain Intensity Difference on 4-Point Categorical Scale (PID4)

PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). (NCT01559259)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Ibuprofen 200 mg + Acetaminophen 500 mg0.30.91.51.61.71.71.71.61.41.20.90.80.60.50.3
Ibuprofen 250 mg + Acetaminophen 500 mg0.20.71.21.51.61.61.61.51.41.21.00.70.60.50.4
Ibuprofen 300 mg + Acetaminophen 500 mg0.30.81.41.61.71.71.71.61.61.31.00.80.70.60.4
Ibuprofen 400 mg0.20.51.11.41.51.61.61.51.31.21.00.80.70.60.5
Placebo0.10.10.10.10.00.10.10.10.20.20.20.20.20.20.3

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Cumulative Percentage of Participants With Meaningful Relief

"Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy." (NCT01559259)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,,
Interventionpercentage of participants (Number)
0.25 hours0.5 hours1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours11 hours12 hours
Ibuprofen 200 mg + Acetaminophen 500 mg1.133.365.681.185.690.090.091.191.191.191.191.191.191.191.1
Ibuprofen 250 mg + Acetaminophen 500 mg1.123.754.869.977.481.783.984.986.087.188.288.288.288.288.2
Ibuprofen 300 mg + Acetaminophen 500 mg3.422.567.477.584.388.889.989.989.989.989.989.989.989.989.9
Ibuprofen 400 mg1.113.054.366.373.980.481.582.683.784.885.985.985.985.985.9
Placebo0.00.03.36.710.010.013.313.316.716.716.716.720.020.020.0

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Cumulative Percentage of Participants With Confirmed First Perceptible Relief

Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy. (NCT01559259)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,,
Interventionpercentage of participants (Number)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Ibuprofen 200 mg + Acetaminophen 500 mg26.773.388.991.191.191.191.191.191.191.191.191.191.191.191.1
Ibuprofen 250 mg + Acetaminophen 500 mg18.366.783.986.088.288.288.288.288.288.288.288.288.288.288.2
Ibuprofen 300 mg + Acetaminophen 500 mg28.177.588.889.989.989.989.989.989.989.989.989.989.989.989.9
Ibuprofen 400 mg19.663.080.484.885.985.985.985.985.985.985.985.985.985.985.9
Placebo3.310.016.716.720.020.020.020.020.020.020.020.020.020.020.0

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Time-Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 8 Hours (SPRID 0-8)

SPRID4:Time-weighted sum of pain relief rating (PRR) and pain intensity difference (PID) based on 4 point categorical severity rating scale (PRID) over 8 hours.SPRID 0-8 score range:-8 (worst score) to 56 (best score).PRID: sum of PRR and PID at each time point.PRID score range:-1= worst score to 7= best score.PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).PRR assessed on 5-point categorical scale with range:0 =no relief to 4 =complete relief. (NCT01559259)
Timeframe: From 0 hour up to 8 hours post-dose

Interventionunits on a scale (Mean)
Placebo5.0
Ibuprofen 200 mg + Acetaminophen 500 mg30.8
Ibuprofen 250 mg + Acetaminophen 500 mg29.6
Ibuprofen 300 mg + Acetaminophen 500 mg31.7
Ibuprofen 400 mg28.8

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Time-weighted Sum of Pain Intensity Difference on 4-Point Categorical Scale (SPID4) Over 2, 6, 8 and 12 Hours Post-Dose

Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score). (NCT01559259)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 8 hours0 to 12 hours
Ibuprofen 200 mg + Acetaminophen 500 mg2.79.111.213.3
Ibuprofen 250 mg + Acetaminophen 500 mg2.48.510.712.9
Ibuprofen 300 mg + Acetaminophen 500 mg2.79.311.614.1
Ibuprofen 400 mg2.28.210.413.0
Placebo0.10.71.02.0

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Participant Global Evaluation of Study Medication

Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent. (NCT01559259)
Timeframe: 12 hour

Interventionunits on a scale (Mean)
Placebo1.0
Ibuprofen 200 mg + Acetaminophen 500 mg3.8
Ibuprofen 250 mg + Acetaminophen 500 mg3.4
Ibuprofen 300 mg + Acetaminophen 500 mg3.6
Ibuprofen 400 mg3.5

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Pain Intensity Difference on 11-Point Numerical Scale (PID11)

PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score). (NCT01559259)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Ibuprofen 200 mg + Acetaminophen 500 mg1.03.04.75.35.55.75.55.34.63.93.12.51.91.61.1
Ibuprofen 250 mg + Acetaminophen 500 mg0.82.54.25.05.35.55.45.14.84.23.52.72.11.71.5
Ibuprofen 300 mg + Acetaminophen 500 mg0.92.64.55.35.65.75.65.35.04.23.22.82.52.01.7
Ibuprofen 400 mg0.41.73.84.65.05.25.14.94.43.93.52.92.52.21.9
Placebo0.10.20.10.0-0.10.10.30.20.40.30.30.50.60.60.7

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Time to Treatment Failure

Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. (NCT01559259)
Timeframe: From 0 hour up to 12 hours post-dose

Interventionhours (Median)
Placebo1.6
Ibuprofen 200 mg + Acetaminophen 500 mg9.7
Ibuprofen 250 mg + Acetaminophen 500 mg10.1
Ibuprofen 300 mg + Acetaminophen 500 mg11.1
Ibuprofen 400 mg10.4

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Subject Acceptability of the Syrup

"In response to the question How did you like the warming sensation you have experienced for this product?, the number of patients answering Like extremely or Like very much or Like moderately or Like slightly~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely" (NCT01576809)
Timeframe: 1 hour

Interventionparticipants (Number)
Upper Respiratory Tract Infection36

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Safety and Tolerability of the Syrup

Number of participants with adverse events. (NCT01576809)
Timeframe: 1 hour

Interventionparticipants (Number)
Upper Respiratory Tract Infection6

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Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup

Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation (NCT01576809)
Timeframe: 1 minutes

Interventionmm (Mean)
Upper Respiratory Tract Infection34.6

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Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup

Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation (NCT01586962)
Timeframe: 1 minute

Interventionmm (Mean)
Upper Respiratory Infections34.2

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Subject Acceptability of the Syrup

"How do you like the warming sensation you have experienced for this product?~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely" (NCT01586962)
Timeframe: 1 hour

InterventionParticipants (Number)
Upper Respiratory Infections39

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Safety and Tolerability of the Syrup

Number of participants with adverse events. (NCT01586962)
Timeframe: 1 hour

InterventionParticipants (Number)
Upper Respiratory Infections9

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Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire

"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score." (NCT01587274)
Timeframe: Baseline and one week after discharge from emergency department

Interventionunits on a scale (Median)
Opioid5
Skeletal Muscle Relaxant4
Naproxen Alone7

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Satisfaction With Pain Relief

an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief. The scale range is from 0-10, where 0 is complete dissatisfaction with pain relief and 10 is complete satisfaction. (NCT01588158)
Timeframe: at the follow-up, 2 weeks after the operation with suture removal

Interventionunits on a scale (Mean)
Vicodin 5/325 mg6.75
Acetaminophen 325 mg6.67

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Pain Patients Expect After Surgery

an 11-point ordinal scale to assess the amount of pain the patients expect after surgery. The scale range is from 0-10, where 0 is no pain expected and 10 is the worst pain expected (NCT01588158)
Timeframe: 1 day

Interventionunits on a scale (Mean)
Vicodin 5/325 mg3.5
Acetaminophen 325 mg4

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Expectation of Pain Relief

An 11-point ordinal scale to assess the expectation of how well the pain medication will work after surgery. The scale range is from 0-10, where 0 is not effective at all and 10 is completely effective. (NCT01588158)
Timeframe: 1 day

Interventionunits on a scale (Mean)
Vicodin 5/325 mg8.25
Acetaminophen 325 mg8.33

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Pain Scale

11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had. (NCT01588158)
Timeframe: At the follow-up 2 weeks after the surgery with suture removal

Interventionunits on a scale (Mean)
Vicodin 5/325 mg4.5
Acetaminophen 325 mg1.3

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QuickDASH

The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. (NCT01588158)
Timeframe: At the follow-up 2 weeks after the surgery with suture removal

Interventionunits on a scale (Mean)
Vicodin 5/325 mg46.0
Acetaminophen 325 mg36.4

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QuickDASH

The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. (NCT01588158)
Timeframe: At enrollment prior to surgery

Interventionunits on a scale (Mean)
Vicodin 5/325 mg41.5
Acetaminophen 325 mg33.3

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PSEQ

The pain self efficacy questionnaire measures a patient's belief about his/her ability to complete a task despite his/her pain. The scale range is from 0-60, where 60 represents higher self-efficacy beliefs. (NCT01588158)
Timeframe: 1 day

Interventionunits on a scale (Mean)
Vicodin 5/325 mg41.75
Acetaminophen 325 mg46

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PHQ-9

Patient Health Questionnaire-9 to assess symptoms of depression. The scale range is from 0-27, where 0 is no symptoms of depression and 27 is severe depression. (NCT01588158)
Timeframe: 1 day

Interventionunits on a scale (Mean)
Vicodin 5/325 mg6.5
Acetaminophen 325 mg4.7

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Pain Scale

11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had. (NCT01588158)
Timeframe: At enrollment prior to surgery

Interventionunits on a scale (Mean)
Vicodin 5/325 mg4.75
Acetaminophen 325 mg6

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Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria

(NCT01598701)
Timeframe: From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes

Interventionminutes (Mean)
Intravenous Acetaminophen11.4
Placebo13.5

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Time to Extubation at Emergence From Anesthesia

(NCT01598701)
Timeframe: Time from of discontinuation of anesthetic to time of extubation, an average of 7 minutes

Interventionminutes (Median)
Intravenous Acetaminophen6
Placebo8

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Post-Operative Side Effects

Patients will be monitored for 24 hours post-operatively to detect the incidence of any drug or opioid-related side effects. These side effects were not considered to be adverse events. (NCT01598701)
Timeframe: 24 Hours Post-Operatively

,
InterventionParticipants (Count of Participants)
EmesisItchingDizzinessDrowsiness
Intravenous Acetaminophen2381424
Placebo2051419

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Post-Operative Pain

Patients will be assessed for pain using a Visual Analogue Scale (VAS) Scale at set time points after surgery (0,1,2,4,8,12,16,20,24 hours post-operatively). The Visual Analogue Scale (VAS) scale was measured on a scale of 0 - 10 (0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Higher values on the VAS represent a worse outcome. The two rows below report: 1. the average VAS score for the least amount of pain reported per group and 2. the average VAS score of the worst amount of pain reported per group. (NCT01598701)
Timeframe: 24 Hours Post-Operatively

,
Interventionunits on a scale (Mean)
Least amount of pain reportedWorst amount of pain reported
Intravenous Acetaminophen1.46.3
Placebo2.66.4

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Post-Operative Opioid Requirement

Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs. (NCT01598701)
Timeframe: 24 hours post-operatively

InterventionMorphine Equivalents (Median)
Intravenous Acetaminophen11.0
Placebo10.1

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Number of Participants With Level 3 Postoperative Hemorrhage

Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage. (NCT01605903)
Timeframe: Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.

InterventionParticipants (Count of Participants)
Treatment With Ibuprofen10
Treatment With Acetaminophen4

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Asthma Control Days

proportion of study days on which asthma was controlled, measured by electronic diary (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period

Interventionproportion of days (Mean)
Acetaminophen.86
Ibuprofen.87

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Health Care Utilization

frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period

Interventionunscheduled health visits per 46 weeks (Mean)
Acetaminophen.75
Ibuprofen.76

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Exacerbation Frequency

the number of asthma exacerbations requiring systemic corticosteroids (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period

Interventionasthma exacerbations per 46 weeks (Mean)
Acetaminophen0.81
Ibuprofen.87

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Asthma Rescue Medication Use

average albuterol rescue use per week, measured by electronic diary (NCT01606319)
Timeframe: last 46 weeks of 48 week treatment period

Interventioninhalations per week (Mean)
Acetaminophen2.8
Ibuprofen3

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Number of Participants With Best Overall Response (BOR)

BOR is response recorded from start of treatment until disease progression/recurrence. Best lesion response was defined by Recist Criteria V1 (for target and non-target lesions) and RANO criteria (for glioblastoma multiforme): complete response (CR)- disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to less than (<) 10 mm; partial response (PR)- at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum longest diameter; stable disease (SD)- steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; progressive disease (PD): at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded since treatment started. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm, or appearance of one or more new lesions. (NCT01607905)
Timeframe: Up to maximum duration of 45 months

,,,,,,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgression (Objective)Progressive Disease due to symptomatic deteriorationNot Evaluable
Arm A (Colorectal Cancer)01152849
Arm B (Gynecological Cancer)039602
Arm C (Squamous Cell Cancer)005835
Arm D (Castrate-resistant Prostate Cancer)0011503
Arm E (Glioblastoma Multiforme)000501
Arm F (Melanoma)113414
Arm G (Other Solid Tumors)012010114

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Maximum Observed Plasma Concentration (Cmax) of Selinexor

Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data. (NCT01607905)
Timeframe: Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes

Interventionnanogram per milliliter (Geometric Mean)
Selinexor Dose: 3 mg/m^230
Selinexor Dose: 6 mg/m^275
Selinexor Dose: 12 mg/m^2149
Selinexor Dose: 16.8 mg/m^2168
Selinexor Dose: 20 mg/m^2220
Selinexor Dose: 23 mg/m^2308
Selinexor Dose: 28 mg/m^2293
Selinexor Dose: 30 mg/m^2413
Selinexor Dose: 35 mg/m^2349
Selinexor Dose: 39 mg/m^2528
Selinexor Dose: 40 mg/m^2442
Selinexor Dose: 45 mg/m^2390
Selinexor Dose: 50 mg/m^2507
Selinexor Dose: 55 mg/m^2505
Selinexor Dose: 58 mg/m^2561
Selinexor Dose: 65 mg/m^2896
Selinexor Dose: 70 mg/m^2521
Selinexor Dose: 80 mg/m^2765
Selinexor Dose: 85 mg/m^21371

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Duration of Stable Disease (SD)

Duration of stable disease was defined as the time from the date of first dose to first documented radiologic evidence of disease recurrence or progression, as defined by RECIST v1.1 (for solid tumors) or RANO criteria (for GBM and AnaA). (NCT01607905)
Timeframe: From first dose of study drug administration to first documented evidence of disease recurrence or progression (maximum duration of 45 months)

InterventionDays (Median)
Arm A (Colorectal Cancer)53
Arm B (Gynecological Cancer)119
Arm C (Squamous Cell Cancer)52
Arm D (Castrate-resistant Prostate Cancer)133
Arm E (Glioblastoma Multiforme)43
Arm F (Melanoma)52
Arm G (Other Solid Tumors)134

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Area Under the Concentration Time Curve From the Time of Dosing to Time in Plasma (AUC0-t) of Selinexor

AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration. (NCT01607905)
Timeframe: Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes

Interventionnanogram hour per milliliter (Geometric Mean)
Selinexor Dose: 3 mg/m^2333
Selinexor Dose: 6 mg/m^2707
Selinexor Dose: 12 mg/m^21578
Selinexor Dose: 16.8 mg/m^21369
Selinexor Dose: 20 mg/m^22446
Selinexor Dose: 23 mg/m^23387
Selinexor Dose: 28 mg/m^23106
Selinexor Dose: 30 mg/m^23861
Selinexor Dose: 35 mg/m^23691
Selinexor Dose: 39 mg/m^24885
Selinexor Dose: 40 mg/m^25255
Selinexor Dose: 45 mg/m^24390
Selinexor Dose: 50 mg/m^25490
Selinexor Dose: 55 mg/m^25803
Selinexor Dose: 58 mg/m^25888
Selinexor Dose: 65 mg/m^28482
Selinexor Dose: 70 mg/m^27210
Selinexor Dose: 80 mg/m^29838
Selinexor Dose: 85 mg/m^211485

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Area Under the Concentration Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Selinexor

AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated). It was calculated as AUC0-t + Ct/kel, where: Ct = the last observed non-zero concentration and Kel = elimination rate constant. (NCT01607905)
Timeframe: Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes

Interventionnanogram hour per milliliter (Geometric Mean)
Selinexor Dose: 3 mg/m^2355
Selinexor Dose: 6 mg/m^2808
Selinexor Dose: 12 mg/m^21613
Selinexor Dose: 16.8 mg/m^21455
Selinexor Dose: 20 mg/m^22269
Selinexor Dose: 23 mg/m^23332
Selinexor Dose: 28 mg/m^23936
Selinexor Dose: 30 mg/m^23961
Selinexor Dose: 35 mg/m^24585
Selinexor Dose: 39 mg/m^25014
Selinexor Dose: 40 mg/m^25294
Selinexor Dose: 45 mg/m^23395
Selinexor Dose: 50 mg/m^25688
Selinexor Dose: 55 mg/m^25894
Selinexor Dose: 58 mg/m^26567
Selinexor Dose: 65 mg/m^210265
Selinexor Dose: 80 mg/m^29025
Selinexor Dose: 85 mg/m^211830

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Apparent Volume of Distribution of Selinexor (Vd/F)

Vd/F was calculated as Dose/(kel * AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram). (NCT01607905)
Timeframe: Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes

Interventionliter per kilogram (Geometric Mean)
Selinexor Dose: 3 Milligram Per Square Meter (mg/m2)1.8
Selinexor Dose: 6 mg/m21.4
Selinexor Dose: 12 mg/m21.4
Selinexor Dose: 16.8 mg/m21.6
Selinexor Dose: 20 mg/m21.6
Selinexor Dose: 23 mg/m21.6
Selinexor Dose: 28 mg/m21.5
Selinexor Dose: 30 mg/m21.6
Selinexor Dose: 35 mg/m21.6
Selinexor Dose: 39 mg/m21.5
Selinexor Dose: 40 mg/m21.9
Selinexor Dose: 45 mg/m22.8
Selinexor Dose: 50 mg/m21.9
Selinexor Dose: 55 mg/m21.9
Selinexor Dose: 58 mg/m21.8
Selinexor Dose: 65 mg/m21.5
Selinexor Dose: 80 mg/m21.8
Selinexor Dose: 85 mg/m21.4

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Apparent Total Body Clearance (CL/F) of Selinexor

CL/F was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram). (NCT01607905)
Timeframe: Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes

Interventionliter per hour per kilogram (Geometric Mean)
Selinexor Dose: 3 mg/m^20.20
Selinexor Dose: 6 mg/m^20.18
Selinexor Dose: 12 mg/m^20.19
Selinexor Dose: 16.8 mg/m^20.20
Selinexor Dose: 20 mg/m^20.19
Selinexor Dose: 23 mg/m^20.19
Selinexor Dose: 28 mg/m^20.18
Selinexor Dose: 30 mg/m^20.17
Selinexor Dose: 35 mg/m^20.20
Selinexor Dose: 39 mg/m^20.20
Selinexor Dose: 40 mg/m^20.19
Selinexor Dose: 45 mg/m^20.27
Selinexor Dose: 50 mg/m^20.18
Selinexor Dose: 55 mg/m^20.20
Selinexor Dose: 58 mg/m^20.20
Selinexor Dose: 65 mg/m^20.15
Selinexor Dose: 80 mg/m^20.22
Selinexor Dose: 85 mg/m^20.18

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Elimination Half-Life (t1/2) of Selinexor

t1/2 was defined as elimination half-life, it was calculated as ln(2)/kel, where In = natural logarithm and kel = elimination rate constant. (NCT01607905)
Timeframe: Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes

Interventionhours (Median)
Selinexor Dose: 3 mg/m^26.2
Selinexor Dose: 6 mg/m^25.6
Selinexor Dose: 12 mg/m^25.0
Selinexor Dose: 16.8 mg/m^25.7
Selinexor Dose: 20 mg/m^25.6
Selinexor Dose: 23 mg/m^25.8
Selinexor Dose: 28 mg/m^25.7
Selinexor Dose: 30 mg/m^26.5
Selinexor Dose: 35 mg/m^26.0
Selinexor Dose: 39 mg/m^25.9
Selinexor Dose: 40 mg/m^26.9
Selinexor Dose: 45 mg/m^27.3
Selinexor Dose: 50 mg/m^27.3
Selinexor Dose: 55 mg/m^26.2
Selinexor Dose: 58 mg/m^26.5
Selinexor Dose: 65 mg/m^26.9
Selinexor Dose: 80 mg/m^25.7
Selinexor Dose: 85 mg/m^25.3

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Overall Survival (OS)

OS was calculated from the date of first dose to date of death. Participants who were still alive prior to the data cutoff for final efficacy analysis, or who dropout prior to study end, were censored at the day they were last known to be alive. The OS was calculated using the Kaplan-Meier method. (NCT01607905)
Timeframe: From first dose of study drug administration to date of death (maximum duration of 45 months)

InterventionDays (Median)
Arm A (Colorectal Cancer)136
Arm B (Gynecological Cancer)491
Arm C (Squamous Cell Cancer)161
Arm D (Castrate-resistant Prostate Cancer)354
Arm E (Glioblastoma Multiforme)103
Arm F (Melanoma)NA
Arm G (Other Solid Tumors)290

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Progression-free Survival (PFS)

Progression-free survival was calculated from the date of first dose of study treatment to first documented evidence of disease recurrence or progression or death due to any cause. Patients who are last known to be alive and without evidence of progression will be censored at time of last evaluable disease assessment. If date of progression or death occurred after more than 1 missed disease assessment interval, patients are censored at the time of last evaluable disease assessment prior to the missed assessment. Progressive disease was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded since the treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions also constituted progressive disease. (NCT01607905)
Timeframe: From start of study drug administration until PD or discontinuation from the study or death (maximum duration of 45 months)

InterventionDays (Median)
Arm A (Colorectal Cancer)53
Arm B (Gynecological Cancer)119
Arm C (Squamous Cell Cancer)52
Arm D (Castrate-resistant Prostate Cancer)127
Arm E (Glioblastoma Multiforme)41
Arm F (Melanoma)52
Arm G (Other Solid Tumors)88

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE was defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as an AE that meets one or more of the mentioned criteria; is fatal, life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events. Number of participants with TEAEs and TESAEs were reported. (NCT01607905)
Timeframe: From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)

,,,,,,
InterventionParticipants (Count of Participants)
Participants with TEAEsParticipants with TESAEs
Arm A (Colorectal Cancer)5930
Arm B (Gynecological Cancer)2013
Arm C (Squamous Cell Cancer)219
Arm D (Castrate-resistant Prostate Cancer)218
Arm E (Glioblastoma Multiforme)62
Arm F (Melanoma)155
Arm G (Other Solid Tumors)4624

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Number of Participants With Treatment-emergent Adverse Events (TEAEs) Greater Than or Equal to Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. A treatment related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. (NCT01607905)
Timeframe: From start of study drug administration to 30 days after last dose of study treatment (maximum duration of 45 months)

InterventionParticipants (Count of Participants)
Arm A (Colorectal Cancer)50
Arm B (Gynecological Cancer)17
Arm C (Squamous Cell Cancer)16
Arm D (Castrate-resistant Prostate Cancer)17
Arm E (Glioblastoma Multiforme)4
Arm F (Melanoma)11
Arm G (Other Solid Tumors)35

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Percentage of Participants With Objective Response

Objective response rate (ORR) was determined as percentage of participants who had either CR or PR, as defined by RECIST v1.1 (for solid tumors). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target/non target) must have reduction in short axis to <10 mm and PR was defined as at least 30% decrease in sum of diameters of target lesions. ORR was calculated as a proportion and included a 2 sided 95% CI using the exact (Clopper-Pearson) method. (NCT01607905)
Timeframe: Up to maximum duration of 45 months

Interventionpercentage of participants (Number)
Arm A (Colorectal Cancer)1.8
Arm B (Gynecological Cancer)15.0
Arm C (Squamous Cell Cancer)0
Arm D (Castrate-resistant Prostate Cancer)0
Arm E (Glioblastoma Multiforme)0
Arm F (Melanoma)14.3
Arm G (Other Solid Tumors)2.2

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Number of Participants Who Experienced Dose Limiting Toxicity (DLT)

Evaluation of DLTs was only conducted in participants who participated in the Dose-escalation Phase. A DLT was defined as any of the following, considered possibly related to drug administration, occurring in the first 28 days (or 21 days for participants on Schedule 8) at the target dose (ie, for Schedule 2 this meant the first 4 weeks after the 12 mg/m2 run-in week): Missed selinexor doses due to drug-related toxicities, discontinuation of a participant due to a toxicity that was at least possibly related to study drug before completing Cycle 1. (NCT01607905)
Timeframe: Cycle 1 only (28-day cycle)

InterventionParticipants (Count of Participants)
Arm A (Colorectal Cancer)1
Arm B (Gynecological Cancer)0
Arm C (Squamous Cell Cancer)0
Arm D (Castrate-resistant Prostate Cancer)0
Arm E (Glioblastoma Multiforme)0
Arm F (Melanoma)1
Arm G (Other Solid Tumors)2

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Time of Maximum Observed Concentration in Plasma (Tmax) of Selinexor

Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data. (NCT01607905)
Timeframe: Cycle1, Day1: Pre-dose, 30, 60, 120, 240, 480 minutes

Interventionhours (Median)
Selinexor Dose: 3 mg/m^21
Selinexor Dose: 6 mg/m^22.1
Selinexor Dose: 12 mg/m^22.0
Selinexor Dose: 16.8 mg/m^22.1
Selinexor Dose: 20 mg/m^22.3
Selinexor Dose: 23 mg/m^22.1
Selinexor Dose: 28 mg/m^23.1
Selinexor Dose: 30 mg/m^22.9
Selinexor Dose: 35 mg/m^23.8
Selinexor Dose: 39 mg/m^23.1
Selinexor Dose: 40 mg/m^23.9
Selinexor Dose: 45 mg/m^24.2
Selinexor Dose: 50 mg/m^23.0
Selinexor Dose: 55 mg/m^23.8
Selinexor Dose: 58 mg/m^23.1
Selinexor Dose: 65 mg/m^22.0
Selinexor Dose: 70 mg/m^28.0
Selinexor Dose: 80 mg/m^23.9
Selinexor Dose: 85 mg/m^23.9

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Postoperative Vital Sign (Respiratory Rate)

Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

Interventionbreaths per minute (Mean)
IV Acetaminophen17.4
Control17.2

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Postoperative Vital Sign (Systolic Blood Pressure)

Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

InterventionmmHg (Mean)
IV Acetaminophen133
Control144

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Number of Participants Who Experienced Postoperative Morbidity (Nausea)

Post-operative nausea will be monitored and measured through direct observation and nursing clinical record (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

Interventionparticipants (Number)
IV Acetaminophen13
Control10

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Total Doses of Postoperative Opiate (Morphine) Use

The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine. (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

Interventiondoses (Median)
IV Acetaminophen1.5
Control2.5

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Postoperative Vital Sign (Diastolic Blood Pressure)

Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

InterventionmmHg (Mean)
IV Acetaminophen75
Control78.3

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Postoperative Vital Sign (Pulse)

Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

Interventionbeats per minute (Mean)
IV Acetaminophen76.3
Control80

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Number of Participants Who Received Intraoperative Supplemental Fentanyl

Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate. (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

Interventionparticipants (Number)
IV Acetaminophen9
Control4

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Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale

VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain). (NCT01608308)
Timeframe: 15 minutes and 120 minutes Post-Operatively

,
Interventionunits on a scale (Median)
15 minutes (n=24, 26)120 minutes (n=7, 11)
Control02
IV Acetaminophen00

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Postoperative Vital Sign (Temperature)

Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery. (NCT01608308)
Timeframe: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

InterventionFahrenheit (Mean)
IV Acetaminophen97.1
Control97.4

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Summary of Pain Intensity Using the Leuven Neonatal Pain Scale (LNPS) in Neonates

The LNPS is used for assessing pain intensity in neonates. Scores on the scale run from 0-14. Higher scores mean worse pain. (NCT01635101)
Timeframe: within 24 Hours

,,
Interventionscore on a scale (Mean)
at 0 hoursat 6 hoursat 12 hoursat 18 hoursat 24 hours
High Dose Acetaminophen0.81.01.81.81.3
Low Dose Acetaminophen0.81.12.21.00.8
Placebo1.11.22.00.80.9

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Pain Intensity Using the FLACC Score in Older Infants

The FLACC scale is used to assess pain intensity in older infants. The scale is scored in a range of 0-10 with 0 representing no pain. A higher score means more pain. (NCT01635101)
Timeframe: within 24 hours

,,
Interventionscore on a scale (Mean)
at 0 hoursat 6 hoursat 12 hoursat 18 hoursat 24 hours
High Dose Acetaminophen1.81.21.70.10.8
Low Dose Acetaminophen2.20.50.81.32.0
Placebo1.81.52.41.30.1

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Pain Intensity Using the FLACC Score in Intermediate Aged Infants

The Face, Leg, Activity, Cry, and Consolability (FLACC) scale is used to assess pain intensity in intermediate aged infants. The scale is scored in a range of 0-10 with 0 representing no pain. A higher score means more pain. (NCT01635101)
Timeframe: within 24 hours

,,
Interventionscore on a scale (Mean)
at 0 hoursat 6 hoursat 12 hoursat 18 hoursat 24 hours
High Dose Acetaminophen1.62.10.080.90.9
Low Dose Acetaminophen0.60.71.21.41.4
Placebo1.21.41.80.50.3

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Total Rescue Opioid Consumption

Total micrograms per kilogram (µg/kg) of rescue opioid used during the same 24 hours the subject is on study medication (NCT01635101)
Timeframe: in 24 hours

Interventionµg/kg (Mean)
Low Dose Acetaminophen166.9
High Dose Acetaminophen179.9
Placebo180.2

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Time to First Rescue Medication

(NCT01635101)
Timeframe: within 24 hours

Interventionhours (Median)
Low Dose Acetaminophen4.78
High Dose Acetaminophen4.76
Placebo3.81

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Summary of Pain Intensity Using the LNPS in Younger Infants

The LNPS is used for assessing pain intensity in younger infants. Scores on the scale run from 0-14. Higher scores mean worse pain. (NCT01635101)
Timeframe: within 24 hours

,,
Interventionscore on a scale (Mean)
at 0 hoursat 6 hoursat 12 hoursat 18 hoursat 24 hours
High Dose Acetaminophen1.51.31.81.71.3
Low Dose Acetaminophen2.12.12.21.62.3
Placebo2.22.41.92.12.9

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Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task

The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). (NCT01686646)
Timeframe: Baseline, 60 minutes and upto 120 minutes post treatment administration

,,,
Interventionmilliseconds (msec) (Median)
60 minutes120 minutes
Paracetamol (1000)2.4-6.0
Paracetamol (500)-9.9-14.0
Paracetamol + Caffeine Combination (1000/130)-1.4-10.3
Paracetamol + Caffeine Combination (500/65)-0.9-12.5

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Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated. (NCT01686646)
Timeframe: Baseline to 120 minutes post treatment administration

InterventionCorrect responses (Least Squares Mean)
Paracetamol + Caffeine Combination (1000/130)7.3
Paracetamol (1000)4.4
Paracetamol + Caffeine Combination (500/65)6.2
Paracetamol (500)3.5

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Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test

Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. (NCT01686646)
Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

,,,
InterventionCorrect responses (Median)
60 minutes120 minutes
Paracetamol (1000)6.06.0
Paracetamol (500)5.57.0
Paracetamol + Caffeine Combination (1000/130)10.011.0
Paracetamol + Caffeine Combination (500/65)8.09.0

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Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test

The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). (NCT01686646)
Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

,,,
Interventionmsec (Least Squares Mean)
60 minutes120 minutes
Paracetamol (1000)1.5-5.3
Paracetamol (500)-2.2-4.6
Paracetamol + Caffeine Combination (1000/130)-3.0-11.0
Paracetamol + Caffeine Combination (500/65)-4.4-8.0

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Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task

The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs). (NCT01686646)
Timeframe: Baseline, 30 minutes and up to 60 minutes post treatment administration

,,,
Interventionmsec (Least Squares Mean)
60 minutes120 minutes
Paracetamol (1000)-9.8-10.4
Paracetamol (500)-12.0-15.4
Paracetamol + Caffeine Combination (1000/130)-16.7-21.2
Paracetamol + Caffeine Combination (500/65)-10.8-18.0

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Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test

Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. (NCT01686646)
Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

,,,
InterventionCorrect responses (Median)
Number of Accurate Responses to SAT at 60 minsNumber of Accurate Responses to SAT at 120 mins
Paracetamol (1000)0.51.0
Paracetamol (500)0.02.0
Paracetamol + Caffeine Combination (1000/130)1.02.0
Paracetamol + Caffeine Combination (500/65)2.01.0

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Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task

The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column. (NCT01686646)
Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

,,,
Interventioninaccurate and missed responses (Mean)
Incorrect responses at 60 minutesIncorrect responses at 120 minutesMissed responses at 60 minutesMissed responses at 120 minutes
Paracetamol (1000)-2.8-1.7-4.8-4.8
Paracetamol (500)-2.4-3.3-3.1-3.5
Paracetamol + Caffeine Combination (1000/130)-5.7-4.5-8.1-7.6
Paracetamol + Caffeine Combination (500/65)1.4-0.8-4.8-6.5

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Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test

For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column. (NCT01686646)
Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

,,,
Interventionincorrect and missed responses (Mean)
Incorrect responses at 60 minutesIncorrect responses at 120 minutesMissed responses at 60 minutesMissed responses at 120 minutes
Paracetamol (1000)-4.2-4.9-7.6-9.1
Paracetamol (500)-3.3-5.0-6.2-7.8
Paracetamol + Caffeine Combination (1000/130)-6.5-7.1-10.2-12.2
Paracetamol + Caffeine Combination (500/65)-5.4-5.6-9.8-10.2

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Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test

For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column. (NCT01686646)
Timeframe: Baseline, 60 minutes and up to 120 minutes post treatment administration

,,,
Interventionincorrect and missed responses (Mean)
Incorrect responses at 60 minutesIncorrect responses at 120 minutesMissed responses at 60 minutesMissed responses at 120 minutes
Paracetamol (1000)-1.1-2.3-1.9-2.0
Paracetamol (500)-1.6-2.8-0.8-2.4
Paracetamol + Caffeine Combination (1000/130)-4.6-4.4-2.7-2.8
Paracetamol + Caffeine Combination (500/65)-4.2-4.3-2.3-2.2

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Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated. (NCT01686646)
Timeframe: Baseline to 60 minutes post treatment administration

InterventionCorrect responses (Least Squares Mean)
Paracetamol + Caffeine Combination (1000/130)8.3
Paracetamol (1000)4.8
Paracetamol + Caffeine Combination (500/65)4.5
Paracetamol (500)2.7

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Time of First Opioid Analgesia in PACU

Mean time to first drug administration among patients requiring opioid analgesia in the PACU. (NCT01691690)
Timeframe: 0-90 minutes post-operatively

Interventionminutes (Mean)
IV Acetaminophen56.80
Saline Placebo Infused Intraoperatively60.46

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Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each

Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine. (NCT01691690)
Timeframe: 8-12 hours post-operatively

,
InterventionParticipants (Count of Participants)
hydrocodone/acetaminophenoxycodoneNSAIDSacetaminophenmorphine
IV Acetaminophen68311531
Saline Placebo Infused Intraoperatively57392220

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FLACC Pain Score Greater Than or Equal to 4

The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score >/= 4 at one or more time points. (NCT01691690)
Timeframe: 0-60 mins post-operatively

InterventionParticipants (Count of Participants)
IV Acetaminophen58
Saline Placebo69

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Average Length of Stay (LOS)

To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission. (NCT01699815)
Timeframe: Baseline to discharge (1-4 days)

Interventiondays (Mean)
Preemptive Group2.5
Closure Group2.0

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Pain Medication Consumption Rates

Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders. (NCT01699815)
Timeframe: Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug

Interventionparticipants (Number)
Preemptive Group50
Closure Group42

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Changes in Postoperative Pain Scores

To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain (NCT01699815)
Timeframe: preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug

,
Interventionunits on a scale (Mean)
preoperatively (baseline)PACU arrival (2-3 hour)6 hrs post study drug12 hrs post study drug18 hrs post study drug24 hrs post study drug
Closure Group2.51.52.62.32.62.9
Preemptive Group2.70.92.62.52.73.0

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Incidence of Post-operative Vomiting

Percentage of subjects with at least one episode of post-operative vomiting (NCT01721486)
Timeframe: From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.

InterventionParticipants (Count of Participants)
Study Group1
Control Group3

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FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores

FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU. (NCT01721486)
Timeframe: At time of admission into PACU.

Interventionunits on a scale (Median)
Study Group0
Control Group0

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Parental Satisfaction With Pain Control.

Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge. (NCT01721486)
Timeframe: 24 hours post hospital discharge.

Interventionunits on a scale (Median)
Study Group9
Control Group8

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Total Pain Medication

All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents. (NCT01721486)
Timeframe: From time of PACU admission until 24 hours post-operatively.

Interventionmg (Median)
Study Group1.7
Control Group2.2

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Change From Baseline in VAS-pain Score at Week 4

VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT01728246)
Timeframe: Baseline and Week 4 Last Observation Carried Forward (LOCF)

Interventionmm (Mean)
Tramadol/Paracetamol (APAP)-45.027
Non-Tramadol/APAP-34.266

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Percentage of Participants Who Discontinued Because of Rescue Medication

Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. (NCT01728246)
Timeframe: Baseline up to Week 4

Interventionpercentage of participants (Number)
Tramadol/Paracetamol (APAP)0.41
Non-Tramadol/APAP2.16

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Change From Baseline in ODI Score at Week 4

The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability. (NCT01728246)
Timeframe: Baseline and Week 4 (LOCF)

,
Interventionunits on a scale (Mean)
BaselineChange at Week 4 (LOCF)
Non-Tramadol/APAP57.23-15.177
Tramadol/Paracetamol (APAP)58.24-19.102

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Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2

VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. (NCT01728246)
Timeframe: Baseline and Week 2

,
Interventionmm (Mean)
BaselineChange at Week 2
Non-Tramadol/APAP68.03-21.972
Tramadol/Paracetamol (APAP)71.86-29.721

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Postanesthesia Pain Score

Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain. (NCT01737593)
Timeframe: 5 minutes post-emergence

Interventionunits on a scale (Mean)
Acetaminophen PR8.27
Acetaminophen PO - Low Dose8.41
Acetaminophen PO - High Dose8.08

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Postanesthesia Pain Score

Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain. (NCT01737593)
Timeframe: Prior to discharge, up to 3 hours after induction.

Interventionunits on a scale (Mean)
Acetaminophen PR5.95
Acetaminophen PO - Low Dose6.03
Acetaminophen PO - High Dose5.92

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Postanesthesia Emergence Agitation (EA) Score

"EA was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. This scale measures if the: 1. Child makes eye contact with the caregiver, 2. Child's actions are purposeful, 3. Child is aware of his/her surroundings, 4. Child is restless, 5. Child is inconsolable.~Items 1, 2, and 3 are reversed scored as follows: 4 _ not at all, 3 _ just a little, 2 _ quite a bit, 1 _ very much, 0 _ extremely. Items 4 and 5 are scored as follows: 0 _ not at all, 1 _ just a little, 2 _ quite a bit, 3 _ very much, 4_extremely. Scores of each item are summed to obtain a total PAED scale score, range 0-20, with higher PAED scores indicating a greater degree of emergence delirium.~The average PAED score of all the time points is use" (NCT01737593)
Timeframe: Induction,Emergence(spontaneous extremity movement),and every 5 min after emergence until the patient is discharged. This is an average of 3 hours till discharge.

Interventionunits on a scale (Mean)
Acetaminophen by Rectum (PR)5.63
Acetaminophen by Mouth (PO) - Low Dose6.19
Acetaminophen by Mouth (PO) - High Dose6.37

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Postanesthesia Pain Score

Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain. (NCT01737593)
Timeframe: 15 minutes post-emergence

Interventionunits on a scale (Mean)
Acetaminophen PR6.83
Acetaminophen PO - Low Dose7.22
Acetaminophen PO - High Dose7.36

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Postanesthesia Pain Score

Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain. (NCT01737593)
Timeframe: 30 minutes post-emergence

Interventionunits on a scale (Mean)
Acetaminophen PR6.52
Acetaminophen PO - Low Dose6.78
Acetaminophen PO - High Dose6.42

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Postanesthesia Pain Score

Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain. (NCT01737593)
Timeframe: 45 minutes post-emergence

Interventionunits on a scale (Mean)
Acetaminophen PR6.77
Acetaminophen PO - Low Dose6.18
Acetaminophen PO - High Dose6.71

[back to top]

Postanesthesia Pain Score

Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain. (NCT01737593)
Timeframe: Emergence (spontaneous extremity movement)

Interventionunits on a scale (Mean)
Acetaminophen PR9.0
Acetaminophen PO - Low Dose8.56
Acetaminophen PO - High Dose8.79

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Postanesthesia Pain Score

Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain. (NCT01737593)
Timeframe: Induction

Interventionunits on a scale (Mean)
Acetaminophen PR7.78
Acetaminophen PO - Low Dose8.66
Acetaminophen PO - High Dose8.69

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F2-isoprostanes After 72 Hours of Acetaminophen or Placebo

F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation. (NCT01739361)
Timeframe: 72 hours after randomization

Interventionpg/mL (Median)
Acetaminophen33.4
Placebo40.15

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In-hospital Mortality

percent of patients who died in the hospital (NCT01739361)
Timeframe: Patients will be followed through the end of their hospital stay, an average of 5 weeks

InterventionParticipants (Count of Participants)
Acetaminophen1
Placebo4

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Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo

serum creatinine measurements at 72 hours (NCT01739361)
Timeframe: 72 hours

Interventionmg/dL (Median)
Acetaminophen1.04
Placebo1.36

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Opioid Requirement After Surgery

The purpose of the study was to determine whether more patients undergoing craniotomies would not require any opioids (i.e., opioid consumption reduced to zero) during the first 24 postoperative hours when receiving intravenous (IV) acetaminophen during that time compared to those receiving placebo (normal saline). (NCT01739699)
Timeframe: during first 24 hours after surgery

InterventionParticipants (Count of Participants)
Acetaminophen10
Placebo4

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Time to Rescue Medication in Both Groups

Time (minutes) from end of procedure to first rescue dose in either PACU or ICU (NCT01739699)
Timeframe: 0 to 24 hours after surgery

Interventionminutes (Median)
Acetaminophen22
Placebo37

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# of Participants With Delirium Measured by a Positive CAM-ICU Every 8 Hours for 24 Hours in Both Groups-

"Delirium was assessed in each of the participants upon arrival to the ICU using the Confusion Assessment Method for the ICU (CAM-ICU). The CAM-ICU was performed for each participant every 8 hours following admission for the first 24 hours~The CAM ICU scoring is based on a scale of 0-7, 0-2=no delirium, 3-5=miild delirium, 6-7=severe delirium. The positive CAM ICU consists of features 1 and 2 and either 3 or 4:~Features 1: Acute onset or fluctuating course Features 2: Inattention Features 3: Disorganized thinking Features 4: Altered level of consciousness" (NCT01739699)
Timeframe: during first 24 hours after surgery

,
InterventionParticipants (Count of Participants)
ICU Arrival8 Hours16 Hours24 Hours
Acetaminophen1000
Placebo0000

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Median Difference in ICU Length of Stay/Hospital Length of Stay Between Both Groups

(NCT01739699)
Timeframe: from 0 to estimated 24 hours after surgery

,
Interventionhours (Median)
Hospital Length of stayICU length of stay
Acetaminophen71.7526
Placebo75.528

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Median Difference in Temperature Between Intervention and Placebo Groups

Temperature measure in degrees celcius during the first 24hours postoperatively in increments of 8 hours. (NCT01739699)
Timeframe: from 0 to estimated maximum 24 hours after surgery

,
InterventionDegrees Celcius (Median)
ICU Arrival8 Hours16 Hours24 Hours
Acetaminophen36.636.736.736.8
Placebo36.736.836.836.7

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Number of Participants Who Had a Successful Neurologic Exams Between Intervention and Placebo Group as Determined by a Neurosurgical Provider by Answering Either Yes or No

Successful neurologic exams are performed by neurosurgical team during the first 24 hour period. Successful neurologic exams will be provided by a neurosurgical professional and they will answer Yes or No if the exam is appropriate. (NCT01739699)
Timeframe: from 0 to estimated maximum of 24 hours after surgery

,
InterventionParticipants (Count of Participants)
ICU arrival8 Hours16 Hours24 Hours
Acetaminophen57636053
Placebo61646055

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Sedation Scores Measured by Richmand-Agitation-Sedation Scale (RASS) Every 8 Hours for 24 Hours in Both Groups

Sedation scores will be evaluated by providers through the Richmand-Agitation-Sedation Scale (RASS) system every 8 hours for the first 24hour postoperatively. The RASS is a 10 point scale with four levels for anxiety or agitation (+1 to +4 (indicates more agitation and alertness the higher number you have)), one level to indicate a calm and alert state (0), and 5 levels of deeper sedation (-1 to -5 ( the more negative number indicating a deeper level of sedation)) patients. It helps guide sedation therapy at the bedside. There are no worse outcomes with different levels of sedation scores. However, typically, we try to keep the scores in the range of 0-+1 to be able to appropriately assess patients and allow them to be mobile in a safe fashion. (NCT01739699)
Timeframe: during first 24 hours after surgery

,
Interventionmedian of RASS scores (Median)
ICU arrival8 hours16 hours24 hours
Acetaminophen0000
Placebo0000

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Median Satisfaction Scores on a Verbal Score From 1(Not Satisfied at All) to 100 (Very Satisfied)

on a verbal score 1-100, 1 would mean that the patient is not satisfied at all and 100 would mean that the patient was very satisfied. (NCT01739699)
Timeframe: During first 24 hours after surgery

Interventionunits on a scale (Median)
Acetaminophen87.5
Placebo80

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Amount of Rescue Medication in PACU in Both Groups

(NCT01739699)
Timeframe: 0 to 24 hours after surgery

Interventionmg (Median)
Acetaminophen0.5
Placebo0.5

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Pain VAS Scores (1-100) Every 8 Hours for 24 Hours in Both Groups

Pain was measured using the Visual Analog Scale (VAS) for each patient at the time of arrival and every eight hours after arrival for the first 24 hours of ICU stay. A VAS score of 1 indicates little or no pain and a VAS score of 100 indicates severe pain. (NCT01739699)
Timeframe: during first 24 hours after surgery

,
Interventionunits on a scale (Median)
ICU Arrival8 Hours16 Hours24 Hours
Acetaminophen35303030
Placebo50453020

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Time to Rescue Medication

Time to rescue medication was evaluated. (NCT01755702)
Timeframe: Baseline to 6 hours post dose

Interventionminutes (Median)
Paracetamol/Caffeine119.0
Ibuprofen150.0
Paracetamol129.5
Placebo62.0

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Number of Participants With Complete Headache Relief

Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject. (NCT01755702)
Timeframe: Baseline to 2 hours

,,,
InterventionParticipants (Number)
Headache resolved within 1 hourHeadache resolved within 2 hour
Ibuprofen730
Paracetamol425
Paracetamol/Caffeine1529
Placebo724

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Time to First Perceptible Headache Relief

Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief. (NCT01755702)
Timeframe: Baseline to 6 hours

Interventionminutes (Median)
Paracetamol/Caffeine30
Ibuprofen30
Paracetamol30
Placebo30

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Headache Severity

"Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.~Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain." (NCT01755702)
Timeframe: Baseline to 4 hours

,,,
InterventionScore on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes120 minutes240 minutes
Ibuprofen0.200.771.612.362.763.083.05
Paracetamol0.200.781.512.002.602.942.67
Paracetamol/Caffeine0.351.031.772.502.972.942.82
Placebo0.180.851.382.032.572.673.00

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Headache Relief Scores

Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief. (NCT01755702)
Timeframe: Baseline to 4 hours

,,,
InterventionScore on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes120 minutes240 minutes
Ibuprofen0.080.841.612.493.163.463.75
Paracetamol0.290.811.462.052.953.353.24
Paracetamol/Caffeine0.151.091.872.793.363.503.50
Placebo0.080.871.702.212.953.003.55

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Total Pain Relief (TOTPAR)

"TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~It was calculated using the following formula.~TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point." (NCT01755702)
Timeframe: Baseline to 4 hours

,,,
InterventionScore on a scale (Mean)
TOTPAR (0-60 minutes)TOTPAR (0-90 minutes)TOTPAR (0-120 minutes)TOTPAR (0-240 minutes)
Ibuprofen1.372.964.9412.08
Paracetamol1.142.664.6210.65
Paracetamol/Caffeine1.573.375.0811.73
Placebo1.262.794.1811.19

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Sum of TOTPAR and SPID (SPRID)

"Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:~SPRIDt = TOTPARt + SPIDt~TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain." (NCT01755702)
Timeframe: Baseline to 4 hours

,,,
InterventionScore on a scale (Mean)
SPRID (0-60 minutes)SPRID (0-90 minutes)SPRID (0-120 minutes)SPRID (0-240 minutes)
Ibuprofen2.715.669.5022.00
Paracetamol2.285.148.9419.35
Paracetamol/Caffeine3.056.439.5021.16
Placebo2.425.227.8720.70

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Sum of Pain Intensity Difference (SPID)

"Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.~Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.~It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity." (NCT01755702)
Timeframe: Baseline to 4 hours

,,,
InterventionScore on a scale (Mean)
SPID (0-60 minutes)SPID (0-90 minutes)SPID (0-120 minutes)SPID (0-240 minutes)
Ibuprofen1.342.694.569.93
Paracetamol1.152.484.328.69
Paracetamol/Caffeine1.493.064.429.43
Placebo1.162.423.699.51

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Patients Global Assessment in Response to Treatment

Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent. (NCT01755702)
Timeframe: Baseline to 8 weeks

,,,
InterventionScore on a scale (Number)
Score 0 (Very poor)Score 1 (Poor)Score 2 (Neutral)Score 3 (Good)Score 4 (Very Good)
Ibuprofen1151918
Paracetamol1161511
Paracetamol/Caffeine10101612
Placebo2431712

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Pain-relief

"The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours.~Pain was measured using the vas analogue scale (range 0-10, where 0 = no pain (score 0) and 100 mm = worst pain (score 10)" (NCT01756209)
Timeframe: 3 and 18 months

Interventionunits on a scale*hr (Mean)
Acetaminophen5.6
Ibuprofen5.1
Mg + Acetaminophen2.25
Mg + Ibuprofen2.2

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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01782885)
Timeframe: 24 weeks

,
Interventionunits on a scale (Mean)
Stiffness (24 weeks)Pain (24 weeks)Functional capacity (24 weeks)Total score (24 weeks)
Acetaminophen1.95.316.723.5
Intra-articular Injection of PRP0.82.97.911.7

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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01782885)
Timeframe: 0 weeks

,
Interventionunits on a scale (Mean)
Stiffness (0 weeks)Pain (0 weeks)Functional capacity (0 weeks)Total score (0 weeks)
Acetaminophen3.08.024.435.5
Intra-articular Injection of PRP2.97.425.335.7

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Change in Visual Analog Scale (VAS)

The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain? (NCT01782885)
Timeframe: 0-24 weeks

,
InterventionCentimeters (Mean)
VAS (0 weeks)VAS (6 weeks)VAS (12 weeks)VAS (24 weeks)
Acetaminophen5.93.84.13.7
Intra-articular Injection of PRP4.91.91.92.2

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Change in SF-12v2 Health Survey

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (NCT01782885)
Timeframe: 6 weeks

,
Interventionunits on a scale (Mean)
Mental Component SummaryPhysical Component Summary
Acetaminophen49.841.1
Intra-articular Injection of PRP55.447.6

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Change in SF-12v2 Health Survey

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (NCT01782885)
Timeframe: 24 weeks

,
Interventionunits on a scale (Mean)
Mental Component SummaryPhysical Component Summary
Acetaminophen52.341.4
Intra-articular Injection of PRP54.349.9

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Change in SF-12v2 Health Survey

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (NCT01782885)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Mental Component SummaryPhysical Component Summary
Acetaminophen50.741.7
Intra-articular Injection of PRP55.948.8

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Change in SF-12v2 Health Survey

The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. (NCT01782885)
Timeframe: 0 weeks

,
Interventionunits on a scale (Mean)
Mental Component SummaryPhysical Component Summary
Acetaminophen50.837.7
Intra-articular Injection of PRP44.238.0

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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01782885)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Stiffness (12 weeks)Pain (12 weeks)Functional capacity (12 weeks)Total score (12 weeks)
Acetaminophen2.25.718.426.3
Intra-articular Injection of PRP0.92.78.112.0

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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)

The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. (NCT01782885)
Timeframe: 6 weeks

,
Interventionunits on a scale (Mean)
Stiffness (6 weeks)Pain (6 weeks)Functional capacity (6 weeks)Total score (6 weeks)
Acetaminophen2.35.818.226.2
Intra-articular Injection of PRP1.13.18.712.8

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VAS Pain Score 6 Hours Post-Operation

"6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)." (NCT01783236)
Timeframe: 6 Hours Post-Operation

Interventionmm (Median)
Saline Placebo68.5
IV Acetaminophen39

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Total Number of PCA Requests in First 24 Hours Post-Operation

The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation (NCT01783236)
Timeframe: 24 hours post-operation

InterventionPCA requests (Median)
Saline Placebo41
IV Acetaminophen43

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VAS Pain Score 2 Hours Post Operation

"2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)." (NCT01783236)
Timeframe: 2 Hours Post Operation

Interventionmm (Median)
Saline Placebo75.5
IV Acetaminophen49

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Total Morphine Consumption (mg)

How much morphine the subject consumes in the first 24 hours after surgery (mg). (NCT01783236)
Timeframe: 24 hours

Interventionmg (Median)
Saline Placebo34.5
IV Acetaminophen44

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VAS Score 24 Hours Post-Operation

"24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)." (NCT01783236)
Timeframe: 24 hours post-operation

Interventionmm (Median)
Saline Placebo53
IV Acetaminophen16.5

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Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale

Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities (NCT01798316)
Timeframe: 1 hour following surgery

InterventionUnits on a numerical rating scale (Median)
IV Acetaminophen3
Standard of Care3

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Number of Patients Requiring Rescue Analgesia for Breakthrough Pain

Number of patients requiring rescue analgesia medication during first hour of PACU stay (NCT01798316)
Timeframe: 1 hour following surgery

InterventionParticipants (Count of Participants)
IV Acetaminophen28
Standard of Care20

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Number of Participants With Postoperative Nausea and Vomiting (PONV).

"Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay.~PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching." (NCT01798316)
Timeframe: 4 hours plus/minus 30 minutes

InterventionParticipants (Count of Participants)
IV Acetaminophen15
Standard of Care17

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Number of Participants With Post Discharge Nausea and Vomiting (PDNV)

"Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery.~PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge." (NCT01798316)
Timeframe: Up to two days following surgery

InterventionParticipants (Count of Participants)
IV Acetaminophen4
Standard of Care10

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Narcotic Use During PACU Stay

Narcotic medication administered during PACU stay in morphine milligram equivalents (NCT01798316)
Timeframe: 4 hours plus/minus 30 minutes

InterventionMorphine milligram equivalents (Mean)
IV Acetaminophen13.3
Standard of Care16.8

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Highest Pain Intensity Score Using Numeric Rating Scale (NRS)

Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities. (NCT01798316)
Timeframe: 4 hours plus/minus 30 minutes

InterventionUnits on a numerical rating scale (Median)
IV Acetaminophen6
Standard of Care6

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Patient Satisfaction on a 5 Point Likert Scale

Number of patients very satisfied or satisfied with pain and PONV management during hospital stay (NCT01798316)
Timeframe: Up to one week following surgery

InterventionParticipants (Count of Participants)
IV Acetaminophen38
Standard of Care35

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Time to the First Rescue Medication Administered Because of Insufficient Pain Relief

The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular [directly into muscle] or intravenous injection [directly into vein]). (NCT01814878)
Timeframe: Baseline up to Day 3

InterventionMinutes (Mean)
Tramadol Hydrochloride (HCl)/Acetaminophen ER1339
Tramadol HCl/Acetaminophen IR1212

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Dosage of Rescue Medication Administered Because of Insufficient Pain Relief

The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection). (NCT01814878)
Timeframe: Baseline up to Day 3

InterventionMilligram (Mean)
Tramadol Hydrochloride (HCl)/Acetaminophen ER50.0
Tramadol HCl/Acetaminophen IR51.7

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Total Pain Relief (TOTPAR) Score

Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48. (NCT01814878)
Timeframe: Hour 6, 12, 24, 48

,
InterventionUnits on scale (Mean)
Hour 6Hour 12Hour 24Hour 48
Tramadol HCl/Acetaminophen IR6.814.731.061.7
Tramadol Hydrochloride (HCl)/Acetaminophen ER6.012.527.155.6

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Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief

The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection). (NCT01814878)
Timeframe: Baseline up to Day 3

InterventionDoses (Mean)
Tramadol Hydrochloride (HCl)/Acetaminophen ER2.1
Tramadol HCl/Acetaminophen IR1.4

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Patient Global Impression of Change (PGIC) Score

The PGIC was used to assess the degree of participant's overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened). (NCT01814878)
Timeframe: Day 3

InterventionUnits on scale (Mean)
Tramadol Hydrochloride (HCl)/Acetaminophen ER2.71
Tramadol HCl/Acetaminophen IR2.60

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Sum of Pain Intensity Difference (SPID) at Hour 48

The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best). (NCT01814878)
Timeframe: Hour 48

InterventionUnits on scale (Mean)
Tramadol Hydrochloride (HCl)/Acetaminophen ER32.5
Tramadol HCl/Acetaminophen IR37.2

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Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)

The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <= 3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48. (NCT01814878)
Timeframe: Hour 6, 12, 24, 48

,
InterventionUnits on scale (Mean)
Hour 6Hour 12Hour 24Hour 48
Tramadol HCl/Acetaminophen IR10.923.149.197.0
Tramadol Hydrochloride (HCl)/Acetaminophen ER9.619.641.885.9

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Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24

The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24. (NCT01814878)
Timeframe: Hour 6, 12, 24

,
InterventionUnits on scale (Mean)
Hour 6Hour 12Hour 24
Tramadol HCl/Acetaminophen IR3.98.117.6
Tramadol Hydrochloride (HCl)/Acetaminophen ER3.67.014.6

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Duodenal Mucosal Damage (DMD) Scores

DMD was measured using a 5- point Lanza scale: 0 - normal duodenum; 1 - mucosal hemorrhages; 2 - one or two erosions; 3 - numerous areas of erosions and 4 - more than 10 erosions/ ulcers. (NCT01822665)
Timeframe: Day 7

InterventionScore on a scale (Mean)
Paracetamol Tablet (1000 mg)0.15
Ibuprofen Capsule (400 mg)0.26
Ibuprofen Tablet (400 mg)0.23
Placebo Tablet0.00

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Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule

Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer. (NCT01822665)
Timeframe: Day 7

InterventionScores on a scale (Mean)
Paracetamol Tablet (1000 mg)0.33
Ibuprofen Capsule (400 mg)1.48

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GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet

Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer. (NCT01822665)
Timeframe: Day 7

InterventionScore on a scale (Mean)
Paracetamol Tablet (1000 mg)0.33
Ibuprofen Capsule (400 mg)1.48
Ibuprofen Tablet (400 mg)1.05
Placebo Tablet0.14

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Incidence of Gastric and/or Duodenal Mucosal Injury

Number of participants with endoscopy score equal to or more than 2 were determined based on Lanza score for both gastric and duodenal mucosal damage. (NCT01822665)
Timeframe: Day 7

InterventionParticipants (Number)
Ibuprofen Capsule (400 mg)12
Ibuprofen Tablet (400 mg)8
Paracetamol Tablet (1000 mg)4
Placebo Tablet0

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Incidence of Fecal Occult Blood

The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood). (NCT01822665)
Timeframe: Day 7

,,,
InterventionParticipants (Number)
Score 0 = no fecal occult bloodScore 1 = fecal occult blood present
Ibuprofen Capsule (400 mg)230
Ibuprofen Tablet (400 mg)220
Paracetamol Tablet (1000 mg)270
Placebo Tablet220

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Total Bilirubin (mg/dL)

(NCT01822821)
Timeframe: Measured at 1 day and 2 days after surgery

,
Interventionmg/dL (Median)
overall bilirubinpostoperative day 1 bilirubinpostoperative day 2 bilirubin
IV Acetaminophen0.70.70.6
Placebo0.70.70.6

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Cumulative Opioid Consumption

Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents. (NCT01822821)
Timeframe: End of surgery through 24 hours after surgery

Interventionmg morphine equivalents (Median)
IV Acetaminophen97
Placebo117

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Duration of Mechanical Ventilation (Minutes)

Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation. (NCT01822821)
Timeframe: End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.

Interventionminutes (Median)
IV Acetaminophen214
Placebo190

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Hospital Length of Stay

Evaluate whether IV acetaminophen hospital length of stay (NCT01822821)
Timeframe: end of surgery through hospital discharge

Interventiondays (Median)
IV Acetaminophen6.2
Placebo6.1

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Intensive Care Unit (ICU) Length of Stay

Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay. (NCT01822821)
Timeframe: End of surgery through discharge from ICU

Interventionhours (Median)
IV Acetaminophen214
Placebo190

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Postoperative Nausea and Vomiting

Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected. (NCT01822821)
Timeframe: End of surgery through 24 hours after surgery

InterventionParticipants (Count of Participants)
IV Acetaminophen16
Placebo21

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Alanine Aminotransferase (ALT); U/L

(NCT01822821)
Timeframe: Two days after surgery or date of death from any cause, whichever came first

,
InterventionU/L (Median)
Overall ALTpostoperative day 1 ALTpostoperative day 2 ALT
IV Acetaminophen181817
Placebo191918

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Aspartate Aminotransferase (AST); U/L

(NCT01822821)
Timeframe: Two days after surgery or date of death from any cause, whichever came first

,
InterventionU/L (Median)
Overall ASTpostoperative day 1 ASTpostoperative day 2 AST
IV Acetaminophen354031
Placebo334031

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Pain Intensity

Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable). (NCT01822821)
Timeframe: End of surgery through 24 hours after surgery

,
Interventionunits on a scale (Mean)
overall pain scores4 hours after surgery6 hours after surgery8 hours after surgery12 hours after surgery16 hours after surgery20 hours after surgery24 hours after surgery
IV Acetaminophen3.14.63.53.22.43.02.92.5
Placebo4.05.04.44.43.53.64.23.5

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Postoperative Sedation

Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation. (NCT01822821)
Timeframe: Measured at 8, 16, and 24 hours after surgery

,
Interventionunits on a scale (Median)
8 hours after surgery16 hours after surgery24 hours after surgery
IV Acetaminophen000
Placebo000

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Pain

Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain. (NCT01823224)
Timeframe: 24 hours after discharge

,
InterventionNRS scale (Mean)
pre-opArrival in PACUDischarge from PACUDischarge+6hrsDischarge+12hrsDischarge+18hrsDischarge+24hrs
Group 11.411.612.364.815.094.123.96
Group 21.732.322.644.814.714.214.09

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Total Opioid Consumption From Time of First Waking to T24

"Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:~Opioid consumption from first waking to T4~Total opioid consumption from T0 to T4~Total opioid consumption from time of first waking to T24" (NCT01823224)
Timeframe: every 6 hours for 24 hours

,
Interventionmilligrams (Mean)
PACUHome ConsumptionTotal consumption from peration to 24 hrs
Group 113.4636.96153.38
Group 217.4139.56163.86

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Need for Rescue Pain Relief

The need for additional analgesics (NCT01827475)
Timeframe: 1 hour

Interventionparticipants (Number)
Ibuprofen11
Acetaminophen10
Ibuprofen-acetaminophen Combination5

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Pain Severity

Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain) (NCT01827475)
Timeframe: 1 hour

Interventionmm (Mean)
Ibuprofen39
Acetaminophen43
Ibuprofen-acetaminophen Combination42

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Rate of Rescue Medication

Number of participants that took rescue medication over the total number of participants for a given treatment group (NCT01842633)
Timeframe: 4 hours

Interventionnumber of participants (Number)
Paracetamol/ Caffeine Caplets2
Ibuprofen Caplets4
Placebo Caplets4

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Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours

"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)." (NCT01842633)
Timeframe: Up to 4 hours post dose

Interventionscore on a scale (Mean)
Paracetamol/ Caffeine Caplets-6.13
Ibuprofen Caplets-5.78
Placebo Caplets-5.86

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Time to Perceptible Headache Relief

Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1. (NCT01842633)
Timeframe: Baseline up to 4 hours

Interventionminutes (min.) (Median)
Paracetamol/ Caffeine Caplets27.00
Ibuprofen Caplets29.67
Placebo Caplets27.00

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Time to the Use of Rescue Medication.

Time taken by the participants to use the rescue medication (NCT01842633)
Timeframe: Up to 4 hours

InterventionMinutes (Mean)
Paracetamol/ Caffeine Caplets239.00
Ibuprofen Caplets235.14
Placebo Caplets235.55

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Change From Baseline in Headache Pain Intensity

Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). (NCT01842633)
Timeframe: At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.

,,
Interventionscore on a scale (Mean)
At 10 min.At 15 min.At 20 min.At 25 min.At 30 min.At 40 min.At 50 min.At 60 min.At 90 min.At 120 min.At 180 min.At 240 min.
Ibuprofen Caplets-0.01-0.06-0.21-0.34-0.51-0.75-0.93-1.17-1.48-1.73-1.90-1.91
Paracetamol/ Caffeine Caplets-0.03-0.10-0.27-0.45-0.66-0.92-1.07-1.26-1.51-1.76-1.95-2.01
Placebo Caplets-0.04-0.10-0.21-0.36-0.55-0.75-0.96-1.14-1.39-1.69-1.93-1.95

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Headache Relief

The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome. (NCT01842633)
Timeframe: At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,

,,
Interventionscore on a scale (Mean)
10 min.15 min.20 min.25 min.30 min.40 min.50 min.60 min.90 min.120 min.180 min.240 min.
Ibuprofen Caplets0.030.160.490.771.171.621.912.342.913.373.593.55
Paracetamol/ Caffiene Caplets0.070.330.681.061.371.862.152.422.853.353.693.72
Placebo Caplets0.110.270.600.881.221.491.822.142.683.033.443.32

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Number of Participants With Perceptible Pain Relief

(NCT01842633)
Timeframe: Baseline up to 4 hours

,,
Interventionnumber of participants (Number)
number of participantsnumber of censored participants
Ibuprofen Caplets611
Paracetamol/ Caffeine Caplets620
Placebo Caplets330

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Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours

"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.~The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)." (NCT01842633)
Timeframe: From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose

,,
Interventionscore on a scale (Mean)
At 1 hour (n=62, 61, 33)At 2 hour (n=62, 61, 33)At 3 hour (n=61, 62, 32)
Ibuprofen Caplets-0.56-2.02-3.86
Paracetamol/ Caffeine Caplets-0.64-2.21-4.09
Placebo Caplets-0.57-2.04-3.97

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Time to Meaningful Headache Relief

Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2. (NCT01842633)
Timeframe: Baseline up to 4 hours

Interventionmin. (Median)
Paracetamol/ Caffeine Caplets43.33
Ibuprofen Caplets54.17
Placebo Caplets46.67

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Total Pain Relief (TOTPAR)

TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose. (NCT01842633)
Timeframe: From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose

,,
Interventionscore on a scale (Mean)
Baseline-1 hour (62, 61, 33)Baseline-2 hour (62, 61, 33)Baseline-3 hour (61, 62, 33)Baseline-4 hour (59, 59, 33)
Ibuprofen Caplets1.174.057.5111.05
Paracetamol/ Caffeine Caplets1.314.287.8411.57
Placebo Caplets1.143.827.3510.47

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Number of Pain Free Participants

Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose. (NCT01842633)
Timeframe: 1 hour and 2 hour post dose

,,
Interventionnumber of participants (Number)
At 1 hourAt 2 hour
Ibuprofen Caplets1741
Paracetamol/Caffeine Caplets1838
Placebo Caplets620

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Number of Participants With Meaningful Pain Relief

(NCT01842633)
Timeframe: Baseline up to 4 hours

,,
Interventionnumber of participants (Number)
number of participantsnumber of censored participants
Ibuprofen Caplets602
Paracetamol/ Caffeine Caplets611
Placebo Caplets321

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Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)

SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose. (NCT01842633)
Timeframe: From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose

,,
Interventionscore on a scale (Mean)
At 1 hour (n=62, 61, 33)At 2 hour (n=62, 61, 33)At 3 hour (n=61, 62, 32)At 4 hour (n=59, 59, 33)
Ibuprofen Caplets0.612.033.645.28
Paracetamol/ Caffeine Caplets0.672.073.755.44
Placebo Caplets0.571.783.384.61

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Global Evaluation of Response to Treatment

Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral [neither poor nor good], 3-good, or 4-very good). (NCT01842633)
Timeframe: 4 hours

Interventionscore on a scale (Mean)
Paracetamol/ Caffeine Caplets2.88
Ibuprofen Caplets2.81
Placebo Caplets2.66

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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4

Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain. (NCT01843660)
Timeframe: Hour 4

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride (HCl)-Paracetamol2.56

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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6

Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain. (NCT01843660)
Timeframe: Hour 6

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride (HCl)-Paracetamol2.39

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Number of Participants Who Required Additional Dosage Administration

Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported. (NCT01843660)
Timeframe: Baseline up to Hour 2

InterventionParticipants (Number)
Tramadol Hydrochloride (HCl)-Paracetamol97

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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5

Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain. (NCT01843660)
Timeframe: Hour 0.5

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride (HCl)-Paracetamol5.29

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Number of Participants With Overall Analgesic Satisfaction Score

Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported. (NCT01843660)
Timeframe: Hour 6

InterventionParticipants (Number)
Participants' evaluation: Very unsatisfiedParticipants' evaluation: UnsatisfiedParticipants' evaluation: AverageParticipants' evaluation: SatisfiedParticipants' evaluation: Very satisfiedPhysicians' evaluation: Very unsatisfiedPhysicians' evaluation: UnsatisfiedPhysicians' evaluation: AveragePhysicians' evaluation: SatisfiedPhysicians' evaluation: Very satisfied
Tramadol Hydrochloride (HCl)-Paracetamol339207669111133159710126

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Number of Participants With Analgesic Satisfaction Score

Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported. (NCT01843660)
Timeframe: Hour 6

InterventionParticipants (Number)
Very goodGoodAveragePoorMissing
Tramadol Hydrochloride (HCl)-Paracetamol128659212291

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Number of Participants With Pain Relief Score at Hour 0.5

Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier). (NCT01843660)
Timeframe: Hour 0.5

InterventionParticipants (Number)
CompleteSignificantModerateMildNoneExacerbated
Tramadol Hydrochloride (HCl)-Paracetamol7922093263941

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Number of Participants With Pain Relief Score at Hour 1

Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier). (NCT01843660)
Timeframe: Hour 1

InterventionParticipants (Number)
CompleteSignificantModerateMildNoneExacerbated
Tramadol Hydrochloride (HCl)-Paracetamol462262713321540

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Number of Participants With Pain Relief Score at Hour 2

Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier). (NCT01843660)
Timeframe: Hour 2

InterventionParticipants (Number)
CompleteSignificantModerateMildNoneExacerbated
Tramadol Hydrochloride (HCl)-Paracetamol104351270230740

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Number of Participants With Pain Relief Score at Hour 4

Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier). (NCT01843660)
Timeframe: Hour 4

InterventionParticipants (Number)
CompleteSignificantModerateMildNoneExacerbated
Tramadol Hydrochloride (HCl)-Paracetamol22248419486430

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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3

Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain. (NCT01843660)
Timeframe: Hour 3

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride (HCl)-Paracetamol2.93

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Number of Participants With Pain Relief Score at Hour 6

Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier). (NCT01843660)
Timeframe: Hour 6

InterventionParticipants (Number)
CompleteSignificantModerateMildNoneExacerbated
Tramadol Hydrochloride (HCl)-Paracetamol30437721878511

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Number of Participants With Pain Relief Score at Hour 3

Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier). (NCT01843660)
Timeframe: Hour 3

InterventionParticipants (Number)
CompleteSignificantModerateMildNoneExacerbated
Tramadol Hydrochloride (HCl)-Paracetamol17939230799520

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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2

Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain. (NCT01843660)
Timeframe: Hour 2

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride (HCl)-Paracetamol3.52

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Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1

Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain. (NCT01843660)
Timeframe: Hour 1

InterventionUnits on a scale (Mean)
Tramadol Hydrochloride (HCl)-Paracetamol4.32

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Postoperative Opioid Consumption

Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents. (NCT01852955)
Timeframe: 24 hour

Interventionoral mg of morpine equivalents (Median)
IV Acetaminophen20
Placebo30

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Quality of Recovery at 24 Hours(QoR-40 Instrument)

Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery). (NCT01852955)
Timeframe: 24 hours after the surgical procedure

Interventionunits on a scale (Median)
IV Acetaminophen189
Placebo183

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Postoperative Pain in the Post Anesthesia Care Unit

Postoperative pain within the post anesthesia care unit after surgery. Area under the numeric rating scale for pain versus time curve in the post anesthesia care unit (score * min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). Area under a curve units of the horizontal axis multiplied by the units of the vertical axis. A higher value indicates more pain and time in the Post Anesthesia Care Unit.The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC. (NCT01852955)
Timeframe: Time in the post anesthesia care unit after surgery (average of 5 hours)

Intervention(units on a scale * minutes (Median)
IV Acetaminophen255
Placebo240

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Sedation Scale

Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionscore on a scale (Mean)
1 hour post-op in Recovery Room24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine5.04.2
Placebo Pills and Injectables4.64.3

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Intraoperative Medication Use: Ketorolac and Lidocaine

All participants received standard induction medications. (NCT01868425)
Timeframe: From induction until arrival in post anesthesia care unit.

,
Interventionmg (Mean)
Intraoperative KetorolacIntraoperative Lidocaine
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine15.071.5
Placebo Pills and Injectables14.765.6

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Intraoperative Medication Use: Fentanyl

All participants received standard induction medications. (NCT01868425)
Timeframe: From induction until arrival in post anesthesia care unit.

Interventionmcg (Mean)
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine125
Placebo Pills and Injectables128

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Number of Participants With Complications From the Procedure

(NCT01868425)
Timeframe: Up to 24 hours following surgery

InterventionParticipants (Count of Participants)
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine0
Placebo Pills and Injectables0

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Post-Operative Incidence of Nausea

Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
InterventionParticipants (Count of Participants)
Nausea Post op to dischargeNausea - discharge to 24 hour
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine1624
Placebo Pills and Injectables1223

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Opioid Consumption in the Immediate Postoperative Period

"This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The immediate postoperative period covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours." (NCT01868425)
Timeframe: Up to 10 hours

Interventionmorphine mg equivalents (Mean)
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine12.0
Placebo Pills and Injectables14.4

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Incidence of Post-Operative Pruritus

Pruritus in recovery and through the first 24 hours post-op. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
InterventionParticipants (Count of Participants)
Number of patients with pruritis OR to dischargeNumber of patients with pruritis discharge to 24 h
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine813
Placebo Pills and Injectables1019

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Time to Discharge

Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery). (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionminutes (Mean)
Discharge from Recovery RoomDischarge from Outpatient Center
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine64.8132.1
Placebo Pills and Injectables61.4123.6

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Number of Participants Who Received Medication for Nausea

Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
InterventionParticipants (Count of Participants)
Anti-Nausea Medication Before DischargeAnti-Nausea Medication after Discharge
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine86
Placebo Pills and Injectables73

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Pain Scores During Recovery

Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain. (NCT01868425)
Timeframe: up to 24 hours postoperatively

,
Interventionscore on a scale (Mean)
Lowest Score Upon Arrival to Recovery RoomHighest Score Upon Arrival to Recovery Room1 hour post-op24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine2.34.83.42.4
Placebo Pills and Injectables3.05.53.82.6

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Post-Operative Nausea Scores

Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible). (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionscore on a scale (Mean)
Post Operative (recovery room)24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine1.22.2
Placebo Pills and Injectables0.71.6

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Post-Operative Pruritis Score

Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionscore on a scale (Mean)
Post Operative (recovery room)24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine0.40.7
Placebo Pills and Injectables0.71.2

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2-hour Change Over Time Core Temperature

change over time core temperature after study drug administration (adjusted to baseline core temperature) (NCT01869699)
Timeframe: 2 hours

Interventiondegrees Celsius (Mean)
Normal Saline Placebo-0.01
Acetaminophen-0.8

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2-hour Change Over Time Heart Rate

2-hour change over time heart rate from time of study drug administration (means adjusted to baseline HR) (NCT01869699)
Timeframe: Baseline to 2 hours

InterventionBPM (Mean)
Normal Saline Placebo2
Acetaminophen-6

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Respiratory Rate

time weighted average for respiratory rate over 4 hours. Respiratory rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the respiratory rate values was divided by time in minutes. (NCT01869699)
Timeframe: Baseline to 4 hours post study drug administration

Interventionbreaths per minute (Mean)
Normal Saline Placebo22
Acetaminophen21

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Heart Rate

time-weighted average heart rate over 4 hours. Heart rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the heart rate values was divided by time in minutes. (NCT01869699)
Timeframe: Baseline to 4 hours post study drug administration

Interventionbeats per minute (Mean)
Normal Saline Placebo92
Acetaminophen87

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Core Body Temperature

time-weighted average core body temperature over 4 hours. Core temperature was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the core temperature values was divided by time in minutes. (NCT01869699)
Timeframe: Baseline to 4 hours post study drug administration

Interventiondegrees Celsius (Mean)
Normal Saline Placebo38.4
Acetaminophen37.9

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Systolic Blood Pressure

time-weighted average systolic blood pressure over 4 hours. Systolic blood pressure was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the systolic blood pressure values was divided by time in minutes. (NCT01869699)
Timeframe: Baseline to 4 hours post study drug administration

Interventionmm Hg (Mean)
Normal Saline Placebo143
Acetaminophen127

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2-hour Change Over Time Systolic Blood Pressure

2-hour change over time SBP from study drug administration (means adjusted to baseline SBP) (NCT01869699)
Timeframe: Baseline to 2 hours

Interventionmm Hg (Mean)
Normal Saline Placebo-0.1
Acetaminophen-24

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Swiss Spinal Stenosis (SSS) Questionnaire Score

Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks. (NCT01943435)
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).

Interventionunits on a scale (Mean)
Medical Care-2.0
Group Exercise-1.7
Manual Therapy and Exercise-4.1

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Sense Wear Armband

Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions. (NCT01943435)
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).

Interventionminutes per day (Mean)
Medical Care-23.1
Group Exercise4.3
Manual Therapy and Exercise-6.0

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Self Paced Walking Test (SPWT)

Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters. (NCT01943435)
Timeframe: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).

Interventionmeters (Mean)
Medical Care130.5
Group Exercise219.2
Manual Therapy and Exercise267.8

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Narcotic Requirement After Surgery

The primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group. (NCT01948505)
Timeframe: 48 hours

InterventionMorphine Equivalents (Mean)
Experimental Group123.5
Placebo Group134.2

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Time to Confirmed First Perceptible Pain Relief

Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief. (NCT01960114)
Timeframe: Within 12 Hours

InterventionMinutes (Median)
PlaceboNA
ACE ER 1500 mg26.817

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Duration of Pain Relief

Minutes until rescue medication was given. (NCT01960114)
Timeframe: Within 12 Hours

InterventionMinutes (Median)
Placebo106.5
ACE ER 1500 mgNA

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Time to Meaningful Pain Relief

Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them. (NCT01960114)
Timeframe: Within 12 Hours

InterventionMinutes (Median)
PlaceboNA
ACE ER 1500 mg84.675

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Patient Global Evaluation

Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent. (NCT01960114)
Timeframe: 12 Hours

,
Interventionpercentage of participants (Number)
Poor (0)Fair (1)Good (2)Very Good (3)Excellent (4)
ACE ER 1500 mg18.311.214.635.820.1
Placebo63.29.08.312.86.8

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Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)

Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h. (NCT01960114)
Timeframe: 10 Hours

Interventionunits on a scale (Least Squares Mean)
Placebo5.745
ACE ER 1500 mg30.986

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Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.

Number of subjects who are free of photophobia at the 2-hour assessment. (NCT01973205)
Timeframe: 2 hours

Interventionparticipants (Number)
Placebo116
Acetaminophen 250 mg and Aspirin 250 mg127

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Number of Subjects Who Are Pain Free at the 2-hour Assessment

Number of subjects who are pain free at the 2-hour assessment (NCT01973205)
Timeframe: 2 hours

Interventionparticipants (Number)
Placebo69
Acetaminophen 250 mg and Aspirin 250 mg90

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Number of Subjects Who Are Nausea Free at the 2-hour Assessment

Number of subjects who are nausea free at the 2-hour assessment (NCT01973205)
Timeframe: 2 hours

Interventionparticipants (Number)
Placebo208
Acetaminophen 250 mg and Aspirin 250 mg244

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Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.

Number of subjects who are free of phonophobia at the 2-hour assessment. (NCT01973205)
Timeframe: 2 hours

Interventionparticipants (Number)
Placebo142
Acetaminophen 250 mg and Aspirin 250 mg164

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Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration

NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline. (NCT01983111)
Timeframe: 2 weeks

InterventionScores on a scale (Mean)
Buprenorphine-1.19
Tramadol/Acetaminophen-1.70

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Clinical Global Impression of Change(CGIC)

The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse. (NCT01983111)
Timeframe: 6 weeks

InterventionScores on 1 to 7 point (Mean)
Buprenorphine2.28
Tramadol/Acetaminophen2.43

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Patient Global Impressions of Change(PGIC)

"In the PP set, Number of participants with categorical change in overall satisfaction.~PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse)." (NCT01983111)
Timeframe: 6 weeks

InterventionScores on 1 to 7point (Mean)
Buprenorphine2.32
Tramadol/Acetaminophen2.45

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Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.

NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline. (NCT01983111)
Timeframe: baseline and 6 weeks

InterventionScores on a scale (Mean)
Buprenorphine-2.32
Tramadol/Acetaminophen-2.75

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Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose

"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for 'Motor capability', 'Self-care', 'Daily activities', 'Pain/discomfort', 'Depression/anxiety' and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life." (NCT01983111)
Timeframe: Baseline and at 6 weeks

InterventionEQ-5D Total score (Mean)
Buprenorphine0.09
Tramadol/Acetaminophen0.21

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Duration of Response

Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kgNA
Daratumumab 16 mg/kg7.4

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Overall Survival

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method. (NCT01985126)
Timeframe: Approximately up to 3 years

Interventionmonths (Median)
Daratumumab 8 mg/kg19.45
Daratumumab 16 mg/kg18.60

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Percentage of Participants With Overall Response

Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; PR: >= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionpercentage of participants (Number)
Daratumumab 8 mg/kg11.1
Daratumumab 16 mg/kg29.2

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Time to Disease Progression

Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kg4.86
Daratumumab 16 mg/kg3.71

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Percentage of Participants With Clinical Benefit

Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionpercentage of participants (Number)
Daratumumab 8 mg/kg22.2
Daratumumab 16 mg/kg34.0

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Progression Free Survival

Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first. (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kg4.86
Daratumumab 16 mg/kg3.65

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Time to Response

Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). (NCT01985126)
Timeframe: Up to 14.4 Months

Interventionmonths (Median)
Daratumumab 8 mg/kg0.99
Daratumumab 16 mg/kg0.99

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Postoperative Opioid Consumption

To learn if opioid consumption is reduced when IV acetaminophen is provided immediately post-operatively. (NCT02025634)
Timeframe: up to 8 hours

Interventionmg (Mean)
Intravenous Acetaminophen3
Placebo (0.9% Normal Saline Infusion)2

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"Total Time in Post Anesthesia Care Unit (PACU) (or Recovery Room)"

To ascertain if the total time the participant remains in the PACU (from admission to discharge) differs between those who received IV acetaminophen versus those who do not receive IV acetaminophen. (NCT02025634)
Timeframe: up to 8.6 hours

Interventionhours (Mean)
Intravenous Acetaminophen3.30
Placebo (0.9% Normal Saline Infusion)3.40

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Postoperative Pain Levels

To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible. (NCT02025634)
Timeframe: up to 8 hours

Interventionscore on a scale (Mean)
Intravenous Acetaminophen1.3160
Placebo (0.9% Normal Saline Infusion)2.1362

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Opioid Rescue - 48 Hours

Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine (NCT02028715)
Timeframe: First 48 hours including pre-operative and intra-operative medications

InterventionMilligrams of intravenous morphine equiv (Mean)
Experimental (Normal Saline)54.4803
Experimental (IV Acetaminophen)48.9253

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Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (NCT02028715)
Timeframe: At 24 hours 48 hours, and discharge (up to 7 days)

,
Interventionscore on a scale (Mean)
At 24 hoursAt 48 hoursAt Discharge
Experimental (IV Acetaminophen)4.194.044.23
Experimental (Normal Saline)4.214.084.58

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Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (NCT02028715)
Timeframe: At 24 hours, 48 Hours, and Discharge (up to 7 days)

,
Interventionscore on a scale (Mean)
At 24 hoursAt 48 hoursAt Discharge
Experimental (IV Acetaminophen)3.583.853.88
Experimental (Normal Saline)3.713.673.54

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Return of Bowel Function

Time to return of bowel function (passage of flatus) in hours (NCT02028715)
Timeframe: Duration of hospital stay (up to 7 days).

InterventionHours (Mean)
Experimental (Normal Saline)68.0878
Experimental (IV Acetaminophen)56.5696

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Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (NCT02028715)
Timeframe: At 24 hours, 48 Hours, and Discharge (up to 7 days)

,
Interventionscore on a scale (Mean)
At 24 hoursAt 48 hoursAt Discharge
Experimental (IV Acetaminophen)4.233.693.35
Experimental (Normal Saline)3.583.753.79

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Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge

Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (NCT02028715)
Timeframe: At 24 hours, 48 Hours, and Discharge (up to 7 days)

,
Interventionscore on a scale (Mean)
At 24 hoursAt 48 hoursAt Discharge
Experimental (IV Acetaminophen)3.733.503.65
Experimental (Normal Saline)3.884.124.17

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Length of Stay

Mean length of post-operative stay in days (NCT02028715)
Timeframe: Surgery to discharge

InterventionDays (Mean)
Experimental (Normal Saline)3.62
Experimental (IV Acetaminophen)3.57

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Efficacy Comparison of Pain Intensity Level

"Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours.~The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome.~The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test." (NCT02029235)
Timeframe: 1 week post-operatively

,
Interventionscore on a scale (0-100, higher = worse) (Mean)
Daily average pain intensity level on PostOp Day 1Daily average pain intensity level on PostOp Day 2Daily average pain intensity level on PostOp Day 3Daily average pain intensity levelon PostOp Day 4Daily average pain intensity level on PostOp Day 5Daily average pain intensity level on PostOp Day 6Daily average pain intensity level on PostOp Day 7
Acetaminophen/Hydrocodone (AH) Group24.0730.1622.1118.5316.6113.5813.00
Acetaminophen/Ibuprofen (AIBU) Group22.1722.2215.6713.1714.0313.4412.67

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Efficacy Comparison of Pain Relief

"Subjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours.~Daily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome.~The daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models" (NCT02029235)
Timeframe: 1 week postoperatively

,
Interventionscore on a scale (0-3, higher = better) (Mean)
Daily average pain relief on PostOp Day 1Daily average pain relief on PostOp Day 2Daily average pain relief on PostOp Day 3Daily average pain relief on PostOp Day 4Daily average pain relief on PostOp Day 5Daily average pain relief on PostOp Day 6Daily average pain relief on PostOp Day 7
Acetaminophen/Hydrocodone (AH) Group1.531.762.332.462.542.842.88
Acetaminophen/Ibuprofen (AIBU) Group1.842.272.632.912.882.872.96

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Duration in Days of Graft-versus-Host Disease in Transplanted Participants

Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant

InterventionDays (Mean)
Enrolled, Transplanted7

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Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

,
InterventionEvents (Number)
InfectionWound complicationsPost-transplant diabetesHemorrhagic cystitisMalignancy
Enrolled, Not Transplanted00000
Enrolled, Transplanted20000

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Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

,
InterventionEvents (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Enrolled, Not Transplanted00000
Enrolled, Transplanted00200

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Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology

This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

Interventionparticipants (Number)
Acute Cellular Rejection Banff Grade IAAcute Cellular Rejection Banff Grade IBAcute Cellular Rejection Banff Grade IIAAcute Cellular Rejection Banff Grade IIBAcute Cellular Rejection Banff Grade IIIAcute Antibody Mediated Rejection
Enrolled, Transplanted000000

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Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery

Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher. (NCT02029638)
Timeframe: Post-Transplant Neutrophil Nadir to Neutrophil Recover

InterventionDays (Mean)
Enrolled, Transplanted15

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Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy

AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation. (NCT02029638)
Timeframe: First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)

InterventionDays (Mean)
Enrolled, Transplanted9.5

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Number of Days From Transplant to Platelet Count Recovery

Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood. (NCT02029638)
Timeframe: Transplant to Platelet Count Recovery

InterventionDays (Mean)
Enrolled, Transplanted36

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Percent of Participants Who Achieved Operational Tolerance

Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval. (NCT02029638)
Timeframe: Transplantation through 52 Weeks after Discontinuation of All Immunosuppression

InterventionPercent of participants (Number)
Enrolled, Transplanted0

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Number of Transplanted Participants With Engraftment Syndrome

Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection

Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants With Acute Renal Allograft Rejection

Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed

Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal. (NCT02029638)
Timeframe: Transplant to 52 Weeks after Discontinuation of All Immunosuppression

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation

Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal

Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection. (NCT02029638)
Timeframe: Initiation of Immunosuppression Withdrawal to End of Study (to 25 months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Participants Free From Return to Immunosuppression for the Duration of the Study

Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 Months)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted0

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Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant

Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. (NCT02029638)
Timeframe: Transplant to Two Years Post-Transplant

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment

Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionDays (Mean)
Enrolled, Transplanted23

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Number of Transplanted Participants Who Died

Number of participant deaths after receiving a transplant per protocol. (NCT02029638)
Timeframe: Transplant to End of Study (Up to 25 months After Enrollment)

InterventionParticipants (Count of Participants)
Enrolled, Transplanted1

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Time to First Flatus/Bowel Movement

Length of time from the end of surgery to the time of first flatus or bowel movement. (NCT02043704)
Timeframe: 9000 minutes

Interventionminutes (Median)
IV Acetaminophen3977
Saline1899

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for headache. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen6
Saline3

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for insomnia. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen8
Saline2

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for itching. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen11
Saline5

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Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery

Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded. (NCT02043704)
Timeframe: 24 hours

Interventionmgs (Median)
IV Acetaminophen13
Saline15

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for nausea/vomiting. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen27
Saline22

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for rash/hives. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen0
Saline0

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for respiratory depression. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen0
Saline0

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for shortness of breath. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen4
Saline0

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Narcotic Associated Side Effects

The incidence of known narcotic associated side effects will be recorded for urinary retention. (NCT02043704)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
IV Acetaminophen29
Saline20

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Pain While Active - 18 hr

Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active. (NCT02043704)
Timeframe: 18 hours

Interventionmm (Median)
IV Acetaminophen42.0
Saline50.0

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Time to Ambulation

Length of time from the end of surgery to the time of ambulation. (NCT02043704)
Timeframe: 1800 minutes

Interventionminutes (Median)
IV Acetaminophen1295
Saline1252

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Time to First Rescue Narcotic

The time from the end of surgery to the time any IV narcotic is given. (NCT02043704)
Timeframe: 24 hours

Interventionminutes (Median)
IV Acetaminophen27
Saline41

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Length of Stay

Length of hospital stay (admission to discharge) will be collected. (NCT02046382)
Timeframe: 2-7 days

Interventionhours (Median)
IV Acetaminophen78
Normal Saline78

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Number of Participants With Narcotic Associated Side Effects

Only outcome for nausea/emesis is reported. (NCT02046382)
Timeframe: 2-7 days

InterventionParticipants (Count of Participants)
IV Acetaminophen17
Normal Saline9

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Total Amount of Ibuprofen During Inpatient Stay

Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected. (NCT02046382)
Timeframe: 2-7 days

Interventionmg (Mean)
IV Acetaminophen4786
Normal Saline5260

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Total Oxycodone (mg)

Total oxycodone (mg) for breakthrough pain during inpatient stay (NCT02046382)
Timeframe: approximately 2 - 7 days

Interventionmg (Mean)
IV Acetaminophen47.0
Normal Saline65.0

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Vital Signs

Routine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate. Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor. (NCT02061774)
Timeframe: 4-hour intervals (+/- 30 minutes) for 24-hrs averaged

Interventionparticipants with 100% vitals completed (Number)
Acetaminophen10
PlaceboComparator11

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VAS

The Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings. 0-10 Numeric pain intensity scale. 0 is no pain, 5 is moderate pain, and 10 is worst possible pain (NCT02061774)
Timeframe: Q4 x 24 hours averaged

Interventionscore on a scale (Median)
Acetaminophen6
PlaceboComparator8.5

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Total PCA Morphine

Amount of morphine used during surgery (NCT02061774)
Timeframe: Duration of operation

Interventionmg (Median)
Acetaminophen41.6
PlaceboComparator36.6

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Level of 100% Sedation

Sedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli. (NCT02061774)
Timeframe: 4-hr intervals for a 24-hr period averaged

Interventionparticipants of 100% sedation (Number)
Acetaminophen10
PlaceboComparator11

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Visual Analog Score (VAS) Pain Score

Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst (NCT02069184)
Timeframe: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours

,
Interventionscores on a scale (Mean)
0 hr pain after CS6 hours after CS pain12 hours after CS18 hours after CS24 hours after CS32 hours after CS40 hours after CS48 hours after CS
IV Acetaminophen2.23.41.23.14.03.12.03.2
Saline as Placebo1.43.62.32.95.12.91.22.6

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Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge

No patients were re hospitalized in the first 7 days (NCT02069184)
Timeframe: From time of discharge to 1 week after discharge

Interventionpercentage of patients (Number)
IV Acetaminophen0
Saline as Placebo0

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"Percentage of Patients With Adverse Events After the Surgery"

Subjects were specifically asked about adverse events such as nausea, vomiting, pruritus and breathing difficulties and information regarding their bowel movements. This information was collected on a scale of none, mild, moderate or severe. These are categorical outcomes. (NCT02069184)
Timeframe: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.

,
Interventionpercentage of patients (Number)
24 hour nausea24 hour vomiting24 hour itching24 hour breathing difficulty
IV Acetaminophen2221579
Saline as Placebo2727636

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Opioid Requirements in Cesarean Section (C-section) Patient Population

(NCT02069184)
Timeframe: 24 and 48 hours after Cesarean Section

,
Interventionmg (Mean)
24 hours cumulative48 hours cumulative
IV Acetaminophen4458
Saline as Placebo4857

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Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section

Sedation was assessed on a scale of 1-3 (1= wide awake, 2= sleepy but easily aroused, 3= sleepy and difficult to arouse). These assessments were made at the same time points as the pain assessments by the same research assistant. Score 1 is the only good outcome. (NCT02069184)
Timeframe: Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section

Interventionpercentage of patients (Number)
IV Acetaminophen95
Saline as Placebo95

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Pain Medication Usage ( NSAIDS)

Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events. (NCT02069184)
Timeframe: For the first 24 hours after the c-section until the patient is discharged or up to 48 hours

Interventionpercentage of patients (Number)
IV Acetaminophen27
Saline as Placebo30.3

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Compare the Time to Union of Fractures and Osteotomies in Skeletally Immature Patients Administered NSAIDs for Pain Control, Versus Those Administered Acetaminophen for Pain Control.

(NCT02076321)
Timeframe: The subject will be enrolled/assessed up to 6 months post-injury/osteotomy.

InterventionDays (Mean)
Acetaminophen41.2
NSAID (Ibuprofen)40.5

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Total Morphine Dosage

Total dose of morphine used will be recorded for each patient. (NCT02112448)
Timeframe: 24 hours

Interventionmg/kg (Mean)
Continuous Infusion0.9
As Needed Dosing0.23

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Length of Stay

Length of stay will be recorded for each subject. (NCT02112448)
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause or discharge, whichever came first, assessed up to 100 months

Interventiondays (Mean)
As Needed Dosing4.9
Continuous Infusion8.4

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Cumulative Narcotic Consumption Over the First 24 Hours

Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage. (NCT02155738)
Timeframe: First 24 hours

Interventionmg (Mean)
Vaginal Surgery - Placebo32.5
Vaginal Surgery - IV Acetaminophen31.6
Laparoscopic Surgery - Placebo47.4
Laparoscopic Surgery - IV Acetaminophen44.5

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Interference of Pain With Physical, Mental and Social Activities

"Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7.~This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score.~A higher PROMIS score indicates more 'hurt' or pain." (NCT02155738)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Vaginal Surgery - Placebo18.4
Vaginal Surgery - IV Acetaminophen22.0
Laparoscopic Surgery - Placebo22.9
Laparoscopic Surgery - IV Acetaminophen25.2

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Change From Baseline in Postoperative Pain

"VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.~For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score.~The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain." (NCT02155738)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Vaginal Surgery - Placebo20.5
Vaginal Surgery - IV Acetaminophen29.2
Laparoscopic Surgery - Placebo20.7
Laparoscopic Surgery - IV Acetaminophen20.1

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Incidence of Postoperative Nausea and Vomiting

Patients were asked about postoperative nausea and vomiting in the postanesthesia care unit, at 4-hour intervals while awake through the remaining initial day of surgery, and on the first and second postoperative mornings. (NCT02156154)
Timeframe: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

InterventionParticipants (Count of Participants)
Intravenous Acetaminophen140
Intravenous 0.9% Sodium Chloride124

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Incidence of Low Respiratory Function Event

A low respiratory function event was defined as an episode of less than 40% of predicted minute ventilation for 2 minutes. (NCT02156154)
Timeframe: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

InterventionParticipants (Count of Participants)
Intravenous Acetaminophen52
Intravenous 0.9% Sodium Chloride50

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Duration of Hypoxemia

Hypoxemia is measured as minutes with hypoxemia (Spo2 <90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively. (NCT02156154)
Timeframe: the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter.

Interventionmin/h (Median)
Intravenous Acetaminophen0.7
Intravenous 0.9% Sodium Chloride1.1

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Time-weighted Pain Score During Initial 48 Postoperative Hours

Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. Pain was recorded at roughly 15-minute intervals in the postanesthesia care unit and at 4-hour intervals on surgical wards (NCT02156154)
Timeframe: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

Interventionscore on a scale (Mean)
Intravenous Acetaminophen4.2
Intravenous 0.9% Sodium Chloride4.4

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Fatigue Score on Morning of Postoperative Day 1

Fatigue scores were calculated on a scale of 1 to 10, with 1 being no fatigue and 10 being the worst fatigue imaginable. (NCT02156154)
Timeframe: Postoperative day 1

Interventionscore on a scale (Mean)
Intravenous Acetaminophen5
Intravenous 0.9% Sodium Chloride4.9

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Total Anesthetic Dose From Induction to Extubation

Total anesthetic dose is measured in minimal alveolar concentration hours. (NCT02156154)
Timeframe: Induction to extubation (3 hours on average)

Interventionminimal alveolar concentration hours (Median)
Intravenous Acetaminophen2.9
Intravenous 0.9% Sodium Chloride2.9

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Time Weighted Pain Score in Post Anesthesia Care Unit

Pain scores were calculated on a visual analog scale of 0 to 10, with 0 being no pain and 10 being the most pain imaginable; time-weighted mean was calculated as the area under the curve of the pain score measurements divided by total measurement time. (NCT02156154)
Timeframe: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

Interventionscore on a scale (Mean)
Intravenous Acetaminophen4.3
Intravenous 0.9% Sodium Chloride4.4

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Time Spent in Sitting or Upright Position

Treatment effect data are reported as ratios of geometric means (NCT02156154)
Timeframe: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

Interventionhours (Median)
Intravenous Acetaminophen2.2
Intravenous 0.9% Sodium Chloride2.2

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Opioid Consumption - Intravenous Morphine Equivalents

Total opioid consumption over the initial 48 postoperative hours was extracted from patients' medical records and converted to intravenous morphine equivalents (NCT02156154)
Timeframe: Initial 48 postoperative hours

Interventionmg (Median)
Intravenous Acetaminophen50
Intravenous 0.9% Sodium Chloride58

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Lowest RASS Score During Initial 48 Postoperative Hours

Sedation was estimated by the RASS score and recorded at 2-hour intervals by ward nurses per clinical routine during the initial 48 postoperative hours. The Richmond Agitation-Sedation Scale (RASS) is scored from -5 to +4, with -5 being unarousable, 0 being alert and calm, and +4 being combative. (NCT02156154)
Timeframe: Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

Interventionscore on a scale (Mean)
Intravenous Acetaminophen-0.96
Intravenous 0.9% Sodium Chloride-0.89

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Pain Scores

"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated." (NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

InterventionUnits on a scale (Mean)
Paravertebral Block4.66
TAP Block2.66
Epidural1.75
No Block (PCA Alone)6

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Time to First Bowel Movement

(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Interventiondays (Mean)
Paravertebral Block1
TAP Block2
Epidural1
No Block (PCA Alone)2

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Quality of Recovery

Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged. (NCT02164929)
Timeframe: 72 hours

InterventionUnits on a scale (Mean)
Paravertebral Block89.5
TAP Block117
Epidural115.5
No Block (PCA Alone)99

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Length of Stay

(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

InterventionDays (Mean)
Paravertebral Block2.66
TAP Block4.33
Epidural4
No Block (PCA Alone)3.5

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Time to First Ingestion of Solid Food

(NCT02164929)
Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

InterventionDays (Mean)
Paravertebral Block1
TAP Block2
Epidural0.75
No Block (PCA Alone)1.5

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Postoperative Opioid Consumption

If opioid other than fentanyl is used, the dose will be converted to morphine equivalent. (NCT02164929)
Timeframe: 24 hours after surgery

Interventionmcg (Mean)
Paravertebral Block734
TAP Block666
Epidural125
No Block (PCA Alone)1017.5

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Mean Visual Analogue Scale (VAS) Pain Score at Rest

The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. (NCT02179892)
Timeframe: Post-Surgery 24 Hours, 48 Hours, 72 Hours

,
Interventionunits on a scale (Mean)
24 Hours Post Surgery48 Hours Post Surgery72 Hours Post Surgery
Group 1-Exparel4.21.81.8
Group 2-Bupivacaine and Dexamethasone IV3.53.33.5

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Mean Visual Analogue Scale (VAS) Pain Score With Movement

The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. (NCT02179892)
Timeframe: Post-Surgery 24 Hours, 48 Hours, 72 Hours

,
Interventionunits on a scale (Mean)
24 Hours Post Surgery48 Hours Post Surgery72 Hours Post Surgery
Group 1-Exparel6.86.63.6
Group 2-Bupivacaine and Dexamethasone IV5.86.34.8

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Mean Opioid Consumption

The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group. (NCT02179892)
Timeframe: Post Surgery (Up to 72 Hours)

Interventionmilligrams (Mean)
Group 1-Exparel507
Group 2-Bupivacaine and Dexamethasone IV392

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Mean Time of First Opioid Use

The time of first opioid use after surgery will be recorded for up to 72 hours. (NCT02179892)
Timeframe: Post-surgery (Up to 72 Hours)

Interventionhours (Mean)
Group 1-Exparel58
Group 2-Bupivacaine and Dexamethasone IV46

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Neuraxial Analgesic Drug Consumption Per Hour

subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery. (NCT02181387)
Timeframe: up to 24 hours

Interventionmilliliters (Mean)
Acetaminophen155.19
Placebo143.41

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Percent of Participants With Adverse Events (AEs) Attributable to the Donor Alloantigen Reactive Tregs (darTregs) Infusion

"AEs classified by the site investigator/clinician as possibly or definitely related to the study treatment, the Donor Alloantigen Reactive Tregs (darTregs) infusion. These AEs include:~infusion reaction~Grade 3 or higher cytokine release syndrome (Reference: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009) grading criteria~malignant cellular transformation." (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

InterventionPercent of Participants (Number)
Cohort 20

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Percent of Participants With Grade 3 or Higher Infectious Adverse Event(s)

"The severity of infectious adverse events (AEs) was classified into grades as follows:~Grade 1 = asymptomatic; clinical or diagnostic observation only; intervention with oral antibiotic, antifungal, or antiviral agent only; no invasive intervention required~Grade 2 = symptomatic; intervention with intravenous antibiotic, antifungal, or antiviral agent; invasive intervention may be required~Grade 3 = any infection associated with hemodynamic compromise requiring pressors; any infection necessitating intensive care unit level of care; any infection necessitating operative intervention; any infection involving the central nervous system; any infection with a positive fungal blood culture; any proven or probable aspergillus infection; any tissue invasive fungal infection; any pneumocystis jiroveci infection~Grade 4 = life-threatening infection~Grade 5 = death resulting from infection" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

InterventionPercent of Participants (Number)
Cohort 10
Cohort 211.1

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Percent of Participants With Grade 2 or Higher Hematologic Adverse Events (AEs) of Anemia, Neutropenia, and/or Thrombocytopenia

"The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):~Grade 1 = mild AE~Grade 2 = moderate AE~Grade 3 = severe and undesirable AE~Grade 4 = life-threatening or disabling AE~Grade 5 = death" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

,
InterventionPercent of Participants (Number)
AnemiaNeutropeniaThrombocytopenia
Cohort 166.716.716.7
Cohort 222.200

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Percent of Participants With Biopsy-Proven Acute and/or Chronic Rejection

"Biopsy-proven acute rejection graded as Mild, Moderate or Severe, per 1997 Banff classification. Chronic Rejection graded using Banff 2000 classification.~References: 1.) Banff Schema for Grading Liver Allograft Rejection: An International Consensus Document developed by an international panel of experts in liver transplantation pathology, hepatology, and surgery (Hepatology 1997; 25(3): 658-663). 2.) Update of the International Banff Schema for Liver Allograft Rejection: Working Recommendations for the Histopathologic Staging and Reporting of Chronic Rejection (Hepatology 2000; 31(3): 792-799)." (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

,
InterventionPercent of Participants (Number)
Mild Acute RejectionModerate Acute RejectionSevere Acute RejectionChronic Rejection
Cohort 10000
Cohort 211.1000

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Percent of Participants With Grade 3 or Higher Wound Complication(s) Adverse Event(s)

"The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 (4/28/2009):~Grade 3 wound complications are defined as Hernia without evidence of strangulation; fascial disruption/dehiscence; primary wound closure or revision by operative intervention indicated~Grade 4 complications are defined as Hernia with evidence of strangulation; major reconstruction flap, grafting, resection, or amputation indicated" (NCT02188719)
Timeframe: Transplantation to 40 Weeks Post Transplantation

InterventionPercent of Participants (Number)
Cohort 10
Cohort 20

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"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire"

"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4" (NCT02205983)
Timeframe: End of study (time 0 and approximately 4 weeks later), week 4 reported.

,,,
Interventionunits on a scale (Mean)
Feel DrugLike DrugFeel HighWant More
1000 mg Acetaminophen289.61157.38
2 mg Hydromophone7.4125.96.088.0
4 mg Hydromphone14.7535.5810.3326.83
Dextrose5.764.152.612.65

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Pain Relief (PAR) Scores at 3 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 3 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.59
Acetaminophen 1000 mg5.39
JNJ-10450232 250 mg2.90
JNJ-10450232 1000 mg5.40

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Pain Relief (PAR) Scores at 24 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 24 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.44
Acetaminophen 1000 mg2.20
JNJ-10450232 250 mg2.33
JNJ-10450232 1000 mg4.96

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Pain Relief (PAR) Scores at 2 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 2 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.17
Acetaminophen 1000 mg5.88
JNJ-10450232 250 mg2.53
JNJ-10450232 1000 mg4.90

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Pain Relief (PAR) Scores at 16 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 16 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.09
Acetaminophen 1000 mg2.23
JNJ-10450232 250 mg2.07
JNJ-10450232 1000 mg4.96

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Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 8 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.15
Acetaminophen 1000 mg1.99
JNJ-10450232 250 mg1.51
JNJ-10450232 1000 mg4.00

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Pain Relief (PAR) Scores at 15 Minutes Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 15 minutes post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.27
Acetaminophen 1000 mg0.52
JNJ-10450232 250 mg0.33
JNJ-10450232 1000 mg0.38

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Pain Relief (PAR) Scores at 8 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 8 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.41
Acetaminophen 1000 mg3.10
JNJ-10450232 250 mg2.63
JNJ-10450232 1000 mg5.62

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Pain Relief (PAR) Scores at 12 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 12 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.34
Acetaminophen 1000 mg2.57
JNJ-10450232 250 mg2.53
JNJ-10450232 1000 mg5.16

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Pain Relief (PAR) Scores at 10 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 10 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.28
Acetaminophen 1000 mg2.67
JNJ-10450232 250 mg2.81
JNJ-10450232 1000 mg5.40

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Pain Relief (PAR) Scores at 1.5 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 1.5 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.01
Acetaminophen 1000 mg5.88
JNJ-10450232 250 mg2.13
JNJ-10450232 1000 mg3.97

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Pain Relief (PAR) Scores at 1 Hour Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 1 hour post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.84
Acetaminophen 1000 mg5.18
JNJ-10450232 250 mg1.68
JNJ-10450232 1000 mg3.09

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Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 9 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.19
Acetaminophen 1000 mg1.69
JNJ-10450232 250 mg1.73
JNJ-10450232 1000 mg3.91

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Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 7 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.13
Acetaminophen 1000 mg2.38
JNJ-10450232 250 mg1.66
JNJ-10450232 1000 mg3.94

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Pain Relief (PAR) Scores at 7 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 7 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.41
Acetaminophen 1000 mg3.62
JNJ-10450232 250 mg2.80
JNJ-10450232 1000 mg5.57

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Pain Relief (PAR) Scores at 6 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 6 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.32
Acetaminophen 1000 mg4.42
JNJ-10450232 250 mg2.92
JNJ-10450232 1000 mg5.68

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Pain Relief (PAR) Scores at 5 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 5 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.17
Acetaminophen 1000 mg5.00
JNJ-10450232 250 mg3.05
JNJ-10450232 1000 mg5.77

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Pain Relief (PAR) Scores at 45 Minutes Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 45 minutes post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.64
Acetaminophen 1000 mg4.42
JNJ-10450232 250 mg1.52
JNJ-10450232 1000 mg2.11

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Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 6 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.12
Acetaminophen 1000 mg3.04
JNJ-10450232 250 mg1.69
JNJ-10450232 1000 mg4.07

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Pain Relief (PAR) Scores at 4 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 4 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.92
Acetaminophen 1000 mg5.31
JNJ-10450232 250 mg2.99
JNJ-10450232 1000 mg5.83

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Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 5 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.01
Acetaminophen 1000 mg3.56
JNJ-10450232 250 mg1.82
JNJ-10450232 1000 mg4.14

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Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 45 minutes post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.28
Acetaminophen 1000 mg3.22
JNJ-10450232 250 mg0.91
JNJ-10450232 1000 mg1.51

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Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 4 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.91
Acetaminophen 1000 mg3.78
JNJ-10450232 250 mg1.79
JNJ-10450232 1000 mg4.17

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Pain Relief (PAR) Scores at 30 Minutes Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 30 minutes post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.60
Acetaminophen 1000 mg2.38
JNJ-10450232 250 mg0.90
JNJ-10450232 1000 mg1.03

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Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 30 minutes post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.25
Acetaminophen 1000 mg1.59
JNJ-10450232 250 mg0.46
JNJ-10450232 1000 mg0.71

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Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 3 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.71
Acetaminophen 1000 mg3.84
JNJ-10450232 250 mg1.69
JNJ-10450232 1000 mg3.86

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Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 24 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.15
Acetaminophen 1000 mg1.41
JNJ-10450232 250 mg1.29
JNJ-10450232 1000 mg3.47

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Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 2 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.41
Acetaminophen 1000 mg4.20
JNJ-10450232 250 mg1.43
JNJ-10450232 1000 mg3.48

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Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 16 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.93
Acetaminophen 1000 mg1.37
JNJ-10450232 250 mg1.08
JNJ-10450232 1000 mg3.43

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Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 15 minutes post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.13
Acetaminophen 1000 mg0.25
JNJ-10450232 250 mg0.06
JNJ-10450232 1000 mg0.21

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Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 12 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.08
Acetaminophen 1000 mg1.57
JNJ-10450232 250 mg1.39
JNJ-10450232 1000 mg3.61

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Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 11 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.03
Acetaminophen 1000 mg1.58
JNJ-10450232 250 mg1.57
JNJ-10450232 1000 mg3.70

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Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 1.5 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.37
Acetaminophen 1000 mg4.35
JNJ-10450232 250 mg1.23
JNJ-10450232 1000 mg2.85

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Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)

Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). (NCT02209181)
Timeframe: 6 Hours

Interventionunits on a scale (Least Squares Mean)
Placebo4.37
Acetaminophen 1000 mg20.75
JNJ-10450232 250 mg8.95
JNJ-10450232 1000 mg20.56

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Duration of Pain Relief After Dosing (Time to Rescue Medication)

Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given. (NCT02209181)
Timeframe: Completed at time of the first rescue medication (hours post dose), estimated up through Day 2

Interventionminutes (Median)
Placebo109.0
Acetaminophen 1000 mg468.5
JNJ-10450232 250 mg129.0
JNJ-10450232 1000 mgNA

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Pain Relief (PAR) Scores at 11 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 11 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.26
Acetaminophen 1000 mg2.63
JNJ-10450232 250 mg2.75
JNJ-10450232 1000 mg5.25

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Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 1 hour post dose

Interventionunits on a scale (Least Squares Mean)
Placebo0.25
Acetaminophen 1000 mg3.98
JNJ-10450232 250 mg1.03
JNJ-10450232 1000 mg2.19

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Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose

Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity. (NCT02209181)
Timeframe: Baseline to 10 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo1.08
Acetaminophen 1000 mg1.60
JNJ-10450232 250 mg1.57
JNJ-10450232 1000 mg3.87

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Subject Global Evaluation

How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent). (NCT02209181)
Timeframe: Completed at hour 12 or at time of the first rescue medication (hours post dose).

,,,
Interventionpercentage of participants (Number)
Poor (0)Fair (1)Good (2)Very Good (3)Excellent (4)
Acetaminophen 1000 mg12.19.130.342.46.1
JNJ-10450232 1000 mg28.86.122.730.312.1
JNJ-10450232 250 mg55.14.321.715.92.9
Placebo62.714.911.910.40.0

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Pain Relief (PAR) Scores at 9 Hours Post Dose

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief). (NCT02209181)
Timeframe: 9 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo2.46
Acetaminophen 1000 mg2.73
JNJ-10450232 250 mg2.98
JNJ-10450232 1000 mg5.50

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Anti-Emetic Consumption

Mean dose of anti-emetic medication in milligrams given over 24 hours (NCT02227316)
Timeframe: 24 hours

InterventionMilligrams (Mean)
Intravenous Ibuprofen16.00
Intravenous Acetaminophen19.50
IV Ibuprofen/IV Acetaminophen22.25
Intravenous Placebo/Intravenous Placebo19.50

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Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen

Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category. (NCT02227316)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Intravenous Ibuprofen6.48
Intravenous Acetaminophen7.27
IV Ibuprofen/IV Acetaminophen6.16
Intravenous Placebo/Intravenous Placebo5.30

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Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen

Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category. (NCT02227316)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Intravenous Ibuprofen4.52
Intravenous Acetaminophen4.22
IV Ibuprofen/IV Acetaminophen3.90
Intravenous Placebo/Intravenous Placebo3.34

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Maximum Nausea Intensity

Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category. (NCT02227316)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Intravenous Ibuprofen5.62
Intravenous Acetaminophen5.25
IV Ibuprofen/IV Acetaminophen6.41
Intravenous Placebo/Intravenous Placebo3.71

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Opioid Consumption

Mean opioid consumption in morphine equivalents over 24 hours (NCT02227316)
Timeframe: 24 hours

InterventionMorphine equivalent (Mean)
Intravenous Ibuprofen75.75
Intravenous Acetaminophen69.63
IV Ibuprofen/IV Acetaminophen48.44
Intravenous Placebo/Intravenous Placebo62.28

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Mean Nausea Intensity

Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category. (NCT02227316)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Intravenous Ibuprofen1.52
Intravenous Acetaminophen3.20
IV Ibuprofen/IV Acetaminophen3.59
Intravenous Placebo/Intravenous Placebo2.38

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Patient/Family Satisfaction With Pain Management

Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery. (NCT02236130)
Timeframe: one week after the surgery

InterventionParticipants (Count of Participants)
General10
Regional11

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Total Hydrocodone Dose (mg/kg)

(NCT02236130)
Timeframe: day 2 and day 8 after the surgery

,
Interventionmg/kg (Mean)
Day 2 Total hydrocodone use in mg/kgDay 8 Total hydrocodone use in mg/kg
General1.221.45
Regional1.362.15

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the Change From Baseline in 20 Meters Walking Time

Post treatment comparison of 20 meters walking time between the groups When the time increases, clinical of the patient worses (NCT02237989)
Timeframe: 3 months

Interventionseconds (Mean)
Paracetamol18.84
Native Collagen Type 2 + Paracetamol18

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the Change From Baseline in Coll2-1 Levels

Post treatment comparison of Coll2-1 levels between groups (NCT02237989)
Timeframe: 3 months

Interventionmicrogram/ml (Median)
Paracetamol130
Native Collagen Type 2 + Paracetamol155.25

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the Change From Baseline in Pain During Walking Visual Analog Scale (VAS Walking)

Post treatment comparison of VAS walking between the groups minimum score is 0, maximum score is 10. The clinic of the patient worses when the score increases. (NCT02237989)
Timeframe: 3 months

Interventionscore on a scale (Median)
Paracetamol3
Native Collagen Type 2 + Paracetamol3

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the Change From Baseline in Short Form 36 / Bodily Pain Subgroup

Post treatment comparison of short form 36-bodily pain between groups minimum score 0 maximum score 100 When the score increases, clinic of patient gets better (NCT02237989)
Timeframe: 3 months

Interventionscore (Median)
Paracetamol51
Native Collagen Type 2 + Paracetamol52

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the Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score

Post treatment comparison of WOMAC between the groups minimum score is 0, maximum score is 100. The clinic of the patient worses when the score increases. (NCT02237989)
Timeframe: 3 months

Interventionunits on a scale (Median)
Paracetamol52
Native Collagen Type 2 + Paracetamol44

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Hospital Length of Stay (LOS)

Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours. (NCT02244619)
Timeframe: Pre-op admission to hospital discharge

InterventionHours (Median)
Oral Acetaminophen58.0
IV Acetaminophen58.5

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Time to First Rescue Opioid (PRN Order)

(NCT02244619)
Timeframe: During post-op period up to 24 hrs after surgery

InterventionMinutes (Median)
Oral Acetaminophen38.0
IV Acetaminophen41.0

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Time to First Ambulation - 10 Feet

(NCT02244619)
Timeframe: During post-op period up to 24 hours after surgery

InterventionHours (Median)
Oral Acetaminophen18.5
IV Acetaminophen18.8

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Post-operative Nausea and Vomiting

(NCT02244619)
Timeframe: During post-op period up to 24 hrs after surgery

,
InterventionParticipants (Count of Participants)
NauseaVomiting
IV Acetaminophen5317
Oral Acetaminophen5119

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Total Post-operative Use of Opioids

Post-operative use of opioids, measured in morphine milligram equivalent (MME) units (NCT02244619)
Timeframe: During post-op period up to 24 hrs after surgery

InterventionMorphine milligram equivalents (MME) (Median)
Oral Acetaminophen21.7
IV Acetaminophen21.7

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Post-Anesthesia Care Unit (PACU) Length of Stay, Hours

PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours. (NCT02244619)
Timeframe: PACU admission time until PACU discharge time

InterventionHours (Median)
Oral Acetaminophen2.2
IV Acetaminophen2.1

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Patient-rated Pain in the Post-operative Period

Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient. (NCT02244619)
Timeframe: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery

InterventionVisual analog pain scale (0-10) (Median)
Oral Acetaminophen3.6
IV Acetaminophen3.4

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Count of Participants: Frequency of Non-renal Flares by Week 24

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 24

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)2110
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Count of Participants: Frequency of Non-renal Flares by Week 48

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 48

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flares2 Non-renal flare
Rituximab/Cyclophosphamide (RC)2020
Rituximab/Cyclophosphamide/Belimumab (RCB)2001

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Count of Participants: Frequency of Non-renal Flares by Week 96

"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
0 Non-renal flares1 Non-renal flare2 Non-renal flares
Rituximab/Cyclophosphamide (RC)1840
Rituximab/Cyclophosphamide/Belimumab (RCB)1911

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Frequency of Specific Adverse Events of Interest By Event by Week 96

"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionEvents (Number)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)013003
Rituximab/Cyclophosphamide/Belimumab (RCB)016000

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Frequency of Specific Adverse Events of Interest By Participant, By Week 96

"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0." (NCT02260934)
Timeframe: Week 96

,
InterventionParticipants (Count of Participants)
Any event leading to death≥Grade 2 leukopenia or thrombocytopeniaPremature ovarian failureMalignancyVenous thromboembolic event
Rituximab/Cyclophosphamide (RC)06002
Rituximab/Cyclophosphamide/Belimumab (RCB)06000

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Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)57.155.061.1
Rituximab/Cyclophosphamide/Belimumab (RCB)30.030.027.8

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Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96

"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)19.015.016.7
Rituximab/Cyclophosphamide/Belimumab (RCB)5.015.011.1

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Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)23.835.033.3
Rituximab/Cyclophosphamide/Belimumab (RCB)30.042.142.9

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Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96

"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)14.320.00.0
Rituximab/Cyclophosphamide/Belimumab (RCB)15.830.027.8

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Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96

"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)46.760.053.3
Rituximab/Cyclophosphamide/Belimumab (RCB)55.073.771.4

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Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96

"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs." (NCT02260934)
Timeframe: Week 0 to Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)9.122.727.3
Rituximab/Cyclophosphamide/Belimumab (RCB)4.89.59.5

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Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96

"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL." (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
InterventionPercentage of Participants (Number)
Week 24Week 48Week 96
Rituximab/Cyclophosphamide (RC)31.335.740.0
Rituximab/Cyclophosphamide/Belimumab (RCB)6.311.830.8

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Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96

The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)000
Rituximab/Cyclophosphamide/Belimumab (RCB)000

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Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96

The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity. (NCT02260934)
Timeframe: Week 24, Week 48 and Week 96

,
Interventionpercentage of participants (Number)
Week 0 to Week 24Week 0 to Week 48Week 0 to Week 96
Rituximab/Cyclophosphamide (RC)18.245.563.6
Rituximab/Cyclophosphamide/Belimumab (RCB)14.328.647.6

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Percentage of Participants With a Sustained Complete Response

"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions." (NCT02260934)
Timeframe: Week 48, Week 96

Interventionpercentage of participants (Number)
Rituximab/Cyclophosphamide (RC)26.7
Rituximab/Cyclophosphamide/Belimumab (RCB)28.6

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Number of Participants Who Received Rescue Medications

(NCT02267772)
Timeframe: 24 hours after administration

InterventionParticipants (Count of Participants)
IV Acetaminophen30
IV Morphine19

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Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)

The visual analogue scale (VAS) ranges from 0mm to 140mm. The subject will be asked to mark with a pen on the scale to rate their pain. Negative differences in scores indicated a pain score worse than baseline and positive differences indicated an improved pain score from baseline. (NCT02267772)
Timeframe: baseline, 120 minutes after administration

,
Interventionscore on a scale (Mean)
pre-labor groupfirst stage of labor group
IV Acetaminophen2.67-18.2
IV Morphine3.2-4.8

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Number of Participants With Fetal Heart Rate Changes

Changes in fetal heart rate tracing include acceleration, decelerations, and variability. (NCT02267772)
Timeframe: 1 hour after administration

,
InterventionParticipants (Count of Participants)
absence of accelerationslate decelerationsminimal or absent variability
IV Acetaminophen414
IV Morphine1213

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Number of Participants With Maternal Side Effects

Maternal side effects include nausea, vomiting, headache, pruritus, insomnia, and drowsiness. (NCT02267772)
Timeframe: 1 hour after administration

,
InterventionParticipants (Count of Participants)
nauseavomitingheadachepruritusinsomniadrowsiness
IV Acetaminophen2052517
IV Morphine2364715

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Total Amount of Study Drug Administered

(NCT02267772)
Timeframe: 24 hours after administration

,
Interventionmilligrams (Mean)
pre-labor group1st stage of labor group
IV Acetaminophen16001055
IV Morphine6.42.3

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Number of Headache Days

study participants completed a one week diary at home stating if they had headaches. (NCT02268058)
Timeframe: one week

Interventionnumber of headache days (Mean)
tx 1: Acetaminophen and Education4
Tx 2: Ibuprofen and Education3
Tx 3: Ibuprofen/Acetaminophen/Education3
Tx 4: no Routine Meds and Education4

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Headache Intensity Per Day for One Week

The Numerical Rating Scale (NRS) will be used to capture the intensity of the headache experience. The NRS was initially developed for acute post procedural pain and is now a common measure for headache and disease related pain with well established reliability and validity as a self report measure in this age group. Children meeting the inclusion criteria also meet the criteria for self report. The numerical rating scale includes indicators from 0 to 10 with 0 being the 'no pain' and 10 being 'the worst pain ever'. The child when diarizing the headaches will report a pain intensity score for each headache type in their one week headache diary. Study participants and their parent will be given instruction regarding reporting the headache instruction. The headache intensity scores were averaged for the day per participant. (NCT02268058)
Timeframe: one week

,,,
Interventionunits on a scale (Median)
day one n=19, n=20, n= 20, n=20day two n=19, n=20, n=20, n=20day 3 n=19, n= 20, n=20, n=20day 4 n=19, n=18, n=4, n=20day five n=18, n=3, n=0, n=20day 6 n=12, n=0, n=0, n=20,day 7 n=4, n=0, n=0, n=18
tx 1: Acetaminophen and Education8655443.5
Tx 2: Ibuprofen and Education86433NANA
Tx 3: Ibuprofen/Acetaminophen/Education7532.5NANANA
Tx 4: no Routine Meds and Education8866555

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Percentage of Study Participants That Returned to School at One Week Post Concussion

patients/family were asked if the child returned to school one week after their injury (NCT02268058)
Timeframe: one week

Interventionpercentage of participants (Number)
tx 1: Acetaminophen and Education33
Tx 2: Ibuprofen and Education61
Tx 3: Ibuprofen/Acetaminophen/Education79
Tx 4: no Routine Meds and Education21

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Number of Headaches a Day

the patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period. (NCT02268058)
Timeframe: one week

,,,
Interventionheadaches per day (Median)
day one n=19, n=20, n= 20, n=20day two n=19, n=20, n=20, n=20day 3 n=19, n= 20, n=20, n=20day 4 n=19, n=18, n=4, n=20day four n=18, n=3, n=0, n=20day 6 n=12, n=0, n=0, n=20,day 7 n=4, n=0, n=0, n=18
tx 1: Acetaminophen and Education4433321
Tx 2: Ibuprofen and Education33321NANA
Tx 3: Ibuprofen/Acetaminophen/Education3221NANANA
Tx 4: no Routine Meds and Education4444433

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Blood Pressure

systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressures (MAP) will be monitored for 4 hours post intervention (NCT02280239)
Timeframe: 4 hours post intervention

,
InterventionmmHg (Mean)
SBP: Pre-Intervention (2 hours)SBP: Post-Intervention (4 hours)DBP: Pre-Intervention (2 hours)DBP: Post-Intervention (4 hours)MAP: Pre-Intervention (2 hours)MAP: Post-Intervention (4 hours)
Acetaminophen Group122.6119.566.265.484.182.4
Control Group141.6141.557.451.080.875.5

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Clinically Significant Hypotension

Clinically significant hypotension is defined as an acute drop in mean arterial pressure requiring treatment. Treatment is defined as either a 500 cc (or greater) fluid bolus and/or an increase in inotrope support of greater than 5 mcg/min over baseline. (NCT02280239)
Timeframe: 4 hours post acetaminophen administration

InterventionParticipants (Count of Participants)
Control Group0
Acetaminophen Group0

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Fever Burden

"Continuous measurements of core body temperature will be recorded for 6 hours. Fever burden (FB) is defined as area between the 6 hour temperature curve and 38.3°C cut-off and it is reported in °C-hour.~PRE-INTERVENTION FB: is reported for a 2 hour period. POST-INTERVENTION FB: post-intervention fever burden is reported for a 6 hour period and average hourly fever burden.~Peak Temperature: is the highest recorded temperature for the study period in °C Minimum Temperature: is the lowest recorded temperature for the study period in °C" (NCT02280239)
Timeframe: 6 hours post intervention

,
Intervention°C*hours (Mean)
Pre-Intervention FB (2 hours)Post-Intervention FB (6 hours)
Acetaminophen Group2.165.65
Control Group0.970.74

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Equivalent-volume Fluid Administered Post Intervention

Total crystalloid and colloid fluid will be converted the the equi-volume dose (with the ratio 1.4:1 (as per Finfer et al.(2004) & Vincent and Weil (2006) before making comparisons between the treatment and control groups. (NCT02280239)
Timeframe: 4 hours post intervention

,
InterventionmL (Mean)
Pre-Intervention (2 hours) Total fluid INTAKEPre-Intervention (2 hours) Total fluid OUTPUTPost-Intervention (4 hours) Total Fluid INTAKEPost-Intervention (4 hours) Total Fluid OUTPUT
Acetaminophen Group298370612852
Control Group23580734245

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Equivalent-dose of Vasoactive Medication Post Intervention

"Total dose of all vasoactive medications will be converted to total Equidose value (with the formula 10 mcg/min norepinephrine ≈ 5 mcg/kg/min dopamine ≈ 10 mcg/min epinephrine ≈ 1 mcg/min phenylephrine ≈ 0.02 u/min vasopressin as per Russell et al. (2008)) before comparing the treatment and control groups~Only 2 of the 6 participants were on low-dose vasoactive medications, (i.e., one was on norepinephrine and the other was on milrinone) therefore the pre-planned conversion calculation was not done." (NCT02280239)
Timeframe: 4 hours post intervention

,
Interventionmcg (Number)
Pre-Intervention (2 hours) TOTAL NorepinephrinePre-Intervention (2 hours) TOTAL MilrinonePost-Intervention (4 hours) TOTAL NorepinephrinePost-Intervention (4 hours) TOTAL Milrinone
Acetaminophen GroupNA6000.0NA7000.0
Control Group167.0NA576.0NA

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Faces Pain Score

Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980. (NCT02296840)
Timeframe: 2 weeks after surgery

Interventionunits on a scale (Mean)
Ibuprofen158.95
Hydrocodone-acetaminophen219.94

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Number of Participants With Post-operative Bleeding

The occurrence of post-operative bleeding at the surgical site for each participant will be assessed by review of the participant's study records and clinical records and by questioning the caregiver in follow-up. If postoperative bleeding has occurred, details of the episode of bleeding will also be obtained (requirement for surgical intervention, observation at home, or observation at the hospital). (NCT02296840)
Timeframe: 2 weeks after surgery

InterventionParticipants (Count of Participants)
Ibuprofen2
Hydrocodone-acetaminophen0

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Tmax - Time of Occurrence of Cmax

Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration. (NCT02305017)
Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Interventionhours (Mean)
Opicapone Alone2.0
Opicapone Plus Paracetamol2.0

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AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.

AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration. (NCT02305017)
Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Interventionng.h/mL (Mean)
Opicapone Alone2451
Opicapone Plus Paracetamol2850

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AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification

AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration (NCT02305017)
Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Interventionng.h/mL (Mean)
Opicapone Alone2416
Opicapone Plus Paracetamol2818

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Cmax - Maximum Plasma Concentration

Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration (NCT02305017)
Timeframe: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose

Interventionng/mL (Mean)
Opicapone Alone895
Opicapone Plus Paracetamol986

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Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12

Participants assessed their daily pain and stiffness each morning (upon awakening) during the 12-week treatment period using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain / no stiffness) to 10 (extreme pain / extreme stiffness). Composite daily pain/stiffness score was calculated as sum of scores of pain and stiffness each morning divided by 2, ranging from 0 (no pain/stiffness) to 10 (extreme pain/stiffness). The mean of pain, mean of stiffness, and mean pain /stiffness composite score was calculated. Change from baseline was calculated as the difference between Daily Pain, stiffness and composite score each morning with that at baseline and was presented per week. A negative change from Baseline indicated improvement. (NCT02311881)
Timeframe: Baseline, Week 12

,,
Interventionscore on a scale (Mean)
Pain at Baseline (n= 224, 225, 227)Pain at Week 12(n= 176, 175, 177)Pain, Change at Week 12 (n= 176, 175, 177)Stiffness at Baseline (n= 224, 225, 227)Stiffness at Week 12(n= 176, 175, 177)Stiffness, Change at Week 12(n= 176, 175, 177Composite at Baseline (n= 224, 225, 227)Composite at Week 12(n= 176, 175, 177)Composite, Change at Week 12(n= 176, 175, 177
Paracetamol 1330 mg Thrice Daily (TID)6.273.80-2.496.133.63-2.446.203.71-2.46
Paracetamol 2000 mg Twice Daily (BID)6.393.80-2.546.203.56-2.566.303.68-2.55
Placebo6.633.82-2.916.383.72-2.766.513.77-2.83

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Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI)

Chronic Pain Sleep Inventory (CPSI) was assessed, based on the three questions: CPSI-1-'Trouble falling asleep': How often the participant had trouble falling asleep? , CPSI-3-'Awakening due to pain at night': How often the subject was awakened by pain during the night, CPSI-4- Awakening due to pain in the morning': How often the participant was awakened by pain in the morning? The participants responded to these questions via 0-100mm VAS, ranging from 0 (never) to 100 (always). Sleep problem index (SPI) was calculated as mean of these three CPSI questions, ranging from 0 (never affected by pain during sleep) to 100 (always affected by pain during sleep). (NCT02311881)
Timeframe: Baseline, Week 4, Week 8, Week 12

,,
Interventionmm (Mean)
At Baseline, CPSI-1At Baseline, CPSI-3At Baseline, CPSI-4At Baseline, Sleep Problems IndexAt Week 4, CPSI-1At Week 4, Change in CPSI-1At Week 4, CPSI-3At Week 4, Change in CPSI-3At Week 4, CPSI-4At Week 4, Change in CPSI-4At Week 4, Sleep Problems IndexAt Week 4, Change in Sleep Problems IndexAt Week 8, CPSI-1At Week 8, Change in CPSI-1At Week 8, CPSI-3At Week 8, Change at CPSI-3At Week 8, CPSI-4At Week 8, Change at CPSI-4At Week 8, Sleep Problems IndexAt Week 8, Change in Sleep Problems IndexAt Week 12, CPSI-1At Week 12, Change in CPSI-1At Week 12, CPSI-3At Week 12, Change in CPSI-3At Week 12, CPSI-4At Week 12, Change in CPSI-4At Week 12, Sleep Problems IndexAt Week 12, Change in Sleep Problems Index
Paracetamol 1330 mg Thrice Daily (TID)57.7757.1956.9457.2629.23-27.6128.94-27.5128.85-27.5228.96-27.5929.22-27.4529.45-26.9129.12-26.7829.20-27.1126.90-30.1726.63-29.9926.85-29.7326.72-30.03
Paracetamol 2000 mg Twice Daily (BID)60.4059.2158.4959.3632.32-27.8732.54-26.6331.70-26.5532.16-27.0430.53-29.9830.25-29.1630.33-28.1930.33-29.1526.73-33.1226.95-32.2327.26-30.9026.96-32.11
Placebo61.3060.5061.3061.0434.01-27.4432.75-27.6933.80-27.4733.52-27.5330.84-31.3429.71-30.8331.02-30.1130.50-30.7827.64-34.4327.42-33.0127.79-32.9727.61-33.48

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Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment

The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 100=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 100=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 100=extreme stiffness). WOMAC Total Index was calculated at baseline and each time point as sum of scores of all 24 WOMAC questions divided by 2400, ranging from 0 (no pain/difficulty/stiffness) to 1 (extreme pain/ difficulty/stiffness). Change from baseline was calculated as WOMAC Total Index at specific time point minus WOMAC Total Index at baseline. A negative change from Baseline indicated improvement. (NCT02311881)
Timeframe: Baseline up to week 12

Interventionmm (Mean)
Paracetamol 2000 mg Twice Daily (BID)-0.28
Paracetamol 1330 mg Thrice Daily (TID)-0.26
Placebo-0.27

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Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment

The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Pain was measured using visual analogue scale (VAS) ranging from 0mm (no pain) to 100mm (extreme pain) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 5 WOMAC Pain items: 1-walking on flat, 2-going up down stairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. Mean WOMAC Pain subscale score was calculated at each visit as the sum of 5 pain category scores divided by 5. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline). (NCT02311881)
Timeframe: Baseline up to week 12

Interventionmillimeter(mm) (Least Squares Mean)
Paracetamol 2000 mg Twice Daily (BID)-28.25
Paracetamol 1330 mg Thrice Daily (TID)-25.89
Placebo-25.74

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Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment

The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC stiffness was measured using VAS ranging from 0mm (no stiffness) to 100mm (maximum stiffness) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 2 WOMAC stiffness categories: 1- after awakening in the morning; 2- later in the day. Mean WOMAC stiffness was calculated for baseline and each time point (sum of scores for 2 stiffness categories divided by 2). Change from baseline was calculated for each visit as mean WOMAC stiffness subscale score at specific time point minus mean WOMAC stiffness subscale score at baseline. A negative change from Baseline indicated improvement. The time-weighted mean change from baseline was calculated as area under the curve of change from baseline divided by nominal time of the last on-therapy visit (week 12) from randomization (baseline). (NCT02311881)
Timeframe: Baseline up to week 12

Interventionmm (Mean)
Paracetamol 2000 mg Twice Daily (BID)-27.68
Paracetamol 1330 mg Thrice Daily (TID)-25.61
Placebo-26.16

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Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment

The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Physical function was measured using VAS ranging from 0mm (no difficulty) to 100mm (extreme difficulty) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 17 WOMAC Physical function categories. Mean WOMAC Physical function was calculated for baseline and each time point (sum of scores for 17 physical function categories divided by 17). Change from baseline was calculated for each visit as mean WOMAC physical function subscale score minus mean baseline WOMAC physical function subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline). (NCT02311881)
Timeframe: Baseline up to Week 12

Interventionmm (Mean)
Paracetamol 2000 mg Twice Daily (BID)-28.24
Paracetamol 1330 mg Thrice Daily (TID)-26.23
Placebo-26.68

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Number of Participants Classified as Responder

"A participant was considered a responder if his/her improvement from baseline (change from baseline at week 12) satisfied at least one of the two criteria high' or 'moderate' improvement as follows:- High improvement: 50% improvement from baseline in the last available WOMAC pain score or 60% improvement from baseline in the last available WOMAC physical function score. Moderate improvement: Fulfills two out of three criteria: 30% improvement from baseline in the last available WOMAC Pain score, 20% improvement from baseline in the last available WOMAC Physical Function score, 25% improvement from baseline in the last available GPAOA." (NCT02311881)
Timeframe: Baseline, Week 12

Interventionparticipants (Number)
Paracetamol 2000 mg Twice Daily (BID)157
Paracetamol 1330 mg Thrice Daily (TID)148
Placebo159

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Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks

Participants recorded use of rescue medication daily in their patient diary. The mean number of doses of rescue medications taken per day during the 12-week treatment period was calculated. (NCT02311881)
Timeframe: every day up to 12 weeks

Interventionnumber of rescue medication pills/day (Mean)
Paracetamol 2000 mg Twice Daily (BID)0.356
Paracetamol 1330 mg Thrice Daily (TID)0.200
Placebo0.337

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Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA)

"Participants performed an instantaneous GPAOA via a 0-100mm VAS, ranging from 0 (best ever) to 100 (worst ever) with respect to With respect to your arthritis condition, how would you describe yourself now? GPAOA was calculated periodically during the 12 week treatment period." (NCT02311881)
Timeframe: Baseline, Week 4, Week 8, Week 12

,,
Interventionmm (Mean)
At BaselineAt Week 4Change from baseline at Week 4At Week 8Change from baseline at Week 8At Week 12Change from baseline at Week 12
Paracetamol 1330 mg Thrice Daily (TID)69.2041.46-27.7837.62-31.1536.04-33.04
Paracetamol 2000 mg Twice Daily (BID)68.2339.34-29.0236.08-32.5132.41-36.15
Placebo69.7942.93-26.8339.09-31.0035.44-34.31

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Patient Global Assessment of Response to Therapy (PGART)

The PGART is a global assessment of the participant's response to therapy, was measured using on a 5 point Likert scale as follows: 0=None (no good at all, ineffective), 1= Poor (some effect, but unsatisfactory), 2= Fair (reasonable effect, but could be better), 3= Good (satisfactory effect with occasional episodes of pain and/or stiffness), 4= Excellent (ideal response, virtually pain-free). Mean PGART scores from 5 point Likert scale was calculated periodically (at Week 4, Week 8, Week 12) for the 12 week treatment period. (NCT02311881)
Timeframe: Week 4, Week 8, Week 12

,,
Interventionscore on a scale (Mean)
At Week 4 (n=197, 188, 202)At Week 8(n=196, 184, 192)At Week 12(n=189, 182, 181)
Paracetamol 1330 mg Thrice Daily (TID)2.432.402.46
Paracetamol 2000 mg Twice Daily (BID)2.502.582.62
Placebo2.252.442.43

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Postoperative Pain (Pain Scores From 0-10 Scale)

This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores. (NCT02313675)
Timeframe: 7 days

Interventionunits on a scale (Mean)
IV Tylenol2.0
IV Toradol2.9
IV Tylenol/Toradol Combination2.7
Saline2.0

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Opioid Consumption (Number of Pills Taken)

"Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively~Outcome measure reported below is mean number of opioid pills consumed per day." (NCT02313675)
Timeframe: 7 days

Interventionpills consumed (Mean)
IV Tylenol0.2
IV Toradol0.7
IV Tylenol/Toradol Combination1.0
Saline0.7

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Mixed Apnoea Index (MAI)

Number of obstructive and central apnoeas per hours of nights sleep, Events/hour (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Interventionevents/hour (Mean)
APAP A (AirSense)0.115
APAP B (Apex)0.220

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Mean Oxygen Desaturation Index (ODI)

Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.

Interventionevents/hour (Mean)
APAP A (AirSense)7.94
APAP B (Apex)10.63

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Mean O2 Saturation

Mean blood oxygen Saturation, % (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Intervention% total hemoglobin (Mean)
APAP A (AirSense)94.210
APAP B (Apex)93.680

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Mean Apnoea-Hypopnoea-Index (AHI)

AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour). (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)

Interventionevents/hour (Mean)
APAP A (AirSense Auto Set)6.21
APAP B (Apex iCH Auto)7.45

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Hypopnoea-Index HI

Number of Hypopnoeas per hour of nights sleep, Events/hour (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Interventionevents/hour (Mean)
APAP A (AirSense)3.17
APAP B (Apex)5.49

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Central Apnoea Index (CAI)

Number of central apnoeas during hours of sleep, events/hour (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Interventionevents/hour (Mean)
APAP A (AirSense)2.36
APAP B2.51

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Flow Limitation (%)

Percent of flow-limited breaths in relation to the overall breaths at night. (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Intervention% overall breaths (Mean)
APAP A (AirSense)49.25
APAP B (Apex)43.16

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Obstructive Apnoea Index (OAI)

Number of obstructive apnoeas per hour of nights sleep, Events/hour (NCT02357706)
Timeframe: 1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B

Interventionevents/hour (Mean)
APAP A (AirSense)0.580
APAP B (Apex)0.885

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PACU Time

Time spent in the post-anesthesia care unit post-operatively. (NCT02359305)
Timeframe: 45-60 minutes post-operatively

Interventionminutes (Mean)
IV Acetaminophen48
Rectal Acetaminophen50.4

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Average FLACC Pain Score in the PACU

The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. (NCT02359305)
Timeframe: 0-60 minutes post-operatively

Interventionunits on a scale 0-10 (Mean)
IV Acetaminophen0.3
Rectal Acetaminophen0.6

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Acetaminophen Dosage

One time in the OR prior to the start of surgery (NCT02359305)
Timeframe: Baseline

Interventionmg/kg (Mean)
IV Acetaminophen8.6
Rectal Acetaminophen30.7

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Opioid Use

A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital (NCT02369211)
Timeframe: 0-24 hours

Interventionmorphine milligram equivalents (Median)
Intravenous Acetaminophen42
Placebo50

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Hospital Length of Stay

This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home. (NCT02369211)
Timeframe: 1-3 days

InterventionDays (Median)
Intravenous Acetaminophen0.81
Placebo0.82

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Post Anesthesia Care Unit Length of Stay

The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward. (NCT02369211)
Timeframe: approximately 30-240 min

Interventionminutes (Mean)
Intravenous Acetaminophen124
Placebo132

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Pain Score

"Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain).~Mean pain score over first 24 hours postoperatively was collected." (NCT02369211)
Timeframe: 0-24 hours after surgery

Interventionscore on a scale (Mean)
Intravenous Acetaminophen0.62
Placebo0.88

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Acute Pain

Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale. (NCT02389361)
Timeframe: In recovery room

Interventionunits on a scale (Median)
Group Z1.5
Group PT1.74

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Narcotic Medication Use

The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery. The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group. Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables. (NCT02400580)
Timeframe: 24 hours

InterventionMorphine Equivalents (Mean)
Intravenous IV Acetaminophen16.4
Normal Saline18.4

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Nausea Before Surgery as Compared to After Surgery

A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine. Less nausea is considered preferable to more nausea. The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group. (NCT02400580)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Intravenous IV Acetaminophen0.69
Normal Saline0.85

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Number of Participants Who Vomited Within 24 Hours of Operation

A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one. Vomiting is reported as either having vomited or not vomited. The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group. (NCT02400580)
Timeframe: 24 hours

InterventionParticipants (Count of Participants)
Intravenous IV Acetaminophen1
Normal Saline2

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Readiness for Discharge

Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated. The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group. (NCT02400580)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Intravenous IV Acetaminophen7.76
Normal Saline8.15

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Postoperative Pain

The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain. (NCT02400580)
Timeframe: 24 hours

Interventionunits on a visual analog scale (Mean)
Intravenous IV Acetaminophen3.55
Normal Saline3.11

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Having a Feeling of General Well-being at One Month

Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire. The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group. (NCT02400580)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Intravenous IV Acetaminophen4.11
Normal Saline4.31

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Duration of Post-operative Nausea

Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify) (NCT02401529)
Timeframe: 7 days

,
Interventionparticipants (Number)
no nauseaone daytwo daysthree days
IV Dexamethasone and Oral Prednisolone333140
Placebo218156

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Average Frequency of Meals Per Day

average frequency of meals (1 meal, 2 meals, if more specify) (NCT02401529)
Timeframe: average number of meals consumed per day for the 1st three days post-surgery

,
Interventionparticipants (Number)
1 meal2 meals3 meals
IV Dexamethasone and Oral Prednisolone22028
Placebo13415

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Average Amount of Meal Per Day

adequacy of meals (inadequate, adequate) (NCT02401529)
Timeframe: 3 days

,
Interventionparticipants (Number)
inadequateadequate
IV Dexamethasone and Oral Prednisolone1634
Placebo2723

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Occurence of Postoperative Vomiting

Postoperative vomiting occurrence (yes, no) (NCT02401529)
Timeframe: 7 days

,
Interventionparticipants (Number)
yesno
IV Dexamethasone and Oral Prednisolone2525
Placebo3614

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Onset of 1st Post-operative Oral Intake

feeding onset (1st day i. surgery day, 2nd day, 3rd day) (NCT02401529)
Timeframe: Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery

,
Interventionparticipants (Number)
surgery day1st day after surgery
IV Dexamethasone and Oral Prednisolone464
Placebo3713

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Onset of Post-operative Nausea

Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day) (NCT02401529)
Timeframe: onset of 1st ocurence of nausea attack within the 1st week post-surgery

,
Interventionparticipants (Number)
no nauseaimmediately1st dayimmediately and 1st day
IV Dexamethasone and Oral Prednisolone331043
Placebo2181110

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Total Number of Post-operative Vomiting Episodes

Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify) (NCT02401529)
Timeframe: total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery

,
Interventionparticipants (Number)
no vomitingoncetwicethree timesmore than 3 times
IV Dexamethasone and Oral Prednisolone2513741
Placebo1491980

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Occurence of Post-operative Nausea

Postoperative nausea occurence (yes, no) (NCT02401529)
Timeframe: 7 days

,
Interventionparticipants (Number)
yesno
IV Dexamethasone and Oral Prednisolone1733
Placebo2921

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Maximum Severity of Post-operative Pain

5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting) (NCT02401529)
Timeframe: The severest pain grade felt within a week

,
Interventionparticipants (Number)
Low disability and low intensityhigh disability and moderate intensityhigh disability and high intensity
IV Dexamethasone and Oral Prednisolone37130
Placebo26213

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Duration of Post-operative Pain

4 selections (1 day, 2 days, 3 days, if more specify) (NCT02401529)
Timeframe: number of days at which pain was experienced within the the 1st sevn days post -surgery

,
Interventionparticipants (Number)
one daytwo daysthree days
IV Dexamethasone and Oral Prednisolone36113
Placebo23198

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Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure

Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure) (NCT02418182)
Timeframe: 60 minutes post-procedure

Interventionscore on a scale (Median)
Control2
Experimental2

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Median of Cumulative Pain Scores Up to 24 Hours Post Procedure

Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure (NCT02418182)
Timeframe: 24-hours post-procedure

Interventionscore on a scale (Median)
Control1
Experimental2

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Number of Participants With Use of Analgesics in the First 24 Hours After Discharge

Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure (NCT02418182)
Timeframe: 60-minutes post-procedure to 24-hours after procedure

InterventionParticipants (Count of Participants)
Control25
Experimental27

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Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure

Number of participants requiring use of analgesic medications in the post-operative recovery suite (NCT02418182)
Timeframe: 60-minutes post-procedure

InterventionParticipants (Count of Participants)
Control11
Experimental18

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Oral Morphine Equivalent (Narcotic Usage)

This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison. (NCT02432456)
Timeframe: 24-48 hours post infusion

,
Interventionoral morphine equivalents (Median)
AdultElderly
Ketamine Infusion69.025
Placebo Infusion6744

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Oral Morphine Equivalent (Narcotic Usage) in Severely Injured

This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison. (NCT02432456)
Timeframe: Total Index Hospitalization up to 365 days

,
Interventionoral morphine equivalents (Median)
AdultElderly
Ketamine Infusion153.067.5
Placebo Infusion170.586.8

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Respiratory Failure

Respiratory failure within this trial was defined by the need for unanticipated intubation and/or transfer to ICU for respiratory support. (NCT02432456)
Timeframe: Total Index Hospitalization up to 365 days

,
InterventionParticipants (Count of Participants)
AdultElderly
Ketamine Infusion20
Placebo Infusion30

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Visual Analog Numeric Pain Score

Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable. (NCT02432456)
Timeframe: 12-24 hours post infusion

,
Interventionscore on a scale (Mean)
AdultElderly
Ketamine Infusion5.75.1
Placebo Infusion6.15.2

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Visual Analog Numeric Pain Score

Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable. (NCT02432456)
Timeframe: 24-48 hours post infusion

,
Interventionscore on a scale (Mean)
AdultElderly
Ketamine Infusion5.65.1
Placebo Infusion5.84.4

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Regional Anesthesia Utilization

This is a measure of the Epidural Placement rates. Epidural placement was binary as in patient received or did not receive an epidural infusion catheter for supplemental pain management. (NCT02432456)
Timeframe: Total Index Hospitalization up to 365 days

,
Interventionparticipants (Number)
AdultElderly
Ketamine Infusion74
Placebo Infusion36

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Length of Stay

Total hospital length of stay in days up to 365 days. (NCT02432456)
Timeframe: Total Index Hospitalization up to 365 days

,
Interventiondays (Median)
AdultElderly
Ketamine Infusion55
Placebo Infusion4.06

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Hallucination

Hallucinations were documented and confirmed by the treating medical team. (NCT02432456)
Timeframe: Total Index Hospitalization up to 365 days

,
InterventionParticipants (Count of Participants)
AdultElderly
Ketamine Infusion02
Placebo Infusion12

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Oral Morphine Equivalent (Narcotic Usage)

This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison. (NCT02432456)
Timeframe: 12-24 hours post infusion

,
Interventionoral morphine equivalents (Median)
AdultElderly
Ketamine Infusion4521.3
Placebo Infusion45.030

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Length of Hospital Stay

Monitoring the length of hospital stay after undergoing surgery (NCT02452320)
Timeframe: Participants will be followed for the duration of hospital stay, expected average of 3 days.

Interventiondays (Median)
Placebo1.96
Acetaminophen IV1.87

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Hospital Costs

Accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital. (NCT02452320)
Timeframe: Costs incurred during hospital stay, expected average of 3 days.

InterventionDollars (USD) (Median)
Placebo12,977
Acetaminophen IV12,885

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Quality of Recovery-15 Patient Survey

Survey asking 15 questions with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Possible scores range from 0-150, and scores with a higher value indicate a better outcome. Each subject was administered a baselineQoR-15 survey prior to surgery, and then one on postoperative days (POD) 1 and 2. If a subject was discharged prior to POD2, they were not given a QoR-15 survey that day. (NCT02452320)
Timeframe: Patients will be followed for the duration of hospital stay, expected average of 3 days.

,
Interventionunits on a scale (Mean)
POD 1POD 2
Acetaminophen IV108.6117.1
Placebo107.2118.3

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Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores

Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) (NCT02455518)
Timeframe: 1 hour

Interventionunits on a scale (Number)
Oxycodone/Acetaminophen3.1
Hydrocodone/Acetaminophen2.4
Codeine/Acetaminophen2.7
Ibuprofen/Acetaminophen2.9

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Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores

Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) (NCT02455518)
Timeframe: 2 hours

Interventionunits on a scale (Number)
Oxycodone/Acetaminophen4.4
Hydrocodone/Acetaminophen3.5
Codeine/Acetaminophen3.9
Ibuprofen/Acetaminophen4.3

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Number of Participants Achieving Efficacy Status Post Receipt of a Single Intravenous (IV) Dose of Donor Alloantigen Reactive Regulatory T Cells (darTregs)

Efficacy was assessed by determining the number (and percentage) of participants who have received darTreg infusion and are identified as operationally tolerant, defined by maintaining stable allograft function (assessed by liver tests) and histology (determined by central pathologist reading in comparison to screening liver biopsy at study entry) in the absence of immunosuppression for one year. (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 52 weeks after darTreg infusion

InterventionParticipants (Count of Participants)
Initiated Immunosuppression Withdrawal, Received darTregs0

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Number of Participants Who Experience at Least One Episode of Biopsy Proven Acute Rejection, Clinical Acute Rejection, or Chronic Rejection

"A participant was considered to have met this endpoint if they experienced at least one episode of biopsy proven acute rejection, clinical acute rejection, or chronic rejection based on local pathology.~Biopsy proven acute rejection was assessed as Grade I or higher based on the Banff (1997) global criteria featuring the following grades:~Indeterminate~Grade I Mild Acute Rejection~Grade II Moderate Acute Rejection~Grade III Severe Acute Rejection.~Clinical AR was determined based on the participant receiving treatment for rejection with or without biopsy confirmation of rejection.~Chronic rejection was determined by the presence of abnormal total and direct bilirubin in the conjunction with liver pathology fulfilling the Banff (2000) criteria as outlined:~Early Stage Chronic Rejection~Late Stage Chronic Rejection." (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 52 weeks after darTreg infusion

InterventionParticipants (Count of Participants)
Initiated Immunosuppression Withdrawal5

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Number of Participants Who Experienced Grade 3 or Higher Adverse Events (AEs) Deemed Attributable to darTreg Infusion

The National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade the severity of all AEs. A participant was considered to have met this endpoint if they experienced at least one CTCAE Grade 3 or higher AE deemed attributable (i.e., considered at least possibly related) to darTreg infusion (infusion reaction, cytokine release syndrome). (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion

InterventionParticipants (Count of Participants)
Initiated Immunosuppression Withdrawal, Received darTregs0

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Count of Participants by Severity of Biopsy Proven Acute Rejection and/or Chronic Rejection

"Participants are counted in each grade of rejection they experienced; however, a participant is only counted once within a specific grade. Biopsy proven acute rejection and Chronic rejection were graded based on local pathology according to the Banff (1997 for Acute Rejection; 2000 for Chronic Rejection) global assessment criteria as outlined below.~Biopsy proven acute rejection was assessed as Grade I or higher using the following grades:~Indeterminate~Grade I Mild Acute Rejection~Grade II Moderate Acute Rejection~Grade III Severe Acute Rejection.~Chronic rejection was determined by the presence of abnormal total and direct bilirubin in the conjunction with liver pathology fulfilling the Banff criteria as outlined:~Early Stage Chronic Rejection~Late Stage Chronic Rejection." (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 52 weeks after darTregs infusion

InterventionParticipants (Count of Participants)
Mild Acute RejectionModerate Acute RejectionSevere Acute RejectionEarly Stage Chronic RejectionLate Stage Chronic Rejection
Initiated Immunosuppression Withdrawal20000

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Proportion of Liver Transplant Recipients Who Are Able to Reduce Calcineurin Inhibitor Dosing by 75 Percent and Discontinue a Second Immunosuppression Drug (if Applicable) With Stable Liver Function Tests (LFTs) for ≥ 12 Weeks

The ability to reduce baseline, standard of care calcineurin inhibitor dosing following transplantation was measured by determining the number of subjects who were able to tolerate a 75 percent reduction in their calcineurin inhibitors along with discontinuation of either prednisone or mycophenolate mofetil following initiation of immunosuppression withdrawal. (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion

InterventionProportion of Participants (Number)
Initiated Immunosuppression Withdrawal0.20

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Number of Participants With Study Defined Grade 3 or Higher Infections

"The following grading system was applied to AEs of infection:~Grade 1: asymptomatic; clinical or diagnostic observation only; intervention with oral antibiotic, antifungal, or antiviral agent only; no invasive intervention required~Grade 2: symptomatic; intervention with intravenous antibiotic, antifungal, or antiviral agent; invasive intervention may be required~Grade 3: any infection associated with hemodynamic compromise requiring pressors; any infection necessitating intensive care unit level of care; any infection necessitating operative intervention; any infection involving the central nervous system; any infection with a positive fungal blood culture; any proven or probable aspergillus infection; any tissue invasive fungal infection; any pneumocystis jiroveci infection~Grade 4: life-threatening infection~Grade 5: death resulting from infection~A participant was considered to have met this endpoint if they experienced at least one Grade 3 or higher infection." (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion

InterventionParticipants (Count of Participants)
Initiated Immunosuppression Withdrawal0

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Number of Participants With Any Malignancy

Number of participants with any malignancy, including Post -Transplant Lymphoproliferative Disorder (PTLD). PTLD is a specific type of malignancy that can occur following transplantation of a solid organ and is characterized by a proliferation of B cells, which may result in lymphoma. (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion

InterventionParticipants (Count of Participants)
Initiated Immunosuppression Withdrawal0

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Number of Liver Transplant Recipients Who Experience the Composite Outcome

This measure includes refractory acute rejection, chronic rejection, re-transplantation, and death. Rejection was diagnosed based on local pathology. Participants are considered to have met this endpoint if they experience any one of these events at least once. (NCT02474199)
Timeframe: From initiation of immunosuppression withdrawal to 52 weeks after darTreg infusion

InterventionParticipants (Count of Participants)
Initiated Immunosuppression Withdrawal0

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Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)

Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome. (NCT02480114)
Timeframe: Up to 3 months post-treatment

InterventionParticipants (Count of Participants)
Arm I Standard of Care0
Arm II Standard of Care Plus Gabapentin0

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Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)

Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom. (NCT02480114)
Timeframe: Up to 3 months post-treatment

Interventionscore on a scale (Median)
Arm I Standard of Care1.91
Arm II Standard of Care Plus Gabapentin1.23

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Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))

The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain. (NCT02480114)
Timeframe: Up to 3 months post-treatment

Interventionscore on a scale (Median)
Arm I Standard of Care4.26
Arm II Standard of Care Plus Gabapentin3.68

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SPID Scores Over the Intervals During the First 36 Hours Following the First Dose of Study Drug

The SPID was calculated as the time-weighted sum of PID at each time point over the intervals during the first 36 hours. The SPID was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. LS mean was calculated using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data. (NCT02487108)
Timeframe: 0 to 6, 0 to 12, 0 to 24, and 0 to 36 hours

,,,
Interventionunits on a scale (Least Squares Mean)
SPID 0-6SPID 0-12SPID 0-24SPID 0-36
Placebo3.76.421.144.2
TV-46763 10.0 mg/325 mg9.119.150.988.2
TV-46763 5.0 mg/325 mg8.315.843.978.2
TV-46763 7.5 mg/325 mg8.316.544.581.1

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Total Rescue Medication Use (Number of Tablets Used)

Total rescue medication (oral nonprescription ibuprofen) use (number of tablets used) over 6, 12, 24, and 48 hours after the first dose of study drug was calculated. (NCT02487108)
Timeframe: 6, 12, 24, and 48 hours

,,,
Interventiontablets (Least Squares Mean)
Total rescue medication use over 6 hoursTotal rescue medication use over 12 hoursTotal rescue medication use over 24 hoursTotal rescue medication use over 48 hours
Placebo1.22.03.04.4
TV-46763 10.0 mg/325 mg0.61.11.62.1
TV-46763 5.0 mg/325 mg0.81.42.12.9
TV-46763 7.5 mg/325 mg0.71.41.92.6

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Number of Participants With Adverse Events (AEs)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. (NCT02487108)
Timeframe: Day 1 up to Day 13

InterventionParticipants (Count of Participants)
Placebo56
TV-46763 5.0 mg/325 mg79
TV-46763 7.5 mg/325 mg87
TV-46763 10.0 mg/325 mg106

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Summed Pain Intensity Difference (SPID) Score Calculated Over the First 48 Hours (SPID48) After the First Dose of Study Drug on an 11-Point Numerical Pain Rating Scale (NPRS-11)

The SPID48 was calculated as the time-weighted sum of pain intensity difference (PID) at each time point over 48 hours. The SPID48 was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. Least square (LS) mean was calculated using an analysis of covariance (ANCOVA) with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data. (NCT02487108)
Timeframe: 48 hours

Interventionunits on a scale (Least Squares Mean)
Placebo76.5
TV-46763 5.0 mg/325 mg115.4
TV-46763 7.5 mg/325 mg120.5
TV-46763 10.0 mg/325 mg129.9

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Time to Onset of Meaningful Pain Relief (MPR)

Time to meaningful pain relief (MPR) after the first dose of study drug was calculated using the stopwatch technique. The MPR stopwatch was started immediately after administration of the first dose of study drug (time zero [T0]). The stopwatch was given to the participant with the instructions to stop the stopwatch when he or she first experienced meaningful pain relief (time to meaningful relief). Kaplan-Meier method was used to calculate the data. (NCT02487108)
Timeframe: Day 1

Interventionhour (Median)
PlaceboNA
TV-46763 5.0 mg/325 mg1.9
TV-46763 7.5 mg/325 mg1.3
TV-46763 10.0 mg/325 mg1.8

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Time to Onset of Perceptible Pain Relief (PPR)

Time to perceptible pain relief (PPR) (i.e., onset of pain relief) after the first dose of study drug was calculated using the stopwatch technique. The PPR stopwatch was started immediately after administration of the first dose of study drug (time zero [T0]) and it was given to the participant with the instructions to stop the stopwatch when he or she first perceived pain relief (time to perceptible relief). Kaplan-Meier method was used to calculate the data. (NCT02487108)
Timeframe: Day 1

Interventionhour (Median)
Placebo0.8
TV-46763 5.0 mg/325 mg0.5
TV-46763 7.5 mg/325 mg0.5
TV-46763 10.0 mg/325 mg0.6

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Time to Peak PID

Time to peak PID after the first dose of study drug but before the second dose of study drug was calculated. Kaplan-Meier method was used to calculate the data. Multiple imputation method was used to handle missing pain intensity scores at scheduled time points. (NCT02487108)
Timeframe: Within 6 hours

Interventionhours (Median)
Placebo3.0
TV-46763 5.0 mg/325 mg2.0
TV-46763 7.5 mg/325 mg1.53
TV-46763 10.0 mg/325 mg2.0

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Number of Participants Taking Rescue Medication

Number of participants taking rescue medication (oral nonprescription ibuprofen) over 6, 12, 24, and 48 hours after the first dose of study drug were calculated. (NCT02487108)
Timeframe: 6, 12, 24, and 48 hours

,,,
InterventionParticipants (Count of Participants)
Rescue medication use over 6 hoursRescue medication use over 12 hoursRescue medication use over 24 hoursRescue medication use over 48 hours
Placebo101124132132
TV-46763 10.0 mg/325 mg62849399
TV-46763 5.0 mg/325 mg7696101106
TV-46763 7.5 mg/325 mg7498107110

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Number of Participants With a 30% Reduction in Pain Intensity Measured Using NPRS-11 Scores

Number of participants with a 30% reduction in NPRS-11 scores was reported at 6, 12, 24, and 48 hours after the first dose of study drug. (NCT02487108)
Timeframe: 2, 4, 6, 12, 24, and 48 hours

,,,
InterventionParticipants (Count of Participants)
2 hours4 hours6 hours12 hours24 hours48 hours
Placebo413932386786
TV-46763 10.0 mg/325 mg8360667691100
TV-46763 5.0 mg/325 mg714456558396
TV-46763 7.5 mg/325 mg764151548092

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Number of Participants With a 50% Reduction in Pain Intensity Measured Using NPRS-11 Scores

Number of participants with a 50% reduction in NPRS-11 scores was reported at 6, 12, 24, and 48 hours after the first dose of study drug. (NCT02487108)
Timeframe: 2, 4, 6, 12, 24, and 48 hours

,,,
InterventionParticipants (Count of Participants)
2 hours4 hours6 hours12 hours24 hours48 hours
Placebo272018224673
TV-46763 10.0 mg/325 mg634045527590
TV-46763 5.0 mg/325 mg522940336675
TV-46763 7.5 mg/325 mg632839316379

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Pain Intensity Difference (PID) Scores

The PID was based on the NPRS-11, which is an 11-point Likert-type scale in which 0 means no pain and 10 means the most intense pain imaginable. PID was calculated at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours after the first dose of study drug. LS mean was calculated using ANCOVA with treatment and center as factors and the baseline pain intensity score as a covariate. Multiple imputation method was used to handle missing data. (NCT02487108)
Timeframe: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, and 6 hours

,,,
Interventionunits on a scale (Least Squares Mean)
0.25 hour0.5 hour0.75 hour1 hour1.5 hours2 hours3 hours4 hours5 hours6 hours
Placebo0.10.50.60.70.80.81.00.70.60.4
TV-46763 10.0 mg/325 mg0.00.51.11.52.02.11.71.31.61.7
TV-46763 5.0 mg/325 mg0.20.50.91.41.61.91.81.31.41.3
TV-46763 7.5 mg/325 mg0.10.81.41.82.22.21.71.01.21.3

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Time Discharge

Time patient meets discharge criteria will be recorded (NCT02487303)
Timeframe: 24 hours postoperative

Interventionhours (Mean)
Acetaminophen Intravenous48.4
Acetaminophen Oral48.6
No Acetaminophen50.5

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Time to First Opiate Rescue

Time to first opiate pain medicine requested by patient (NCT02487303)
Timeframe: 48 hours

Interventionhours (Mean)
Acetaminophen Intravenous25.3
Acetaminophen Oral24.0
No Acetaminophen21.3

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VAS (Visual Analog Scale)

"Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]) ." (NCT02487303)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Acetaminophen Intravenous37.8
Acetaminophen Oral44.3
No Acetaminophen50.8

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Cumulative Postoperative Opiate Consumption

Cumulative opiate consumption (IV morphine equivalents) (NCT02487303)
Timeframe: 24 hours

Interventionmg (Mean)
Acetaminophen Intravenous2.9
Acetaminophen Oral3.8
No Acetaminophen5.7

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The Percent of Participants Whose Day 2 Serum CRR Was Less Than 30%.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 2 serum CRR was less than 30%. (NCT02495077)
Timeframe: Day 2 post-transplantation

Interventionpercentage of participants (Number)
Experimental57.1
Control68.6

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Percent of Participants That Required at Least One Dialysis Treatment.

Dialysis within the first week post-transplant is used in the setting of delayed graft function (DGF). Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. (NCT02495077)
Timeframe: 1 week post-transplantation

Interventionpercentage of participants (Number)
Experimental31.0
Control35.7

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Percent of Participants With Only Graft Failure.

Participants who experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental2.7
Control2.7

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR.

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental3.8
Control1.4

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR)

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection.Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 month post-transplantation

Interventionpercentage of participants (Number)
Experimental4.2
Control3.0

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection. Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental12.8
Control7

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR) or Borderline Rejection.

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of borderline or greater than or equal to IA with or without clinical symptoms within 6 months of transplant were determined to have met the endpoint. Severity is graded as Borderline, IA, IB, IIA, IIB, or III, with borderline representing possible cellular rejection, IA being the mildest form of cellular rejection, and III being the most severe form of cellular rejection.Criteria include: Borderline-no intimal arteritis is present but foci of mild tubulitis; IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental8.5
Control6.1

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Percent of Participants With Biopsy Proven Acute Cellular Rejection (BPAR).

Acute cellular rejection was defined based on central lab pathology interpretation using the Banff 2007 criteria. Participants with a Banff grade of greater than or equal to IA with or without clinical symptoms within 24 months of transplant were determined to have met the endpoint. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Criteria include: IA-significant interstitial infiltration and foci of moderate tubulitis; IB-significant interstitial infiltration and foci of severe tubulitis; IIA-mild to moderate intimal arteritis; IIB-severe intimal arteritis; III-transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental5.1
Control4.2

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Percent of Participants With BK Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site.

Participants were considered to have met this endpoint if they had a reported case of BK viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of participants (Number)
Experimental28.9
Control13.4

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Percent of Participants With CMV Viremia That Require a Change in Immunosuppression or Anti-viral Treatment as Per Standard of Care at the Site

Participants were considered to have met this endpoint if they had a reported case of CMV viremia that required a change in their existing immunosuppression or the use of anti-viral therapy. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental18.4
Control11.6

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Percent of Participants With de Novo DSA.

Donor specific antibody (DSA) can be formed post-transplant as part of the recipient's alloimmune response to the transplanted organ. DSA was determined by a central laboratory. Participants with newly developed DSA (i.e., de novo) following transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental8.0
Control3.6

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR).

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 24 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participant (Number)
Experimental1.3
Control0.0

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection AMR or Suspicious for AMR

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR or suspicious for AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, C4d staining positive, or suspicious. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes; suspicious-when 2 of 3 factors for acute/active are present. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental2.8
Control0.0

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Percent of Participants With Malignancy.

Participants were considered to have met this endpoint if they had a reported case of malignancy. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of Participants (Number)
Experimental1.8
Control0.9

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Percent of Participants With Mycobacterial or Fungal Infections

Participants were considered to have met this endpoint if they had at least one mycobacterial of fungal infection. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental6.1
Control6.3

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Percent of Participants With Primary Non-Function (PNF), Defined as Dialysis-dependency for More Than 3 Months.

Post-transplant dialysis is sometimes required in the setting of kidney transplant. If such dialysis continues for more than 3 months, the participant is considered to have PNF and, as such, meets this endpoint definition. (NCT02495077)
Timeframe: Transplantation through at least month 3 up to month 24

InterventionPercent of Participants (Number)
Experimental2.8
Control0.9

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Percent of Participants With Death or Graft Failure.

Participants who died or experienced graft failure were considered to have met this endpoint. Graft failure was defined as the need for post-transplant dialysis for more than 56 days. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental5.3
Control7.1

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The Difference Between the Mean eGFR (Modified MDRD) in the Experimental vs. Control Groups.

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the month 24 eGFR for each treatment group. (NCT02495077)
Timeframe: 24-Month post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental52.45
Control57.35

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The Percent of Participants Who Need Dialysis After Week 1.

Participants who needed dialysis after the first week post-transplant were considered to have met this endpoint. (NCT02495077)
Timeframe: 1 week to 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental9.0
Control2.8

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Percent of Participants With Biopsy Proven Acute Antibody Mediated Rejection (AMR)

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive.Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation

InterventionParticipants (Count of Participants)
Experimental0.0
Control0.0

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Percent of Participants With BANFF Chronicity Scores > or Equal 2 on the 24 Month Biopsy.

The Banff 2013 classification involves scoring numerous characteristics of renal biopsy specimens. The ci (interstitial fibrosis) and ct (tubular atrophy) scores are two such characteristics. The scores can take values of 0, 1, 2, or 3 for each characteristic (ci and ct), indicating increasing severity of disease as the scores increase. Participants are considered to have met this endpoint if their ci + ct score on the 24 month biopsy summed to be > or equal to 2. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental73.1
Control36.4

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Percent of Participants With Any Infection Requiring Hospitalization or Resulting in Death.

Participants were considered to have met this endpoint if they had an infection that required hospitalization or resulted in death. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental43.0
Control39.3

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The Percent of Participants Whose Day 5 Serum CRR Was Less Than 70%.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. A participant was considered to have met this endpoint if their day 5 serum CRR was less than 70%. (NCT02495077)
Timeframe: Day 5 post-transplantation

Interventionpercentage of participants (Number)
Experimental74.4
Control88.4

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Number of Dialysis Sessions.

The number of dialysis sessions a person had during their first 8 weeks post-transplant was used for this endpoint. (NCT02495077)
Timeframe: 8 weeks post-transplantation

InterventionDialysis sessions (Mean)
Experimental0.14
Control0.26

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eGFR Values as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental38.93
Control39.96

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eGFR Values as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Day 7 post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental41.01
Control41.85

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Duration of Delayed Graft Function (DGF), Defined as Time From Transplantation to the Last Required Dialysis Treatment.

Participants are considered to have had DGF if they had at least one dialysis treatment in the first week post-transplant. For this endpoint, duration was calculated as the date of last post-transplant dialysis treatment minus the date of the first post-transplant dialysis treatment. (NCT02495077)
Timeframe: First post-transplant dialysis treatment to last post-transplant dialysis treatment

InterventionDays (Mean)
Experimental13.27
Control15.74

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Days From Transplantation Until Event (ACR, AMR, or Hospitalization for Infection and/or Malignancy)

Participants are considered to have met this endpoint if they experienced biopsy-proven T-cell mediated rejection (ACR) or antibody mediated rejection (AMR) based on central pathology reading or were hospitalized for infection and/or malignancy. For participants who met one or more of these three components, the earliest event date of the three components was used as the time of meeting the endpoint. Participants who did not meet any of the three components were censored at their last date of follow-up. Event (or censor) day was calculated as event (or censor) date minus transplant date. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionDays to event (Median)
Experimental642
Control613

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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 5 Divided by the First Creatinine After Surgery.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 5 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 5 post-transplantation

InterventionPercentage (Mean)
Experimental47.06
Control43.37

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Creatinine Reduction Ratio (CRR), Defined as the First Creatinine on Day 2 Divided by he First Creatinine After Surgery

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. CRR was calculated as the day 1 post-transplant creatinine value minus the day 2 creatinine value divided by the day 1 creatinine value and multiplied by 100, resulting in a percentage. Higher numbers indicate a greater reduction in serum creatinine and, thus, potentially better kidney function. (NCT02495077)
Timeframe: Day 2 post-transplantation

InterventionPercentage (Mean)
Experimental24.28
Control20.97

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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental8.1
Control11.6

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Change in eGFR Between Post-transplant Nadir and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. Post-transplant nadir was defined as the lowest value of eGFR from the first 6 months post-transplant. The change in eGFR between nadir and month 24 was calculated as the month 24 eGFR minus the nadir eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental8.5
Control12.0

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Change in eGFR Between 6 Months and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental1.0
Control5.2

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Change in eGFR Between 6 Months and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 6 and 24 was calculated as the month 24 eGFR minus the month 6 eGFR for each participant. A window of +/- 21 days was used for month 6 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 6 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental0.8
Control4.8

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Change in eGFR Between 3 Months and 24 Months as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental2.8
Control4.8

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Change in eGFR Between 3 Months and 24 Months as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. The change in eGFR between months 3 and 24 was calculated as the month 24 eGFR minus the month 3 eGFR for each participant. A window of +/- 14 days was used for month 3 and +/- 1 month was used for month 24. (NCT02495077)
Timeframe: 3 months and 24 months post-transplantation

InterventionmL/min/1.73m2 (Mean)
Experimental2.7
Control4.4

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BANFF Grades of First AMR.

Antibody mediated rejection (AMR) was defined based on central lab pathology interpretation using the Banff 2013 criteria. Participants with a Banff finding of AMR within 6 months of transplant were determined to have met the endpoint. AMR is classified as acute/active, chronic/active, or C4d staining positive. Criteria include: acute/active-histologic evidence of acute tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of donor-specific antibodies (DSAs); chronic/active-morphologic evidence of chronic tissue injury, evidence of current/recent antibody interaction with vascular endothelium, and serologic evidence of DSAs; C4d staining positive-linear C4d staining in peritubular capillaries, glomerulitis=0, peritubular capillary=0, chronic glomerulopathy=0, no acute cell-mediated rejection or borderline changes. (NCT02495077)
Timeframe: 6 months post-transplantation

InterventionParticipants (Count of Participants)
Experimental0
Control0

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The Percent of Participants With a Serum Creatinine of More Than 3 mg/dL.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. This endpoint is ascertaining slow graft function in the immediate days post-transplant. A participant was considered to have met this endpoint if their day 5 serum creatinine was greater than 3 mg/dL. (NCT02495077)
Timeframe: Day 5 post-transplantation

Interventionpercentage of participants (Number)
Experimental47.4
Control42.9

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Change From Baseline (Immediately After Surgery) in Serum Creatinine.

Serum creatinine (mg/dL) is used to measure kidney function. A normal result is 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women. Higher results indicate poorer kidney function, as creatinine is removed from the body by the kidneys. eGFR values from 24, 48, and 72 hours post-transplant (i.e., days 1, 2, and 3) were used to generate an estimate of the serum creatinine at each time point of interest for each treatment group. (NCT02495077)
Timeframe: 24, 48 and 72 hours post-transplantation

,
Interventionmg/dL (Mean)
24 Hours48 Hours72 Hours
Control6.855.875.21
Experimental7.356.245.77

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eGFR Values as Measured by CKD-EPI

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 90, and 180 post-transplantation

,
InterventionmL/min/1.73m2 (Mean)
Day 30Day 90Day 180
Control50.6351.4452.65
Experimental49.2949.8050.56

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eGFR Values as Measured by MDRD

Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. eGFR was estimated using the Modification of Diet in Renal Disease (MDRD) equation. A value of 90+ means kidney function is normal. A value between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Values between 30 and 59 indicates moderately reduced kidney function. Values between 15 and 29 indicate severely reduced kidney function. Values below 15 indicate very severe or endstage kidney failure. eGFR values from day 7 and months 1, 3, 6, 12, 18, and 24 were used to generate an estimate of the eGFR at each time point of interest for each treatment group. (NCT02495077)
Timeframe: Days 30, 60, and 180 post-transplantation

,
InterventionmL/min/1.73m2 (Mean)
Day 30Day 90Day 180
Control48.2048.9950.16
Experimental46.6447.1447.89

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Percent of Participants With Impaired Wound Healing Manifested by Wound Dehiscence, Wound Infection, or Hernia at the Site of the Transplant Incision

Participants were considered to have met this endpoint if they had a reported case of impaired wound healing at the site of the transplant incision manifested by one wound dehiscence, wound infection, or hernia. (NCT02495077)
Timeframe: 24 months post-transplantation

InterventionPercent of participants (Number)
Experimental7.9
Control11.6

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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.

Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the 24 month post-transplant follow-up. (NCT02495077)
Timeframe: 24 months post-transplantation

Interventionpercentage of participants (Number)
Experimental16.2
Control27

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Percent of Participants With Locally Treated Rejection, Defined as Treatment Administered for Rejection Based on Clinical Signs or Biopsy Findings.

Biopsies were read by the local pathologist at the hospital where the participant was a patient. These local reads informed clinical care for the participant, which may or may not include prescribing/administering medication to the participant to help with clinical concerns or findings noted on a biopsy. Participants were considered to have met this endpoint if they have a report of receiving treatment for clinical or biopsy-proven rejection during the first 6 months post-transplant. (NCT02495077)
Timeframe: 6 months post-transplantation

Interventionpercentage of participants (Number)
Experimental12.6
Control20.5

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Pulse Oximetry

(NCT02498483)
Timeframe: Baseline 4 hours

,
Interventionpercentage of oxygen saturation (Mean)
Baseline4 Hours post-circumcision
Acetaminophen Arm98.897.5
Non-treatment Arm98.298.4

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Change in Salivary Cortisol Rise

(NCT02498483)
Timeframe: Baseline and 4 hours

,
Interventionnmol/L (Mean)
Baseline30 minutes post-circumcision
Acetaminophen Arm0.3891.085
Non-treatment Arm0.4270.811

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Neonatal Infant Pain Scale (NIPS)

"The Neonatal Infant Pain Scale (NIPS) is a behavioral scale and can be utilized with both full-term and pre-term infants. The tool uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) indicators: facial expression, cry, breathing patterns, arms, legs and state of arousal. Each behavioral indicator is scored with 0 or 1 except cry, which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants are observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7, with a score of 0-2 indicating mild to no pain and no suggested intervention (better outcome) to a score >4 indicating severe pain, suggesting non-pharmacological and/or pharmacological interventions may be needed." (NCT02498483)
Timeframe: Baseline and 4 hours

,
Interventionscore on a scale (Mean)
Baseline4 Hours post-circumcision
Acetaminophen Arm2.51.0
Non-treatment Arm3.21.4

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Heart Rate

(NCT02498483)
Timeframe: Baseline and 4 hours

,
InterventionBeats per minute (Mean)
Baseline4 Hours post-circumcision
Acetaminophen Arm138.7125
Non-treatment Arm128.8124.8

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Respiratory Rate

(NCT02498483)
Timeframe: Baseline and 4 hours

,
Interventionbreaths per minute (Mean)
Baseline4 Hours post-circumcision
Acetaminophen Arm59.742
Non-treatment Arm4543.6

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Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]

AUC(0-inf) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period. (NCT02504775)
Timeframe: 2 days

Interventionh*μg/mL (Mean)
Tylenol® Caplets15.972
Mejoral® 500 Tablets15.620

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Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]

AUC(0-t) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 hours (h) after each period. (NCT02504775)
Timeframe: 2 days

Interventionhours*microgram/millilitre (h*μg/mL) (Mean)
Tylenol® Caplets (Reference)15.212
Mejoral® 500 Tablets (Test)14.698

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Maximum Plasma Concentration (Cmax)

Cmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period. (NCT02504775)
Timeframe: 2 days

Interventionmicogram per mililitre (μg/mL) (Mean)
Tylenol® Caplets7.182
Mejoral® 500 Tablets8.118

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Time to Reach Maximum Plasma Concentration (Tmax)

Tmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period. (NCT02504775)
Timeframe: 2 days

InterventionHours (h) (Mean)
Tylenol® Caplets0.719
Mejoral® 500 Tablets0.738

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Number of Patients Admitted Post Operatively

(NCT02519023)
Timeframe: 72 hours post-procedure

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine11
Surgical Infiltration With Bupivacaine16

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Number of Participants With Nausea and Vomiting

(NCT02519023)
Timeframe: 72 hours post-procedure

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine10
Surgical Infiltration With Bupivacaine16

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Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)

the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30. (NCT02519023)
Timeframe: 0-72 hours post-procedure

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine8
Surgical Infiltration With Bupivacaine13

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Maximal Pain Score Patient Felt From 48-72 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 48-72 hours after surgery

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine2
Surgical Infiltration With Bupivacaine3

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Maximal Pain Score for Patient From Time 24-48 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 24-48 hours after surgery

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine3
Surgical Infiltration With Bupivacaine4

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Length of Time in Phase 1 and Phase 2 of Recovery

time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge. (NCT02519023)
Timeframe: an expected average of 120 mins

Interventionhours (Median)
TAP-Block With Liposomal Bupivacaine3.3
Surgical Infiltration With Bupivacaine3.1

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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

(NCT02519023)
Timeframe: 0-24 post-procedure

Interventionmg of morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine7.5
Surgical Infiltration With Bupivacaine22.5

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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

opioid use from time 48-72 hours in mg morphine equivalents (NCT02519023)
Timeframe: 48-72 hours after end of surgery

Interventionmg morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine0
Surgical Infiltration With Bupivacaine5

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Total Opioid Use for Pain Control

total opioid used from time 0 after surgery through 72 hours after surgery was complete. (NCT02519023)
Timeframe: 72 hours

Interventionmg Morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine20.8
Surgical Infiltration With Bupivacaine25.0

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Quality of Recovery 15 (QoR15) Score

The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome. (NCT02519023)
Timeframe: 72 hours post-procedure

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine126
Surgical Infiltration With Bupivacaine115

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Maximal Pain Score of Patient From Time 0-24 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 0-24 hours after surgery

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine3
Surgical Infiltration With Bupivacaine5

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Patient Satisfaction With Pain Management

number of patients who answered yes to if they were satisfied with their pain management (NCT02519023)
Timeframe: at 72 hours after surgery

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine30
Surgical Infiltration With Bupivacaine24

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Overall Benefit of Analgesia Score (OBAS)

The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome. (NCT02519023)
Timeframe: 72 hours post-procedure

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine2
Surgical Infiltration With Bupivacaine3

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Opioid Used From 24-48 Hours Post Surgery

opioids in mg of morphine equivalents used from 24-48 hours after surgery (NCT02519023)
Timeframe: 24-48 hours after the end of surgery

Interventionmg of morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine0
Surgical Infiltration With Bupivacaine.5

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Secondary Outcome: Total Dose of Opioid Pain Medication in Morphine Equivalents/kg/Hour

Compare the total dose of opioid pain medication in morphine equivalents/kg/hour required during the ED evaluation of children with suspected forearm fractures after randomization and treatment with IN ketamine or IN fentanyl. (NCT02521415)
Timeframe: participants will be followed during the emergency department length of stay, estimated to average 6 hours

Interventionmorphine equivalents/kg/hr (Median)
Ketamine0.04
Fentanyl0.05

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Exploratory Outcome: Reduction in Age Appropriate Pain Scale Scores

Mean difference in the reduction of the pain scale scores at 20 minutes. Two commonly used, age appropriate and previously validated, pediatric pain assessment tools were used: FACES Pain Scale - Revised for children ages 4-10 and the Visual Analog Scale for children ages 11-17. The FACES Pain Scale - Revised is a self-reported measure of pain intensity developed for children with pain intensity represented by images of grimacing faces on a scale of 0 (no pain) to 10 (maximum pain). The Visual Analog Scale is a self-reported measure of pain intensity where patients mark their pain level on a 10 cm line that represents a continuum of no pain at 0 cm and worst pain at 10 cm. For analysis, pain scale data were merged and reported as values form 0 to 100. The minimum clinically significant reduction in pain was defined as a decrease of 20. (NCT02521415)
Timeframe: 20 minutes

Interventionunits on a scale (Mean)
Ketamine44
Fentanyl35

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Duration of Delirium

Duration of delirium will be analyzed, measured from 24 hours post-operation and daily until discharge. Additional measurements will be made at 1 month and 1 year after discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM). (NCT02546765)
Timeframe: Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month and 1- year following the date of surgery

Interventiondays (Median)
Acetaminophen and Dexmedetomidine1
Acetaminophen and Propofol1
Placebo and Dexmedetomidine1
Placebo and Propofol3

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ICU Length of Stay

Defined by the number of days admitted in the ICU prior to transfer to the general cardiac surgical floor (NCT02546765)
Timeframe: Measured in days admitted in the ICU, an average of 2 days

Interventionhours (Median)
Acetaminophen and Dexmedetomidine28.8
Acetaminophen and Propofol30.3
Placebo and Dexmedetomidine49.1
Placebo and Propofol29.3

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Incidence of Delirium

Incidence of delirium will be analyzed between patients treated with and without IV acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM). (NCT02546765)
Timeframe: Participants will be followed for the duration of the hospital stay, an average of 5 days

InterventionParticipants (Count of Participants)
Acetaminophen and Dexmedetomidine2
Acetaminophen and Propofol4
Placebo and Dexmedetomidine8
Placebo and Propofol9

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Hospital Length of Stay

Defined by the number of days admitted in the hospital following the completion of surgery. (NCT02546765)
Timeframe: Measured in days admitted in the hospital, an average of 6 days

Interventiondays (Median)
Acetaminophen and Dexmedetomidine8
Acetaminophen and Propofol8
Placebo and Dexmedetomidine9
Placebo and Propofol8

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Montreal Cognitive Assessment (MoCA)

MoCA scores at discharge will be reported in order to assess the occurrence of postoperative cognitive decline. Blinded study staff trained in administering the assessments will collect the data. MoCA is scored on a scale from 0 [worst] to 30 [best]; ǂA MoCA score of 24 would be equivalent to an Mini-Mental State Examination (MMSE) of about 27 or 28. Depending on education and peak intellectual attainment, such a score could be consistent with being either cognitively normal, or having very early mild cognitive impairment. Certainly such a person would be capable of living independently in the community and managing most or all of their affairs. (NCT02546765)
Timeframe: On the day of discharge, an average of 6 days

Interventionscore on a scale (Median)
Acetaminophen and Dexmedetomidine23
Acetaminophen and Propofol24
Placebo and Dexmedetomidine24
Placebo and Propofol23

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Postoperative Opioid Consumption in Morphine Equivalents

Defined by the amount of additional opioid (IV morphine or hydromorphone) and oral acetaminophen medications required in the first 48 hours postoperatively. Values will be converted to morphine equivalents for analysis. Total morphine equivalent is calculated as the sum of (fentanyl dose x 100)+(hydromorphone dose x 4)+morphine dose+(oxycodone dose x 1.5) (NCT02546765)
Timeframe: Participants will be followed for the first 48 hours postoperatively.

Interventionmcg (Median)
Acetaminophen and Dexmedetomidine10050
Acetaminophen and Propofol12611
Placebo and Dexmedetomidine11382
Placebo and Propofol12616

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Severity of Delirium

Severity of delirium will be analyzed, measured from 24 hours post-operation and daily until discharge. The worst severity experienced while in the hospital will be analyzed. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method Severity Score (CAM-S, Confusion Assessment Method-Severity). range 0 [best/no delirium] to 19 [worst]; Minimal Clinical Important Difference (MCID) 2 points (NCT02546765)
Timeframe: Participants will be followed for the duration of the hospital stay, an average of 6 days

Interventionunits on a scale (Median)
Acetaminophen and Dexmedetomidine10
Acetaminophen and Propofol8
Placebo and Dexmedetomidine6
Placebo and Propofol9

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Follow up Incidence of Cognitive Dysfunction

The follow up incidence of cognitive dysfunction will be analyzed at 1 month after discharge. T-MoCA is Telephone Montreal Cognitive Assessment Scale (MOCA). The T-MoCA is scored out of 22. The minimum score is 0 (worst) and maximum score is 22 (best). T-MOCA is converted back to 30 (full MOCA) with the help of conversion algorithms to a full MOCA.Example: 19/22 converts back to 30 by performing the following equation: (19×30) ÷ 22. The total converted score is 25.9 or 26/30 which is considered in the normal range. (NCT02546765)
Timeframe: Patients will be assessed for cognitive dysfunction with T-MOCA at 1 month following the date of surgery

Interventionunits on a scale (Median)
Acetaminophen and Dexmedetomidine17
Acetaminophen and Propofol18
Placebo and Dexmedetomidine19
Placebo and Propofol18

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Post-operative Anti-emetic Usage

Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine5.14
Placebo9.93

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Quality of Life Measurement

Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation. (NCT02601027)
Timeframe: Pre-operative Baseline and Post-operative (2-6 months)

,
Interventionscore on a scale (Mean)
Pre-operative baselinePost-operative (2 to 6 month)
0.125% Bupivacaine97.30342.11
Placebo99.08358.00

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Time to First Bowel Movement

Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.67
Placebo1.62

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Post-operative Narcotic Usage

Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine139.3
Placebo169.2

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Time to Ambulation

Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.28
Placebo1.45

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Post-operative Pain Score

Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation. (NCT02601027)
Timeframe: 2 days

Interventionunits on a scale (Mean)
0.125% Bupivacaine3.76
Placebo3.96

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Nausea Score Score at 24 and 48 After Delivery

Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
Interventionunits on a scale (Mean)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol1.80.2
Choice: Low Protocol1.10.2
Choice: Medium Protocol1.50.2
No Choice1.30.3

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Opioid Consumption in the 0-48 Hour Study Periods.

Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods. (NCT02605187)
Timeframe: 0-24 and 24-48 hour postoperative periods

,,,
Interventionmilligram morphine equivalents (MMEQ) (Median)
0-24 hours24-48 hours
Choice: High Protocol530
Choice: Low Protocol50
Choice: Medium Protocol105
No Choice1010

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Pain Scores

Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain. (NCT02605187)
Timeframe: 3, 6, 12, 24, 36 and 48 hours after delivery

,,,
Interventionunits on a scale (Mean)
Pain at rest at 3 hoursPain at movement at 3 hoursPain at rest at 6 hoursPain at movement at 6 hoursPain at rest at 12 hoursPain at movement at 12 hoursPain at rest at 24 hoursPain at movement at 24 hoursPain at rest tat 36 hoursPain at movement at 36 hoursPain at rest at 48 hoursPain at movement at 48 hours
Choice: High Protocol2.24.11.53.81.73.22.33.63.14.83.34.8
Choice: Low Protocol1.83.42.74.42.14.71.94.11.74.02.03.9
Choice: Medium Protocol1.93.22.23.81.93.62.24.32.64.52.03.6
No Choice1.63.22.34.01.53.02.24.51.53.51.73.5

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Pruritus Score at 24 and 48 After Delivery

Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching. (NCT02605187)
Timeframe: 24 and 48 hours following delivery

,,,
Interventionunits on a scale (Mean)
24 hours after delivery48 hours after delivery
Choice: High Protocol4.51.1
Choice: Low Protocol1.70.2
Choice: Medium Protocol3.71.0
No Choice4.20.8

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Patient Overall Satisfaction With Postoperative Analgesia

Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied. (NCT02605187)
Timeframe: 24 and 48 hours after delivery

,,,
Interventionunits on a scale (Mean)
24 hours after delivery48 hours after delivery
Choice: High Protocol93.389.3
Choice: Low Protocol90.392.6
Choice: Medium Protocol94.191.2
No Choice87.289.9

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Counts of Participants With Presence of Nausea

Count of participants with nausea through 48 hours after delivery. (NCT02605187)
Timeframe: 0-48 hours after delivery

InterventionParticipants (Count of Participants)
No Choice11
Choice: Low Protocol7
Choice: Medium Protocol33
Choice: High Protocol10

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Time to Discharge

Minutes from delivery until discharge. (NCT02605187)
Timeframe: Delivery through discharge (average 4 days)

Interventionminutes (Mean)
No Choice4771.9
Choice: Low Protocol4652.1
Choice: Medium Protocol5278.9
Choice: High Protocol5722.3

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Average Number of Vomiting Episodes After Delivery

(NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
Interventionvomiting episodes (Mean)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol1.30
Choice: Low Protocol0.30
Choice: Medium Protocol0.50
No Choice0.60

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Count of Participants Who Need Medical Treatment of Pruritus

Count of participants who need medical treatment of pruritus during first 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol30
Choice: Low Protocol20
Choice: Medium Protocol122
No Choice72

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Count of Participants Who Need Opioid Use

Count of participants who need opioid use through 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol1314
Choice: Low Protocol148
Choice: Medium Protocol5042
No Choice2723

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Count of Participants With Presence of Pruritus

Count of participants with pruritus through 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol137
Choice: Low Protocol113
Choice: Medium Protocol6329
No Choice2712

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Counts of Participants Who Need Medical Treatment for Nausea

Counts of participants who need medical treatment of nausea through 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol90
Choice: Low Protocol91
Choice: Medium Protocol200
No Choice80

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Number of Participants With Vital Signs of Clinical Concern

Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Severe Adverse Events

Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Post-injection Systemic Reactions

All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Laboratory Results of Potential Clinical Concern

Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant. (NCT02613910)
Timeframe: Up to Week 156

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Injection Site Reactions

Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Infections

All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities

12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled. (NCT02613910)
Timeframe: Up to Week 60

InterventionParticipants (Number)
Ofatumumab0

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Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)

Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported. (NCT02613910)
Timeframe: Up to Week 156

InterventionParticipants (Number)
Any SAEAny AESI
Ofatumumab00

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Change in Pain Intensity Over Time

"Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).~Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)].~Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes" (NCT02621619)
Timeframe: baseline to 5 min, 15 min, 30 min, and 45 minutes

,
Interventionunits on a scale (Mean)
Baseline to 5 minutesBaseline to 15 minutesBaseline to 30 minutesBaseline to 45 minutes
IV Acetaminophen + 0.5 mg IV Hydromorphone3.44.75.15.5
Placebo + 0.5 mg IV Hydromorphone2.94.04.85.2

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Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused

"Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).~Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)].~Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given." (NCT02621619)
Timeframe: baseline and 60 minutes after medication was infused

Interventionunits on a scale (Mean)
IV Acetaminophen + 0.5 mg IV Hydromorphone5.8
Placebo + 0.5 mg IV Hydromorphone5.2

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Morphine Equivalents of Postoperative Opioid Usage

Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours (NCT02643394)
Timeframe: an expected average of 6 hours

InterventionMorphine equivalent (mg) (Median)
Oral Acetaminophen5
Intravenous Acetaminophen5

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Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)

Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU) (NCT02643394)
Timeframe: 1-h postoperatively

Interventionunits on a scale (Median)
Oral Acetaminophen2
Intravenous Acetaminophen2

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Quality of Recovery-9 (QoR-9).

To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2. (NCT02647788)
Timeframe: Postoperative Day 2

InterventionScores on a scale (Mean)
Acetaminophen/Ibuprofen16.91
Acetaminophen/Codeine16.65

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Number of Pills Used

(NCT02647788)
Timeframe: From the time of surgery to first clinic visit (post-op day 6 to 8)

InterventionPills (Mean)
Acetaminophen/Ibuprofen13.72
Acetaminophen/Codeine14.14

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Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score

To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable. (NCT02647788)
Timeframe: Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores

,
Interventionscore on a scale (Mean)
VAS Pain Day 1VAS Pain Day 2VAS Pain Day 3VAS Pain Day 4VAS Pain Day 5VAS Pain Day 6VAS Pain Day 7
Acetaminophen/Codeine3.512.402.261.931.481.351.01
Acetaminophen/Ibuprofen2.902.361.691.471.231.291.17

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Phase 2: Vital Signs

Systolic and Diastolic Blood Pressure (mmHg) (NCT02654860)
Timeframe: at screening, at baseline (before the spinal injection) and at end of the study (Day 6).

,,,
InterventionmmHg (Mean)
systolic Blood Pressure at screeningsystolic Blood Pressure at baselinesystolic Blood Pressure at end of the study (day6)Diastolic Blood Pressure at screeningDiastolic Blood Pressure at baselineDiastolic Blood Pressure at end of the study (day6)
120 mg Paracetamol 3% (4mL)148.5138.7133.590.977.879
60 mg Paracetamol 3% (2 mL)137145.513087.18379.5
90 mg Paracetamol 3% (3 mL)144.6146.3130.385.778.978.2
Phase II Only: Saline Solution 0.9%147.7144.8138.18785.983.1

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Phase 2: SpO2

Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. (NCT02654860)
Timeframe: at screening, at baseline (before the spinal injection) and at the end of the study (day 6)

,,,
InterventionOxygen Saturation percentage (Mean)
screeningbaselineend of the study (day 6)
120 mg Paracetamol 3% (4mL)98.2797.3397.8
60 mg Paracetamol 3% (2 mL)97.9397.2797.73
90 mg Paracetamol 3% (3 mL)9897.0797.53
Phase II Only: Saline Solution 0.9%97.8096.8797.6

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Phase 2: Time to Sensory Block

Time to maximum level of sensory block (NCT02654860)
Timeframe: Intraoperative

Interventionminutes (Median)
60 mg Paracetamol 3% (2 mL)18
90 mg Paracetamol 3% (3 mL)15
120 mg Paracetamol 3% (4mL)15
Phase II Only: Saline Solution 0.9%17

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Phase 2: Time to Regression of Spinal Block

"Time period from spinal injection (time 0 h) to the time when the Bromage score returns to 0 and sensitive perception returns to S1. Bromage scale:~I - Free movement of legs and feet II - Just able to flex knees with free movement of feet III - Unable to flex knees, but with free movement of feet IV - Unable to move legs or feet" (NCT02654860)
Timeframe: from readiness for surgery,then every 10 min until the maximum level is reached (two consecutive observations with the same level of sensory block) and then every 30 min until regression of spinal block

Interventionminutes (Median)
60 mg Paracetamol 3% (2 mL)285
90 mg Paracetamol 3% (3 mL)246
120 mg Paracetamol 3% (4mL)265
Phase II Only: Saline Solution 0.9%280

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Phase 2: Time to Readiness for Surgery

Time period from completion of spinal injection (time 0 h) to achievement of sensory and motor block adequate for surgery. (NCT02654860)
Timeframe: Intraoperative

Interventionminutes (Median)
60 mg Paracetamol 3% (2 mL)9
90 mg Paracetamol 3% (3 mL)10
120 mg Paracetamol 3% (4mL)10
Phase II Only: Saline Solution 0.9%8

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Phase 2: Time to First Morphine Use

Phase 2: Time to first morphine use (minutes) (NCT02654860)
Timeframe: Postoperative, up to 48 hours after end of surgery

Interventionminutes (Median)
60 mg Paracetamol 3% (2 mL)351
90 mg Paracetamol 3% (3 mL)236
120 mg Paracetamol 3% (4mL)318
Phase II Only: Saline Solution 0.9%279

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Phase 2: Number of Participants With Need for Supplemental Analgesia

Phase 2: Need for supplementary analgesia, other than the planned morphine PCA (NCT02654860)
Timeframe: Postoperative, up to 48 hours after end of surgery

InterventionParticipants (Count of Participants)
60 mg Paracetamol 3% (2 mL)9
90 mg Paracetamol 3% (3 mL)11
120 mg Paracetamol 3% (4mL)11
Phase II Only: Saline Solution 0.9%10

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Phase 2:Maximum Level of Sensory Block

Sensorial block will be verified by bilateral Pinprick test using a 20-G hypodermic needle and will be recorded. Pinprick sensation will be scored as being present (score 1) or absent (score 0). Onset of sensory block is defined as an absent touch sensation (score 0) (NCT02654860)
Timeframe: Intraoperative

,,,
Interventionparticipants (Number)
T1T2T3T4T5T6T7T8T9T10T11
120 mg Paracetamol 3% (4mL)000003110010
60 mg Paracetamol 3% (2 mL)00002417021
90 mg Paracetamol 3% (3 mL)00021427200
Phase II Only: Saline Solution 0.9%000103628200

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Phase2: Concomitant Medications

record the concomitant medications intaked during the study (NCT02654860)
Timeframe: at screening, at baseline until the end of the study (Day 6)

,,,
Interventionparticipants (Number)
heparin groupSecond-generation cephalosporinsSolutions affecting the electrolyte balanceDirect factor Xa inhibiAmino acidspropofolAdrenergic and dopaminergic agentsPropionic acid derivativesPyrazolonesAcetic acid derivatives and related substancesOsmotically acting laxativesProton pump inhibitorsSerotonin (5HT3) antagonistsBenzodiazepine derivativesANTIEMETICS AND ANTINAUSEANTSOther opioidsPlatelet aggregation inhibitors excl. heparinAngiotensin II antagonists,Natural opium alkaloids
120 mg Paracetamol 3% (4mL)1515151412131210118642411001
60 mg Paracetamol 3% (2 mL)15151515141110746121211110
90 mg Paracetamol 3% (3 mL)15151515131311877346021110
Phase II Only: Saline Solution 0.9%15151515151412698334232101

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Phase 2: ECG

Electrocardiography is the process of producing an electrocardiogram (ECG), it is a graph of voltage versus time of the electrical activity of the heart using electrodes placed on the skin. (NCT02654860)
Timeframe: screening, baseline and end of study (Day 6±1)

InterventionParticipants (Count of Participants)
screening72042191screening72042192screening72042193screening72042194baseline72042191baseline72042193baseline72042192baseline72042194end of study72042192end of study72042193end of study72042191end of study72042194
normalAbnormal, Not Clinically SignificantAbnormal, Clinically Significant
60 mg Paracetamol 3% (2 mL)10
90 mg Paracetamol 3% (3 mL)9
Phase II Only: Saline Solution 0.9%11
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)6
Phase II Only: Saline Solution 0.9%4
60 mg Paracetamol 3% (2 mL)13
90 mg Paracetamol 3% (3 mL)11
120 mg Paracetamol 3% (4mL)11
60 mg Paracetamol 3% (2 mL)2
90 mg Paracetamol 3% (3 mL)4
120 mg Paracetamol 3% (4mL)4
Phase II Only: Saline Solution 0.9%3
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)0
120 mg Paracetamol 3% (4mL)0
60 mg Paracetamol 3% (2 mL)12
90 mg Paracetamol 3% (3 mL)13
Phase II Only: Saline Solution 0.9%12
60 mg Paracetamol 3% (2 mL)3
90 mg Paracetamol 3% (3 mL)2
Phase II Only: Saline Solution 0.9%0

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Phase 2: Pain Intensity

Phase 2: Pain intensity at rest evaluated as VAS scores ( 0-100 mm visual analogue scale : 0 is the absence pain and 100 is the maximum pain sensation) (NCT02654860)
Timeframe: baseline (0 h), 1, 6, 9, 12, 15, 24, and 48 h after anaesthetic IT injection and at discharge

,,,
Interventionunits on a scale (Mean)
baseline1 hour after anaesthetic6 hours after anaesthetic9 hours after anaesthetic12 hours after anaesthetic15 hours after anaesthetic24 hours after anaesthetic48 hours after anaestheticDischarge
120 mg Paracetamol 3% (4mL)24.5020.317.311.210.613.67.74.8
60 mg Paracetamol 3% (2 mL)11.9021.521.613.115.411.46.12.5
90 mg Paracetamol 3% (3 mL)17.3032.213.610.110.29.53.24.1
Phase II Only: Saline Solution 0.9%10.7042.326.317.920.5168.78.0

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Phase 2: Morphine

Phase 2: Total morphine use (NCT02654860)
Timeframe: At 24 and 48 h after anaesthetic IT injection and entire study period, up to 7 days

,,,
Interventionmg (Mean)
first 24 hoursfirst 48 hoursentire study period
120 mg Paracetamol 3% (4mL)22.833.533.8
60 mg Paracetamol 3% (2 mL)14.124.524.8
90 mg Paracetamol 3% (3 mL)12.615.815.8
Phase II Only: Saline Solution 0.9%14.32121.1

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The Effect of Liposomal Bupivacaine on Length of Hospital Stay

Length of hospital stay will be determined for patients in each group, in total hours. (NCT02659501)
Timeframe: 24-60 hours

Interventionhrs (Mean)
Bupivacaine With Epinephrine Injections46.7
Liposomal Bupivacaine29.8

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The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.

Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively. (NCT02659501)
Timeframe: Average Pain Scores 24 hours Post-Operatively

Interventionscore on a scale (Mean)
Bupivacaine With Epinephrine Injections3.66
Liposomal Bupivacaine3.68

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The Effect of Liposomal Bupivacaine on Antiemetic Consumption

The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively. (NCT02659501)
Timeframe: 24 hours

Interventionmg of ondansetron (Mean)
Bupivacaine With Epinephrine Injections7.33
Liposomal Bupivacaine5.75

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The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption

Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively. (NCT02659501)
Timeframe: 24 hours

Interventionmg of diazepam/hr (Mean)
Bupivacaine With Epinephrine Injections0.35
Liposomal Bupivacaine0.18

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The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption

Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour. (NCT02659501)
Timeframe: 24 hours

InterventionMorphine equivalent dosage per hour (Mean)
Bupivacaine With Epinephrine Injections1.31
Liposomal Bupivacaine.76

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Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area

Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6 (NCT02678416)
Timeframe: within 6 hours

,,,
Interventionscores on a scale (Mean)
Baseline0.25 Hours0.5 Hours0.75 Hours1 Hour2 Hours3 Hours4 Hours6 Hours
Part 2: IV Acetaminophen5.45.25.05.05.05.35.45.55.6
Part 2: IV Morphine5.64.94.74.74.65.15.05.25.4
Part 2: Oral Acetaminophen5.55.35.15.14.95.15.25.45.5
Part 2: Placebo5.55.55.35.45.25.65.55.55.5

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Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model

The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief). (NCT02678416)
Timeframe: within 6 hours

Interventionscore on a scale (Mean)
IV Acetaminophen0.73
Oral Acetaminophen-0.64
Placebo-0.36
Morphine0.36

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Time to the Onset of Analgesia-Time to Onset of Analgesia (Measured as Time to Perceptible Pain Relief Confirmed by Meaningful Pain Relief) Using the Two-stopwatch Method

"Two-stopwatch method~Start two stopwatches ('Stopwatch A' and 'Stopwatch B') at the same time that the infusion of study drug is initiated. This is Time 0.~The participant is given 'Stopwatch A' and instructed to Stop 'Stopwatch A' when you first feel any pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the pain you have now. (Perceptible Pain Relief)~When the participant stops the 'Stopwatch A', the participant then was asked Do you consider the pain relief you experienced meaningful?~If the participant answered No, then the participant was given the Stopwatch B and instructed to Stop 'Stopwatch B' when you feel the pain relief is meaningful to you (Meaningful Pain Relief)~If the subject did not experience perceptible pain relief, they would retain 'Stopwatch A' for the entire 6 hour evaluation period." (NCT02689063)
Timeframe: 6 hours

Interventionminutes (Median)
Maxigesic IV9.4
IV Acetaminophen23.9
IV Ibuprofen13.8
Placebo IV0

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Time to the First Dose of Rescue Medication

Time to first use of rescue medication (duration of analgesia) (NCT02689063)
Timeframe: 48 hrs

Interventionhours (Mean)
Maxigesic IV12.98
IV Acetaminophen5.62
IV Ibuprofen3.09
Placebo IV2.92

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Time to Peak Pain Relief

"Time to peak pain relief-Peak Pain Relief was assessed on Pain Relief scores recorded up until the first dose of rescue (First Pre-Rescue Pain Relief score inclusive). Time for participants who experienced peak pain relief was summarized.~Note: For the reader to interpret this outcome measure, a very short Time to Peak Pain Relief indicates the absence of analgesic effect for a treatment because peak pain relief was determined prior to the first dose of rescue medication (or 48 hours if no rescue medication was used)." (NCT02689063)
Timeframe: 48 hrs after the first dose

Interventionhours (Mean)
Maxigesic IV4.00
IV Acetaminophen2.46
IV Ibuprofen1.47
Placebo IV0.91

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Percentage of Subjects Using Rescue Medication

The percentage of participants who used at lease one dose of rescue medication was summarized in each treatment group (NCT02689063)
Timeframe: 48 hrs after the first dose

InterventionParticipants (Count of Participants)
Maxigesic IV56
IV Acetaminophen70
IV Ibuprofen70
Placebo IV48

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Percentage of Participants With Complete Pain Relief

"Pain relief score was assessed on a 5-point categorical scale at each scheduled time point after Time 0:~0 = No pain relief (the pain is the same, or worse, than the starting pain)~= A little pain relief (the pain is less than half gone)~= some pain relief (the pain is about half gone)~= A lot pain relief (the pain is more than half gone)~= Complete pain relief (the pain is completely gone)~Assessed at scheduled time points:~5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6 hours after the first dose of the study drug~Immediately before and 2 hours after each subsequent dose (doses 2-8) of the study drug while awake~At the end of 48 hours of double-blind treatment period~Immediately before taking each dose of the rescue medication if additional analgesia is required.~At the time of withdrawal (if applicable)" (NCT02689063)
Timeframe: 48 hours after the first dose

InterventionParticipants (Count of Participants)
Maxigesic IV29
IV Acetaminophen7
IV Ibuprofen16
Placebo IV4

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Percentage of Participants Who Obtained a Peak Pain Relief -Value of 3 ('A Lot of Relief') or 4 ('Complete Relief') Prior to the First Dose of Rescue

"Peak Pain Relief was assessed on Pain Relief scores (on a 5 point categorical rating-please see outcome measure description No. 7) recorded up until the first dose of rescue (First Pre-Rescue Pain Relief score inclusive).~The percentage of participants who achieve the peak pain relief was summarized." (NCT02689063)
Timeframe: 48 hours after the first dose

InterventionParticipants (Count of Participants)
Maxigesic IV22
IV Acetaminophen11
IV Ibuprofen4
Placebo IV3

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"VAS Pain Intensity Score-marking on a 100 mm VAS Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm). A High VAS Score Indicates a More Intensive Pain Level Experienced."

"VAS Pain intensity score at each scheduled assessment time point VAS pain intensity score-marking on a 100 mm VAS scale with anchors for no pain (0 mm) and worst pain imaginable (100 mm). A high VAS score indicates a more intensive pain level experienced." (NCT02689063)
Timeframe: 48 hours after the first dose

Interventionscore on a scale (Mean)
Maxigesic IV18.43
IV Acetaminophen29.28
IV Ibuprofen27.21
Placebo IV28.22

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"VAS Pain Intensity Difference (PID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long VAS Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm)."

"VAS Pain intensity difference (PID) at each scheduled assessment time point after Time 0.~A Pain Intensity Difference (PID) is the difference between the Visual Analogue Scale (VAS) pain intensity score recorded at baseline and a score recorded at any time after the first dose of study medication. Taken together, a patient's PID scores capture the pain relief profile attributable to the assigned study medication. A high PID score indicates a better pain relief experienced." (NCT02689063)
Timeframe: 48 hours after the first dose

Interventionscore on a scale (Mean)
Maxigesic IV52.50
IV Acetaminophen38.95
IV Ibuprofen45.04
Placebo IV37.24

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"The Percentage of Participants Who Evaluated Their Study Drug as Excellent on a 5-point Categorical Scale Global Evaluation of Study Drug"

"At the end of 48 hours study period, participants will be asked to How do you rate the study medication? on a 5 point categorical scale:~Poor~Fair~Good~Very Good~Excellent The high score means the participants believed that a better treatment for pain relief received." (NCT02689063)
Timeframe: 48 hrs after the first dose

InterventionParticipants (Count of Participants)
Maxigesic IV24
IV Acetaminophen5
IV Ibuprofen8
Placebo IV1

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"Summed Pain Intensity Difference (SPID)-Calculated From the Pain Intensity Scores Recorded on a 100mm Long Scale With Anchors for no Pain (0 mm) and Worst Pain Imaginable (100 mm)."

"A Pain Intensity Difference (PID) is the difference between the Visual Analogue Scale (VAS) pain intensity score recorded at baseline and a score recorded at any time after the first dose of study medication. Taken together, a patient's PID scores capture the pain relief profile attributable to the assigned study medication. A high PID score indicates a better pain relief experienced.~The extent of pain relief can then be calculated by the Area Under the Curve the PID scores (also referred to as the Sum of Pain Intensity Differences [SPID]). SPID48 scores were adjusted by the time interval from baseline to the final VAS score used in the SPID, using the following formula:~Time-adjusted SPID48 (mm) = SPID (mm*hr) / Time (hr) In the event that a patient required rescue medication, the SPID was calculated up until the first Pre-Rescue VAS pain assessment (inclusive)." (NCT02689063)
Timeframe: 48 hours after the first dose

Interventionscore on a scale (Mean)
Maxigesic IV23.4
IV Acetaminophen10.4
IV Ibuprofen9.5
Placebo IV-1.3

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Number of Participants With Treatment Emergent Adverse Events (AEs)

Treatment-emergent Adverse events coded to MedDRA v 20.0 Preferred Term and System Organ Class Code were tabulated as the counts and percentages by treatment group. (NCT02689063)
Timeframe: Day 7

InterventionParticipants (Count of Participants)
Maxigesic IV52
IV Acetaminophen45
IV Ibuprofen58
Placebo IV39

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TOTPAR-6, TOTPAR-12, TOTPAR-24, TOTPAR-48

"Total Pain Relief (TOTPAR) is a measure of total Area Under the Curve of Pain Relief scores. In the event that a patient required rescue medication, the TOTPAR endpoints were calculated using Pain Relief Assessments recorded prior to the first dose of rescue (i.e. inclusive of the first pre-rescue Pain Relief score).~Pain relief scores were obtained by marking on a 5-point categorical rating at scheduled time points.~The high score means more pain relief experienced:~0 = No pain relief (the pain is the same, or worse, than the starting pain)~= A little pain relief (the pain is less than half gone)~= some pain relief (the pain is about half gone)~= A lot pain relief (the pain is more than half gone)~= Complete pain relief (the pain is completely gone) Each of these variables were derived from pain relief scores recorded prior to the first dose of rescue medication in the first 6 (0-48), 12 (0-48), 24 (0-48) or 48 (0-48) hours of the study." (NCT02689063)
Timeframe: 6, 12, 24, 48 hours after the first dose

,,,
Interventionscore on a scale*hour (Mean)
TOTPAR 6TOTPAR 12TOTPAR 24TOTPAR 48
IV Acetaminophen4.596.748.6613.28
IV Ibuprofen3.344.466.5111.95
Maxigesic IV6.8411.8622.1343.98
Placebo IV1.601.822.494.51

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Total Use of Rescue Medication

Total use of rescue analgesia over 0 to 24 hours and over 0 to 48 hours (NCT02689063)
Timeframe: 24, 48 hrs after the first dose

,,,
Interventionmg (Mean)
Total Dose in 48 hrsTotal Dose in 24 hrs
IV Acetaminophen33.123.7
IV Ibuprofen32.422.1
Maxigesic IV22.917.2
Placebo IV44.729.6

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SPID-6, SPID-12, SPID-24-VAS SPID Over 0 to 6 Hours (SPID-6), Over 0 to 12 Hours (SPID-12), and Over 0 to 24 Hours (SPID-24) After Time 0 (=the First Dose)

"Time adjusted SPID-6, SPID-12, SPID-24 were derived in a similar manner to the Time-adjusted SPID-48 (i.e. up until the first Pre-Rescue VAS inclusive). Please see the primary outcome measure descriptions.~Each of these variables were derived from VAS (Visual Analogue Scale) scores recorded prior to the first dose of rescue medication in the first 6 (to calculate SPID6), 12 (to calculate SPID12) or 24 hours (to calculate SPID24) of the study.~VAS pain intensity scores were obtained by marking on a 100 mm VAS scale with anchors for no pain (0 mm) and worst pain imaginable (100 mm). The VAS was completed at rest." (NCT02689063)
Timeframe: 6, 12, 24 hours after the first dose

,,,
Interventionscore on a scale (Mean)
SPID 6SPID 12SPID 24
IV Acetaminophen10.139.429.59
IV Ibuprofen9.018.448.64
Maxigesic IV20.1020.6321.99
Placebo IV-1.49-1.66-1.54

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Cumulative Fentanyl Dose

(NCT02691572)
Timeframe: 24 h

Interventionmcg (Mean)
Wound Infiltration157.4
Transversus Abdominis Plane Block153.3

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Veterans Rand - 12

"The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome.~This score range apply to both PCS and MCS." (NCT02700451)
Timeframe: 2 year follow up

,,
Interventionscore on a scale (Mean)
PCS scoreMCS score
Intravenous (IV) Placebo51.244.5
IV Acetaminophen51.146.7
IV Ketorolac46.646.4

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Veterans Rand - 12

"The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome.~This score range apply to both PCS and MCS." (NCT02700451)
Timeframe: 3 month follow up

,,
Interventionscore on a scale (Mean)
PCS scoreMCS score
Intravenous (IV) Placebo48.744.3
IV Acetaminophen42.345.3
IV Ketorolac43.145.0

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Veterans Rand - 12

"The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome.~This score range apply to both PCS and MCS." (NCT02700451)
Timeframe: pre-operative

,,
Interventionscore on a scale (Mean)
PCS scoreMCS Score
Intravenous (IV) Placebo34.242.9
IV Acetaminophen34.542.0
IV Ketorolac34.743.9

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Numerical Pain Rating Scale

Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level (NCT02700451)
Timeframe: 2 year follow up

,,
Interventionscore on a scale (Median)
2 year - Current pain level2 year - Best pain level2 year - Worst pain level
Intravenous (IV) Placebo301.5
IV Acetaminophen12.58.518
IV Ketorolac4113

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Numerical Pain Rating Scale

Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level (NCT02700451)
Timeframe: 1 days and 3 days

,,
Interventionunits on a scale (Median)
POD1 - Current pain levelPOD1 - Best pain levelPOD1 - Worst pain levelPOD3 - Current pain levelPDO3 - Best pain levelPOD3 - Worst pain level
Intravenous (IV) Placebo4624.589.5472583
IV Acetaminophen422174523972.5
IV Ketorolac392362662384

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Brief Pain Inventory

The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring. (NCT02700451)
Timeframe: 1 day and 3 days

,,
Interventionscore on a scale (Median)
POD1 - Pain has interfered with General ActivityPOD1 - Pain has interfered with MoodPOD1 - Pain has interfered with Walking AbilityPOD1 - Pain has interfered with Normal workPOD1 - Pain has interfered with Relation with otherPOD1 - Pain has interfered with SleepPOD1 - Pain has interfered with Enjoyment of lifePOD3 - Pain has interfered with General ActivityPOD3 - Pain has interfered with MoodPOD3 - Pain has interfered with Walking AbilityPOD3 - Pain has interfered with Normal workPOD3 - Pain has interfered with Relation with otherPOD3 - Pain has interfered with SleepPOD3 - Pain has interfered with Enjoyment of life
Intravenous (IV) Placebo947102.559734.510246.5
IV Acetaminophen91.5781.5678568458
IV Ketorolac6.52580358559267

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Oswestry Disability Index

The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. (NCT02700451)
Timeframe: pre-operative

Interventionpercentage (Mean)
IV Ketorolac36.3
Intravenous (IV) Placebo35.4
IV Acetaminophen40.6

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Oswestry Disability Index

The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. (NCT02700451)
Timeframe: 3 month follow up

Interventionpercentage (Mean)
IV Ketorolac22.8
Intravenous (IV) Placebo18.8
IV Acetaminophen25.0

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Oswestry Disability Index

The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. (NCT02700451)
Timeframe: 1 year follow up

Interventionpercentage (Mean)
IV Ketorolac16.9
Intravenous (IV) Placebo12.1
IV Acetaminophen17.8

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Oswestry Disability Index

The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. (NCT02700451)
Timeframe: 2 year follow up

Interventionpercentage (Mean)
IV Ketorolac14.7
Intravenous (IV) Placebo11.4
IV Acetaminophen16.0

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Perioperative Complications - Drain Output

Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded (NCT02700451)
Timeframe: Hospital Stay (1-4 days)

,,
InterventionmL (Median)
Total Drain output 24HTotal Drain output 48HTotal Drain output 72HTotal Drain output at discharge
Intravenous (IV) Placebo235305335335
IV Acetaminophen240320340340
IV Ketorolac270390390390

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Numerical Pain Rating Scale

Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level (NCT02700451)
Timeframe: 1 year follow up

,,
Interventionscore on a scale (Median)
1-year - Current pain level1-year - Best pain level1-year - Worst pain level
Intravenous (IV) Placebo708
IV Acetaminophen13925
IV Ketorolac6411

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Perioperative Opioid Use

Measure the impact of treatment on total opioid use during the hospital stay (NCT02700451)
Timeframe: Hospital stay (2-4 days)

,,
Interventionoral morphine equivalents (OME) (mmg) (Median)
OME total in the first 72HOME total to discharge
Intravenous (IV) Placebo306.6324
IV Acetaminophen192.4237.9
IV Ketorolac86.2588.95

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Veterans Rand - 12

"The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome.~This score range apply to both PCS and MCS." (NCT02700451)
Timeframe: 1 year follow up

,,
Interventionscore on a scale (Mean)
PCS scoreMCS score
Intravenous (IV) Placebo47.645.0
IV Acetaminophen48.445.3
IV Ketorolac48.142.8

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Length of Stay

Will record date of discharge (NCT02700451)
Timeframe: Hospital Stay (1-4 days)

InterventionHour (Mean)
IV Ketorolac49.5
Intravenous (IV) Placebo77
IV Acetaminophen70

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Narcotic Use at 2 Weeks Postop

Assessment of the amount of narcotic use postoperatively at 2 weeks. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents (NCT02703259)
Timeframe: 2 weeks

Interventionmorphine milligram equivalents (Mean)
Gabapentin167.2
Control187.3

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Narcotic Use at 24 Hours Postop

Assessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents (NCT02703259)
Timeframe: 24 hours

Interventionmorphine milligram equivalents (Mean)
Gabapentin158.8
Control175.0

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Subjective Pain at 2 Weeks Postop

"Assessment of the subject pain score postoperatively at 2 weeks. will use a numeric analog scale from 0-10.~The pain scale ranging from 0-10 with 0 representing No Pain and 10 representing the Worst Pain Possible" (NCT02703259)
Timeframe: 2 weeks

Interventionscore on a scale (Mean)
Gabapentin1.3
Control1.4

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Subjective Pain at 24 Hours Postoperative

Pain score assesses patient subjective pain via patient reported numeric analogue scale, range 0-10 with 0 being no pain and 10 being severe pain. (NCT02703259)
Timeframe: 24 hours

Interventionscore on a scale (Mean)
Gabapentin3.4
Control3.4

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Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively

Will assess for known symptoms of gabapentin postoperatively at 2 weeks. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction (NCT02703259)
Timeframe: 2 weeks

,
InterventionParticipants (Count of Participants)
DizzinessBlurred visionSomnolenceDifficulty walkingTremulousnessNauseaVomiting
Control83215271
Gabapentin1241854120

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Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively

Will assess for known symptoms of gabapentin postoperatively at 24 hours. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction (NCT02703259)
Timeframe: 24 hours

,
InterventionParticipants (Count of Participants)
DizzinessBlurred VisionSomnolenceDifficulty walkingTremulousnessNauseaVomiting
Control84231162515
Gabapentin177201311249

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Number of Participants With Treatment Emergent Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 24 hours after discharge (up to 32 hours) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. (NCT02761980)
Timeframe: Baseline up to 24 hours after discharge (up to 32 hours)

InterventionParticipants (Count of Participants)
Placebo1
Ibuprofen 250 mg+Acetaminophen 500 mg1
Ibuprofen 250 mg0
Acetaminophen 500 mg0

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Time to Rescue Medication

Time to rescue medication (other than study treatment) (in minutes) was defined as time from first dosing of study medication to the time a participant first takes a rescue medication, or to the end of the study time for participants that do not take any rescue medication prior to the end of the study. The rescue medication was defined as medication received for the treatment of fever during the time period from the administration of study medication to the time of end of the study. (NCT02761980)
Timeframe: 0 to 8 hours post dose

Interventionminutes (Median)
PlaceboNA
Ibuprofen 250 mg+Acetaminophen 500 mgNA
Ibuprofen 250 mgNA
Acetaminophen 500 mgNA

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Time Weighted Sum of Temperature Difference From 6 to 8 Hours

WSTD 6-8 was defined as time-weighted sum of temperature differences between 6 to 8 hours post-dose, weighted by time elapsed between each 2 consecutive time points within 6 to 8 hours (6.5, 7, 7.5 and 8 hours). Temperature difference was defined as temperature at 6 hours minus the temperature at specified time points (6.5, 7, 7.5 and 8 hours). (NCT02761980)
Timeframe: 6 to 8 hours postdose

Interventiondegrees fahrenheit (Mean)
Placebo4.96
Ibuprofen 250 mg+Acetaminophen 500 mg5.69
Ibuprofen 250 mg5.49
Acetaminophen 500 mg5.84

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Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6

WSTD 0-2, 0-4 and 0-6 was defined as time-weighted sum of temperature differences over each specified time interval (0-2 hour, 0-4 hour and 0-6 hour), weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour), within each time interval. Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point within each specified time interval: 1) 0-2 hour (20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes) , 2) 0-4 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4 hour), 3) 0-6 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour). (NCT02761980)
Timeframe: 0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose

,,,
Interventiondegrees fahrenheit (Mean)
WSTD 0-2WSTD 0-4WSTD 0-6
Acetaminophen 500 mg0.213.417.65
Ibuprofen 250 mg-0.192.616.65
Ibuprofen 250 mg+Acetaminophen 500 mg0.483.697.95
Placebo-0.421.795.26

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Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours

WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). (NCT02761980)
Timeframe: 0 to 8 hours post-dose

Interventiondegrees fahrenheit (Mean)
Placebo9.28
Ibuprofen 250 mg+Acetaminophen 500 mg12.54
Ibuprofen 250 mg11.09
Acetaminophen 500 mg12.39

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Time to Return to Normal Body Temperature

Time to return to normal body temperature was defined as time from initial measurement of normal body temperature (at baseline; before administration of first test dose of RSE to induce pyrexia) till the time at which normal temperature was achieved again after pyrexia. Normal body temperature was defined as the last non-missing body temperature value, assessed prior to or at the time of first RSE test dose. (NCT02761980)
Timeframe: Baseline (pre-dose) up to 8 hours post dose

Interventionminutes (Median)
Placebo360
Ibuprofen 250 mg+Acetaminophen 500 mg330
Ibuprofen 250 mg390
Acetaminophen 500 mg330

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% of Patients Achieving 50% of Max TOTPAR

"Percentage of patients who achieved at least 50% of the maximum TOTPAR at 8 hours. In the present trial the achievable TOTPAR over 8 hours ranges between 0 and 32." (NCT02777970)
Timeframe: 8 hours post-dose

Interventionpercentage of patients (Number)
Tramadol/Dexketoprofen47.7
Tramadol/Paracetamol35.5
Placebo5.3

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% of Patients Achieving at Least 30% of PI (Pain Intensity) Reduction Over 8 Hours Post-dose

Percentage of patients who achieve at least 30% of PI Reduction versus baseline Over 8 Hours Post-dose. Percentage change of PI is calculated using the baseline value minus the PI assessed at 8 hours post-dose divided for the baseline value, then multiplied for 100. (NCT02777970)
Timeframe: 8 hours post-dose

Interventionpercentage of patients (Number)
Tramadol/Dexketoprofen40.0
Tramadol/Paracetamol35.5
Placebo9.9

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% of Patients Requiring RM (Rescue Medication)

Percentage of patients who required RM within the first over 8 hours post-dose. (NCT02777970)
Timeframe: 8 hours post-dose

Interventionpercentage of patients (Number)
Tramadol/Dexketoprofen51.2
Tramadol/Paracetamol55.0
Placebo88.5

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PGE (Patient Global Evaluation)

PGE of the study medication (measured according to a five-point VRS from 1 = poor to 5 = excellent) at 8 hours post-dose or whenever the patient uses Rescue Medication (RM). (NCT02777970)
Timeframe: 8 hours postdose

Interventionunits on a scale (Mean)
Tramadol/Dexketoprofen3.6
Tramadol/Paracetamol2.8
Placebo1.5

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TOTPAR6 (Total Pain Relief Over 6 Hours Post-dose)

"TOTPAR calculated as the weighted sum of the PAR scores, measured according to a 5-point VRS (Verbal Rating Scale) from 0=no relief to 4=complete relief, over 6 hours post-dose (TOTPAR6).~The TOTPAR6 ranges from a minimum of 0 to a maximum of 24." (NCT02777970)
Timeframe: 6 hours post-dose

Intervention5-point Verbal Rating Scale (Mean)
Tramadol/Dexketoprofen13.0
Tramadol/Paracetamol9.2
Placebo1.9

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Time to Confirmed FPPAR (First Perceptible Pain Relief)

"Time to confirmed FPPAR (time to onset of analgesia) - i.e. time to FPPAR if confirmed by experiencing Meaningful Pain Relief (MPAR)~FPPAR and MPAR assessed by using stopwatches:~'first perceptible' PAR (FPPAR), i.e, at the moment they first felt any PAR whatsoever;~'meaningful' PAR (MPAR, ie, when the relief from pain became meaningful to them)" (NCT02777970)
Timeframe: 2 hours post-dose

Interventionminutes (Median)
Tramadol/Dexketoprofen21
Tramadol/Paracetamol24

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers

An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. (NCT02797522)
Timeframe: From first dose of study drug through Day 29 (± 1 day)

,,,,,,
InterventionParticipants (Count of Participants)
>/= 1 TEAE>/= 1 Serious TEAE>/= 1 Related TEAE>/= 1 Related Serious TEAE
NHV Participants: Cohort 11000
NHV Participants: Cohort 22000
NHV Participants: Cohort 33010
NHV Participants: Cohort 44020
NHV Participants: Cohort 53020
NHV Participants: Cohort 62010
NHV Participants: Placebo10030

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Number of Participants With TEAEs: CHB Participants

An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related. (NCT02797522)
Timeframe: From first dose of study drug through Day 142 (± 3 days)

,,,
InterventionParticipants (Count of Participants)
>/= 1 TEAE>/= 1 Serious TEAE>/= 1 Related TEAE>/= 1 Related Serious TEAE
CHB Participants: Cohort 3b2000
CHB Participants: Cohort 3c4020
CHB Participants: Cohort 4b1111
CHB Participants: Cohort 4c1000

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Number of Participants Requiring Additional Anti-emetics

Number of Participants Requiring Additional Anti-emetics (anti-vomiting) (NCT02832687)
Timeframe: From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

InterventionParticipants (Count of Participants)
Normal Saline8
Acetaminophen7

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The Level of C-reactive Protein

Concentration of the plasma C-reactive protein (CRP) (NCT02832687)
Timeframe: Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU)

,
Interventionpg/ml *1000 (Median)
CRP after IVCRP in ORCRP 1h in PACU
Acetaminophen1710.91410.71090.1
Normal Saline1062.6893.4746.6

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Readiness for Discharge

Number (percentage) of Participants with Readiness for Discharge (achieving discharge-readiness status at end of 2- hours post-surgery evaluated using the SPEEDs criteria: oxygen saturation, pain control, emesis control, extremity movement, dialogue, and stable vital signs. (NCT02832687)
Timeframe: 2 hours following surgery

InterventionParticipants (Count of Participants)
Normal Saline26
Acetaminophen33

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Plasma Stress Markers

Concentration of the plasma stress markers including epinephrine, norepinephrine, cortisol, interleukins (IL) 6, 8 and 10. (NCT02832687)
Timeframe: Before administration of any drug (after placement of intravenous (IV) line), before surgical incision (in operating room (OR)), and 1 h after arrival in post-anesthesia care unit (PACU)

,
Interventionpg/ml (Median)
Epinephrine After IVEpinephrine In OREpinephrine 1h in PACUNorepinephrine After IVNorepinephrine In ORNorepinephrine 1h in PACUCortisol After IVCortisol in ORCortisol 1h in PACUIL-6 after IVIL-6 in ORIL-6 1h in PACUIL-8 after IVIL-8 in ORIL-8 1h in PACUIL-10 after IVIL-10 in ORIL-10 1h in PACU
Acetaminophen655812864454788454.649150.12.329.98.36.412.511.91.9
Normal Saline484215264353268950.545.6175.91.41.67.98.76.613.70.60.51.9

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Total Dosage of Post Operative Opioids

Total dosage of post operative opioids (hydromorphone) (NCT02832687)
Timeframe: From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.

Interventionmg (Median)
Normal Saline1.2
Acetaminophen1

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Time to Rescue Pain Medication

Time to the first dose of pain medication (NCT02832687)
Timeframe: From arrival in PACU to the first dose of pain medication is given during 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.

Interventionminutes (Median)
Normal Saline19
Acetaminophen23

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Post Operative Pain Scores

"Pain scores every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour.~Visual Analogue Scale (VAS) for pain was used: score on a scale from 0 (no pain) to 10 (worst pain) were recorded." (NCT02832687)
Timeframe: Every 15 min for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

,
Interventionscore on a scale from 0 to 10 (Median)
15 minutes30 minutes45 minutes60 minutes75 minutes90 minutes105 minutes120 minutes
Acetaminophen77644333
Normal Saline98755556.5

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Patient Satisfaction Survey

Survey asking patients about their satisfaction with the experience, pain control, and anesthetic rated on a 5 point Likert scale, with 1 being dissatisfied/unlikely and 5 being most satisfied/very likely. Subscales were summed to receive total score. (NCT02832687)
Timeframe: For patients going home the day of surgery the survey is given prior to departing the hospital (approx 5 hours post surgery). For those being admitted, the survey is given once discharge criteria are met in the PACU (approx 3 hours post surgery).

Interventionscore on a scale (Median)
Normal Saline4
Acetaminophen4

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Number of Participants With Post Operative Nausea and Vomiting

Number of Participants with Post Operative Nausea and Vomiting (NCT02832687)
Timeframe: From arrival in PACU for 2 hours or until achieving discharge-readiness, whatever comes first, an average of 1 hour

InterventionParticipants (Count of Participants)
Normal Saline9
Acetaminophen10

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Subject Satisfaction at 48 Hours

Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. (NCT02839876)
Timeframe: 48 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen9
Oral Acetaminophen9

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Subject Satisfaction at 24 Hours

Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. (NCT02839876)
Timeframe: 24 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen9
Oral Acetaminophen9

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Straight Leg Raise

Number of participants who are able to complete the active straight leg test. The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level. If the subject can do this, the test is positive. (NCT02839876)
Timeframe: Postoperative day 1

InterventionParticipants (Count of Participants)
Intravenous Acetaminophen16
Oral Acetaminophen11

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Self-paced Walk Test

Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point. (NCT02839876)
Timeframe: Postoperative day 1

Interventionseconds (Mean)
Intravenous Acetaminophen86
Oral Acetaminophen63

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Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)

Pain scores (using NRS-11 scale) at with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 1 hour after arrival to PACU

Interventionscore on a scale (Median)
Intravenous Acetaminophen2.0
Oral Acetaminophen2.0

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Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)

Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 1 hour after arrival to PACU

Interventionscore on a scale (Median)
Intravenous Acetaminophen1.0
Oral Acetaminophen1.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)

Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: preoperatively

Interventionscore on a scale (Median)
Intravenous Acetaminophen7.0
Oral Acetaminophen7.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)

Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: preoperatively

Interventionscore on a scale (Median)
Intravenous Acetaminophen1.0
Oral Acetaminophen2.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)

Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 8 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen3.0
Oral Acetaminophen5.5

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)

Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 8 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen2.0
Oral Acetaminophen3.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)

Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 48 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen5.0
Oral Acetaminophen5.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)

Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 48 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen2.0
Oral Acetaminophen2.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)

Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 36 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen5.0
Oral Acetaminophen4.5

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)

Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 36 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen3.0
Oral Acetaminophen2.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)

Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 24 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen5.0
Oral Acetaminophen4.0

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Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)

Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: 24 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen2.0
Oral Acetaminophen1.0

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Opioid Consumption (Other)

morphine equivalent units of intravenous and oral opioids (NCT02839876)
Timeframe: 0-48 hours

Interventionmorphine milliequivalent (Median)
Intravenous Acetaminophen6.2
Oral Acetaminophen6.8

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Number of Participants Able to Complete the Supine to Sit Test

Number of participants able to go from supine to a sitting position independently. (NCT02839876)
Timeframe: Postoperative day 1

InterventionParticipants (Count of Participants)
Intravenous Acetaminophen10
Oral Acetaminophen6

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Heel Slide Test

Number of participants who are able to complete the heel-slide test. The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion. If the subject can do this, the test is positive. If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative. (NCT02839876)
Timeframe: Postoperative day 1

InterventionParticipants (Count of Participants)
Intravenous Acetaminophen25
Oral Acetaminophen16

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Analgesic Consumption as Measured by Patient Diary

morphine equivalent units of oral opioids and other non-opioids (NCT02839876)
Timeframe: day 30

Interventionmg (Median)
Intravenous Acetaminophen0
Oral Acetaminophen0

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24 Hour Opioid Consumption

Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively (NCT02839876)
Timeframe: 24 hours

Interventionmorphine milliequivalent (Median)
Intravenous Acetaminophen3.0
Oral Acetaminophen3.4

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Overall Hospital Admission Costs

difference in total hospital admission cost between groups (NCT02839876)
Timeframe: 0-72 hours

InterventionUS dollars (Median)
Intravenous Acetaminophen14682
Oral Acetaminophen14782

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Hospital Length of Stay

Time to both discharge readiness and to actual discharge (NCT02839876)
Timeframe: 0-72 hours

Interventiondays (Median)
Intravenous Acetaminophen1
Oral Acetaminophen1

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Worst Pain (Day 30)

Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain). (NCT02839876)
Timeframe: day 30

Interventionscore on a scale (Median)
Intravenous Acetaminophen1.0
Oral Acetaminophen0

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Subject Satisfaction at 48 Hours (48 Hours)

Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied. (NCT02839876)
Timeframe: 48 hours

Interventionscore on a scale (Median)
Intravenous Acetaminophen9
Oral Acetaminophen9

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Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen

The area under the plasma drug concentration-time curve (AUC) is an estimate of how much drug remains available for the body to use, within a certain amount of time after the drug is administered. AUC6 is reported for each of the 6-hour dosing periods of acetaminophen before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration (NCT02848729)
Timeframe: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration

,,,
Interventionhour*microgram per milliliter (h*mcg/mL) (Mean)
Treatment A: Oral AcetaminophenTreatment B: IV Acetaminophen
First Dose - Before Morphine Co-administration31.0042.56
Fourth Dose - After Morphine Co-administration52.3849.05
Second Dose - During Morphine Co-administration28.5144.37
Third Dose - During Morphine Co-administration25.3143.59

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Maximum Concentration (Cmax) of Acetaminophen

Following the administration of drugs, the plasma concentration generally reaches a single, well-defined peak which is the most drug that is available for the body to use (Cmax). Cmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12), and after (hours 12-18) morphine co-administration for each route of acetaminophen administration. (NCT02848729)
Timeframe: hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration

,,,
Interventionmcg/mL (Mean)
Treatment A: Oral AcetaminophenTreatment B: IV Acetaminophen
First Dose - Before Morphine Co-administration11.622.6
Fourth Dose - After Morphine Co-administration13.528.5
Second Dose - During Morphine Co-administration7.2917.0
Third Dose - During Morphine Co-administration7.2517.5

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Time to Maximum Concentration (Tmax) of Acetaminophen

Following the administration of drugs, the time at which the plasma concentration reaches Cmax is called Tmax. Tmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration. (NCT02848729)
Timeframe: hours -6 to 0, 0-6, 6-12 and 12-18 during treatment with each mode of acetaminophen administration

,,,
Interventionhours (Mean)
Oral AcetaminophenIV Acetaminophen
First Dose - Before Morphine Co-administration1.480.25
Fourth Dose - After Morphine Co-administration2.840.25
Second Dose - During Morphine Co-administration1.640.50
Third Dose - During Morphine Co-administration3.260.51

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Area Under the Plasma Concentration-time Curve Over 18 Hours (AUC18) for Acetaminophen After First Morphine Co-administration

AUC18 is reported for the 18-hour treatment period after first morphine co-administration, for each route of acetaminophen administration (NCT02848729)
Timeframe: hours 0-18 during treatment with each mode of acetaminophen administration

Interventionhour*microgram per milliliter (h*mcg/mL) (Mean)
Treatment A: Oral AcetaminophenTreatment B: IV Acetaminophen
After First Dose of Morphine Co-administration82.5063.58

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Postoperative Duration of Hospital Stay

The investigators will measure postoperative time to discharge (NCT02881996)
Timeframe: 1 week

Interventiondays (Median)
IV Tylenol3.9
No IV Tylenol4.5

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Time Until PCA Discontinued After the Operation

The investigators hypothesize that the use of intravenous (IV) acetaminophen in addition to IV ketorolac with narcotic pain pump will decrease time to transition off PCA/NCA to oral pain medications. (NCT02881996)
Timeframe: 4 days

Interventionhours (Mean)
IV Tylenol76.4
No IV Tylenol86.7

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Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen

A brief survey on satisfaction with pain control during the first 24 hours post-partum and the second 24 hours post-partum, as well as overall during post-partum stay will be administered prior to discharge using a 1-5 Likert scale: 1=not satisfied to 5=extremely satisfied. (NCT02891174)
Timeframe: 24 hours and 48 hours after initial study medication administration

,
Interventionunits on a scale (Median)
Period 1Period 2Overall
Acetaminophen Followed by Ibuprofen44.54.5
Ibuprofen Followed by Acetaminophen333

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Mean Pain Score by Nursing Assessment

Pain scores using a 0-10 scale as assessed by nursing during the 48 hours from initial study medication administration will be abstracted from the participant's medical record. Clinical Pain Scale: 0=no pain to 10=worst pain. All pain scores during the first intervention (0-24 hours) and second intervention (24-48) are included according to intention-to-treat principles. (NCT02891174)
Timeframe: 0-24 hours and 24-48 hours after initial study medication administration

Interventionscore on a scale (Mean)
Ibuprofen2.2
Acetaminophen2.3

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Change in Self-reported Pain Score 2 Hours After First Intervention

Prior to the first dose of pain medication, participants will take a brief, self-administered survey to assess abdominal and overall pain using a 0-10 scale. Two hours after the first dose of study drug, participants will repeat the self-administered survey to assess abdominal, perineal, and overall pain using a 0-10 scale. Clinical Pain Scale: 0=no pain to 10=worst pain. (NCT02891174)
Timeframe: At the time of first dose of study drug and 2 hours after

,
Interventionscore on a scale (Mean)
Abdominal painPerineal painOverall pain
Acetaminophen-0.31.0-0.6
Ibuprofen-0.6-1.1-0.7

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Difference in Systolic Blood Pressure (SBP)

The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen. (NCT02891174)
Timeframe: 24 hours following intervention

,
InterventionmmHg (Mean)
Baseline systolic blood pressureSystolic blood pressure after exposureObserved Difference in systolic blood pressure
Acetaminophen132.0129.1-2.9
Ibuprofen131.8129.1-2.7

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Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.

To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing diastolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of diastolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of diastolic blood pressures from 24 hours to 47 hours after delivery. (NCT02902172)
Timeframe: 2 days

InterventionmmHg (Mean)
Acetaminophen0.4
NSAID2.7

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Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.

To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery. (NCT02902172)
Timeframe: 2 days

InterventionmmHg (Mean)
Acetaminophen7.5
NSAID5

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Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima

Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima. (NCT02910167)
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 days

InterventionPercentage of Patients (Number)
Patient took the medication with liquids (Yes)Patient took the medication with liquids (No)Type of liquid used (Water)Type of liquid used (Juice)Type of liquid used (Other)Amount of liquid used (A straw/sip)Amount of liquid used (1/4 cup)Amount of liquid used (1/2 cup)Amount of liquid used (A full cup)Amount of liquid used (More than a cup)Storage of medicine (In a dry and fresh location)Storage of medicine (In a hot location)Storage of medicine (In the refrigerator)Storage of medicine (Other)Reason - Not taking medicine (No symptoms anymore)Reason - Not taking medicine (Forgot it)Reason - Not taking medicine (Had no time)Reason - Not taking medicine (Other)Reason - Not taking medicine (No answer)
Buscapina Compositum N100.00.094.782.90.33.833.044.718.198.00.30.01.851.423.45.612.27.5

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Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment

Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N. (NCT02910167)
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 days

InterventionPercentage of Patients (Number)
Abdominal pain (upper)DiarrhoeaNauseaConstipationAbdominal PainDizzinessSomnolenceCoughUrine color abnormalHeadache + nauseaNausea + constipationFlatulence + constipationPolydipsia + abdominal pain (upper)
Buscapina Compositum N0.30.30.30.30.30.31.20.30.30.30.30.30.3

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Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients

Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients. (NCT02910167)
Timeframe: From the initial dose of study drug until end of the follow up period, up to 113 days

InterventionPercentage of Patients (Number)
Buscapina Compositum N0.0

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Length of Hospitalization

number of days from delivery until hospital discharge (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

Interventiondays (Mean)
Acetaminophen4.0
Ibuprofen3.8

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Mean Arterial Pressure Over the Entire Postpartum Hospitalization

computed mean arterial pressure using all measured blood pressures during postpartum hospitalization (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionmmHg (Mean)
Acetaminophen97.3
Ibuprofen37.6

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Mean Daily Pain Level, as Reported by Patient on Scale From 1-10, Stratified by Postpartum Day

Mean daily pain level, as reported by patient on scale from 1-10 (10 is most severe). (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

Interventionunits on a scale (Mean)
Acetaminophen2.4
Ibuprofen1.8

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Mean Maximum Measured Blood Pressure for Entire Postpartum Hospitalization (in mm Hg)

(NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

Interventionmm Hg (Mean)
Acetaminophen165
Ibuprofen168

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Need for Antihypertensives (Either Oral or Intravenous) for Acute Lowering of Blood Pressure

Proportion in each arm who required one or more doses of antihypertensive medication given for acute lowering of BP (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen26
Ibuprofen30

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Proportion of Study Participants in Each Study Arm Who Have Any Postpartum Severe Range BPs

Severe-range hypertension (defined as SBP > 160 mmHg or DBP >1100 mmHg) during postpartum stay (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen31
Ibuprofen34

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Proportion of Study Participants in Each Study Arm With Delayed Postpartum Hemorrhage

Delayed postpartum hemorrhage is defined as > 1000 mL of blood loss occuring > 24 hours after delivery (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen0
Ibuprofen0

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Proportion of Study Participants in Each Study Arm With New Onset Postpartum Acute Kidney Injury

Acute kidney injury is defined as serum creatinine > 1.1mg/dL or double the baseline value (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen0
Ibuprofen0

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Proportion of Study Participants in Each Study Arm With New Onset Postpartum Elevation of Liver Function Tests (AST, ALT) Above Twice the Normal Limit

AST: Aspartate aminotransferase; ALT: alanine aminotransferase (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen1
Ibuprofen0

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Proportion of Study Participants Requiring the Use of Scheduled Oral Antihypertensives at Discharge

(NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen31
Ibuprofen33

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The Proportion of Study Participants Requiring the Use of Intravenous Antihypertensives

The proportion of study participants in each study arm who require any IV antihypertensives to acutely lower blood pressure during their postpartum hospital stay. (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen26
Ibuprofen30

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Use of Opioid Analgesics, Measured in Morphine Milligram Equivalents Per Day, Stratified by Postpartum Day

(NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

,
Interventionmorphine equivalents, mg (Mean)
postpartum day 0postpartum day 1postpartum day 2
Acetaminophen22.632.345.4
Ibuprofen22.127.528.9

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Composite of Adverse Events

Adverse events include seizure, stroke, posterior reversible encephalopathy syndrome, repeat course of IV magnesium sulfate for seizure prophylaxis. (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

InterventionParticipants (Count of Participants)
Acetaminophen0
Ibuprofen0

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Duration of Severe-range Hypertension After Delivery

length of time from delivery to the last severe range blood pressure (160/110mm Hg) measured (NCT02911701)
Timeframe: duration of postpartum hospitalization (approximately 3-7 days)

Interventionhours (Mean)
Acetaminophen38.0
Ibuprofen35.3

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Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose

Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst) to 10 (best). (NCT02912650)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose

,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 12 hours
Acetaminophen 650 mg5.716.024.7
Ibuprofen 250 mg6.323.136.3
Ibuprofen 250 mg + Acetaminophen 500 mg7.727.541.8
Placebo0.32.96.8

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Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])

Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). (NCT02912650)
Timeframe: 6 to 8 hours post-dose

Interventionunits on a scale (Mean)
Placebo1.9
Ibuprofen 250 mg + Acetaminophen 500 mg11.3
Ibuprofen 250 mg9.5
Acetaminophen 650 mg5.6

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Cumulative Percentage of Participants With Confirmed First Perceptible Relief

Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy. (NCT02912650)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,
Interventionpercentage of participants (Number)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Acetaminophen 650 mg26.157.071.571.571.571.571.571.571.571.571.571.571.571.571.5
Ibuprofen 250 mg25.161.777.179.479.479.479.479.479.479.479.479.479.479.479.4
Ibuprofen 250 mg + Acetaminophen 500 mg29.766.981.484.985.586.686.686.686.686.686.686.686.686.686.6
Placebo8.916.121.425.025.028.628.628.628.628.628.628.628.628.628.6

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Cumulative Percentage of Participants With Meaningful Relief

"Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy." (NCT02912650)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,
Interventionpercentage of participants (Number)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Acetaminophen 650 mg1.821.852.158.267.367.367.969.169.769.770.371.571.571.571.5
Ibuprofen 250 mg0.013.746.360.075.475.477.178.378.978.978.978.979.479.479.4
Ibuprofen 250 mg + Acetaminophen 500 mg1.221.559.368.682.082.083.184.385.585.585.585.585.585.585.5
Placebo0.00.03.68.916.121.423.226.826.826.826.826.828.628.628.6

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Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])

Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score). (NCT02912650)
Timeframe: 0 to 8 hours post-dose

Interventionunits on a scale (Mean)
Placebo4.1
Ibuprofen 250 mg + Acetaminophen 500 mg34.3
Ibuprofen 250 mg28.9
Acetaminophen 650 mg19.4

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Participant's Global Evaluation of Study Medication

Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent. (NCT02912650)
Timeframe: 0 to 12 hours post-dose

Interventionunits on a scale (Mean)
Placebo1.0
Ibuprofen 250 mg + Acetaminophen 500 mg3.4
Ibuprofen 250 mg3.0
Acetaminophen 650 mg2.6

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Cumulative Percentage of Participants With Treatment Failure

Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported. (NCT02912650)
Timeframe: 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,
Interventionpercentage of participants (Number)
1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Acetaminophen 650 mg6.710.318.827.935.238.844.251.556.460.062.463.6
Ibuprofen 250 mg6.910.313.116.618.321.725.733.142.348.655.460.0
Ibuprofen 250 mg + Acetaminophen 500 mg2.94.17.07.68.110.516.924.435.546.551.755.8
Placebo39.351.862.564.366.167.969.669.669.669.669.671.4

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Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours

Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported. (NCT02912650)
Timeframe: 6 hours, 8 hours post-dose

,,,
Interventionpercentage of participants (Number)
6 hour8 hour
Acetaminophen 650 mg38.851.5
Ibuprofen 250 mg21.733.1
Ibuprofen 250 mg + Acetaminophen 500 mg10.524.4
Placebo67.969.6

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Pain Intensity Difference on 11-Point Numerical Scale (PID11)

PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score). (NCT02912650)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Acetaminophen 650 mg0.72.03.33.43.32.92.72.62.21.81.61.41.41.31.2
Ibuprofen 250 mg0.51.83.33.94.34.54.34.23.83.12.62.31.91.61.6
Ibuprofen 250 mg + Acetaminophen 500 mg0.62.24.14.85.15.35.25.04.43.83.12.42.01.71.5
Placebo0.00.20.20.10.20.60.60.70.70.60.60.60.70.70.7

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Pain Intensity Difference on 4-Point Categorical Scale (PID4)

PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). (NCT02912650)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Acetaminophen 650 mg0.200.610.980.980.920.810.740.750.630.500.450.360.370.320.27
Ibuprofen 250 mg0.120.460.891.091.221.251.211.131.020.830.670.600.500.400.39
Ibuprofen 250 mg + Acetaminophen 500 mg0.150.601.181.361.471.551.151.441.271.040.880.690.520.450.38
Placebo0.000.050.040.000.050.160.160.140.160.130.110.110.130.130.13

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Pain Relief Rating (PRR) Score

"Participants answered a question: how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief." (NCT02912650)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Acetaminophen 650 mg0.501.201.861.901.861.661.551.501.291.141.030.950.950.880.85
Ibuprofen 250 mg0.361.111.852.082.282.352.272.182.011.681.401.311.191.030.97
Ibuprofen 250 mg + Acetaminophen 500 mg0.511.292.192.472.652.752.712.642.362.041.751.411.201.060.97
Placebo0.180.300.440.480.550.700.710.730.800.770.730.730.750.780.75

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Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)

PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief. (NCT02912650)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

,,,
Interventionunits on a scale (Mean)
0.25 hour0.5 hour1 hour1.5 hour2 hour3 hour4 hour5 hour6 hour7 hour8 hour9 hour10 hour11 hour12 hour
Acetaminophen 650 mg0.71.82.82.92.82.52.32.21.91.61.51.31.31.21.1
Ibuprofen 250 mg0.51.62.73.23.53.63.53.33.02.52.11.91.71.41.4
Ibuprofen 250 mg + Acetaminophen 500 mg0.71.93.43.84.14.34.24.13.63.12.62.11.71.51.3
Placebo0.20.40.50.50.60.90.90.91.00.90.80.80.90.90.9

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Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose

Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12 and -3 (worst score) to 9 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score). (NCT02912650)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose

,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 8 hours0 to 12 hours6 to 8 hours
Acetaminophen 650 mg1.64.65.56.81.6
Ibuprofen 250 mg1.76.47.99.82.5
Ibuprofen 250 mg + Acetaminophen 500 mg2.28.09.911.93.2
Placebo0.10.70.91.40.4

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Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose

TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours. TOTPAR total score range: 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief. (NCT02912650)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose

,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 12 hours
Acetaminophen 650 mg3.29.215.0
Ibuprofen 250 mg3.512.319.9
Ibuprofen 250 mg + Acetaminophen 500 mg4.114.623.0
Placebo0.93.88.3

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Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose

TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief. (NCT02912650)
Timeframe: 0 to 8 hours, 6 to 8 hours post-dose

,,,
Interventionunits on a scale (Mean)
0 to 8 hours6 to 8 hours
Acetaminophen 650 mg11.43.5
Ibuprofen 250 mg15.45.1
Ibuprofen 250 mg + Acetaminophen 500 mg18.46.2
Placebo5.32.3

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Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose

SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief. (NCT02912650)
Timeframe: 0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose

,,,
Interventionunits on a scale (Mean)
0 to 2 hours0 to 6 hours0 to 8 hours0 to 12 hours6 to 8 hours
Acetaminophen 650 mg4.913.816.921.95.0
Ibuprofen 250 mg5.218.623.229.67.6
Ibuprofen 250 mg + Acetaminophen 500 mg6.322.528.234.99.3
Placebo0.94.56.29.72.7

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Time to Treatment Failure

Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. (NCT02912650)
Timeframe: 0 to 12 hours post-dose

Interventionminutes (Median)
Placebo107.0
Ibuprofen 250 mg + Acetaminophen 500 mg629.0
Ibuprofen 250 mg608.5
Acetaminophen 650 mg449.0

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Time to Onset of Meaningful Pain Relief

"Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy." (NCT02912650)
Timeframe: 0 to 12 hours post-dose

Interventionminutes (Median)
PlaceboNA
Ibuprofen 250 mg + Acetaminophen 500 mg47.9
Ibuprofen 250 mg65.9
Acetaminophen 650 mg56.6

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Time to Confirmed Onset of First Perceptible Relief

Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy. (NCT02912650)
Timeframe: 0 to 12 hours post-dose

Interventionminutes (Median)
PlaceboNA
Ibuprofen 250 mg + Acetaminophen 500 mg21.3
Ibuprofen 250 mg24.6
Acetaminophen 650 mg24.2

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NICU Admission

Rate of admission to the neonatal intensive care unit (NCT02922985)
Timeframe: after birth and before hospital discharge

InterventionParticipants (Count of Participants)
Placebo Control Group2
Multimodal Pain Regimen Group6

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Need for Respiratory Support

neonate receipt of oxygen by nasal cannula or mechanical ventilation (NCT02922985)
Timeframe: after birth and before hospital discharge

InterventionParticipants (Count of Participants)
Placebo Control Group0
Multimodal Pain Regimen Group4

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Hospital Length of Stay

Time to discharge from hospital, measured in hours (NCT02922985)
Timeframe: From time of hospital admission to time of discharge home up to 168 hours.

Interventionhours (Median)
Placebo Control Group50.2
Multimodal Pain Regimen Group50

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Apgar Score at 5 Minutes

This is the Apgar score of the newborn collected at 5 minutes. Range is from 0-10, with the higher scores meaning a better outcome. (NCT02922985)
Timeframe: 5 minutes after birth

Interventionscore on a scale (Median)
Placebo Control Group9
Multimodal Pain Regimen Group9

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Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)

Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents (NCT02922985)
Timeframe: 48 hours post cesarean delivery

Interventionmorphine milligram equivalents (Median)
Placebo Control Group42
Multimodal Pain Regimen Group49.5

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Time to First Administration of Opioid Pain Medication Post Operatively

Time, in hours, to first administration of opioid pain medication post operatively (NCT02922985)
Timeframe: 48 hours post cesarean delivery

Interventionhours (Median)
Placebo Control Group6.05
Multimodal Pain Regimen Group6.35

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Pain Score at 6-12 Hours Post Operatively

Pain score at 6-12 hours post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome). (NCT02922985)
Timeframe: 6-12 hours post-operatively

Interventionscore on a scale (Median)
Placebo Control Group6
Multimodal Pain Regimen Group6

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Pain Score at 48 Hours Post-operatively

Pain Score at 48 Hours Post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome). (NCT02922985)
Timeframe: 48 hours post-operatively

Interventionscore on a scale (Median)
Placebo Control Group4
Multimodal Pain Regimen Group3

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Pain Score at 24 Hours Post-operatively

Pain Score at 24 Hours Post Operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome). (NCT02922985)
Timeframe: 24 hours post-operatively

Interventionscore on a scale (Median)
Placebo Control Group5
Multimodal Pain Regimen Group6

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Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.

Number of opioid pain tablets remaining on post-operative day #7 from hospital discharge as reported by patients (NCT02922985)
Timeframe: 7 days post delivery

InterventionTablets (Median)
Placebo Control Group18
Multimodal Pain Regimen Group19

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Number of Participants That Did Not Need Opioid Analgesic Prescriptions

To determine the number of patients who did not require prescribed opioid analgesic'rescue' after pharmacogenomic-guided acute postoperative dental pain management versus those taking the non-guided combined formulation of hydrocodone and acetaminophen. (NCT02932579)
Timeframe: 6 hours

InterventionParticipants (Count of Participants)
Standard of Care7
Pharmacogenomic Group4

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Mean Pain Score

To compare the pain control outcomes between a single-dose of pharmacogenomics- testing-driven-prescription of ibuprofen (400mg) or acetaminophen (650mg) with those of single-dose (standard of care) of combined formulation of hydrocodone and acetaminophen (5/650mg). A visual analog scale for dental pain will be used. Scale ranges from 0-100 with 100 worse pain. (NCT02932579)
Timeframe: 6 hours

Interventionunits on a scale (Mean)
Standard of Care41.9
Pharmacogenomic Group28.9

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Difference in Number of Days Requiring Rescue Pain Medication

The number of days on narcotic pain medication following surgery will be compared between the two treatment groups (NCT02934191)
Timeframe: 2 weeks post-operative

InterventionDays (Mean)
Acetaminophen/Oxycodone + Celecoxib5.00
Acetaminophen/Oxycodone + Placebo5.75

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Difference in Amount of Rescue Pain Medication Consumed

The total amount of rescue pain medication consumed in the 2-week postop period will be compared between the two treatment groups. (NCT02934191)
Timeframe: 2 weeks post-operative

Interventionmg/kg (Mean)
Acetaminophen/Oxycodone + Celecoxib1.03
Acetaminophen/Oxycodone + Placebo1.40

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Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)

AST was a measure of executive attention. The test displayed an arrow which can appear on either side of the screen and can point in either direction. Each trial displayed a cue at the top of the screen that indicates whether to press the right or left button. Some trials displayed congruent stimuli (e.g. arrow on the right side of the screen pointing to the right) whereas other trials display incongruent stimuli which require a higher cognitive demand (e.g. arrow on the right side of the screen pointing to the left). The AST congruency cost was the difference between the median latencies of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. It was calculated by subtracting the median of congruent from incongruent latency. A positive score indicated response was faster on congruent trials and a negative score indicated response was faster on incongruent trials. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
Interventionmsec (Median)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol46.2523.00
Paracetamol and Caffeine-3.25-8.25
Placebo2.5022.50

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Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)

OTS was a measure of executive function and takes approximately 10 minutes to complete. The participant was shown two displays containing three coloured balls. The displays were presented in such a way that they can easily be perceived as stacks of coloured balls held in stockings or socks suspended from a beam. There was a row of numbered boxes along the bottom of the screen. The test administrator first demonstrated to the participant how to use the balls in the lower display to copy the pattern in the upper display, and completed one demonstration problem, where the solution requires one move. The participant then completed three further problems, one each of two moves, three moves, and four moves. Next, the participant was shown further problems, and participants worked out in their head how many moves the solutions to these problems required, and then touch the appropriate box at the bottom of the screen to indicate their response. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
InterventionOTS of correct first box choice (Mean)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol0.002.17
Paracetamol and Caffeine-2.67-1.83
Placebo-0.20-1.40

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Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)

RVP task was measures of attention. A white box appeared in the centre of the computer screen, inside which digits, from 2 to 9, appeared in a pseudo-random order, at the rate of 100 digits per minute. Participants were requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. The RVPA (A prime) was the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range will be 0.00 to 1.00; bad to good). RVP metric was a measure of how good the subject was at detecting target sequences. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
Interventionmsec (Median)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol0.00-0.01
Paracetamol and Caffeine-0.04-0.02
Placebo-0.030.00

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Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)

This task was a measure of grip strength. The participant held the dynamometer in their dominant hand and the arm was swung from above the head to by the side of the body. If the dominant arm or hand was painful then the non-dominant hand was used. The participant was instructed to assert maximum effort during the squeezing motion and maintain it for about 4 seconds using a metronome. Participant conducted the movement 4-times (1 practice effort and 3 test efforts) and there was a 1-minute recovery period between each effort. (NCT02974114)
Timeframe: At Day 2 (pre and post-treatment) and Day 3 of the study

,,
InterventionKilogram (Kg) (Mean)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol-3.87-2.80
Paracetamol and Caffeine-1.980.68
Placebo-1.70-0.46

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Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)

From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. GRF was measured during the movement analyzed using a force plate interfaced with a computer. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
InterventionNewtons (Mean)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol-19.80-13.85
Paracetamol and Caffeine3.354.21
Placebo3.753.08

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Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)

Error adjusted SRT was one of the main outcomes of the Axon Sports Priming Application. The Axon Sports Priming Application is a computerized test performed on a tablet device that measures cognitive performance, namely psychomotor speed. Axon sports test assessment included 1. Pain-state assessment performed at Visit 2 (Day 2 pre-treatment assessment and post-treatment assessment 1hour [hr] ± 15 minutes [mins] post-dosing) and 2. Pain-free assessment performed at Visit 3 (Day 3). (NCT02974114)
Timeframe: At Day 2 (pre and post-treatment) and Day 3 of the study

,,
Interventionmilliseconds (msec) (Median)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol0.070.01
Paracetamol and Caffeine0.050.04
Placebo0.060.00

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Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)

The reaction time of five-choice reaction time task (provided by Cambridge Cognition) was measured. In five-choice reaction time task, all the participants hold down a button at the bottom of the screen till a yellow spot appears in one of the five circles at the top of the screen. Participants then released the button and touch inside of the circle where the yellow spot appeared as quickly as they can. The median duration, between the onset of the stimulus and the release of the button, was recorded as reaction time. Calculated for correct, assessed trials where the stimulus appeared in any one of five locations. (NCT02974114)
Timeframe: At Day 2 (pre and post-treatment) and Day 3 of the study

,,
Interventionmsec (Median)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol-1.7512.50
Paracetamol and Caffeine2.0025.75
Placebo-1.00-8.00

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Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)

SWM task was a measure of working memory. The task involved number of coloured squares (boxes) being shown on the screen. The aim of this test was to find one blue token in the boxes shown to the participants by process of elimination and used these to fill up an empty column on the right-hand side of the screen. The number of boxes gradually increased up to a maximum of eight boxes to search and the colour and position of the boxes changed from trial to trial. SWM between errors was defined as times the participant revisited a box in which a token has previously been found. This was calculated for trials of four, six and eight tokens. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
InterventionSWM between errors (Mean)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol25.1713.50
Paracetamol and Caffeine-9.334.83
Placebo13.80-9.80

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Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)

Participants performed a walking assessment in comfortable walking shoes to measure gait parameter stride length. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
InterventionCentimeter (Mean)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol-0.08-0.06
Paracetamol and Caffeine-0.06-0.04
Placebo-0.02-0.04

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Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)

Time to standing provides a simple assessment of physical mobility. From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Time to standing recorded which was measured using a stopwatch. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
InterventionSeconds (Median)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol0.13-0.08
Paracetamol and Caffeine0.10-0.01
Placebo0.090.04

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Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)

Participants performed a walking assessment in comfortable walking shoes to measure gait parameter walking speed over 5-10m for each foot. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first. (NCT02974114)
Timeframe: At Day 2 (pre and post-treatment) and Day 3

,,
Interventionmeters/second (Mean)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol-0.10-0.07
Paracetamol and Caffeine-0.11-0.10
Placebo-0.02-0.03

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Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)

Participants performed a walking assessment in comfortable walking shoes to measure gait parameter contact phase. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first. (NCT02974114)
Timeframe: At Day 2 (pre and post treatment) and Day 3 of the study

,,
InterventionSeconds (Median)
Change from pain-free state at Day 2 pre-treatmentChange from pain-free state at Day2 post-treatment
Paracetamol0.030.02
Paracetamol and Caffeine0.030.03
Placebo0.000.01

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Proportion of Patients With Severe Pain Score of 7 or Higher

A secondary endpoint is the proportion of patients with pain scores in the severe pain range (7 or higher) on numeric pain rating scale of 0 to 10; higher score more severe. (NCT02994940)
Timeframe: 24 hrs period following surgery

InterventionParticipants (Count of Participants)
Oral Acetaminophen15
Intravenous Acetaminophen17

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Plasma Acetaminophen Level 1 - End of Surgery

mg/L acetaminophen in the plasma at the end of surgery (NCT02994940)
Timeframe: at the end of surgery, about 1 hour after IV Dose

Interventionmg/L (Median)
Oral Acetaminophen22
Intravenous Acetaminophen20

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Plasma Acetaminophen Level 2 - 3 Hours After IV Study Drug Administration

mg/L acetaminophen in the plasma 3 hours after IV study drug administration (NCT02994940)
Timeframe: Outcome will be measured 3hrs post first IV Dose

Interventionmg/L (Median)
Oral Acetaminophen18
Intravenous Acetaminophen11

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Total Dose of Opioid

Total dose of opioid, in morphine equivalents, that the patient receives for breakthrough pain in the 24 hour period following surgery. (NCT02994940)
Timeframe: Within 24hrs

Interventionmcg/kg (Median)
Oral Acetaminophen147.6
Intravenous Acetaminophen125.4

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Percentage of Participants With Objective Response

Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC. (NCT02999633)
Timeframe: Baseline until disease progression or death (maximum duration: 12.1 weeks)

Interventionpercentage of participants (Number)
Isatuximab0

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Opioid Use

Oral morphine equivalents, cumulative, POD 0-3. Recorded in Medication Usage Database. (NCT03020966)
Timeframe: Day of surgery to post-operative day 3

InterventionOral Morphine Equivalent (mg) (Mean)
Oral Tylenol108
Intravenous Tylenol121

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Opioid Side Effects

The Opioid-Related Symptom Distress Scale (ORSDS) is a Likert scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. Frequency is rated on a 4-point scale (1= 'Rarely', 4= 'Almost constantly'). Severity is rated on a 4-point scale (1= 'Slightly', 4= 'Very'). Bothersomeness is rated on a 5-point scale (0.8= 'Not at all', 4.0= 'Very much'). The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS score is the average of 12 symptom-specific scores. (NCT03020966)
Timeframe: 24 hours after surgery (Post-operative day 1)

Interventionscore on a scale (Mean)
Oral Tylenol0.4
Intravenous Tylenol0.3

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Pain With Physical Therapy on Post-operative Day 1

Numerical rating scale of pain on a scale of 0-10, with 0 representing the minimum value of no pain and 10, representing the maximum, defined as being pain as bad as imaginable. (NCT03020966)
Timeframe: 24 hours after the operation (post-operative day 1)

Interventionscore on a scale (Mean)
Oral Tylenol3.6
Intravenous Tylenol3.9

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Pain Visual Analogue Scale

10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable. (NCT03055507)
Timeframe: Post-operative day 3

Interventionunits on a scale (Mean)
Control3.0
Ibuprofen1.7

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0-4 Bleeding Scale

Previously used 0-4 scale to indicate amount of nasal bleeding. 0 indicating no bleeding and 4 indicating life threatening bleeding. (NCT03055507)
Timeframe: Post-operative days 1, 3, and 7

,
Interventionscore on a scale (Mean)
Post-operative day 1Post-operative day 3Post-operative day 7
Control1.51.50.7
Ibuprofen0.90.90.3

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Bleeding Visual Analogue Scale

10-cm visual analogue scale used to indicate amount of nasal bleeding post-operatively. 0 = no bleeding, 10 = life-threatening bleeding (NCT03055507)
Timeframe: Post-operative days 1, 3, and 7

,
Interventionunits on a scale (Mean)
Post-operative day 1Post-operative day 3Post-operative day 7
Control3.23.21.2
Ibuprofen2.32.30.5

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Number of Opioid Pills

Number of opioid pills taken daily following surgery (NCT03055507)
Timeframe: Post-operative days 1-7

Interventionpills per day (Mean)
Control4
Ibuprofen4

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Pain Visual Analogue Scale (VAS)

10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable. (NCT03055507)
Timeframe: Post-operative day 1

Interventionunits on a scale (Mean)
Control3.3
Ibuprofen2.3

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Pain Visual Analogue Scale

10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable. (NCT03055507)
Timeframe: Post-operative day 7

Interventionunits on the pain visual analogue scale (Mean)
Control3.3
Ibuprofen2.3

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Post Operative Fentanyl Consumption

Post operative administration of fentanyl in micrograms per Kilogram of weight after intra-operative pain management in the Post Anesthesia Care Unit (PACU) (NCT03062488)
Timeframe: first 60 minutes in the PACU

Interventionmicrogram per Kg of weight (Mean)
Opioid Only0.64
Opioid Plus PO Analgesic0.72
Opioid Plus IV Acetaminophen0.58

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Emergence Agitation (EA) as Measured by Standardized PAED Scale

Post Anesthesia Emergence Delirium (PAED) Scale 0 - 20. EA defined as a score equal or greater than 12 (NCT03062488)
Timeframe: first 60 minutes of recovery post anesthesia

Interventionscore on a scale (Mean)
Opioid Only5.3
Opioid Plus PO Analgesic4.99
Opioid Plus IV Acetaminophen6.29

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Post Operative Pain

Measured on scale of 0-10 0-3 = mild pain 4-6 = moderate pain 7-10 = severe pain Tools used for each age subgroup: FLACC Score for patients 24 months to 4 years of age and sedated patients at time of assessment, Wong-Baker FACES for patients between 4 and 7 years of age, and Numeric Pain Scores for patients equal/greater than 7 years of age (NCT03062488)
Timeframe: Average in first 60 minutes of recovery post anesthesia

Interventionscore on a scale (Mean)
Opioid Only2.58
Opioid Plus PO Analgesic2.56
Opioid Plus IV Acetaminophen2.51

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Oocyte Yield

The number of oocytes retrieved from the patient's ovaries as part of an in vitro-fertilization treatment. This includes both immature and mature oocytes. (NCT03073980)
Timeframe: 0 days

Interventionoocytes (Mean)
Group A: IV Acetaminophen/PO Placebo12.6
Group B: IV Placebo/PO Acetaminophen13.4
Group C: IV Placebo/ PO Placebo11.4

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Rescue Medication Required

One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room. (NCT03073980)
Timeframe: During procedure and immediately post-operative in recovery room within 45 minutes

InterventionParticipants (Count of Participants)
Group A: IV Acetaminophen/PO Placebo4
Group B: IV Placebo/PO Acetaminophen10
Group C: IV Placebo/ PO Placebo8

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Time to Discharge From the Post-operative Recovery Room

Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void. (NCT03073980)
Timeframe: 0-6 hours post-procedure

Interventionminutes (Mean)
Group 1: IV Acetaminophen/PO Placebo60.1
Group 2: IV Placebo/PO Acetaminophen58.8
Group 3: Placebo / Standard of Care57.6

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Post-operative Pain Score Difference 10 Mins From Pre-operative

Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score. (NCT03073980)
Timeframe: Pain was measured pre-operatively and at 10 minutes post-procedure.

Interventionscore on a scale (Mean)
Group 1: IV Acetaminophen/PO Placebo1.3
Group 2: IV Placebo/PO Acetaminophen1.3
Group 3: IV Placebo/PO Placebo1.8

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Postoperative Nausea and Vomiting

One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2 (NCT03073980)
Timeframe: 0-2 days

InterventionParticipants (Count of Participants)
Group A: IV Acetaminophen/PO Placebo3
Group B: IV Placebo/PO Acetaminophen4
Group C: IV Placebo/ PO Placebo2

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Procedure Length

Duration of egg retrieval (NCT03073980)
Timeframe: 0-2 hours

Interventionminutes (Mean)
Group A: IV Acetaminophen/PO Placebo13.5
Group B: IV Placebo/PO Acetaminophen13.7
Group C: IV Placebo/ PO Placebo14.1

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Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message. (NCT03080493)
Timeframe: 8 hours after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Median)
Gabapentin2
Placebo Oral Capsule2.5

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Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment. (NCT03080493)
Timeframe: 5 minutes after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Median)
Gabapentin1
Placebo Oral Capsule2

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Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message. (NCT03080493)
Timeframe: 2 hours after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Median)
Gabapentin3.5
Placebo Oral Capsule4

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Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)

Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion) (NCT03080493)
Timeframe: Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)

InterventionParticipants (Count of Participants)
Gabapentin35
Placebo Oral Capsule40

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Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D&E procedure. (NCT03080493)
Timeframe: Time of presentation for D&E (day after dilator insertion)

InterventionNumeric rating scale pain score change (Median)
Gabapentin0.5
Placebo Oral Capsule1

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Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message. (NCT03080493)
Timeframe: 4 hours after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Mean)
Gabapentin3
Placebo Oral Capsule3.5

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Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year

"The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.~0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain." (NCT03084536)
Timeframe: At 1 year

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks0

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Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure

"The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).~The higher the score the better quality of life.~Scores are standardized to a mean of 50 with a range of -0.809-70.71." (NCT03084536)
Timeframe: At baseline and 1 year post-surgery

Interventionscore on a scale (Median)
Preoperative PECS Blocks-3.1
Placebo PECS Blocks-0.8

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Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year

"The participant is asked to rate their pain by circling the one number that best describes their pain on the average.~0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain." (NCT03084536)
Timeframe: At 1 year

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks0

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Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure

"The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).~The higher the score the better quality of life.~Scores are standardized to a mean of 50 with a range of -1.465-77.09." (NCT03084536)
Timeframe: At baseline and 1 year post-surgery

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks1.9

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Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year

"The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.~0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain.~The scores for each subsection will be averaged." (NCT03084536)
Timeframe: At 1 year

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks0

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Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)

The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain. (NCT03088826)
Timeframe: 60 minutes

Interventionunits on a scale (Mean)
MSIR and Acetaminophen Group3.95
Oxycodone and Acetaminophen Group3.95

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Postoperative Opioid Use

Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period. (NCT03104816)
Timeframe: Within 24 hours after surgery

,,
Interventionmg (Mean)
PACU doseWard dose
Acetaminophen IV Soln 10 MG/ML (A)1.29.8
Hydromorphone (Control Arm) (C)1.713
PO Acetaminophen (B)1.310.4

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Amount of Discomfort

Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. (NCT03105518)
Timeframe: PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3

Interventionunits on a scale (Mean)
Time 0; ≤10 FolliclesTime 0; > 10 FolliclesTime 15; ≤10 FolliclesTime 15; >10 FolliclesTime 30; ≤10 FolliclesTime 30; >10 FolliclesTime 60; ≤10 FolliclesTime 60; >10 FolliclesTime POD 3; ≤ 10 FolliclesTime POD 3; > 10 Follicles
Analgesia Options1.533.252.683.611.662.930.972.191.441.64

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Amount of Discomfort Following Discharge Until Embryo Transfer

Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer. (NCT03105518)
Timeframe: After 1 hrs but less than 3 days

Interventionunits on a scale (Mean)
POD1; ≤10 FolliPOD1; >10 FolliclesPOD2; ≤10 FolliPOD2; >10 Folli
Analgesia Options2.153.211.282.50

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Maximum Post-op Pain Score

Rated on a maximum post-op pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. (NCT03131713)
Timeframe: 48 hours after surgery

Interventionscore on a maximum post-op scale (Mean)
Control14
Intervention13.6

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Number of Participants Using Post-operative Analgesic

Number of participants using over the counter and prescribed non-opioid and opioid pain medications (NCT03131713)
Timeframe: 48 hours after surgery

InterventionParticipants (Count of Participants)
Control27
Intervention34

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Anxiety

Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome. (NCT03131713)
Timeframe: Day of surgery

Interventionscore on an anxiety scale (Mean)
Control7.6
Intervention2.2

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Thirst

Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome. (NCT03131713)
Timeframe: Day of surgery

Interventionscore on a thirst scale (Mean)
Control9.4
Intervention10.5

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Hunger

Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome. (NCT03131713)
Timeframe: Day of surgery

Interventionunits on a hunger scale (Mean)
Control19.9
Intervention17.9

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Maximum Pain Score

Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome. (NCT03131713)
Timeframe: Day of surgery

Interventionunits on a pain scale (Mean)
Control2.8
Intervention1.2

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Fatigue

Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome. (NCT03131713)
Timeframe: Day of surgery

Interventionscore on a fatigue scale (Mean)
Control12
Intervention10.7

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Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline

Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10=worst possible pain. Change is calculated as Numerical Rating Scale before medication is administered (denoted as baseline) minus NRS 2- hours past baseline. Higher numbers indicate better outcomes. (NCT03173456)
Timeframe: Prior to ingestion of study medication to 2 hours after ingestion of the study medication

Interventionunits on a scale (Mean)
400 Ibuprofen/APAP4.3
800 Ibuprofen/APAP4.6
Codeine/APAP4.4
Hydrocodone/APAP4.5
Oxycodone/APAP4.7

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Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline

Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome. (NCT03173456)
Timeframe: Prior to Ingestion of study medication to one hour after ingestion of the study medication

InterventionUnits on a scale (Mean)
400 Ibuprofen/APAP3.0
800 Ibuprofen/APAP3.0
Codeine/APAP3.4
Hydrocodone/APAP3.1
Oxycodone/APAP3.3

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Percentage of Patients Who Received Rescue Medication

Number of patients who received additional analgesics divided by total number of patients x 100 (NCT03173456)
Timeframe: Entire two-hour time period

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP29
800 Ibuprofen/APAP28
Codeine/APAP26
Hydrocodone/APAP27
Oxycodone/APAP28

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Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain

Number of patients who would choose to take study medication again divided by number of patients x 100. Question asked at end of two-hour time period (NCT03173456)
Timeframe: End of two-hour time period

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP78
800 Ibuprofen/APAP83
Codeine/APAP75
Hydrocodone/APAP89
Oxycodone/APAP81

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Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication

Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100 (NCT03173456)
Timeframe: From time of ingestion of study medication to one hour later

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP26
800 Ibuprofen/APAP37
Codeine/APAP33
Hydrocodone/APAP34
Oxycodone/APAP37

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Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication

Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100 (NCT03173456)
Timeframe: From time of ingestion of study medication to two hours later

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP31
800 Ibuprofen/APAP44
Codeine/APAP40
Hydrocodone/APAP51
Oxycodone/APAP49

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Post-operative Emesis

Frequency of emesis and rescue antiemetic requirement will be documented (NCT03198871)
Timeframe: These will be evaluated from the time of PACU admission until 72 hours postoperatively.

,
InterventionParticipants (Count of Participants)
Emesis incidence 0-72 hoursAntiemetic use
Acetaminophen Injectable Product1231
Sodium Chloride 0.9%, Intravenous1445

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Patient Satisfaction

Overall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale (NRS) with 0- being worst satisfaction and 10 - best satisfaction. (NCT03198871)
Timeframe: These measurements will be taken at time of discharge up to 30 days, whichever comes first

,
Interventionscore on a scale (Median)
Patient satisfaction score, overallPatient Satisfaction score, pain management
Acetaminophen Injectable Product1010
Sodium Chloride 0.9%, Intravenous1010

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Time to Oral Intake

The time it takes for the patient to ingest orally post-surgery will be measured. (NCT03198871)
Timeframe: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively

Interventionhours (Median)
Acetaminophen Injectable Product12.15
Sodium Chloride 0.9%, Intravenous9.40

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Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)

The time from PACU admission to PACU discharge to the floor will be measured. (NCT03198871)
Timeframe: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively

Interventionminutes (Median)
Acetaminophen Injectable Product129.00
Sodium Chloride 0.9%, Intravenous152.50

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Intensive Care Delirium Screening Checklist (ICDSC)

Number of patients who score greater than a 4 on the 0-8 point ICDSC scale to assess delirium scores. 8 separate levels of signs for delirium assessed (1. altered level of consciousness, 2. inattention, 3. disorientation, 4. hallucination, delusion, or psychosis, 5. psychomotor agitation or retardation, 6. inappropriate speech or mood, 7. sleep-wake cycle disturbance, 8. symptom fluctuation), with 0 points awarded when patient does not exhibit above signs of delirium and 1 point awarded per confirmed sign of delirium. Score then totaled, 0 = normal, 1-3 = subsyndromal delirium, 4-8 = delirium. (NCT03198871)
Timeframe: The delirium scores will first be measured every 12 hours for 72 hours after surgery.

InterventionParticipants (Count of Participants)
Acetaminophen Injectable Product0
Sodium Chloride 0.9%, Intravenous0

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Time to Ambulation

The time it takes for the patient to successfully ambulate post-surgery will be measured. (NCT03198871)
Timeframe: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively

Interventionhours (Median)
Acetaminophen Injectable Product18.82
Sodium Chloride 0.9%, Intravenous17.38

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Number of Participants With Readmission to the Hospital

If the patient is readmitted to the hospital after being fully discharged, the event will be recorded. (NCT03198871)
Timeframe: From the time of consent until 30 days post-operatively

InterventionParticipants (Count of Participants)
Acetaminophen Injectable Product9
Sodium Chloride 0.9%, Intravenous10

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Postoperative Pain Intensity

Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative. (NCT03198871)
Timeframe: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.

InterventionParticipants (Count of Participants)
Acetaminophen Injectable Product33
Sodium Chloride 0.9%, Intravenous42

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Time to Bowel Movement

The time it takes for the first bowel movement postoperatively will be measured. (NCT03198871)
Timeframe: From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge

Interventionhours (Median)
Acetaminophen Injectable Product46.30
Sodium Chloride 0.9%, Intravenous64.66

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Total Post-operative Narcotic Consumption

Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg. (NCT03198871)
Timeframe: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first

,
Interventionmg (Median)
0-24 hours24-48 hours48-72 hours0-48 hours0-72 hours
Acetaminophen Injectable Product27.431.33074105.00
Sodium Chloride 0.9%, Intravenous364537.588.8127.1

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SF-12 Health Survey

Survey to assess patient's overall health (via a combination of mental and physical health assessment) at 30 days post-discharge. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average (NCT03198871)
Timeframe: These measurements will take place at 30-days post hospital discharge

,
InterventionZ-scores (difference compared to the pop (Median)
SF 12 Physical scoreSF 12 Mental score
Acetaminophen Injectable Product38.7254.02
Sodium Chloride 0.9%, Intravenous38.0752.08

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Post-operative Nausea

Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable. (NCT03198871)
Timeframe: These will be evaluated from the time of PACU admission until 72 hours postoperatively.

,
Interventionscore on a scale (Mean)
Nausea score POD 1 (am visit)Nausea score POD 1 (pm visit)Nausea score POD 2 (am visit)Nausea score POD 2 (pm visit)Nausea score POD 3 (am visit)Nausea score POD 3 (pm visit)
Acetaminophen Injectable Product1.130.490.710.550.320.56
Sodium Chloride 0.9%, Intravenous0.600.920.750.690.660.78

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Time to Hospital Discharge

The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured. (NCT03198871)
Timeframe: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first

Interventiondays (Median)
Acetaminophen Injectable Product4.08
Sodium Chloride 0.9%, Intravenous4.94

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes

Percentage of participants with confirmed perceptible relief by 16 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 16 minutes

InterventionPercentage of Participants (Number)
Placebo10.2
Test ACM 1000 mg52.2

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes

Percentage of participants with confirmed perceptible relief by 27 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 27 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg70.7

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes

Percentage of participants with confirmed perceptible relief by 28 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 28 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg70.7

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes

Percentage of participants with confirmed perceptible relief by 14 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 14 minutes

InterventionPercentage of Participants (Number)
Placebo8.5
Test ACM 1000 mg31.7

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes

Percentage of participants with confirmed perceptible relief by 22 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 22 minutes

InterventionPercentage of Participants (Number)
Placebo16.9
Test ACM 1000 mg62.7

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes

Percentage of participants with confirmed perceptible relief by 23 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 23 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg66.3

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes

Percentage of participants with confirmed perceptible relief by 24 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 24 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg67.5

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes

Percentage of participants with confirmed perceptible relief by 13 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 13 minutes

InterventionPercentage of Participants (Number)
Placebo8.5
Test ACM 1000 mg25.7

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes

Percentage of participants with confirmed perceptible relief by 25 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 25 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg69.5

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes

Percentage of participants with confirmed perceptible relief by 21 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 21 minutes

InterventionPercentage of Participants (Number)
Placebo15.3
Test ACM 1000 mg60.2

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes

Percentage of participants with confirmed perceptible relief by 26 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 26 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg69.9

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes

Percentage of participants with confirmed perceptible relief by 29 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 29 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg73.5

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes

Percentage of participants with confirmed perceptible relief by 20 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 20 minutes

InterventionPercentage of Participants (Number)
Placebo13.6
Test ACM 1000 mg58.2

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Time to Confirmed Perceptible Pain Relief

Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. (NCT03224403)
Timeframe: within 4 hours

Interventionminutes (Median)
PlaceboNA
Test ACM 1000 mg15.7
Commercial ACM 1000 mg20.2
Commercial IBU 400 mg23.2

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Time to Meaningful Pain Relief

Minutes until meaningful pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participants are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them. (NCT03224403)
Timeframe: Within 4 hours

Interventionminutes (Median)
PlaceboNA
Test ACM 1000 mg46.1
Commercial ACM 1000 mg44.2
Commercial IBU 400 mg43.9

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes

Percentage of participants with confirmed perceptible relief by 12 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 12 minutes

InterventionPercentage of Participants (Number)
Placebo8.5
Test ACM 1000 mg21.7

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes

Percentage of participants with confirmed perceptible relief by 30 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 30 minutes

InterventionPercentage of Participants (Number)
Placebo18.6
Test ACM 1000 mg75.1

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes

Percentage of participants with confirmed perceptible relief by 19 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 19 minutes

InterventionPercentage of Participants (Number)
Placebo13.6
Test ACM 1000 mg56.2

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes

Percentage of participants with confirmed perceptible relief by 11 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 11 minutes

InterventionPercentage of Participants (Number)
Placebo8.5
Test ACM 1000 mg18.1

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes

Percentage of participants with confirmed perceptible relief by 17 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 17 minutes

InterventionPercentage of Participants (Number)
Placebo13.6
Test ACM 1000 mg53.8

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes

Percentage of participants with confirmed perceptible relief by 18 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 18 minutes

InterventionPercentage of Participants (Number)
Placebo13.6
Test ACM 1000 mg55.0

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Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes

Percentage of participants with confirmed perceptible relief by 15 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified. (NCT03224403)
Timeframe: by 15 minutes

InterventionPercentage of Participants (Number)
Placebo10.2
Test ACM 1000 mg41.4

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Number of Participants That Require Admission

To explore the difference in the rates admission rates in children treated with sucralfate versus placebo. (NCT03241030)
Timeframe: 6 hours from the time of enrollment

InterventionParticipants (Count of Participants)
Experimental Group1
Placebo Group2

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Number of Participants With Unscheduled Visits

Will call families to find out about any unscheduled visits. (NCT03241030)
Timeframe: Approximately 72 hours from ED visit

InterventionParticipants (Count of Participants)
Experimental Group4
Placebo Group6

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Oral Intake in ml/kg

Will quantify the amount (in ml/kg) of liquid ingested after intervention. (NCT03241030)
Timeframe: Approximately 60 minutes after medication administration.

Interventionoral intake in ml/kg (Median)
Experimental Group9.7
Placebo Group10.7

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Number of Participants That Require Intravenous Fluid Administration

To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo. (NCT03241030)
Timeframe: 6 hours from the time of enrollment

InterventionParticipants (Count of Participants)
Experimental Group5
Placebo Group1

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Changes in the Immune Parameters Obtained From Blood Samples

All evaluable participants will have determinations of many immune parameters at baseline, 3 months, and 6 months. The changes in the parameters obtained from blood samples will be determined at baseline vs. 3 months, and baseline vs. 6 months. Comparisons of the paired values will be performed using a Wilcoxon signed rank test, and a Hochberg adjustment may be used. (NCT03258593)
Timeframe: baseline, 3 weeks, and 5 weeks

,,
Interventionpg/mL (Median)
3 weeks Interferon Gamma (IFN-γ) vs Baseline5 weeks Interferon Gamma (IFN-γ) vs Baseline3 weeks Interleukin 6 (IL-6) vs Baseline5 weeks Interleukin 6 (IL-6) vs Baseline3 weeks Interleukin 8 (IL-8) vs Baseline5 weeks Interleukin 8 (IL-8) vs Baseline3 weeks Interleukin 10 (IL-10) vs Baseline5 weeks Interleukin 10 (IL-10) vs Baseline3 weeks Tumor Necrosis Factor Alpha (TNF-α) vs Baseline5 weeks Tumor Necrosis Factor Alpha (TNF-α) vs Baseline
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg0.6401.7500.1800.2200.880-0.1600.070.1200.2600.270
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg4.3403.2900.3950.5400.730-0.3950.1200.1050.4000.240
Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg3.8503.1200.2800.4000.860-0.1800.1200.1200.3500.270

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Dose-Limiting Toxicity (DLT)

A DLT will be defined as any Grade 3 or higher toxicity that occurs during the initial 6-week period the subject is on treatment (i.e., the DLT evaluation period). Grade 3 is severe, grade 4 is life-threatening and grade 5 is death related to adverse event. (NCT03258593)
Timeframe: 6 weeks

,
Interventionpercentage of participants (Number)
Grade 3Grade 4Grade 5
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg000
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg33.300

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Number of Grades 1-5 Adverse Events

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening, and grade 5 is death related to adverse event. (NCT03258593)
Timeframe: Through study completion, an average of 315 days

,,
Interventionadverse events (Number)
Grade 1Grade 2Grade 3Grade 4Grade 5
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg33000
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg129400
Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg1512400

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Disease Free Survival (DFS)

A DFS curve will be created using the Kaplan-Meier method based on all participants considered to be evaluable based on having received protocol treatment. DFS survival is defined as the time from the start of treatment until disease recurrence or death. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a bladder biopsy or transurethral resection of bladder tumor (TURBT). (NCT03258593)
Timeframe: Assessed from start of therapy to disease recurrence or last follow up; up to 1 year.

InterventionWeeks (Median)
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg12.8
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg50.1
Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg13.2

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Maximum Tolerated Dose (MTD) of Durvalumab

The MTD will be identified based on being the dose level at which 0 or 1 participants in 6 has a dose-limiting toxicity (DLT). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the initial 6-week period the subject is on treatment (i.e., the DLT evaluation period). Grade 3 is severe, grade 4 is life-threatening and grade 5 is death related to adverse event. (NCT03258593)
Timeframe: 6 weeks

InterventionMg (Number)
All Participants1500

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Maximum Tolerated Dose (MTD) of Vicineum

The MTD will be identified based on being the dose level at which 0 or 1 participants in 6 has a dose-limiting toxicity (DLT). A DLT will be defined as any Grade 3 or higher toxicity that occurs during the initial 6-week period the subject is on treatment (i.e., the DLT evaluation period). Grade 3 is severe, grade 4 is life-threatening and grade 5 is death related to adverse event. (NCT03258593)
Timeframe: 6 weeks

InterventionMg (Number)
All Participants30

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Response Rate

The response to treatment will be determined for evaluable participants who receive treatment and was measured as follows: Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Complete response rate for carcinoma in situ (CIS) is defined as the absence of CIS upon follow-up biopsies. Disease progression is defined as upstaging from a lower stage to a higher stage (e.g., Ta to T1-T4 or T1 to T2-4; CIS to T1 or CIS to T2-T4; or any N+ or M+ in these high-grade tumors). (NCT03258593)
Timeframe: From enrollment until event occurrence (recurrence, progression); twelve weeks.

,,
Interventionpercentage of participants (Number)
Complete responseRecurrenceDisease progression
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg66.633.333.3
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg41.658.325
Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg46.653.326.6

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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03258593)
Timeframe: Through study completion, an average of 315 days.

InterventionParticipants (Count of Participants)
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg12
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg3

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Change in Programmed Death-ligand 1 (PD-L1) Levels Between Participants Who Respond and Have Stable Disease (SD), and Those With Progressive Disease (PD)

PD-L1 levels will be obtained at baseline and after treatment with both agents. The change will be compared between those who respond or have stable disease (SD (clinical benefit=Complete Response (CR)+Partial Response (PR)+SD) and those with progressive disease (PD). Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted. (NCT03258593)
Timeframe: Baseline and after treatment, from enrollment up to 5 weeks

,,
Interventionpg/mL (Median)
PDL1 level changes in participants with SD (treatment vs baseline)PDL1 level changes in participants with PD (treatment vs baseline
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg342.5228.4
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg533.8516
Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg505.9494.8

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Change in Programmed Death-ligand 1 (PD-L1) Levels Between Responders and Non-Responders

PD-L1 levels will be obtained at baseline and after treatment with both agents. The change in levels will be determined between the two measurements, and these changes will be compared between responders and non-responders. Although it is expected to have low power, in each case the comparisons between the two response categories will be made using a Wilcoxon rank sum test, with the resulting p-value intended to help describe the differences noted. (NCT03258593)
Timeframe: Baseline and after treatment with both agents, from enrollment up to 5 weeks

,,
Interventionpg/mL (Median)
Responders PDL1 levels after treatment (vs baselineNon-responders PDL1 levels after treatment (vs baseline)
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg342.5228.4
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg573.4505.9
Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg533.8489.7

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Pharmacokinetic Parameters in Urine Maximum Concentration (Cmax) of Vicineum

Evaluate the pharmacokinetic parameters of Vicineum obtained by urine samples. Urinary Vicineum (in ng/mL). (NCT03258593)
Timeframe: Baseline, week 1, week 6, week 12

,,
Interventionng/mL (Median)
BaselineWeek 1, Day 1Week 1Week 6Week 12
Expansion Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg1.5305.41.51.57.5
Run-In Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg2.54320.02.63.23.5
Total Cohort - Durvalumab 1500mg Intravenous (IV) Every 4 Weeks (Q4WK) + Vicineum 30 mg3.23738.74.74.34.8

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Pain Level

"pain level measured by objective and subjective scales.~1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean less pain and a point towards the right will mean more pain. After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain." (NCT03372382)
Timeframe: 2-4 weeks postpartum

Interventionmillimeters on a scale (Mean)
Ibuprofen Plus Acetaminophen12.3
Ibuprofen Plus Acetaminophen/Hydrocodone15.9

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Ibuprofen Usage

The average number of ibuprofen pills needed or used for pain control (NCT03404518)
Timeframe: First 7 days after surgery

Interventionpills (Mean)
Norco and Ibuprofen4.5
Ibuprofen and Norco7.7

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Patient Pain Level

The average reported pain score using the Numeric Rating Scale (0-10) with 0 representing no pain and 10 as worse imaginable pain. (NCT03404518)
Timeframe: Average reported pain for first 7 days after surgery

InterventionScores on a scale (Mean)
Norco and Ibuprofen3.5
Ibuprofen and Norco2.8

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Narcotic Usage

The average number of narcotic pills needed or used for pain control (NCT03404518)
Timeframe: First 7 days after surgery

InterventionPills (Mean)
Norco and Ibuprofen4.9
Ibuprofen and Norco2.0

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Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 30 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A33.24
Treatment Group B20.87

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Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 45 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A24.79
Treatment Group B7.21

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Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 60 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A20.07
Treatment Group B4.26

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Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 75 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A14.73
Treatment Group B3.28

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Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 90 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A8.84
Treatment Group B2.45

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Small Intestine Transit Time

Small intestinal transit time was calculated by determining the arrival time of the radiolabeled investigational drug formulation at the cecum or colon region from scintigraphic imaging and subtracting the gastric emptying value. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionminutes (Median)
Treatment Group A184.0
Treatment Group B139.5

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Total Area Under the Gastric Emptying Curve

Total area under the gastric emptying curve was evaluated by scintigraphic imaging, performed after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A56.80
Treatment Group B32.61

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Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 105 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A6.06
Treatment Group B1.72

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Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes

Area under the gastric emptying curve from time 0 to 105 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 105 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A53.16
Treatment Group B31.81

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Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes

Area under the gastric emptying curve from time 0 to 120 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 120 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A54.49
Treatment Group B32.15

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Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes

Area under the gastric emptying curve from time 0 to 15 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 15 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A19.38
Treatment Group B16.96

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Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes

Area under the gastric emptying curve from time 0 to 180 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 180 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A56.69
Treatment Group B32.61

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Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes

Area under the gastric emptying curve from time 0 to 240 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 240 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A56.80
Treatment Group B32.61

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Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes

Area under the gastric emptying curve from time 0 to 30 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 30 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A31.16
Treatment Group B25.11

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Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes

Area under the gastric emptying curve from time 0 to 45 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 45 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A38.36
Treatment Group B28.19

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Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes

Area under the gastric emptying curve from time 0 to 60 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 60 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A43.69
Treatment Group B29.60

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Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes

Area under the gastric emptying curve from time 0 to 75 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 75 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A48.71
Treatment Group B30.61

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Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes

Area under the gastric emptying curve from time 0 to 90 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 90 minutes post dose on Day 1

Interventionpercentage dose*hour (Mean)
Treatment Group A51.32
Treatment Group B31.29

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Gastric Emptying Half-Life

Gastric emptying half-life was defined as the time required by the stomach to empty 50% of the ingested meal and was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionminutes (Median)
Treatment Group A25.00
Treatment Group B5.00

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Mean Time for Gastric Emptying by Measuring 25 Percent Values

Mean time to gastric emptying by 25 percent (GE25%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionminutes (Mean)
Treatment Group A12.614
Treatment Group B12.171

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Mean Time for Gastric Emptying by Measuring 50 Percent Values

Mean time to gastric emptying by 50 percent (GE50%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionminutes (Mean)
Treatment Group A22.643
Treatment Group B16.134

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Mean Time for Gastric Emptying by Measuring 90 Percent Values

Mean time to gastric emptying by 90 percent (GE90%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionminutes (Mean)
Treatment Group A84.929
Treatment Group B36.214

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Mean Time to Complete Gastric Emptying

Mean time to complete gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m-DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionminutes (Mean)
Treatment Group A121.2
Treatment Group B65.3

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Mean Time to Onset of Gastric Emptying

Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie [mcCi] isotope-technetium-99m-diethylene-triamine-pentaacetate [DTPA]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon. (NCT03415243)
Timeframe: Predose until 10 hours post dose on Day 1

Interventionminutes (Mean)
Treatment Group A1.107
Treatment Group B8.534

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Number of Participants With Clinically Significant Change in Laboratory Test Values

Haematological, biochemistry, urinalysis and virological parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. (NCT03415243)
Timeframe: From baseline up to Day 1

InterventionParticipants (Count of Participants)
Treatment Group A0
Treatment Group B0

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Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 120 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A4.34
Treatment Group B0.99

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Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 15 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A67.00
Treatment Group B49.77

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Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 180 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A0.64
Treatment Group B0.00

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Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration

Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation. (NCT03415243)
Timeframe: 240 minutes post dose on Day 1

Interventionpercentage of radiolabeled drug (Mean)
Treatment Group A0.00
Treatment Group B0.00

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Time to Ambulation

Time to unassisted ambulation (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)139
60 mg Paracetamol 3% (2 mL)115
90 mg Paracetamol 3% (3 mL)125
Placebo, 0.9% Saline Solution125

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Time to Eligibility for Discharge

Time to eligibility for home discharge (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)170
60 mg Paracetamol 3% (2 mL)165
90 mg Paracetamol 3% (3 mL)170
Placebo, 0.9% Saline Solution168

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Time to First Urine

Time to first spontaneous urine voiding (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)155
60 mg Paracetamol 3% (2 mL)140
90 mg Paracetamol 3% (3 mL)145
Placebo, 0.9% Saline Solution150

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Time to Sensory Block

Time to maximum level of sensory block (bilateral Pinprick test using a 20-G hypodermic needle) (NCT03428230)
Timeframe: Intraoperative

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)10
60 mg Paracetamol 3% (2 mL)10
90 mg Paracetamol 3% (3 mL)10
Placebo, 0.9% Saline Solution10

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Time to Regression of Spinal Block

Time period from spinal injection to the complete regression of sensory block to S1. (NCT03428230)
Timeframe: Up to 4 hours after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)100
60 mg Paracetamol 3% (2 mL)100
90 mg Paracetamol 3% (3 mL)90
Placebo, 0.9% Saline Solution95

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Percentage of Patients Requiring Supplementary Analgesia, Other Than the Planned Level 1 or 2 Analgesia

Percentage of patients requiring supplementary analgesia, other than the planned level 1 or 2 analgesia (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

,,,
Interventionparticipants (Number)
level 1level 2
30 mg Paracetamol 3% (1 mL)62
60 mg Paracetamol 3% (2 mL)50
90 mg Paracetamol 3% (3 mL)74
Placebo, 0.9% Saline Solution10

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Pain Intensity at Rest Evaluated Using a 0-100 mm VAS

The study primary efficacy measures will be the VAS scores at each predefined time-point after the anaesthetic intrathecal injection until eligibility for home discharge ( VAS scale is 0-100 mm, where 0 is no pain and 100 is maximum pain) (NCT03428230)
Timeframe: Pain intensity at rest evaluated using a 0-100 mm VAS at baseline (within 30 min before NIMP IT injection, 0 h), 1, 1.25, 1.5, 1.75, 2 h after NIMP IT injection, then every 30 min after NIMP IT injection until eligibility for home discharge.

,,,
Interventionscore on a scale (Mean)
baseline1 hour after NIMP1.25 hour after NIMP1.50 hour after NIMP1.75 hour after NIMP2 hours after NIMP2.5 hours after NIMP3 hours after NIMP3.5 hours after NIMP4 hours after NIMP4.5 hours after NIMPbefore discharge
30 mg Paracetamol 3% (1 mL)9.60.14.65.99.514.116.92119.76.82.53.7
60 mg Paracetamol 3% (2 mL)16.90.11.94.515.117.88.79.66.813.304.1
90 mg Paracetamol 3% (3 mL)18.43.46.216.421.422.814.77.314.215.322.9
Placebo, 0.9% Saline Solution8.100.61.23.63.97.210.411.40011.3

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Pain at Rest AUCt1-t2

AUC t1-t2 is defined as the area under the pain intensity curve at the specified time-intervals (NCT03428230)
Timeframe: Up to 4 hours after injection

,,,
Interventionscore on a scale*h (Mean)
AUC 0-2 hoursAUC 0-4 hours
30 mg Paracetamol 3% (1 mL)1334.6
60 mg Paracetamol 3% (2 mL)14.826
90 mg Paracetamol 3% (3 mL)26.492.2
Placebo, 0.9% Saline Solution4.449.7

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Time to Onset of Spinal Block (i.e. Time to Readiness for Surgery)

Spinal block/Readiness for surgery is defined as the presence of an adequate motor block (Bromage's score ≥ 2) and loss of Pinprick sensation, according to the Investigator's opinion. Time to readiness for surgery is defined as the time from the spinal injection (time 0 h) to achievement of readiness for surgery. (NCT03428230)
Timeframe: Up to 20 minutes after injection

Interventionminutes (Median)
30 mg Paracetamol 3% (1 mL)5
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)2
Placebo, 0.9% Saline Solution5

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Total Number of Partecipants Receiving Analgesic 2

Total Number of Partecipants Receiving Tramadol i.v. 1 mg/kg (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)2
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)4
Placebo, 0.9% Saline Solution0

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Total Number of Partecipants Receiving Analgesic 1

Total number of partecipants receiving Ketorolac i.v. [Toradol] 30 mg (NCT03428230)
Timeframe: From surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Percentage of Patients Requiring Rescue Anaesthesia

Percentage of patients requiring rescue anaesthesia (NCT03428230)
Timeframe: from surgery day to 1 hour after injection

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)14
60 mg Paracetamol 3% (2 mL)15
90 mg Paracetamol 3% (3 mL)15
Placebo, 0.9% Saline Solution14

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Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Discharge

Percentage of Patients Requiring Level 2 Analgesia From Surgery End Until Eligibility for Home Discharge (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)2
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)4
Placebo, 0.9% Saline Solution0

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Percentage of Patients Requiring Level 1 Analgesia From Surgery End Until Eligibility for Discharge

Percentage of patients requiring level 1 analgesia from surgery end until eligibility for home discharge (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Partecipants Received Level 2 Analgesia

Partecipants received Tramadol i.v. 1 mg/kg administration (level 2 analgesia) (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)2
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)4
Placebo, 0.9% Saline Solution0

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Percentage of Patients Requiring Analgesia in the First 4 h After Surgery End

Percentage of patients requiring analgesia (level 1 or level 2) in the first 4 h after surgery end (NCT03428230)
Timeframe: from surgery day to 4 hours after surgery end

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Percentage of Patients Requiring Analgesia in the First 2 h After Surgery End

Percentage of patients requiring analgesia (level 1 or level 2) in the first 2 h after surgery end (NCT03428230)
Timeframe: Form surgery day to 2 hours after surgery end

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)5
60 mg Paracetamol 3% (2 mL)3
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution0

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Percentage of Patients Requiring Analgesia From Surgery End Until Eligibility for Discharge

Percentage of patients requiring analgesia (level 1 or level 2) from surgery end until eligibility for home discharge (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Partecipants to Received Level 1 Analgesia

Partecipants to received Ketorolac i.v. [Toradol] 30 mg administration (level 1 analgesia) (NCT03428230)
Timeframe: from surgery day to 24 hours after surgery

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)6
60 mg Paracetamol 3% (2 mL)5
90 mg Paracetamol 3% (3 mL)7
Placebo, 0.9% Saline Solution1

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Pain at Rest AUClast

AUClast is defined as the area under the pain intensity curve from 0 h up to the last assessment time (NCT03428230)
Timeframe: Up to 24 hours after injection

Interventionscore on a scale*h (Mean)
30 mg Paracetamol 3% (1 mL)34
60 mg Paracetamol 3% (2 mL)24.7
90 mg Paracetamol 3% (3 mL)42
Placebo, 0.9% Saline Solution15.7

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Number of Participants With Neurological Complications Including TNS

Number of Participants with Neurological Complications Including TNS at 24 h post-dose and at day 7±1 (NCT03428230)
Timeframe: From anaesthetic intrathecal injection up to day 7±1 (i.e. 6±1 days after analgesic/anaesthetic IT injection and surgery)

InterventionParticipants (Count of Participants)
30 mg Paracetamol 3% (1 mL)0
60 mg Paracetamol 3% (2 mL)0
90 mg Paracetamol 3% (3 mL)0
Placebo, 0.9% Saline Solution0

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Nausea

% of patients with nausea (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)71.4
Lumbar Plexus Catheter (6 Years and Older)55.6
Patient Controlled Analgesia (6 Years and Older)71.4

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Maximum Pain Score

"Mean of Maximum Pain Score POD 0-2~Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC) for children 1-3 years of age, Faces Pain Scale - Revised (FPS-R) for children over age 3 and the Numeric scale (0-10) for children over age 7.~minimum value = 0, maximum value 10 (higher score is worse)" (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionscore on a scale (Mean)
Lumbar Epidural Catheter (< 6 Years Old)5.5
Lumbar Plexus Catheter (< 6 Years Old)4.3
Lumbar Epidural Catheter (6 Years and Older)6.4
Lumbar Plexus Catheter (6 Years and Older)5.5
Patient Controlled Analgesia (6 Years and Older)6.5

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Hospital Length of Stay

Total hospital length of stay (NCT03435692)
Timeframe: Through hospital stay, an average of 2-3 days.

Interventiondays (Mean)
Lumbar Epidural Catheter (< 6 Years Old)1.9
Lumbar Plexus Catheter (< 6 Years Old)2
Lumbar Epidural Catheter (6 Years and Older)2.9
Lumbar Plexus Catheter (6 Years and Older)2.5
Patient Controlled Analgesia (6 Years and Older)3.2

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Itching

% of patients with itching (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)28.6
Lumbar Plexus Catheter (6 Years and Older)22.2
Patient Controlled Analgesia (6 Years and Older)42.9

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Muscle Spasm

% of patients w/ muscle spasm (NCT03435692)
Timeframe: Post-Operative days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)80
Lumbar Plexus Catheter (< 6 Years Old)55.6
Lumbar Epidural Catheter (6 Years and Older)100
Lumbar Plexus Catheter (6 Years and Older)44.4
Patient Controlled Analgesia (6 Years and Older)71.4

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Total Perioperative Morphine Equivalents

All administered opioids measured as morphine equivalents (mg/kg) (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionmg/kg (Mean)
Lumbar Epidural Catheter (< 6 Years Old)0.54
Lumbar Plexus Catheter (< 6 Years Old)0.7
Lumbar Epidural Catheter (6 Years and Older)0.85
Lumbar Plexus Catheter (6 Years and Older)0.83
Patient Controlled Analgesia (6 Years and Older)2.23

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Post-operative Opioid Consumption

From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl. (NCT03445390)
Timeframe: Up to 24 hours post-operative

Interventionug (Mean)
Acetaminophen228
Placebo312

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Count of Participants Requiring Anti-emetic Administration

(NCT03445390)
Timeframe: Up to 24 hours post-operative

InterventionParticipants (Count of Participants)
Acetaminophen20
Placebo20

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Post-operative Pain

Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group. (NCT03445390)
Timeframe: Up to 24 hours post-operative

,
Interventionunits on a scale (Mean)
Post-operative hour 0 to 12Post-operative hour 13 to 24Post-operative hour 0 to 24
Acetaminophen3.42.73.1
Placebo3.82.63.2

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Lane Departures

"Total number of lane departures per drive~The total number of lane departures across the drive were analyzed using the SAS GLM procedure." (NCT03447353)
Timeframe: over course of each simulator drive, approximately 35 minutes per visit

Interventioncount (Mean)
"Sober or Double Placebo"23.8
Active Xanax, Active Norco72.0
Active Xanax, Placebo Norco64.4
Placebo Xanax, Active Norco22.3

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SDLP

"Standard Deviation of Lane Position~Standard deviation of lane position was analyzed using the SAS GLM function to identify changes in driver performance. Values represents means across the driving environments studied." (NCT03447353)
Timeframe: over course of each simulator drive, approximately 35 minutes per visit

Interventioncentimeters (Mean)
"Sober or Double Placebo"35.2
Active Xanax, Active Norco49.8
Active Xanax, Placebo Norco50.0
Placebo Xanax, Active Norco33.5

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TOTPAR 6-12 Hours

Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 24. Higher scores was indicative of more pain relief. (NCT03448536)
Timeframe: From 6 hours to 12 hours post-dose

InterventionScores on a scale * hours (Least Squares Mean)
Naproxen Sodium15.72
Acetaminophen11.97

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TOTPAR Over 0-6 Hours

Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 22. Higher scores was indicative of more pain relief. (NCT03448536)
Timeframe: Up to 6 hours post-dose

InterventionScores on a scale * hours (Least Squares Mean)
Naproxen Sodium13.46
Acetaminophen12.90

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Number of Participants by Global Evaluation Scores

Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.' (NCT03448536)
Timeframe: Up to 12 hours post-dose

,
InterventionParticipants (Count of Participants)
PoorFairGoodVery goodExcellent
Acetaminophen1342383825
Naproxen Sodium1026256035

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SPID Over 0-6 Hours

Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55. (NCT03448536)
Timeframe: Up to 6 hours post-dose

InterventionScores on a scale * hours (Least Squares Mean)
Naproxen Sodium23.47
Acetaminophen21.94

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Pain Intensity Difference (PID) Scores at Each Evaluation

Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. (NCT03448536)
Timeframe: Up to 12 hours post-dose

,
InterventionScores on a scale (Mean)
30 minutes1 hour3 hours6 hours9 hours12 hours
Acetaminophen0.92.14.04.33.63.5
Naproxen Sodium0.81.94.15.14.95.0

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Pain Relief Scores at Each Evaluation

Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). (NCT03448536)
Timeframe: Up to 12 hours post-dose

,
InterventionScores on a scale (Mean)
30 minutes1 hour3 hours6 hours9 hours12 hours
Acetaminophen0.91.62.32.42.01.9
Naproxen Sodium0.91.42.32.72.62.7

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Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours

Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 46. Higher scores was indicative of more pain relief. (NCT03448536)
Timeframe: Up to 12 hours post-dose

InterventionScores on a scale * hours (Least Squares Mean)
Naproxen Sodium29.18
Acetaminophen24.87

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Summed Pain Intensity Difference (SPID) Over 0-12 Hours

Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115. (NCT03448536)
Timeframe: Up to 12 hours post-dose

InterventionScores on a scale * hours (Least Squares Mean)
Naproxen Sodium53.62
Acetaminophen43.82

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Time to First Intake of Rescue Medication

Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment. (NCT03448536)
Timeframe: Up to 12 hours post-dose

InterventionHours (Median)
Naproxen SodiumNA
AcetaminophenNA

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SPID Over 6-12 Hours

Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60. (NCT03448536)
Timeframe: From 6 hours to 12 hours post-dose

InterventionScores on a scale * hours (Least Squares Mean)
Naproxen Sodium30.15
Acetaminophen21.88

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Patient Reported Pain

Pain measured from 0 (no pain) to 10 (worst pain) (NCT03468920)
Timeframe: through study visit, less than 24 hours

Interventionscore on a scale (Mean)
Arm 1: IV Acetaminophen Group4.12
Arm 2: PO Acetaminophen Group4.37

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Number of Participants Who Experienced Postoperative Nausea and Vomiting

Did patient experience negative effects of pain medication (postoperative nausea and vomiting) (NCT03468920)
Timeframe: through study visit, less than 24 hours

InterventionParticipants (Count of Participants)
Arm 1: IV Acetaminophen Group8
Arm 2: PO Acetaminophen Group6

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Length of Stay

Minutes from entering PACU to end of Phase II (NCT03468920)
Timeframe: through study visit, less than 24 hours

Interventionminutes (Mean)
Arm 1: IV Acetaminophen Group88.25
Arm 2: PO Acetaminophen Group92.88

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Patient Satisfaction

Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied) (NCT03468920)
Timeframe: up to 2 days after surgery

Interventionscore on a scale (Mean)
Arm 1: IV Acetaminophen Group9.45
Arm 2: PO Acetaminophen Group9.77

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Number of Participants Who Received Opioid Administration in PACU

Number of Participants who Received Opioid Administration in PACU (NCT03468920)
Timeframe: through study visit, less than 24 hours

InterventionParticipants (Count of Participants)
Arm 1: IV Acetaminophen Group31
Arm 2: PO Acetaminophen Group34

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Number of Intensive Care Unti (ICU) Days

"The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval." (NCT03472469)
Timeframe: 30 days

InterventionICU days (Mean)
Original MMPR - Descending Dose Arm0.21
MAST MMPR - Escalating Dose Arm0.21

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Number of Participants Discharged From the Hospital With an Opioid Prescription

(NCT03472469)
Timeframe: Up to 30 days

InterventionParticipants (Count of Participants)
Original MMPR - Descending Dose Arm527
MAST MMPR - Escalating Dose Arm476

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Number of Hospital Days

"The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval." (NCT03472469)
Timeframe: 30 days

Interventionhospital days (Mean)
Original MMPR - Descending Dose Arm4.97
MAST MMPR - Escalating Dose Arm5.12

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Pharmacy Costs

The costs of the pain medications given during the specified time period. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)

Interventiondollars (Median)
Original MMPR - Descending Dose Arm507
MAST MMPR - Escalating Dose Arm397

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Pain as Assessed by Score on the Numeric Rating Scale (NRS)

An average will be calculated of the daily numeric rating scale (NRS) for pain (0=no pain, 10=worst pain). This assessment is used in verbal participants. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)

Interventionunits on a scale (Median)
Original MMPR - Descending Dose Arm3.3
MAST MMPR - Escalating Dose Arm3.3

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Pain as Assessed by Score on the Behavioral Pain Scale (BPS)

An average will be calculated of the daily score on the Behavioral Pain Scale (BPS). BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)

Interventionscore on a scale (Median)
Original MMPR - Descending Dose Arm2.5
MAST MMPR - Escalating Dose Arm2.3

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Number of Ventilator Days

"The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval." (NCT03472469)
Timeframe: 30 days

Interventionventilator days (Mean)
Original MMPR - Descending Dose Arm0.08
MAST MMPR - Escalating Dose Arm0.06

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Opioid Use Per Day

Opioid use per day is calculated by tallying the dose equivalency of all opioids received and dividing by the number of days hospitalized. Morphine milligram equivalents (MME) per day are reported. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)

InterventionMME per day (Median)
Original MMPR - Descending Dose Arm48
MAST MMPR - Escalating Dose Arm34

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Overall Costs

the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)

Interventiondollars (Median)
Original MMPR - Descending Dose Arm20093
MAST MMPR - Escalating Dose Arm19561

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Total Time That Temperature is ≥ 38.3ºC

Time in minutes where the temperature is ≥ 38.3ºC during the 48 hours of control versus intervention administration. (NCT03496545)
Timeframe: 48 hours

InterventionMinutes (Mean)
Acetaminophen216
Bromocriptine and Acetaminophen300

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Total Time to First Temperature < 37.5ºC

Time in minutes it took after medication administration for the temperature to reach < 37.5ºC. (NCT03496545)
Timeframe: 48 hours

InterventionMinutes (Mean)
Acetaminophen253.5
Bromocriptine and Acetaminophen556

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Temperature Burden

Mean total body temperature burden above 37°C over 48 hours during which patient receives either control or intervention medication. (NCT03496545)
Timeframe: over 48 hours

InterventionTemperature in degrees Celsius (Mean)
Acetaminophen37.8
Bromocriptine and Acetaminophen37.7

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Incidence of Adverse Events - Symptomatic Hypotension, Nausea and Headache

Episodes of symptomatic hypotension, including decrease in supine systolic and diastolic pressures of greater than 20mm and 10mm Hg respectively with patient reported accompanying symptoms of light headedness or dizziness and incidence of nausea and headache. (NCT03496545)
Timeframe: Nursing assessment at every shift during 48 hour study period after first drug administration

,
InterventionParticipants (Count of Participants)
Decrease in blood pressureNauseaHeadache
Acetaminophen1228
Bromocriptine and Acetaminophen17312

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Score on Visual Analog Scale (VAS) of Pain

"Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. The higher the score, the worse the pain." (NCT03510910)
Timeframe: 24 hours post-surgery

Interventionscore on a scale (Mean)
Acetaminophen Along With a Reduced Quantity of Percocet5.30
Percocet Only4.98

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Patient Satisfaction

Satisfaction was reported on a Likert-type scale of 1-10 (the higher the score, the higher the satisfaction) (NCT03510910)
Timeframe: 7 days post-surgery

Interventionscore on a scale (Mean)
Acetaminophen Along With a Reduced Quantity of Percocet8.48
Percocet Only8.83

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Morphine-equivalent Consumption

Amount of oxycodone/acetaminophen (Percocet) in 5mg/325mg doses will be recorded in number of pills (NCT03510910)
Timeframe: 7 days post-surgery

Interventionpills (Mean)
Acetaminophen Along With a Reduced Quantity of Percocet6.33
Percocet Only5.69

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Score on Visual Analog Scale (VAS) of Pain

"Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. The higher the score, the worse the pain." (NCT03510910)
Timeframe: 7 days post-surgery

Interventionscore on a scale (Mean)
Acetaminophen Along With a Reduced Quantity of Percocet3.20
Percocet Only2.83

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Score on Visual Analog Scale (VAS) of Pain

"Pain severity scores at rest will be assessed by use of VAS. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. The higher the score, the worse the pain." (NCT03510910)
Timeframe: 4 days post-surgery

Interventionscore on a scale (Mean)
Acetaminophen Along With a Reduced Quantity of Percocet3.55
Percocet Only3.20

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Improvement in NPS Pain Score by >=50%

The number of patients who minimally achieved a 50% improvement in NPS pain score from 0 to 60 minutes. (NCT03521102)
Timeframe: 60 minutes after administration of medication

InterventionParticipants (Count of Participants)
Acetaminophen 1000mg IV30
Hydromorphone 0.5mg IV43

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Need for Rescue Medication

Number of participants who required additional analgesic medication for the treatment of pain at any time during their ED course. (NCT03521102)
Timeframe: 120 minutes following administration of medication

InterventionParticipants (Count of Participants)
Acetaminophen 1000mg IV37
Hydromorphone 0.5mg IV31

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Clinical Improvement in NRS Pain Score

"Pain improvement was assessed using an NRS (numeric rating scale) to assess pain on a range of 0-10. Participants were asked to verbalize intensity of pain on the scale with zero meaning no pain and 10 meaning the worst pain imaginable. Pain was assessed at baseline and 60 minutes later to determine if clinically important improvement in pain was achieved. Clinically important improvement in pain was defined as an improvement of >=1.3 points on the 0-10 scale." (NCT03521102)
Timeframe: 60 minutes following administration of medication

InterventionParticipants (Count of Participants)
Acetaminophen 1000mg IV62
Hydromorphone 0.5mg IV63

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Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment

"Pain scores were measured and recorded by selecting a number [0-10] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax.~The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain." (NCT03523988)
Timeframe: 6 hours after orthodontic treatment

,,
Interventionscores on a scale (Mean)
RestBitingChewing
Acetaminophen0.62.02.3
Acetaminophen and Ibuprofen1.02.03.1
Ibuprofen2.62.94.0

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Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment

"Pain scores were measured and recorded by selecting a number [0-10] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax.~The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain." (NCT03523988)
Timeframe: 2 days after orthodontic treatment

,,
Interventionscores on a scale (Mean)
RestBitingChewing
Acetaminophen1.32.32.9
Acetaminophen and Ibuprofen0.40.91.6
Ibuprofen1.42.33.1

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Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment

"Pain scores were measured and recorded by selecting a number [0-10] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax.~The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain." (NCT03523988)
Timeframe: 1 day after orthodontic treatment

,,
Interventionscores on a scale (Mean)
RestBitingChewing
Acetaminophen1.92.93.6
Acetaminophen and Ibuprofen1.12.12.7
Ibuprofen2.02.53.9

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Simple Shoulder Test

Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. (NCT03540030)
Timeframe: 2 Weeks

Interventionscore on a scale (Median)
Observational2.0
Non-Opioid Intervention2.0

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Nausea

rate of nausea (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention1340
Observational5232

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Simple Shoulder Test

Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. (NCT03540030)
Timeframe: 2 Months

Interventionscore on a scale (Median)
Observational6
Non-Opioid Intervention6

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Post Op Pain

Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain) (NCT03540030)
Timeframe: 24 hours

Interventionscore on a scale (Median)
Observational3.0
Non-Opioid Intervention2.0

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Additional Post Op Pain

post-operative pain: measured on a 0 (no pain) -10 (worst) numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months. A score of 0(no pain) is preferable to 10(worst possible pain) (NCT03540030)
Timeframe: 6hrs, 12hrs, 2weeks, 2 months

,
Interventionscore on a scale (Median)
6 Hrs12 hrs2 weeks2 months
Non-Opioid Intervention0.000.820
Observational241.30.7

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Falls

rate of falls (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention4274
Observational4242

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Morphine Use

Morphine milli-equivalents In-hospital post-operative. Continuous scale of MME, no defined better/worse. Measured as number and dose of medications taken. For example, if the patient received an opioid, the drug and dose was recorded and converted to MME. A time frame of when to assess opioid use in-hospital post-operative was not used but was a continuous monitor for rescue opioid from in-hospital post-operative through discharge. (NCT03540030)
Timeframe: In-hospital Stay

InterventionMorphine milli-equivalents (Median)
Observational45.0
Non-Opioid Intervention19.0

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ASES

American Shoulder and Elbow Surgeons (ASES) Shoulder Score for pain and function. Range 0-100. Low score = worse shoulder condition. Function, disability, and pain subscores (all ranges 0-50), and are summed for total ASES score. (NCT03540030)
Timeframe: 2 Weeks

Interventionunits on a scale (Median)
Observational54.3
Non-Opioid Intervention54.2

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Constipation

rate of constipation (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention13220
Observational1992

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Constipation

rate of constipation (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention4274
Observational7212

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Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore

quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. (NCT03540030)
Timeframe: 2 Weeks

,
Interventionscore on a scale (Median)
PCSMCS
Non-Opioid Intervention35.059.1
Observational36.756.3

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Pain Satisfaction

Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention2924
Observational2352

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Pain Satisfaction

Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention3410
Observational2712

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Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore

quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. (NCT03540030)
Timeframe: 2 Months

,
Interventionscore on a scale (Median)
PCSMCS
Non-Opioid Intervention40.360.8
Observational38.458.7

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Nausea

rate of nausea (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention1300
Observational0282

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Falls

rate of falls (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention5300
Observational1272

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Inpatient Admission

Percentage of patients admitted to the inpatient unit for parenteral pain management (NCT03541980)
Timeframe: 120 minutes

InterventionParticipants (Count of Participants)
Intervention25
Placebo21

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Pain Scores

Scale of 1-10 Pain scale, Min value 1, Max value 10, higher score is worse (NCT03541980)
Timeframe: at disposition

Interventionpain intensity measured on scale 1-10 (Mean)
Intervention5.5
Placebo5.2

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Adverse Effects

Rate of adverse effects experienced by patients from opioid administration vs acetaminophen administration (NCT03541980)
Timeframe: 120 minutes

InterventionParticipants (Count of Participants)
Intervention0
Placebo0

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Cumulative Opioid Dosing

Total dosing of opioid given after initial evaluation in mg/kg (NCT03541980)
Timeframe: 120 minutes

Interventionmg/kg (Mean)
Intervention.2
Placebo.2

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Percentage of the Patients Reporting Satisfaction

How satisfied were patients with the management of their pain (NCT03541980)
Timeframe: 120 minutes

Interventionpercent (Mean)
Intervention84
Placebo85

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Percentage of Patients Who Received Additional Pain Medication Within 60 Minutes of Administration of Study Medication

Difference in percentage of patients who received additional pain medication within 60 minutes of administration of study medication in the two arms of the study (NCT03553498)
Timeframe: Baseline to 60 minutes post-baseline

InterventionParticipants (Count of Participants)
IV Hydromorphone and IV Acetaminophen2
IV Hydromorphone and Placebo2

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Percentage of Patients Who Received Additional Pain Medication Between 61 and 120 Minutes After Administration of Study Medications

Difference in percentage of patients who received additional pain medication between 61 and 120 minutes after administration of study medication by study group (NCT03553498)
Timeframe: 61 to 120 minutes post-baseline

InterventionParticipants (Count of Participants)
IV Hydromorphone and IV Acetaminophen2
IV Hydromorphone and Placebo4

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Percentage of Patients Who Want Additional Analgesics

"Number of patients who answer yes to question: Do you want more pain medication divided by number of patients" (NCT03553498)
Timeframe: Immediately after administration of study medication to 120 minutes after administration of study medication

InterventionParticipants (Count of Participants)
IV Hydromorphone and IV Acetaminophen21
IV Hydromorphone and Placebo29

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Change in Numerical Rating Scale of Pain (NRS) Before Treatment to 60 Minutes After Treatment

The between group difference in change in NRS pain scores from before administration of study medications to 60 minutes post administration of study medications. The NRS is a previously validated and reproducible measure of pain intensity ranging from 0 = no pain, to 10 = worst possible pain. Higher values indicate more pain relief from before treatment to 60 minutes after treatment (NCT03553498)
Timeframe: Before treatment to 60 minutes after treatment

Interventionunits on a scale (Mean)
IV Hydromorphone and IV Acetaminophen6.2
IV Hydromorphone and Placebo5.4

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Best Objective Response

Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a <50% decrease or <25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a <50% decrease or <25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology. (NCT03554005)
Timeframe: Up to 40 Weeks

,,,,,
InterventionParticipants (Count of Participants)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Not Evaluated
PEG Interferon Alfa-2b 0.75 mcg/kg OW00100
PEG Interferon Alfa-2b 1.5 mcg/kg OW00200
PEG Interferon Alfa-2b 3 mcg/kg OW10001
PEG Interferon Alfa-2b 4.5 mcg/kg OW01010
PEG Interferon Alfa-2b 6 mcg/kg OW30611
PEG Interferon Alfa-2b 7.5 mcg/kg OW04421

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Number of Participants Who Experienced an Adverse Event

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT03554005)
Timeframe: Up to 42 Weeks

InterventionParticipants (Count of Participants)
PEG Interferon Alfa-2b 0.75 mcg/kg OW1
PEG Interferon Alfa-2b 1.5 mcg/kg OW2
PEG Interferon Alfa-2b 3 mcg/kg OW1
PEG Interferon Alfa-2b 4.5 mcg/kg OW2
PEG Interferon Alfa-2b 6 mcg/kg OW11
PEG Interferon Alfa-2b 7.5 mcg/kg OW11

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Number of Participants Who Discontinued Treatment Due to an Adverse Event

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT03554005)
Timeframe: Up to 40 Weeks

InterventionParticipants (Count of Participants)
PEG Interferon Alfa-2b 0.75 mcg/kg OW0
PEG Interferon Alfa-2b 1.5 mcg/kg OW0
PEG Interferon Alfa-2b 3 mcg/kg OW0
PEG Interferon Alfa-2b 4.5 mcg/kg OW0
PEG Interferon Alfa-2b 6 mcg/kg OW0
PEG Interferon Alfa-2b 7.5 mcg/kg OW3

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Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire

"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians." (NCT03554018)
Timeframe: Baseline and one week after discharge from emergency department

Interventionunits on a scale (Mean)
Acetaminophen11.1
Placebo11.9

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Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale

Data collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. (NCT03554018)
Timeframe: 7 days after discharge from emergency department

InterventionParticipants (Count of Participants)
Acetaminophen16
Placebo15

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Patient Satisfaction.

Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction (NCT03558555)
Timeframe: 7 days post surgery

Interventionscore on a scale (Mean)
Oral Acetaminophen5.05
Acetaminophen IV Soln6.20

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Patient Reported Total Narcotic Use Post-discharge

home opiod use (NCT03558555)
Timeframe: average 7 days

InterventionMME (Mean)
Oral Acetaminophen14.06
Acetaminophen IV Soln17.56

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PACU Length of Stay

Time in PACU (NCT03558555)
Timeframe: up to 24 hours after PACU arrival

Interventionminutes (Mean)
Oral Acetaminophen82.93
Acetaminophen IV Soln64.05

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Total MME Intraoperatively

Total Morphine Milligram Equivalent (MME) use intraoperatively (NCT03558555)
Timeframe: Day 1

InterventionMME (Mean)
Oral Acetaminophen63.75
Acetaminophen IV Soln57.24

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PACU Visual Analogue Pain Scores

Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain. (NCT03558555)
Timeframe: baseline, 1 hour, and Day 1 discharge

,
Interventionscore on a scale (Mean)
Baseline1 hourDischarge from PACU, up to 2.5 hours6 hour post op24 hour post op
Acetaminophen IV Soln1.522.411.594.274.16
Oral Acetaminophen2.132.881.453.823.64

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Total Narcotic Use in PACU.

Total narcotic use in PACU expressed in total morphine milligram equivalents (MME) (NCT03558555)
Timeframe: Day 1

InterventionMME (Mean)
Oral Acetaminophen11.33
Acetaminophen IV Soln9.83

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Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4

Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness. (NCT03570554)
Timeframe: Day 4

InterventionScores on a scale (Least Squares Mean)
Naproxen-5.2
Acetaminophen ER-5.3
Celecoxib-4.8
Placebo-1.3

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Sum of Change in Brief Arthritis Stiffness Scale (BASS) Scores Over the 4-day Treatment Period

Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness. This endpoint was calculated by summing the changes from baseline (CFB) in BASS scores at Days 2, 3, and 4 of the treatment periods. (NCT03570554)
Timeframe: 4 days

InterventionScores on a scale (Least Squares Mean)
Naproxen-12.6
Acetaminophen ER-13.6
Celecoxib-11.7
Placebo-2.3

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Absolute Brief Arthritis Stiffness Scale (BASS) Score at Each Time Point

Brief Arthritis Stiffness Scale (BASS) is a patient-reported outcome (PRO) instrument measuring of the severity of osteoarthritis-related stiffness in the target knee joint. The BASS score ranges from 0 to 40 and a higher score indicates worse stiffness. (NCT03570554)
Timeframe: 4 days

,,,
InterventionScores on a scale (Least Squares Mean)
Day 1Day 2Day 3Day 4
Acetaminophen ER23.319.718.418.0
Celecoxib24.620.618.918.5
Naproxen23.020.818.418.1
Placebo22.623.222.422.0

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Current Pain Intensity Level

The patient will be administered a survey and asked to rate their current pain intensity level (1 week post surgery) on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of greater pain intensity. (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia1.14
Opioid Analgesia1.37

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Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery

Unused medications is defined as the proportion of prescribed pills that were unused at 1 week post surgery as reported by the patient. More unused medications may indicate the potential to decrease the dosage needed. (NCT03584373)
Timeframe: 1 week post surgery

Interventionproportion of unused pills (Mean)
Non-Opioid Analgesia0.63
Opioid Analgesia0.58

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Satisfaction With Pain Relief

The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia8.70
Opioid Analgesia8.85

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Average Pain Intensity Level

The patient will be administered a survey and asked to rate their average pain intensity level since undergoing surgery. The patient will be asked to rate this average pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of higher average pain intensity. (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia3.34
Opioid Analgesia4.50

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Perception of an Acceptable Pain Intensity Level

The patient will be administered a survey and asked to rate what their perception or belief of an acceptable pain intensity level would be since undergoing the surgery. The patient will be asked to rate this acceptable pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 equaling no pain, and 10 being the worst possible pain. Higher scores are indicative of the patient's belief of an acceptable pain intensity level. (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia2.73
Opioid Analgesia3.28

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Rates of Constipation

Percentage of patients who experienced constipation any time during the week after surgery. A lower percentage of constipation may indicate less incidence of adverse events. (NCT03584373)
Timeframe: 1 week post surgery

InterventionParticipants (Count of Participants)
Non-Opioid Analgesia11
Opioid Analgesia17

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Peak Pain Intensity Level

The patient will be administered a survey and asked to rate the worst/peak pain intensity level since undergoing the surgery. The patient will be asked to rate this worst pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scoring is indicative of worst/peak pain intensity level since the time of surgery (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia5.61
Opioid Analgesia7.52

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Additional Contacts With Provider

By chart review, unscheduled interactions with the healthcare system related to pain will be counted.These will include phone calls related to pain, unscheduled visits to the office or emergency department (NCT03588910)
Timeframe: 1 week post operative

InterventionUnscheduled patient contacts (Number)
Number of Oxycodone Tablets Typically Prescribed1
Half the Number of Oxycodone Tablets Typically Prescribed4

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Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery

During the survey phone call on day 7, participants will be asked to report the total number of oxycodone tablets used since the surgery. (NCT03588910)
Timeframe: 7 days post-operative

InterventionOxycodone Tablets (Median)
Number of Oxycodone Tablets Typically Prescribed2.5
Half the Number of Oxycodone Tablets Typically Prescribed2.0

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Number of Oxycodone Tablets Used Day 1

During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery. (NCT03588910)
Timeframe: 24 hours post-operative

InterventionOxycodone Tablets (Median)
Number of Oxycodone Tablets Typically Prescribed1.0
Half the Number of Oxycodone Tablets Typically Prescribed1.0

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Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)

Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) (NCT03588910)
Timeframe: 1 day post operative

InterventionScore on Numeric Pain Scale (Median)
Number of Oxycodone Tablets Typically Prescribed5.0
Half the Number of Oxycodone Tablets Typically Prescribed5

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Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)

Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) (NCT03588910)
Timeframe: 7 days post operative

InterventionScore on Numeric Pain Scale (Median)
Number of Oxycodone Tablets Typically Prescribed2.0
Half the Number of Oxycodone Tablets Typically Prescribed1.3

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Total Opioid Consumption (in Daily Morphine Equivalents)

Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo (NCT03599089)
Timeframe: [time frame: 96 hours]

Interventionmg morphine equivalents/day (Mean)
CA-008 0.7 mg (0.05 mg/mL Concentration)42.50
CA-008 2.1 mg (0.15 mg/mL Concentration)37.71
CA-008 4.2 mg (0.3 mg/mL Concentration)28.22
Placebo56.11

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Percentage of Subjects Opioid Free

Percentage of subjects who are opioid-free for CA-008 compared to placebo. (NCT03599089)
Timeframe: [time frame: 96 hours]

Interventionpercentage of subjects (Number)
CA-008 0.7 mg (0.05 mg/mL Concentration)19.4
CA-008 2.1 mg (0.15 mg/mL Concentration)16.7
CA-008 4.2 mg (0.3 mg/mL Concentration)26.3
Placebo5.4

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Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)

Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose (NCT03599089)
Timeframe: [time frame: 96 hours]

Interventionscores on a scale*hour (Mean)
CA-008 0.7 mg (0.05 mg/mL Concentration)317.09
CA-008 2.1 mg (0.15 mg/mL Concentration)321.72
CA-008 4.2 mg (0.3 mg/mL Concentration)266.86
Placebo400.56

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Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. (NCT03605914)
Timeframe: 120 hours (day 5 after operation)

Interventionunits on a scale (Mean)
NSAID17.2
Opioid18.9

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Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. (NCT03605914)
Timeframe: 72 hours (day 3 after operation)

Interventionunits on a scale (Mean)
NSAID22.9
Opioid27.9

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Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. (NCT03605914)
Timeframe: 48 hours (day 2 after operation)

Interventionunits on a scale (Mean)
NSAID24.2
Opioid28.3

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Pain Score as Assessed by a 100mm Visual Analogue Scale (VAS)

The range of scores on the VAS is 0 to 100, with 100 being the highest level of pain. (NCT03605914)
Timeframe: 24 hours (day 1 after operation)

Interventionunits on a scale (Mean)
NSAID30.2
Opioid40.7

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Number of Participants With Bleeding Complications

Bleeding complications are defined as complications necessitating a trip to the emergency room or requiring intervention for epistaxis. (NCT03605914)
Timeframe: 5 days after operation

InterventionParticipants (Count of Participants)
NSAID0
Opioid0

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Average Pain Burden

Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain. (NCT03618823)
Timeframe: 14 days post-operatively

,
InterventionScore on a scale (Mean)
BeforeAfter
Non-opioid Pain Control Group5.662.24
Opioid Pain Control Group5.782.33

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Mean of Total Quantity of Pain Medications Taken

Using the take-home pain diary, the total amount in mL of each analgesic used over 14 days by each patient in a group will be averaged and reported. (NCT03618823)
Timeframe: 14 days post-operatively

,
InterventionMilliliters (Mean)
AcetaminophenIbuprofenOxycodone
Non-opioid Pain Control326.98334.652.96
Opioid Pain Control292.48324.146.47

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Average Dose of Each Analgesic Used

In the take-home pain diary, patients will record the amount of medication taken for each dose. The mean value of these doses will be calculated and averaged within each group to determine the average dose of each analgesic used. (NCT03618823)
Timeframe: 14 days post-operatively

,
InterventionMilliliters (Mean)
AcetaminophenIbuprofenOxycodone
Non-opioid Pain Control7.527.530.04
Opioid Pain Control6.547.530.13

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Overall Pain Relief Satisfaction

"Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a Likert scale. Patients will respond to the following statement I am happy with the pain relief I received in the last 14 days with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value, from 0 (strongly disagree) to 4 (strongly agree), and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores mean a better outcome." (NCT03618823)
Timeframe: 14 days post-operatively

Interventionscore on a scale (Mean)
Opioid Pain Control3.35
Non-opioid Pain Control3.09

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Number of Participants With Readmissions

Number of participants with hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary. (NCT03618823)
Timeframe: 14 days post-operatively

InterventionParticipants (Count of Participants)
Opioid Pain Control3
Non-opioid Pain Control8

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Number of Participants With ED (Emergency Department) or Urgent Care Visits

Number of participants with emergency department or urgent care visits in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary. (NCT03618823)
Timeframe: 14 days post-operatively

InterventionParticipants (Count of Participants)
Opioid Pain Control8
Non-opioid Pain Control11

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Post-operative Nursing Phone Calls

Number of post-operative phone calls to nursing staff, obtained using the electronic medical record. (NCT03618823)
Timeframe: 14 days post-operatively

Interventionpost-operative phone calls (Mean)
Opioid Pain Control0.35
Non-opioid Pain Control0.47

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Non-opioid Group Switching to Opioid Group

Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary. (NCT03618823)
Timeframe: 14 days post-operatively

InterventionParticipants (Count of Participants)
Non-opioid Pain Control7

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Duration of Each Analgesic Used

Using the results of the take-home pain diary, we will calculate the average number of days of use of each analgesic for each group. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use. (NCT03618823)
Timeframe: 14 days post-operatively

,
Interventiondays (Mean)
AcetaminophenIbuprofenOxycodone
Non-opioid Pain Control8.648.750.45
Opioid Pain Control8.618.492.62

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Number of Participants

Number of participants requiring escape pills (NCT03631433)
Timeframe: 4 day postoperative survey

InterventionParticipants (Count of Participants)
Ibuprofen20
Ibuprofen/Acetaminophen Combination18

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Heft Parker Visual Analog Scale Pain Scale Pain Measurements

Heft-Parker Visual Analog Scale measurements (0-170mm scale) Higher values are a worse outcome. (NCT03631433)
Timeframe: 4 day postoperative survey

Interventionunits on a scale (Mean)
Ibuprofen63
Ibuprofen/Acetaminophen Combination60

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Sum Pain Intensity Difference Scores

Beginning post-surgery (at initiation of Dose 2), Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used. (NCT03652818)
Timeframe: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)

Interventionscore on a scale (Least Squares Mean)
Group A/ Placebo Group-2.4292
Group B/ APAP Group-68.0778
Group C/ PGB Group-68.3533
Group D/ Combination Co-dosing Group-93.3645
Group E/ Combination Split-dosing Group-82.4099

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Total Pain Relief Measure

Beginning post-surgery (at initiation of Dose 2), Pain Relief was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used. (NCT03652818)
Timeframe: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)

Interventionscore on a scale (Least Squares Mean)
Group A/ Placebo Group17.1038
Group B/ APAP Group88.2775
Group C/ PGB Group94.4433
Group D/ Combination Co-dosing Group121.9596
Group E/ Combination Split-dosing Group91.8373

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Number of Participants With Differing Patient Global Evaluation Scores

Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported. (NCT03652818)
Timeframe: Upto 12.25 hours

,,,,
InterventionParticipants (Count of Participants)
(0) Poor(1) Fair(2) Good(3) Very good(4) Excellent
Group A/ Placebo Group133120
Group B/ APAP Group12785
Group C/ PGB Group82461
Group D/ Combination Co-dosing Group034105
Group E/ Combination Split-dosing Group01162

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Cumulative Number of Participants With Onset of Meaning Pain Relief (MPR) Confirmed at 24 Hours After Dose 2

Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2. (NCT03652818)
Timeframe: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours

InterventionParticipants (Count of Participants)
Group A/ Placebo Group3
Group B/ APAP Group20
Group C/ PGB Group11
Group D/ Combination Co-dosing Group17
Group E/ Combination Split-dosing Group10

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Cumulative Number of Participants With Onset of First Perceptible Relief (FPR) Confirmed at 24 Hours After Dose 2

Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2. (NCT03652818)
Timeframe: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours

InterventionParticipants (Count of Participants)
Group A/ Placebo Group12
Group B/ APAP Group23
Group C/ PGB Group17
Group D/ Combination Co-dosing Group22
Group E/ Combination Split-dosing Group10

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Percentage of Patients With Any Nausea Over 48 Hours

Percentage of patients with any nausea over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-10836
Norco55
Placebo15

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Number of Doses of Study Medication Taken Over Days 3to7

Number of doses of study medication taken over Days 3 to 7 (NCT03657810)
Timeframe: Day3 to Day7

Interventiondoses (Mean)
CL-10810.0
Norco8.4
Placebo6.2

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Percentage of Participants With OINV Over 48 Hours

Number and Percentage of participants With opioid-induced nausea and vomiting (OINV) who experienced any Vomiting / use of Anti-Emetic Medication Over 48 Hours (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-1088
Norco31
Placebo4

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Percentage of Patients With Any Nausea or Vomiting Over 48 Hours

Percentage of patients with any nausea or vomiting over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-10837
Norco55
Placebo16

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Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)

Percentage of patients with any Post-discharge Nausea and Vomiting (PDNV) over Days 3 to 7 (NCT03657810)
Timeframe: Day 3 to 7

InterventionParticipants (Count of Participants)
CL-1089
Norco12
Placebo6

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Number of Doses of Study Medication Taken Per Day Over Days 3to7

Number of doses of study medication taken per day over Days 3 to 7 (NCT03657810)
Timeframe: Day3 to Day7

,,
Interventiondoses per day (Mean)
Number of Doses of Study Medication Taken over Day 3Number of Doses of Study Medication Taken over Day 4Number of Doses of Study Medication Taken over Day 5Number of Doses of Study Medication Taken over Day 6Number of Doses of Study Medication Taken over Day 7
CL-1083.02.11.91.81.1
Norco2.41.91.71.50.9
Placebo2.11.41.11.00.6

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The Sum of Pain Intensity Differences (on PI-NRS) Over 48 Hours (SPID48)

"The SPID48 endpoint is calculated from the PI-NRS values at baseline, every 30 minutes until hour 12, then every hour (when awake) until hour 48 as follows:~Each subsequent PI-NRS value is subtracted from the baseline PI-NRS value.~Each difference is weighted by the elapsed time from the previous PI-NRS value to the current one.~The weighed differences are summed to yield the SPID48.~Summed pain intensity differences over 48 hours (SPID48) will be compared for patients treated with CL-108 5 mg and those treated with placebo. Pain intensity will be measured on a 0-10 Pain Intensity Numerical Rating Scale (PI-NRS), where 0 is no pain and 10 is severe pain." (NCT03657810)
Timeframe: Up to 48 hours

Interventionscore on a scale (Mean)
CL-108108.5
Norco94.8
Placebo78.7

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Percentage of Patients With Complete Absence of OINV (no Nausea, no Vomiting, and no Use of Anti-emetic Medication) Over 48 Hours

Percentage of patients with complete absence of OINV (no nausea, no vomiting, and no use of anti-emetic medication) over 48 hours comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg) (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-10850
Norco34
Placebo27

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Percentage of Patients With Any Vomiting Over 48 Hours

Percentage of patients with any vomiting over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-1083
Norco19
Placebo2

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The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).

"Number of patients with requests for breakthrough pain medication. Requests for breakthrough pain medication is defined as having pain scores >4 using the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= no pain, 10worst pain imaginable)" (NCT03679013)
Timeframe: 24 hours, 48 hours, 72 hours after post-surgical treatment

,
InterventionParticipants (Count of Participants)
24 hours48 hours72 hours
Opioid Based Standard of Care Regimen.771
Opioid Sparing Pain Regimen.211

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Average Pain Score at 24, 48 and 72 Hours Post-operatively

"Participants were assessed by rating their pain according to the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= no pain, 10=worst pain imaginable)~The minimum and maximum pain scores per participant were aggregated at timepoints of 24 hours, 48 hours, and 72 hours after the start of post-operative treatment" (NCT03679013)
Timeframe: at 24, 48, and 72 hours after the start of post-operative treatment

,
Interventionscore on a scale (Mean)
Minimum Pain Score at 24 hoursMaximum Pain Score at 24 hoursMinimum Pain Score at 48 hoursMaximum Pain Score at 48 hoursMinimum Pain Score at 72 hoursMaximum Pain Score at 72 hours
Opioid Based Standard of Care Regimen.1716.7502.5
Opioid Sparing Pain Regimen.0.093.180.183.6402.36

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Number of Participants With Ileus During Hospitalization

The number of participants with occurrences of ileus during hospitalization. (NCT03679013)
Timeframe: Surgery completion through study completion up to one week.

InterventionParticipants (Count of Participants)
Opioid Based Standard of Care Regimen.0
Opioid Sparing Pain Regimen.0

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Percentge of Subjects Receiving no Opioid Rescue

(NCT03695367)
Timeframe: 0-24 hours, 24-48 hours, 24-72 hours, 48-72 hours

,
InterventionParticipants (Count of Participants)
0-24 hours24-48 hours24-72 hours48-72 hours
Cohort 1: HTX-011 + MMA Regimen30323233
Cohort 2: HTX-011 + MMA Regimen + Ketorolac27292828

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Percentage of Subjects Receiving no Opioid Rescue

(NCT03695367)
Timeframe: 72 hours

InterventionParticipants (Count of Participants)
Cohort 1: HTX-011 + MMA Regimen30
Cohort 2: HTX-011 + MMA Regimen + Ketorolac27

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Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.

(NCT03695367)
Timeframe: 72 hours

InterventionParticipants (Count of Participants)
Cohort 1: HTX-011 + MMA Regimen5
Cohort 2: HTX-011 + MMA Regimen + Ketorolac6

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Percentge of Subjects Receiving no Opioid Rescue

(NCT03695367)
Timeframe: Day 28

InterventionParticipants (Count of Participants)
Cohort 1: HTX-011 + MMA Regimen28
Cohort 2: HTX-011 + MMA Regimen + Ketorolac24

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Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])

(NCT03695367)
Timeframe: 72 hours

InterventionMME, morphine milligram equivalents (Mean)
Cohort 1: HTX-011 + MMA Regimen0.59
Cohort 2: HTX-011 + MMA Regimen + Ketorolac1.32

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Ductus Arteriosus Closure/Constriction Rate

Ductal closure/constriction rate as defined based on the echocardiographic findings. Ductal closure/constriction will be defined as the complete closure of ductus or ductal diameter <1 mm (NCT03701074)
Timeframe: 24-48 hours after the completion of study intervention

InterventionParticipants (Count of Participants)
Ibuprofen and Acetaminophen Arm (Intervention Arm)0
Ibuprofen and Placebo Arm (Control Arm)0

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Average Pain Score

Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) in post-anesthesia care unit (PACU). (NCT03714919)
Timeframe: 1 hr post-op

Interventionpain score (Mean)
Non-opiod Pain Relief0

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Extubation Time

Amount of time in the PACU before patient is ready to be extubated. (NCT03714919)
Timeframe: 1 hr post-op

Interventionminutes (Median)
Non-opiod Pain Relief23

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Time in PACU

Total time in PACU before patient met discharge criteria. (NCT03714919)
Timeframe: 1-2 hr post-op

Interventionminutes (Median)
Non-opiod Pain Relief56

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Number of Participants With Sedation, Nausea/Vomiting, or Hallucinations

Presence of sedation, nausea/vomiting, or hallucinations post-operatively. (NCT03714919)
Timeframe: 2 hours post-op

Interventionparticipants (Number)
SedationNausea/VomitingHallucinations
Non-opiod Pain Relief710

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End of Surgery to Hospital Discharge

Length of time before patient is ready to be discharged home. (NCT03714919)
Timeframe: 2-3 hours post-op

Interventionminutes (Median)
Non-opiod Pain Relief122

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 5

Interventionunits on a scale (Mean)
Experimental Group10.1
Control Group7.8

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 2

Interventionunits on a scale (Mean)
Experimental Group23.0
Control Group21.6

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 4

Interventionunits on a scale (Mean)
Experimental Group1.5
Control Group1.9

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 5

Interventionunits on a scale (Mean)
Experimental Group1.7
Control Group1.6

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 6

Interventionunits on a scale (Mean)
Experimental Group1.5
Control Group1.4

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 7

Interventionunits on a scale (Mean)
Experimental Group1.3
Control Group1.4

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: BPI score will be collected at the preoperative visit

Interventionunits on a scale (Mean)
Experimental Group1.6
Control Group1.0

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score was collected for postoperative day 1

Interventionunits on a scale (Mean)
Experimental Group30.2
Control Group29.4

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 2

Interventionunits on a scale (Mean)
Experimental Group27.0
Control Group23.5

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 3

Interventionunits on a scale (Mean)
Experimental Group19.2
Control Group22.5

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 4

Interventionunits on a scale (Mean)
Experimental Group14.1
Control Group16.8

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 5

Interventionunits on a scale (Mean)
Experimental Group15.8
Control Group15.0

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Medication Log

Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group. (NCT03783702)
Timeframe: Postoperative day 1 to 7

,
InterventionAverage number of medication doses/day (Mean)
Oxycodone POD1Oxycodone POD2Oxycodone POD3Oxycodone POD4Oxycodone POD5Oxycodone POD6Oxycodone POD7Acetaminophen POD1Acetaminophen POD2Acetaminophen POD3Acetaminophen POD4Acetaminophen POD5Acetaminophen POD6Acetaminophen POD7Ibuprofen POD1Ibuprofen POD2Ibuprofen POD3Ibuprofen POD4Ibuprofen POD5Ibuprofen POD6Ibuprofen POD7
Control Group0.60.40.30.30.30.102.11.91.61.51.31.10.60000000
Experimental Group0.30.10.10.10.10.102.01.81.31.00.90.90.60.60.50.40.30.40.30.2

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 7

Interventionunits on a scale (Mean)
Experimental Group8.1
Control Group10.1

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for preoperative visit (the day before surgery)

Interventionunits on a scale (Mean)
Experimental Group12.4
Control Group8.5

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 2

Interventionunits on a scale (Mean)
Experimental Group2.5
Control Group2.3

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 3

Interventionunits on a scale (Mean)
Experimental Group1.9
Control Group2.1

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected at the preoperative visit

Interventionunits on a scale (Mean)
Experimental Group0
Control Group0

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 1

Interventionunits on a scale (Mean)
Experimental Group36.3
Control Group38.9

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 1

Interventionunits on a scale (Mean)
Experimental Group2.8
Control Group2.9

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 7

Interventionunits on a scale (Mean)
Experimental Group4.6
Control Group5.4

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 6

Interventionunits on a scale (Mean)
Experimental Group6.5
Control Group6.6

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 3

Interventionunits on a scale (Mean)
Experimental Group15.9
Control Group12.9

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 4

Interventionunits on a scale (Mean)
Experimental Group9.3
Control Group11.8

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 6

Interventionunits on a scale (Mean)
Experimental Group13.9
Control Group11.7

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Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)

Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours (NCT03789318)
Timeframe: 96 hours

Interventionscore on a scale (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 12.8
Placebo for Cohort 12.0
CA-008 10 mg (0.1 mg/mL)3.0
CA-008 15 mg (0.15 mg/mL)2.8
Placebo for Cohorts 2 and 31.8

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Time to Opioid Cessation or Freedom

Time to the last use of opioid (NCT03789318)
Timeframe: From Surgery to Day 17

Interventionhours (Median)
CA-008 5 mg (0.05 mg/mL) Cohort 156.37
Placebo for Cohort 155.42
CA-008 10 mg (0.1 mg/mL)83.89
CA-008 15 mg (0.15 mg/mL)59.55
Placebo for Cohorts 2 and 342.26

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Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores

Pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) from 0 to T96 hours (NCT03789318)
Timeframe: 0 to 96 hours

Interventionscore on a scale*hours (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 1392.98
Placebo for Cohort 1392.67
CA-008 10 mg (0.1 mg/mL)384.94
CA-008 15 mg (0.15 mg/mL)406.88
Placebo for Cohorts 2 and 3356.23

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Total Opioid Consumption

The sum of daily opioid consumption (in morphine equivalents) (NCT03789318)
Timeframe: 0 to 96 hours

Interventionmg morphine equivalents (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 185.83
Placebo for Cohort 196.67
CA-008 10 mg (0.1 mg/mL)69.77
CA-008 15 mg (0.15 mg/mL)58.00
Placebo for Cohorts 2 and 377.85

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Percent of Opioid Free Subjects

Percent of subjects who were opioid free at 0-96 hours (NCT03789318)
Timeframe: 0 to 96 hours

InterventionParticipants (Count of Participants)
CA-008 5 mg (0.05 mg/mL) Cohort 10
Placebo for Cohort 10
CA-008 10 mg (0.1 mg/mL)1
CA-008 15 mg (0.15 mg/mL)1
Placebo for Cohorts 2 and 30

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Number of Participants Who Are Minimal Residual Disease (MRD)-Free

MRD-free is defined as participants with no hairy cell leukemia (HCL) in the blood and bone marrow aspirate flow determined by immunohistochemistry (IHC) and flow cytometry of blood and bone marrow aspirate. (NCT03805932)
Timeframe: 28-42 days after day 1 of the last treatment.

InterventionParticipants (Count of Participants)
Moxetumomab - Dose Escalation 30 mcg/kg2
Moxetumomab - Dose Expansion 40 mcg/kg11

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Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT03805932)
Timeframe: Date treatment consent signed to date off study, approximately 11 months and 13 days for the first group, and 4 months and 3 days for the second group.

InterventionParticipants (Count of Participants)
Moxetumomab - Dose Escalation 30 mcg/kg3
Moxetumomab - Dose Expansion 40 mcg/kg15

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Number of Participants With a Dose-limiting Toxicity (DLT)

Dose limiting toxicity (DLT) is defined as all treatment related Grade 3-5 adverse events (AEs) occurring from the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose of moxetumomab pasudotox-tdfk treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. (NCT03805932)
Timeframe: From the initiation of moxetumomab pasudotox-tdfk therapy to within 30 days after the last dose

InterventionParticipants (Count of Participants)
Moxetumomab - Dose Escalation 30 mcg/kg0
Moxetumomab - Dose Expansion 40 mcg/kg0

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Number of Participants Whose Cancer Shrinks or Disappears After Treatment

Number of participants whose cancer shrinks or disappears after treatment defined as minimal residual disease. MRD is no hairy cell leukemia (HCL) in the blood and bone marrow aspirate flow determined by immunohistochemistry (IHC) and flow cytometry of blood and bone marrow aspirate. (NCT03805932)
Timeframe: 28-42 days after day 1 of the last treatment.

InterventionParticipants (Count of Participants)
Moxetumomab - Dose Escalation 30 mcg/kg2
Moxetumomab - Dose Expansion 40 mcg/kg11

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Time-to-exhaustion

Duration of time exercising before reaching peak exertion, defined as cadence drop below 40 revolutions per minute (RPM) for >/= 5 seconds, or patient reaches volitional exhaustion in accordance with American Thoracic Society standard test termination criteria. (NCT03824938)
Timeframe: from start of exercise test until self-reported exhaustion, up to 30 minutes

Interventionseconds (Mean)
Placebo551.7
Aspirin331.6
Acetaminophen578.2

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Exercise-induced Body Temperature Change

Change in body temperature from pre- to post- maximal exercise test. (NCT03824938)
Timeframe: from start of exercise test until self-reported exhaustion, up to 30 minutes

Interventiondegrees Fahrenheit (Mean)
Placebo0.68
Aspirin0.006
Acetaminophen0.31

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Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 8 Hours (SPID 0-8)

Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-8 hours was from -80 to 80. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (8 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 8 hours. (NCT03879408)
Timeframe: Baseline (0 hour) up to 8 hours post-dose

InterventionUnits on a scale (Least Squares Mean)
Arm 1: Placebo3.24
Arm 2: Naproxen Sodium 440 mg34.11
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg39.98
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg45.27
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg29.58

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Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 8 Hours (TOTPAR 0-8)

TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 80. Higher scores was indicative of more pain relief. (NCT03879408)
Timeframe: Baseline (0 hour) up to 8 hours post-dose

InterventionUnits on a scale (Least Squares Mean)
Arm 1: Placebo11.12
Arm 2: Naproxen Sodium 440 mg47.19
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg54.37
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg60.78
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg41.61

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Pain Relief (PAR) Scores at Individual Timepoints

"Participants answered a question at individual time points: how much relief do you have from your starting pain? on a 11-point PR-NRS. Scale ranged from 0=no relief to 10=complete relief. Higher score indicated improvement in pain." (NCT03879408)
Timeframe: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours

,,,,
InterventionUnits on a scale (Least Squares Mean)
0.25 hours0.5 Hours0.75 Hours1 Hours1.25 Hours1.5 Hours2 Hours3 Hours4 Hours5 Hours6 Hours7 Hours8 Hours9 Hours10 Hours11 Hours12 Hours
Arm 1: Placebo0.450.510.771.061.131.181.081.371.661.591.531.511.651.611.731.861.89
Arm 2: Naproxen Sodium 440 mg0.802.274.115.295.996.366.626.521.466.456.266.055.955.735.715.715.62
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg1.363.465.105.916.466.897.377.617.687.437.236.806.636.275.665.335.18
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg1.074.035.716.607.177.657.978.248.468.238.157.947.717.447.497.267.25
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg1.043.235.086.036.406.446.386.265.965.544.884.504.233.883.663.913.98

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Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation

Participants were asked to rate their overall impression of the study medication using the following scale: poor (0), fair (1), good (2), very good (3), and excellent (4) where higher score represented better outcome. (NCT03879408)
Timeframe: Up to 12 hours

InterventionUnits on a Scale (Least Squares Mean)
Arm 1: Placebo0.8
Arm 2: Naproxen Sodium 440 mg2.7
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg2.9
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg3.3
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg2.7

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Pain Intensity Difference (PID) Scores at Individual Time Points

Pain Intensity was self-reported over 12 hours, using a pain rating of 0-10 on the PI-NRS, with score ranged from 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to baseline at each time point after study drug administration. (NCT03879408)
Timeframe: 0.25 hours, 0.5 hours, 0.75 hours, 1 hours, 1.25 hours, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 11 hours, and 12 hours

,,,,
InterventionUnits on a scale (Least Squares Mean)
0.25 hours0.5 Hours0.75 Hours1 Hours1.25 Hours1.5 Hours2 Hours3 Hours4 Hours5 Hours6 Hours7 Hours8 Hours9 Hours10 Hours11 Hours12 Hours
Arm 1: Placebo0.250.070.240.450.340.310.220.340.530.500.470.400.480.530.640.690.71
Arm 2: Naproxen Sodium 440 mg0.581.823.153.974.504.724.874.754.634.594.504.364.174.044.013.993.91
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg1.012.613.824.414.875.185.495.625.645.515.284.964.744.463.873.633.53
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg0.853.064.314.955.425.766.016.176.316.136.065.825.685.415.435.165.16
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg00.792.363.774.484.714.744.674.514.263.893.393.082.902.562.422.712.66

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Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 6 Hours (TOTPAR 0-6)

Time-weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 60. Higher scores was indicative of more pain relief. (NCT03879408)
Timeframe: Baseline (0 hour) up to 6 hours post-dose

InterventionUnits on a scale (Least Squares Mean)
Arm 1: Placebo7.96
Arm 2: Naproxen Sodium 440 mg35.20
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg40.94
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg45.13
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg32.88

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Time-Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)

TOTPAR was measured using a PR-NRS ranging from 0-10 (0 = no relief, 10 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores was indicative of more pain relief. (NCT03879408)
Timeframe: Baseline (0 hour) up to 12 hours post-dose

InterventionUnits on a scale (Least Squares Mean)
Arm 1: Placebo18.20
Arm 2: Naproxen Sodium 440 mg69.96
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg76.80
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg90.22
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg57.03

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Time-Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 6 Hours (SPID 0-6)

Time-weighted sum of the pain intensity difference (SPID) score was measured using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-6 hours was from -60 to 60. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment. Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 6 hours. (NCT03879408)
Timeframe: Baseline (0 hour) up to 6 hours post-dose

InterventionUnits on a scale (Least Squares Mean)
Arm 1: Placebo2.36
Arm 2: Naproxen Sodium 440 mg25.59
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg30.28
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg33.77
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg23.60

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Time-weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)

Time-weighted sum of the pain intensity difference score was measured using a PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain). The possible range of SPID for 0-12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief. PID was the difference between baseline pain intensity and pain intensity at assessment (12 hours). Time-weighted sum of the pain intensity difference scores were derived by first multiplying each PID score by the time from the previous time point and adding these time-weighted PID scores together over the intervals from 0 to 12 hours. (NCT03879408)
Timeframe: Baseline (0 hour) up to 12 hours post-dose

InterventionUnits on a scale (Least Squares Mean)
Arm 1: Placebo5.80
Arm 2: Naproxen Sodium 440 mg50.07
Arm 3: Naproxen Sodium 220 mg + Acetaminophen 650 mg55.47
Arm 4: Naproxen Sodium 440 mg + Acetaminophen 1000 mg66.43
Arm 5: Hydrocodone 10 mg + Acetaminophen 650 mg39.94

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Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)

Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 24 hours (NCT03885596)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
CA-008 Cohort 10.6
CA-008 Cohort 21.7
CA-008 Cohort 35.1
Exparel6.0

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Opioid Consumption

Summary of opioid consumption in oral morphine equivalents (NCT03885596)
Timeframe: 0-72 hours

Interventionmg morphine equivalents (Mean)
CA-008 (Vocacapsaicin) Cohort 110.83
CA-008 (Vocacapsaicin) Cohort 23.33
CA-008 (Vocacapsaicin) Cohort 338.33
Exparel80.83

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Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h

Area Under the Curve of pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) over 72 hours (NCT03885596)
Timeframe: 0-72 hours

Interventionscore on a scale*hour (Mean)
CA-008 Cohort 172.30
CA-008 Cohort 266.24
CA-008 Cohort 3203.76
Exparel306.58

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Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)

Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 48 hours (NCT03885596)
Timeframe: 48 hours

Interventionscore on a scale (Mean)
CA-008 Cohort 11.3
CA-008 Cohort 20.6
CA-008 Cohort 32.7
Exparel4.8

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Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)

Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 72 hours (NCT03885596)
Timeframe: 72 hours

Interventionscore on a scale (Mean)
CA-008 Cohort 11.2
CA-008 Cohort 20.3
CA-008 Cohort 32.0
Exparel4.6

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Duration of Headache Free Period at 7 Days

(NCT03951649)
Timeframe: 7 days

Interventiondays (Median)
Occipital Nerve Block6
Oral Acetaminophen/Caffeine Group1

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Number of Participants With Development of Hypertensive Disease of Pregnancy Within 28 Days

(NCT03951649)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Occipital Nerve Block9
Oral Acetaminophen/Caffeine Group4

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Number of Participants With Development of Hypertensive Disease of Pregnancy Within 7 Days

(NCT03951649)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Occipital Nerve Block7
Oral Acetaminophen/Caffeine Group2

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Number of Participants With Injection Site Complication (Infection, Hematoma, and Ecchymosis)

Other: Pain at injection site (NCT03951649)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Occipital Nerve Block0
Oral Acetaminophen/Caffeine Group2

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Number of Participants With Need for Crossover Treatment

(NCT03951649)
Timeframe: 4 hours

InterventionParticipants (Count of Participants)
Occipital Nerve Block9
Oral Acetaminophen/Caffeine Group14

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Number of Participants With Need for Representation for Treatment of Headache With 28 Days

Emergency department for treatment of headache since treatment asked at 28 day follow up (NCT03951649)
Timeframe: 28 days

InterventionParticipants (Count of Participants)
Occipital Nerve Block5
Oral Acetaminophen/Caffeine Group1

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Number of Participants With Need for Second Line Treatment

(NCT03951649)
Timeframe: 120 min

InterventionParticipants (Count of Participants)
Occipital Nerve Block5
Oral Acetaminophen/Caffeine Group5

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Number of Participants With Response to Occipital Nerve Block in Pregnancy

Based on guidelines from the International Headache Society the primary outcome is the portion of women who experience resolution of headache or improvement of headache to mild range (VRS ≤ 3) at 2 hours following treatment with Occipital nerve block as compared to acetaminophen/caffeine cocktail. (NCT03951649)
Timeframe: 60-300 min

InterventionParticipants (Count of Participants)
Occipital Nerve Block20
Oral Acetaminophen/Caffeine Group16

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Response to Cross Over Treatment at 60 Min

"Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain.~Total Minimum score=0 Total Maximum score=10~Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved." (NCT03951649)
Timeframe: 60 min

Interventionscore on a scale (Median)
Occipital Nerve Block6
Oral Acetaminophen/Caffeine Group3

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Response to Second Line Treatment at 60 Min

"Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain.~Total Minimum score=0 Total Maximum score=10~Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved." (NCT03951649)
Timeframe: 180min

Interventionscore on a scale (Median)
Occipital Nerve Block6
Oral Acetaminophen/Caffeine Group4

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Response to Treatment Within 2 Hours

"Visual/verbal Rating Score (VRS). VRS is used to assess pain in patients. With 0 representing no pain at all and 10 representing worst possible pain.~Total Minimum score=0 Total Maximum score=10~Higher values represent worse pain. If VRS=0, then the headache pain is considered resolved." (NCT03951649)
Timeframe: 2 hrs

Interventionscore on a scale (Median)
Occipital Nerve Block6.0
Oral Acetaminophen/Caffeine Group6.5

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Number of Participants With Need for Admission for Treatment of Headache

(NCT03951649)
Timeframe: 7 hours

InterventionParticipants (Count of Participants)
Occipital Nerve Block0
Oral Acetaminophen/Caffeine Group0

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Number of Participants With Need for Neurology Consult

(NCT03951649)
Timeframe: 5 hours

InterventionParticipants (Count of Participants)
Occipital Nerve Block4
Oral Acetaminophen/Caffeine Group2

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1) Pain Control Based on Patient Global Assessment (PGA)."-NCT03974932">

"Percentage of Subjects Achieving a Score of Good or Better (>1) Pain Control Based on Patient Global Assessment (PGA)."

Patient's Global Assessment (PGA) of pain control is a 4-point scale in which subjects rate how well their pain has been controlled (0 = Poor; 1 = Fair; 2 = Good; 3 = Excellent). (NCT03974932)
Timeframe: 24 hours, 48 hours, 72 hours, Day 11

,,,
InterventionParticipants (Count of Participants)
24 Hours48 Hours72 HoursDay 11
Cohort 1 and Cohort 2 (Pooled)60616650
Cohort 3: Group A10111211
Cohort 3: Group B14141511
Cohort 416161815

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Maximum Concentration (Cmax)

(NCT03974932)
Timeframe: 72 hours

,,,
Interventionng/mL (Mean)
BupivacaineMeloxicam
Cohort 1 and Cohort 2 (Pooled)566238
Cohort 3: Group A534247
Cohort 3: Group B742251
Cohort 4851385

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Mean Overall Benefit of Analgesia Score (OBAS).

Subjects were questioned about their overall benefit of analgesia. Overall benefit of analgesia score (OBAS) assesses current pain at rest, vomiting, itching, sweating, freezing, dizziness, and overall satisfaction with postoperative pain during the previous 24 hours. To calculate the OBAS score, each of the subscale scores (0=minimum; 4=maximum) are summed for a combined OBAS score. Possible scores could range from 0 to 28 with a lower score indicating greater benefit. (NCT03974932)
Timeframe: 24 hours, 48 hours, 72 hours, Day 11

,,,
InterventionScores on a scale (Mean)
24 Hours48 Hours72 HoursDay 11
Cohort 1 and Cohort 2 (Pooled)6.55.75.15.0
Cohort 3: Group A7.44.94.15.2
Cohort 3: Group B7.65.94.94.9
Cohort 45.95.34.84.9

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Mean Total TSQM-9 Score

The Treatment Satisfaction Questionnaire for Medication (TSQM-9) contains 9 items assessing Effectiveness, Convenience, and Global Satisfaction domains. Responses to items are rated on a 5-point or 7-point rating scale. Scores for each domain are computed by adding the TSQM items in each domain and then transforming the values in to a composite score ranging from 0 to 100, with higher scores representing higher satisfaction. (NCT03974932)
Timeframe: 72 hours through Day 11

,,,
InterventionScores on a scale (Mean)
Global Satisfaction Domain - 72 HoursEffectiveness Doman - 72 HoursConvenience Domain - 72 HoursGlobal Satisfaction Domain - Day 11Effectiveness Doman - Day 11Convenience Domain - Day 11
Cohort 1 and Cohort 2 (Pooled)86.986.490.178.076.390.1
Cohort 3: Group A77.080.284.574.569.486.9
Cohort 3: Group B89.384.093.172.869.480.9
Cohort 486.881.986.982.967.090.6

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Percentage of Subjects Who First Achieve an MPADSS Score ≥9.

Subjects were assessed for readiness for discharge using the Modified Post-Anesthesia Discharge Scoring System (MPADSS) that assesses 5 clinical variables: vital signs, ambulation, nausea/vomiting, pain, and surgical bleeding, each on a 3-point scale of 0, 1, or 2 with 0 being the worst score and 2 being the best score. Subjects with an MPADSS score of 9 or 10 were considered ready for discharge. (NCT03974932)
Timeframe: 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24, hours, 36 hours, 48 hours, 60 hours, 72 hours

,,,
InterventionParticipants (Count of Participants)
Through 2 HoursThrough 4 HoursThrough 6 HoursThrough 8 HoursThrough 12 HoursThrough 24 HoursThrough 36 HoursThrough 48 HoursThrough 60 HoursThrough 72 Hours
Cohort 1 and Cohort 2 (Pooled)15162129384552575759
Cohort 3: Group A23667812121213
Cohort 3: Group B225891113131515
Cohort 4037881518191919

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Percentage of Subjects With Severe Pain.

Severe Pain defined as a VAS score ≥7.5 cm. (NCT03974932)
Timeframe: 24 hours, 48 hours, 72 hours

,,,
InterventionParticipants (Count of Participants)
24 Hours48 Hours72 Hours
Cohort 1 and Cohort 2 (Pooled)262923
Cohort 3: Group A455
Cohort 3: Group B555
Cohort 4667

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Time of Occurrence of Maximum Concentration (Tmax)

(NCT03974932)
Timeframe: 72 hours

,,,
Interventionhours (Median)
BupivacaineMeloxicam
Cohort 1 and Cohort 2 (Pooled)21.0547.13
Cohort 3: Group A20.5458.58
Cohort 3: Group B20.1437.17
Cohort 422.4848.58

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Median Time to First Opioid Rescue Medication.

(NCT03974932)
Timeframe: Through 72 hours

InterventionHours (Median)
Cohort 1 and Cohort 2 (Pooled)6.12
Cohort 3: Group A5.63
Cohort 3: Group B9.96
Cohort 412.76

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Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).

"The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from no pain to pain as bad as it could be. Subjects were asked to mark their current pain level on the line." (NCT03974932)
Timeframe: 12 through 48 hours

Interventionpain intensity score*hr (Mean)
Cohort 1 and Cohort 2 (Pooled)155.57
Cohort 3: Group A185.27
Cohort 3: Group B161.36
Cohort 4126.59

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Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).

"Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents no pain and 10 represents worst pain. NRS scores are measured at rest." (NCT03974932)
Timeframe: 72 hours

Interventionpain intensity score*hr (Mean)
Cohort 1 and Cohort 2 (Pooled)309.89
Cohort 3: Group A355.20
Cohort 3: Group B311.00
Cohort 4245.00

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Mean AUC of VAS Scores.

"The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from no pain to pain as bad as it could be. Subjects were asked to mark their current pain level on the line." (NCT03974932)
Timeframe: 72 hours

Interventionpain intensity score*hr (Mean)
Cohort 1 and Cohort 2 (Pooled)277.03
Cohort 3: Group A319.81
Cohort 3: Group B276.87
Cohort 4216.18

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Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).

(NCT03974932)
Timeframe: 72 hours

InterventionMME, morphine milligram equivalency (Mean)
Cohort 1 and Cohort 2 (Pooled)26.40
Cohort 3: Group A31.50
Cohort 3: Group B23.40
Cohort 417.62

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Median Time to First Ambulation Postsurgery.

(NCT03974932)
Timeframe: 72 hours

InterventionHours (Median)
Cohort 1 and Cohort 2 (Pooled)20.66
Cohort 3: Group A23.20
Cohort 3: Group B26.72
Cohort 420.58

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Percentage of Subjects Unable to Participate in Each Rehabilitation Session Because of Pain.

(NCT03974932)
Timeframe: 72 hours

InterventionParticipants (Count of Participants)
Cohort 1 and Cohort 2 (Pooled)23
Cohort 3: Group A1
Cohort 3: Group B2
Cohort 43

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Percentage of Subjects Who Are Discharged Home vs to a Skilled Nursing Facility.

Number Analyzed represents Subjects who were discharged home. (NCT03974932)
Timeframe: 72 hours

InterventionParticipants (Count of Participants)
Cohort 1 and Cohort 2 (Pooled)61
Cohort 3: Group A10
Cohort 3: Group B16
Cohort 420

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Percentage of Subjects Who Are Opioid-free

(NCT03974932)
Timeframe: 72 Hours to Day 11

Interventionparticipants (Number)
Cohort 1 and Cohort 2 (Pooled)25
Cohort 3: Group A4
Cohort 3: Group B3
Cohort 410

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Percentage of Subjects Who Are Opioid-free Through 72 Hours Who Remain Opioid-free Through Day 11.

(NCT03974932)
Timeframe: 72 hours through Day 11

InterventionParticipants (Count of Participants)
Cohort 1 and Cohort 2 (Pooled)9
Cohort 3: Group A1
Cohort 3: Group B0
Cohort 45

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Percentage of Subjects Who do Not Receive an Opioid Prescription at Discharge.

(NCT03974932)
Timeframe: 72 hours

InterventionParticipants (Count of Participants)
Cohort 1 and Cohort 2 (Pooled)41
Cohort 3: Group A8
Cohort 3: Group B12
Cohort 413

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Percentage of Subjects Who do Not Receive an Opioid Prescription Between Discharge and the Day 11 Visit.

(NCT03974932)
Timeframe: 72 hours through Day 11

InterventionParticipants (Count of Participants)
Cohort 1 and Cohort 2 (Pooled)44
Cohort 3: Group A8
Cohort 3: Group B8
Cohort 417

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Mean Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52

HAQ-DI is a self-report functional status instrument that is filled out by the participant and measures disability over the past week via 20 questions relating to 8 domains of function: dressing, grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. The HAQ-DI ranges from 0 to 3 with higher values indicating higher disability. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-0.35
Pegloticase + Placebo-0.31

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Percentage of Participants With Complete Resolution of ≥ 1 Tophi at Week 52

Percentage of participants with complete resolution of ≥ 1 tophi (using digital photography) at Week 52 in participants with tophi at baseline. Participants with resolution of ≥ 1 tophi at a visit are participants with resolution of ≥ 1 tophi at the visit (i.e. have complete response), and no progressive disease for any other tophi. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionpercentage of participants (Number)
Pegloticase + MTX53.8
Pegloticase + Placebo31.0

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Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

Responders are defined as participants achieving and maintaining sUA < 6 mg/dL for at least 80% of the time during Month 6. Month 6 includes pre- and post-infusion sUA assessments at Weeks 20 and 22, non-infusion sUA at Weeks 21 and 23, pre-infusion sUA at Week 24 and any unscheduled sUA between Week 20 and Week 24. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders. (NCT03994731)
Timeframe: Month 6 (Weeks 20, 21, 22, 23 and 24)

Interventionpercentage of participants (Number)
Pegloticase + MTX71.0
Pegloticase + Placebo38.5

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Percentage of sUA (sUA < 6 mg/dL) Responders During Month 12

Responders are defined as participants achieving and maintaining sUA <6 mg/dL for at least 80% of the time during Month 12 (Weeks 48, 50 and 52). Month 12 includes pre- and post-infusion sUA Weeks 48 and 50, pre-infusion sUA at Week 52, and any unscheduled sUA assessments done at unscheduled visits between Week 48 and 52. A participant must have had ≥ 2 sUA observations from different visits in order to be eligible as a responder. Participants meeting the stopping rule (those with a pre-infusion sUA >6 mg/dL at 2 consecutive scheduled trial visits beginning with the Week 2 Visit stopped pegloticase dosing) were counted as non-responders. (NCT03994731)
Timeframe: Month 12 (Weeks 48, 50 and 52)

Interventionpercentage of participants (Number)
Pegloticase + MTX60.0
Pegloticase + Placebo30.8

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Mean Change From Baseline HAQ Pain Score at Week 52

The HAQ-Pain score rates the participant's pain over the past week from 0 to 100 with 0 = no pain and 100 = severe pain. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-31.02
Pegloticase + Placebo-22.59

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Mean Change From Baseline in HAQ Health Score at Week 52

The HAQ health scale is a self-reported measure of overall health. Participants are asked to rate how they are doing, considering all the ways arthritis affects them, on a scale of 0 to 100, where 0 represents very well and 100 represents very poor. A change from baseline value of 0 is imputed at the first post-baseline visit for any participants without post-baseline values. (NCT03994731)
Timeframe: Baseline, Week 52

Interventionscore on a scale (Least Squares Mean)
Pegloticase + MTX-28.85
Pegloticase + Placebo-18.69

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Thermal Threshold Detection (Heat Pain)

Standardized quantitative sensory testing is performed to measure heat pain threshold (assesses the threshold at which heat pain sensation is first detected). Measured in Celsius. (NCT03997851)
Timeframe: 3 minutes

,,,
InterventionDegrees celsius (Mean)
After histamine itch inductionAfter non-histamine itch induction
Topical 1% Acetaminophen Gel43.9444.30
Topical 2.5% Acetaminophen Gel44.5144.03
Topical 5% Acetaminophen Gel43.9543.99
Topical Vehicle Gel44.0744.20

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Peak Itch Intensity Between the Vehicle and Active Treatments During Histaminergic Itch Induction

"Peak itch intensity between the vehicle and 3 other active treatments (5%, 2.5%, and 1% acetaminophen gels) after histaminergic itch induction. Itch intensity was measured on a 10cm scale visual analog scale for 10 minutes. 0 was weighted with no itch and 10 was weighted with most itch imaginable." (NCT03997851)
Timeframe: 10 minutes

InterventionIntensity score (Mean)
Topical 5% Acetaminophen Gel2.04
Topical 2.5% Acetaminophen Gel2.38
Topical 1% Acetaminophen Gel2.91
Topical Vehicle Gel3.07

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Peak Itch Intensity Between the Vehicle and Active Treatments During Non-histaminergic Itch Induction

"Peak itch intensity between the vehicle and 3 other active treatments (5%, 2.5%, and 1% acetaminophen gels) after non-histaminergic itch induction (cowhage). Itch intensity was measured on a 10cm scale visual analog scale for 10 minutes. 0 was weighted with no itch and 10 was weighted with most itch imaginable." (NCT03997851)
Timeframe: 10 minutes

InterventionIntensity score (Mean)
Topical 5% Acetaminophen Gel4.5
Topical 2.5% Acetaminophen Gel3.94
Topical 1% Acetaminophen Gel5.32
Topical Vehicle Gel5.79

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Mean Change From Baseline to 24 Hours in Vital Signs (Diastolic Blood Pressure)

Change from Baseline in diastolic blood pressure is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Diastolic blood pressure is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min) (NCT04018612)
Timeframe: 0 to 24 hours

Interventionmm Hg (Mean)
High Dose APAP-0.2
Low Dose APAP2.3
Placebo5.2

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Half-life

The half-life (t 1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. (NCT04018612)
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose

Interventionhours (Mean)
High Dose APAP2.565
Low Dose APAP2.360

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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time. The samples were collected at 5 min prior to Dose 1, and at 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose 1. (NCT04018612)
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose

Interventionhour*nanogram per milliliter (Geometric Mean)
High Dose APAP75925.2553
Low Dose APAP55018.1382

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Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours After Dosing (AUC 0-24h)

The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The values for pharmacokinetic (PK) evaluable population-excluding participants with positive pre-dose concentrations have been populated. The samples were collected at 5 min prior to Dose 1, and at 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose 1. (NCT04018612)
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose

Interventionmicrogram*hour/milliliter (Least Squares Mean)
High Dose APAP236326.3081
Low Dose APAP231104.0073

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Mean Change From Baseline to 24 Hours in Vital Signs (Respiratory Rate)

Change from Baseline in respiratory rate was the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Respiratory rate was obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min) (NCT04018612)
Timeframe: 0 to 24 hours

Interventionbreaths/minute (Mean)
High Dose APAP0.3
Low Dose APAP-0.6
Placebo-1.3

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Time to Treatment Failure

Time to treatment failure is defined as time to first dose of rescue medication after Dose 1 or withdrawal from the study for any reason. If a participant does not take rescue medication or withdraw from the study prior to 24 hours, the participant was censored at 24 hours (NCT04018612)
Timeframe: 0 to 24 Hours

,,
Interventionhours (Median)
Median time to treatment failure- for moderate baseline categorical pain intensity scoreMedian time to treatment failure for severe baseline categorical pain intensity score
High Dose APAPNANA
Low Dose APAPNANA
Placebo3.6801.335

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Maximum Observed Plasma Concentration (Cmax)

The Plasma Concentration (Cmax) is defined as maximum observed concentration (NCT04018612)
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose

Interventionnanogram per milliliter (ng/ml) (Geometric Mean)
High Dose APAP39531.4
Low Dose APAP28495.6

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Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups

"Upon initiation of the infusion of Dose 1, the participants were given stopwatch #1 and asked to press the stopwatch when they first perceived any pain relief (first perceptible pain relief [FPR]) ; a record of the time was noted in the participant record.~If a participant does not record perceptible pain relief and prematurely discontinued from the study prior to 24 hours, then the participant was censored at time of drop out. If a participant does not record perceptible pain relief prior to taking rescue medication, the participant was censored at 24 hours" (NCT04018612)
Timeframe: 0 to 24 Hours

,,
Interventionhours (Median)
Median time to FPR-C (hours)- for moderate baseline categorical pain intensity scoreMedian time to FPR-C (hours)- for severe baseline categorical pain intensity score
High Dose APAP0.2150.160
Low Dose APAP0.1600.220
Placebo0.5950.890

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Time to Meaningful Perceptible Relief (MPR) Measure Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups

"Upon initiation of the infusion of Dose 1, the participants were given a second stopwatch and asked to press the stopwatch if and when they feel any meaningful perceptible relief; a record of the time was noted in the participant record.~If a participant does not record perceptible pain relief and was prematurely discontinued from the study prior to 24 hours, then the participant was censored at time of drop out. If a participant does not record perceptible pain relief prior to taking rescue medication, the participant was censored at 24 hours." (NCT04018612)
Timeframe: 0 to 24 Hours

,,
Interventionhours (Median)
Median time to MPR (hours)- for moderate baseline categorical pain intensity scoreMedian time to MPR (hours)- for severe baseline categorical pain intensity score
High Dose APAP0.6600.680
Low Dose APAP0.3100.870
PlaceboNANA

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Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration

Pain Relief is reported on a 5-Point Categorical Pain Relief Assessment scale: 0 = No Pain Relief, 1 = A Little Pain Relief, 2 = Some Pain Relief, 3 = A Lot of Pain Relief, 4 = Complete Pain Relief. (NCT04018612)
Timeframe: 0 to 24 hours

,,
Interventionscore on a scale (Mean)
0.50.7511.251.752.253.254.255.256.257.258.259.2510.2511.2512.2514.2516.2518.2520.2522.2524.25
High Dose APAP1.72.02.12.32.32.22.02.01.91.91.82.22.62.62.72.72.12.12.52.72.72.5
Low Dose APAP1.82.02.22.22.02.01.71.61.51.92.22.42.52.72.52.42.62.32.42.62.62.7
Placebo0.60.60.60.60.60.60.80.71.52.12.52.22.12.02.01.61.81.82.12.22.32.5

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Pain Intensity Rating at Different Timepoints After Dose 1 Administration

Pain intensity is reported using the 11-point Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). (NCT04018612)
Timeframe: 0 to 24 hours

,,
Interventionscore on a scale (Mean)
0.50.7511.251.752.253.254.255.256.257.258.259.2510.2511.2512.2514.2516.2518.2520.2522.2524.25
High Dose APAP4.84.03.63.43.53.63.94.04.04.24.33.52.92.82.72.53.63.82.92.72.62.8
Low Dose APAP4.44.03.73.53.83.94.54.64.74.03.43.12.82.53.03.02.53.13.02.62.52.4
Placebo6.16.06.06.26.26.26.06.04.53.22.73.23.33.53.54.14.04.03.43.23.02.61

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Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration

Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to Baseline at each time point after Dose 1 administration. A baseline assessment was defined as the last non-missing result prior to administration of the first dose of study medication (NCT04018612)
Timeframe: Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 hours (± 10 min)

,,
Interventionscore on a scale (Mean)
0.50.7511.251.752.253.254.255.256.257.258.259.2510.2511.2512.2514.2516.2518.2520.2522.2524.25
High Dose APAP-2.5-3.3-3.7-3.9-3.9-3.8-3.4-3.4-3.3-3.2-3.0-3.8-4.5-4.6-4.7-4.9-3.7-3.5-4.4-4.7-4.7-4.6
Low Dose APAP-3.1-3.5-3.8-4.0-3.7-3.6-3.0-2.9-2.8-3.5-4.1-4.4-4.7-5.0-4.5-4.5-5.0-4.4-4.5-4.9-5.0-5.1
Placebo-0.7-0.8-0.8-0.7-0.7-0.7-0.9-0.9-2.4-3.7-4.2-3.7-3.6-3.4-3.3-2.7-2.9-2.9-3.5-3.6-3.9-4.3

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Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale.

Pain Relief Rating (PR) was scored on a 5-point scale (0=no-, 1=a little-, 2=some-, 3=a lot of-, and 4=complete- PR). PR was collected at initiation of Dose 1 (T0) and post dose 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours. TOTPAR24 is calculated as Sum ([T(i) - T(i-1)] x (PR(i-1) + PR(i)) / 2), where T(0)=0, T(i) is the actual time, and PR(i) is the pain relief score at time i. and calculated as Σ[T(i) -T(i-1)] x [(PR(i-1) + PR(i))/2], where T(0)=0, T(i) is the scheduled time, and PR(i) is the pain relief (PR) score at time i. (NCT04018612)
Timeframe: Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours

Interventionscore on a scale (Mean)
High Dose APAP55.82
Low Dose APAP55.24
Placebo43.11

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Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale

Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). Time weighted sum of pain intensity difference from 0 to 24 hours was reported. Pain Intensity (PI-NPRS) was collected at initiation of Dose 1 (T0) and post dose 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min). SPID24 was include all nominal timepoints from T0 to T24.25 hours. SPID is calculated as Σ[T(i) -T(i-1)] x [(PID(i-1) + PID(i))/2], where T(0)=0, T(i) is the scheduled time, and PID(i) is the pain intensity difference (PID) score at time i. Pain intensity differences were calculated with respect to Baseline. A baseline assessment is defined as the last non-missing result prior to administration of the first dose of study medication. (NCT04018612)
Timeframe: Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours

Interventionscore on a scale (Least Squares Mean)
High Dose APAP-96.80
Low Dose APAP-100.69
Placebo-74.96

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Patient Global Evaluation of the Study Medication

Patients Global Evaluation was assessed on a scale of 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent) at 24.25 hours post-dose 1 or at participant withdrawal (if applicable), whichever occurred first. Least squares mean of the score are reported. (NCT04018612)
Timeframe: 0 to 24 Hours

Interventionscore on a scale (Least Squares Mean)
High Dose APAP2.8
Low Dose APAP2.7
Placebo2.3

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Mean Change From Baseline to 24 Hours in Vital Signs (Temperature)

Change from Baseline in temperature is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Temperature is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min) (NCT04018612)
Timeframe: 0 to 24 hours

Interventiondegrees Celsius (Mean)
High Dose APAP0.12
Low Dose APAP0.21
Placebo0.06

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Mean Change From Baseline to 24 Hours in Vital Signs (Systolic Blood Pressure)

Change from Baseline in systolic blood pressure is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Systolic blood pressure is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min). (NCT04018612)
Timeframe: 0 to 24 hours

Interventionmm Hg (Mean)
High Dose APAP1.6
Low Dose APAP1.0
Placebo9.2

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Mean Change From Baseline to 24 Hours in Vital Signs (Pulse Rate)

Change from Baseline in pulse rate is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Pulse rate is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min) (NCT04018612)
Timeframe: 0 to 24 hours

Interventionbeats/minute (Mean)
High Dose APAP5.0
Low Dose APAP4.2
Placebo5.7

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Pain Evaluation

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). (NCT04066426)
Timeframe: At the second week

Interventionscore on a scale (Mean)
Naproxen Sodium+Codeine Phosphate3.58
Naproxen Sodium+Dexamethasone5.28
Naproxen Sodium4.33
Paracetamol4.34

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Pain Evaluation

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). (NCT04066426)
Timeframe: At the first week

Interventionscore on a scale (Mean)
Naproxen Sodium+Codeine Phosphate4.68
Naproxen Sodium+Dexamethasone5.93
Naproxen Sodium4.95
Paracetamol4.60

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Pain Evaluation

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain) (NCT04066426)
Timeframe: Pre-treatment (baseline)

Interventionscore on a scale (Mean)
Naproxen Sodium+Codeine Phosphate6.38
Naproxen Sodium+Dexamethasone6.93
Naproxen Sodium5.76
Paracetamol5.49

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Pain Evaluation

Evaluation of changes in Visual Analog Scale measurements by groups (0 = no pain; 10 = unbearable pain). (NCT04066426)
Timeframe: At the first month

Interventionscore on a scale (Mean)
Naproxen Sodium+Codeine Phosphate2.93
Naproxen Sodium+Dexamethasone5.28
Naproxen Sodium3.69
Paracetamol4.38

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Chronic Use of Pain Medication

"Number of participants who answered Yes to the survey question, Do you take pain medication, including narcotics, for any other medical condition?" (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm4
Study Arm2

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Highest Subjective Pain Score

Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. (NCT04149964)
Timeframe: 7 days

Interventionscore on a scale (Median)
Standard of Care Arm6.0
Study Arm5.0

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Lowest Subjective Pain Score

Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. (NCT04149964)
Timeframe: 7 days

Interventionscore on a scale (Median)
Standard of Care Arm2.0
Study Arm2.0

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Participant Use of Acetaminophen as Needed

Number of participants who took acetaminophen as needed during the first postoperative week. (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm12
Study Arm2

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Participant Use of Additional Pain Medication

Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week. (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm3
Study Arm1

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Participant Use of Scheduled Acetaminophen Around the Clock

Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week. (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm3
Study Arm11

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Percentage of Time Participant Experienced Severe Pain

Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain. (NCT04149964)
Timeframe: 7 days

Interventionpercentage of time (Median)
Standard of Care Arm0
Study Arm0

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Number of Doses of Opiate (Narcotic) Pain Medication

Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week. (NCT04149964)
Timeframe: 7 days

Interventionnumber of doses (Median)
Standard of Care Arm1.0
Study Arm1.5

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Opioid Use

Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 12 hours following surgery (NCT04175509)
Timeframe: The first 12 hours following surgery

InterventionMorphine Milligram Equivalents (Mean)
Rectal Acetaminophen15.52
Intravenous Acetaminophen14.17

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Operative Time

Operative time in minutes determined by the operating room record (NCT04175509)
Timeframe: From the start to end of the surgery

InterventionMinutes (Mean)
Rectal Acetaminophen88.71
Intravenous Acetaminophen90.89

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Estimated Blood Loss

Total estimated blood loss in millilitres for the surgery (NCT04175509)
Timeframe: During the duration of the surgery, from start to end time, on average 1.5 hours

InterventionMillilitres (Mean)
Rectal Acetaminophen273.53
Intravenous Acetaminophen347.37

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Opioid Use

Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 24 hours following surgery, or upon discharge, whichever comes first. (NCT04175509)
Timeframe: The first 24 hours following surgery, or upon discharge, whichever comes first.

InterventionMorphine Milligram Equivalents (Mean)
Rectal Acetaminophen25.75
Intravenous Acetaminophen23.71

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Opioid Use

Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 6 hours following surgery (NCT04175509)
Timeframe: The first 6 hours following surgery

InterventionMorphine Milligram Equivalents (Mean)
Rectal Acetaminophen6.74
Intravenous Acetaminophen7.97

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Postoperative Pain: Standardized Pain Scale

Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) measured every 4 hours for the 24 hours, or discharge, whichever comes first. Time points were averaged for each participate and reported as a single value. (NCT04175509)
Timeframe: The first 24 hours following surgery, or upon discharge, whichever comes first.

Interventionscore on a scale (Mean)
Rectal Acetaminophen2.82
Intravenous Acetaminophen3.18

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Postoperative Pain: Standardized Pain Scale

Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) for the first 6 hours after surgery. Time points were averaged for each participate and reported as a single value. (NCT04175509)
Timeframe: The first 6 hours following surgery

Interventionscore on a scale (Mean)
Rectal Acetaminophen3.13
Intravenous Acetaminophen1.36

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Postoperative Pain: Standardized Pain Scale

Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) for the first 12 hours after surgery. Time points were averaged for each participate and reported as a single value. (NCT04175509)
Timeframe: The 12 hours following surgery

Interventionscore on a scale (Mean)
Rectal Acetaminophen2.99
Intravenous Acetaminophen3.36

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Feasibility Determined by Accrual, Adherence and Patient Retention.

Feasibility will be determined by accrual (as confirmed by registration to the trial), adherence and patient retention (as measured and relayed by the wearable patch/sensor). (NCT04194528)
Timeframe: adherence and retention - 6 weeks; accrual - 6 months

InterventionParticipants (Count of Participants)
Oxycodone/Acetaminophen (5/325 mg) DMP1

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Pain Levels Recorded With a Visual Analogue Scale

Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level. (NCT04246541)
Timeframe: 2 weeks postoperatively

Interventionscore on a scale (Mean)
Control25.6
Ketorolac28.8

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Narcotic Medication Consumed

Number of oxycodone- acetaminophen tablets consumed (NCT04246541)
Timeframe: up to 5 days postoperatively

Interventiontablets (Mean)
Control5.7
Ketorolac3.5

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Narcotic Medication

Number of oxycodone-acetaminophen tablets (NCT04246554)
Timeframe: 5 days

Interventiontablets (Mean)
Control12.4
Ketorolac5.5

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Postoperative Visual Analogue Scale Scores

Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level. (NCT04246554)
Timeframe: Up to 8 weeks postoperative

Interventionscore on a scale (Mean)
Control50.4
Ketorolac40.0

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)

An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study drug until study cut-off date). (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
TEAEsTESAEs
Cohort A: Participants With cPRA >=99.90%30
Cohort B: Participants With cPRA 80.00% to 99.89%40

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Number of Participants With Anti-drug Antibodies (ADA) Against Isatuximab

ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Treatment-induced ADATreatment boosted ADA
Cohort A: Participants With cPRA >=99.90%00
Cohort B: Participants With cPRA 80.00% to 99.89%00

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Duration for Achieving Target cPRA

Duration of achieving target cPRA was defined as the time (in weeks) from laboratory sample collection date of achieving target cPRA (defined as the reduction of cPRA required to achieve at least 100% increase of LCD) the first time up to the laboratory sample collection date when no longer achieving target cPRA calculated using OPTN calculator or the date of death due to any cause, whichever occurs first. The duration of achieving target cPRA was assessed using the Kaplan-Meier method. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventionweeks (Median)
Cohort A: Participants With cPRA >=99.90%NA
Cohort B: Participants With cPRA 80.00% to 99.89%7.29

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Duration of Response (DOR)

Duration of response (DOR) was defined as time (in weeks) from laboratory sample collection date used in determining a participant to be a responder (defined as participants meeting at least one of the predefined desensitization efficacy criteria: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer [>=75% reduction from Baseline] to achieve target cPRA; elimination of >=1 anti-HLA antibody i.e. MFI reduced to <2000 as measured by a SAB assay, for antibodies with Baseline MFI >=3000) up to the laboratory sample collection date when participant was confirmed as no longer meeting any response criterion (i.e., non-responder) or the date of death due to any cause, whichever occurs first. DOR was analyzed using Kaplan-Meier method. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

Interventionweeks (Median)
Cohort A: Participants With cPRA >=99.90%NA
Cohort B: Participants With cPRA 80.00% to 99.89%NA

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Number of Kidney Transplant Offers

Number of kidney transplants offers received for each participant was reported in the outcome measure. Data on transplant offers were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiontransplant offers (Number)
Cohort A: Participants With cPRA >=99.90%3
Cohort B: Participants With cPRA 80.00% to 99.89%3

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Number of Participants Achieving Target cPRA

Target calculated panel reactive antibodies (cPRA) was defined as the reduction of cPRA required to achieve at least 100% increase of likelihood of compatible donor (LCD). Number of participants who achieved target cPRA was assessed using the Organ Procurement and Transplantation Network (OPTN) calculator during the specified timepoint were reported in this outcome measure. Participants who retained their target cPRA values were censored at the date of the last available laboratory assessment achieving their target cPRA. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

InterventionParticipants (Count of Participants)
Cohort A: Participants With cPRA >=99.90%4
Cohort B: Participants With cPRA 80.00% to 99.89%2

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Number of Participants With Graft Survival at 6 Months Post-Transplant

Number of participants with graft survival status as functioning at 6-months post-transplant was reported in this outcome measure. (NCT04294459)
Timeframe: At 6 Months post-transplant

InterventionParticipants (Count of Participants)
Cohort A: Participants With cPRA >=99.90%1
Cohort B: Participants With Calculated Panel Reactive Antibodies (cPRA) 80.00% to 99.89%0

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Percentage of Participants With Response

Response was defined as the percentage of participants meeting at least one of the predefined desensitization efficacy criteria as measured by single antigen bead (SAB) assay as follows: reduction in cPRA resulting in at least 100% increase of likelihood of finding a compatible donor; reduction in antibody titer (>=75% reduction from Baseline) to achieve target cPRA; elimination of >=1 human leukocyte antigen (HLA) antibody (i.e., mean fluorescence intensity [MFI] reduced to <2000) as measured by a SAB assay, for antibodies with Baseline MFI >=3000. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

Interventionpercentage of participants (Number)
Cohort A: Participants With cPRA >=99.90%83.3
Cohort B: Participants With cPRA 80.00% to 99.89%81.8

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Pharmacokinetics (PK) Parameters: Concentration Observed at the End of First Intravenous Infusion (Ceoi) of Isatuximab

Ceoi is the plasma concentration observed at the end of intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At End of infusion on Cycle 1 Day 1

Interventionmicrograms per milliliter (mcg/mL) (Mean)
Cohort A: Participants With cPRA >=99.90%290
Cohort B: Participants With cPRA 80.00% to 99.89%270

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PK Parameters: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 168 Hours Over the Dosing Interval (AUC0-168 Hours) After First Infusion of Isatuximab

AUC0-168 hours was defined as the area under the plasma concentration versus time curve from time 0 to 168 hours post dose calculated using trapezoidal method after first infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmicrograms*hours/milliliter (mcg*h/mL) (Mean)
Cohort A: Participants With cPRA >=99.90%29400
Cohort B: Participants With cPRA 80.00% to 99.89%20000

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PK Parameters: Last Concentration Observed Above the Lower Limit of Quantification (Clast) After the First Infusion of Isatuximab

Clast was defined as the last concentration of isatuximab observed above the lower limit of quantification calculated using non-compartmental analysis after the first infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%104
Cohort B: Participants With cPRA 80.00% to 99.89%76.3

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PK Parameters: Maximum Concentration Observed (Cmax) After the First Infusion of Isatuximab

Cmax was defined as the maximum concentration observed after the first administration calculated using the noncompartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%295
Cohort B: Participants With cPRA 80.00% to 99.89%285

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PK Parameters: Time of Clast (Tlast) After First Infusion of Isatuximab

Tlast was defined as the time of last concentration observed above the lower limit of quantification, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionhours (Median)
Cohort A: Participants With cPRA >=99.90%166.00
Cohort B: Participants With cPRA 80.00% to 99.89%167.00

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PK Parameters: Time Taken to Reach Cmax (Tmax) After the First Infusion of Isatuximab

Tmax was defined as the time to reach Cmax, calculated using the non-compartmental analysis after the intravenous infusion of isatuximab. (NCT04294459)
Timeframe: At Start of infusion (SOI), End of infusion (EOI), EOI+4H (initial protocol) EOI+1H (amended protocol), 72H and 168H on Day 1 of Cycle 1

Interventionhours (Median)
Cohort A: Participants With cPRA >=99.90%3.67
Cohort B: Participants With cPRA 80.00% to 99.89%3.40

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PK Parameters: Trough Plasma Concentrations (Ctrough) of Isatuximab

Ctrough was the plasma concentration of isatuximab observed just before (pre-dose) treatment administration. (NCT04294459)
Timeframe: Cycle 2 Day 1

Interventionmcg/mL (Mean)
Cohort A: Participants With cPRA >=99.90%308
Cohort B: Participants With cPRA 80.00% to 99.89%246

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Time to First Transplant Offer

Time to first transplant offer was defined as time (in days) from date of first study treatment dose up to date of first kidney transplant offer. Data on transplant status were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiondays (Median)
Cohort A: Participants With cPRA >=99.90%373
Cohort B: Participants With cPRA 80.00% to 99.89%156

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Time to Transplant

Time to transplant was defined as time (in days) from date of first study treatment dose up to date of kidney transplant. Data on transplant status were collected and followed up until study cut-off date. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

Interventiondays (Median)
Cohort A: Participants With cPRA >=99.90%445
Cohort B: Participants With cPRA 80.00% to 99.89%259.5

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Number of Participants With Abnormal Electrolytes Parameters

Abnormal electrolyte parameters assessed were hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypercalcemia, hypocalcemia, blood bicarbonate decreased, hypermagnesemia, hypomagnesemia and chloride. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Chloride was estimated as per PCSA criteria: <80 millimoles per liter (mmol/L) and >115 mmol/L. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Hypernatremia: Grade 1Hypernatremia: Grade 2Hypernatremia: Grade 3Hypernatremia: Grade 4Hyponatremia: Grade 1Hyponatremia: Grade 2Hyponatremia: Grade 3Hyponatremia: Grade 4Hyperkalemia: Grade 1Hyperkalemia: Grade 2Hyperkalemia: Grade 3Hyperkalemia: Grade 4Hypokalemia: Grade 1Hypokalemia: Grade 2Hypokalemia: Grade 3Hypokalemia: Grade 4Hypercalcemia: Grade 1Hypercalcemia: Grade 2Hypercalcemia: Grade 3Hypercalcemia: Grade 4Hypocalcemia: Grade 1Hypocalcemia: Grade 2Hypocalcemia: Grade 3Hypocalcemia: Grade 4Hypermagnesemia: Grade 1Hypermagnesemia: Grade 2Hypermagnesemia: Grade 3Hypermagnesemia: Grade 4Hypomagnesemia: Grade 1Hypomagnesemia: Grade 2Hypomagnesemia: Grade 3Hypomagnesemia: Grade 4Chloride (PCSA): <80 mmol/LChloride (PCSA): >115 mmol/L
Cohort A: Participants With cPRA >=99.90%0000400023100001010060002000300000
Cohort B: Participants With cPRA 80.00% to 99.89%0000100061200000100052000000300000

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Number of Participants With Abnormal Metabolism Parameters

Abnormal metabolism parameters assessed were hypoglycemia, hypoalbuminemia and glycated Hemoglobin (HbA1c). The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. HbA1c was estimated as per PCSA criteria: >8%. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Hypoglycemia: Grade 1Hypoglycemia: Grade 2Hypoglycemia: Grade 3Hypoglycemia: Grade 4Hypoalbuminemia: Grade 1Hypoalbuminemia: Grade 2Hypoalbuminemia: Grade 3Hypoalbuminemia: Grade 4
Cohort A: Participants With cPRA >=99.90%11003200
Cohort B: Participants With cPRA 80.00% to 99.89%20000200

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Number of Participants With Anti-Human Leukocyte Antigen (HLA)-Antibody Reduction

Number of participants with anti-HLA-antibody (Baseline MFI >=3000) reduced to <2000 as measured using a SAB assay per central laboratory assessment was reported in this outcome measure. Participants were categorized in various categories of number of antibodies which were reduced as: none, 1-5, >5-10, >10-15, and >15. If multiple visits had the same number of total anti-HLA antibody reduction, the last visit data was summarized. (NCT04294459)
Timeframe: From first dose of study drug until end of follow-up period (maximum duration: up to 39.1 weeks)

,
InterventionParticipants (Count of Participants)
None1-5 antibodies>5-10 antibodies>10-15 antibodies>15 antibodies
Cohort A: Participants With cPRA >=99.90%24411
Cohort B: Participants With cPRA 80.00% to 99.89%24401

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Number of Participants With Hematological Abnormalities

Abnormal hematological parameters assessed were anemia, platelet count decreased, neutrophil count decreased, lymphocyte count decreased and monocytes. The hematological abnormality grades were based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. Monocytes were assessed as per potentially clinically significant abnormality (PCSA) criteria defined as: greater than (>) 0.7*10^9/L. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Anemia: Grade 1Anemia: Grade 2Anemia: Grade 3Anemia: Grade 4Platelet count decreased: Grade 1Platelet count decreased: Grade 2Platelet count decreased: Grade 3Platelet count decreased: Grade 4Neutrophil count decreased: Grade 1Neutrophil count decreased: Grade 2Neutrophil count decreased: Grade 3Neutrophil count decreased: Grade 4Lymphocyte count decreased: Grade 1Lymphocyte count decreased: Grade 2Lymphocyte count decreased: Grade 3Lymphocyte count decreased: Grade 4Monocytes (PCSA) > 0.7*10^9/L
Cohort A: Participants With cPRA >=99.90%63002000000041103
Cohort B: Participants With cPRA 80.00% to 99.89%82006000000021003

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Number of Participants With Liver Function Abnormalities

Abnormal liver function parameters assessed were Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, Alkaline phosphatase (ALP) increased, and Total bilirubin (TB) increased. The abnormal grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
ALT increased: Grade 1ALT increased: Grade 2ALT increased: Grade 3ALT increased: Grade 4AST increased: Grade 1AST increased: Grade 2AST increased: Grade 3AST increased: Grade 4ALP increased: Grade 1ALP increased: Grade 2ALP increased: Grade 3ALP increased: Grade 4TB increased: Grade 1TB increased: Grade 2TB increased: Grade 3TB increased: Grade 4
Cohort A: Participants With cPRA >=99.90%1000100030000000
Cohort B: Participants With cPRA 80.00% to 99.89%1000000020000000

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Number of Participants With Renal Function Abnormalities

Abnormal renal parameters assessed were creatinine increased and estimated Glomerular Filtration Rate (eGFR). The renal function abnormality grades were based on NCI-CTCAE, Version 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. eGFR was assessed as per PCSA criteria: 60 (less than equal to) <= to less than (<) 90 milliliter/minute/1.73 meter square (mL/min/1.73m^2) (Mild), 30<= to <60 mL/min/1.73m^2 (Moderate), 15<=to <30 mL/min/1.73m^2 (Severe), <15 mL/min/1.73m^2 (End Stage Renal Disease). (NCT04294459)
Timeframe: From first dose of study drug until study cut-off date (maximum duration: up to 97.7 weeks)

,
InterventionParticipants (Count of Participants)
Creatinine increased: Grade 1Creatinine increased: Grade 2Creatinine increased: Grade 3Creatinine increased: Grade 4eGFR: 60<= - <90 mL/min/1.73m^2eGFR: 30<= - <60 mL/min/1.73m^2eGFR: 15<= - <30 mL/min/1.73m^2eGFR: <15 mL/min/1.73m^2
Cohort A: Participants With cPRA >=99.90%0011100012
Cohort B: Participants With cPRA 80.00% to 99.89%003800011

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Amount of Rescue Medication

"To quantify the use of opioid analgesics in treatment of post-operative dental pain, the amount of rescue medications (opioids) was converted to a standard unit, which was Morphine Milligram Equivalent (MME) using below formula:~MME/Day = Strength per Unit × (Number of units / Days supply) × MME conversion factor" (NCT04307940)
Timeframe: Up to 12 hours postdose

InterventionMorphine Milligram Equivalent (MME) (Mean)
Naproxen Sodium7.8
Hydrocodone / APAP9.3
Placebo10.5

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Sum of Pain Intensity Difference Over 6 Hours (SPID 0-6)

Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 6 hours ranges from -60 to 60. A higher value indicates a better pain reduction. (NCT04307940)
Timeframe: Up to 6 hours postdose

InterventionScores on a scale*hours (Least Squares Mean)
Naproxen Sodium28.41
Hydrocodone / APAP24.35
Placebo6.23

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Number of Participants Required or Did Not Reqiure Rescue Pain Medication

(NCT04307940)
Timeframe: Up to 12 hours postdose

,,
InterventionParticipants (Count of Participants)
Number of participants required rescue pain medicationNumber of participants did not require any rescue pain medication
Hydrocodone / APAP4340
Naproxen Sodium1868
Placebo2914

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Total Pain Relief Over 6 Hours (TOTPAR 0-6)

Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 6 hours ranges from 0 to 24, a higher value indicates more pain relief. (NCT04307940)
Timeframe: Up to 6 hours postdose

InterventionScores on a scale*hours (Least Squares Mean)
Naproxen Sodium14.53
Hydrocodone / APAP12.69
Placebo5.14

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Total Pain Relief Over 12 Hours (TOTPAR 0-12)

Pain relief is measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief). Total Pain Relief is calculated as the area under the curve of pain relief score over time for the given time period by multiplying the pain relief score at each time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. TOTPAR over 12 hours ranges from 0 to 48, a higher value indicates more pain relief. (NCT04307940)
Timeframe: Up to 12 hours postdose

InterventionScores on a scale*hours (Least Squares Mean)
Naproxen Sodium28.41
Hydrocodone / APAP21.31
Placebo10.63

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Time to First Use of Rescue Medication

If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment. (NCT04307940)
Timeframe: Up to 12 hours postdose

InterventionHours (Median)
Naproxen SodiumNA
Hydrocodone / APAP10.42
Placebo2.57

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Sum of Pain Intensity Difference Over 12 Hours (SPID 0-12)

Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each post dose time point, pain intensity difference (PID) is derived by subtracting the pain intensity at the post dose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference is indicative of improvement. Sum of Pain Intensity Differences (SPIDs) was calculated by multiplying the PID score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values over the specific time period. SPID over 12 hours ranges from -120 to 120. A higher value indicates a better pain reduction. (NCT04307940)
Timeframe: Up to 12 hours postdose

InterventionScores on a scale*hours (Least Squares Mean)
Naproxen Sodium53.20
Hydrocodone / APAP38.39
Placebo13.57

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Duration of Pain at Least Half Gone Over 6 Hours

(NCT04307940)
Timeframe: Up to 6 hours postdose

InterventionHours (Least Squares Mean)
Naproxen Sodium4.60
Hydrocodone / APAP4.08
Placebo1.49

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Duration of Pain at Least Half Gone Over 12 Hours

(NCT04307940)
Timeframe: Up to 12 hours postdose

InterventionHours (Least Squares Mean)
Naproxen Sodium8.87
Hydrocodone / APAP6.57
Placebo3.31

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Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values

"Percentage of Guardian™ Sensor (3) values within 20% of YSI™ plasma glucose value (±20 mg/dL [1.1 mmol/L] when YSI™ value less than or equal to (≤) 80 mg/dL [4.4 mmol/L]) during the 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly.~20% agreement = Number of Guardian™ Sensor (3) values within 20% (±20 mg/dL) of YSI™ plasma glucose value / Total number of paired Guardian™ Sensor (3) and YSI™ plasma glucose points * 100%." (NCT04378114)
Timeframe: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported

,,,
InterventionPercentage of readings (Mean)
(-1, 0] hour(0, 1] hour(1, 2] hour(2, 3] hour(3, 4] hour(4, 5] hour
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen96.4073.7065.4378.9187.9791.03
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm99.0377.9772.0878.9288.2793.44
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen94.4467.8247.3764.6473.9175.97
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm93.2768.9054.8266.5773.0576.88

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Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose

"Bias (mg/dL) between the Guardian™ Sensor (3) values and YSI™ plasma glucose values 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly.~Bias = Mean of [Guardian™ Sensor (3) values - YSI™ plasma glucose values]." (NCT04378114)
Timeframe: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported

,,,
Interventionmg/dL (Mean)
(-1,0] hour(0,1] hour(1,2] hour(2,3] hour(3,4] hour(4,5] hour
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen-4.4513.2821.9914.528.984.35
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm-4.7810.6418.8613.528.774.93
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen0.8619.5729.9221.8517.2213.40
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm-0.4614.8325.4219.6014.7011.12

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Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose

"Mean absolute relative difference (MARD, %) between the Guardian™ Sensor (3) values and YSI™ plasma glucose 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly.~Mean Absolute Relative Difference = Mean of ([absolute difference of Guardian™ Sensor (3) values and YSI™ plasma glucose / YSI™ plasma glucose] * 100%)." (NCT04378114)
Timeframe: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported

,,,
InterventionPercent (Mean)
(-1, 0] hour(0, 1] hour(1, 2] hour(2, 3] hour(3, 4] hour(4, 5] hour
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Abdomen6.5616.0918.6012.9210.068.70
Subjects With Diabetes Wearing Guardian™ Sensor (3), C Algorithm, Arm5.9913.2215.8312.249.608.52
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Abdomen8.3818.0224.2218.4415.8713.87
Subjects With Diabetes Wearing Guardian™ Sensor (3), Zeus Algorithm, Arm8.4516.6521.2617.7215.5813.98

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Post-operative Uncorrected Visual Acuity Right and Left Eye

Right and left eye uncorrected visual acuity at post-operative month 6. (NCT04399122)
Timeframe: Post-operative month 6.

,
InterventionlogMAR (Mean)
Right Eye logMARLeft Eye logMAR
Acetaminophen With Codeine-0.07-0.06
Acetaminophen With Oxycodone-0.05-0.06

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Post-operative Average Pain Score

The PRK Post-Operative Pain Survey consisted of a scale of 0 - 10 with a score of 0 equal to no pain, a score of 1 - 3 equal to mild pain, a score of 4 - 6 equal to moderate pain and a score of 7 - 10 equal to severe pain (NCT04399122)
Timeframe: 2 days post surgery

Interventionunits on a scale (Mean)
Acetaminophen With Codeine2.82
Acetaminophen With Oxycodone3.58

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Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period

Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period (NCT04429022)
Timeframe: 0-14 days

InterventionParticipants (Count of Participants)
Prospective Cohort1
Historical Control3

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Total Opioid Pain Medications Required Through 3-24h Post op in MME

Total opioid pain medications required through 3-24h post op in MME (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort.20
Historical Control12.27

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Estimated Blood Loss

milliliters (mL) (NCT04429022)
Timeframe: 0-300 minutes

Interventionmilliliters (Mean)
Prospective Cohort63.50
Historical Control58.46

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Length of Stay in Hours

Length of stay in hours (NCT04429022)
Timeframe: 0- 240 hours

Interventionhours (Mean)
Prospective Cohort12.05
Historical Control35.82

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Operative Time

minutes (NCT04429022)
Timeframe: 0-300 minutes

Interventionminutes (Mean)
Prospective Cohort128.80
Historical Control139.69

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort3.82
Historical Control5.13

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Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)

Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME) (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort2.00
Historical Control5.32

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort1.75
Historical Control5.43

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Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale From Hour 0 to Hour 12 (SPI0-12), Hour 12 to Hour 24 (SPI12-24), and Hour 24 to Hour 48 (SPI24-48).

Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals at 0-12, 12-24 and 24-48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time interval (0-12, 12-24 and 24-48 hours). This outcome was compared between a combination of PGB and APAP, APAP alone, and placebo. (NCT04495283)
Timeframe: 0, 12, 24, 48 hours

,,
Interventionscore on a scale (Least Squares Mean)
SPI 0-12SPI 12-24SPI 24-48
APAP (Group B)49.0969.35184.33
PGB and APAP (Group A)33.0950.92126.83
Placebo (Group C).58.8988.95221.58

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Summed Pain Intensity (SPI) Assessed by Numeric Rating Scale Over Time

Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals from 0 hour till each time point at 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time intervals. (NCT04495283)
Timeframe: 0, 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours

,,
Interventionscore on a scale (Mean)
SPI 0-1SPI 0-2SPI 0-4SPI 0-6SPI 0-8SPI 0-10SPI 0-12SPI 0-14SPI 0-16SPI 0-18SPI 0-20SPI 0-24SPI 0-28SPI 0-32SPI 0-36SPI 0-40SPI 0-44SPI 0-48
APAP (Group B)0.732.398.0217.0928.0938.7149.0958.6267.9878.4986.24108.25128.83148.93169.44186.70199.95223.24
PGB and APAP (Group A)0.261.265.6312.6820.0026.2533.0941.1249.0855.8461.4977.1788.94100.85114.43126.45139.54153.08
Placebo (Group C).0.452.169.6220.7133.6445.9558.8972.1784.4697.57108.32134.91158.01180.50203.32224.78246.09267.51

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Total Consumption of Opioid Rescue Medication Through 24 Hours and 48 Hours

The total consumption of opioid rescue analgesia through 24 hours and through 48 hours was reported (NCT04495283)
Timeframe: 24 hours and 48 hours

,,
Interventionoral morphine equivalents (Mean)
Consumption of Rescue Medication through 24 hoursConsumption of Rescue Medication through 48 hours
APAP (Group B)19.2433.39
PGB and APAP (Group A)9.8617.36
Placebo (Group C).28.8843.88

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Percentage of Participants Who Were Opioid Free Over Time

Percentages of participants who did not take opioid (rescue medication) over time. (NCT04495283)
Timeframe: 12 to 48 hours

,,
Interventionpercentage of participants (Number)
During 12-24 HoursDuring 12-48 Hours
APAP (Group B)45.728.6
PGB and APAP (Group A)65.748.6
Placebo (Group C).35.329.4

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Maximum Observed Concentration for PGB and APAP

The Plasma Concentration (Cmax) is defined as the maximum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. (NCT04495283)
Timeframe: Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion

Interventionnanogram per milliliter (ng/ml) (Geometric Mean)
Mean Cmax Values of Acetaminophen-First Dose
APAP (Group B)16847

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Total Consumption of Rescue Medication

The total consumption of rescue analgesia was reported. (NCT04495283)
Timeframe: 7 days

Interventionoral morphine equivalents (Mean)
PGB and APAP (Group A)17.79
APAP (Group B)34.24
Placebo (Group C).44.76

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Time to First Use of Rescue Medication From Hour 0

Time to first use of rescue medication from Hour 0 was reported. Hour 0 was defined as the end of surgery (i.e., completion of the last suture). (NCT04495283)
Timeframe: 7 days

Interventionhours (Median)
PGB and APAP (Group A)11.60
APAP (Group B)5.78
Placebo (Group C).4.31

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Summed Pain Intensity (SPI) Compared Between Group A and Group B

Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) -was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and APAP alone (Group B) from Hour 0 to Hour 48 (SPI0-48) (NCT04495283)
Timeframe: 0 to 48 hours

Interventionscore on a scale (Least Squares Mean)
PGB and APAP (Group A)153.08
APAP (Group B)223.24

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Summed Pain Intensity (SPI) Between Group A and Group C

Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, was used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: Sum (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and placebo (Group C) from Hour 0 to Hour 48 (SPI0-48) (NCT04495283)
Timeframe: 0 to 48 hours

Interventionscore on a scale (Least Squares Mean)
PGB and APAP (Group A)153.08
Placebo (Group C).267.51

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Percentage of Participants Who Used Rescue Medication

Percentage of participants who used rescue medication is reported (NCT04495283)
Timeframe: 7 days

Interventionpercentage of participants (Number)
PGB and APAP (Group A)57.1
APAP (Group B)80.0
Placebo (Group C).82.4

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Minimum Observed Concentration for PGB and APAP

The Plasma Concentration (Cmin) is defined as the minimum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. (NCT04495283)
Timeframe: Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion

Interventionnanogram per milliliter (ng/ml) (Geometric Mean)
PGB and APAP (Group A)NA
APAP (Group B)NA

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Maximum Observed Concentration for PGB and APAP

The Plasma Concentration (Cmax) is defined as the maximum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. (NCT04495283)
Timeframe: Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion

Interventionnanogram per milliliter (ng/ml) (Geometric Mean)
Mean Cmax Values of Pregabalin- First DoseMean Cmax Values of Pregabalin- Last DoseMean Cmax Values of Acetaminophen-First Dose
PGB and APAP (Group A)100681296028700

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Number of Participants Who Were Alive and Had COVID-19 Symptoms by Type of Therapy During a 14-day Follow-up

Survival analysis. The time it takes for 50% of COVID-19 patients to improve symptoms during a 14-day follow-up with dual therapy vs. triple therapy (NCT04673214)
Timeframe: 14 days

,
InterventionParticipants (Count of Participants)
CoughtFeverHeadacheOdynophagiaRhinorrheaAnosmiaConjunctivitisDiarrheaMyalgiaChest painDyspnea of movementDyspnea at rest
Double Therapy161062617341382325149
Triple Therapy267735163381135331816

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Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS

Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated using Pearson's Chi-square test as categorical variables. (NCT04673214)
Timeframe: 14 days

,
InterventionParticipants (Count of Participants)
Number of Participants with Improvement in Clinical EvaluationNumber of Participants with Therapeutic Failure
Double Therapy442
Triple Therapy596

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Average Days of COVID-19 Symptoms Under Treatment of Early Intervention Due to Outcome in UMF 13 and 20 of the IMSS

Statistical differences were evaluated using Student's t test for quantitative variables. The average duration of days with clinical symptoms of COVID-19 under early intervention treatment by outcome in the improvement of the modification of the clinical evolution of symptoms vs. therapeutic failure. (NCT04673214)
Timeframe: 14 days

,
InterventionDays (Mean)
CoughFeverHeadacheRhinorrheaOdynophagiaDiarrheaMyalgiaAnosmiaConjunctivitisChest PainDyspnea of movementDyspnea at RestMajor SymptomsMinor Symptoms
Modification of Evolution Clinic72645266142153
Therapeutic Failure41212152113322

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Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.

Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy. (NCT04673214)
Timeframe: 14 days

,
Interventiondays (Mean)
CoughFeverHeadacheRhinorrheaOdynophagiaDiarrheaMyalgiaAnosmiaConjunctivitisChest painDyspnea of movementDysnea at restMajor symptomsMinor symptomstreatment start day
DOUBLE THERAPY726352652521534
TRIPLE THERAPY725351561422534

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Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm

The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration. (NCT04766996)
Timeframe: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)

Interventionscore on a scale (Mean)
Baseline
Professional Staff4.35

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Total Post-operative Opioid Requirements With Non-opioid Drug Regimen

Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication. (NCT04766996)
Timeframe: Up to 5 weeks

Interventionmilligrams (Mean)
Prospective Cases Undergoing Non-opioid Drug Regimen400

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Change From Baseline in Pain Scores on Postoperative Day 2, as Measured by the Wong-Baker 0-to-10 Pain Scale

Change in pain scores obtained with the Wong-Baker 0-to-10 pain scale between the 2 groups on postoperative day 2. The Wong-Baker 0-to-10 pain scale is used for rating the severity of pain, with scores ranging from 0 to 10, and higher scores indicating greater severity of pain. (NCT05544734)
Timeframe: Baseline, 2 days

Interventionscore on a scale (Mean)
Hydrocodone 5mg/Acetaminophen 325mg2.1
Acetaminophen 1000mg + Ibuprofen 400mg2.4

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