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naproxen

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Description

Naproxen: An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

naproxen : A methoxynaphthalene that is 2-methoxynaphthalene substituted by a carboxy ethyl group at position 6. Naproxen is a non-steroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, kidney stones, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, bursitis, and for the treatment of primary dysmenorrhea. It works by inhibiting both the COX-1 and COX-2 enzymes. [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 CID156391
CHEMBL ID154
CHEBI ID7476
SCHEMBL ID3046
MeSH IDM0014467

Synonyms (321)

Synonym
naproxeno
naproxene
AC-1363
(+)-2-(methoxy-2-naphthyl)-propionsaeure
naproxenum
BIDD:GT0062
AB00052049-04
BRD-K59197931-236-09-6
BRD-K59197931-001-02-9
2-naphthaleneacetic acid, 6-methoxy-.alpha.-methyl-, (s)-
DIVK1C_000242
KBIO1_000242
naprux
anaprox
proxen
naprium
naixan
aleve
diocodal
dysmenalgit
apo-napro-na
naproxen (jp17/usp/inn)
D00118
naprosyn (tn)
SPECTRUM_000977
IDI1_000242
BSPBIO_002067
naproxi 500
atiflan
rs-3540
cg 3117
DUK ,
2-naphthaleneacetic acid, 6-methoxy-alpha-methyl-, (s)-
nafasol
dysmenalgit n
artrixen
narma
soproxen
proxen le
prafena
napflam
naxopren
naproxeno [inn-spanish]
artagen
naxyn 250
napxen
danaprox
headlon
acusprain
apronax
anexopen
apo-naproxen
flexen
pronaxen
priaxen
congex
narocin
daprox
napmel
naprosyne
naprosyn lle forte
ccris 5265
naprius
naposin
bipronyl
sinton
einecs 244-838-7
naprontag
nycopren
roxen
nalyxan
sinartrin
leniartil
patxen
(+)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
naxen f
rs 3540
napratec
saritilron
naproxi 250
arthrisil
anax
hsdb 3369
lefaine
naxen
rahsen
clinosyn
naproxenum [inn-latin]
naxid
sutony
flanax forte
vinsen
naxyn 500
propionic acid, 2-(6-methoxy-2-naphthyl)-, (+)-
sutolin
2-naphthaleneacetic acid, 6-methoxy-alpha-methyl-, (+)-
artroxen
flexipen
napren e
traumox
u-ritis
d-2-(6'-methoxy-2'-naphthyl)-propionsaeure [german]
naprosyn lle
naxyn
naproxene [inn-french]
rheumaflex
velsay
tohexen
fuxen
genoxen
novonaprox
d-2-(6-methoxy-2-naphthyl)propionic acid
equiproxen (veterinary)
methoxypropiocin
proxen lle
napren
ec-naprosyn
noflam
(+)-2-(methoxy-2-naphthyl)-propionsaeure [german]
(+)naproxen
PRESTWICK_349
cas-22204-53-1
NCGC00016759-01
PRESTWICK2_000791
SPECTRUM5_001327
LOPAC0_000792
prexan
d-naproxen
(2s)-2-(6-methoxy-2-naphthyl)propanoic acid
veradol
calosen
naprosyn
reuxen
bonyl
floginax
(+)-naproxen
axer
xenar
(s)-6-methoxy-.alpha.-methyl-2-naphthaleneacetic acid
laraflex
equiproxen
2-naphthaleneacetic acid, 6-methoxy-.alpha.-methyl-, (.alpha.s)-
UPCMLD-DP001:001
naproxen
22204-53-1
C01517
SR-01000075977-3
naproxen, meets usp testing specifications
(s)-2-(6-methoxy-2-naphthyl)propionic acid
UPCMLD-DP001
(+)-(s)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
(+)-2-(methoxy-2-naphthyl)-propionic acid
(+)-2-(6-methoxy-2-naphthyl)propionic acid
(s)-(+)-2-(6-methoxy-2-naphthyl)propionic acid
(s)-(+)-naproxen
(+)-(s)-naproxen
(s)-2-(6-methoxy-2-naphthyl)propanoic acid
naprolag
(s)-naproxen
DB00788
(s)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
(s)-(+)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid, 98%
NCGC00161591-01
KBIO2_001457
KBIO2_006593
KBIOGR_000597
KBIO2_004025
KBIO3_001567
KBIOSS_001457
SPECTRUM3_000514
NINDS_000242
SPBIO_000966
SPECTRUM2_001043
SPECTRUM4_000069
SPBIO_002861
PRESTWICK1_000791
PRESTWICK0_000791
SPECTRUM1500425
(2s)-2-(6-methoxynaphthalen-2-yl)propanoic acid
NPS ,
NCGC00021127-01
HMS2091H12
HMS2089N21
chebi:7476 ,
nsc-757239
nsc-750183
pn400 component naproxen
CHEMBL154 ,
HMS500M04
cmwtzpsulfxxja-vifpvbqesa-
inchi=1/c14h14o3/c1-9(14(15)16)10-3-4-12-8-13(17-2)6-5-11(12)7-10/h3-9h,1-2h3,(h,15,16)/t9-/m0/s1
(s)-(+)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
M1021
HMS1920P13
nsc750183
AKOS005267223
s-naproxen
bdbm50339185
(s)-2-(6-methoxynaphthalen-2-yl)propanoic acid
(s)-2-(6-methoxy-naphthalen-2-yl)-propionic acid
dtxsid4040686 ,
dtxcid2020686
tox21_301953
NCGC00255562-01
pharmakon1600-01500425
nsc757239
CCG-40130
NCGC00016759-02
d-2-(6'-methoxy-2'-naphthyl)-propionsaeure
nsc 750183
xenar-cr
57y76r9atq ,
naproxen [usan:usp:inn:ban:jan]
unii-57y76r9atq
nsc 757239
ec 244-838-7
dl naproxen
mnpa
proxine
panoxen
naprosine
NCGC00016759-03
AM20060551
naproxen [inn]
naproxen [mi]
naproxen [vandf]
vimovo component naproxen
naproxen [usp-rs]
(+)-(s)-6-methoxy-.alpha.-methyl-2-naphthaleneacetic acid
naproxen [usan]
naproxen [who-dd]
naproxen [orange book]
naproxen [inci]
naproxen [mart.]
naproxen component of vimovo
naproxen [jan]
naproxen [ep monograph]
naproxen [green book]
naproxen [hsdb]
naproxen [usp monograph]
EPITOPE ID:139974
gtpl5230
naprosy
HY-15030
SCHEMBL3046
ME-0100
(s)-(+)-2-(6-methoxy-naphthalen-2-yl)-propionic acid
(+)(s)2-(6-methoxy-2-naphthyl)-propionic acid
(2s)-2-(6-methoxy(2-naphthyl))propanoic acid
(s)-2-(6-methoxy-2-naphthyl)-propionic acid
Q-201447
apranax
(s)-6-methoxy-alpha-methyl-2-naphthaleneacetate
naproxen(+)
(s)-(+)-naproxene
naproxen, british pharmacopoeia (bp) reference standard
(s)-6-methoxy-.alpha.-methyl-2-naphthalene acetic acid
2-(6-methoxy-2-naphthyl)propanoic acid , (+)-
(+)-6-methoxy-.alpha.-methyl-2-naphthaleneacetic acid
(+)-6-methoxy-.alpha.-methyl-2-napthaleneacetic acid
2-naphthaleneacetic acid, 6-methoxy-.alpha.-methyl-, (+)-
HMS3649M13
AB00052049_05
mfcd00010500
4PO0
4OR0
sr-01000075977
naproxen, vetranal(tm), analytical standard
naproxen, united states pharmacopeia (usp) reference standard
naproxen, pharmaceutical secondary standard; certified reference material
naproxen, european pharmacopoeia (ep) reference standard
naproxen 1.0 mg/ml in methanol
sr-01000003110
SR-01000003110-5
SR-01000075977-4
SBI-0050769.P004
naproxen,(s)
d-naproxen; (2s)-2-(6-methoxynaphthalen-2-yl)propanoic acid; (s)-6-methoxy-?-methyl-2-naphthaleneacetic acid; d-2-(6-methoxy-2-naphthyl)propionic acid
131991-52-1
naproxen 100 microg/ml in acetonitrile
SR-01000075977-10
Q1215575
BRD-K59197931-001-03-7
EN300-139795
SDCCGSBI-0050769.P005
(2s)-2-(6-methoxynaphth-2-yl)propanoic acid
(alphas)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
HMS3886C15
O10203
(s)-(+)-2-(6-methoxy-2-naphthyl)propionic acid;(s)-(+)-6-methoxy-alpha-methyl-2-naphthaleneacetic acid
S5177
NCGC00016759-38
(s)-2-(6-methoxynaphthalen-2-yl)propanoicacid
propionic acid, 2-(methoxy-2-naphthyl)-, ()-
naproxene (inn-french)
()-2-(methoxy-2-naphthyl)-propionic acid
naproxenum (inn-latin)
naproxen oral suspension
naproxen oral
(+)-2-(methoxy-2-naphthyl)-propionsaure
equiproxen 10% solution
equiproxen granules
naproxen delayed release
m01ae02
naproxen (usp-rs)
d-2-(6'-methoxy-2'-naphthyl)-propionic acid
naproxeno (inn-spanish)
naproxen (usp monograph)
2-naphthleneacetic acid, 6-methoxy-alpha-methyl-, (+)-
naproxen (usan:usp:inn:ban:jan)
naproxendelayed release
ec-naproxen
naproxen (ep monograph)
sallus pain relief collection with naproxen
m02aa12
2-naphthaleneacetic acid, 6-methoxy-alpha-methyl, (s)-
g02cc02
()-2-(methoxy-2-naphthyl)-propionsaeure
naproxen (mart.)
Z1695772815
naproxen, 1mg/ml in methanol

Research Excerpts

Overview

Naproxen is a widely used nonsteroidal anti-inflammatory drug (NSAID) Used for mild-to-moderate pains, arthritis, and other immune-mediated disorders. Naproxen has relatively low selectivity for cyclooxygenase-2 (COX-2), thereby having decreased risk for cardiovascular (CV) events.

ExcerptReferenceRelevance
"Naproxen is a widely used nonsteroidal anti-inflammatory drug (NSAID) in pediatric population, used for mild-to-moderate pains, arthritis, and other immune-mediated disorders. "( Clinician's dilemma: Naproxen-induced liver injury.
Bansal, N; Guleria, S; Sharma, A; Sharma, S; Surya, M,
)
1.89
"Naproxen is a non-steroidal antiinflammatory drug (NSAID), which is generally used among the NSAIDs."( Anticancer and Antimicrobial Activities of Naproxen and Naproxen Derivatives.
Han, Mİ; Küçükgüzel, ŞG, 2020
)
1.54
"Naproxen is a promising strategy for immune interception in LS. "( Naproxen chemoprevention promotes immune activation in Lynch syndrome colorectal mucosa.
Bommi, PV; Brown, PH; Chang, K; Francisco-Cruz, A; Gelincik, O; Kanth, P; Kopelovich, L; Lee, JJ; Lim, R; Lipkin, SM; Liu, DD; Lynch, PM; Marnett, LJ; Milne, GL; Mork, ME; Perloff, M; Revuelta, M; Reyes-Uribe, L; Richmond, E; Samadder, NJ; Sei, S; Shoemaker, RH; Solis, LM; Stoffel, EM; Szabo, E; Taggart, MW; Umar, A; Vilar, E; Vornik, L; Wistuba, II; Wu, W; You, YN, 2021
)
3.51
"Naproxen is a widely used non-steroidal anti-inflammatory drug for the control of postoperative inflammatory signs and symptoms in dentistry. "( Simultaneous separation of naproxen and 6-O-desmethylnaproxen metabolite in saliva samples by liquid chromatography-tandem mass spectrometry: Pharmacokinetic study of naproxen alone and associated with esomeprazole.
Calvo, AM; Dionísio, TJ; Faria, FC; Morettin, M; Oliveira, GM; Santos, CF, 2020
)
2.3
"Naproxen is an NSAID with relatively low selectivity for cyclooxygenase-2 (COX-2), thereby having decreased risk for cardiovascular (CV) events."( The protective effects of naproxen against interleukin-1β (IL-1β)- induced damage in human umbilical vein endothelial cells (HUVECs).
Dang, F; Hao, R; Lan, B; Mu, Y; Wang, R; Wu, Y, 2021
)
1.64
"Naproxen is a one of the most popular non-steroidal anti-inflammatory drugs (NSAIDs) entering the environment as a result of high consumption. "( Enzymes Involved in Naproxen Degradation by Planococcus sp. S5.
Domaradzka, D; Guzik, U; Hupert-Kocurek, K; Wojcieszyńska, D, 2016
)
2.2
"Naproxen is a typical and well-known analgesic classified as non-steroidal anti-inflammatory drug (NSAID) and is commercialized as tablets or liquid-filled capsules. "( Improving the drug release of Naproxen Sodium tablets by preparing granules and tablets with a preferred mixing ratio of hydrates.
Bär, D; Debus, H; Fischer, W; Grune, C; Imming, P; Mäder, K; Tosch, S, 2017
)
2.19
"Naproxen is a non-steroidal anti-inflammatory drug (NSAID) and has been frequently detected in surface waters around the world. "( Chronic toxicity and endocrine disruption of naproxen in freshwater waterfleas and fish, and steroidogenic alteration using H295R cell assay.
Choi, K; Ji, K; Kho, Y; Kim, P; Kwak, K; Lee, J; Ryu, J, 2018
)
2.18
"Naproxen is a nonsteroidal anti-inflammatory drug that exhibits phototoxic side effects in humans, but its mechanism of phototoxicity is ambiguous. "( Unveiling the Photophysical and Photochemical Reaction Process of Naproxen via Ultrafast Femtosecond to Nanosecond Laser Flash Photolysis.
Huang, G; Li, MD; Liang, R; Sun, SS, 2019
)
2.19
"Naproxen (NAP) is a widely used drug for the treatment of pain and inflammatory conditions. "( Study of naproxen in some aqueous solutions of choline-based deep eutectic solvents: Solubility measurements, volumetric and compressibility properties.
Martinez, F; Mokhtarpour, M; Shekaari, H; Zafarani-Moattar, MT, 2019
)
2.37
"Naproxen (NPX) is a nonsteroidal anti-inflammatory drug (NSAID) that has been frequently detected in aquatic environments worldwide."( Long-term exposure to the non-steroidal anti-inflammatory drug (NSAID) naproxen causes thyroid disruption in zebrafish at environmentally relevant concentrations.
Chen, L; Dai, Q; Guo, H; Liu, J; Liu, W; Niu, L; Sun, X; Tu, W; Xu, C; Ye, J, 2019
)
1.47
"Naproxen is a non-steroidal anti-inflammatory drug that has previously been shown to exert antiviral activity against influenza A virus by inhibiting nucleoprotein (NP) binding to RNA. "( Naproxen Exhibits Broad Anti-influenza Virus Activity in Mice by Impeding Viral Nucleoprotein Nuclear Export.
Cui, L; Fan, W; Gao, GF; Jiao, P; Li, J; Liu, W; Mahesutihan, M; Shang, Y; Sun, L; Wang, D; Zhang, S; Zheng, W, 2019
)
3.4
"Naproxen is a widely used nonsteroidal anti-inflammatory drug. "( Degradation of naproxen by UV, VUV photolysis and their combination.
Alapi, T; Apáti, L; Arany, E; Dombi, A; Gajda-Schrantz, K; Ilisz, I; Mazellier, P; Szabó, RK, 2013
)
2.19
"Naproxen is an NSAID with documented efficacy in pain management; however, it is associated with serious dose-related adverse events. "( A phase 2 study of naproxen submicron particle capsules in patients with post-surgical dental pain.
Altman, R; Daniels, S; Strand, V; Young, CL, 2013
)
2.16
"Naproxen is a non-steroidal anti-inflammatory drug (NSAID); its efficacy in acute migraine has not been established by systematic reviews."( Naproxen with or without an antiemetic for acute migraine headaches in adults.
Derry, S; Law, S; Moore, RA, 2013
)
2.55
"Naproxen is an important non-steroidal anti-inflammatory drug with many pharmacological and biological properties. "( Naproxen intercalates with DNA and causes photocleavage through ROS generation.
Husain, MA; Rehman, SU; Sarwar, T; Tabish, M; Yaseen, Z, 2013
)
3.28
"Naproxen (Np) is an example of a non-steroidal anti-inflammatory drug (NSAID) commonly used for the reduction of pain and inflammation. "( Preparation and evaluation of microemulsion formulations of naproxen for dermal delivery.
Karasulu, HY; Ustündağ Okur, N; Yavaşoğlu, A, 2014
)
2.09
"Naproxen C0 is a potential antiviral candidate blocking influenza nucleoprotein function."( Structure-based design of novel naproxen derivatives targeting monomeric nucleoprotein of Influenza A virus.
Bertrand, H; Di Primo, C; Quideau, S; Slama-Schwok, A; Tarus, B; Zedda, G, 2015
)
1.42
"Naproxen is an anti-inflammatory drug that affects cellular calcium ion (Ca(2+)) homeostasis and viability in different cells. "( Naproxen-induced Ca2+ movement and death in MDCK canine renal tubular cells.
Chang, HT; Chen, FA; Cheng, HH; Cheng, JS; Chou, CT; Jan, CR; Kuo, CC; Kuo, DH; Liang, WZ; Shieh, P; Sun, TK; Tseng, HW, 2015
)
3.3
"Naproxen is a nonsteroidal anti-inflammatory drug with a long half-life and narrow margin of safety in dogs. "( Intravenous lipid emulsion therapy in three cases of canine naproxen overdose.
Corsi, R; Herring, JM; McMichael, MA; Wurlod, V,
)
1.82
"Naproxen is a non-steroidal anti-inflammatory drug (NSAID), belonging to propionic acid group, and its chemical structure is a 6-metoxi-metil-2-naftalenoacetic acid. "( Fixed Drug Eruption Due to Selective Hypersensitivity to Naproxen with Tolerance to other Propionic Acid NSAIDs.
Cabeza, CM; De Barrio Fernandez, M; Fernandez, RP; Gamboa, AR; Noguerado-Mellado, B; Perez-Ezquerra, PR, 2016
)
2.12
"Naproxen (NPX) is a frequently used nonsteroidal anti-inflammatory drug for rheumatoid arthritis (RA). "( Modeling Sex Differences in Pharmacokinetics, Pharmacodynamics, and Disease Progression Effects of Naproxen in Rats with Collagen-Induced Arthritis.
Almon, RR; DuBois, DC; Jusko, WJ; Li, X, 2017
)
2.11
"Naproxen is a non-steroidal anti-inflammatory drug which can be used for the treatment of inflammatory disorders like uveitis and arthirit rheumatoid. "( Preparation and physicochemical characterization of naproxen-PLGA nanoparticles.
Adibkia, K; Ahadi, F; Davaran, S; Javadzadeh, Y; Mohammadi, G; Sabzevari, A, 2010
)
2.05
"Naproxen etemesil is a lipophilic, non-acidic, inactive prodrug of naproxen that is hydrolysed to pharmacologically active naproxen once absorbed."( Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen - a proof-of-concept, randomized, double-blind, active-comparator study.
Bouchner, L; David, J; Goldstein, JL; Grim, J; Jungwirthová, A; Pešek, F; Searle, S; Sewell, KL; Skopek, J; Spindel, E; Ulč, I, 2010
)
1.35
"Naproxen/esomeprazole is a fixed-dose combination of the NSAID naproxen and the proton pump inhibitor esomeprazole. "( Naproxen/esomeprazole fixed-dose combination: for the treatment of arthritic symptoms and to reduce the risk of gastric ulcers.
Dhillon, S, 2011
)
3.25
"Naproxen is a non-steroidal anti-inflammatory drug (NSAID) widely used for symptomatic relief of arthritis and other painful disorders, such as dysmenorrheal. "( Naproxen-induced fixed drug eruption: a case report.
Akyazi, H; Baltaci, D; Kara, IH; Mungan, S, 2011
)
3.25
"Naproxen (NAP) is a non-steroidal anti-inflammatory drug (NSAIDs) under active investigation for AD."( Interaction of naproxen amphiphilic derivatives with biomembrane models evaluated by differential scanning calorimetry and Langmuir-Blodgett studies.
Castelli, F; Giuffrida, MC; Micieli, D; Pignatello, R; Sarpietro, MG, 2011
)
1.44
"Naproxen (Nap) is an NSAID used as a neuroprotective agent to treat several neurodegenerative diseases. "( Pharmacokinetic and ulcerogenic studies of naproxen prodrugs designed for specific brain delivery.
Sheha, M, 2012
)
2.08
"Naproxen (Nap) is a commonly used drug for antiphlogosis and analgesia, but its dissolution rate in water is quite low. "( Effects of particle morphology, pore size and surface coating of mesoporous silica on Naproxen dissolution rate enhancement.
Gao, YP; Guo, Z; Li, J; Liu, XM; Ma, L; Yuan, Y; Zhang, H, 2013
)
2.06
"Naproxen sodium is an alternative in the initial treatment of osteoarthritis and may be preferred to acetaminophen as first-line therapy in patients with moderate or severe pain."( Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee.
Golden, HE; Minic, M; Moskowitz, RW,
)
1.1
"Naproxen is an effective and low-cost adjunct for optimization of pain control and lung recovery after CABG. "( Postoperative naproxen after coronary artery bypass surgery: a double-blind randomized controlled trial.
Bédard, P; Bourke, ME; Kulik, A; Mesana, TG; Nathan, HJ; Penning, J; Ruel, M; Sawyer, L, 2004
)
2.13
"Naproxen is an anti-inflammatory pharmaceutical that has been detected in natural and engineered aquatic environments. "( Naproxen removal from water by chlorination and biofilm processes.
Boyd, GR; Grimm, DA; Zhang, S, 2005
)
3.21
"Naproxen is a nonsteroidal anti-inflammatory drug widely used as an analgesic and anti-inflammatory agent. "( Sulphation of o-desmethylnaproxen and related compounds by human cytosolic sulfotransferases.
Falany, CN; Ström, P; Swedmark, S, 2005
)
2.07
"Naproxen is a nonsteroidal anti-inflammatory drug, which is widely used for its analgesic, antipyretic and anti-inflammatory effects."( Naproxen-induced lichen planus: report of 55 cases.
Birgin, B; Fetil, E; Güneş, AT; Ilknur, T; Ozkan, S, 2006
)
2.5
"Naproxen is a nonsteroidal antiinflammatory drug (NSAID) with an antiinflammatory, analgesic, antipyretic and tocolytic activity. "( [Developmental toxicity of naproxen].
Burdan, F; Przybylski, P; Sykut, J, 2007
)
2.08
"Naproxen proved to be an effective inhibitor of prostaglandin synthesis, as did indomethacin."( The effect of antidiuretic hormone, indomethacin and naproxen on prostaglandin synthesis of experimentally infected and healthy kidneys.
Kaihola, HL; Kangas, L; Nieminen, L; Pulkkinen, M; Túri, S, 1982
)
1.24
"Naproxen is an acidic drug that is highly bound to plasma albumin."( Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions.
Segre, EJ, 1980
)
2.43
"Naproxen is a nonsteroidal anti-inflammatory drug commonly used in the clinical treatment of joint disease. "( In vivo effects of naproxen on composition, proteoglycan metabolism, and matrix metalloproteinase activities in canine articular cartilage.
Azzo, W; Lane, N; Mow, VC; Ratcliffe, A; Rosenwasser, MP; Saed-Nejad, F, 1993
)
2.06
"Naproxen is an anti-inflammatory drug widely used in the management of pain and in the treatment of migraine and headache. "( Disposition of naproxen after oral administration during and between migraine attacks.
Bertolotti, M; Pini, LA; Trenti, T; Vitale, G, 1993
)
2.08
"Naproxen is a stereochemically pure nonsteroidal anti-inflammatory drug of the 2-arylpropionic acid class. "( Clinical pharmacokinetics of naproxen.
Anderson, KE; Davies, NM, 1997
)
2.03
"Naproxen is a nonsteroidal anti-inflammatory drug characterized by its low wettability and poor water solubility. "( Effect of PEG 4000 on the dissolution rate of naproxen.
Martín, C; Martínez-Ohárriz, MC; Sánchez, M; Vélaz, I,
)
1.83
"Naproxen is a commonly used nonsteroidal anti-inflammatory drug (NSAID) whose side effects include tinnitus and transient hearing loss. "( Naproxen-associated sudden sensorineural hearing loss.
Lassen, LF; McKinnon, BJ, 1998
)
3.19
"Naproxen is a classic non-steroidal anti-inflammatory drug (NSAID) with established analgesic and anti-inflammatory potency. "( Safety and tolerability of naproxen ophthalmic solution in comparison to placebo.
Marrano, M; Milazzo, G; Müller, M; Pabst, G; Papa, V; Roth, HW; Santocono, M; Waitzinger, J, 1999
)
2.04
"Naproxen sodium (NS) is a nonsteroidal anti-inflammatory drug used in painful and inflammatory diseases. "( Physical characterization of naproxen sodium hydrate and anhydrate forms.
Barthélémy, C; Di Martino, P; Martelli, S; Palmieri, GF, 2001
)
2.04
"Naproxen CR is an effective and tolerable drug in the treatment of knee OA. "( Comparison of the efficacy and safety of naproxen CR and nabumetone in the treatment of patients with osteoarthritis of the knee.
Cha, HS; Jeon, CH; Kim, JS; Koh, EM; Koh, JH; Lee, CK, 2001
)
2.02
"Naproxen is a propionic acid derivative with analgesic and anti-inflammatory activity which has been widely used in the treatment of rheumatic diseases. "( Naproxen up to date: a review of its pharmacological properties and therapeutic efficacy and use in rheumatic diseases and pain states.
Avery, GS; Brogden, RN; Heel, RC; Speight, TM, 1979
)
3.15
"Naproxen is a useful drug for long-term use in patients with rheumatoid arthritis, including those who have proved intolerant of or experienced inadequate symptomatic relief from other nonsteriodal anti-inflammatory agents."( Naproxen in rheumatoid arthritis. Extended trial.
Ansell, BM; Gumpel, JM; Hill, AG; Hill, HF; Mowat, AG; Stoppard, M, 1976
)
2.42
"Naproxen is a useful alternative agent for the treatment of acute gout."( Multicentre trial of naproxen and phenylbutazone in acute gout.
Davies, J; Dixon, AS; Engler, C; Hamilton, EB; Liyanage, SP; Scott, JT; Sturge, RA, 1977
)
1.3
"Naproxen is a useful alternative agent for the treatment of acute gout."( Multi-centre trial of naproxen and phenylbutazone in acute gout.
Dixon, ST; Engler, C; Hamilton, EB; Liyanage, SP; Scott, JT; Sturge, RA, 1977
)
1.29
"Naproxen appears to be an efficacious and remarkably safe drug in the long-term therapy of rheumatoid arthritis, even in the presence of significant upper gastrointestinal symptomatology."( An open trial of naproxen in rheumatoid arthritis patients with significant esophageal, gastric, and duodenal lesions.
Boost, G; Roth, SH, 1975
)
1.32
"Naproxen is a potent anti-inflammatory drug whose action is attributed to inhibition of prostaglandin biosynthesis. "( Inhibition of endothelial cell prostaglandin H synthase gene expression by naproxen.
Loose-Mitchell, DS; Ohashi, K; Sanduja, R; Sanduja, SK; Wu, KK; Zyglewska, T, 1992
)
1.96
"Naproxen is a commonly used nonsteroidal anti-inflammatory drug which may be added to the growing list of pharmacologic agents associated with infiltrative pulmonary lesions."( Pulmonary infiltrates with eosinophilia due to naproxen.
Fujimura, M; Kanaya, H; Kawamura, Y; Kurashima, K; Kurumaya, H; Matsuda, T; Namura, M; Ogawa, H; Ohka, T; Yasui, M,
)
1.11
"Naproxen sodium is a new non-steroid antiinflammatory drug. "( [Clinical use of naproxen sodium in muscular skeletal disorders].
Tang, FS, 1990
)
2.06
"Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) advocated for use in painful and inflammatory rheumatic and certain nonrheumatic conditions. "( Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states.
Clissold, SP; Todd, PA, 1990
)
3.16
"Naproxen sodium is a drug characterized by rapid and complete absorption after oral administration, highly protein-bound distribution, relatively simple metabolism, and renal excretion. "( Pharmacokinetics of naproxen sodium.
Moyer, S, 1986
)
2.04
"Naproxen is an effective antipyretic in patients with cancer."( The effect of naproxen on fever in children with malignancies.
Azeemuddin, SK; Kim, TH; Ragab, AH; Vega, RA, 1987
)
1.35
"Naproxen sodium seems to be an effective and safe treatment for migraine attacks."( Acute migraine attack therapy: comparison of naproxen sodium and an ergotamine tartrate compound.
Dordain, G; Dry, J; Pradalier, A; Rancurel, G; Rascol, A; Verdure, L, 1985
)
1.25
"Naproxen sodium is an inhibitor of platelet aggregation and prostaglandin synthesis and is also a potent anti-inflammatory agent. "( Naproxen in prophylaxis of migraine.
Ellis, DJ; Ziegler, DK, 1985
)
3.15

Effects

Naproxen has a propensity to cause ulcers whereas zinc ions are known to possess an anti-ulcer and anti-inflammatory activity. Naproxen, which has an excellent cardiovascular profile, or epidermal growth factor receptor inhibitors may be effective in an adjuvant setting.

Naproxen has an excellent cardiovascular profile, or epidermal growth factor receptor inhibitors may be effective in an adjuvant setting. Naproxen suppositories have been shown to be well tolerated over a 9-week pe.

ExcerptReferenceRelevance
"Naproxen has a beneficial role in reducing the total occurrence of HO, Brooker I and II HO after hip surgery. "( A systematic review and meta-analysis of naproxen for prevention heterotopic ossification after hip surgery.
Chen, X; Wang, KL; Zhang, AH; Zhao, QX, 2019
)
2.22
"Naproxen, which has an excellent cardiovascular profile, or epidermal growth factor receptor inhibitors may be effective in an adjuvant setting."( Screening agents for preventive efficacy in a bladder cancer model: study design, end points, and gefitinib and naproxen efficacy.
Grubbs, CJ; Juliana, MM; Lubet, RA; Steele, VE, 2010
)
1.29
"Naproxen has an inherent weak thrombocyte inhibitory action below the ASA response threshold."( Interference of NSAIDs with the thrombocyte inhibitory effect of aspirin: a placebo-controlled, ex vivo, serial placebo-controlled serial crossover study.
Kasemier, J; Meek, IL; Movig, KL; van de Laar, MA; Vonkeman, HE, 2013
)
1.11
"Naproxen has a propensity to cause ulcers whereas zinc ions are known to possess an anti-ulcer and anti-inflammatory activity. "( Zinc-naproxen complex: synthesis, physicochemical and biological evaluation.
Dhawan, S; Sharma, J; Singla, AK, 2003
)
2.28
"Naproxen has a high therapeutic index and a shallow dose-response curve, so the effect of other drugs on its pharmacokinetics is not likely to have a large clinical impact."( Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions.
Segre, EJ, 1980
)
2.43
"Naproxen has a beneficial role in reducing the total occurrence of HO, Brooker I and II HO after hip surgery. "( A systematic review and meta-analysis of naproxen for prevention heterotopic ossification after hip surgery.
Chen, X; Wang, KL; Zhang, AH; Zhao, QX, 2019
)
2.22
"As naproxen has been demonstrated to be associated with the lowest cardiovascular adverse events in comparison with both COX-2 selective inhibitors and conventional NSAIDs, we have been developing a Naproxen-PC formulation for evaluation in animal models and clinical trials."( Naproxen-PC: a GI safe and highly effective anti-inflammatory.
Dial, EJ; Lichtenberger, LM; Moore, JE; Romero, JJ, 2009
)
2.31
"Naproxen, which has an excellent cardiovascular profile, or epidermal growth factor receptor inhibitors may be effective in an adjuvant setting."( Screening agents for preventive efficacy in a bladder cancer model: study design, end points, and gefitinib and naproxen efficacy.
Grubbs, CJ; Juliana, MM; Lubet, RA; Steele, VE, 2010
)
1.29
"Naproxen and estrogens have been studied for this use."( Management of menstrual migraine: a review of current abortive and prophylactic therapies.
Bushnell, C; Sullivan, E, 2010
)
1.08
"Naproxen has an inherent weak thrombocyte inhibitory action below the ASA response threshold."( Interference of NSAIDs with the thrombocyte inhibitory effect of aspirin: a placebo-controlled, ex vivo, serial placebo-controlled serial crossover study.
Kasemier, J; Meek, IL; Movig, KL; van de Laar, MA; Vonkeman, HE, 2013
)
1.11
"Naproxen has a propensity to cause ulcers whereas zinc ions are known to possess an anti-ulcer and anti-inflammatory activity. "( Zinc-naproxen complex: synthesis, physicochemical and biological evaluation.
Dhawan, S; Sharma, J; Singla, AK, 2003
)
2.28
"Naproxen has been detected in municipal sewage outflows and in surface waters and could reach agricultural land through the application of municipal biosolids or reclaimed water."( Fate of the nonsteroidal anti-inflammatory drug naproxen in agricultural soil receiving liquid municipal biosolids.
Chapman, R; Hendel, JG; Lapen, DR; Topp, E, 2008
)
1.32
"Naproxen has a high therapeutic index and a shallow dose-response curve, so the effect of other drugs on its pharmacokinetics is not likely to have a large clinical impact."( Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions.
Segre, EJ, 1980
)
2.43
"Naproxen suppositories have been shown to be well tolerated over a 9-week period."( Naproxen suppositories in combination with oral naproxen, indomethacin and ibuprofen in the treatment of rheumatoid arthritis.
Engler, C; Seifert, MH, 1980
)
2.43
"Naproxen CR tablets have been obtained from its microspheres prepared by coprecipitation with Eudragit L100-55. "( Response surface methodology to obtain naproxen controlled release tablets from its microspheres with Eudragit L100-55.
Faltinek, J; Khan, MA; Reddy, IK; Vaithiyalingam, SR; Zaghloul, AA,
)
1.84
"Naproxen has been well studied in rheumatoid arthritis and is as effective as aspirin but better tolerated, thus enabling more patients to continue with treatment."( Naproxen up to date: a review of its pharmacological properties and therapeutic efficacy and use in rheumatic diseases and pain states.
Avery, GS; Brogden, RN; Heel, RC; Speight, TM, 1979
)
2.42
"Naproxen has been shown to suppress uterine motility in both situations, in both species, whether administered by parenteral or oral routes."( Effects of naproxen on uterine contractility in vivo.
Vickery, BH, 1979
)
1.37
"Naproxen, however, has only once been reported to cause meningitis."( Naproxen-induced recurrent aseptic meningitis.
Lehany, AM; Weksler, BB, 1991
)
2.45
"Naproxen sodium has been formulated in a parenteral dosage form. "( Naproxen parenteral formulation studies.
Lalla, JK; Peswani, KS,
)
3.02
"Naproxen has recently been described as a cause for drug-induced pseudoporphyria and eight examples of this are reported."( Pseudoporphyria from nonsteroidal antiinflammatory drugs.
Duffill, MB; Taylor, BJ, 1987
)
0.99
"Naproxen has been administered for 22 febrile episodes of unknown etiology in 21 patients with malignant tumors. "( [Antipyretic effect of naproxen in neoplastic fever].
Ando, Y; Hashimoto, S; Kondo, M; Kuribayashi, T; Nakayama, T; Tominaga, S, 1987
)
2.03

Actions

Naproxen seems to cause the lowest cardiovascular events of the common NSAIDs other than aspirin. Naproxen may also allow the limitation of extensive fever workups and prolonged empiric antibiotic therapy in these patients.

ExcerptReferenceRelevance
"Naproxen was proved to cause changes at both cellular and tissue levels in roots, which was also reflected in their anatomy and morphology."( Root response in Pisum sativum under naproxen stress: Morpho-anatomical, cytological, and biochemical traits.
Babula, P; Kummerová, M; Sendecká, K; Svobodníková, L; Zezulka, Š, 2020
)
1.55
"Naproxen seems to cause the lowest cardiovascular events of the common NSAIDs other than aspirin."( Chemopreventive efficacy of naproxen and nitric oxide-naproxen in rodent models of colon, urinary bladder, and mammary cancers.
Boring, D; Grubbs, CJ; Juliana, MM; Kopelovich, L; Lubet, RA; Patlolla, J; Rao, CV; Steele, VE; Zhang, Y, 2009
)
1.37
"Naproxen was devoid a lower protecting activity on myocardial infarction, and PGI2 inhibition may have played a critical role in this context."( Nitric oxide and prostacyclin pathways: an integrated mechanism that limits myocardial infarction progression in anaesthetized rats.
Berti, F; Brini, AT; Clement, MG; De Gennaro Colonna, V; Manfredi, B; Polvani, G; Rossoni, G, 2006
)
1.06
"Naproxen may also allow the limitation of extensive fever workups and prolonged empiric antibiotic therapy in these patients, and prevent delays in systemic therapy or supportive care."( The effect of naproxen on fever in patients with advanced gynecologic malignancies.
Economos, K; Lucci, JA; Miller, DS; Richardson, B; Yazigi, R, 1995
)
1.37
"2. Naproxen did not inhibit glycogenolysis stimulation caused by glucagon."( Naproxen inhibits hepatic glycogenolysis induced by Ca(2+)-dependent agents.
Bracht, A; Ishii-Iwamoto, EL; Nascimento, EA; Yamamoto, NS, 1995
)
2.25
"NO-naproxen was found to produce significantly less gastric damage despite inducing similar increases in plasma TNF alpha to naproxen. "( NO-naproxen vs. naproxen: ulcerogenic, analgesic and anti-inflammatory effects.
Appleyard, CB; Calignano, A; Cirino, G; Davies, NM; Del Soldato, P; McKnight, W; Røseth, AG; Wallace, JL, 1997
)
1.54

Treatment

Naproxen was the only treatment to be more effective on all different radiographic subscores than etanercept. Naproxen-treated mice had diminished load-induced bone formation as well as a significant loss in toughness in non-loaded bone.

ExcerptReferenceRelevance
"Naproxen was the only treatment to be more effective on all different radiographic subscores than etanercept."( Structural efficacy of NSAIDs, COX-2 inhibitor and glucocorticoid compared with TNFα blocker: a study in adjuvant-induced arthritis rats.
Bordy, R; Demougeot, C; Prati, C; Totoson, P; Verhoeven, F; Wendling, D, 2019
)
1.24
"Naproxen-treated mice had diminished load-induced bone formation as well as a significant loss in toughness in non-loaded bone, which were not observed in aspirin-treated mice."( Naproxen impairs load-induced bone formation, reduces bone toughness, and diminishes woven bone formation following stress fracture in mice.
Fertala, A; Park, J; Tomlinson, RE, 2019
)
2.68
"In naproxen-treated rats, we found greater expression in hepatic stellate cells and mononuclear cells of cytoprotective factors, such as vascular endothelial growth factor."( Nonselective inhibition of prostaglandin-endoperoxide synthases by naproxen ameliorates acute or chronic liver injury in animals.
Bahde, R; Gupta, S; Kapoor, S, 2014
)
1.15
"Naproxen-treated patients did not show significant improvement in back pain."( Gabapentin versus naproxen in the management of failed back surgery syndrome; a randomized controlled trial.
Azemati, S; Khosravi, MB; Sahmeddini, MA, 2014
)
1.46
"Naproxen treatment notably reduces PGE2 production and iNOS expression, reflecting the COX-NOS crosstalk already reported, although it causes an important increment in TNF-alpha synthesis in the epidermis of irradiated mice."( Time-course evaluation and treatment of skin inflammatory immune response after ultraviolet B irradiation.
Ferrari, A; Leoni, J; Maglio, DH; Paz, ML; Weill, FS, 2008
)
1.07
"or naproxen 250 mg b.i.d. Treatment periods were separated by a washout period of 28 days."( The impact of selective and non-selective non-steroid anti-inflammatory drugs on secondary hemostasis in healthy volunteers.
Damkier, P; Larsen, TB; Schjerning, O, 2009
)
0.87
"Naproxen treatment (20 and 40 mg/kg per os [PO] and intraperitoneally) started 2 weeks after the induction of CP for 3 weeks."( High-dose naproxen aggravates pancreatic fibrosis in a rat model of chronic pancreatitis.
Bai, Y; Gao, J; Li, Z; Wu, W; Zhang, W; Zhao, T; Zou, D, 2010
)
1.48
"Naproxen treatment was highly effective in general, inducing a symptom-free status in 43% of our patients after 6 months. "( Chronic nonbacterial osteomyelitis in childhood: prospective follow-up during the first year of anti-inflammatory treatment.
Beck, C; Beer, M; Gattenlöhner, S; Girschick, HJ; Hofmann, U; Morbach, H; Raab, P; Stenzel, M; Tappe, D, 2010
)
1.8
"(S)- naproxen (1) was treated with thionyl chloride to yield acid chloride (2) which was then reacted with different heterocyclic moieties and aryl acids to yield the (S)-naproxen analogs (3a-k)."( Computer aided discovery of potential anti-inflammatory (S)-naproxen analogs as COX-2 inhibitors.
Divya, P; Raghavendra, NM; Ramakrishna, K; Rao, AV; Sirisha, V, 2013
)
1.09
"Naproxen treatment (WK N) induced an increased by 14%."( Naproxen, clenbuterol and insulin administration ameliorates cancer cachexia and reduce tumor growth in Walker 256 tumor-bearing rats.
Curi, R; Fabrício, VE; Fernandes, LC; Fernandez, R; Folador, A; Gobbo-Bordon, D; Hirabara, SM; Jakobi, S; Moretto, KD; Piffar, PM; Pinto, GJ; Rohn, TV; Tchaikovski, O; Tosta, E, 2003
)
2.48
"Naproxen pretreatment (20 mg/kg) resulted in significantly less brain edema."( Naproxen reduces excitotoxic neurodegeneration in vivo with an extended therapeutic window.
Hewett, JA; Hewett, SJ; Silakova, JM, 2004
)
2.49
"Naproxen treatment was associated with a significantly greater ulceration rate compared with placebo."( A randomized, controlled comparison of ibuprofen at the maximal over-the-counter dose compared with prescription-dose celecoxib on upper gastrointestinal mucosal injury.
Cryer, B; Kimmey, MB; Riff, DS; Rothstein, RI; Scheiman, JM; Wolfe, MM, 2004
)
1.04
"Naproxen treatment was generally effective."( Chronic non-bacterial osteomyelitis in children.
Girschick, HJ; Kirschner, S; Lipsky, PE; Müller-Hermelink, HK; Papadopoulos, T; Raab, P; Schneider, P; Surbaum, S; Trusen, A, 2005
)
1.05
"Naproxen treatment was also associated with greater reductions in tender/painful joint count than placebo (all, P<0.001)."( A comparison of valdecoxib and naproxen in the treatment of rheumatoid arthritis symptoms.
Brown, MT; Kivitz, AJ; Verburg, KM; Williams, GW, 2006
)
1.34
"Naproxen treatment did not suppress ovulation in any of the cycles and did not affect the corpus luteum function."( The effect of a prostaglandin synthetase inhibitor on the hormonal profile and the endometrium in women.
Eneroth, P; Johannisson, E; Landgren, BM; Lundström, V, 1983
)
0.99
"With naproxen or ibuprofen treatments, mean diastolic blood pressure increased less than 3 mm Hg."( Assessment of blood pressure during treatment with naproxen or ibuprofen in hypertensive patients treated with hydrochlorothiazide.
Goodfriend, TL; Klassen, D; Peterson, CA; Schuna, AA; Young, DY, 1993
)
0.99
"Naproxen-treated patients experienced significantly (p < 0.002) more dyspepsia as compared with patients treated with nabumetone or ibuprofen and significantly (p < or = 0.001) more nabumetone-treated patients experienced diarrhea than patients treated with naproxen, ibuprofen, or piroxicam."( Safety experience with nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in osteoarthritis and rheumatoid arthritis.
DeLapp, RE; Eversmeyer, W; Jensen, CP; Poland, M, 1993
)
1.26
"NO-naproxen-treated rats exhibited no significant gastric damage."( Effect of a nitric oxide-releasing naproxen derivative on hypertension and gastric damage induced by chronic nitric oxide inhibition in the rat.
Del Soldato, P; McKnight, W; Muscará, MN; Wallace, JL, 1998
)
1.09
"Naproxen treatment partially prevented ovariectomy-induced loss or less gain in BMD, in a significant manner, in the femoral neck cortical area, and also in L1 compressive strength and stiffness."( Bone mineral density and biomechanical properties of spine and femur of ovariectomized rats treated with naproxen.
Dequeker, J; Genant, HK; Geusens, P; Jiang, Y; Zhao, J, 1998
)
1.24
"Naproxen treatment, irrespective of type of operation, did not require rescue analgesics, while two patients after CTS treated with paracetamol did."( Acute postoperative swelling after hand surgery: an exploratory, double-blind, randomised study with paracetamol, naproxen, and placebo.
Fyllingen, G; Haugstvedt, JR; Husby, T; Skoglund, LA, 2001
)
1.24
"The naproxen-sodium treatment decreased prostaglandins F and E in menstrual blood and uterine jet washings by 60--80 per cent."( Suppression of uterine activity by prostaglandin synthetase inhibitors.
Pulkkinen, MO, 1979
)
0.74
"Naproxen treatment did not alter virus shedding or serum neutralizing antibody responses in participants with experimental rhinovirus colds, but it had a beneficial effect on the symptoms of headache, malaise, myalgia, and cough. "( Effects of naproxen on experimental rhinovirus colds. A randomized, double-blind, controlled trial.
Gwaltney, JM; Hayden, FG; Hendley, JO; Riker, DK; Sorrentino, JV; Sperber, SJ, 1992
)
2.12
"Naproxen treatment producing a serum level of 9.4 mcg/ml reduced bone volume in OX rats consuming water with 156.25 mg/l (p less than .05)."( Long-term effect of naproxen on cancellous bone in ovariectomized rats.
Coble, T; Kimmel, DB; Lane, N, 1992
)
1.33
"Naproxen treatment for 5 days with 2 mg/kg per day or 20 mg/kg per day reduced iPGF from 6.71 +/- 0.93 to 2.19 +/- 0.34 and 1.01 +/- 0.18 ng/100 mg tissue, respectively (P less than 0.01)."( Influence of naproxen on uterine PGF2 alpha and the antifertility effect of IUDs in rats.
Li, Y; Liu, YQ; Tang, DC; Wu, XR; Zhao, BR, 1989
)
1.37
"Naproxen treatment significantly decreased net protein degradation and prostaglandin E2 production in infected chicks to values seen in muscles of healthy controls."( Prostaglandin-dependent muscle wasting during infection in the broiler chick (Gallus domesticus) and the laboratory rat (Rattus norvegicus).
Baracos, VE; Tian, S, 1989
)
1
"Naproxen treatment, but not placebo treatment, markedly attenuated in vitro uterine PGE2, PGF2 alpha, and PGI2 releases, suppressed OT responsiveness, and prolonged gestation."( Effects of inhibition of prostaglandin synthesis on uterine oxytocin receptor concentration and myometrial gap junction density in parturient rats.
Berezin, I; Chan, WY; Daniel, EE, 1988
)
1
"Naproxen treatment was associated with a statistically significant decrease in total joint swelling."( Double-blind crossover comparison of piroxicam and naproxen in the treatment of active osteoarthritis.
Hodge, RH, 1985
)
1.24
"Naproxen treatment did not suppress ovulation in any cycle and did not affect the corpus luteum function either in group 1 or in group 2."( The effect of a prostaglandin synthetase inhibitor on the hormonal profile and the endometrium in women.
Eneroth, P; Johannisson, E; Landgren, BM; Lundström, V, 1985
)
0.99
"On naproxen treatment, 52% of the patients had no severe headaches, whereas 19% had no severe headaches during placebo."( Successful migraine prophylaxis with naproxen sodium.
Ellis, DJ; Keenan, PA; Welch, KM, 1985
)
1.06
"Treatment with naproxen improved cough and shortness of breath in COVID-19 patients; such that, compared with placebo, naproxen intake was associated with 2.90 (95% CI: 1.10-7.66) and 2.82 (95% CI: 1.05-7.55) times more improvement in cough and shortness of breath, respectively. "( Efficacy of naproxen in the management of patients hospitalized with COVID-19 infection: A randomized, double-blind, placebo-controlled, clinical trial.
Abbasi, S; Asadi, M; Bitaraf, S; Cheldavi, A; Ebrahimzadeh, M; Jelvay, S; Mobarak, S; Mohammadi, A; Mousaviasl, S; Naghshi, S; Radmanesh, E; Sayar, S; Zardehmehri, F,
)
0.86
"Treatment with naproxen can improve cough and shortness of breath in COVID-19-infected patients. "( Efficacy of naproxen in the management of patients hospitalized with COVID-19 infection: A randomized, double-blind, placebo-controlled, clinical trial.
Abbasi, S; Asadi, M; Bitaraf, S; Cheldavi, A; Ebrahimzadeh, M; Jelvay, S; Mobarak, S; Mohammadi, A; Mousaviasl, S; Naghshi, S; Radmanesh, E; Sayar, S; Zardehmehri, F,
)
0.86
"Treatment with naproxen (an NSAID commonly used for inflammatory pain) attenuated the CFA-induced effects."( Gait analysis and weight bearing in pre-clinical joint pain research.
Ängeby Möller, K; Holappa, J; Immonen, J; Stenfors, C; Suominen, A; Svärd, H, 2018
)
0.82
"Pretreatment with naproxen in the WRS model caused an increase in severity of damage and a decrease in NOS activity."( Effects of conventional and hydrogen sulfide-releasing non-steroidal anti-inflammatory drugs in rats with stress-induced and epinephrine-induced gastric damage.
Biletska, L; Bondarchuk, T; Fomenko, I; Panasyuk, N; Sklyarov, A; Wallace, JL, 2014
)
0.73
"Treatment with naproxen increased the thickness of the corneal and epithelial layers of the oesophagus, as well as producing disorganization of the muscle plate and irregular submucosal oedema. "( Exposure to non-steroid anti-inflammatory drugs (NSAIDs) and suppressing hydrogen sulfide synthesis leads to altered structure and impaired function of the oesophagus and oesophagogastric junction.
Bula, N; Gavrilyuk, E; Khyrivska, D; Wallace, JL; Zayachkivska, O, 2015
)
0.77
"Pretreatment with naproxen (7 and 14 mg/kg, ip), rofecoxib (5 and 10 mg/kg, ip) and valdecoxib (5 and 10 mg/kg, ip) significantly improved locomotor activity, antianxiety effect, memory retention (memory deficit) and attenuated oxidative damage (lowering of raised malondialdehyde, nitrite activity, restoration of reduced glutathione and catalase activity as compared to immobilization stress group (p < 0.05)."( Protective effect of non-selective and selective COX-2-inhibitors in acute immobilization stress-induced behavioral and biochemical alterations.
Dhir, A; Kumar, A; Kumari, B,
)
0.45
"Treatment with naproxen resulted in showing a significant preventive effect."( Role of naproxen as anti-oxidant in selenite cataract.
Gupta, SK; Joshi, S, 1994
)
1.06
"Treatment with naproxen was not found to change the composition (water, collagen, and proteoglycan) of the articular cartilage."( In vivo effects of naproxen on composition, proteoglycan metabolism, and matrix metalloproteinase activities in canine articular cartilage.
Azzo, W; Lane, N; Mow, VC; Ratcliffe, A; Rosenwasser, MP; Saed-Nejad, F, 1993
)
0.95
"Pretreatment with naproxen did not affect the basal release of R-PGE or the basal FBF but inhibited both the release of R-PGE and the increase in FBF following NIC."( Prostaglandins contribute to the vasodilation induced by nicotinic acid.
Eklund, B; Kaijser, L; Nowak, J; Wennmalm, A, 1979
)
0.58
"Day treatment with naproxen, which has a relatively long half life time decrease the need for supplementary treatment at night."( [Naproxen versus indomethacin as night-time medication for patients with rheumatoid arthritis].
Haerslev, T; Hansen, TM; Jespersen, SM; Mathiesen, FK; Wester, JU, 1991
)
1.51
"Pretreatment with naproxen reduced renal sensitivity to furosemide (right shift of the dose response curve) in all the donors but in only 2 of the patients."( Response to furosemide during dehydration with and without naproxen pretreatment of kidney donors and renal transplant recipients.
Hammarlund-Udenaes, M; Odlind, BG; Sjöström, PA, 1991
)
0.85
"Treatment with naproxen sodium, 550 mg, 30 minutes following completion of surgery was just as effective as presurgical administration in controlling postoperative pain."( A comparison of preoperative and postoperative naproxen sodium for suppression of postoperative pain.
Grover, BJ; Sisk, AL, 1990
)
0.88
"Treatment with naproxen (6-methoxy-alpha-methyl-2-naphthaleneacetic acid), an inhibitor of prostaglandin production, decreased weight losses of body and muscle, and significantly inhibited muscle protein wasting in infected chicks and rats."( Prostaglandin-dependent muscle wasting during infection in the broiler chick (Gallus domesticus) and the laboratory rat (Rattus norvegicus).
Baracos, VE; Tian, S, 1989
)
0.62

Toxicity

The available evidence suggests that naproxen sodium is more effective but may cause more adverse events than placebo in the acute treatment of moderate to severe migraine. Prespecified gastrointestinal adverse events were more frequent with Naproxen than with either lumiracoxib dose or placebo.

ExcerptReferenceRelevance
" Clinicians are encouraged to report possible adverse drug reactions to the National Registry of Drug-Induced Ocular Side Effects, which has been moved to the Department of Ophthalmology, University of Oregon Health Sciences Center, Portland, OR 97201."( Interim report: National Registry of Possible Drug-Induced Ocular Side Effects.
Fraunfelder, FT, 1979
)
0.26
" Since previous studies with enteric coated naproxen tablets indicated a favourable side effect profile compared to plain tablets, the present data indicates that enteric coated formulations are not all alike, and should be studied individually."( Naproxen-associated gastroduodenal toxicity: enteric coated granules versus plain tablets.
Aabakken, L; Gamst, ON; Osnes, M; Ugstad, M; Winther, R, 1992
)
1.99
" The most common adverse effects that occurred were related to the gastrointestinal tract, nervous system, skin, and special senses."( Clinical efficacy and safety of nabumetone in rheumatoid arthritis and osteoarthritis.
Fleischmann, RM, 1992
)
0.28
" Within the free plasma concentration range in this large patient group, we could detect no association between free naproxen concentration and efficacy score or between free concentrations and adverse events."( Naproxen free plasma concentrations and unbound fractions in patients with osteoarthritis: relation to age, sex, efficacy, and adverse events.
Hundal, O; Husby, G; Rugstad, HE, 1991
)
1.93
" Ketorolac was well tolerated, with rates of adverse events generally lower than those of the opiate comparators."( Analgesic efficacy and safety of single-dose oral and intramuscular ketorolac tromethamine for postoperative pain.
Brown, CR; Bynum, LJ; Clarke, PJ; Dickie, G; Evans, SA; Moodie, JE; Smith, BA; Wild, VM, 1990
)
0.28
"This randomised single blind controlled study examines adverse reactions to standard Naprosyn (naproxen) 750 mg daily with controlled release naproxen, Naprosyn CR, 750 mg daily, in a total of 520 patients."( A safety profile of controlled release naproxen tablets.
Allen, B; Edwards, IR, 1989
)
0.76
" The nature and severity of adverse effects were recorded for each treatment period."( Comparison of the gastrointestinal side effects of naproxen formulated as plain tablets, enteric-coated tablets, or enteric-coated granules in capsules.
Aabakken, L; Bjørnbeth, BA; Hofstad, B; Larsen, S; Olaussen, B; Osnes, M, 1989
)
0.53
" By posttreatment endoscopy, nabumetone was significantly less toxic to the gastrointestinal tract than was naproxen."( Endoscopy-controlled study of the safety of nabumetone compared with naproxen in arthritis therapy.
Roth, SH, 1987
)
0.72
" The evidence of renal toxic effects became manifest after an episode of dehydration."( Naproxen nephrotoxicity in a 2-year-old child.
Piel, CF; Ray, PE; Rigolizzo, D; Wara, DR, 1988
)
1.72
" Documentation is derived from clinical trials, post-marketing surveillance, special studies, and spontaneous reports of adverse drug reactions from foreign countries."( Worldwide safety experience with diclofenac.
Catalano, MA, 1986
)
0.27
" The purpose of the present study was to look for an association of plasma drug concentration with the variables of: age, sex, adverse events and efficacy."( Piroxicam and naproxen plasma concentrations in patients with osteoarthritis: relation to age, sex, efficacy and adverse events.
Giercksky, KE; Herland, OB; Holme, I; Hundal, O; Husby, G; Rugstad, HE, 1986
)
0.63
"In the Norwegian comparative trials of piroxicam and naproxen in osteoarthritis, conducted by Husby and co-workers and Rugstad et al, relationships between plasma drug concentrations and the following were examined: efficacy in patients with osteoarthritis; all adverse reactions; and serious adverse events, which included gastrointestinal ulceration or bleeding and congestive heart failure."( The Norway study: plasma concentrations, efficacy, and adverse events.
Rugstad, HE, 1986
)
0.52
" Finally, the worldwide database of more than 77,000 patients monitored in postmarketing surveillance studies is examined to assess gastrointestinal side effects and the relation of age and sex to these adverse events."( Clinical benefits and comparative safety of piroxicam. Analysis of worldwide clinical trials data.
Meisel, AD, 1986
)
0.27
" It was found that compounds with polar substituents at the 2 or 3 position of the ring system are less acutely toxic while maintaining antiinflammatory activity."( Effect of structural change on acute toxicity and antiinflammatory activity in a series of imidazothiazoles and thiazolobenzimidazoles.
Ariyan, ZS; Fogt, SW; Heilman, RD; Matthews, RJ; Powers, LJ; Rippin, DJ, 1981
)
0.26
" In conclusion, nimesulide appears to be a safe and effective treatment for paediatric patients with pharyngo-amygdalitis and it has shown superior efficacy and tolerability when compared with naproxen."( Assessment of the efficacy and safety of nimesulide vs naproxen in paediatric patients with respiratory tract infections. A comparative single-blind study.
Arista Viveros, HA; Lopez, E; Lujan, ME; Maciel, RM; Salmòn Rodriguez, LE; Trujillo, CL, 1993
)
0.72
" Local adverse events were minimum for both groups."( Single blind study to evaluate the efficacy and safety of naproxen gel compared with diclophenac emulgel in the treatment of soft tissue injuries.
Butrón, F; Galicia, A; Martinez-Zurita, F; Zamora, G, 1994
)
0.53
" The incidence of adverse events caused by either drug was the same."( A comparative study of the efficacy and toxicity of etodolac and naproxen in the treatment of osteoarthritis.
Bird, H; Chikanza, IC; Clarke, B; Grahame, R; Hopkins, R; MacFarlane, DG,
)
0.37
" The incidence of > or = 1 adverse event considered by the investigator to be related or probably related to therapy was similar in all groups."( Safety experience with nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in osteoarthritis and rheumatoid arthritis.
DeLapp, RE; Eversmeyer, W; Jensen, CP; Poland, M, 1993
)
0.54
" The photomixtures obtained in the presence of oxygen were clearly more toxic to cultured hepatocytes than those obtained under anaerobic conditions."( Involvement of drug-derived peroxides in the phototoxicity of naproxen and tiaprofenic acid.
Castell, JV; Gomez-Lechon, MJ; Grassa, C; Martinez, LA; Miranda, MA; Tarrega, P, 1993
)
0.53
" 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,
)
0.41
" There were no significant between-group differences in the numbers of patients who had an adverse experience, a serious adverse experience, or an adverse experience leading to study discontinuation; there were also no significant between-group differences in the distribution of adverse experiences."( Efficacy and safety of etodolac and naproxen in patients with osteoarthritis of the knee: a double-blind, placebo-controlled study.
Ballard, I; Constantine, G; Dore, R; McDonald, P,
)
0.41
" Meloxicam was better tolerated in the gastrointestinal (GI) tract, with fewer GI adverse events in the meloxicam-treated group (30."( A six-month double-blind trial to compare the efficacy and safety of meloxicam 7.5 mg daily and naproxen 750 mg daily in patients with rheumatoid arthritis.
Barceló, P; Bevis, PJ; Bluhmki, E; Distel, M; Le Loët, X; Schattenkirchner, M; Wojtulewski, JA, 1996
)
0.51
" Significantly more Naprosyn- than placebo-treated patients had at least 1 severe digestive system adverse event (AE); 1 drug-related AE; or 1 drug-related, digestive-system AE."( Clinical efficacy and safety of Naprelan versus Naprosyn in the treatment of rheumatoid arthritis.
Lisse, JR, 1996
)
0.29
"SC-58635 achieves analgesic and antiinflammatory efficacy in arthritis through selective COX-2 inhibition, without showing any evidence of 2 of the toxic effects of COX-1 inhibition associated with nonsteroidal antiinflammatory drugs."( Preliminary study of the safety and efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor: efficacy and safety in two placebo-controlled trials in osteoarthritis and rheumatoid arthritis, and studies of gastrointestinal and platelet effects.
Geis, GS; Hubbard, RC; Isakson, PC; Lanza, FL; Lipsky, PE; Schwartz, BD; Simon, LS; Talwalker, S, 1998
)
0.3
" The objective of this meta-analysis is to evaluate the frequency of occurrence of all adverse events in subjects taking various doses of OTC naproxen sodium as compared to placebo."( A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis.
Bansal, V; Dex, T; Garreffa, S; Proskin, H, 2001
)
0.77
" Among them, only 1patient in the naproxen CR group terminated the study prematurely due to an adverse event of dyspepsia."( Comparison of the efficacy and safety of naproxen CR and nabumetone in the treatment of patients with osteoarthritis of the knee.
Cha, HS; Jeon, CH; Kim, JS; Koh, EM; Koh, JH; Lee, CK, 2001
)
0.86
" The incidence of adverse events was monitored throughout the study."( Efficacy and safety of the COX-2 specific inhibitor valdecoxib in the management of osteoarthritis of the hip: a randomized, double-blind, placebo-controlled comparison with naproxen.
Bevirt, T; Makarowski, W; Recker, DP; Zhao, WW, 2002
)
0.51
" Valdecoxib 5 mg and 10 mg demonstrated similar tolerability compared to placebo and a lower incidence of GI-related adverse effects compared with naproxen."( Efficacy and safety of the COX-2 specific inhibitor valdecoxib in the management of osteoarthritis of the hip: a randomized, double-blind, placebo-controlled comparison with naproxen.
Bevirt, T; Makarowski, W; Recker, DP; Zhao, WW, 2002
)
0.71
" 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
)
0.55
" 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
)
0.58
" The drug has been shown to possess analgesic, anti-inflammatory, antipyretic antibronchocostrictory and antiplatelet properties at doses which are safe for the gastrointestinal tract."( The metabolic effects of inhibitors of 5-lipoxygenase and of cyclooxygenase 1 and 2 are an advancement in the efficacy and safety of anti-inflammatory therapy.
Celotti, F; Durand, T, 2003
)
0.32
" This work presents the use of a sample translation technique (STT) as a means to minimize these adverse effects."( Use of a sample translation technique to minimize adverse effects of laser irradiation in surface-enhanced Raman spectrometry.
De Jesús, MA; Giesfeldt, KS; Sepaniak, MJ, 2003
)
0.32
" There were no significant differences in adverse event reporting between groups."( Comparison of the analgesic efficacy and safety of nonprescription doses of naproxen sodium and Ibuprofen in the treatment of osteoarthritis of the knee.
Minic, M; Schiff, M, 2004
)
0.55
" Prespecified gastrointestinal adverse events were more frequent with naproxen than with either lumiracoxib dose or placebo."( Efficacy, safety and tolerability of lumiracoxib in patients with rheumatoid arthritis.
Alten, R; Geusens, P; Kralidis, G; Krammer, G; Richardson, P; Rovensky, J; Sloan, VS, 2004
)
0.56
" Safety parameters were assessed by evaluating the frequency of adverse events in the 3 groups."( A randomized, double-blind clinical trial of two doses of meloxicam compared with naproxen in children with juvenile idiopathic arthritis: short- and long-term efficacy and safety results.
Alessio, M; Artamonova, V; Baildam, E; Bandeira, M; Buoncompagni, A; Emminger, W; Falcini, F; Foeldvari, I; Gerloni, V; Hanft, G; Joos, R; Kone-Paut, I; Lenhardt, A; Martini, A; Mouy, R; Nikishina, I; Pachanov, ED; Prieur, AM; Ruperto, N; Schwarz, R; Shachbazian, Y; Sigmund, R; Simianer, S; Zulian, F, 2005
)
0.55
" There were no differences in the frequency of adverse events or abnormal laboratory values between the 3 groups."( A randomized, double-blind clinical trial of two doses of meloxicam compared with naproxen in children with juvenile idiopathic arthritis: short- and long-term efficacy and safety results.
Alessio, M; Artamonova, V; Baildam, E; Bandeira, M; Buoncompagni, A; Emminger, W; Falcini, F; Foeldvari, I; Gerloni, V; Hanft, G; Joos, R; Kone-Paut, I; Lenhardt, A; Martini, A; Mouy, R; Nikishina, I; Pachanov, ED; Prieur, AM; Ruperto, N; Schwarz, R; Shachbazian, Y; Sigmund, R; Simianer, S; Zulian, F, 2005
)
0.55
" This article reviews the current state of selective COX-2 inhibitors, discusses the mechanistic evidence underlying the cardiovascular risk associated with selective COX-2 inhibition, outlines the pharmacodynamics of aspirin effects on platelets and the interference of propionic acid derivatives (ibuprofen and naproxen) with these effects, and poses that aspirin confounding may have led to the erroneous conclusion of naproxen-associated adverse cardiovascular outcomes in the ADAPT trial."( The cardiovascular toxicity of selective and nonselective cyclooxygenase inhibitors: comparisons, contrasts, and aspirin confounding.
Konstantinopoulos, PA; Lehmann, DF, 2005
)
0.5
"The occurrence of pharmaceuticals in the environment is of great concern and only few data are available about the adverse effects of such molecules and their derivatives on non-target aquatic organisms."( Ecotoxicity of naproxen and its phototransformation products.
Isidori, M; Lavorgna, M; Nardelli, A; Parrella, A; Previtera, L; Rubino, M, 2005
)
0.68
"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
"The use and adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs) in outpatients with rheumatic diseases has not yet been studied enough."( [Analysis of the use and adverse effects of non-steroidal anti-inflammatory drugs: a pilot study].
Perić, A; Toskić-Radojicić, M, 2006
)
0.33
" According to the answers given by the patients, the most often adverse reactions were gastric complaints such as nausea (11."( [Analysis of the use and adverse effects of non-steroidal anti-inflammatory drugs: a pilot study].
Perić, A; Toskić-Radojicić, M, 2006
)
0.33
" Gastric complains such as nausea and gastric pain of mild intensity were the most often adverse effects of NSAIDs reported by our patients."( [Analysis of the use and adverse effects of non-steroidal anti-inflammatory drugs: a pilot study].
Perić, A; Toskić-Radojicić, M, 2006
)
0.33
" Measurements also included physical examination and adverse events."( The efficacy and safety of aceclofenac versus placebo and naproxen in women with primary dysmenorrhoea.
Fortea, J; Lamarca, R; Letzel, H; Mégard, Y; Raber, A, 2006
)
0.58
" 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
)
0.33
" 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
)
0.33
" Safety was assessed by observation of adverse experiences and laboratory and physical evaluations."( Evaluation of the efficacy and safety of etoricoxib compared with naproxen in two, 138-week randomised studies of patients with osteoarthritis.
Bergman, G; Curtis, SP; Ko, AT; Malmstrom, K; Mehta, A; Reginster, JY; Reicin, AS, 2007
)
0.58
" Safety evaluations included adverse events and laboratory tests."( Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine.
Alexander, WJ; Cady, RK; Frishberg, BM; Kori, SH; Lener, SE; Ruoff, GE; Winner, P; Zhang, Y, 2007
)
0.59
" The most common treatment-related adverse events were nausea, muscle tightness, and dizziness."( Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine.
Alexander, WJ; Cady, RK; Frishberg, BM; Kori, SH; Lener, SE; Ruoff, GE; Winner, P; Zhang, Y, 2007
)
0.59
" The adverse events did not differ from those expected for the individual components alone, and no new or unexpected findings occurred."( Twelve-month tolerability and safety of sumatriptan-naproxen sodium for the treatment of acute migraine.
Alexander, WJ; Cady, RK; Frishberg, BM; Kori, SH; Lener, SE; Ruoff, GE; Winner, P; Zhang, Y, 2007
)
0.59
" By contrast, adverse effects on rates of LDL and membrane lipid oxidation were not observed with other chemically distinct (sulfonamide) COX-2 inhibitors under identical conditions."( A biological rationale for the cardiotoxic effects of rofecoxib: comparative analysis with other COX-2 selective agents and NSAids.
Day, CA; Jacob, RF; Mason, RP; Walter, MF, 2007
)
0.34
" Such critical adverse reactions are mostly dependent on COX-1 inhibition."( Anti-inflammatory and side effects of cyclooxygenase inhibitors.
Demircan, B; Karagöz, Y; Süleyman, H,
)
0.13
" Finally, strong data exist to suggest that NG440 is a safe formula for human consumption."( Clinical safety and efficacy of NG440: a novel combination of rho iso-alpha acids from hops, rosemary, and oleanolic acid for inflammatory conditions.
Bland, JS; Carroll, B; Darland, G; Hall, A; Katke, J; Lamb, J; Lerman, RH; Minich, DM; Tripp, M, 2007
)
0.34
" As naproxen has been demonstrated to be associated with the lowest cardiovascular adverse events in comparison with both COX-2 selective inhibitors and conventional NSAIDs, we have been developing a Naproxen-PC formulation for evaluation in animal models and clinical trials."( Naproxen-PC: a GI safe and highly effective anti-inflammatory.
Dial, EJ; Lichtenberger, LM; Moore, JE; Romero, JJ, 2009
)
2.35
" Safety endpoints included vital signs and adverse events."( Efficacy, safety, and tolerability of the cyclooxygenase-inhibiting nitric oxide donator naproxcinod in treating osteoarthritis of the hip or knee.
Aguirre, D; Karlsson, J; Pivodic, A; Schnitzer, TJ, 2009
)
0.35
" In addition, the incidence of adverse events with 2 sumatriptan/naproxen sodium tablets administered 2 hours apart was lower than that with the single dose."( Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine.
Haberer, LJ; Lener, SE; McDonald, SA; Taylor, DR; Walls, CM, 2010
)
0.82
" Both doses of naproxcinod were well-tolerated, with most adverse events being mild or moderate."( Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study.
Duquesroix, B; Frayssinet, H; Kivitz, A; Schnitzer, TJ, 2010
)
0.36
" Treatment effects and adverse effects were expressed as risk ratio."( Meta-analysis of the efficacy and safety of naproxen sodium in the acute treatment of migraine.
Lertpipopmetha, V; Poolsup, N; Suksomboon, N; Suthisisang, CC; Tepwitukgid, B, 2010
)
0.62
"The available evidence suggests that naproxen sodium is more effective but may cause more adverse events than placebo in the acute treatment of moderate to severe migraine."( Meta-analysis of the efficacy and safety of naproxen sodium in the acute treatment of migraine.
Lertpipopmetha, V; Poolsup, N; Suksomboon, N; Suthisisang, CC; Tepwitukgid, B, 2010
)
0.89
" 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
" Safety assessments included adverse events and in-office blood pressure measurements."( Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: a randomized, double-blind, parallel-group, multicenter study.
Baerwald, C; Duquesroix, B; Ferreira, T; Frayssinet, H; Verdecchia, P, 2010
)
0.57
" Naproxcinod and naproxen had similar adverse event and general safety profiles."( Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: a randomized, double-blind, parallel-group, multicenter study.
Baerwald, C; Duquesroix, B; Ferreira, T; Frayssinet, H; Verdecchia, P, 2010
)
0.91
" The flavocoxid group had significantly fewer upper gastrointestinal (UGI) and renal (edema) adverse events (AEs) as well as a strong trend toward fewer respiratory AEs."( Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee.
Bart, B; Bell, M; Burnett, BP; Caldron, P; Ermolova, T; Kantemirova, R; Khokhlov, A; Kopenkin, S; Levy, RM; Mazurov, V; Pillai, L, 2010
)
0.59
"Derris scandens Benth extracts were efficacious and safe for the treatment of knee OA."( Efficacy and safety of Derris scandens Benth extracts in patients with knee osteoarthritis.
Bunjob, M; Chinswangwatanakul, P; Kuptniratsaikul, V; Pinthong, T; Thamlikitkul, V; Thanakhumtorn, S, 2011
)
0.37
" The antiproliferative, anti-inflammatory and toxic effects of Nap-DTH were assessed, at the cellular level, using various in vitro methods."( Therapeutic and cytotoxic effects of the novel antipsoriasis codrug, naproxyl-dithranol, on HaCaT cells.
Heard, CM; Lau, WM; Ng, KW; White, AW, 2011
)
0.37
" However, this group of drugs is associated with serious adverse drug reactions."( Differential involvement of mitochondrial dysfunction, cytochrome P450 activity, and active transport in the toxicity of structurally related NSAIDs.
Unlü, B; van Leeuwen, JS; Vermeulen, NP; Vos, JC, 2012
)
0.38
"To study the adverse effects of Celecoxib and compare them with those of other non-steroidal anti-inflammatory drugs (NSAIDs) in an Asian Indian cohort."( How safe is Celecoxib for Asian-Indian patients with rheumatic diseases?
Chandra, C; Chandy, SJ; Danda, D; Iliyas, MM; Mathew, AJ, 2013
)
0.39
" All the recorded adverse events were noted and compared between the Celecoxib and non-selective NSAID users."( How safe is Celecoxib for Asian-Indian patients with rheumatic diseases?
Chandra, C; Chandy, SJ; Danda, D; Iliyas, MM; Mathew, AJ, 2013
)
0.39
" Multiple NSAID users had higher adverse events (6."( How safe is Celecoxib for Asian-Indian patients with rheumatic diseases?
Chandra, C; Chandy, SJ; Danda, D; Iliyas, MM; Mathew, AJ, 2013
)
0.39
" This research has shown that ethanolic extracts of these three macrofungi could be good sources of safe and effective antioxidant and antinflammatory agents for biopharmaceutical exploitation."( Assessment of anti-inflammatory, lipid peroxidation and acute toxicity of extracts obtained from wild higher basidiomycetes mushrooms collected from Akure (southwest Nigeria).
Jimenez, M; Nieto-Camacho, A; Oyetayo, VO; Rodriguez, BE, 2012
)
0.38
" Adverse event incidence was comparable across tanezumab doses but higher than with placebo or naproxen."( Efficacy and safety of tanezumab versus naproxen in the treatment of chronic low back pain.
Bramson, C; Brown, MT; Gimbel, JS; Keller, DS; Kivitz, AJ; Nemeth, MA; Verburg, KM; West, CR, 2013
)
0.88
" The toxicity evaluation illustrated the formation of some intermediate products that were more toxic than NPX during the photodegradation of NPX."( [Photodegradation of naproxen in aqueous systems by UV irradiation: mechanism and toxicity of photolysis products].
Liu, GG; Lü, WY; Ma, DJ; Xie, CP; Yao, K; Zhou, LH, 2013
)
0.71
" In the pooled analysis from all five studies, incidences of treatment-emergent adverse events (AEs) (including prespecified NSAID-associated upper GI AEs and cardiovascular AEs), serious AEs, and AE-related discontinuations were stratified by LDA subgroups."( Impact of concomitant low-dose aspirin on the safety and tolerability of naproxen and esomeprazole magnesium delayed-release tablets in patients requiring chronic nonsteroidal anti-inflammatory drug therapy: an analysis from 5 Phase III studies.
Angiolillo, DJ; Datto, C; Raines, S; Yeomans, ND, 2014
)
0.63
" Of particular concern is the occurrence of pharmaceutical mixtures, which may lead to increased adverse effects compared to individual compounds."( Individual and mixture toxicity of pharmaceuticals naproxen, carbamazepine, and sulfamethoxazole to Australian striped marsh frog tadpoles (Limnodynastes peronii).
Cameron, MC; Lanctôt, CM; Melvin, SD, 2014
)
0.65
" Safety assessments included adverse events, physical and neurological examinations, laboratory tests and vital signs."( Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain.
Brown, MT; Ekman, EF; Greenberg, HS; Schnitzer, TJ; Smith, MD; Spierings, EL; Verburg, KM; West, CR, 2015
)
0.42
" Adverse event frequency was higher with tanezumab than with NSAIDs and highest with combination therapy."( Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain.
Brown, MT; Ekman, EF; Greenberg, HS; Schnitzer, TJ; Smith, MD; Spierings, EL; Verburg, KM; West, CR, 2015
)
0.42
" The toxicity evaluation illustrated that some of the intermediate products formed were more toxic than naproxen."( Photodegradation of naproxen in water under simulated solar radiation: mechanism, kinetics, and toxicity variation.
Liu, G; Lv, W; Ma, D; Xiao, H; Yao, K; Zhang, X, 2014
)
0.94
"The assessment of safety in traditional toxicology protocols relies on evidence arising from observed adverse events (AEs) in animals and on establishing their correlation with different measures of drug exposure (e."( Model-based analysis of thromboxane B₂ and prostaglandin E₂ as biomarkers in the safety evaluation of naproxen.
Danhof, M; Della Pasqua, O; Sahota, T; Sanderson, I, 2014
)
0.62
"Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure."( Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data.
Kruhlak, NL; Zhu, X, 2014
)
0.4
" Firstly, PCIS were incubated with 0-200 μM diclofenac (DCF), one of the most intensively studied NSAIDs, to investigate whether they could correctly reflect the toxic mechanisms."( Precision cut intestinal slices are an appropriate ex vivo model to study NSAID-induced intestinal toxicity in rats.
de Graaf, IA; Groothuis, GM; Niu, X; van der Bij, HA, 2014
)
0.4
" However, severe and numerous adverse events are associated with vismodegib use."( Cholestatic hepatic injury associated with vismodegib, aspirin, and naproxen use: a case study and review of vismodegib safety.
Ash, MM; Jolly, PS, 2015
)
0.65
"Herein, we describe a potential serious adverse effect associated with vismodegib use."( Cholestatic hepatic injury associated with vismodegib, aspirin, and naproxen use: a case study and review of vismodegib safety.
Ash, MM; Jolly, PS, 2015
)
0.65
" Tanezumab was associated with greater incidence of peripheral sensory adverse events (paresthesia, hyperesthesia, hypoesthesia, burning sensation), pain in extremity, peripheral edema, and arthralgia."( Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen.
Annis, KM; Bello, AE; Brown, MT; Ekman, EF; Gimbel, JS; Keller, DS; Smith, MD; Verburg, KM; West, CR, 2014
)
0.61
" However, they have significant adverse cardiovascular effects."( Prevention of chemically induced urinary bladder cancers by naproxen: protocols to reduce gastric toxicity in humans do not alter preventive efficacy.
Bode, A; Boring, DL; Grubbs, CJ; Juliana, MM; Lubet, RA; Minasian, L; Scheiman, JM; Steele, VE; White, J, 2015
)
0.66
"Despite the increasing importance of biomarkers as predictors of drug effects, toxicology protocols continue to rely on the experimental evidence of adverse events (AEs) as a basis for establishing the link between indicators of safety and drug exposure."( Model-based prediction of the acute and long-term safety profile of naproxen in rats.
Danhof, M; Della Pasqua, O; Sahota, T; Sanderson, I, 2015
)
0.65
" Secondary endpoints, including Patient's and Physician's Global Assessments of Arthritis, Western Ontario and McMaster Universities OA Index (WOMAC), use of complementary and alternative medicines, incidence of treatment-emergent adverse events (TEAEs) and measurements of upper gastrointestinal tolerability, were also assessed."( Efficacy and safety of nonsteroidal anti-inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo-controlled study.
Bao, W; Behar, R; Essex, MN; O'Connell, MA, 2016
)
0.43
" Celecoxib was shown to be safe and well tolerated in this patient population."( Efficacy and safety of nonsteroidal anti-inflammatory drugs in Asian patients with knee osteoarthritis: summary of a randomized, placebo-controlled study.
Bao, W; Behar, R; Essex, MN; O'Connell, MA, 2016
)
0.43
" The two NSAIDs proved to be safe and efficacious in the experimental model used."( Selective inhibition by aspirin and naproxen of mainstream cigarette smoke-induced genotoxicity and lung tumors in female mice.
Balansky, R; D'Oria, C; De Flora, S; Ganchev, G; Iltcheva, M; La Maestra, S; Micale, RT; Steele, VE, 2016
)
0.71
"Many adverse drug reactions are caused by the cytochrome P450 (CYP)-dependent activation of drugs into reactive metabolites."( Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
Jones, LH; Nadanaciva, S; Rana, P; Will, Y, 2016
)
0.43
" The benefit-risk profile of mefenamic acid should now be re-evaluated in light of effective and less toxic alternatives."( Central nervous system toxicity of mefenamic acid overdose compared with other NSAIDs: an analysis of cases reported to the United Kingdom National Poisons Information Service.
Cooper, G; Crichton, S; Eddleston, M; Kamour, A; Lupton, DJ; Thomas, SH; Thompson, JP; Vale, JA, 2017
)
0.46
" Excluding patients who reached study endpoints, 21 (8%) patients in the celecoxib group and 17 (7%) patients in the naproxen group had adverse events leading to discontinuation of treatment."( Gastrointestinal safety of celecoxib versus naproxen in patients with cardiothrombotic diseases and arthritis after upper gastrointestinal bleeding (CONCERN): an industry-independent, double-blind, double-dummy, randomised trial.
Au, KWL; Chan, FKL; Chan, H; Cheong, PK; Ching, JYL; Kee, KM; Kyaw, MH; Lam, K; Lee, V; Lo, A; Ng, SC; Suen, BY; Tse, YK; Wong, GLH; Wong, VWS; Wu, JCY, 2017
)
0.93
" The treatment results and adverse events in each group were compared."( The efficacy and safety of naproxen in acute rheumatic fever: The comparative results of 11-year experience with acetylsalicylic acid and naproxen.
Arı, ME; Azak, E; Çetin, İİ; Çevik, BŞ; Ekici, F; Eminoğlu, S; Kibar, AE; Kocabaş, A; Orgun, A; Sürücü, M, 2016
)
0.73
" The outcome was major nonsteroidal anti-inflammatory drug toxicity, including time to first occurrence of major adverse cardiovascular events, important gastrointestinal events, renal events, and all-cause mortality."( The Risk of Major NSAID Toxicity with Celecoxib, Ibuprofen, or Naproxen: A Secondary Analysis of the PRECISION Trial.
Borer, JS; Brennan, DM; Husni, ME; Libby, PA; Lincoff, AM; Lϋscher, TF; Menon, V; Nissen, SE; Solomon, DH; Wisniewski, LM; Yeomans, ND, 2017
)
0.69
"Non-steroidal anti-inflammatory drugs (NSAIDs), both non-selective and selective cyclooxygenase-2 (COX-2) inhibitors, are among the most widely prescribed drugs worldwide, but associate with increased blood pressure (BP) and adverse cardiovascular (CV) events."( Differential blood pressure effects of ibuprofen, naproxen, and celecoxib in patients with arthritis: the PRECISION-ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety Versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement)
Beckerman, B; Borer, JS; Davey, DA; Fayyad, R; Flammer, AJ; Graham, DY; Husni, ME; Iorga, D; Krum, H; Libby, P; Lincoff, AM; Lüscher, TF; Menon, V; Nissen, SE; Ruschitzka, F; Solomon, DH; Wisniewski, LM; Yeomans, ND, 2017
)
0.71
" The incidence of gastrointestinal and other adverse events were higher on naproxen than on β-d-mannuronic acid and placebo."( Evaluation of the efficacy and safety of β-d-mannuronic acid in patients with ankylosing spondylitis: A 12-week randomized, placebo-controlled, phase I/II clinical trial.
Aghazadeh, Z; Ahmadi, H; Cuzzocrea, S; Fattahi, MJ; Hashemi, SN; Hosseini, M; Jafarnezhad-Ansariha, F; Jamshidi, AR; Mahmoudi, M; Matsuo, H; Mirshafiey, A; Rehm, BHA; Vojdanian, M; Yekaninejad, MS, 2018
)
0.71
"To determine the relative risks of cardiovascular (CV), gastrointestinal (GI), and renal adverse events during long-term treatment with celecoxib, compared with ibuprofen and naproxen, in patients with osteoarthritis (OA) and patients with rheumatoid arthritis (RA)."( Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical Trial.
Bao, W; Berger, MF; Borer, JS; Graham, DY; Husni, ME; Libby, P; Lincoff, AM; Lüscher, TF; Menon, V; Nissen, SE; Solomon, DH; Wang, Q; Wisniewski, LM; Wolski, KE; Yeomans, ND, 2018
)
0.67
" The main outcomes were the first occurrence of a major adverse CV event, GI event, or renal event, and mortality."( Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical Trial.
Bao, W; Berger, MF; Borer, JS; Graham, DY; Husni, ME; Libby, P; Lincoff, AM; Lüscher, TF; Menon, V; Nissen, SE; Solomon, DH; Wang, Q; Wisniewski, LM; Wolski, KE; Yeomans, ND, 2018
)
0.48
"Treatment with celecoxib at approved dosages conferred a similar or lower risk of CV, GI, and renal adverse events compared with treatment with ibuprofen or naproxen in patients with OA and patients with RA."( Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical Trial.
Bao, W; Berger, MF; Borer, JS; Graham, DY; Husni, ME; Libby, P; Lincoff, AM; Lüscher, TF; Menon, V; Nissen, SE; Solomon, DH; Wang, Q; Wisniewski, LM; Wolski, KE; Yeomans, ND, 2018
)
0.68
"To ascertain if etoricoxib increases the risk of gastrointestinal adverse events (GAEs) compared with placebo, diclofenac, and naproxen in the treatment of patients with osteoarthritis (OA) or rheumatoid arthritis (RA)."( Gastrointestinal safety of etoricoxib in osteoarthritis and rheumatoid arthritis: A meta-analysis.
Feng, X; Mei, H; Tian, M; Zhang, W, 2018
)
0.69
" There were no significant differences in adverse events between groups, regardless of age."( Analgesic efficacy and safety of non-prescription doses of naproxen sodium in the management of moderate osteoarthritis of the knee or hip.
An, R; Couto, A; Moon, J; Paredes-Diaz, A; Troullos, E, 2018
)
0.72
" 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
" Rates of treatment-emergent adverse events were low and evenly distributed between treatment arms."( Efficacy and Safety of Febuxostat Extended and Immediate Release in Patients With Gout and Renal Impairment: A Phase III Placebo-Controlled Study.
Becker, MA; Castillo, M; Gunawardhana, L; Hunt, B; Kisfalvi, K; Saag, KG; Whelton, A, 2019
)
0.51
" The most common adverse events in the pooled group were abdominal discomfort, abdominal distention, dyspepsia, and nausea, but none of these was deemed to be clinically meaningful."( Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms.
Amazonas, RB; Bocchi de Oliveira, MF; Ecclissato, C; Macêdo, EA; Pott Júnior, H; Scheinberg, M, 2018
)
0.7
" The results of these studies indicated that phospholipids with NSAIDs at both sn-1 and sn-2 positions (15 and 16) were more toxic than ibuprofen or naproxen themselves, whereas 2-lysophosphatidylcholines (7 and 8) were less toxic against all tested cell lines."( Syntheses and cytotoxicity of phosphatidylcholines containing ibuprofen or naproxen moieties.
Grudniewska, A; Kiełbowicz, G; Kocbach, B; Kłobucki, M; Maciejewska, G; Ugorski, M; Urbaniak, A; Wawrzeńczyk, C, 2019
)
0.94
" The risk score was designed to predict the 1-year occurrence of major toxicity among NSAID users, including major adverse cardiovascular events, acute kidney injury, significant gastrointestinal events, and mortality."( Derivation and Validation of a Major Toxicity Risk Score Among Nonsteroidal Antiinflammatory Drug Users Based on Data From a Randomized Controlled Trial.
Husni, ME; Nissen, S; Paynter, N; Shao, M; Solomon, DH; Wolski, K, 2019
)
0.51
" Patients in the naproxen group had more incidence of gastrointestinal and others adverse events in comparison with Guluronic acid and placebo groups."( The safety and efficacy of Guluronic acid (G2013) in ankylosing spondylitis: A randomized controlled parallel clinical trial.
Afraei, S; Hosseini, M; Jamshidi, AR; Khadem Azarian, S; Mahmoudi, M; Mirshafiey, A; Mostafaei, S; Nazeri, S; Vojdanian, M, 2019
)
0.85
"7%) drug-related adverse reactions were observed during the whole study, 80% of those were mild."( [The efficacy and safety of naproxen in the treatment of nonspecific lumbalgia: the results of an open multi-center study (NEST)].
Doronina, OB; Gankina, OA; Levin, OS; Shirokov, VA; Skoromets, AA; Tabeeva, GR; Trinitatsky, YV; Vasenina, EE, 2019
)
0.81
", ultraviolet radiation) in surface waters are of particular concern; these products can be more hydrophobic, persistent, and toxic than their parent compounds."( Naproxen and Its Phototransformation Products: Persistence and Ecotoxicity to Toad Tadpoles (Anaxyrus terrestris), Individually and in Mixtures.
Cory, WC; Ramirez, JN; Rein, LC; Welch, AM, 2019
)
1.96
" •Prolonged exposure of nontargeted organisms to naproxen can cause adverse effects."( Naproxen in the environment: its occurrence, toxicity to nontarget organisms and biodegradation.
Guzik, U; Wojcieszyńska, D, 2020
)
2.26
" 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
)
0.87
" In this article, we review the data supporting the use of OTC naproxen to effectively treat a variety of types of acute pain, including dysmenorrhea, headache, and dental pain, as well as review adverse effects."( Efficacy and Safety of Naproxen for Acute Pain.
Brunton, S; Weisman, SM, 2020
)
1.11
" Adverse drug reactions may be renal, gastrointestinal, hematological, or immunologic."( Efficacy and Safety of NSAIDs in Infants: A Comprehensive Review of the Literature of the Past 20 Years.
Gorenflo, M; Saur, P; van den Anker, JN; van Dyk, M; Welzel, T; Ziesenitz, VC, 2022
)
0.72

Pharmacokinetics

Thiamine diphosphate administered intraperitoneally in a dose of 10 mg/kg (one time a day for a week) does not change the analgesic effect of naproxene.

ExcerptReferenceRelevance
" In healthy volunteers the following values were obtained for various pharmacokinetic parameters: tmax = 2 hr; Cmax = 52."( Pharmacokinetics of naproxen in healthy volunteers and in patients with diabetic microangiopathy.
Calvo, MV; de Pablo, F; Dominguez-Gil, A; Miralles, JM, 1979
)
0.58
" Pharmacokinetic parameters (area under the serum concentration-time curve [AUC], maximum plasma concentration, terminal half-life, renal clearance, and urinary recovery) were assessed for zidovudine and its glucuronide metabolite."( Evaluation of the in vivo effect of naproxen on zidovudine pharmacokinetics in patients infected with human immunodeficiency virus.
Cameron, DW; Gallicano, K; Garber, G; Hawley-Foss, N; Huang, L; McGilveray, I; Pakuts, A; Sahai, J, 1992
)
0.56
"15, ANOVA) on the above pharmacokinetic parameters for both zidovudine and its metabolite."( Evaluation of the in vivo effect of naproxen on zidovudine pharmacokinetics in patients infected with human immunodeficiency virus.
Cameron, DW; Gallicano, K; Garber, G; Hawley-Foss, N; Huang, L; McGilveray, I; Pakuts, A; Sahai, J, 1992
)
0.56
"Therapeutic doses of naproxen do not significantly affect the pharmacokinetic disposition of zidovudine."( Evaluation of the in vivo effect of naproxen on zidovudine pharmacokinetics in patients infected with human immunodeficiency virus.
Cameron, DW; Gallicano, K; Garber, G; Hawley-Foss, N; Huang, L; McGilveray, I; Pakuts, A; Sahai, J, 1992
)
0.88
" The two dosage forms were bioequivalent in terms of total AUC; however, the Cmax of the controlled-release product was lower, and the Tmax longer than that of the conventional product."( Pharmacokinetic evaluation of conventional and controlled-release product of naproxen.
Babbini, M; Galli, G; Palazzini, E, 1990
)
0.51
" In a single dose pharmacokinetic study, the rate of absorption of the sustained-release preparation was less than that of a conventional-release preparation but the extent of absorption was the same."( Pharmacokinetic properties and clinical efficacy of once-daily sustained-release naproxen.
Colgan, BV; Devane, JG; Kelly, JG; Kinney, CD; Mulligan, S, 1989
)
0.5
" Short- and long-term pharmacokinetic parameters were determined."( Effects of food and sucralfate on the pharmacokinetics of naproxen and ketoprofen in humans.
Besner, JG; Caillé, G; du Souich, P; Gervais, P; Vézina, M, 1989
)
0.52
" The main mechanism of naproxen sodium action, inhibition of prostaglandin synthesis, makes the drug effective in combating pain and inflammation, while its relatively long half-life permits a two times daily dosing."( Pharmacokinetics of naproxen sodium.
Moyer, S, 1986
)
0.91
" The half-life is longer in the synovial fluid than in the serum, 23 hours versus 17 hours."( [Serum, synovial and intra-articular pharmacokinetics of naproxen after one-gram oral administration in patients with rheumatoid polyarthritis].
Baudel, F; Bouvier, M; Delcambre, B; Fournié, B; Heraud, A; Hercelin, B; Jube, L; Masson, C; Menkes, C; Renier, JC, 1988
)
0.52
"After multiple oral doses of 500 mg naproxen twice daily, eight young healthy male volunteers and six male and female elderly patients participated in a pharmacokinetic study."( Pharmacokinetics of high-dosage naproxen in elderly patients.
Gribnau, FW; Jansen, PA; Tan, Y; Van de Putte, LB; Van den Ouweland, FA; Van Ginneken, CA, 1988
)
0.83
"The pharmacokinetic properties of naproxen (375 mg twice daily and 750 mg twice daily) were evaluated in 23 young (age range, 19 to 32 years) and 25 elderly (age range, 65 to 74 years) healthy male volunteers."( Steady state pharmacokinetics of naproxen in young and elderly healthy volunteers.
Basch, C; Cohen, A, 1988
)
0.84
" Although the time necessary to attain Cmax (tmax) for the three drugs tended to increase, only for indomethacin was this increase significant."( Single dose pharmacokinetics of ketoprofen, indomethacin, and naproxen taken alone or with sucralfate.
Besner, JG; Caillé, G; Du Souich, P; Gervais, P,
)
0.37
" Since gastrointestinal side effects can seriously compromise the efficacy of nonsteroidal anti-inflammatory drug therapy, and since it seems reasonable to assume that sucralfate may adsorb nonsteroidal anti-inflammatory drugs, the influence of sucralfate on the pharmacokinetic parameters of naproxen was assessed in 12 healthy volunteers."( Effects of concurrent sucralfate administration on pharmacokinetics of naproxen.
Besner, JG; Caille, G; du Souich, P; Gervais, P; Vezina, M, 1987
)
0.68
"The pharmacokinetic differences between two dosage regimens of naproxen (1000 mg once daily vs 500 mg twice daily) were studied at steady-state in seven healthy male volunteers."( Pharmacokinetics of naproxen at two dosage regimens in healthy volunteers.
Franssen, MJ; Gribnau, FW; Tan, Y; van de Putte, LB; van Ginneken, CA, 1986
)
0.83
" Its metabolic half-life averages 13 hours."( Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions.
Segre, EJ, 1980
)
1.7
"The described pharmacokinetic program for TI-59 is in clinical practice applicable in analyses of plasma concentration profiles established after single-dose, intravenous or oral administration of drugs showing one- or two-compartment first-order pharmacokinetics."( Pharmacokinetic analysis and calculations using a program for the minicalculator TI-59.
Nielsen-Kudsk, F, 1981
)
0.26
" The average value of Cmax is 18."( Pharmacokinetics of naproxen in patients with hypoproteinemia.
Calvo, MV; Dominguez-Gil, A; Muriel, C, 1981
)
0.59
" After IV injection of a 5 mg/kg dose, plasma concentrations decreased biexponentially, with an average elimination half-life of 74 hours."( Pharmacokinetics of naproxen in the dog.
Frey, HH; Rieh, B, 1981
)
0.59
" In healthy subjects the elimination half-life of naproxen was 17."( Pharmacokinetics of naproxen in subjects with normal and impaired renal function.
Anttila, M; Haataja, M; Kasanen, A, 1980
)
0.84
" The plasma half-life of naproxen averaged 16."( Steady-state pharmacokinetics of enteric-coated naproxen tablets compared with standard naproxen tablets.
Jung, D; Schwartz, KE,
)
0.69
"Five prodrugs of S(+)-2-(6-methoxy-2-naphthyl)propionic acid (naproxen), in which the drug was bound by ester linkages to diethyleneglycol (I), triethyleneglycol (II), octanediol (III), butyl-triethyleneglycol (IV), and butyl-tetraethyleneglycol (V), respectively, were prepared and tested for their pharmacokinetic properties after oral administration."( Pharmacokinetic results on naproxen prodrugs based on poly(ethyleneglycol)s.
Bernasconi, R; Ferruti, P; Latini, R; Peroni, I; Ranucci, E; Sartore, L, 1994
)
0.83
" Although the apparent maximum peak plasma concentration (Cmax) was greater in children who received tablets compared with those who received the suspension, Cmax/area under the curve (AUC), apparent time to maximum peak concentration (tmax), Ka, and estimated time to 10%, 50%, and 90% absorption (T10, T50, T90) were not different."( Comparison of the pharmacokinetics of naproxen tablets and suspension in children.
Blasier, D; Dietrich, A; Kearns, GL; Mortensen, ME; Walson, PD; Wells, TG, 1994
)
0.56
" Their pharmacokinetic performance was evaluated and compared with that of a standard naproxen tablet in 12 healthy human volunteers."( Comparative pharmacokinetic evaluation of compressed naproxen suppositories in humans.
Diwan, PV; Sastry, MS, 1993
)
0.76
" 10 days after galactosamine injection all pharmacokinetic parameters, as well as those of liver function, returned to basal levels."( Pharmacokinetics and pharmacodynamics of naproxen in acute experimental hepatitis.
Castañeda-Hernández, G; Favari, L; Hoyo-Vadillo, C, 1993
)
0.55
" None of the other pharmacokinetic parameters exhibited any significant diurnal variations."( Pharmacokinetics of single-dose administration of naproxen at 10:00 and 22:00 hours.
Rambhau, D; Rao, BR; Rao, VV, 1993
)
0.54
" The mean elimination half-life of naproxen was 24."( The pharmacokinetics of naproxen, its metabolite O-desmethylnaproxen, and their acyl glucuronides in humans. Effect of cimetidine.
Guelen, PJ; Van Den Biggelaar-Martea, M; Verwey-Van Wissen, CP; Vree, ML; Vree, TB, 1993
)
0.87
" Age had no significant effect on the pharmacodynamic parameter Emax, the maximum percent inhibition of TxB2 formation."( Effects of age on the pharmacodynamics of naproxen in the rat.
Boudinot, FD; Satterwhite, JH,
)
0.4
"The potential pharmacokinetic and pharmacodynamic interactions between zileuton, a 5-lipoxygenase inhibitor, and naproxen, a nonsteroidal anti-inflammatory drug that acts as a cyclo-oxygenase inhibitor, have been investigated in 24 healthy volunteers."( The pharmacokinetic and pharmacodynamic interactions between the 5-lipoxygenase inhibitor zileuton and the cyclo-oxygenase inhibitor naproxen in human volunteers.
Awni, WM; Braeckman, RA; Cavanaugh, JH; Dubé, LM; Granneman, GR; Linnen, PJ; Locke, CS, 1995
)
0.71
" bolus administration of flurbiprofen to the mouse (n = 4) and the rat (n = 6) with on-line HPLC analysis of microdialysates to unbound concentrations using the in vivo loss of flurbiprofen by retrodialysis carried out just before the start of the pharmacokinetic experiment."( Intravenous microdialysis in the mouse and the rat: development and pharmacokinetic application of a new probe.
Deridder, G; Evrard, PA; Verbeeck, RK, 1996
)
0.29
"The developed techniques can be used to carry out routine pharmacokinetic studies in the mouse and the rat illustrated by our experiments with flurbiprofen, a compound with very high plasma protein binding."( Intravenous microdialysis in the mouse and the rat: development and pharmacokinetic application of a new probe.
Deridder, G; Evrard, PA; Verbeeck, RK, 1996
)
0.29
" There was, however, no significant difference in the elimination half-life (rate constant), time to reach peak concentration (Cmax), mean residence time (MRT), or area under first moment curve (AUMC)."( Dose dependent pharmacokinetics of naproxen in man.
Ahmad, SI; Alam, SM; Niazi, SK, 1996
)
0.57
" Pharmacokinetic and pharmacodynamic analysis confirmed the findings of previous Phase I studies in healthy subjects."( A double-blind, randomized, parallel-group study of the pharmacokinetics and onset of action of Naprelan in patients following oral surgery.
Gaston, G, 1996
)
0.29
" Thiamine diphosphate administered intraperitoneally in a dose of 10 mg/kg (one time a day for a week) does not change pharmacokinetic and analgesic effect of naproxene."( [The modification of the pharmacokinetics and analgesic effect of naproxen by cimetidine, phenobarbital and thiamine diphosphate].
Pentiuk, AA; Stanislavchuk, NA; Vovk, OG,
)
0.57
" The study demonstrate that the microdialysis technique offers a means to investigate pharmacokinetic drug-drug interactions."( Alterations in methotrexate pharmacokinetics by naproxen in the rat as measured by microdialysis.
Andersen, A; Ekstrøm, PO; Giercksky, KE; Slørdal, L, 1997
)
0.55
" Pharmacokinetic data showed that the sustained-release formulation reached significantly delayed mean peak plasma levels (Cmax) in both single- and multiple-dose studies and lower Cmax in a single-dose study than the conventional formulation."( Single- and multiple-dose pharmacokinetic comparison of a sustained-release tablet and conventional tablets of naproxen in healthy volunteers.
Lu, W; Wei, S; Xia, Q; Zhang, Q; Zhou, D, 1998
)
0.51
" The pharmacokinetic parameters were calculated by using model-independent methods."( Lack of pharmacokinetic interaction between sumatriptan and naproxen.
Rambhau, D; Rao, BR; Rao, YM; Srinivasu, P, 2000
)
0.55
"The pharmacokinetic interactions between BAY 12-9566 and two nonsteroidal anti-inflammatory drugs (NSAIDs), naproxen and ibuprofen, were investigated in osteoarthritis (OA) patients."( Pharmacokinetics, safety, and tolerability of BAY 12-9566 and nonsteroidal anti-inflammatory agents (naproxen, ibuprofen) during coadministration in patients with osteoarthritis.
Agarwal, V; Liu, P; Shah, A; Sundaresan, P; Woodruff, M, 2001
)
0.74
"The potential for a pharmacokinetic interaction between naproxen and diphenhydramine was examined in a randomized three-way crossover design with a 1-week washout between dosing."( Absence of pharmacokinetic interaction between orally co-administered naproxen sodium and diphenhydramine hydrochloride.
Barker, SH; Gillen, MV; Helsinger, SA; Hunt, TL; Kindberg, CG; Powell, JH; Toothaker, RD, 2000
)
0.79
" The contribution of the pharmacokinetic properties of a coxib to achieving this goal has been overlooked to some degree for available coxibs."( Pharmacokinetic and pharmacodynamic aspects of the ideal COX-2 inhibitor: a rheumatologist's perspective.
Day, RO,
)
0.13
" Using the rationale of the BCS, it can be argued that biowaivers can, however, also be granted on the basis of standard pharmacokinetic data."( Biowaivers for oral immediate-release products: implications of linear pharmacokinetics.
Faassen, F; Vromans, H, 2004
)
0.32
" Pharmacokinetic parameters were determined following an intravenous administration of aciclovir (5 mg kg(-1)) to rats in the presence and absence of ketoprofen or naproxen (25 mg kg(-1))."( Effects of non-steroidal anti-inflammatory drugs on the pharmacokinetics and elimination of aciclovir in rats.
Gwak, HS; Han, HK; Oh, JH, 2005
)
0.52
"We investigated the occurrence of pharmacodynamic interaction between low-dose aspirin and naproxen."( Pharmacodynamic interaction of naproxen with low-dose aspirin in healthy subjects.
Capone, ML; Di Gregorio, P; Grana, M; Merciaro, G; Patrignani, P; Renda, G; Ricciotti, E; Sciulli, MG; Tacconelli, S, 2005
)
0.84
" The pharmacodynamic interaction between the two drugs was then investigated in four healthy volunteers who received aspirin (100 mg daily) for 6 days and then the combination of aspirin and naproxen for further 6 days: aspirin 2 h before naproxen (500 mg, twice-daily dosing)."( Pharmacodynamic interaction of naproxen with low-dose aspirin in healthy subjects.
Capone, ML; Di Gregorio, P; Grana, M; Merciaro, G; Patrignani, P; Renda, G; Ricciotti, E; Sciulli, MG; Tacconelli, S, 2005
)
0.8
" Moreover, the rapid recovery of platelet COX-1 activity and function supports the occurrence of a pharmacodynamic interaction between naproxen and aspirin."( Pharmacodynamic interaction of naproxen with low-dose aspirin in healthy subjects.
Capone, ML; Di Gregorio, P; Grana, M; Merciaro, G; Patrignani, P; Renda, G; Ricciotti, E; Sciulli, MG; Tacconelli, S, 2005
)
0.82
" This pharmacodynamic interaction might undermine the sustained inhibition of platelet COX-1 that is necessary for aspirin's cardioprotective effects."( Pharmacodynamic interaction of naproxen with low-dose aspirin in healthy subjects.
Capone, ML; Di Gregorio, P; Grana, M; Merciaro, G; Patrignani, P; Renda, G; Ricciotti, E; Sciulli, MG; Tacconelli, S, 2005
)
0.61
"Human pharmacokinetic parameters are often predicted prior to clinical study from in vivo preclinical pharmacokinetic data."( Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
Jolivette, LJ; Ward, KW, 2005
)
0.33
" In this open-label study, the effect of lansoprazole 30 mg qd and naproxen 500 mg bid on the pharmacokinetic profile of methotrexate was investigated."( Coadministration of lansoprazole and naproxen does not affect the pharmacokinetic profile of methotrexate in adult patients with rheumatoid arthritis.
Amer, F; Andhivarothai, N; Kukulka, MJ; Vakily, M, 2005
)
0.84
"The present study aims to investigate the pharmacokinetic interaction between non-steroidal anti-inflammatory drugs and tetracycline in rats."( Pharmacokinetic interaction of tetracycline with non-steroidal anti-inflammatory drugs via organic anion transporters in rats.
Han, HK; Oh, YH, 2006
)
0.33
"1%, a half-life (t1/2) of 3 to 10 h and does not accumulate after repeated once- and twice-daily dosing."( Clinical pharmacokinetics of the cyclooxygenase inhibiting nitric oxide donator (CINOD) AZD3582.
Björnsson, MA; Fagerholm, U, 2005
)
0.33
"To investigate the pharmacokinetic interactions between zalcitabine and nonsteroidal anti-inflammatory drugs (NSAIDs) in rats."( Altered pharmacokinetics of zalcitabine by concurrent use of NSAIDs in rats.
Han, HK; Oh, YH, 2006
)
0.33
"Zalcitabine was administered to rats via an iv injection (20 mg/kg) in the presence or absence of ketoprofen or naproxen (20 mg/kg), and the pharmacokinetic parameters were determined by using non-compartmental analysis."( Altered pharmacokinetics of zalcitabine by concurrent use of NSAIDs in rats.
Han, HK; Oh, YH, 2006
)
0.54
"Compared with the control (zalcitabine alone), pretreatment with ketoprofen or naproxen 30 min prior to intravenous administration of zalcitabine significantly altered the pharmacokinetic profiles of zalcitabine in rats."( Altered pharmacokinetics of zalcitabine by concurrent use of NSAIDs in rats.
Han, HK; Oh, YH, 2006
)
0.56
" In study 2, 90% confidence intervals for febuxostat C(max) and AUC extended above that range, with increases of 28% and 40% in Cmax and AUC24, respectively."( Pharmacokinetic interactions of concomitant administration of febuxostat and NSAIDs.
Joseph-Ridge, N; Khosravan, R; Vernillet, L; Wu, JT, 2006
)
0.33
" The plasma concentration of naproxen was determined by HPLC analysis with UV detection, and the pharmacokinetic parameters were calculated."( Effect of CYP2C9*3 allele on the pharmacokinetics of naproxen in Korean subjects.
Bae, JW; Byun, SA; Chang, YS; Choi, CI; Jang, CG; Kim, HJ; Kim, JH; Kim, MJ; Lee, SY; Park, YS, 2009
)
0.89
"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
)
0.84
"To describe the pharmacokinetic and safety profiles of sumatriptan 85 mg formulated with RT Technology (RT) and naproxen sodium 500 mg in a fixed-dose combination tablet (sumatriptan/naproxen sodium) that targets both serotonergic dysmodulation and inflammation in migraine."( Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine.
Haberer, LJ; Lener, SE; McDonald, SA; Taylor, DR; Walls, CM, 2010
)
0.8
" The pharmacokinetics of 2 sumatriptan/naproxen sodium tablets administered 2 hours apart were consistent with the pharmacokinetic predictions from a single dose of the combination tablet."( Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine.
Haberer, LJ; Lener, SE; McDonald, SA; Taylor, DR; Walls, CM, 2010
)
0.85
"The combination tablet of sumatriptan/naproxen sodium has unique pharmacokinetic properties."( Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine.
Haberer, LJ; Lener, SE; McDonald, SA; Taylor, DR; Walls, CM, 2010
)
0.86
" Blood samples for pharmacokinetic assessment were collected up to 14 hours after the administration of the first dose."( Pharmacokinetics and tolerability of sumatriptan after single-dose administration of a fixed-dose combination tablet of sumatriptan/naproxen sodium 85/500 mg followed two hours later by subcutaneous sumatriptan 4- or 6-mg injection: a randomized, open-lab
Berges, A; Lener, SE; McDonald, SA; Walls, C, 2010
)
0.56
" With S/N + S4, sumatriptan Cmax and AUC(0-14) did not exceed those with S100 + S100."( Pharmacokinetics and tolerability of sumatriptan after single-dose administration of a fixed-dose combination tablet of sumatriptan/naproxen sodium 85/500 mg followed two hours later by subcutaneous sumatriptan 4- or 6-mg injection: a randomized, open-lab
Berges, A; Lener, SE; McDonald, SA; Walls, C, 2010
)
0.56
" Concentration data for plasma and DBS samples were determined and pharmacokinetic (PK) profiles in plasma and in DBS samples were compared."( Determination of naproxen using DBS: evaluation & pharmacokinetic comparison of human plasma versus human blood DBS.
Bergeron, A; Furtado, M; Garofolo, F; Guibord, P; Latour, S; Lefebvre, M; Macarthur, RB; Mess, JN; Michon, J; Rufiange, M; Youhnovski, N, 2010
)
0.7
" Pharmacokinetic profiles were obtained in satellite animals."( Pharmacokinetic-pharmacodynamic modeling of the inhibitory effects of naproxen on the time-courses of inflammatory pain, fever, and the ex vivo synthesis of TXB2 and PGE2 in rats.
Angesjö, M; Berge, OG; Krekels, EH; Möller, KA; Sjögren, I; Visser, SA, 2011
)
0.6
" Suitability of the new assay was assessed in comparison with 36 reported bioanalytical assays and the pharmacokinetic results obtained by the new method were compared to 11 reported studies in humans."( An LC-MS/MS procedure for the quantification of naproxen in human plasma: development, validation, comparison with other methods, and application to a pharmacokinetic study.
Elsinghorst, PW; Holzgrabe, U; Kinzig, M; Rodamer, M; Sörgel, F, 2011
)
0.62
" In conclusion, there are no pharmacokinetic drug interactions between naproxen and esomeprazole."( Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium.
Fort, J; Sostek, M; Wang-Smith, L; Zhang, Y, 2012
)
0.83
" A population pharmacokinetic model was built using the NONMEM software."( Plasma and cerebrospinal fluid pharmacokinetics of naproxen in children.
Hooker, AC; Kokki, H; Kokki, M; Kumpulainen, E; Lehtonen, M; Manner, M; Ranta, VP; Välitalo, P, 2012
)
0.63
" The development of NSAIDs having safer therapeutic profile depends on the better understanding of their mechanisms, physicochemical and pharmacokinetic properties."( Self-organizing molecular field analysis of NSAIDs: assessment of pharmacokinetic and physicochemical properties using 3D-QSPkR approach.
Kumar, M; Sinha, VR; Thareja, S, 2012
)
0.38
" Three studies were conducted to evaluate the pharmacokinetic and pharmacodynamic interactions of edoxaban 60 mg coadministered with low-dose (100 mg) ASA, high-dose (325 mg) ASA, or naproxen (500 mg) in healthy subjects (n = 126)."( The effects of the antiplatelet agents, aspirin and naproxen, on pharmacokinetics and pharmacodynamics of the anticoagulant edoxaban, a direct factor Xa inhibitor.
Chen, S; Lee, F; Mendell, J; Samama, MM; Shi, M; Worland, V, 2013
)
0.83
" Also, this assay was applied to determine the pharmacokinetic parameters of naproxen in six healthy Turkish volunteers who had been given 220 mg of naproxen."( HPLC method for naproxen determination in human plasma and its application to a pharmacokinetic study in Turkey.
Asci, A; Erdem, AF; Yilmaz, B, 2014
)
0.98
"It is well-known that old animals show physiologic and/or pathologic variation that could modify the pharmacokinetics of drugs and the related pharmacodynamic response."( Naproxen in the horse: pharmacokinetics and side effects in the elderly.
Cagnardi, P; Conti, MB; Della Rocca, G; Di Salvo, A; Marchesi, MC, 2014
)
1.85
"To assess pharmacokinetic and pharmacodynamic interactions between naproxen (a non-steroidal anti-inflammatory drug) and apixaban (an oral, selective, direct factor-Xa inhibitor)."( Evaluation of the effect of naproxen on the pharmacokinetics and pharmacodynamics of apixaban.
Barrett, YC; Boyd, RA; Byon, W; Frost, C; Gandhi, MD; LaCreta, F; Pursley, J; Shenker, A; Wang, J; Zhang, D, 2014
)
0.93
" The pharmacokinetic parameters, including Cmax, AUC0-t, AUC0-∞, and Tmax, were measured, and all treatment-emergent adverse events and their associations with the study medications were recorded throughout the entire study."( Pharmacokinetic comparison study of a combination containing 500 mg of Naproxen and 20 mg of Esomeprazole: a randomized, single-dose, 2-way crossover, open-label study in healthy Korean men.
Choi, HG; Im, YJ; Jeon, JY; Jin, C; Kim, EY; Kim, H; Kim, MG; Kim, Y; Kwak, SS; Lee, SY; Wang, HM, 2015
)
0.65
" Both formulations had very similar Cmax, AUC, and t½ values, but the Tmax of naproxen appeared earlier in the test formulation than in the reference formulation and that of esomeprazole appeared later in the test formulation than in the reference formulation."( Pharmacokinetic comparison study of a combination containing 500 mg of Naproxen and 20 mg of Esomeprazole: a randomized, single-dose, 2-way crossover, open-label study in healthy Korean men.
Choi, HG; Im, YJ; Jeon, JY; Jin, C; Kim, EY; Kim, H; Kim, MG; Kim, Y; Kwak, SS; Lee, SY; Wang, HM, 2015
)
0.88
" After validation, the method was successfully applied to a pharmacokinetic study of naproxcinod and naproxen in rats."( Simultaneous quantification of naproxcinod and its active metabolite naproxen in rat plasma using LC-MS/MS: application to a pharmacokinetic study.
Cao, D; Du, Y; Hao, Y; Shang, W; Shi, Q; Shi, X; Sun, M; Wang, S; Wang, Y; Xue, N; Zhang, K, 2015
)
0.87
" The Cmax (mean ± standard deviation) and AUC0-t (mean ± standard deviation) for naproxen in HCP1004 were 61."( Comparison of the pharmacokinetics and tolerability of HCP1004 (a fixed-dose combination of naproxen and esomeprazole strontium) and VIMOVO® (a marketed fixed-dose combination of naproxen and esomeprazole magnesium) in healthy volunteers.
Choi, Y; Han, H; Lim, KS; Shin, D; Yu, KS, 2015
)
0.86
" The validated method was successfully applied to a pharmacokinetic study with simultaneous administration of naproxen sodium and sumatriptan succinate tablet formulations in healthy volunteers."( Development and validation of an LC-ESI-MS/MS method for the simultaneous quantification of naproxen and sumatriptan in human plasma: application to a pharmacokinetic study.
Bellorio, KB; Brêtas, CM; Brêtas, JM; César, IC; Mundim, IM; Pianetti, GA; Teixeira, Lde S, 2016
)
0.87
" Its pharmacokinetic profile after single and multiple dosing was compared to immediate release (IR) naproxen sodium in two randomized, open-label, crossover studies, under fasting and fed conditions."( Pharmacokinetic profile of extended-release versus immediate-release oral naproxen sodium after single and multiple dosing under fed and fasting conditions: two randomized, open-label trials.
Laurora, I; Wang, Y, 2016
)
0.88
" Primary variables: pharmacokinetic parameters after singleday administration (day 1) and at steady state after multiple-day administration (day 6)."( Pharmacokinetic profile of extended-release versus immediate-release oral naproxen sodium after single and multiple dosing under fed and fasting conditions: two randomized, open-label trials.
Laurora, I; Wang, Y, 2016
)
0.67
"The results obtained from this study suggested that NP, APE and pure AN existed pharmacokinetic herb-drug interactions in rat which is correlated with anti-arthritic study."( Herb-drug interaction of Andrographis paniculata (Nees) extract and andrographolide on pharmacokinetic and pharmacodynamic of naproxen in rats.
Balap, A; Lohidasan, S; Mahadik, K; Sinnathambi, A, 2017
)
0.66
" Open-label pharmacokinetic studies were performed in volunteers or subjects with hyperuricemia (serum uric acid ≥ 8 mg/dL) to investigate interactions of lesinurad (with and without concurrent XOIs) with colchicine and 2 nonsteroidal anti-inflammatory drugs: naproxen and indomethacin."( Evaluation of Pharmacokinetic Interactions Between Lesinurad, a New Selective Urate Reabsorption Inhibitor, and Commonly Used Drugs for Gout Treatment.
Bucci, G; Gillen, M; Kerr, B; Lee, C; Shen, Z; Tieu, K; Wilson, D, 2017
)
0.63
" An innovative minimal physiologically based pharmacokinetic (mPBPK) model incorporating nonlinear albumin binding of NPX in both plasma and interstitial fluid (ISF) was applied."( Modeling Sex Differences in Pharmacokinetics, Pharmacodynamics, and Disease Progression Effects of Naproxen in Rats with Collagen-Induced Arthritis.
Almon, RR; DuBois, DC; Jusko, WJ; Li, X, 2017
)
0.67
" The prostate tissue penetration and related pharmacokinetic parameters were evaluated by non-compartmental analysis."( Penetration and pharmacokinetics of non-steroidal anti-inflammatory drugs in rat prostate tissue.
Radhakrishnan, J; Radhakrishnan, R; Yellepeddi, VK, 2018
)
0.48
" A two-factor analysis of variance (ANOVA) with replication indicated an overall statistically significant difference in the pharmacokinetic parameters for celecoxib, diclofenac, ibuprofen, and naproxen."( Penetration and pharmacokinetics of non-steroidal anti-inflammatory drugs in rat prostate tissue.
Radhakrishnan, J; Radhakrishnan, R; Yellepeddi, VK, 2018
)
0.67
" The pharmacokinetic data indicated that celecoxib has the highest penetration and retention in rat prostate tissues."( Penetration and pharmacokinetics of non-steroidal anti-inflammatory drugs in rat prostate tissue.
Radhakrishnan, J; Radhakrishnan, R; Yellepeddi, VK, 2018
)
0.48
" The pharmacokinetic parameters of selected prodrugs and the liberated nap were studied after oral and intraperitoneal administration in male wistar rats."( Pharmacokinetic studies of naproxen amides of some amino acid esters with promising colorectal cancer chemopreventive activity.
Aboul-Fadl, T; Al-Hamad, SS; Fouad, EA, 2018
)
0.78
"Physiologically-based population pharmacokinetic modeling (popPBPK) coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can serve as a powerful tool to establish virtual bioequivalence and set clinically relevant specifications."( Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen.
Cristofoletti, R; Dressman, J; Fotaki, N; Loisios-Konstantinidis, I; Turner, DB, 2020
)
0.75
"We reviewed published and unpublished studies of naproxen (NAP) and NAPSO to establish the pharmacokinetic relationship between dosage, plasma concentration, and efficacy, and to compare the analgesic efficacy of NAPSO 220, 440, and 550 mg or NAP 500 mg versus placebo and active comparators."( Pharmacokinetic linearity of naproxen and efficacy of naproxen sodium at various doses
.
Cattry, E; Lila, AM; Paredes-Diaz, A; Parfenov, VA, 2020
)
1.1
"The pharmacokinetic linearity associated with NAP means that data on efficacy for the lower OTC doses of NAPSO can be extrapolated to the higher OTC doses."( Pharmacokinetic linearity of naproxen and efficacy of naproxen sodium at various doses
.
Cattry, E; Lila, AM; Paredes-Diaz, A; Parfenov, VA, 2020
)
0.85
" Values for total clearance of compounds from plasma should be one of the most important pharmacokinetic parameters for predictions."( Predicted values for human total clearance of a variety of typical compounds with differently humanized-liver mouse plasma data.
Ito, S; Iwamoto, K; Kamimura, H; Mizunaga, M; Nakayama, K; Negoro, T; Nishiwaki, M; Nomura, Y; Suemizu, H; Yamazaki, H; Yoneda, N, 2020
)
0.56
" To further understand the absorption, distribution, and metabolism of this drug alone and in combination with esomeprazole, we will analyze the pharmacokinetic parameters of naproxen and its major metabolite, 6-O-desmethylnaproxen, in saliva samples."( Simultaneous separation of naproxen and 6-O-desmethylnaproxen metabolite in saliva samples by liquid chromatography-tandem mass spectrometry: Pharmacokinetic study of naproxen alone and associated with esomeprazole.
Calvo, AM; Dionísio, TJ; Faria, FC; Morettin, M; Oliveira, GM; Santos, CF, 2020
)
1.05
" The aim of this study was to evaluate the pharmacokinetic interaction between tegoprazan and commonly used NSAIDS, namely, naproxen, aceclofenac, and celecoxib."( Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects.
Kang, M; Kim, B; Kim, MG; Moon, SJ; Shin, N, 2022
)
1.18
" Pharmacokinetic blood samples were collected up to 24 hours after the last dose."( Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects.
Kang, M; Kim, B; Kim, MG; Moon, SJ; Shin, N, 2022
)
0.97
"Seventeen subjects from cohort 1, sixteen subjects from cohort 2, and thirteen subjects from cohort 3 were included in the pharmacokinetic analysis."( Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects.
Kang, M; Kim, B; Kim, MG; Moon, SJ; Shin, N, 2022
)
0.97
"Changes in the maximum aceclofenac or celecoxib concentrations were detected after concurrent administration with tegoprazan, which were considered mainly due to the pharmacodynamic effect of tegoprazan."( Pharmacokinetic Interactions Between Tegoprazan and Naproxen, Aceclofenac, and Celecoxib in Healthy Korean Male Subjects.
Kang, M; Kim, B; Kim, MG; Moon, SJ; Shin, N, 2022
)
0.97
" Both naproxen and 6-O-desmethylnaproxen in saliva samples can be effectively quantified using LC-MS/MS, this methodology proved to be rapid, sensitive, accurate and selective for each drug and allows for the analysis of their pharmacokinetic parameters, in both situations."( Simultaneous separation of naproxen and 6-O-desmethylnaproxen metabolite in saliva samples by liquid chromatography-tandem mass spectrometry: Pharmacokinetic study of naproxen alone and associated with esomeprazol-Results.
Calvo, AM; Dionísio, TJ; Faria, FAC; Oliveira, GM; Polanco, NLDH; Santos, CF; Siqueira-Sandrin, VS, 2022
)
1.5

Compound-Compound Interactions

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. The pharmacokinetics of gabapentin enacarbil were evaluated in healthy adults after administration alone or in combination with naproxen.

ExcerptReferenceRelevance
"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
)
0.7
" Two preplanned comparisons were made: (a) Spinal manipulative therapy (SMT) combined with trunk strengthening exercises (TSE) vs."( Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial.
Anderson, AV; Boline, PD; Bronfort, G; Goldsmith, CH; Nelson, CF,
)
0.13
"Five weeks of SMT or NSAID therapy in combination with supervised trunk exercise, followed by and additional 6 wk of supervised exercise alone."( Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial.
Anderson, AV; Boline, PD; Bronfort, G; Goldsmith, CH; Nelson, CF,
)
0.13
" For the management of CLBP, trunk exercise in combination with SMT or NSAID therapy seemed to be beneficial and worthwhile."( Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial.
Anderson, AV; Boline, PD; Bronfort, G; Goldsmith, CH; Nelson, CF,
)
0.13
" Nonsteroidal anti-inflammatory drugs (NSAID) such as tolfenamic acid and naproxen sodium combined with sumatriptan have demonstrated efficacy in reducing recurrence observed with the single use of this drug."( Dexamethasone decreases migraine recurrence observed after treatment with a triptan combined with a nonsteroidal anti-inflammatory drug.
Barbosa, JS; Krymchantowski, AV, 2001
)
0.54
"High-throughput characterization of drug-drug interactions in plasma protein binding was demonstrated by using a surface plasmon resonance (SPR) biosensor."( Rapid characterization of drug-drug interaction in plasma protein binding using a surface plasmon resonance biosensor.
Kuroda, Y; Saito, M; Sakai, H; Yamaoka, T, 2008
)
0.35
" While earlier trials have either compared corticosteroid injections to physical therapy or to naproxen orally, we will compare the clinical effect of physiotherapy alone or physiotherapy combined with corticosteroid injection in the initial treatment of acute tennis elbow."( Physiotherapy alone or in combination with corticosteroid injection for acute lateral epicondylitis in general practice: a protocol for a randomised, placebo-controlled study.
Brage, S; Holmedal, Ø; Lindbaek, M; Olaussen, M, 2009
)
0.57
"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
)
0.66
" 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
)
0.85
" To examine the potential for drug-drug interactions at these two transporters, the pharmacokinetics of gabapentin enacarbil were evaluated in healthy adults after administration alone or in combination with either naproxen (an MCT-1 substrate) or cimetidine (an OCT2 substrate)."( Clinical pharmacokinetic drug interaction studies of gabapentin enacarbil, a novel transported prodrug of gabapentin, with naproxen and cimetidine.
Blumenthal, R; Cundy, KC; Ho, J; Lal, R; Luo, W; Sukbuntherng, J; Vicente, V, 2010
)
0.75
" Accordingly, pharmacokinetic drug-drug interactions can occur when one drug modifies lysosomal volume such that the degree of lysosomal sequestration of secondarily administered drugs is significantly altered."( Evaluating the roles of autophagy and lysosomal trafficking defects in intracellular distribution-based drug-drug interactions involving lysosomes.
Kong, A; Krise, JP; Logan, R, 2013
)
0.39
"Scope of the study was (1) to develop a lean quantitative calibration for real-time near-infrared (NIR) blend monitoring, which meets the requirements in early development of pharmaceutical products and (2) to compare the prediction performance of this approach with the results obtained from stratified sampling using a sample thief in combination with off-line high pressure liquid chromatography (HPLC) and at-line near-infrared chemical imaging (NIRCI)."( Assessment of powder blend uniformity: Comparison of real-time NIR blend monitoring with stratified sampling in combination with HPLC and at-line NIR Chemical Imaging.
Bakri, B; Hauck, G; Reich, G; Weimer, M, 2015
)
0.42
"A fast and low-cost sample preparation method of graphene based dispersive solid-phase extraction combined with gas chromatography-mass spectrometric (GC-MS) analysis, was developed."( Graphene oxide-based dispersive solid-phase extraction combined with in situ derivatization and gas chromatography-mass spectrometry for the determination of acidic pharmaceuticals in water.
Lee, HK; Li, SF; Naing, NN, 2015
)
0.42

Bioavailability

Nonlinear relationship between dose and bioavailability was observed which leads to a less than proportional increase in naproxen concentrations with increasing doses. The controlled release preparation allows more constant plasma levels of Naproxen.

ExcerptReferenceRelevance
"The bioavailability (plasma concentrations, AUC) of a rectal formulation (suppository) of naproxen was investigated in six healthy volunteers by comparison with an oral preparation (tablets)."( Naproxen plasma levels in volunteers after single-dose administration by oral and rectal routes.
Desager, JP; Harvengt, C; Vanderbist, M, 1976
)
1.92
" It is concluded that the bioavailability of CR naproxen is not substantially altered by the ingestion of food."( Bioavailability of a new controlled-release oral naproxen formulation given with and without food.
Babbini, M; Cristofori, M; Palazzini, E, 1992
)
0.79
" The experimental data show that the bioavailability of the controlled release preparation is equal to that of standard release naproxen; however, the controlled release preparation allows more constant plasma levels of naproxen and, when administered once a day for prolonged periods, is capable of maintaining effective concentrations for most of the dosing period."( Pharmacokinetics of a controlled release preparation of naproxen.
Ambrosioni, E; Galli, G; Palazzini, E; Strocchi, E, 1991
)
0.73
"The bioavailability and pharmacokinetics of a new controlled-release tablet (CRT) of naproxen (750 mg tablet) have been determined, relative to an equivalent dose of conventional product (CT), by a cross-over study in twenty healthy volunteers."( Pharmacokinetic evaluation of conventional and controlled-release product of naproxen.
Babbini, M; Galli, G; Palazzini, E, 1990
)
0.73
"The bioavailability of naproxen after oral administration of aqueous solutions of various dextran-naproxen ester prodrugs in pigs was determined."( Macromolecular prodrugs. XV. Colon-targeted delivery--bioavailability of naproxen from orally administered dextran-naproxen ester prodrugs varying in molecular size in the pig.
Harboe, E; Johansen, M; Larsen, C; Olesen, HP, 1989
)
0.82
" In a single dose pharmacokinetic study, the rate of absorption of the sustained-release preparation was less than that of a conventional-release preparation but the extent of absorption was the same."( Pharmacokinetic properties and clinical efficacy of once-daily sustained-release naproxen.
Colgan, BV; Devane, JG; Kelly, JG; Kinney, CD; Mulligan, S, 1989
)
0.5
" Bioavailability was estimated from serum concentration and cumulative urinary metabolite excretion data, both determined up to 96 hours after drug administration."( Transcutaneous absorption of naproxen gel.
Eenhoorn, PC; Gribnau, FW; Tan, Y; van den Ouweland, FA, 1989
)
0.57
" Results in group 1 showed that neither ketoprofen bioavailability nor maximal plasma concentration and time to reach maximal concentration were affected by the administration of sucralfate."( Effects of food and sucralfate on the pharmacokinetics of naproxen and ketoprofen in humans.
Besner, JG; Caillé, G; du Souich, P; Gervais, P; Vézina, M, 1989
)
0.52
" A preliminary bioavailability study of two of the lead structures is presented."( Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
Blythin, DJ; Bober, LA; Chiu, PJ; Conn, DJ; Domalski, MS; Kaminski, JJ; Solomon, DM; Spitler, J; Verbiar, LL; Wong, SC, 1986
)
0.27
" The lymphatic absorption rate was increased by adjusting the length of an n-alkyl chain introduced between the alpha- or beta-position of glycerol and the drug residue."( Studies on intestinal lymphatic absorption of drugs. II. Glyceride prodrugs for improving lymphatic absorption of naproxen and nicotinic acid.
Ando, H; Furuuchi, S; Harigaya, S; Sugihara, J; Takashima, K, 1988
)
0.49
"We explored the bioavailability and kinetics of naproxen (N) in 12 healthy volunteers treated orally with single doses of 500 mg and retreated after a washout period with the same dose of N plus sulglycotide (S) 200 mg."( Lack of influence of sulglycotide on naproxen bioavailability in healthy volunteers.
Berté, F; Cenedese, A; Cornelli, U; di Valserra, MB; Feletti, F; Nazzari, M, 1988
)
0.8
" Sucralfate decreased significantly the rate of absorption (ka) of naproxen and indomethacin, but not that of ketoprofen; it had no significant effect on the elimination half-life and area under the plasma concentration as a function of time curves (AUC0----infinity) of the three drugs."( Single dose pharmacokinetics of ketoprofen, indomethacin, and naproxen taken alone or with sucralfate.
Besner, JG; Caillé, G; Du Souich, P; Gervais, P,
)
0.61
" Naproxen was well absorbed from the controlled-release tablet (about 90%) compared with the conventional tablet."( A multiple-dose pharmacokinetic comparison of naproxen as a once-daily controlled-release tablet and a twice-daily conventional tablet.
Cohen, A; Garg, DC; Gonzalez, MA; Hsiao, C; Ling, TL; Weidler, DJ; Yee, JP, 1987
)
1.44
" Average serum profiles for tablets and suppositories were very similar and gave a relative bioavailability of suppositories compared to tablets of 103% +/- 4%, suggesting comparable efficacy of the two administration forms."( Bioavailability of naproxen tablets and suppositories in steady state.
Gylding-Sabroe, JP; Gøtzsche, PC; Larsen, NE; Marinelli, K; Sørensen, K, 1983
)
0.59
" In this study naproxen sodium suppositories were compared with naproxen tablets and naproxen suppositories with respect to plasma concentrations and bioavailability of naproxen."( Bioavailability of naproxen sodium suppositories.
Aarbakke, J; Gamst, ON; Vesje, AK, 1984
)
0.95
"The effect of Mylanta on naproxen bioavailability was studied in 11 healthy volunteers."( Effect of Mylanta on naproxen bioavailability.
Bankhurst, AD; Ding, TL; Mroszczak, E; Weber, SS, 1981
)
0.89
" The bioavailability compared with healthy volunteers receiving the same dose was 45."( Pharmacokinetics of naproxen in patients with hypoproteinemia.
Calvo, MV; Dominguez-Gil, A; Muriel, C, 1981
)
0.59
" After naproxen was given orally, absorption was rapid, and the bioavailability ranged between 68% and 100%."( Pharmacokinetics of naproxen in the dog.
Frey, HH; Rieh, B, 1981
)
1.04
" The relative bioavailability of ibuprofen and naproxen, following oral administration of ibudice and napdice, was 96% and 74%, respectively, and the rate of absorption was not significantly different from that obtained following oral dosing of the parent compound."( Pharmacokinetic analysis of diethylcarbonate prodrugs of ibuprofen and naproxen.
Avnir, D; Bialer, M; Ladkani, D; Samara, E, 1995
)
0.78
" The relative rectal bioavailability of naproxen from the compressed suppositories was 96."( Comparative pharmacokinetic evaluation of compressed naproxen suppositories in humans.
Diwan, PV; Sastry, MS, 1993
)
0.8
" Pharmacokinetic data showed a slight delay in drug absorption during attacks (absorption half-life and time of maximum drug concentration were increased during attacks), but overall bioavailability of naproxen, as reflected by area under the curve (AUC) and maximum plasma drug concentration were unchanged."( Disposition of naproxen after oral administration during and between migraine attacks.
Bertolotti, M; Pini, LA; Trenti, T; Vitale, G, 1993
)
0.83
" These results show that use of IPM can significantly improve the bioavailability of naproxen in topical preparations."( Effectiveness and mode of action of isopropyl myristate as a permeation enhancer for naproxen through shed snake skin.
Jun, HW; Suh, H, 1996
)
0.74
"Representative nonsteroidal anti-inflammatory drug (NSAID) cyclooxygenase inhibitors such as ibuprofen, naproxen, and indomethacin were used as orally bioavailable scaffolds to design selective 5-lipoxygenase (5-LO) inhibitors."( Nonsteroidal anti-inflammatory drugs as scaffolds for the design of 5-lipoxygenase inhibitors.
Bell, RL; Bouska, J; Brooks, CD; Carter, GW; Dellaria, JF; Hulkower, KI; Kolasa, T; Rodriques, KE; Summers, JB, 1997
)
0.51
"The S-naproxen betainate sodium salt monohydrate (naproxen-betaNa, CAS 104124-26-7, Aprenin) was synthesized to improve bioavailability and tolerability of naproxen."( Absorption and distribution of naproxen in rats orally treated with naproxen betainate sodium salt monohydrate. Comparison with naproxen.
Benatti, P; Cerutti, R; Marzo, A; Marzo, P; Reiner, V; Ripamonti, M; Wool, C, 1997
)
1.06
" The non-compartmental pharmacokinetic parameters obtained were statistically processed according to the EU guidance note on bioavailability and bioequivalence Cmax, AUC0-24h and AUC0-infinity were normalized to the dose of 502 mg of naproxen and log-transformed before statistical analysis to assess bioequivalence."( Comparative bioavailability study on naproxen betainate sodium salt monohydrate and naproxen sodium salt in healthy volunteers.
Cerutti, R; Maggi, GC; Marzo, A; Marzo, P; Monti, N; Ripamonti, M; Wool, C, 1997
)
0.75
" The bioavailability of naproxen in the topical gel was approximately 2% of the applied dose in dogs."( Pharmacokinetic and local tissue disposition studies of naproxen-following topical and systemic administration in dogs and rats.
Dzimianski, MT; Jun, HW; Lu, GW; Suh, H, 1997
)
0.85
"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,
)
0.61
" Naproxen was well absorbed from the sustained-release tablet (approximately 97%) compared with the conventional tablet."( Single- and multiple-dose pharmacokinetic comparison of a sustained-release tablet and conventional tablets of naproxen in healthy volunteers.
Lu, W; Wei, S; Xia, Q; Zhang, Q; Zhou, D, 1998
)
1.42
" Solid dispersions naproxen:PEG 4000 have been prepared in order to improve the solubility and dissolution rate of the drug, since these factors can be the limiting steps for absorption and bioavailability of poorly soluble drugs."( Effect of PEG 4000 on the dissolution rate of naproxen.
Martín, C; Martínez-Ohárriz, MC; Sánchez, M; Vélaz, I,
)
0.72
" There was no significant change in the bioavailability of theses NSAIDs during omeprazole therapy in this study."( Lack of drug-drug interaction between three different non-steroidal anti-inflammatory drugs and omeprazole.
Andersson, T; Bredberg, E; Lagerström, PO; Naesdal, J; Wilson, I, 1998
)
0.3
" The extent of absorption did not differ in the three situations tested, whereas the rate of absorption was fastest in fasting conditions, lowest with the evening dose and intermediate after the high-fat content breakfast."( Bioavailability, food effect and tolerability of S-naproxen betainate sodium salt monohydrate in steady state.
Cerutti, R; Dal Bo, L; Marzo, A; Wool, C, 1998
)
0.55
"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
" The steady state bioavailability of naproxen metabolised from AZD3582 was 95% (95% confidence interval 87-101%) of that after naproxen administration."( Gastrointestinal safety of AZD3582, a cyclooxygenase inhibiting nitric oxide donator: proof of concept study in humans.
Atherton, CT; Bebb, JR; Bjarnason, IT; Fagerholm, U; Hawkey, CJ; Jones, JI; Jonzon, B; Karlsson, P; Skelly, MM, 2003
)
0.59
" Its oral bioavailability (F) appears to be maximally a few per cent, and increases by several-fold after food intake."( Clinical pharmacokinetics of the cyclooxygenase inhibiting nitric oxide donator (CINOD) AZD3582.
Björnsson, MA; Fagerholm, U, 2005
)
0.33
"The design, synthesis and characterization of a series of zero generation (G0) PAMAM dendrimer-based prodrugs for the potential enhancement of drug solubility and bioavailability are described."( Synthesis, characterization and stability of dendrimer prodrugs.
Attwood, D; D'Emanuele, A; Freeman, S; Najlah, M, 2006
)
0.33
"The bioavailability of naproxen sodium (CAS 26159-34-2) after administration of two oral suspensions, reference or test (Pactens), was compared in 24 healthy subjects."( Comparative bioavailability of two oral suspensions of naproxen sodium.
Carrasco-Portugal, Mdel C; Flores-Murrieta, FJ; Herrera, JE; Medina-Santillán, R; Reyes-García, G, 2006
)
0.89
" These physicochemical results indicate that solid molecular dispersions based on PHEMA hydrogels can effectively enhance the dissolution and therefore should be potentially useful in improving the oral bioavailability of poorly water-soluble drugs."( Solid molecular dispersions of poorly water-soluble drugs in poly(2-hydroxyethyl methacrylate) hydrogels.
Lee, PI; Zahedi, P, 2007
)
0.34
" A complete cross-over bioavailability study of the optimized formulation of the developed CR tablets and marketed immediate release tablets was performed in 6 healthy male volunteers."( In vitro and in vivo studies on HPMC-K-100 M matrices containing naproxen sodium.
Chandrasekar, MJ; Gopinath, R; Kumar, SM; Nanjan, MJ; Srinivasan, R; Suresh, B, 2007
)
0.58
" ELN441958 is a novel small molecule bradykinin B(1) receptor antagonist exhibiting high oral bioavailability and potent systemic efficacy in rhesus monkey inflammatory pain."( Pharmacological, pharmacokinetic, and primate analgesic efficacy profile of the novel bradykinin B1 Receptor antagonist ELN441958.
Bova, MP; Butelman, ER; Chavez, RA; Chen, L; Dreyer, M; Fukuda, JY; Garofalo, AW; Hawkinson, JE; Holcomb, R; Hom, DS; Ko, MC; Liao, A; Malmberg, AB; Ruslim, L; Samant, B; Simmonds, S; Szoke, BG; Wadsworth, A; Zeitz, KP; Zhang, H; Zmolek, W, 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 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
)
0.78
"Naproxen, a non-steroidal anti-inflammatory drug (NSAID), is a biopharmaceutics classification system (BCS) class II drug whose bioavailability is rate-limited by its dissolution."( Enhanced dissolution rate and synchronized release of drugs in binary systems through formulation: Amorphous naproxen-cimetidine mixtures prepared by mechanical activation.
Aaltonen, J; Allesø, M; Chieng, N; Rades, T; Rantanen, J; Rehder, S, 2009
)
2.01
" We examined the effects of elevated acetaldehyde within the gastrointestinal tract on the permeability and bioavailability of hydrophilic markers and drug molecules of variable molecular weight and geometry."( The ethanol metabolite acetaldehyde increases paracellular drug permeability in vitro and oral bioavailability in vivo.
Eddington, ND; Fisher, SJ; Swaan, PW, 2010
)
0.36
" In addition, food had no significant effect on the bioavailability of naproxen or sumatriptan after administration of sumatriptan/naproxen sodium but slightly delayed the time to peak plasma concentration of sumatriptan by approximately 40 minutes."( Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine.
Haberer, LJ; Lener, SE; McDonald, SA; Taylor, DR; Walls, CM, 2010
)
0.82
" For example, the 1,8-naphthyridine 52 was characterized as an orally bioavailable and brain penetrant TRPV1 antagonist."( Discovery of novel 6,6-heterocycles as transient receptor potential vanilloid (TRPV1) antagonists.
Bakthavatchalam, R; Blum, CA; Boyce, S; Brielmann, H; Burnaby-Davies, N; Caldwell, T; Capitosti, S; Chenard, BL; Conley, R; Cortright, D; Crandall, M; De Lombaert, S; Hodgetts, KJ; Jones, AB; Kershaw, MT; Krause, JE; Martin, WJ; Mason, G; Matson, D; Murphy, BA; Perrett, H; Rycroft, W; Zheng, X, 2010
)
0.36
" Compound 26 was characterized as an orally bioavailable TRPV1 antagonist with moderate brain penetration."( Pyrido[2,3-b]pyrazines, discovery of TRPV1 antagonists with reduced potential for the formation of reactive metabolites.
Bakthavatchalam, R; Blum, CA; Boyce, S; Brian Jones, A; Caldwell, T; Capitosti, S; Chenard, BL; Cortright, D; Crandall, M; Hodgetts, KJ; Krause, JE; Murphy, BA; Zheng, X, 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
"A strong correlation between PK data obtained by the DBS and conventional plasma method was observed, which makes DBS a valuable technique for further naproxen bioavailability and PK investigations and studies."( Determination of naproxen using DBS: evaluation & pharmacokinetic comparison of human plasma versus human blood DBS.
Bergeron, A; Furtado, M; Garofolo, F; Guibord, P; Latour, S; Lefebvre, M; Macarthur, RB; Mess, JN; Michon, J; Rufiange, M; Youhnovski, N, 2010
)
0.9
" Bioavailability studies revealed that both prodrugs 10 and 17 were rapidly cleared from blood with half lives of about 1 h, which will likely decrease systemic adverse effects."( Brain-specific delivery of naproxen using different carrier systems.
Mahmoud, S; Mohammad, A, 2010
)
0.66
"This randomized, 4-way crossover study assessed the single-dose pharmacokinetics and relative bioavailability of naproxen and esomeprazole after administration of a fixed-dose combination tablet of enteric-coated (EC) naproxen 500 mg and non-EC esomeprazole magnesium 20 mg (NAP/ESO tablet)."( Pharmacokinetics and relative bioavailability of a fixed-dose combination of enteric-coated naproxen and non-enteric-coated esomeprazole magnesium.
Fort, J; Sostek, M; Wang-Smith, L; Zhang, Y, 2012
)
0.81
" The study suggested glucosyl thiamine disulfide was a promising carrier to enhance the brain bioavailability of central nervous system active drugs."( Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
Fan, W; Hai, L; Li, X; Li, XK; Wu, Y; Yao, N; Yu, YG, 2011
)
0.58
" The observed limited brain bioavailability of the drug prompted the design of several chemical delivery systems."( Pharmacokinetic and ulcerogenic studies of naproxen prodrugs designed for specific brain delivery.
Sheha, M, 2012
)
0.64
" Calculations show that the total amount of amorphous material is rather low, but even a small amount could have an influence on both chemical and physical stability or influence the bioavailability if uncontrolled crystallization occurs during storage."( Is the amorphous fraction of a dried nanosuspension caused by milling or by drying? A case study with Naproxen and Cinnarizine.
Kayaert, P; Van den Mooter, G, 2012
)
0.59
" However, few studies have assessed the bioavailability of pharmaceuticals to fish in natural waters."( Bioavailability of pharmaceuticals in waters close to wastewater treatment plants: use of fish bile for exposure assessment.
Brozinski, JM; Kronberg, L; Lahti, M; Oikari, A; Segner, H, 2012
)
0.38
"Solid dispersions have been used to improve the bioavailability of poorly water-soluble drugs."( Effect of substrates on naproxen-polyvinylpyrrolidone solid dispersions formed via the drop printing technique.
Harris, MT; Hsu, HY; Simpson, GJ; Taylor, LS; Toth, SJ, 2013
)
0.7
" This is to compare the bioavailability of diflunisal-naproxen fixed-dose combination (FDC) with their separate dosage forms."( Comparative in vitro dissolution and in vivo bioavailability of diflunisal/naproxen fixed-dose combination tablets and concomitant administration of diflunisal and naproxen in healthy adult subjects.
El Bedaiwy, HM; Helmy, SA, 2013
)
0.87
" These findings suggest that cigarette smoke-induced modifications of HSA may affect the binding, transport and bioavailability of specific ligands in smokers."( Cigarette smoke induces alterations in the drug-binding properties of human serum albumin.
Clerici, M; Colombo, G; Colombo, R; Dalle-Donne, I; Gagliano, N; Giustarini, D; Milzani, A; Portinaro, N; Rossi, R; Secundo, F, 2014
)
0.4
" A nonlinear relationship between dose and bioavailability was observed which leads to a less than proportional increase in naproxen concentrations with increasing doses."( Model-based analysis of thromboxane B₂ and prostaglandin E₂ as biomarkers in the safety evaluation of naproxen.
Danhof, M; Della Pasqua, O; Sahota, T; Sanderson, I, 2014
)
0.82
" While an aspirin prodrug exhibited comparable oral bioavailability and antiplatelet activity (i."( Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
Borhade, N; Burhan, A; Desai, DC; Dhiman, M; Gaikwad, P; Gund, M; Nemmani, KVS; Patil, M; Satyam, A; Sharma, A; Sharma, S; Sheikh, J; Thakre, G; Tipparam, SG, 2014
)
0.64
" We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy men."( Pharmacokinetic comparison study of a combination containing 500 mg of Naproxen and 20 mg of Esomeprazole: a randomized, single-dose, 2-way crossover, open-label study in healthy Korean men.
Choi, HG; Im, YJ; Jeon, JY; Jin, C; Kim, EY; Kim, H; Kim, MG; Kim, Y; Kwak, SS; Lee, SY; Wang, HM, 2015
)
0.65
"The production of nanosuspensions has proved to be an effective method for overcoming bioavailability challenges of poorly water soluble drugs."( Process parameter dependent growth phenomena of naproxen nanosuspension manufactured by wet media milling.
Bitterlich, A; Bunjes, H; Dengler, M; Grandeury, A; Juhnke, M; Krautstrunk, I; Kwade, A; Laabs, C, 2015
)
0.67
"Taking into account possible irritation of the skin upon contact with naproxen (NPX) crystals and lower bioavailability after administration of the suspended or ionized drug, the aim of the work was to design and characterize novel and easy-to-formulate gels with the entirely dissolved drug in the acidic form."( Novel organogels for topical delivery of naproxen: design, physicochemical characteristics and in vitro drug permeation.
Białas, W; Froelich, A; Górska, S; Kapela, M; Milanowski, B; Osmałek, T; Szybowicz, M, 2017
)
0.95
" As a result, the novel-NAP/EMZ compound pellets may be a more suitable formulation with potential advantages by improving bioavailability of drug and further reducing undesirable gastrointestinal damages."( Novel naproxen/esomeprazole magnesium compound pellets based on acid-independent mechanism: in vitro and in vivo evaluation.
Kan, S; Liu, J; Lu, J; Zhang, W; Zhao, Y, 2016
)
0.92
" The rate of absorption is delayed under fed conditions."( Pharmacokinetic profile of extended-release versus immediate-release oral naproxen sodium after single and multiple dosing under fed and fasting conditions: two randomized, open-label trials.
Laurora, I; Wang, Y, 2016
)
0.67
" Although higher supersaturation is known to result in faster precipitation, the overall effect of this faster precipitation on the bioavailability is not well understood."( Effect of Extent of Supersaturation on the Evolution of Kinetic Solubility Profiles.
Han, YR; Lee, PI, 2017
)
0.46
"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
" To determine the possibility of pharmacokinetic interactions, the oral bioavailability of naproxen was evaluated in presence and absence of oral DHA."( Supra-Additive Interaction of Docosahexaenoic Acid and Naproxen and Gastric Safety on the Formalin Test in Rats.
Arroyo-Lira, AG; Castañeda-Hernández, G; Chávez-Piña, AE; Ortiz, MI; Rodríguez-Ramos, F, 2017
)
0.92
"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
"The embedding of nanoparticles in orodispersible films (ODFs) is an innovative strategy to improve the bioavailability of poorly water-soluble active pharmaceutical ingredients (API)."( Model-based description of disintegration time and dissolution rate of nanoparticle-loaded orodispersible films.
Finke, JH; Kwade, A; Steiner, D, 2019
)
0.51
" ADMET in silico showed that these compounds are a good oral bioavailability without observed carcinogenesis affect."( Naproxenylamino acid derivatives: Design, synthesis, docking, QSAR and anti-inflammatory and analgesic activity.
Al-Harbi, LM; Alosaimi, AM; El-Gazzar, MA; Elhamid Salim, A; Elhenawy, AA; Khowdiary, MM; Ouidate, A, 2019
)
1.96
"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
" They are therefore considered an important tool in improving oral bioavailability of such APIs."( The influence of polymeric excipients on desupersaturation profiles of active pharmaceutical ingredients. 1: Polyethylene glycol.
Ji, Y; Sadowski, G; Schneider, R; Taspinar, L, 2020
)
0.56
"Amorphous solid dispersion (ASD) is a formulation strategy extensively used to enhance the bioavailability of poorly water soluble drugs."( The design and development of high drug loading amorphous solid dispersion for hot-melt extrusion platform.
Andrews, GP; Jacobs, E; Jones, DS; McCoy, CP; Tian, Y; Wu, H, 2020
)
0.56
"Bioequivalence tests are fundamental step in assessing the equivalence in bioavailability between a test and reference product."( Multivariate Assessment for Bioequivalence Based on the Correlation of Random Effect.
An, H; Shin, D, 2021
)
0.62

Dosage Studied

This study has been undertaken to develop a controlled-release tablet dosage form of naproxen using ethocel (ethyl cellulose) as the rate-controlling polymer. The direct compression properties and antiulcerogenic activity make chitosan glutamate an optimal carrier for developing fast-action oral solid dosage forms of this drug.

ExcerptRelevanceReference
" Patients were assessed and then treated for 7 days with naproxen sodium at a dosage of 275 mg 3 or 4-times daily depending on the severity of pain."( A study of non-articular rheumatic disorders and their response to treatment with naproxen sodium.
Wheatley, D, 1979
)
0.73
" Because of its relatively long plasma half-life, naproxen can with convenieice be given twice daily, and there is some evidence that once daily dosage is as effective in rheumatoid arthritis."( Naproxen up to date: a review of its pharmacological properties and therapeutic efficacy and use in rheumatic diseases and pain states.
Avery, GS; Brogden, RN; Heel, RC; Speight, TM, 1979
)
1.96
" Clinical parameters showed that the best degree of improvement was obtained with the diclofenac 50 mg twice-daily dosage regime."( Comparative clinical trials with diclofenac sodium (Voltarol) and naproxen in rheumatic conditions: investigation of possible changes in diclofenac dose and dose interval.
Bach, GL, 1979
)
0.5
" The daily maintenance dosage from the fourth week of treatment onwards was 75 mg diclofenac and 500 mg naproxen."( [Long-term comparative study: diclofenac (voltaren) and naproxen (proxen) in arthritis].
Placheta, P; Siegmeth, W, 1978
)
0.72
" The pyrogram enables the identification of the drug to be achieved as the pure compound, in a formulated dosage form or excreted in urine."( The identification of ibuprofen and analogues in urine by pyrolysis gas chromatography mass spectrometry.
Irwin, WJ; Slack, JA, 1978
)
0.26
" A dosage of 250 mg twice daily produced sustained improvement in most of the standard clinical measurements."( Naproxen in rheumatoid arthritis. Extended trial.
Ansell, BM; Gumpel, JM; Hill, AG; Hill, HF; Mowat, AG; Stoppard, M, 1976
)
1.7
"Acute inflammation was induced in rats by subcutaneous implantation of plastic sponges, and the penetration of salicylate and naproxen into the inflammatory exudate was studied after oral dosing with these compounds."( Penetration of naproxen and salicylate into inflammatory exudates in the rat.
Anttila, M; Dean, PB; Doherty, NS, 1977
)
0.82
" During an initial period of two to five weeks, the paramethasone dosage was adjusted and other medications replaced by placebo to find the minimum required to keep the patient at a level similar to the one at the beginning of the study."( Naproxen: corticosteroid-sparing effect in rheumatoid arthritis.
Badia Flores, JJ; Valdez Rojas, S, 1975
)
1.7
" The dosage causing a 50% inhibition culture growth (ID50) and minimum concentration, caused by the detachment of the cell from the vessel wall, were determined."( [Effects of drugs on cell culture (II)].
Kameyama, T; Mukaide, A, 1975
)
0.25
" In the case of complex dosage forms, such as enteric-coated tablets, labelling is best undertaken by the addition of a non-radioactive tracer such as samarium-152 oxide or erbium-170 oxide followed by neutron activation of the final product."( Gamma scintigraphy in the evaluation of pharmaceutical dosage forms.
Davis, SS; Hardy, JG; Newman, SP; Wilding, IR, 1992
)
0.28
" The aim of this study was to evaluate the suitable dosage of sodium naproxen for post-surgical pain relief."( [Sodium naproxen in postoperative pain in orthopedics. Comparison of 2 different doses].
Colì, A; Di Fiore, M; Lari, S; Perin, S; Urso, R,
)
0.8
" These data show that NSAIDs can affect the disposition of methotrexate, possibly increasing the potential for toxicity and necessitating dosage adjustments."( The effects of a salicylate, ibuprofen, and naproxen on the disposition of methotrexate in patients with rheumatoid arthritis.
Bradley, JD; Brater, DC; Hall, SD; Jones, DR; Krohn, K; Tracy, TS, 1992
)
0.54
" Second, alterations in alveolar bone metabolism were assessed using 99m-Tc-methylene diphosphonate uptake prior to dosing and 3 months later."( Use of digital radiography to demonstrate the potential of naproxen as an adjunct in the treatment of rapidly progressive periodontitis.
Basch, C; Cogen, R; Jeffcoat, MK; Page, R; Palcanis, K; Reddy, M; Waite, P; Wannawisute, A; Williams, RC, 1991
)
0.52
" The experimental data show that the bioavailability of the controlled release preparation is equal to that of standard release naproxen; however, the controlled release preparation allows more constant plasma levels of naproxen and, when administered once a day for prolonged periods, is capable of maintaining effective concentrations for most of the dosing period."( Pharmacokinetics of a controlled release preparation of naproxen.
Ambrosioni, E; Galli, G; Palazzini, E; Strocchi, E, 1991
)
0.73
"A standard fixed dosing regimen (S) and a variable dosing regimen (VD) of naproxen for patients with knee and hip osteoarthritis were compared in a multicentre, open, controlled, parallel 8-week trial."( Improved cost-effectiveness ratio with a patient self-adjusted naproxen dosing regimen in osteoarthritis treatment.
Brørs, O; Kvien, TK; Nordby, J; Rognstad, S; Staff, PH, 1991
)
0.75
" Each volunteer was dosed with 153Sm-labelled, enteric-coated pellets on two occasions, once whilst fasted and once after breakfast."( Evaluation of an enteric-coated naproxen pellet formulation.
Evans, DF; Gamst, ON; Haga, AK; Hardy, JG; Lamont, GL, 1991
)
0.56
" dosage indicating a stereoselective first-pass effect with higher extraction of the levorotatory enantiomer, which is more potent with respect to beta-adrenoceptor antagonistic activity."( Measurement of carvedilol enantiomers in human plasma and urine using S-naproxen chloride for chiral derivatization.
Henke, W; Langguth, P; Mutschler, E; Schloos, J; Spahn, H, 1990
)
0.51
" The two dosage forms were bioequivalent in terms of total AUC; however, the Cmax of the controlled-release product was lower, and the Tmax longer than that of the conventional product."( Pharmacokinetic evaluation of conventional and controlled-release product of naproxen.
Babbini, M; Galli, G; Palazzini, E, 1990
)
0.51
" Controlled release naproxen was administered at the dosage of a 750 mg/day tablet for 10-15 days; the standard naproxen at the dosage of two 375 mg/day capsules for 10-15 days."( Controlled clinical trial on a new nonsteroidal anti-inflammatory drug (NSAID) therapy for arthropathic patients.
Bedogni, C; Faini, G, 1990
)
0.6
" Dosage adjustments are not usually required in the elderly or those with mild renal or hepatic impairment although it is probably prudent to start treatment at a low dosage and titrate upwards in such groups of patients."( Naproxen. A reappraisal of its pharmacology, and therapeutic use in rheumatic diseases and pain states.
Clissold, SP; Todd, PA, 1990
)
1.72
"Naproxen sodium has been formulated in a parenteral dosage form."( Naproxen parenteral formulation studies.
Lalla, JK; Peswani, KS,
)
3.02
"Naproxen sodium and a cellulose ether derivative were granulated with either water or a poly(meth)acrylic acid ester copolymer aqueous dispersion to make three controlled-release matrix dosage forms."( Effects of various granulating systems on the bioavailability of naproxen sodium from polymeric matrix tablets.
Bormeth, A; Dahl, T; Ling, T; Yee, J, 1990
)
1.96
" The dose-response curve for vasopressin-sensitive Pf showed the Km to be 1 microU ml-1."( Modulation of vasopressin-induced water permeability of the cortical collecting tubule by endogenous and exogenous prostaglandins.
Stokes, JB, 1985
)
0.27
" The dosage for piroxicam was 40 mg on the first and second day of the menstrual cycle, and if necessary an additional 20 mg on the third day."( [Piroxicam versus naproxen in primary dysmenorrhea].
Saltveit, T, 1989
)
0.61
" Therefore, no dosage adjustment of this drug is necessary in elderly patients to achieve similar plasma concentrations following standard dosing in young subjects."( Effect of age on the pharmacokinetics of tenoxicam in comparison to other non-steroidal anti-inflammatory drugs (NSAIDs).
Guentert, TW; Schmitt, M, 1989
)
0.28
" In this study, four NSAIDs were investigated for their phototoxicity potential in human volunteers using an oral dosing protocol."( Photosensitizing potential of certain nonsteroidal anti-inflammatory agents.
Kaidbey, KH; Mitchell, FN, 1989
)
0.28
" The ratio of the glucuronides of (S)-benoxaprofen to that of (R)-benoxaprofen in rhesus monkey urine varied between individual animals and appeared to change through time as dosing continued."( Species-dependent enantioselective glucuronidation of three 2-arylpropionic acids. Naproxen, ibuprofen, and benoxaprofen.
Dulik, DM; el Mouelhi, M; Fenselau, C; Ruelius, HW,
)
0.36
" In addition, diflunisal has a longer duration of action and thus requires less frequent dosing than naproxen."( Comparison of diflunisal and naproxen in the management of acute low back strain.
Aghababian, RV; Heifetz, IN; Volturo, GA, 1986
)
0.78
" Further increase in dosage of both prostaglandin synthesis inhibitors failed to induce further reduction of integrated areas of coronary vasodilatation."( Effects of prostaglandin synthesis inhibition on sympathetic-and parasympathetic-mediated coronary hemodynamic responses.
Condorelli, M; Cuocolo, A; de Luca, N; Patrignani, P; Ricciardelli, B; Trimarco, B; Volpe, M, 1986
)
0.27
" Its pharmacokinetics are little affected by food, by dosage levels (within wide limits), or by mild renal impairment."( Pharmacokinetics of naproxen sodium.
Moyer, S, 1986
)
0.59
" During once daily dosing of naproxen sodium, naproxen should accumulate in synovial fluid, a steady-state being achieved within a week of treatment."( Naproxen kinetics in synovial fluid of patients with osteoarthritis.
Bruno, R; Cano, JP; Cunci, S; Guego, M; Iliadis, A; Jullien, I; Pinhas, H, 1988
)
2.01
" The piroxicam dosage was 40 mg once daily for two days and then 20 mg daily for an additional five days."( Piroxicam and naproxen in acute sports injuries.
Gabor, I; Lereim, P, 1988
)
0.64
" The results indicate that nabumetone and naproxen have comparable efficacy and tolerance at the dosage used, and suggest that a single night-time dosage of nabumetone may be a convenient and useful treatment for osteoarthritis."( A 6-month, double-blind study comparing nabumetone to naproxen in the treatment of osteoarthritis.
Goodman, LA; Pisko, EJ; Rice, D; Strader, K; White, R, 1987
)
0.79
" The dosage of nabumetone was gradually increased."( Nabumetone in the treatment of active adult rheumatoid arthritis.
Brobyn, RD, 1987
)
0.27
" In both dosage groups, pretreatment incidences of clinically meaningful abnormalities in laboratory tests were similar to those in serial observations during treatment."( Hepatic and renal tolerability of long-term naproxen treatment in patients with rheumatoid arthritis.
Turner, R, 1988
)
0.54
" Before the fertility experiments, the pharmacokinetics of the drugs were determined to find dosage regimens by which drug concentrations known as active from human anti-inflammatory therapy could be reached and maintained in the animals."( Effect of non-steroidal anti-inflammatory drugs on fertility of male rats.
Blazaki, D; Löscher, W, 1986
)
0.27
"1 mg/dL or higher, suggesting that a transient increase in Scr may accompany dosage increase."( Kidney function during naproxen therapy in patients at risk for renal insufficiency.
Basch, C; Freer, JP; Katz, RS; Watson, WA, 1988
)
0.59
" Comparison of trough plasma naproxen concentrations (12 hours after each of the last two morning doses) verified steady state and provided no evidence of drug accumulation in either age or dosage group beyond that achieved after seven days of naproxen administration."( Steady state pharmacokinetics of naproxen in young and elderly healthy volunteers.
Basch, C; Cohen, A, 1988
)
0.85
" The naproxen dosage was 250 mg per day for two weeks."( Randomized trial of oral naproxen or local injection of betamethasone in lateral epicondylitis of the humerus.
Eriksson, E; Saartok, T, 1986
)
1.09
" Although there was no excess of side effects in the elderly patients it is suggested that when naproxen is given to elderly patients, therapy should be started at the lower end of the dosage range."( Pharmacokinetics of naproxen in elderly patients.
Lethbridge, J; Littler, T; Martin, N; McVerry, RM; Mukerjee, SK; Orme, ML; Sibeon, R; Tallis, R, 1986
)
0.81
" In this patient, dosing with ibuprofen caused pronounced declines in all urinary prostanoids and a decrease in creatinine clearance."( Reversible acute decrease in renal function by NSAIDs in cirrhosis.
Anderson, SA; Brater, DC; Brown-Cartwright, D, 1987
)
0.27
" There was some evidence that suggests the existence of a dose-response relation-ship."( [Antipyretic effect of naproxen in neoplastic fever].
Ando, Y; Hashimoto, S; Kondo, M; Kuribayashi, T; Nakayama, T; Tominaga, S, 1987
)
0.58
"The pharmacokinetic differences between two dosage regimens of naproxen (1000 mg once daily vs 500 mg twice daily) were studied at steady-state in seven healthy male volunteers."( Pharmacokinetics of naproxen at two dosage regimens in healthy volunteers.
Franssen, MJ; Gribnau, FW; Tan, Y; van de Putte, LB; van Ginneken, CA, 1986
)
0.83
" Patients undergoing lithium therapy might need a reduction of their lithium dosage following naproxen administration."( Lithium interaction with sulindac and naproxen.
Powell, AL; Ragheb, M, 1986
)
0.76
" Forty-four patients received one 275 mg vial of naproxen sodium intramuscularly, while 33 patients were given one vial at the same dosage intravenously."( Treatment of acute pain of ureteral and biliary colic with naproxen sodium administered by the parenteral route.
Bufalino, L; Cavrini, P; Gardini, F; Marsala, F, 1986
)
0.77
"Since the initial marketing in the early 1970s of the nonsteroidal anti-inflammatory agents of the propionic acid type, there has been a gradual escalation of the dosage recommendation for each of these drugs."( Double-blind crossover comparison of piroxicam and naproxen in the treatment of active osteoarthritis.
Hodge, RH, 1985
)
0.52
" Further increase in dosage failed to induce further reduction of integrated areas of coronary vasodilatation, and a correlation was found between the extent of the reduction of the integrated areas of coronary vasodilatation and the dose of indomethacin (r = ."( Late phase of nitroglycerin-induced coronary vasodilatation blunted by inhibition of prostaglandin synthesis.
Condorelli, M; Cuocolo, A; De Simone, A; Ricciardelli, B; Trimarco, B; Van Dorne, D; Volpe, M, 1985
)
0.27
"First and second derivative ultraviolet spectrometric methods are described for the estimation of indomethacin, naproxen, and ibuprofen in pharmaceutical dosage forms."( Quantitation of indomethacin, naproxen, and ibuprofen in pharmaceutical dosage forms by first and second derivative ultraviolet spectrometry.
Abdel-Hamid, ME; Abdel-Khalek, MM; Mahrous, MS,
)
0.63
" The compounds of most interest, 18 and 28, were further tested in a model of adjuvant-induced arthritis; in this system, both compounds were active when dosed intraperitoneally but failed to produce significant activity when dosed orally at subtoxic doses."( Synthesis and antiinflammatory activity of hexahydrothiopyrano[4,3-c]pyrazoles and related analogues.
Millonig, RC; Rovnyak, GC; Schwartz, J; Shu, V, 1982
)
0.26
" Both PGE1 and PGE2 enhanced cellular release of parathyroid hormone, with dose-response characteristics similar to those seen with cAMP."( Prostaglandin-mediated stimulation of adenosine 3',5'-monophosphate accumulation and parathyroid hormone release in dispersed human parathyroid cells.
Attie, MF; Aurbach, GD; Brown, EM; Gardner, DG, 1980
)
0.26
" Dose-response relationships for inhibition of 45Ca uptake were identical with controls in mitochondria isolated from normal or essential fatty acid-deficient Long-Evans rats even though PGE synthesis in essential fatty acid-deficient was only 20% of that in normal rats."( Prostaglandin-independent inhibition of calcium transport by nonsteroidal anti-inflammatory drugs: differential effects of carboxylic acids and piroxicam.
Burch, RM; Halushka, PV; Wise, WC, 1983
)
0.27
" Antrafenine, at both dosage levels, was well tolerated."( Antrafenine, naproxen and placebo in osteoarthritis: a comparative study.
Berry, H; Coquelin, JP; Gordon, A; Seymour, D, 1983
)
0.64
"Three dosage schedules of naproxen--1000 mg in the morning and placebo in the evening, 1000 mg in the evening and placebo in the morning, and 500 mg in the morning and again in the evening--were compared for efficacy in treating rheumatoid arthritis in a 13-week, double-blind, crossover study."( Double-blind crossover study to evaluate the efficacy of a single daily dose of naproxen in rheumatoid arthritis.
Katona, G; Vargas, RB, 1983
)
0.79
" Results show that the drug exhibiting almost no antiinflammatory activity in the rat at the dosage used, phenylbutazone, was the most powerful inhibitor of ossification."( Correlation between ossification and inflammation using a rat experimental model.
de Medicis, R; Lussier, A, 1983
)
0.27
" The dosage of naproxen was 500 mg (2 tablets) initially, followed by 250 mg as needed, with a maximum of 1250 mg daily."( Severe, primary dysmenorrhea treated with naproxen. A prospective, double-blind, crossover investigation.
Hamann, GO, 1980
)
0.88
" Plasma and serum samples collected after naproxen dosing were assayed for both total and (following equilibrium dialysis) unbound drug concentration."( Naproxen disposition in patients with alcoholic cirrhosis.
Blitstein, M; Cello, JP; Jones, RM; Kelly, J; Nierenburg, D; Upton, RA; Williams, RL, 1984
)
1.97
" The mean steady state concentration and the mean half-life, calculated from the 12-hourly dosage schedule, were 45."( Bioavailability of naproxen tablets and suppositories in steady state.
Gylding-Sabroe, JP; Gøtzsche, PC; Larsen, NE; Marinelli, K; Sørensen, K, 1983
)
0.59
" The new formulation with the 500 mg film-coated tablet provides a simplified dosage regimen and simple therapy for the physician with increased patient compliance and a lower rate of drug intake errors."( [Efficacy and tolerance of Proxen 500 mg film-coated tablets in coxarthrosis].
Hawel, R, 1983
)
0.27
" All patients were started on 500 mg naproxen twice daily but adjustment of the dosage was permitted."( A compliance study in general practice of patients switched from phenylbutazone and oxyphenbutazone to naproxen and other non-steroidal anti-inflammatory drugs.
Dickson, DJ; English, JR, 1982
)
0.75
" Naproxen has a high therapeutic index and a shallow dose-response curve, so the effect of other drugs on its pharmacokinetics is not likely to have a large clinical impact."( Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions.
Segre, EJ, 1980
)
2.61
" Patients were allocated at random to treatment with either 800 mg tolmetin sodium daily or 500 mg naproxen daily over a period of 12 weeks, both drugs being given in identical capsule form in a dosage of 2 capsules twice daily."( A double-blind comparative evaluation of tolmetin versus naproxen in osteoarthritis.
Bach-Andersen, R; Persson, B; Telhag, H, 1981
)
0.72
" The whilst both drugs were effective in the long-term treatment of chronic rheumatoid arthritis, proglumetacin appeared to be somewhat more effective than naproxen in reducing the duration of morning stiffness, the articular inflammation score index, erythrocyte sedimentation rate and the dosage of concomitant basic medication."( A 3-month, double-blind study of proglumetacin and naproxen in the treatment of rheumatoid arthritis.
Bozsoky, S; Zahumenszky, Z, 1982
)
0.71
" The doses selected represented the manufacturer's highest recommended dosage for the treatment of arthritic disorders."( A comparative endoscopic evaluation of the damaging effects of nonsteroidal anti-inflammatory agents on the gastric and duodenal mucosa.
Chen, TT; Lanza, FL; Nelson, RS; Rack, MF; Royer, GL; Seckman, CE, 1981
)
0.26
" 3 A final study documented that a more frequent dosage schedule of every 6 h led to clearly higher plasma levels than those achieved with an every 8 h regimen; plasma levels did not plateau."( Bioavailability of naproxen sodium and its relationship to clinical analgesic effects.
Bloomfield, SS; Runkel, R; Segre, E; Sevelius, H, 1980
)
0.59
" However, it is proposed that in naproxen therapy no adjustment of the dosage regimen is necessary in patients with impaired renal function."( Pharmacokinetics of naproxen in subjects with normal and impaired renal function.
Anttila, M; Haataja, M; Kasanen, A, 1980
)
0.87
" The results of this clearly indicate that ketoprofen in a dosage of 12."( Comparison ketoprofen, ibuprofen and naproxen sodium in the treatment of tension-type headache.
Lange, R; Lentz, R, 1995
)
0.56
" The relative bioavailability of ibuprofen and naproxen, following oral administration of ibudice and napdice, was 96% and 74%, respectively, and the rate of absorption was not significantly different from that obtained following oral dosing of the parent compound."( Pharmacokinetic analysis of diethylcarbonate prodrugs of ibuprofen and naproxen.
Avnir, D; Bialer, M; Ladkani, D; Samara, E, 1995
)
0.78
" It appears that a defined concentration-toxicity relationship exists and should be considered when dosage regimens for patients are formulated."( Pharmacokinetic optimisation of the treatment of osteoarthritis.
Brocks, DR; Skeith, KJ, 1994
)
0.29
" The importance of systemically mediated damage was further determined by gastrotoxicity dose-response curves and pyloric ligation experiments in which indomethacin was administered either orally or parenterally, or into stomach or duodenum with the pylorus occluded."( Gastric mucosal damage induced by nonsalicylate nonsteroidal antiinflammatory drugs in rats is mediated systemically.
Giraud, AS; Skeljo, MV; Yeomans, ND, 1993
)
0.29
"(1) Appropriateness of therapy using a four-level safety classification system for the NSAIDs developed by a consensus process; criteria based on safety under the assumption that any particular NSAID is equally likely to be effective when dosed appropriately; (2) evaluation of progression of NSAID therapy using the NSAID Therapy Progression Formula."( Assessing physician choice of nonsteroidal antiinflammatory drugs in a health maintenance organization.
Farris, KB; Kaplan, B; Kirking, DM, 1993
)
0.29
"Diclofenac/misoprostol at twice daily dosing is associated with significantly fewer gastroduodenal ulcers than either piroxicam or naproxen."( Double-blind comparison of efficacy and gastroduodenal safety of diclofenac/misoprostol, piroxicam, and naproxen in the treatment of osteoarthritis.
Bruyn, GA; Geis, GS; Melo Gomes, JA; Roth, SH; Woods, EM; Zeeh, J, 1993
)
0.7
" Dosage increases were permitted after a 2-week trial period."( Efficacy of nabumetone versus diclofenac, naproxen, ibuprofen, and piroxicam in osteoarthritis and rheumatoid arthritis.
DeLapp, RE; Lister, BJ; Poland, M, 1993
)
0.55
" There was a linear dose-response curve that was steeper in women than in men."( Variability in the risk of major gastrointestinal complications from nonaspirin nonsteroidal anti-inflammatory drugs.
Dobson, A; Henry, D; Turner, C, 1993
)
0.29
" administered orally over two 7-day dosing periods."( Gastrointestinal tolerability of lornoxicam compared to that of naproxen in healthy male volunteers.
Aabakken, L; Frenzel, W; Osnes, M, 1996
)
0.53
"Adaptation to gastric damage from nonsteroidal anti-inflammatory drugs (NSAID) has been observed during ongoing dosage in rats and humans."( Gastric microbleeding following single and repeated dosing with naproxen.
Cook, GA; Elliott, SL; Hawkey, CJ; McAlindon, ME; Yeomans, ND, 1995
)
0.53
"To test the hypothesis that unbound concentrations of naproxen in synovial fluid (SF) and plasma (P) are equal over a drug dosage interval at steady state or after a single dose of drug."( Naproxen concentrations in plasma and synovial fluid and effects on prostanoid concentrations.
Day, RO; Francis, H; Geisslinger, G; Vial, J; Williams, KM, 1995
)
1.98
" In addition, the desired pharmacodynamic activity of a once-daily dosage form of naproxen requires rapidly available naproxen for a prompt onset of analgesic activity, as well as a prolonged phase of absorption to provide 24-hour analgesic/anti-inflammatory activity."( IPDAS: a novel technology brings new benefits when applied to naproxen sodium.
Butler, J; Devane, JG; Mulligan, S, 1996
)
0.76
" This allows therapy with a lower dosage than calculated on the basis of plasma concentrations in the case of phenylbutazone and flunixin, possibly also with other NSAIDs having a short plasma half life."( [The tissue cage in dogs--a pharmacologic model for the representation of plasma and tissue kinetics].
Frey, HH; Hashem, A; Scherkl, R, 1996
)
0.29
") opioid analgesic administration (PCA) with fixed schedule and dosage oral/rectal administration of naproxen, and opioid analgesics intramuscularly/orally as needed (i."( A comparison of patient-controlled and fixed schedule analgesia after orthognathic surgery.
Finley, GA; McGrath, P; Multari, J; Precious, DS, 1997
)
0.51
" Etodolac was as effective as naproxen, and the 2 dosage schedules of etodolac were comparable."( Etodolac (Lodine) in the treatment of osteoarthritis: recent studies.
Constantine, G; Schnitzer, TJ, 1997
)
0.59
" IB showed a dose-response relationship which appeared to plateau at doses of 50 and 100 mg/kg."( Effects of the combined oral administration of NSAIDs and dextromethorphan on behavioral symptoms indicative of arthritic pain in rats.
Caruso, FS; Frenk, H; Lu, J; Mao, J; Mayer, DJ; Price, DD, 1996
)
0.29
"Some adaptation occurred in over 90% of subjects after 4 weeks dosing with an NSAID, but adaptation was less frequent in older subjects and in smokers."( The influence of age, gender, Helicobacter pylori and smoking on gastric mucosal adaptation to non-steroidal anti-inflammatory drugs.
Campbell, F; Lipscomb, GR; Rees, WD, 1997
)
0.3
" Nabumetone 1500 mg was chosen for comparison because it is commonly prescribed in a QD dosing regimen for OA."( A double-masked comparison of Naprelan and nabumetone in osteoarthritis of the knee. Naprelan Study Group.
Constantine, G; Fleischmann, RM; Flint, K; Kolecki, B,
)
0.13
" Renal prostaglandin E2 (PGE2) excretion was reduced by NAP in all groups, but most markedly at the conventional dosage (LPS vs."( Targeting naproxen coupled to human serum albumin to nonparenchymal cells reduces endotoxin-induced mortality in rats with biliary cirrhosis.
Albrecht, C; Lebbe, C; Meijer, DK; Melgert, BN; Poelstra, K; Reichen, J; Sägesser, H, 1997
)
0.7
"The aim of the present study was to compare the analgesic efficacy of piroxicam-FDDF (fast dissolving dosage form) with naproxen sodium, following bilateral removal of impacted third molars."( The postoperative analgesic efficacy and safety of piroxicam (FDDF) and naproxen sodium.
Apaydin, S; Gomel, M; Köse, T; Selçuk, E; Tuglular, I, 1998
)
0.74
" The animals were dosed upto the time eschar separated and no raw wound was left."( Influence of naproxen on the healing of open excision wound in rats.
Jamil, K; Margaret, I, 1997
)
0.67
"The 2 arthritis trials identified SC-58635 dosage levels that were consistently effective in treating the signs and symptoms of arthritis and were distinguished from placebo on standard arthritis scales."( Preliminary study of the safety and efficacy of SC-58635, a novel cyclooxygenase 2 inhibitor: efficacy and safety in two placebo-controlled trials in osteoarthritis and rheumatoid arthritis, and studies of gastrointestinal and platelet effects.
Geis, GS; Hubbard, RC; Isakson, PC; Lanza, FL; Lipsky, PE; Schwartz, BD; Simon, LS; Talwalker, S, 1998
)
0.3
"Diclofenac, naproxen, and piroxicam can be administered together with omeprazole 20 mg daily without need for dosage alteration."( Lack of drug-drug interaction between three different non-steroidal anti-inflammatory drugs and omeprazole.
Andersson, T; Bredberg, E; Lagerström, PO; Naesdal, J; Wilson, I, 1998
)
0.68
" Three dosage forms were selected for this study: capsules, suppositories, and creams."( Effect of chemical structure on the release of certain propionic acid derivatives from their dosage forms.
el-Bary, AA; el-Nabarawi, MA; Mohamed, MI, 1998
)
0.3
"To demonstrate that in patients receiving naproxen for the pain of osteoarthritis (OA), the addition of tramadol will allow a reduction in the naproxen dosage without compromising pain relief."( Tramadol allows reduction of naproxen dose among patients with naproxen-responsive osteoarthritis pain: a randomized, double-blind, placebo-controlled study.
Kamin, M; Olson, WH; Schnitzer, TJ, 1999
)
0.86
" The MEND was defined as 250 mg above the naproxen daily dosage at which pain relief was no longer adequate."( Tramadol allows reduction of naproxen dose among patients with naproxen-responsive osteoarthritis pain: a randomized, double-blind, placebo-controlled study.
Kamin, M; Olson, WH; Schnitzer, TJ, 1999
)
0.86
"040) in the treatment effect between the naproxen responders and nonresponders, thus demonstrating a difference in the way responders and nonresponders react to a decrease in naproxen dosage after the addition of tramadol."( Tramadol allows reduction of naproxen dose among patients with naproxen-responsive osteoarthritis pain: a randomized, double-blind, placebo-controlled study.
Kamin, M; Olson, WH; Schnitzer, TJ, 1999
)
0.86
"In patients with painful OA of the knee responding to naproxen 1,000 mg/day, the addition of tramadol 200 mg/day allows a significant reduction in the dosage of naproxen without compromising pain relief."( Tramadol allows reduction of naproxen dose among patients with naproxen-responsive osteoarthritis pain: a randomized, double-blind, placebo-controlled study.
Kamin, M; Olson, WH; Schnitzer, TJ, 1999
)
0.84
" All celecoxib doses were efficacious compared with placebo, although the 50-mg twice-daily dosage regimen was minimally effective."( Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial.
Bensen, WG; Fiechtner, JJ; Geis, GS; Hubbard, RC; Isakson, PC; McMillen, JI; Verburg, KM; Woods, EM; Yu, SS; Zhao, WW, 1999
)
0.3
" The results of this study suggest that no alteration in the sumatriptan dosage will be necessary for migraine patients taking naproxen prophylactic therapy."( Lack of pharmacokinetic interaction between sumatriptan and naproxen.
Rambhau, D; Rao, BR; Rao, YM; Srinivasu, P, 2000
)
0.75
" Veterinary clinicians should monitor the ALB and AAG levels in the plasma of patients and correct dosage regimens according to these levels, where field conditions permit this, in order to ensure the proper usage of drugs with high affinity for ALB or AAG."( Disease-induced alterations in plasma drug-binding proteins and their influence on drug binding percentages in dogs.
Ikenoue, N; Kokue, E; Saitsu, Y; Shimoda, M, 2000
)
0.31
"5 and 16 mg kg(-1)) was evaluated using two dosage regimen protocols: (i) preventive, starting oral administration of the drugs at the time of induction of arthritis and for the following 21 days (day 1 - 21); (ii) therapeutic, starting oral administration of the drugs 7 days after adjuvant injection and for the following 14 days (day 7 - 21)."( NO-naproxen modulates inflammation, nociception and downregulates T cell response in rat Freund's adjuvant arthritis.
Bucci, M; Calignano, A; Cicala, C; Cirino, G; Fiorucci, S; Gerli, R; Ianaro, A; Santucci, L; Wallace, JL, 2000
)
0.93
" A dose-response relationship between celecoxib and upper GI symptoms was not apparent."( Upper gastrointestinal tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo.
Agrawal, NM; Bensen, WG; Burke, TA; Geis, GS; Makuch, RW; Maurath, CJ; Zabinski, RA; Zhao, SZ, 2000
)
0.53
" These varying doses and dosage regimens were studied individually and consisted of 220 to 880 mg administered in single, multiple, and PRN (as needed) doses of naproxen sodium."( A look at the safety profile of over-the-counter naproxen sodium: a meta-analysis.
Bansal, V; Dex, T; Garreffa, S; Proskin, H, 2001
)
0.76
" On day 7 of each dosing phase, serial plasma and 24 h urine samples were collected for analysis."( Effect of naproxen co-administration on valproate disposition.
Addison, RS; Dickinson, RG; Eadie, MJ; Hooper, WD; Parker-Scott, SL, 2000
)
0.71
" A secondary purpose was to obtain an optimized naproxen controlled release solid oral dosage form with a predictable 12 h drug release."( Response surface methodology to obtain naproxen controlled release tablets from its microspheres with Eudragit L100-55.
Faltinek, J; Khan, MA; Reddy, IK; Vaithiyalingam, SR; Zaghloul, AA,
)
0.66
" Comparisons were made between patients taking rofecoxib and those taking either placebo, naproxen (an NSAID with near-complete inhibition of platelet function throughout its dosing interval), or another nonselective NSAIDs used in the development program (diclofenac, ibuprofen, and nabumetone)."( Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib.
Barr, E; Gertz, BJ; Konstam, MA; Reicin, A; Shapiro, D; Sperling, RS; Weir, MR, 2001
)
0.53
" Dosing should be [figure: see text] cautious in old patients, however, because of the ability of NSAIDs and coxibs to cause fluid retention, heart failure, and hypertension."( Gastrointestinal safety of COX-2 specific inhibitors.
Hawkey, CJ; Jones, JI, 2001
)
0.31
"This study has been undertaken to develop a controlled-release tablet dosage form of naproxen using ethocel (ethyl cellulose) as the rate-controlling polymer."( Controlled-release naproxen using micronized ethyl cellulose by wet-granulation and solid-dispersion method.
Ashraf, M; Babar, A; Iqbal, Z, 2002
)
0.87
"The aim of this study was to compare nimesulide-beta-cyclodextrin and naproxen in terms of short-term (2 weeks) pain control with scheduled dosing and medium-term (5."( A randomized, double-blind, multicenter trial of nimesulide-beta-cyclodextrin versus naproxen in patients with osteoarthritis.
Bisogno, S; Di Martino, S; Fioravanti, A; Marcolongo, R; Oldani, V; Scotti, A; Storri, L, 2002
)
0.77
" The primary outcome measures for scheduled dosing were pain on movement (measured by visual analog scale), morning stiffness score, Lequesne index, and adverse events."( A randomized, double-blind, multicenter trial of nimesulide-beta-cyclodextrin versus naproxen in patients with osteoarthritis.
Bisogno, S; Di Martino, S; Fioravanti, A; Marcolongo, R; Oldani, V; Scotti, A; Storri, L, 2002
)
0.54
" On-demand dosing may be an effective and well-tolerated low-dose regimen of nonsteroidal anti-inflammatory drugs for the maintenance of pain control in OA in the medium term."( A randomized, double-blind, multicenter trial of nimesulide-beta-cyclodextrin versus naproxen in patients with osteoarthritis.
Bisogno, S; Di Martino, S; Fioravanti, A; Marcolongo, R; Oldani, V; Scotti, A; Storri, L, 2002
)
0.54
" In the comparative trial, rofecoxib at a dosage of 50 mg/day demonstrated similar efficacy to naproxen at a dosage of 500 mg twice daily."( Rofecoxib for the treatment of rheumatoid arthritis.
Fidan, D; Frankish, R; Garner, S; Judd, M; Towheed, T; Tugwell, P; Wells, G, 2002
)
0.53
" In contrast to standard doses of 2 nonsteroidal antiinflammatory drugs (NSAIDs), a supratherapeutic valdecoxib dosage does not impair platelet function (COX-1)."( Valdecoxib does not impair platelet function.
Kent, JD; Leese, PT; Recker, DP; Talwalker, S, 2002
)
0.31
"This multicenter, randomized, double-blind, placebo-controlled study compared the efficacy and upper gastrointestinal tract safety of valdecoxib at dosages of 5, 10, and 20 mg once daily with placebo and naproxen at the dosage of 500 mg twice daily."( Randomized placebo-controlled trial comparing efficacy and safety of valdecoxib with naproxen in patients with osteoarthritis.
Bevirt, T; Eisen, G; Kivitz, A; Recker, DP; Zhao, WW, 2002
)
0.73
" In the comparative trial, rofecoxib at a dosage of 50 mg/day demonstrated similar efficacy to naproxen at a dosage of 500 mg twice daily."( Rofecoxib for the treatment of rheumatoid arthritis.
Fidan, D; Frankish, R; Garner, S; Judd, M; Towheed, T; Tugwell, P; Wells, G, 2002
)
0.53
" Dose-response and decay curves associated with the broad singlet were found to follow bi-exponentials."( Kinetics of the radicals induced in gamma-irradiated naproxen sodium and apranax. Applicability of ESR technique to monitor radiosterilization of naproxen sodium-containing drugs.
Korkmaz, M; Polat, M, 2002
)
0.56
" The sum of two exponential increasing functions associated with two different radicals of different spectroscopic features and relative weights were found best describing experimental dose-response curve."( ESR detection and dosimetric properties of irradiated naproxen sodium.
Korkmaz, M; Polat, M, 2003
)
0.57
" Enhancer dissolution properties combined with its direct compression feasibility and antiulcerogenic action make CS-L(w) an optimal carrier for developing fast-release oral solid dosage forms of naproxen."( Development and characterization of naproxen-chitosan solid systems with improved drug dissolution properties.
Chemtob, C; Maestrelli, F; Mennini, N; Mura, P; Zerrouk, N, 2003
)
0.78
" Multiple dosing of etoricoxib (up to 150 mg qd) showed no important effects on serum TXB2, bleeding time, or platelet aggregation (COX-1-mediated effects)."( Characterization of etoricoxib, a novel, selective COX-2 inhibitor.
Agrawal, N; Dallob, A; De Schepper, P; DeTora, L; Gertz, B; Gottesdiener, K; Greenberg, H; Hawkey, CJ; Wagner, J; Waldman, S; Wight, N; Wong, P, 2003
)
0.32
" The proposed liquid chromatographic method was successfully applied to the analysis of commercially available naproxen sodium (NS) dosage forms with recoveries of 98."( Simultaneous determination of naproxen and related compounds by HPLC using porous graphitic carbon column.
Darghouth, F; Monser, L, 2003
)
0.82
": Sixty-five healthy male subjects were randomized to receive 8 days' dosing with lumiracoxib 200 mg twice daily (b."( Gastroduodenal tolerability of lumiracoxib vs placebo and naproxen: a pilot endoscopic study in healthy male subjects.
Branson, J; Ford, M; Kellett, N; Mair, S; Milosavljev, S; Rordorf, C; Scott, G, 2003
)
0.56
" In the VIGOR gastrointestinal outcomes trial of >8000 patients, naproxen (an NSAID with aspirin-like sustained antiplatelet effects throughout its dosing interval) was associated with a significantly lower risk of CV events than was rofecoxib."( Selective COX-2 inhibition and cardiovascular effects: a review of the rofecoxib development program.
Gertz, BJ; Reicin, A; Sperling, RS; Weir, MR, 2003
)
0.56
" At the start and end of each dosing period, gastroduodenal injury was assessed by endoscopy and small bowel permeability by differential urinary excretion of lactulose and L-rhamnose."( Gastrointestinal safety of AZD3582, a cyclooxygenase inhibiting nitric oxide donator: proof of concept study in humans.
Atherton, CT; Bebb, JR; Bjarnason, IT; Fagerholm, U; Hawkey, CJ; Jones, JI; Jonzon, B; Karlsson, P; Skelly, MM, 2003
)
0.32
" We also determined the role of cytochrome P450 2C9 (CYP2C9) polymorphism on coumarin dosage and INR in NSAID users."( Potential interaction between acenocoumarol and diclofenac, naproxen and ibuprofen and role of CYP2C9 genotype.
Brouwers, JR; de Jong-van den Berg, LT; de Vries-Bots, AM; Piersma-Wichers, M; Plat, AW; Slomp, J; van Dijk, AA; van Dijk, KN, 2004
)
0.57
" Thus, the direct-compression properties and antiulcerogenic activity, combined with the demonstrated solubilizing power and analgesic effect enhancer ability towards the drug, make chitosan particularly suitable for developing a reduced-dose fast-release solid oral dosage form of naproxen."( Comparison of the effect of chitosan and polyvinylpyrrolidone on dissolution properties and analgesic effect of naproxen.
Chemtob, C; Maestrelli, F; Mennini, N; Mura, P; Zerrouk, N, 2004
)
0.71
"3% (mean+/-SD), respectively, and of the urinary excretion of 11-dehydro-TXB2, an index of systemic biosynthesis of TXA2 in vivo, by 85+/-8% and 78+/-7%, respectively, that persisted throughout the dosing interval."( Clinical pharmacology of platelet, monocyte, and vascular cyclooxygenase inhibition by naproxen and low-dose aspirin in healthy subjects.
Capone, ML; Di Gregorio, P; Grana, M; Merciaro, G; Minuz, P; Patrignani, P; Patrono, C; Ricciotti, E; Sciulli, MG; Tacconelli, S, 2004
)
0.55
" The direct compression properties and antiulcerogenic activity together with the demonstrated dissolution and permeation enhancer abilities toward naproxen make chitosan glutamate an optimal carrier for developing fast-action oral solid dosage forms of this drug."( Influence of chitosan and its glutamate and hydrochloride salts on naproxen dissolution rate and permeation across Caco-2 cells.
Chemtob, C; Maestrelli, F; Mura, P; Zerrouk, N, 2004
)
0.76
" The impact of the dosage to the dissolution rates was also investigated using two different amounts of drug."( Dissolution characteristics of megaloporous tablets prepared with two kinds of matrix granules.
Ertan, G; Güneri, T; Ozgüney, I, 2004
)
0.32
" The unique features of nanosuspensions have enabled their use in various dosage forms, including specialized delivery systems such as mucoadhesive hydrogels."( Nanosuspensions: a promising drug delivery strategy.
Date, AA; Kulkarni, RM; Patravale, VB, 2004
)
0.32
" High quality, larger sample and longer period of randomized controlled trials (possibly with higher dosage of MTX) are needed to verify the uncertainty about the efficacy and toxicity of MTX for the treatment of AS."( Methotrexate for ankylosing spondylitis.
Chen, J; Liu, C, 2004
)
0.32
" These results were confirmed with the results of roentgenographic studies in nine healthy human volunteers to find the shape and integrity of the dosage form."( Formulation and roentgenographic studies of naproxen-pectin-based matrix tablets for colon drug delivery.
Biradar, SS; Khan, A; Kumar, A; Prabhashankar, B; Rao, KP; Satyanath, B; Srishail, SP, 2003
)
0.58
" In the comparative trial, rofecoxib at a dosage of 50 mg/day demonstrated similar efficacy to naproxen at a dosage of 500 mg twice daily."( Rofecoxib for rheumatoid arthritis.
Fidan, DD; Frankish, RR; Garner, SE; Judd, MG; Towheed, TE; Tugwell, P; Wells, G, 2005
)
0.55
" The formation of naproxen products was dependent on pH, chlorine dosage and contact time."( Naproxen removal from water by chlorination and biofilm processes.
Boyd, GR; Grimm, DA; Zhang, S, 2005
)
2.1
" Following dosing of AZD3582 or naproxen, the t1/2 of naproxen was 5, 9-10 and >40 h in rats, minipigs and dogs, respectively."( Pre-clinical pharmacokinetics of the cyclooxygenase-inhibiting nitric oxide donor (CINOD) AZD3582.
Breuer, O; Fagerholm, U; Hoogstraate, J; Swedmark, S, 2005
)
0.61
" 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
"To compare the efficacy, safety, and tolerability of AZD3582 with that of rofecoxib, naproxen, and placebo in patients with osteoarthritis (OA) of the knee, and to define the dosage of AZD3582 (125 mg, 375 mg, and 750 mg twice a day) that is noninferior in efficacy to rofecoxib."( Comparison of the COX-inhibiting nitric oxide donator AZD3582 and rofecoxib in treating the signs and symptoms of Osteoarthritis of the knee.
Hee, A; Kivitz, AJ; Lipetz, RS; Sanders, N; Schnitzer, TJ, 2005
)
0.55
" The naproxen t1/2 and trough steady-state concentrations after AZD3582 and naproxen dosing are similar."( Clinical pharmacokinetics of the cyclooxygenase inhibiting nitric oxide donator (CINOD) AZD3582.
Björnsson, MA; Fagerholm, U, 2005
)
0.84
"The objective of this endoscopic study was to compare the effects on the gastroduodenal mucosa of healthy volunteers of different doses and dosing regimens of AZD3582, a cyclooxygenase-inhibiting nitric oxide donator (CINOD), with equimolar doses of naproxen."( Dose-effect comparisons of the CINOD AZD3582 and naproxen on upper gastrointestinal tract mucosal injury in healthy subjects.
Fornstedt-Wallin, B; Hedman, A; Jonzon, B; Karlsson, P; Wilder-Smith, CH, 2006
)
0.77
" An increased risk was observed for diclofenac and rofecoxib, the latter one with a clear dose-response trend."( Non-steroidal antiinflammatory drugs and the risk of acute myocardial infarction.
García Rodríguez, LA; Hernández-Díaz, S; Varas-Lorenzo, C, 2006
)
0.33
"Physicians' and pharmacists' ability to correctly identify three commonly used oral dosage forms was assessed."( Ability of practitioners to identify solid oral dosage tablets.
Bates, DW; Bult, J; Kim, S; Schiff, GD; Seger, AC, 2006
)
0.33
" Participants were also asked about their experiences and views on current resources and alternatives for identifying oral dosage forms."( Ability of practitioners to identify solid oral dosage tablets.
Bates, DW; Bult, J; Kim, S; Schiff, GD; Seger, AC, 2006
)
0.33
" Overall, 77% expressed dissatisfaction with the current system and 91% favored a universal imprint coding system for oral dosage forms."( Ability of practitioners to identify solid oral dosage tablets.
Bates, DW; Bult, J; Kim, S; Schiff, GD; Seger, AC, 2006
)
0.33
"Understanding the mechanisms underlying the analgesic effect of new cyclooxygenase inhibitors is essential to identify dosing requirements in early stages of drug development."( Correlation between in vitro and in vivo concentration-effect relationships of naproxen in rats and healthy volunteers.
Danhof, M; Della Pasqua, OE; Huntjens, DR; Spalding, DJ, 2006
)
0.56
" 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
)
0.54
" Gastrin was not altered by dosing with naproxen."( Effect of naproxen on gastric acid secretion and gastric pH.
Miner, PB; Redinger, N; Rodriguez-Stanley, S, 2006
)
1
" Subjects were eligible for inclusion in the study if they received an OTC dosage of naproxen (220 mg) or ibuprofen (200 mg)."( Gastrointestinal complications of over-the-counter nonsteroidal antiinflammatory drugs.
Biskupiak, JE; Brixner, DI; Howard, K; Oderda, GM, 2006
)
0.56
" In contrast, naproxen nearly completely inhibited COX-1 over the dosing interval."( A randomized, double-blind, one-week study comparing effects of a novel COX-2 inhibitor and naproxen on the gastric mucosa.
Breese, T; Dale, JC; Harris, SI; Lawson, J; McLaughlin, P; Moberly, JB; Riff, DS; Truitt, KE; Wan, Y; Xu, J, 2007
)
0.92
"Sumatriptan-naproxen sodium was more effective than placebo for headache relief at 2 hours after dosing (study 1, 65% vs 28%; P<."( Sumatriptan-naproxen for acute treatment of migraine: a randomized trial.
Adelman, JU; Alexander, WJ; Barrett, PS; Brandes, JL; Kudrow, D; Lener, SE; O'Carroll, CP; O'Donnell, FJ; Spruill, SE; Stark, SR, 2007
)
1.1
" Increasing dosage (trend P = ."( Smoking, caffeine, and nonsteroidal anti-inflammatory drugs in families with Parkinson disease.
Hancock, DB; Jewett, R; Martin, ER; Scott, BL; Scott, WK; Stacy, MA; Stajich, JM; Vance, JM, 2007
)
0.34
"This multicenter, double-blind, randomized, placebo-controlled, parallel-group study assessed renal function during dosing with etoricoxib 90 mg daily, celecoxib 200 mg twice daily, and naproxen 500 mg twice daily."( Effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs on urinary sodium excretion, blood pressure, and other renal function indicators in elderly subjects consuming a controlled sodium diet.
Gertz, BJ; Gottesdiener, KM; Hilliard, DA; Hreniuk, D; Lasseter, KC; Miller, J; Schwartz, JI; Snyder, KM; Thach, C, 2007
)
0.53
" The potential histological changes were also evaluated after direct dosing of suspensions of naproxen alone and powdered mixtures of inclusion complex-loaded tablet into rat intestinal segments."( Colonic release and reduced intestinal tissue damage of coated tablets containing naproxen inclusion complex.
Lee, BJ; Lee, MK; Piao, ZZ, 2008
)
0.79
" This enabled the commencement of technological work on the design and manufacture of a model dosage form administered to the skin and containing the products of lanolin oxyethylation."( Equilibrium solubilization of lipophilic therapeutic agents by aqueous solutions of products of catalytic oxyethylation of Croda-type lanolin as model excipients of the class of non-ionic surface active agents.
Lukosek, M; Nachajski, MJ; Zgoda, MM, 2007
)
0.34
" Application of the method to the analysis of vigabatrin in serum of dosed patients proved feasible."( Fluorescent high-performance liquid chromatographic analysis of vigabatrin enantiomers after derivatizing with naproxen acyl chloride.
Hsieh, CY; Kwan, AL; Wang, SY; Wu, HL, 2008
)
0.56
" Comparison of isotherms for the target compounds to those for other conventional micropollutants suggested that naproxen and carbamazepine could be effectively removed by applying the same dosage utilized to remove odorous compounds (geosmin and MIB) at very low concentrations."( Adsorption characteristics of selected pharmaceuticals and an endocrine disrupting compound-Naproxen, carbamazepine and nonylphenol-on activated carbon.
Huck, PM; Peldszus, S; Yu, Z, 2008
)
0.78
" Finally, these compounds have shown efficacy when dosed orally in multiple acute and chronic prostaglandin and leukotriene dependent in vivo models."( Indole cytosolic phospholipase A2 alpha inhibitors: discovery and in vitro and in vivo characterization of 4-{3-[5-chloro-2-(2-{[(3,4-dichlorobenzyl)sulfonyl]amino}ethyl)-1-(diphenylmethyl)-1H-indol-3-yl]propyl}benzoic acid, efipladib.
Abraham, WM; Albert, L; Behnke, ML; Chen, L; Clark, JD; Donahue, F; Foley, MA; Goodwin, DG; Hegen, M; Hu, B; Hu, Y; Ipek, M; Keith, J; Kirincich, SJ; Ku, MS; Lee, KL; McKew, JC; Michalak, R; Murphy, EA; Nickerson-Nutter, CL; Ramarao, MK; Shen, MW; Sum, FW; Tam, S; Thakker, P; Thomason, J; Williams, C; Wooder, L; Wu, K; Xu, X, 2008
)
0.35
"Drug nanoparticles are often prepared in a liquid medium, and a drying method such as freeze drying is used to convert them to an oral solid dosage form."( Cryoprotectants for freeze drying of drug nano-suspensions: effect of freezing rate.
Kim, MY; Kim, S; Lee, J; Lee, MK, 2009
)
0.35
" The adequate condition for the chromatographic determination of these compounds in pharmaceutical dosage forms was established based on the different retention behaviors of the species."( Determination of pKa values of nonsteroidal antiinflammatory drug-oxicams by RP-HPLC and their analysis in pharmaceutical dosage forms.
Alsancak, G; Demiralay, EC; Ozkan, SA, 2009
)
0.35
"The aim of this study was to investigate the use of liquisolid technique in improving the dissolution profiles of naproxen in a solid dosage form."( Effects of liquisolid formulations on dissolution of naproxen.
Elkordy, AA; Tiong, N, 2009
)
0.81
" Blood samples were collected at various intervals after dosing to characterise naproxen pharmacokinetics and its effects on PGE(2) and TXB(2) production."( Impact of chronic inflammation on the pharmacokinetic-pharmacodynamic relationship of naproxen.
Danhof, M; Della Pasqua, OE; Huntjens, DR; Spalding, DJ, 2010
)
0.81
" Overall, a minimal effect of CD dosed as a physical mixture was observed and predicted."( Modeling the influence of cyclodextrins on oral absorption of low solubility drugs: II. Experimental validation.
Ahmed, I; Carrier, RL; Gamsiz, ED; Miller, L; Thombre, AG, 2010
)
0.36
"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
)
0.84
" The adverse-event profile of the sumatriptan/naproxen sodium combination tablet did not appear to differ from that of the individual components of the same or similar dosage strengths administered alone or in combination."( Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine.
Haberer, LJ; Lener, SE; McDonald, SA; Taylor, DR; Walls, CM, 2010
)
0.84
" Hence, this method demonstrated to be adequate for in vitro studies of NAP and SUMA in the combinational dosage form, since there is no official monograph, collaborating to the official codes."( In vitro dissolution profile comparison of an anti-migraine combinational drug in dosage form.
Bhojraj, S; Hiremath, VB; Kaliaperumal, K; Nanjan, MJ, 2010
)
0.36
"Drying nanosuspensions into redispersable powders is a critical issue in developing solid dosage forms of drug nanoparticles."( Effective polymeric dispersants for vacuum, convection and freeze drying of drug nanosuspensions.
Kim, S; Lee, J, 2010
)
0.36
"Nineteen male Sprague Dawley rats were divided into three groups and dosed with vehicle, naproxen or naproxcinod by gavage for two weeks."( Intra-renal oxygenation in rat kidneys during water loading: effects of cyclooxygenase (COX) inhibition and nitric oxide (NO) donation.
Du, H; Ji, L; Li, LP; Prasad, PV; Schnitzer, T, 2010
)
0.58
"Freshly excised, full-thickness porcine ear skin was dosed with saturated solutions of the compounds."( Topical delivery of a naproxen-dithranol co-drug: in vitro skin penetration, permeation, and staining.
Heard, CM; Lau, WM; White, AW, 2010
)
0.68
" 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
"Twenty-four hours after the last dosing on day 6 in volunteers receiving aspirin alone or aspirin before naproxen, serum TXB(2) was almost completely inhibited (median [range] 99."( Low-dose naproxen interferes with the antiplatelet effects of aspirin in healthy subjects: recommendations to minimize the functional consequences.
Anzellotti, P; Bruno, A; Capone, ML; Di Francesco, L; Di Gregorio, P; Garcia Rodriguez, LA; Grossi, L; Jeyam, A; Merciaro, G; Patrignani, P; Price, TS; Renda, G; Tacconelli, S; Tontodonati, P, 2011
)
1
"0001) and the 24 hours following morning dosing (LS mean: -2."( Blood pressure effects of naproxcinod in hypertensive patients.
Bittar, N; Chrysant, SG; Djian, J; Duquesroix, B; Pivodic, A; Ramsay, A; Rosen, J; Smith, W; Townsend, R; Weiss, R, 2011
)
0.37
" We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts."( FDA-approved drug labeling for the study of drug-induced liver injury.
Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011
)
0.37
" Patients were treated with sumatriptan-naproxen using a very early intervention paradigm in 4 test migraines over 12 weeks where dosage occurred within 30 minutes of symptom onset."( Sumatriptan-naproxen migraine efficacy in allodynic patients: early intervention.
Hoagland, NA; Hoagland, R; Landy, S, 2012
)
1.03
" Standard solutions of ibuprofen, ketoprofen and naproxen were dosed into the synthetic feed of the MBR."( Enantiospecific fate of ibuprofen, ketoprofen and naproxen in a laboratory-scale membrane bioreactor.
Hashim, NH; Khan, SJ; Nghiem, LD; Stuetz, RM, 2011
)
0.88
"In this article the feasibility of fluidized bed bead coating of nanosuspensions of drugs with significantly different physicochemical properties was investigated as a process to transform nanosuspensions into a solid dosage form."( Bead layering as a process to stabilize nanosuspensions: influence of drug hydrophobicity on nanocrystal reagglomeration following in-vitro release from sugar beads.
Anné, M; Kayaert, P; Van den Mooter, G, 2011
)
0.37
"In this randomized, double-blind, placebo-controlled, single-center trial of 161 consecutive patients undergoing CABG surgery, patients received naproxen 275 mg every 12 hours or placebo at the same dosage and interval over 120 hours immediately after CABG surgery."( Naproxen as prophylaxis against atrial fibrillation after cardiac surgery: the NAFARM randomized trial.
Bodanese, LC; Cirenza, C; da C Guaragna, JC; de Paola, AA; Filho, AC; Horbach, SJ; Lopes, RD; Martini, F; Mehta, RH; Petracco, JB, 2011
)
2.01
" Based on these data, weight can be used as a basis for naproxen dosing in children older than 3 months of age."( Plasma and cerebrospinal fluid pharmacokinetics of naproxen in children.
Hooker, AC; Kokki, H; Kokki, M; Kumpulainen, E; Lehtonen, M; Manner, M; Ranta, VP; Välitalo, P, 2012
)
0.88
"Recently introduced drug-polyelectrolyte complexes prepared by hot-melt extrusion should be processed to solid dosage forms with tailor-made release properties."( Electrolyte-stimulated biphasic dissolution profile and stability enhancement for tablets containing drug-polyelectrolyte complexes.
Breitkreutz, J; Kindermann, C; Matthée, K; Sievert, F, 2012
)
0.38
"Drug-polyelectrolyte complexes enable tailor-made dissolution profiles of solid dosage forms by electrolyte stimulation and increase stability under common storage conditions."( Electrolyte-stimulated biphasic dissolution profile and stability enhancement for tablets containing drug-polyelectrolyte complexes.
Breitkreutz, J; Kindermann, C; Matthée, K; Sievert, F, 2012
)
0.38
"In this study, the potential of wet granulation of ordered mesoporous silica (OMS) material was evaluated to assess the risk of premature drug release during processing and to improve the bulk powder flow properties and compactibility for the development of an immediate release oral dosage form."( Risk assessment of premature drug release during wet granulation of ordered mesoporous silica loaded with poorly soluble compounds itraconazole, fenofibrate, naproxen, and ibuprofen.
Backhuijs, F; Martens, JA; Van den Mooter, G; Vialpando, M, 2012
)
0.58
" Subjects reporting headache pain 2 hours after dosing were randomly assigned into a 12-week double-blind phase, treating 1 moderate-to-severe migraine (attack 2) with placebo (n = 145), suma/nap 10/60 mg (n = 96), 30/180 mg (n = 97), or 85/500 mg (n = 152)."( Randomized trial of sumatriptan and naproxen sodium combination in adolescent migraine.
Derosier, FJ; Goodman, DK; Granberry, WK; Hershey, AD; Jimenez, TB; Lewis, D; Linder, SL; Pearlman, E; Rothner, AD; Runken, MC; Winner, PK, 2012
)
0.65
" Thus, the direct compression properties and reduced ulcerogenic activity, combined with the demonstrated solubilizing power and analgesic effect enhancer ability toward the drug, make naproxen sodium-chitosan spray-dried complexes particularly suitable for developing a reduced-dose, fast-release, solid oral dosage form of naproxen."( Reduced ulcerogenic potential and antiarthritic effect of chitosan-naproxen sodium complexes.
Bhise, KS; Bodhankar, SL; Ghosh, P; Kadam, SS; Paradkar, AR, 2012
)
0.81
"Drug nanoparticles prepared in a liquid medium are commonly freeze-dried for the preparation of an oral dosage in solid dosage form."( Mechanism of freeze-drying drug nanosuspensions.
Chung, NO; Lee, J; Lee, MK, 2012
)
0.38
"The Tekscan(®) WB measurement system was used in MIA rats to examine the acute and chronic dosing effects of drugs that targeted different mechanisms."( Pharmacological validation of early and late phase of rat mono-iodoacetate model using the Tekscan system.
Elmes, SJ; McIntosh, F; Perkins, MN; Rashid, MH; Theberge, Y, 2013
)
0.39
"The taste of oral dosage forms is an important argument regarding patient's compliance and acceptability."( Taste masking of naproxen sodium granules by fluid-bed coating.
Führling, C; Gieseler, H; Stange, U, 2014
)
0.74
" This is to compare the bioavailability of diflunisal-naproxen fixed-dose combination (FDC) with their separate dosage forms."( Comparative in vitro dissolution and in vivo bioavailability of diflunisal/naproxen fixed-dose combination tablets and concomitant administration of diflunisal and naproxen in healthy adult subjects.
El Bedaiwy, HM; Helmy, SA, 2013
)
0.87
" In this in vivo study, oil solutions of the N,N-diethyl glycolamide ester prodrug of naproxen (16 mg/ml) were injected into the rat knee joint by dosing 6 μl formulation per 100g body weight."( Prolonged naproxen joint residence time after intra-articular injection of lipophilic solutions comprising a naproxen glycolamide ester prodrug in the rat.
Agårdh, L; He, W; Larsen, C; Larsen, F; Larsen, SW; Lu, Y; Ostergaard, J; Thing, M; Wu, W, 2013
)
1.02
" All the aspects influencing the adsorption (extraction time, adsorbent dosage and pH) and desorption (desorption time and desorption solvent) of the analyte on the MIPMCNTs have been investigated."( Selective solid-phase extraction of naproxen drug from human urine samples using molecularly imprinted polymer-coated magnetic multi-walled carbon nanotubes prior to its spectrofluorometric determination.
Afkhami, A; Ahmadi, M; Madrakian, T; Soleimani, M, 2013
)
0.66
"This work describes a simple and sensitive method for simultaneous determination of zolmitriptan, naproxen and propranolol in their dosage forms using HPLC."( A rapid and sensitive HPLC assay of some concomitant anti-migraine drugs.
El-Kadi, AO; Lotfy, HM; Michael, AM; Rezk, MR; Shehata, MA, 2014
)
0.62
" Future clinical trials should investigate this association with maximum dosage of drugs, increased treatment duration, and monitoring of social and environmental changes."( NSAIDs are associated with lower depression scores in patients with osteoarthritis.
Aneja, A; Farkouh, ME; Gandhi, S; Greenberg, J; Iyengar, RL; Mosovich, S; Razzouk, L; Thorpe, K, 2013
)
0.39
" Frequent dosing of SumaRT/Nap or naproxen sodium was well tolerated in this study."( Treatment of chronic migraine: a 3-month comparator study of naproxen sodium vs SumaRT/Nap.
Beach, ME; Cady, R; Dexter, K; Freitag, F; Manley, HR; Nett, R, 2014
)
0.92
" Chlorination was relatively not effective for the removal of micropollutants due to the lower chlorine dosage (2 mg L(-1)), lower contact time (1h), and already lower levels of micropollutants at the chlorination stage at WTP."( Occurrence and removal of selected micropollutants in a water treatment plant.
Jo, BI; Nam, SW; Yoon, Y; Zoh, KD, 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
" Innovative new oral and intra-articular pharmaceutically engineered dosage forms are examined."( What's new in NSAID pharmacotherapy: oral agents to injectables.
Atkinson, TJ; Fudin, J; Jahn, HL; Kubotera, N; Rennick, AL; Rhorer, M, 2013
)
0.39
"The present study introduces a miniaturized high-throughput platform to understand the influence of excipients on the performance of oral solid dosage forms during early drug development."( Miniaturized approach for excipient selection during the development of oral solid dosage form.
Cornett, C; Müllertz, A; Munk, T; Raijada, D; Rantanen, J; Sonnergaard, J, 2014
)
0.4
"Solid dispersions are preferentially formulated as solid dosage forms such as tablets and capsules."( Influence of compression forces on the structural stability of naproxen/PVP-VA 64 solid dispersions.
Aarts, J; Van den Mooter, G; Worku, ZA, 2014
)
0.64
" 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
" Therefore, it was found to be an accurate, reproducible, sensitive and highly stability-indicating method and can be successfully applied for routine analysis of simultaneous assay of NPX and ESP in pharmaceutical dosage forms."( A novel ion-pair RP-HPLC method for simultaneous quantification of naproxen and esomeprazole in pharmaceutical formulations.
Kayesh, R; Sultan, MZ,
)
0.37
"This study indicates that a liquid and solid SMEDDS is a strategy for solubility enhancement in the future development of orally delivered dosage forms."( Development of a solid self-microemulsifying drug delivery system (SMEDDS) for solubility enhancement of naproxen.
Čerpnjak, K; Gašperlin, M; Vrečer, F; Zvonar, A, 2015
)
0.63
" Rats were dosed daily with NPX (40 mg/kg body weight/day, gavage) or with the proton pump inhibitor omeprazole (4."( Prevention of chemically induced urinary bladder cancers by naproxen: protocols to reduce gastric toxicity in humans do not alter preventive efficacy.
Bode, A; Boring, DL; Grubbs, CJ; Juliana, MM; Lubet, RA; Minasian, L; Scheiman, JM; Steele, VE; White, J, 2015
)
0.66
"Among their beneficial effects, non-steroidal anti-inflammatory drugs may also exert several side effects which depend on the dosage and the type of these medications."( [Cardiovascular side effects of non-steroidal anti-inflammatory drugs in the light of recent recommendations. Diclofenac is not more dangerous].
Horváth, VJ; Koós, CG; Lakatos, P; Putz, Z; Szabó, G; Tabák, GÁ, 2015
)
0.42
" When co-extruding the core/coat dosage form it was observed that a third layer of polymer, separating the naproxen loaded enteric formulation in the core from the coat, is required to prevent degradation of the acid-labile esomeprazole magnesium at the core/coat interface."( Enteric protection of naproxen in a fixed-dose combination product produced by hot-melt co-extrusion.
De Beer, M; De Beer, T; Monteyne, T; Remon, JP; Vervaet, C; Voorspoels, J; Vynckier, AK, 2015
)
0.94
", adsorption technique, spray-drying process, high-shear granulation, fluid-bed granulation) for preparing solid SMEDDS powders by using solid carriers identified as appropriate and to produce a single (tablets) or multiunit (minitablets) solid dosage form based on prepared solid SMEDDS loaded with naproxen in a dissolved (6% w/w) or supersaturated (18% w/w) state."( Tablets and minitablets prepared from spray-dried SMEDDS containing naproxen.
Čerpnjak, K; Gašperlin, M; Pobirk, AZ; Vrečer, F, 2015
)
0.83
" COX selectivity was determined from dose-response curves by calculating a ratio (COX-2/COX-1) of IC50 values."( In vitro pharmacological evaluation of multitarget agents for thromboxane prostanoid receptor antagonism and COX-2 inhibition.
Bertinaria, M; Buccellati, C; Capra, V; Carnevali, S; Cena, C; Fruttero, R; Garella, D; Hoxha, M; Rolando, B; Rovati, GE; Sala, A, 2016
)
0.43
" From the second to the fifth day of treatment, if patient had VAS >40 mm, increased dosage to four times per day was allowed."( Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain.
Amazonas, RB; Bocchi de Oliveira, MF; Ecclissato, Cda C; Plapler, PG; Scheinberg, MA, 2016
)
0.65
"Orodispersible films possess a great potential as a versatile platform for nanoparticle-loaded oral dosage forms."( Efficient production of nanoparticle-loaded orodispersible films by process integration in a stirred media mill.
Finke, JH; Kwade, A; Steiner, D, 2016
)
0.43
"001 for both); efficacy was sustained over each of the four 12-hour dosing intervals with ibuprofen."( Analgesic Efficacy of a New Immediate-Release/Extended-Release Formulation of Ibuprofen: Results From Single- and Multiple-Dose Postsurgical Dental Pain Studies.
Christensen, S; Daniels, S; Jayawardena, S; Meeves, S; Paluch, E, 2017
)
0.46
" Its pharmacokinetic profile after single and multiple dosing was compared to immediate release (IR) naproxen sodium in two randomized, open-label, crossover studies, under fasting and fed conditions."( Pharmacokinetic profile of extended-release versus immediate-release oral naproxen sodium after single and multiple dosing under fed and fasting conditions: two randomized, open-label trials.
Laurora, I; Wang, Y, 2016
)
0.88
" After oral administration naproxen will act as sustain release dosage and increase patient compliance about six batches of tablet were developed and evaluate ."( Formulation and in vitro evaluation of colchicines and naproxen sodium sustain release tablets in combination for treatment of gout.
Khan, ZM; Mahmood, RK; Mehmood, Y; Raza, SA; Riaz, H; Saleem, N; Yousaf, H, 2016
)
0.98
", dose) on the resulting kinetic solubility profiles of supersaturating dosage forms."( Effect of Extent of Supersaturation on the Evolution of Kinetic Solubility Profiles.
Han, YR; Lee, PI, 2017
)
0.46
" A piezo-actuated micro-valve has been investigated for the dispensing and depositioning of drug nanosuspensions onto substrates to facilitate the manufacturing of solid oral dosage forms."( Impact of Formulation Properties and Process Parameters on the Dispensing and Depositioning of Drug Nanosuspensions Using Micro-Valve Technology.
Bonhoeffer, B; Juhnke, M; Kwade, A, 2017
)
0.46
" dosing of NPX at 50 mg/kg."( Effect of Disease-Related Changes in Plasma Albumin on the Pharmacokinetics of Naproxen in Male and Female Arthritic Rats.
Almon, RR; DuBois, DC; Jusko, WJ; Li, X, 2017
)
0.68
" Lack of quantitative information about the drug exposure-response relationship has resulted in empirical dosage regimens for use of NPX in RA."( Modeling Sex Differences in Pharmacokinetics, Pharmacodynamics, and Disease Progression Effects of Naproxen in Rats with Collagen-Induced Arthritis.
Almon, RR; DuBois, DC; Jusko, WJ; Li, X, 2017
)
0.67
" The method was fully validated for the determination of S-isomers of each drug in their dosage form."( High performance liquid chromatography with photo diode array for separation and analysis of naproxen and esomeprazole in presence of their chiral impurities: Enantiomeric purity determination in tablets.
El-Kimary, EI; Ragab, MAA, 2017
)
0.67
"To develop the first photoactive biomaterial coating capable of controlled drug dosing via inclusion of synthesised drug-3,5-dimethoxybenzoin (DMB) conjugates in a poly(2-methyoxyethyl acrylate) (pMEA) scaffold."( Photochemically Controlled Drug Dosing from a Polymeric Scaffold.
Donnelly, L; Gorman, SP; Hardy, JG; Irwin, NJ; Jones, DS; McCoy, CP, 2017
)
0.46
" Solid dosage forms containing Naproxen Sodium often have to be processed in an applicable dosage form by granulation and tablet compression."( Improving the drug release of Naproxen Sodium tablets by preparing granules and tablets with a preferred mixing ratio of hydrates.
Bär, D; Debus, H; Fischer, W; Grune, C; Imming, P; Mäder, K; Tosch, S, 2017
)
1.03
"This study demonstrates continuous enantiomeric inversion and further biotransformation of chiral profens including ibuprofen, naproxen and ketoprofen by an enzymatic membrane bioreactor (EMBR) dosed with laccase."( Continuous transformation of chiral pharmaceuticals in enzymatic membrane bioreactors for advanced wastewater treatment.
Hai, FI; Khan, SJ; McDonald, JA; Nghiem, LD; Nguyen, LN; Price, WE, 2017
)
0.66
" Interventions included celecoxib at a dosage of 100-200 mg twice daily, ibuprofen at a dosage of 600-800 mg 3 times daily, or naproxen at a dosage of 375-500 mg twice daily."( Differences in Safety of Nonsteroidal Antiinflammatory Drugs in Patients With Osteoarthritis and Patients With Rheumatoid Arthritis: A Randomized Clinical Trial.
Bao, W; Berger, MF; Borer, JS; Graham, DY; Husni, ME; Libby, P; Lincoff, AM; Lüscher, TF; Menon, V; Nissen, SE; Solomon, DH; Wang, Q; Wisniewski, LM; Wolski, KE; Yeomans, ND, 2018
)
0.69
"In four multi-center, multi-dose, randomized, parallel, double-blind, placebo-controlled studies, oral naproxen sodium (age-based dosing regimen: <65 years, 660 mg/day; ≥65 years, 440 mg/day) or placebo was administered over 7 days."( Analgesic efficacy and safety of non-prescription doses of naproxen sodium in the management of moderate osteoarthritis of the knee or hip.
An, R; Couto, A; Moon, J; Paredes-Diaz, A; Troullos, E, 2018
)
0.94
" However, their versatility is limited since the powder component is present throughout the dosage forms fabricated by binder jet 3D printing and material extrusion 3D printing requires high operating temperatures."( Photocurable poly(ethylene glycol) as a bioink for the inkjet 3D pharming of hydrophobic drugs.
Acosta-Vélez, GF; Linsley, CS; Wu, BM; Zhu, TZ, 2018
)
0.48
" Undoubtedly, the enteric dosage forms with naproxen can be considered as safer."( Gellan gum macrobeads loaded with naproxen: The impact of various naturally derived polymers on pH-dependent behavior.
Froelich, A; Kunstman, P; Milanowski, B; Osmałek, TZ; Skotnicki, M; Soból, M; Szybowicz, M, 2018
)
1.02
" No new safety signals were identified for the well-characterized components of this fixed dosed JIA treatment, which was developed to reduce the risk of gastric ulcers."( A 6-month, multicenter, open-label study of fixed dose naproxen/esomeprazole in adolescent patients with juvenile idiopathic arthritis.
Alpan, O; Ball, J; Dare, JA; Francis-Sedlak, M; Goldsmith, D; Gottlieb, B; Gupta, R; Holt, RJ; Jerath, R; Jung, L; LaMoreaux, BD; Lovell, DJ; Naddaf, H; Reinhardt, A; Von Scheven, E; Zeft, A, 2018
)
0.73
" High drug loadings may allow decreasing the pill burden and/or reducing dosage size, which both increase the therapeutic compliance."( Chemically identical but physically different: A comparison of spray drying, hot melt extrusion and cryo-milling for the formulation of high drug loaded amorphous solid dispersions of naproxen.
Dedroog, S; Huygens, C; Van den Mooter, G, 2019
)
0.71
"The manufacture of oral dosage form may induce changes in the physical form of an active pharmaceutical ingredient."( Effect of processing conditions and excipients on dehydration kinetics of sodium naproxen hydrate in formulation.
Garcia-Barriocanal, J; Thakral, NK; Thakral, S, 2019
)
0.74
" We unexpectedly discover a new class of aggregating ligands that exhibit negligible interactions with proteins but act as competitive sinks for the free inhibitor, resulting in bell-shaped dose-response curves."( Mechanisms of Specific versus Nonspecific Interactions of Aggregation-Prone Inhibitors and Attenuators.
Ahmed, R; Boulton, S; Cheng, X; Melacini, G; Selvaratnam, R; Van, K, 2019
)
0.51
"3%) in the dosage of 250 mg twice a day."( Naproxen for the treatment of neoplastic fever: A PRISMA-compliant systematic review and meta-analysis.
Huang, Z; Lin, Z; Liu, T; Wu, Y; Yang, Y; Zhang, H; Zhong, X, 2019
)
1.96
"Liqui-pellet is a new dosage form stemming from pelletisation technology and concept from liquisolid technology."( Optimising the release rate of naproxen liqui-pellet: a new technology for emerging novel oral dosage form.
Ghafourian, T; Lam, M; Nokhodchi, A, 2020
)
0.84
" Thus, we assessed the efficacy associated with different dosing regimens of aspirin and naproxen."( Intermittent Dosing Regimens of Aspirin and Naproxen Inhibit Azoxymethane-Induced Colon Adenoma Progression to Adenocarcinoma and Invasive Carcinoma.
Biddick, L; Janakiram, NB; Li, Q; Lightfoot, S; Lubet, RA; Madka, V; Miller, MS; Mohammed, A; Rao, CV; Sei, S; Singh, A; Steele, VE; Suen, CS; Zhang, Y, 2019
)
1
" Through this work, we have demonstrated that by the implementation of predictive thermodynamic modelling, HDASD formulation design can be integrated into the HME process design to ensure the desired quality of the final dosage form."( The design and development of high drug loading amorphous solid dispersion for hot-melt extrusion platform.
Andrews, GP; Jacobs, E; Jones, DS; McCoy, CP; Tian, Y; Wu, H, 2020
)
0.56
" An optimized dose-response curve is then presented, introducing (±) amphetamine hydrochloride (0."( A Molecularly Imprinted Polymer-based Dye Displacement Assay for the Rapid Visual Detection of Amphetamine in Urine.
Arreguin-Campos, R; Caldara, M; Cleij, TJ; Diliën, H; Eersels, K; Heidt, B; Jimenez-Monroy, KL; Lowdon, JW; Rogosic, R; van Grinsven, B, 2020
)
0.56
" The incentive to convert the novel Liqui-Pellet into Liqui-Tablet was due to the array of inherent advantages of the popular and preferred tablet dosage form."( Liqui-Tablet: the Innovative Oral Dosage Form Using the Newly Developed Liqui-Mass Technology.
Asare-Addo, K; Lam, M; Nokhodchi, A, 2021
)
0.62
" The interplay of hydrodynamics in the vessel and the swelling and erosion of dosage forms often results in substantial deviations from the dissolution behavior obtained under perfect sink approximation."( Studying Drug Release through Polymeric Controlled Release Formulations in United States Pharmacopoeia 2 Apparatus Using Multiphysics Simulation and Experiments.
Jha, PK; Ranjan, A, 2021
)
0.62
"A sensitive and selective method needs to be developed and validated for simultaneous determination of four drugs (amoxacillin, tinidazole, naproxen and lansoprazole), used for treating Helicobacter pylori infection, in their combined dosage forms."( RP-HPLC-DAD Method Development and Validation for Simultaneous Determination of Lansoprazole, Tinidazole, Amoxicillin, and Naproxen in Their Raw Materials and Combined Dosage Form: DOE Approach for Optimization of the Proposed Method.
Hassib, ST; Mostafa, EA; Sharf, MG; Taha, EA, 2022
)
1.13
"The method can be easily implemented in QC studies of the cited drugs in their dosage forms."( RP-HPLC-DAD Method Development and Validation for Simultaneous Determination of Lansoprazole, Tinidazole, Amoxicillin, and Naproxen in Their Raw Materials and Combined Dosage Form: DOE Approach for Optimization of the Proposed Method.
Hassib, ST; Mostafa, EA; Sharf, MG; Taha, EA, 2022
)
0.93
"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
" The validated method was successfully applied to the analysis of DOM and NAP in their laboratory prepared tablets resembling the commercial dosage form, and assay results were favorably compared with a published reference HPLC method."( HPLC-Fluorescence Detection Method for Concurrent Estimation of Domperidone and Naproxen. Validation and Eco-Friendliness Appraisal Studies.
Belal, TS; Guirguis, KM; Shaalan, RA; Zeid, MM, 2023
)
1.14
"Detection of incompatibility between an active pharmaceutical ingredient (API) and excipients, including the selection of the most biopharmaceutical advantageous excipients is extremely important in the pre-formulation process of developing a solid dosage form technology."( FTIR, Raman spectroscopy and HT-XRD in compatibility study between naproxen and excipients.
Gazda, M; Plenis, A; Rojek, B, 2023
)
1.15
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (9)

RoleDescription
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.
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.
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.
gout suppressantA drug that increases uric acid excretion by the kidney (uricosuric drug), decreases uric acid production (antihyperuricemic), or alleviates the pain and inflammation of acute attacks of gout.
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.
drug allergenAny drug which causes the onset of an allergic reaction.
[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
monocarboxylic acidAn oxoacid containing a single carboxy group.
methoxynaphthaleneAny alkyloxynaphthalene bearing one or more methoxy substituents.
[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 (1)

PathwayProteinsCompounds
Naproxen Action Pathway2967

Protein Targets (35)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency0.00500.003245.467312,589.2998AID2517
SMAD family member 2Homo sapiens (human)Potency54.94100.173734.304761.8120AID1346859
SMAD family member 3Homo sapiens (human)Potency54.94100.173734.304761.8120AID1346859
AR proteinHomo sapiens (human)Potency43.64120.000221.22318,912.5098AID743036
thyroid stimulating hormone receptorHomo sapiens (human)Potency0.79430.001318.074339.8107AID926; AID938
estrogen nuclear receptor alphaHomo sapiens (human)Potency54.94100.000229.305416,493.5996AID743075
[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)Ki2.00001.60005.744010.0000AID681340
Prostaglandin G/H synthase 1 Bos taurus (cattle)IC50 (µMol)513.00000.00051.41288.2000AID399404; AID399405
Bile salt export pumpHomo sapiens (human)IC50 (µMol)422.66670.11007.190310.0000AID1443980; AID1449628; AID1473738
Dihydrofolate reductaseHomo sapiens (human)Ki7,000.00000.00000.37564.9000AID1660990
Prostaglandin G/H synthase 1Ovis aries (sheep)IC50 (µMol)15.88210.00032.177410.0000AID1397088; AID1501905; AID160746; AID162151; AID1628933; AID587448; AID633796; AID723698; AID724443
Cytochrome P450 2C9 Homo sapiens (human)IC50 (µMol)50.00000.00002.800510.0000AID1210069
Polyunsaturated fatty acid 5-lipoxygenaseRattus norvegicus (Norway rat)IC50 (µMol)17.00000.00462.018210.0000AID6861
Hormone-sensitive lipaseRattus norvegicus (Norway rat)IC50 (µMol)1.20000.37001.27003.2500AID390722
Aldo-keto reductase family 1 member C4Homo sapiens (human)IC50 (µMol)100.00002.30004.86338.2500AID703399
Prostaglandin G/H synthase 1Homo sapiens (human)IC50 (µMol)7.51020.00021.557410.0000AID161496; AID161654; AID1864906; AID378690; AID402403; AID625243
Adenosine receptor A1Rattus norvegicus (Norway rat)IC50 (µMol)1,015.00000.00020.552110.0000AID399405
Caspase-1Homo sapiens (human)IC50 (µMol)28.66670.00201.70138.8000AID1802657
Adenosine receptor A2aRattus norvegicus (Norway rat)IC50 (µMol)1,015.00000.00120.48289.0000AID399405
Prostaglandin G/H synthase 2Homo sapiens (human)IC50 (µMol)104.40550.00010.995010.0000AID1501906; AID162632; AID162644; AID162666; AID1628937; AID1852387; AID1864907; AID402402; AID587449; AID625244; AID724444
Prostaglandin G/H synthase 2 Rattus norvegicus (Norway rat)IC50 (µMol)0.06000.00291.786810.0000AID160881
Aldo-keto reductase family 1 member C3Homo sapiens (human)IC50 (µMol)0.58670.05002.207010.0000AID1628930; AID257049; AID703400
Caspase-3Homo sapiens (human)IC50 (µMol)28.66670.00021.19798.8000AID1802657
Caspase-4Homo sapiens (human)IC50 (µMol)28.66670.30002.26418.8000AID1802657
Cytochrome P450 2J2Homo sapiens (human)IC50 (µMol)50.00000.01202.53129.4700AID1210069
Caspase-5Homo sapiens (human)IC50 (µMol)28.66670.30002.23588.8000AID1802657
Aldo-keto reductase family 1 member C2 Homo sapiens (human)IC50 (µMol)16.28000.37004.09519.2800AID1628931; AID703401
Caspase-9Homo sapiens (human)IC50 (µMol)28.66670.30002.26418.8000AID1802657
Prostaglandin G/H synthase 2Ovis aries (sheep)IC50 (µMol)509.18000.00101.453910.0000AID1397089; AID399405
Aldo-keto reductase family 1 member C1Homo sapiens (human)IC50 (µMol)100.00000.00603.12657.9000AID703402
Solute carrier family 22 member 6Homo sapiens (human)IC50 (µMol)5.80000.27004.53069.9000AID681160
Prostaglandin G/H synthase 1 Rattus norvegicus (Norway rat)IC50 (µMol)0.06000.00291.823210.0000AID160881
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
[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)
Polyunsaturated fatty acid 5-lipoxygenaseRattus norvegicus (Norway rat)Change100.00000.30003.566710.0000AID6772; AID6773
Polyunsaturated fatty acid 5-lipoxygenaseRattus norvegicus (Norway rat)Inhibition20.00000.03500.78251.5300AID3642
Prostaglandin G/H synthase 2 Rattus norvegicus (Norway rat)Change0.20000.10002.60008.0000AID160868; AID160870
Prostaglandin G/H synthase 1 Rattus norvegicus (Norway rat)Change0.20000.10002.60008.0000AID160868; AID160870
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (251)

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)
response to oxidative stressProstaglandin G/H synthase 1 Bos taurus (cattle)
cellular oxidant detoxificationProstaglandin G/H synthase 1 Bos taurus (cattle)
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)
tetrahydrobiopterin biosynthetic processDihydrofolate reductaseHomo sapiens (human)
one-carbon metabolic processDihydrofolate reductaseHomo sapiens (human)
negative regulation of translationDihydrofolate reductaseHomo sapiens (human)
axon regenerationDihydrofolate reductaseHomo sapiens (human)
response to methotrexateDihydrofolate reductaseHomo sapiens (human)
dihydrofolate metabolic processDihydrofolate reductaseHomo sapiens (human)
tetrahydrofolate metabolic processDihydrofolate reductaseHomo sapiens (human)
tetrahydrofolate biosynthetic processDihydrofolate reductaseHomo sapiens (human)
folic acid metabolic processDihydrofolate reductaseHomo sapiens (human)
positive regulation of nitric-oxide synthase activityDihydrofolate reductaseHomo sapiens (human)
regulation of removal of superoxide radicalsDihydrofolate reductaseHomo 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)
retinoid metabolic processAldo-keto reductase family 1 member C4Homo sapiens (human)
bile acid biosynthetic processAldo-keto reductase family 1 member C4Homo sapiens (human)
steroid metabolic processAldo-keto reductase family 1 member C4Homo sapiens (human)
androgen metabolic processAldo-keto reductase family 1 member C4Homo sapiens (human)
bile acid and bile salt transportAldo-keto reductase family 1 member C4Homo sapiens (human)
daunorubicin metabolic processAldo-keto reductase family 1 member C4Homo sapiens (human)
doxorubicin metabolic processAldo-keto reductase family 1 member C4Homo sapiens (human)
cellular response to jasmonic acid stimulusAldo-keto reductase family 1 member C4Homo sapiens (human)
prostaglandin metabolic processAldo-keto reductase family 1 member C4Homo sapiens (human)
progesterone metabolic processAldo-keto reductase family 1 member C4Homo 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)
cellular response to organic substanceCaspase-1Homo sapiens (human)
pattern recognition receptor signaling pathwayCaspase-1Homo sapiens (human)
proteolysisCaspase-1Homo sapiens (human)
apoptotic processCaspase-1Homo sapiens (human)
signal transductionCaspase-1Homo sapiens (human)
osmosensory signaling pathwayCaspase-1Homo sapiens (human)
protein autoprocessingCaspase-1Homo sapiens (human)
positive regulation of interleukin-1 beta productionCaspase-1Homo sapiens (human)
positive regulation of interleukin-18 productionCaspase-1Homo sapiens (human)
defense response to bacteriumCaspase-1Homo sapiens (human)
regulation of apoptotic processCaspase-1Homo sapiens (human)
positive regulation of canonical NF-kappaB signal transductionCaspase-1Homo sapiens (human)
positive regulation of cysteine-type endopeptidase activity involved in apoptotic processCaspase-1Homo sapiens (human)
icosanoid biosynthetic processCaspase-1Homo sapiens (human)
regulation of inflammatory responseCaspase-1Homo sapiens (human)
positive regulation of inflammatory responseCaspase-1Homo sapiens (human)
protein maturationCaspase-1Homo sapiens (human)
defense response to virusCaspase-1Homo sapiens (human)
pyroptosisCaspase-1Homo sapiens (human)
cellular response to lipopolysaccharideCaspase-1Homo sapiens (human)
cellular response to mechanical stimulusCaspase-1Homo sapiens (human)
cellular response to type II interferonCaspase-1Homo sapiens (human)
cytokine precursor processingCaspase-1Homo sapiens (human)
signaling receptor ligand precursor processingCaspase-1Homo sapiens (human)
AIM2 inflammasome complex assemblyCaspase-1Homo sapiens (human)
positive regulation of tumor necrosis factor-mediated signaling pathwayCaspase-1Homo 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)
retinoid metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
prostaglandin metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
G protein-coupled receptor signaling pathwayAldo-keto reductase family 1 member C3Homo sapiens (human)
response to nutrientAldo-keto reductase family 1 member C3Homo sapiens (human)
steroid metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
positive regulation of cell population proliferationAldo-keto reductase family 1 member C3Homo sapiens (human)
male gonad developmentAldo-keto reductase family 1 member C3Homo sapiens (human)
cellular response to starvationAldo-keto reductase family 1 member C3Homo sapiens (human)
farnesol catabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
cyclooxygenase pathwayAldo-keto reductase family 1 member C3Homo sapiens (human)
keratinocyte differentiationAldo-keto reductase family 1 member C3Homo sapiens (human)
progesterone metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
retinol metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
retinal metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
macromolecule metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
daunorubicin metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
doxorubicin metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
regulation of retinoic acid receptor signaling pathwayAldo-keto reductase family 1 member C3Homo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionAldo-keto reductase family 1 member C3Homo sapiens (human)
testosterone biosynthetic processAldo-keto reductase family 1 member C3Homo sapiens (human)
renal absorptionAldo-keto reductase family 1 member C3Homo sapiens (human)
cellular response to calcium ionAldo-keto reductase family 1 member C3Homo sapiens (human)
cellular response to prostaglandin stimulusAldo-keto reductase family 1 member C3Homo sapiens (human)
cellular response to corticosteroid stimulusAldo-keto reductase family 1 member C3Homo sapiens (human)
cellular response to jasmonic acid stimulusAldo-keto reductase family 1 member C3Homo sapiens (human)
cellular response to prostaglandin D stimulusAldo-keto reductase family 1 member C3Homo sapiens (human)
negative regulation of retinoic acid biosynthetic processAldo-keto reductase family 1 member C3Homo sapiens (human)
regulation of testosterone biosynthetic processAldo-keto reductase family 1 member C3Homo sapiens (human)
positive regulation of endothelial cell apoptotic processAldo-keto reductase family 1 member C3Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processAldo-keto reductase family 1 member C3Homo sapiens (human)
neurotrophin TRK receptor signaling pathwayCaspase-3Homo sapiens (human)
luteolysisCaspase-3Homo sapiens (human)
response to hypoxiaCaspase-3Homo sapiens (human)
B cell homeostasisCaspase-3Homo sapiens (human)
negative regulation of cytokine productionCaspase-3Homo sapiens (human)
proteolysisCaspase-3Homo sapiens (human)
apoptotic processCaspase-3Homo sapiens (human)
DNA damage responseCaspase-3Homo sapiens (human)
axonal fasciculationCaspase-3Homo sapiens (human)
heart developmentCaspase-3Homo sapiens (human)
sensory perception of soundCaspase-3Homo sapiens (human)
learning or memoryCaspase-3Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to osmotic stressCaspase-3Homo sapiens (human)
response to xenobiotic stimulusCaspase-3Homo sapiens (human)
response to UVCaspase-3Homo sapiens (human)
response to woundingCaspase-3Homo sapiens (human)
response to glucoseCaspase-3Homo sapiens (human)
response to X-rayCaspase-3Homo sapiens (human)
regulation of macroautophagyCaspase-3Homo sapiens (human)
protein processingCaspase-3Homo sapiens (human)
hippocampus developmentCaspase-3Homo sapiens (human)
protein catabolic processCaspase-3Homo sapiens (human)
erythrocyte differentiationCaspase-3Homo sapiens (human)
platelet formationCaspase-3Homo sapiens (human)
negative regulation of B cell proliferationCaspase-3Homo sapiens (human)
regulation of protein stabilityCaspase-3Homo sapiens (human)
response to cobalt ionCaspase-3Homo sapiens (human)
response to estradiolCaspase-3Homo sapiens (human)
response to lipopolysaccharideCaspase-3Homo sapiens (human)
glial cell apoptotic processCaspase-3Homo sapiens (human)
response to tumor necrosis factorCaspase-3Homo sapiens (human)
response to nicotineCaspase-3Homo sapiens (human)
response to hydrogen peroxideCaspase-3Homo sapiens (human)
T cell homeostasisCaspase-3Homo sapiens (human)
response to amino acidCaspase-3Homo sapiens (human)
fibroblast apoptotic processCaspase-3Homo sapiens (human)
cell fate commitmentCaspase-3Homo sapiens (human)
negative regulation of cell cycleCaspase-3Homo sapiens (human)
negative regulation of activated T cell proliferationCaspase-3Homo sapiens (human)
striated muscle cell differentiationCaspase-3Homo sapiens (human)
response to glucocorticoidCaspase-3Homo sapiens (human)
neuron apoptotic processCaspase-3Homo sapiens (human)
protein maturationCaspase-3Homo sapiens (human)
anterior neural tube closureCaspase-3Homo sapiens (human)
pyroptosisCaspase-3Homo sapiens (human)
leukocyte apoptotic processCaspase-3Homo sapiens (human)
cellular response to staurosporineCaspase-3Homo sapiens (human)
apoptotic signaling pathwayCaspase-3Homo sapiens (human)
intrinsic apoptotic signaling pathwayCaspase-3Homo sapiens (human)
execution phase of apoptosisCaspase-3Homo sapiens (human)
positive regulation of pyroptosisCaspase-3Homo sapiens (human)
positive regulation of amyloid-beta formationCaspase-3Homo sapiens (human)
epithelial cell apoptotic processCaspase-3Homo sapiens (human)
keratinocyte differentiationCaspase-3Homo sapiens (human)
positive regulation of neuron apoptotic processCaspase-3Homo sapiens (human)
neuron differentiationCaspase-3Homo sapiens (human)
proteolysisCaspase-4Homo sapiens (human)
inflammatory responseCaspase-4Homo sapiens (human)
protein autoprocessingCaspase-4Homo sapiens (human)
defense response to bacteriumCaspase-4Homo sapiens (human)
innate immune responseCaspase-4Homo sapiens (human)
regulation of inflammatory responseCaspase-4Homo sapiens (human)
positive regulation of inflammatory responseCaspase-4Homo sapiens (human)
defense response to Gram-positive bacteriumCaspase-4Homo sapiens (human)
protein maturationCaspase-4Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to endoplasmic reticulum stressCaspase-4Homo sapiens (human)
pyroptosisCaspase-4Homo sapiens (human)
intrinsic apoptotic signaling pathwayCaspase-4Homo sapiens (human)
non-canonical inflammasome complex assemblyCaspase-4Homo sapiens (human)
positive regulation of tumor necrosis factor-mediated signaling pathwayCaspase-4Homo sapiens (human)
cellular response to amyloid-betaCaspase-4Homo sapiens (human)
positive regulation of interleukin-18-mediated signaling pathwayCaspase-4Homo sapiens (human)
apoptotic processCaspase-4Homo sapiens (human)
positive regulation of neuron apoptotic processCaspase-4Homo 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)
proteolysisCaspase-5Homo sapiens (human)
substantia nigra developmentCaspase-5Homo sapiens (human)
protein maturationCaspase-5Homo sapiens (human)
cellular response to mechanical stimulusCaspase-5Homo sapiens (human)
positive regulation of neuron apoptotic processCaspase-5Homo sapiens (human)
apoptotic processCaspase-5Homo sapiens (human)
positive regulation of inflammatory responseCaspase-5Homo sapiens (human)
prostaglandin metabolic processAldo-keto reductase family 1 member C2 Homo sapiens (human)
G protein-coupled receptor signaling pathwayAldo-keto reductase family 1 member C2 Homo sapiens (human)
digestionAldo-keto reductase family 1 member C2 Homo sapiens (human)
steroid metabolic processAldo-keto reductase family 1 member C2 Homo sapiens (human)
positive regulation of cell population proliferationAldo-keto reductase family 1 member C2 Homo sapiens (human)
epithelial cell differentiationAldo-keto reductase family 1 member C2 Homo sapiens (human)
progesterone metabolic processAldo-keto reductase family 1 member C2 Homo sapiens (human)
daunorubicin metabolic processAldo-keto reductase family 1 member C2 Homo sapiens (human)
doxorubicin metabolic processAldo-keto reductase family 1 member C2 Homo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionAldo-keto reductase family 1 member C2 Homo sapiens (human)
cellular response to jasmonic acid stimulusAldo-keto reductase family 1 member C2 Homo sapiens (human)
cellular response to prostaglandin D stimulusAldo-keto reductase family 1 member C2 Homo sapiens (human)
response to hypoxiaCaspase-9Homo sapiens (human)
kidney developmentCaspase-9Homo sapiens (human)
response to ischemiaCaspase-9Homo sapiens (human)
apoptotic processCaspase-9Homo sapiens (human)
DNA damage responseCaspase-9Homo sapiens (human)
intrinsic apoptotic signaling pathway in response to DNA damageCaspase-9Homo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic process by cytochrome cCaspase-9Homo sapiens (human)
protein processingCaspase-9Homo sapiens (human)
platelet formationCaspase-9Homo sapiens (human)
response to cobalt ionCaspase-9Homo sapiens (human)
response to estradiolCaspase-9Homo sapiens (human)
response to lipopolysaccharideCaspase-9Homo sapiens (human)
glial cell apoptotic processCaspase-9Homo sapiens (human)
cellular response to UVCaspase-9Homo sapiens (human)
signal transduction in response to DNA damageCaspase-9Homo sapiens (human)
positive regulation of apoptotic processCaspase-9Homo sapiens (human)
fibroblast apoptotic processCaspase-9Homo sapiens (human)
neuron apoptotic processCaspase-9Homo sapiens (human)
protein maturationCaspase-9Homo sapiens (human)
cellular response to dexamethasone stimulusCaspase-9Homo sapiens (human)
leukocyte apoptotic processCaspase-9Homo sapiens (human)
intrinsic apoptotic signaling pathwayCaspase-9Homo sapiens (human)
epithelial cell apoptotic processCaspase-9Homo sapiens (human)
positive regulation of neuron apoptotic processCaspase-9Homo sapiens (human)
activation of cysteine-type endopeptidase activity involved in apoptotic processCaspase-9Homo sapiens (human)
retinoid metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
xenobiotic metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
digestionAldo-keto reductase family 1 member C1Homo sapiens (human)
bile acid metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
bile acid and bile salt transportAldo-keto reductase family 1 member C1Homo sapiens (human)
intestinal cholesterol absorptionAldo-keto reductase family 1 member C1Homo sapiens (human)
epithelial cell differentiationAldo-keto reductase family 1 member C1Homo sapiens (human)
progesterone metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
retinal metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
cholesterol homeostasisAldo-keto reductase family 1 member C1Homo sapiens (human)
daunorubicin metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
doxorubicin metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
response to organophosphorusAldo-keto reductase family 1 member C1Homo sapiens (human)
cellular response to jasmonic acid stimulusAldo-keto reductase family 1 member C1Homo sapiens (human)
positive regulation of reactive oxygen species metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
prostaglandin metabolic processAldo-keto reductase family 1 member C1Homo sapiens (human)
monoatomic anion transportSolute carrier family 22 member 6Homo sapiens (human)
response to organic cyclic compoundSolute carrier family 22 member 6Homo sapiens (human)
inorganic anion transportSolute carrier family 22 member 6Homo sapiens (human)
organic anion transportSolute carrier family 22 member 6Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 6Homo sapiens (human)
alpha-ketoglutarate transportSolute carrier family 22 member 6Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 6Homo sapiens (human)
sodium-independent organic anion transportSolute carrier family 22 member 6Homo sapiens (human)
transmembrane transportSolute carrier family 22 member 6Homo sapiens (human)
metanephric proximal tubule developmentSolute carrier family 22 member 6Homo sapiens (human)
renal tubular secretionSolute carrier family 22 member 6Homo 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)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (119)

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)
peroxidase activityProstaglandin G/H synthase 1 Bos taurus (cattle)
heme bindingProstaglandin G/H synthase 1 Bos taurus (cattle)
metal ion bindingProstaglandin G/H synthase 1 Bos taurus (cattle)
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)
mRNA regulatory element binding translation repressor activityDihydrofolate reductaseHomo sapiens (human)
mRNA bindingDihydrofolate reductaseHomo sapiens (human)
dihydrofolate reductase activityDihydrofolate reductaseHomo sapiens (human)
folic acid bindingDihydrofolate reductaseHomo sapiens (human)
NADPH bindingDihydrofolate reductaseHomo sapiens (human)
sequence-specific mRNA bindingDihydrofolate reductaseHomo sapiens (human)
NADP bindingDihydrofolate reductaseHomo 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)
retinal dehydrogenase activityAldo-keto reductase family 1 member C4Homo sapiens (human)
aldo-keto reductase (NADPH) activityAldo-keto reductase family 1 member C4Homo sapiens (human)
estradiol 17-beta-dehydrogenase [NAD(P)] activityAldo-keto reductase family 1 member C4Homo sapiens (human)
electron transfer activityAldo-keto reductase family 1 member C4Homo sapiens (human)
bile acid transmembrane transporter activityAldo-keto reductase family 1 member C4Homo sapiens (human)
oxidoreductase activity, acting on NAD(P)H, quinone or similar compound as acceptorAldo-keto reductase family 1 member C4Homo sapiens (human)
dihydrotestosterone 17-beta-dehydrogenase activityAldo-keto reductase family 1 member C4Homo sapiens (human)
androsterone dehydrogenase activityAldo-keto reductase family 1 member C4Homo sapiens (human)
5alpha-androstane-3beta,17beta-diol dehydrogenase activityAldo-keto reductase family 1 member C4Homo sapiens (human)
testosterone dehydrogenase (NAD+) activityAldo-keto reductase family 1 member C4Homo sapiens (human)
androstan-3-alpha,17-beta-diol dehydrogenase activityAldo-keto reductase family 1 member C4Homo sapiens (human)
testosterone 17-beta-dehydrogenase (NADP+) activityAldo-keto reductase family 1 member C4Homo sapiens (human)
chlordecone reductase activityAldo-keto reductase family 1 member C4Homo sapiens (human)
aldose reductase (NADPH) activityAldo-keto reductase family 1 member C4Homo sapiens (human)
ketosteroid monooxygenase activityAldo-keto reductase family 1 member C4Homo sapiens (human)
bile acid bindingAldo-keto reductase family 1 member C4Homo 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)
endopeptidase activityCaspase-1Homo sapiens (human)
cysteine-type endopeptidase activityCaspase-1Homo sapiens (human)
protein bindingCaspase-1Homo sapiens (human)
cysteine-type endopeptidase activator activity involved in apoptotic processCaspase-1Homo sapiens (human)
kinase bindingCaspase-1Homo sapiens (human)
cytokine bindingCaspase-1Homo sapiens (human)
identical protein bindingCaspase-1Homo sapiens (human)
CARD domain bindingCaspase-1Homo sapiens (human)
caspase bindingCaspase-1Homo sapiens (human)
G protein-coupled adenosine receptor activityAdenosine receptor A2aRattus norvegicus (Norway rat)
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)
retinal dehydrogenase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
aldose reductase (NADPH) activityAldo-keto reductase family 1 member C3Homo sapiens (human)
aldo-keto reductase (NADPH) activityAldo-keto reductase family 1 member C3Homo sapiens (human)
estradiol 17-beta-dehydrogenase [NAD(P)] activityAldo-keto reductase family 1 member C3Homo sapiens (human)
all-trans-retinol dehydrogenase (NAD+) activityAldo-keto reductase family 1 member C3Homo sapiens (human)
oxidoreductase activity, acting on NAD(P)H, quinone or similar compound as acceptorAldo-keto reductase family 1 member C3Homo sapiens (human)
phenanthrene 9,10-monooxygenase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
dihydrotestosterone 17-beta-dehydrogenase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
prostaglandin H2 endoperoxidase reductase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
prostaglandin D2 11-ketoreductase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
geranylgeranyl reductase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
ketoreductase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
prostaglandin-F synthase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
15-hydroxyprostaglandin-D dehydrogenase (NADP+) activityAldo-keto reductase family 1 member C3Homo sapiens (human)
androsterone dehydrogenase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
5alpha-androstane-3beta,17beta-diol dehydrogenase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
testosterone dehydrogenase (NAD+) activityAldo-keto reductase family 1 member C3Homo sapiens (human)
androstan-3-alpha,17-beta-diol dehydrogenase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
testosterone 17-beta-dehydrogenase (NADP+) activityAldo-keto reductase family 1 member C3Homo sapiens (human)
ketosteroid monooxygenase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
Delta4-3-oxosteroid 5beta-reductase activityAldo-keto reductase family 1 member C3Homo sapiens (human)
all-trans-retinol dehydrogenase (NADP+) activityAldo-keto reductase family 1 member C3Homo sapiens (human)
bile acid bindingAldo-keto reductase family 1 member C3Homo sapiens (human)
protease bindingCaspase-3Homo sapiens (human)
aspartic-type endopeptidase activityCaspase-3Homo sapiens (human)
cysteine-type endopeptidase activityCaspase-3Homo sapiens (human)
cyclin-dependent protein serine/threonine kinase inhibitor activityCaspase-3Homo sapiens (human)
death receptor bindingCaspase-3Homo sapiens (human)
protein bindingCaspase-3Homo sapiens (human)
peptidase activityCaspase-3Homo sapiens (human)
phospholipase A2 activator activityCaspase-3Homo sapiens (human)
protein-containing complex bindingCaspase-3Homo sapiens (human)
cysteine-type endopeptidase activity involved in apoptotic processCaspase-3Homo sapiens (human)
cysteine-type endopeptidase activity involved in apoptotic signaling pathwayCaspase-3Homo sapiens (human)
cysteine-type endopeptidase activity involved in execution phase of apoptosisCaspase-3Homo sapiens (human)
enzyme activator activityCaspase-3Homo sapiens (human)
lipopolysaccharide bindingCaspase-4Homo sapiens (human)
cysteine-type endopeptidase activityCaspase-4Homo sapiens (human)
protein bindingCaspase-4Homo sapiens (human)
lipid bindingCaspase-4Homo sapiens (human)
CARD domain bindingCaspase-4Homo sapiens (human)
cysteine-type endopeptidase activity involved in apoptotic processCaspase-4Homo 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)
cysteine-type endopeptidase activityCaspase-5Homo sapiens (human)
protein bindingCaspase-5Homo sapiens (human)
cysteine-type peptidase activityCaspase-5Homo sapiens (human)
cysteine-type endopeptidase activity involved in apoptotic processCaspase-5Homo sapiens (human)
aldose reductase (NADPH) activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
estradiol 17-beta-dehydrogenase [NAD(P)] activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
oxidoreductase activity, acting on NAD(P)H, quinone or similar compound as acceptorAldo-keto reductase family 1 member C2 Homo sapiens (human)
phenanthrene 9,10-monooxygenase activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
carboxylic acid bindingAldo-keto reductase family 1 member C2 Homo sapiens (human)
bile acid bindingAldo-keto reductase family 1 member C2 Homo sapiens (human)
androstan-3-alpha,17-beta-diol dehydrogenase activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
ketosteroid monooxygenase activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
trans-1,2-dihydrobenzene-1,2-diol dehydrogenase activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
indanol dehydrogenase activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
androsterone dehydrogenase activityAldo-keto reductase family 1 member C2 Homo sapiens (human)
cysteine-type endopeptidase activityCaspase-9Homo sapiens (human)
protein bindingCaspase-9Homo sapiens (human)
enzyme activator activityCaspase-9Homo sapiens (human)
peptidase activityCaspase-9Homo sapiens (human)
SH3 domain bindingCaspase-9Homo sapiens (human)
protein kinase bindingCaspase-9Homo sapiens (human)
cysteine-type endopeptidase activity involved in apoptotic processCaspase-9Homo sapiens (human)
cysteine-type endopeptidase activity involved in apoptotic signaling pathwayCaspase-9Homo sapiens (human)
aldose reductase (NADPH) activityAldo-keto reductase family 1 member C1Homo sapiens (human)
aldo-keto reductase (NADPH) activityAldo-keto reductase family 1 member C1Homo sapiens (human)
estradiol 17-beta-dehydrogenase [NAD(P)] activityAldo-keto reductase family 1 member C1Homo sapiens (human)
protein bindingAldo-keto reductase family 1 member C1Homo sapiens (human)
oxidoreductase activity, acting on NAD(P)H, quinone or similar compound as acceptorAldo-keto reductase family 1 member C1Homo sapiens (human)
phenanthrene 9,10-monooxygenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
testosterone dehydrogenase [NAD(P)] activityAldo-keto reductase family 1 member C1Homo sapiens (human)
carboxylic acid bindingAldo-keto reductase family 1 member C1Homo sapiens (human)
bile acid bindingAldo-keto reductase family 1 member C1Homo sapiens (human)
3beta-hydroxy-5beta-steroid dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
steroid dehydrogenase activity, acting on the CH-OH group of donors, NAD or NADP as acceptorAldo-keto reductase family 1 member C1Homo sapiens (human)
dihydrotestosterone 17-beta-dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
17-alpha,20-alpha-dihydroxypregn-4-en-3-one dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
5alpha-androstane-3beta,17beta-diol dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
androsterone dehydrogenase (B-specific) activityAldo-keto reductase family 1 member C1Homo sapiens (human)
androstan-3-alpha,17-beta-diol dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
testosterone 17-beta-dehydrogenase (NADP+) activityAldo-keto reductase family 1 member C1Homo sapiens (human)
ketosteroid monooxygenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
trans-1,2-dihydrobenzene-1,2-diol dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
indanol dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
androsterone dehydrogenase activityAldo-keto reductase family 1 member C1Homo sapiens (human)
solute:inorganic anion antiporter activitySolute carrier family 22 member 6Homo sapiens (human)
protein bindingSolute carrier family 22 member 6Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
alpha-ketoglutarate transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
antiporter activitySolute carrier family 22 member 6Homo sapiens (human)
transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
chloride ion bindingSolute carrier family 22 member 6Homo sapiens (human)
identical protein bindingSolute carrier family 22 member 6Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 6Homo sapiens (human)
sodium-independent organic anion transmembrane transporter activitySolute carrier family 22 member 6Homo 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)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (46)

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)
endoplasmic reticulum membraneProstaglandin G/H synthase 1 Bos taurus (cattle)
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)
mitochondrionDihydrofolate reductaseHomo sapiens (human)
cytosolDihydrofolate reductaseHomo sapiens (human)
mitochondrionDihydrofolate reductaseHomo 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)
lipid dropletHormone-sensitive lipaseRattus norvegicus (Norway rat)
cytosolHormone-sensitive lipaseRattus norvegicus (Norway rat)
cytoplasmAldo-keto reductase family 1 member C4Homo sapiens (human)
cytosolAldo-keto reductase family 1 member C4Homo sapiens (human)
extracellular exosomeAldo-keto reductase family 1 member C4Homo sapiens (human)
cytosolAldo-keto reductase family 1 member C4Homo 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)
cytoplasmCaspase-1Homo sapiens (human)
cytosolCaspase-1Homo sapiens (human)
nucleolusCaspase-1Homo sapiens (human)
cytoplasmCaspase-1Homo sapiens (human)
cytosolCaspase-1Homo sapiens (human)
microtubuleCaspase-1Homo sapiens (human)
plasma membraneCaspase-1Homo sapiens (human)
canonical inflammasome complexCaspase-1Homo sapiens (human)
NLRP1 inflammasome complexCaspase-1Homo sapiens (human)
NLRP3 inflammasome complexCaspase-1Homo sapiens (human)
AIM2 inflammasome complexCaspase-1Homo sapiens (human)
protein-containing complexCaspase-1Homo sapiens (human)
IPAF inflammasome complexCaspase-1Homo sapiens (human)
protease inhibitor complexCaspase-1Homo sapiens (human)
Golgi membraneAdenosine receptor A2aRattus norvegicus (Norway rat)
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)
nucleusAldo-keto reductase family 1 member C3Homo sapiens (human)
cytoplasmAldo-keto reductase family 1 member C3Homo sapiens (human)
cytosolAldo-keto reductase family 1 member C3Homo sapiens (human)
extracellular exosomeAldo-keto reductase family 1 member C3Homo sapiens (human)
cytosolAldo-keto reductase family 1 member C3Homo sapiens (human)
nucleusCaspase-3Homo sapiens (human)
cytoplasmCaspase-3Homo sapiens (human)
nucleusCaspase-3Homo sapiens (human)
nucleoplasmCaspase-3Homo sapiens (human)
cytosolCaspase-3Homo sapiens (human)
neuronal cell bodyCaspase-3Homo sapiens (human)
death-inducing signaling complexCaspase-3Homo sapiens (human)
cytosolCaspase-4Homo sapiens (human)
extracellular regionCaspase-4Homo sapiens (human)
mitochondrionCaspase-4Homo sapiens (human)
endoplasmic reticulumCaspase-4Homo sapiens (human)
endoplasmic reticulum membraneCaspase-4Homo sapiens (human)
cytosolCaspase-4Homo sapiens (human)
plasma membraneCaspase-4Homo sapiens (human)
protein-containing complexCaspase-4Homo sapiens (human)
non-canonical inflammasome complexCaspase-4Homo sapiens (human)
cytoplasmCaspase-4Homo sapiens (human)
NLRP1 inflammasome complexCaspase-4Homo 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)
cytosolCaspase-5Homo sapiens (human)
NLRP1 inflammasome complexCaspase-5Homo sapiens (human)
cytoplasmCaspase-5Homo sapiens (human)
cytosolAldo-keto reductase family 1 member C2 Homo sapiens (human)
mitochondrionCaspase-9Homo sapiens (human)
nucleusCaspase-9Homo sapiens (human)
cytosolCaspase-9Homo sapiens (human)
caspase complexCaspase-9Homo sapiens (human)
apoptosomeCaspase-9Homo sapiens (human)
protein-containing complexCaspase-9Homo sapiens (human)
cytosolCaspase-9Homo sapiens (human)
cytoplasmCaspase-9Homo sapiens (human)
cytosolAldo-keto reductase family 1 member C1Homo sapiens (human)
extracellular exosomeAldo-keto reductase family 1 member C1Homo sapiens (human)
cytosolAldo-keto reductase family 1 member C1Homo sapiens (human)
plasma membraneSolute carrier family 22 member 6Homo sapiens (human)
caveolaSolute carrier family 22 member 6Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 6Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 6Homo sapiens (human)
extracellular exosomeSolute carrier family 22 member 6Homo sapiens (human)
protein-containing complexSolute carrier family 22 member 6Homo 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)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (680)

Assay IDTitleYearJournalArticle
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.
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.
AID160870Prostaglandin G/H synthase Inhibitory activity against rat polymorphonuclear leucocytes from female wistar rat, by using PGE-2.1995Journal of medicinal chemistry, Apr-28, Volume: 38, Issue:9
Synthesis and antiinflammatory activity of certain 5,6,7,8-tetrahydroquinolines and related compounds.
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.
AID118143Antiinflammatory activity, administered ip at 150 uM/kg dose was determined against carrageenan-induced mice paw edema model2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID429539Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 40 mg/kg, po administered 30 mins before carrageenan challenge measured after 1 hr2009Bioorganic & medicinal chemistry, May-15, Volume: 17, Issue:10
Chlorzoxazone esters of some non-steroidal anti-inflammatory (NSAI) carboxylic acids as mutual prodrugs: design, synthesis, pharmacological investigations and docking studies.
AID1221776Cytotoxicity against mock transfected HEK293 cells assessed as decrease in cell viability at 1 mM by MTT assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1698003Fraction unbound in rat plasma
AID640983Ulcerogenic effect in Wistar rat assessed as gastric bleeding at 90 mg/kg after 6 hrs2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Synthesis, pharmacological evaluation and docking studies of N-(benzo[d]thiazol-2-yl)-2-(piperazin-1-yl)acetamide analogs as COX-2 inhibitors.
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.
AID1188963Permeability coefficient, log Pe of the compound by PAMPA2014ACS medicinal chemistry letters, Aug-14, Volume: 5, Issue:8
An uncharged oxetanyl sulfoxide as a covalent modifier for improving aqueous solubility.
AID1636440Drug activation in human Hep3B cells assessed as human CYP2D6-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID24203Distribution coefficient in octanol/water at pH 6.51998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID1384716Inhibition of Influenza A virus nucleoprotein/polymerase acidic protein (1 to 27 residues) complex formation at 50 uM in presence of DNA by surface plasmon resonance analysis2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1501461Drug metabolism assessed as CYP2C19 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID177015Antiinflammatory activity assessed by inhibition of carrageenan-induced edema in rats at a dose of 15 mg/kg1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-6-(methylthio)-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-ca rboxyl ic acids and 1-methyl-4-(methylthio)-5-aroylpyrrole-2-acetic acids.
AID183218Compound was tested in vivo for antiinflammatory activity against chronic adjuvant arthritic rat by therapeutic inhibition 2 degree paw after peroral administration of 0.3 mg/kg of dose1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID624647Inhibition of AZT glucuronidation by human UGT enzymes from liver microsomes2005Pharmacology & therapeutics, Apr, Volume: 106, Issue:1
UDP-glucuronosyltransferases and clinical drug-drug interactions.
AID162151Tested for inhibitory activity against Prostaglandin G/H synthase 1 from ovine1995Journal of medicinal chemistry, Sep-29, Volume: 38, Issue:20
Antiinflammatory 4,5-diarylpyrroles. 2. Activity as a function of cyclooxygenase-2 inhibition.
AID1598713Binding affinity to Triton-X 100 at 150 uM by 1H-NMR spectra analysis2019Journal of medicinal chemistry, 05-23, Volume: 62, Issue:10
Mechanisms of Specific versus Nonspecific Interactions of Aggregation-Prone Inhibitors and Attenuators.
AID1864927Toxicity in mouse infected with Candida albicans assessed as BUN level in plasma at 10 ug per 20 g, ip administered on day 2, 4, 6, 8, 10 and 12 and measured on day 14 in presence of fluconazole (Rvb = 8.2 +/- 0.5 mmol/L)
AID640982Ulcerogenic effect in Wistar rat assessed as lesions in stomach area at 90 mg/kg after 6 hrs2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Synthesis, pharmacological evaluation and docking studies of N-(benzo[d]thiazol-2-yl)-2-(piperazin-1-yl)acetamide analogs as COX-2 inhibitors.
AID377747Antiinflammatory activity in mouse assessed as inhibition of phorbol myristyl palmitate-induced ear lobe edema at 1 umol/ear after 24 hrs relative to control2006Journal of natural products, Jul, Volume: 69, Issue:7
Chamazulene carboxylic acid and matricin: a natural profen and its natural prodrug, identified through similarity to synthetic drug substances.
AID631590Half life in Kunming mouse plasma at dose equivalent to 10 mg/kg, iv of naproxen administered as single dose2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
AID1733445Cytotoxicity against human MDA-MB-231 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry, 05-01, Volume: 37Design and synthesis of novel (S)-Naproxen hydrazide-hydrazones as potent VEGFR-2 inhibitors and their evaluation in vitro/in vivo breast cancer models.
AID1698000Apparent permeability in dog MDCKII-LE cells at pH 7.4
AID237685Lipophilicity determined as logarithm of the partition coefficient in the alkane/water system2005Journal of medicinal chemistry, May-05, Volume: 48, Issue:9
Calculating virtual log P in the alkane/water system (log P(N)(alk)) and its derived parameters deltalog P(N)(oct-alk) and log D(pH)(alk).
AID715658Antiinflammatory activity in Wistar albino rat assessed as inhibition of carageenaan-induced paw edema at 45 mg/kg, po administered 1 hr prior to carageenaan-challenge measured at 3 hrs relative to control2012European journal of medicinal chemistry, Nov, Volume: 57Synthesis and pharmacological evaluation of pyrazolo[4,3-c]cinnoline derivatives as potential anti-inflammatory and antibacterial agents.
AID28928Intrinsic permeability of the compound2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
High-throughput permeability pH profile and high-throughput alkane/water log P with artificial membranes.
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.
AID183007Analgesic activity (50 mg/kg, sc)in phenylquinone-induced abdominal constriction assay(PAC)1998Journal of medicinal chemistry, Aug-27, Volume: 41, Issue:18
New cyclooxygenase-2/5-lipoxygenase inhibitors. 3. 7-tert-butyl-2, 3-dihydro-3,3-dimethylbenzofuran derivatives as gastrointestinal safe antiinflammatory and analgesic agents: variations at the 5 position.
AID1175133Tmax in Sprague-Dawley rat 10 mg/kg, po2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
AID540221Volume of distribution at steady state in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1864965Immunostimulatory activity in mouse infected with Candida albicans ATCC SC5314 assessed as increase in CD8+ expression level in spleen in presence of fluconazole by immunohistochemical analysis
AID260547Gastrointestinal toxicity in rat at 1350 umol/kg, sc2006Bioorganic & medicinal chemistry letters, Feb-15, Volume: 16, Issue:4
Synthesis and pharmacochemical study of novel polyfunctional molecules combining anti-inflammatory, antioxidant, and hypocholesterolemic properties.
AID1293304Antiproliferative activity against human UACC-903 cells assessed as reduction in cell viability after 48 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1128737In vivo antidyslipidemic activity against Triton WR 1339-induced hyperlipidemic Wistar rat model assessed as decrease in total cholesterol level in plasma at 56 umol/kg, ip administered as single dose 1 hr after Triton WR 1339 challenge measured after 24 2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
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.
AID723698Inhibition of ovine COX1 assessed as inhibition of PGF2a production by enzyme immunoassay2013Bioorganic & medicinal chemistry, Jan-15, Volume: 21, Issue:2
Synthesis and biological evaluation of some 5-arylidene-2-(1,3-thiazol-2-ylimino)-1,3-thiazolidin-4-ones as dual anti-inflammatory/antimicrobial agents.
AID266762Effective permeability coefficient in 100% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1663613Anticancer activity against human K562 cells assessed as cell growth inhibition measured after 48 hrs by MTT assay2020Bioorganic & medicinal chemistry letters, 07-15, Volume: 30, Issue:14
Synthesis and anticancer activity of open-resorcinarene conjugates.
AID1223486Intrinsic clearance in human hepatocytes from chimeric mouse with humanized liver assessed per 10'6 cells at 10 uM after 0.25 to 2 hrs by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Prediction of in vivo hepatic clearance and half-life of drug candidates in human using chimeric mice with humanized liver.
AID527492Octanol-water partition coefficient, log P of the compound after partitioning between 0.1 M HCl and 1-octanol 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.
AID1195033Antiinflammatory activity against Wistar rat erythrocytes assessed as inhibition of heat-induced hemolysis after 15 mins by membrane stabilizing activity assay2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Synthesis, antinociceptive and anti-inflammatory effects of porphyrins.
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?
AID128488Analgesic activity was assessed from the ability to inhibit phenylquinone-induced writhing in mouse at a dose of 70 mg/kg1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-6-(methylthio)-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-ca rboxyl ic acids and 1-methyl-4-(methylthio)-5-aroylpyrrole-2-acetic acids.
AID467611Dissociation constant, pKa of the compound2009European 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.
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.
AID287966Effect on iPGE2 level in LPS-induced mouse RAW264.7 cells at 10 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID404473Inhibition of carrageenan-induced paw edema in Sprague-Dawley rat administered 2 hrs before carrageenan challenge at 10 mg/kg, po2008Journal of medicinal chemistry, Jun-26, Volume: 51, Issue:12
Indole cytosolic phospholipase A2 alpha inhibitors: discovery and in vitro and in vivo characterization of 4-{3-[5-chloro-2-(2-{[(3,4-dichlorobenzyl)sulfonyl]amino}ethyl)-1-(diphenylmethyl)-1H-indol-3-yl]propyl}benzoic acid, efipladib.
AID28926Effective permeability corrected for ionization2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
High-throughput permeability pH profile and high-throughput alkane/water log P with artificial membranes.
AID1501466Drug metabolism assessed as UGT1A4 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID1628939Selectivity ratio of IC50 for COX2 (unknown origin) to IC50 for human recombinant AKR1C32016Journal of medicinal chemistry, 08-25, Volume: 59, Issue:16
Discovery of (R)-2-(6-Methoxynaphthalen-2-yl)butanoic Acid as a Potent and Selective Aldo-keto Reductase 1C3 Inhibitor.
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?
AID1384725Antiviral activity against Influenza A virus (A/Udorn/1972 (H3N2)) infected in human A549 cells assessed as decrease in viral load after 18 hrs by immunofluorescence analysis2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1221796Cellular uptake in human hepatocytes at 1 mM measured at 6 hrs by LC-MS/MS analysis in absence of acyl glucuronidation inhibitor (-)-borneol2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1397090Selectivity ratio of IC50 for ovine COX1 to IC50 for ovine COX22018Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14
Synthesis and biological properties of aryl methyl sulfones.
AID1221817Cytotoxicity against HEK293 cells expressing UGT1A3 assessed as decrease in cell viability by measuring intracellular ATP content at 1 mM by CellTiter-Glo luminescent assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID178497Antiinflammatory activity was assessed from the ability to inhibit adjuvant-induced arthritis in rats1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-6-(methylthio)-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-ca rboxyl ic acids and 1-methyl-4-(methylthio)-5-aroylpyrrole-2-acetic acids.
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.
AID377722Antiinflammatory activity in mouse assessed as inhibition of phorbol myristyl palmitate-induced ear lobe edema at 0.1 umol/ear after 6 hrs relative to control2006Journal of natural products, Jul, Volume: 69, Issue:7
Chamazulene carboxylic acid and matricin: a natural profen and its natural prodrug, identified through similarity to synthetic drug substances.
AID624618Specific activity of expressed human recombinant UGT2B42000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID116723Acute toxicity as LD50 value was determined in mice administered orally1982Journal of medicinal chemistry, Dec, Volume: 25, Issue:12
Synthesis and antiinflammatory activity of hexahydrothiopyrano[4,3-c]pyrazoles and related analogues.
AID756041Gastrointestinal toxicity in Kunming mouse assessed as ulcer index at 200 mg/kg, po after 4 hrs2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Design, synthesis and biological evaluation of enzymatically cleavable NSAIDs prodrugs derived from self-immolative dendritic scaffolds for the treatment of inflammatory diseases.
AID1273104Cytotoxicity against human FOCUS cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
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.
AID1128818Antiinflammatory activity in mouse assessed as inhibition of xylene-induced ear swelling at 150 mg/kg, ig administered 90 mins prior to xylene challenge measured after 30 mins2014Bioorganic & medicinal chemistry letters, Apr-01, Volume: 24, Issue:7
Synthesis and pharmacological evaluation of novel limonin derivatives as anti-inflammatory and analgesic agents with high water solubility.
AID1744121Inhibition of human ACMSD assessed as QUIN level at 1 mM by HPLC analysis (Rvb = 16.4 +/- 2.9%)2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Diflunisal Derivatives as Modulators of ACMS Decarboxylase Targeting the Tryptophan-Kynurenine Pathway.
AID1698008Hepatic clearance in Wistar Hannover rat at 1 mg/kg, iv
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.
AID183200Compound was tested in vivo for antiinflammatory activity against chronic adjuvant arthritic rat by prophylactic inhibition 2 degree paw after peroral administration of 1 mg/kg of dose1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID1864882Antifungal activity against Aspergillus fumigatus KM8001 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID1077803Cytotoxicity against human BxPC3 cells assessed as growth inhibition after 24 hrs by MTT assay
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.
AID196177Effect on non perforated ulcers(NPU) at the dose of 50 mg/kg.2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID29811Oral bioavailability in human2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1175152Toxicity in rat assessed as gastric lesion and ulcer area at 100 mg/kg, po after 5 hrs2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
AID540217Volume of distribution at steady state in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID135277Neurotoxic dose that causes minimal recognizable neurotoxicity in 50% of animals tested1981Journal of medicinal chemistry, May, Volume: 24, Issue:5
Effect of structural change on acute toxicity and antiinflammatory activity in a series of imidazothiazoles and thiazolobenzimidazoles.
AID1223490Apparent permeability across human differentiated Caco2 cells2012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Predicting phenolic acid absorption in Caco-2 cells: a theoretical permeability model and mechanistic study.
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.
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.
AID266764Membrane permeability, CA(t)/CD(0) in 70% silicon-30% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
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.
AID1384731Selectivity index, ratio of CC50 for MDCK cells to IC50 for Influenza A virus (A/Udorn/1972 (H3N2)) infected in MDCK cells at MOI of 2 after 18 hrs2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1150601Ulcerogenicity in po dosed 24-hrs starved Charles-River rat assessed as lesions on stomach administered as single dose measured after 18 hrs1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Cycloalkanoindoles. 1. Syntheses and antiinflammatory actions of some acidic tetrahydrocarbazoles, cyclopentindoles, and cycloheptindoles.
AID703400Inhibition of human recombinant N-terminal His6-tagged AKR1C3 expressed in Escherichia coli BL21(DE3) cells using 8-Acetyl-2,3,5,6-tetrahydro-1H,4H-11-oxa-3a-aza-benzo[de]anthracen-10-one as substrate after 1 hr by fluorimetric analysis2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
3-(3,4-Dihydroisoquinolin-2(1H)-ylsulfonyl)benzoic Acids: highly potent and selective inhibitors of the type 5 17-β-hydroxysteroid dehydrogenase AKR1C3.
AID1384738Downregulation of COX2 level in human A549 cells infected with Influenza A virus at MOI of 2 at 300 uM after 18 hrs in presence of gamma-ATP by immunofluorescence analysis2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1864888Antifungal activity against Cryptococcus neoformans ZKCC 2209 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID640981Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 30 mg/kg after 2 hrs2012Bioorganic & medicinal chemistry letters, Jan-15, Volume: 22, Issue:2
Synthesis, pharmacological evaluation and docking studies of N-(benzo[d]thiazol-2-yl)-2-(piperazin-1-yl)acetamide analogs as COX-2 inhibitors.
AID1128736In vivo antiinflammatory activity in mouse assessed as decrease in carrageenan-induced paw edema at 0.30 mmol/kg, ip administered immediately after carrageenan injection measured after 3.5 hrs2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
AID631664Cmax in Kunming mouse brain at dose equivalent to 10 mg/kg, iv of naproxen administered as single dose2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
AID1384723Selectivity index, ratio of CC50 for MDCK cells to IC50 for Influenza A virus (A/WSN/1933(H1N1)) infected in MDCK cells at MOI of 2 after 18 hrs2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID540215Volume of distribution at steady state in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1864886Antifungal activity against Candida krusei ATCC 6258 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID1375678Antiarthritic activity in CFA-induced Sprague-Dawley rat rheumatoid arthritis model assessed as increase in tolerated weight on ipsilateral paw at 5.6 mg/kg, po measured up to 60 mins by paw pressure test2018Journal of medicinal chemistry, 06-14, Volume: 61, Issue:11
Discovery of Novel Nonsteroidal Anti-Inflammatory Drugs and Carbonic Anhydrase Inhibitors Hybrids (NSAIDs-CAIs) for the Management of Rheumatoid Arthritis.
AID1221782Cytotoxicity against HEK293 cells expressing UGT assessed as decrease in cell viability at 1 mM measured up to 72 hrs by MTT assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID134578Lethal dose evaluated in NPP assay1981Journal of medicinal chemistry, May, Volume: 24, Issue:5
Effect of structural change on acute toxicity and antiinflammatory activity in a series of imidazothiazoles and thiazolobenzimidazoles.
AID266769Membrane retention in 100% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
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.
AID587451Antiinflammatory activity in po dosed Sprague-Dawley rat assessed as inhibition of carrageenam-induced paw edema administered 1 hr before carrageenan challenge measured after 3 hrs by Plethysmometer2011Journal of medicinal chemistry, Mar-10, Volume: 54, Issue:5
Ethanesulfohydroxamic acid ester prodrugs of nonsteroidal anti-inflammatory drugs (NSAIDs): synthesis, nitric oxide and nitroxyl release, cyclooxygenase inhibition, anti-inflammatory, and ulcerogenicity index studies.
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.
AID1384715Inhibition of Influenza A virus nucleoprotein/polymerase acidic protein (1 to 27 residues) complex formation at 100 nM by surface plasmon resonance analysis2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID472916Analgesic activity against CFA-induced inflammatory pain in Sprague-Dawley rat assessed as reversal of decrease in weight bearing at 20 mg/kg, po qd for 3 days administered 24 hrs after CFA challenge2010Journal of medicinal chemistry, Apr-22, Volume: 53, Issue:8
Discovery of novel 6,6-heterocycles as transient receptor potential vanilloid (TRPV1) antagonists.
AID1293296Antiproliferative activity against human HT-29 cells assessed as reduction in cell viability after 72 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID299738Antiinflammatory activity against carrageenan-induced paw edema in rat at 30 mg/kg, po after 4 hrs2007Bioorganic & medicinal chemistry letters, Aug-15, Volume: 17, Issue:16
Synthesis and pharmacological evaluation of condensed heterocyclic 6-substituted-1,2,4-triazolo[3,4-b]-1,3,4-thiadiazole derivatives of naproxen.
AID756045Cytotoxicity against HEK293 cells assessed as cell viability at 2 to 32 ug/ml after 24 hrs by MTT assay2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Design, synthesis and biological evaluation of enzymatically cleavable NSAIDs prodrugs derived from self-immolative dendritic scaffolds for the treatment of inflammatory diseases.
AID1221846Cytotoxicity against human hepatocytes assessed as decrease in cell viability by measuring intracellular ATP content at 1 mM measured at 6 hrs by CellTiter-Glo luminescent assay in absence of acyl glucuronidation inhibitor (-)-borneol2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1663616Anticancer activity against human SKLU1 cells assessed as cell growth inhibition measured after 48 hrs by MTT assay2020Bioorganic & medicinal chemistry letters, 07-15, Volume: 30, Issue:14
Synthesis and anticancer activity of open-resorcinarene conjugates.
AID266771Permeability in human skin2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1501463Drug metabolism assessed as CYP3A4 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID19262Aqueous solubility2000Bioorganic & medicinal chemistry letters, Jun-05, Volume: 10, Issue:11
Prediction of drug solubility from Monte Carlo simulations.
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.
AID1628933Inhibition of COX1 in ram seminal vesicles using arachidonic acid as substrate assessed as reduction in PGH2 conversion to PGG2 by measuring TMPD oxidation preincubated for 5 mins followed by substrate/TMPD addition measured for 5 mins by colorimetric ass2016Journal of medicinal chemistry, 08-25, Volume: 59, Issue:16
Discovery of (R)-2-(6-Methoxynaphthalen-2-yl)butanoic Acid as a Potent and Selective Aldo-keto Reductase 1C3 Inhibitor.
AID251807Inhibition of CXCL8-induced chemotaxis of human polymorphonuclear cells at 10e-8 M2005Journal of medicinal chemistry, Jun-30, Volume: 48, Issue:13
2-Arylpropionic CXC chemokine receptor 1 (CXCR1) ligands as novel noncompetitive CXCL8 inhibitors.
AID390722Inhibition of HSL in Wistar rat isolated fat cells by spectrophotometric assay2008Journal of medicinal chemistry, Oct-23, Volume: 51, Issue:20
Combining ligand-based pharmacophore modeling, quantitative structure-activity relationship analysis and in silico screening for the discovery of new potent hormone sensitive lipase inhibitors.
AID497302Antiinflammatory activity in rat assessed as inhibition of complete Freund's adjuvant-induced hind paw edema at 20 mg/kg, po administered 1 day after complete Freund's adjuvant challenge QD for 3 consecutive days measured at 24 hrs post dose on day 32010Bioorganic & medicinal chemistry letters, Aug-01, Volume: 20, Issue:15
Pyrido[2,3-b]pyrazines, discovery of TRPV1 antagonists with reduced potential for the formation of reactive metabolites.
AID1744122Inhibition of human ACMSD assessed as picolinic acid level at 1 mM by HPLC analysis (Rvb = 83.6 +/- 3.1%)2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Diflunisal Derivatives as Modulators of ACMS Decarboxylase Targeting the Tryptophan-Kynurenine Pathway.
AID197603Lysozyme-conjugated prodrugs: in vitro stability at pH 51992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID26304Partition coefficient (logD6.5)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1150596Chronic antiinflammatory activity against adjuvant-induced arthritis in po dosed rat assessed as decrease in volume of paw administered for 9 days starting 14 days after adjuvant injection and continued until day 22 by therapeutic test1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Cycloalkanoindoles. 1. Syntheses and antiinflammatory actions of some acidic tetrahydrocarbazoles, cyclopentindoles, and cycloheptindoles.
AID266763Membrane retention in 70% silicon-30% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1663615Anticancer activity against human MCF7 cells assessed as cell growth inhibition measured after 48 hrs by MTT assay2020Bioorganic & medicinal chemistry letters, 07-15, Volume: 30, Issue:14
Synthesis and anticancer activity of open-resorcinarene conjugates.
AID1175139Cmax in Sprague-Dawley rat at 10 mg/kg, po after 2 hrs2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
AID710660Antinociceptive activity in Cav2.2 deficient mouse assessed as reversal of complete Freund's adjuvant-induced pain at 30 mg/kg, po after 1 hr2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Aminopiperidine sulfonamide Cav2.2 channel inhibitors for the treatment of chronic pain.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1158663Antiinflammatory activity in Complete-Freunds adjuvant-induced Sprague-Dawley rat pain model assessed as reversal of mechanical hypersensitivity at 30 mg/kg, po bid for 7 days2014Journal of medicinal chemistry, Jul-10, Volume: 57, Issue:13
Maximizing diversity from a kinase screen: identification of novel and selective pan-Trk inhibitors for chronic pain.
AID1698006Ratio of drug level in cynomolgus monkey blood to plasma administered through iv dosing by LC-MS/MS analysis
AID604743Displacement of radiolabeled warfarin from fatty acid containing human serum albumin site 1 in phosphate buffer at pH 7.4 at 12 uM by fluorescence spectroscopy2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
A combined spectroscopic and crystallographic approach to probing drug-human serum albumin interactions.
AID345900Antiinflammatory activity against carrageenan-induced paw edema in Sprague-Dawley rat at 10 mg/kg, iv2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Reactions of functionalized sulfonamides: application to lowering the lipophilicity of cytosolic phospholipase A2alpha inhibitors.
AID405577Inhibition of human recombinant COX2 at 100 uM2008Journal of natural products, Jun, Volume: 71, Issue:6
Cyclooxygenase (COX)-1 and -2 inhibitory labdane diterpenes from Crassocephalum mannii.
AID177523In vivo inhibitory activity against adjuvant induced arthritis in the rat.2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
Selective cyclooxygenase-2 inhibitors: heteroaryl modified 1,2-diarylimidazoles are potent, orally active antiinflammatory agents.
AID1195148Analgesic activity in Swiss albino mouse assessed as time of licking paws at 50 mg/kg, po measured after 2 hrs by tail flick test relative to control2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
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.
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.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID288193Flux ionization constant, pKa of the membrane permeability coefficient of the compound2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
AID1864896Antifungal activity against fluconazole- resistant Candida albicans 17# assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID1128816Antiinflammatory activity in mouse assessed as xylene-induced ear swollen extent at 150 mg/kg, ig administered 90 mins prior to xylene challenge measured after 30 mins (Rvb = 132.8 +/-16.3%)2014Bioorganic & medicinal chemistry letters, Apr-01, Volume: 24, Issue:7
Synthesis and pharmacological evaluation of novel limonin derivatives as anti-inflammatory and analgesic agents with high water solubility.
AID1864954Antiinflammatory activity in mouse infected with Candida albicans ATCC SC5314 assessed as reduction in COX-2 expression in spleen in presence of fluconazole by hematoxylin staining based inverted microscopic analysis
AID593346Antiinflammatory activity in rat assessed as inhibition of complete Freund's adjuvant-induced paw withdrawal threshold at 20 mg/kg, sc after 60 mins (Rvb = 4.8%)2011Bioorganic & medicinal chemistry letters, Apr-15, Volume: 21, Issue:8
Decahydroquinoline amides as highly selective CB2 agonists: role of selectivity on in vivo efficacy in a rodent model of analgesia.
AID1397089Inhibition of ovine COX2 assessed as reduction in PGH2 production by enzyme immunoassay2018Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14
Synthesis and biological properties of aryl methyl sulfones.
AID781326pKa (acid-base dissociation constant) as determined by Avdeef ref: DOI: 10.1002/047145026X2014Pharmaceutical research, Apr, Volume: 31, Issue:4
Comparison of the accuracy of experimental and predicted pKa values of basic and acidic compounds.
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.
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.
AID1864949Antiinflammatory activity against mouse infected with Candida albicans ATCC SC5314 assessed as reduction in COX-2 expression in spleen in presence of fluconazole by Western blot analysis
AID1175135Cmax in Sprague-Dawley rat at 10 mg/kg, po after 15 mins2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1501905Inhibition of ovine COX1 using arachidonic acid as substrate pretreated for 3 mins followed by substrate addition measured immediately2017Journal of natural products, 09-22, Volume: 80, Issue:9
Lipid Peroxidation and Cyclooxygenase Enzyme Inhibitory Compounds from Prangos haussknechtii.
AID322943Inhibition of COX1 at 100 uM2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
Synthesis and in silico biological activity evaluation of new N-substituted pyrazolo-oxazin-2-one systems.
AID1864874Antifungal actvity against Candida albicans ATCC SC5314 infected in mouse assessed as reduction in fungal infection at 10 ug per 20 g, ip administered on day 2, 4, 6, 8, 10 and 12 and measured on day 14 in presence of fluconazole
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1501465Drug metabolism assessed as UGT1A3 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID1636356Drug activation in human Hep3B cells assessed as human CYP2C9-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID631663Mean residence time in Kunming mouse brain at dose equivalent to 10 mg/kg, iv of naproxen administered as single dose2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
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.
AID29359Ionization constant (pKa)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1852387Inhibition of COX-2 (unknown origin)2022Journal of medicinal chemistry, 10-13, Volume: 65, Issue:19
Hypoxia-Activated Prodrugs with Dual COX-2/CA Inhibitory Effects on Attenuating Cardiac Inflammation under Hypoxia.
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.
AID1660990Inhibition of human DHFR in presence of DHF and NADPH by UV-vis spectrometry by Lineweaver-Burk plot analysis2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
The Structural Basis for Nonsteroidal Anti-Inflammatory Drug Inhibition of Human Dihydrofolate Reductase.
AID1501468Drug metabolism assessed as UGT1A8 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID1223477Total clearance in iv dosed human2012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Prediction of in vivo hepatic clearance and half-life of drug candidates in human using chimeric mice with humanized liver.
AID1195150Antiinflammatory activity in Swiss albino mouse assessed as inhibition of carrageenan-induced paw edema at 50 mg/kg, po administered 1 hr prior to carrageenan challenge measured after 2 hrs relative to control2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
AID42828In vitro inhibition of human recombinant IL-1-beta-induced breakdown of bovine cartilage in a cartilage organ culture assay1994Journal of medicinal chemistry, Sep-16, Volume: 37, Issue:19
Heteroaryl-fused 2-phenylisothiazolone inhibitors of cartilage breakdown.
AID1136193Toxicity in dog assessed as gastrointestinal intolerance at 10 to 30 mg/kg, po administered as single dose1978Journal of medicinal chemistry, Oct, Volume: 21, Issue:10
Synthesis and antiinflammatory activity of 6,11-dihydro-11-oxodibenzo[b,e]thiepinalkanoic acids and related compounds.
AID171861Anti-inflammatory activity by rat adjuvant Arthritis assay. (3h edema).1995Journal of medicinal chemistry, Apr-28, Volume: 38, Issue:9
Synthesis and antiinflammatory activity of certain 5,6,7,8-tetrahydroquinolines and related compounds.
AID184684Gastrointestinal erosive activity was determined by 7-day chronic assay in rats1987Journal of medicinal chemistry, May, Volume: 30, Issue:5
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acids. The 6-substituted compounds.
AID287973Ratio of iPGJ2 to iPGE in LPS-induced mouse RAW264.7 cells at 2 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID1698009Hepatic clearance in cynomolgus monkey at < 1 mg/kg, iv administered as cassette dosing
AID455986Permeability across human Caco-2 cells2009Bioorganic & medicinal chemistry, Oct-01, Volume: 17, Issue:19
Computational modeling of novel inhibitors targeting the Akt pleckstrin homology domain.
AID287974Ratio of iPGJ2 to iPGE in LPS-induced mouse RAW264.7 cells at 10 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID1384722Selectivity index, ratio of CC50 for MDCK cells to IC50 for Influenza A virus (A/WSN/1933(H1N1)) infected in MDCK cells at MOI of 10'-3 after 48 hrs2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1077806Cytotoxicity against human HT-29 cells assessed as growth inhibition after 24 hrs by MTT assay
AID723697Antiinflammatory activity in AKR mouse assessed as inhibition of carrageenan-induced paw edema at 0.01 mmol/kg, ip measured after 3.5 hrs of carrageenan-challenge2013Bioorganic & medicinal chemistry, Jan-15, Volume: 21, Issue:2
Synthesis and biological evaluation of some 5-arylidene-2-(1,3-thiazol-2-ylimino)-1,3-thiazolidin-4-ones as dual anti-inflammatory/antimicrobial agents.
AID28921Partition coefficient (logP) (hexadecane)2001Journal of medicinal chemistry, Mar-15, Volume: 44, Issue:6
High-throughput permeability pH profile and high-throughput alkane/water log P with artificial membranes.
AID346081Inhibition of IgE-specific antigen-induced PGF2alpha release in rat MC9 cells at 0.20 uM2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Reactions of functionalized sulfonamides: application to lowering the lipophilicity of cytosolic phospholipase A2alpha inhibitors.
AID1576544Antiinflammatory activity against TPA-induced ear edema in BALB/c mouse assessed as effect on weight of ear punches at 100 mg/kg, po administered 6 mins prior to TPA challenge and treated twice in 4 hrs and measured after 6 hrs post administration (Rvb = 2019MedChemComm, Oct-01, Volume: 10, Issue:10
Synergistic effect of tolfenamic acid and glycyrrhizic acid on TPA-induced skin inflammation in mice.
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.
AID160881In vitro inhibitory activity against Prostaglandin G/H synthase in rat neutrophils1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID1221819Cytotoxicity against HEK293 cells expressing UGT assessed as LDH leakage at 1 mM after 6 to 24 hrs by spectrophotometric analysis relative to total cell LDH level2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1128739In vivo antidyslipidemic activity against Triton WR 1339-induced hyperlipidemic Wistar rat model assessed as decrease in triglyceride level in plasma at 56 umol/kg, ip administered as single dose 1 hr after Triton WR 1339 challenge measured after 24 hrs2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
AID1663612Anticancer activity against human PC3 cells assessed as cell growth inhibition measured after 48 hrs by MTT assay2020Bioorganic & medicinal chemistry letters, 07-15, Volume: 30, Issue:14
Synthesis and anticancer activity of open-resorcinarene conjugates.
AID751349Plasma concentration in Duncan Hartley guinea pig at 10 mg/kg, po2013Bioorganic & medicinal chemistry letters, Feb-15, Volume: 23, Issue:4
Discovery and SAR of PF-4693627, a potent, selective and orally bioavailable mPGES-1 inhibitor for the potential treatment of inflammation.
AID310931Partition coefficient, log P of the compound2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
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.
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.
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.
AID1698005Ratio of drug level in Wistar Hannover rat blood to plasma administered through iv dosing by LC-MS/MS analysis
AID1293305Antiproliferative activity against human UACC-903 cells assessed as reduction in cell viability after 72 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID181250compound was tested in vivo for antiinflammatory activity against rats by RPAR(reverse passive Arthus reaction) synovitis method1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID414506Antiinflammatory activity against carrageenan-induced inflammation in Albino mouse air ppouch model assessed as number of polymorphonuclear leukocytes infiltration at 30 mg/kg, po administered 1 hr before carrageenan challenge measured after 4 hrs by air 2009Bioorganic & medicinal chemistry letters, Apr-01, Volume: 19, Issue:7
Benzophenone-N-ethyl piperidine ether analogues--synthesis and efficacy as anti-inflammatory agent.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1293298Antiproliferative activity against human MDA-MB-231 cells assessed as reduction in cell viability after 48 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID288194Intrinsic artificial membrane permeability coefficient, log P0 of the compound2007Bioorganic & medicinal chemistry, Jun-01, Volume: 15, Issue:11
QSAR study on permeability of hydrophobic compounds with artificial membranes.
AID310933Permeability across PAMPA membrane after 7 hrs2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID540216Clearance in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID183350Compound was tested in vivo for antiinflammatory activity against chronic adjuvant arthritic rat by therapeutic inhibition 2 degree paw after peroral administration of 5 mg/kg of dose1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID1128732Inhibition of bovine COX-1 assessed as PGF2-alpha formation using arachidonic acid as substrate at 20 uM by enzyme immunoassay2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
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.
AID404481Inhibition of PGF2apha production in arachidonic acid-stimulated mouse MC9 cells2008Journal of medicinal chemistry, Jun-26, Volume: 51, Issue:12
Indole cytosolic phospholipase A2 alpha inhibitors: discovery and in vitro and in vivo characterization of 4-{3-[5-chloro-2-(2-{[(3,4-dichlorobenzyl)sulfonyl]amino}ethyl)-1-(diphenylmethyl)-1H-indol-3-yl]propyl}benzoic acid, efipladib.
AID1916996Antiinflammatory activity against xylene-induced ear swelling ICR mouse model assessed as swelling inhibition ratio at 100 mg/kg, IG measured after 1 hr2022Journal of medicinal chemistry, 11-10, Volume: 65, Issue:21
Discovery of the First Selective IDO2 Inhibitor As Novel Immunotherapeutic Avenues for Rheumatoid Arthritis.
AID1753657Cytotoxicity against human PC-3 cells assessed as reduction in cell viability measured upto 72 hrs by MTT assay2021European journal of medicinal chemistry, Jun-05, Volume: 218New organoselenides (NSAIDs-Se derivatives) as potential anticancer agents: Synthesis, biological evaluation and in silico calculations.
AID18849Estimation of fraction absorbed (Fa) in the human intestine using biosensor technology.2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
SPR biosensor studies of the direct interaction between 27 drugs and a liposome surface: correlation with fraction absorbed in humans.
AID1128733Inhibition of human recombinant COX-2 assessed as PGF2-alpha formation using arachidonic acid as substrate at 20 uM by enzyme immunoassay2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
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.
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?
AID161496Inhibition activity against recombinant human Prostaglandin G/H synthase 11997Journal of medicinal chemistry, Feb-28, Volume: 40, Issue:5
Nonsteroidal anti-inflammatory drugs as scaffolds for the design of 5-lipoxygenase inhibitors.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
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.
AID1256770Antiinflammatory activity in rat assessed as reduction of carrageenan-induced paw oedema at 0.15 mmol/kg, ip administered 5 mins before carrageenan challenge measured after 3.5 hrs2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
Esters of some non-steroidal anti-inflammatory drugs with cinnamyl alcohol are potent lipoxygenase inhibitors with enhanced anti-inflammatory activity.
AID232500Selectivity ratio of COX-1/COX-22000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID305920Solubility in isopropyl myristate2007Bioorganic & medicinal chemistry letters, Mar-01, Volume: 17, Issue:5
N-Alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) prodrugs of carboxylic acid containing drugs.
AID429541Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 40 mg/kg, po administered 30 mins before carrageenan challenge measured after 3 hrs2009Bioorganic & medicinal chemistry, May-15, Volume: 17, Issue:10
Chlorzoxazone esters of some non-steroidal anti-inflammatory (NSAI) carboxylic acids as mutual prodrugs: design, synthesis, pharmacological investigations and docking studies.
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.
AID1273100Cytotoxicity against human HuH7 cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
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]
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.
AID24263Ability to undergo in vitro ester hydrolysis in 80% human plasma ( pH of 7.4) at 37 degree Celsius expressed as half life of N,N-diethylglycolamide ester hydrolysis1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Esters of N,N-disubstituted 2-hydroxyacetamides as a novel highly biolabile prodrug type for carboxylic acid agents.
AID402403Inhibition of COX1-catalyzed prostaglandin biosynthesis 10 mins of preincubation1998Journal of natural products, Oct, Volume: 61, Issue:10
Ursolic acid from Plantago major, a selective inhibitor of cyclooxygenase-2 catalyzed prostaglandin biosynthesis.
AID715657Antiinflammatory activity in Wistar albino rat assessed as inhibition of carageenaan-induced paw edema at 45 mg/kg, po administered 1 hr prior to carageenaan-challenge measured at 4 hrs relative to control2012European journal of medicinal chemistry, Nov, Volume: 57Synthesis and pharmacological evaluation of pyrazolo[4,3-c]cinnoline derivatives as potential anti-inflammatory and antibacterial agents.
AID177511In vivo inhibition of carrageenan-induced hyperalgesia in rats2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID540214Clearance in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1864959Immunostimulatory activity in mouse infected with Candida albicans ATCC SC5314 assessed as reduction in PD-L1 expression in spleen in presence of fluconazole by western blot analysis relative to control
AID607553Antihyperalgesic effect in complete Freund's adjuvant-induced Sprague-Dawley rat inflammatory pain model assessed as reversal of mechanical hypersensitivity at 20 mg/kg, po after 30 mins2011Bioorganic & medicinal chemistry letters, Jul-15, Volume: 21, Issue:14
Identification of non-amidine inhibitors of acid-sensing ion channel-3 (ASIC3).
AID197596Lysozyme-conjugated prodrugs: in vitro stability at pH 51992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
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.
AID756044Antiinflammatory activity in Kunming mouse assessed as inhibition of xylene-induced auricle tumefaction at 200 uM/kg, tid qd for 5 days relative to control2013Bioorganic & medicinal chemistry, Jul-15, Volume: 21, Issue:14
Design, synthesis and biological evaluation of enzymatically cleavable NSAIDs prodrugs derived from self-immolative dendritic scaffolds for the treatment of inflammatory diseases.
AID177361Antiinflammatory activity was evaluated in an adjuvant arthritis (subchronic inflammation) test, after administering compound orally in rats.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Nonsteroidal antiinflammatory agents. 14. Synthesis and pharmacological profile of 6-chloro-5-(cyclopentylmethyl)indan-1-carboxylic acid.
AID346086Inhibition of arachidonic acid-induced PGF2-alpha release in rat MC9 cells at 0.33 uM2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Reactions of functionalized sulfonamides: application to lowering the lipophilicity of cytosolic phospholipase A2alpha inhibitors.
AID305921Partition coefficient, log K between isopropyl myristate and pH 4.0 buffer2007Bioorganic & medicinal chemistry letters, Mar-01, Volume: 17, Issue:5
N-Alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) prodrugs of carboxylic acid containing drugs.
AID703840Inhibition of mPGES-1 in human IL-1beta-stimulated A549 cell microsomes assessed as inhibition of PGE2 formation from PGH2 after 15 mins by RP-HPLC analysis2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
Modified acidic nonsteroidal anti-inflammatory drugs as dual inhibitors of mPGES-1 and 5-LOX.
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.
AID1384718Antiviral activity against Influenza A virus (A/WSN/1933(H1N1)) infected in MDCK cells at MOI of 10'-3 assessed as decrease in viral load after 48 hrs by crystal violet staining-based plaque assay2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID287975Ratio of iPGJ2 to iPGE in LPS-induced mouse RAW264.7 cells at 50 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID178383Effective dose for Anti-inflammatory activity was determined by carrageenan induced rat hind paw edema model2004Bioorganic & medicinal chemistry letters, Feb-23, Volume: 14, Issue:4
Synthesis and evaluation of S-4-(3-thienyl)phenyl-alpha-methylacetic acid.
AID237474Percentage of drug bound in bovine plasma albumin2004Journal of medicinal chemistry, Jul-29, Volume: 47, Issue:16
Contribution of ionization and lipophilicity to drug binding to albumin: a preliminary step toward biodistribution prediction.
AID553251Antihyperalgesic activity in Sprague-Dawley rat model of complete Freund's adjuvant-induced inflammatory pain model assessed as reduction in mechanical allodynia at 10 mg/kg, po measured 4 hrs post dose2011ACS medicinal chemistry letters, Feb-10, Volume: 2, Issue:2
Discovery of PF-04457845: A Highly Potent, Orally Bioavailable, and Selective Urea FAAH Inhibitor.
AID1223478Total clearance in chimeric mouse with humanized liver at 3 mg/kg, iv by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Prediction of in vivo hepatic clearance and half-life of drug candidates in human using chimeric mice with humanized liver.
AID1864890Antifungal activity against Candida albicans ATCC SC5314 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID1864904Antifungal activity against fluconazole- resistant Candida albicans 904 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID604749Binding affinity to fatty acid-containing human serum albumin by equilibrium dialysis2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
A combined spectroscopic and crystallographic approach to probing drug-human serum albumin interactions.
AID1501467Drug metabolism assessed as UGT1A6 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID156089Binding to POPC (palmitoyl-oleolyl-phosphatidyl-choline) liposomes using biosensor system2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
SPR biosensor studies of the direct interaction between 27 drugs and a liposome surface: correlation with fraction absorbed in humans.
AID176212Effective dose was determined in vivo in male lewis rats by rat adjuvant-induced arthritis assay1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Synthesis and biological evaluation of the 1,5-diarylpyrazole class of cyclooxygenase-2 inhibitors: identification of 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benze nesulfonamide (SC-58635, celecoxib).
AID1501464Drug metabolism assessed as UGT1A1 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID587450Selectivity index, ratio of IC50 for ovine COX-1 to IC50 for human recombinant COX-22011Journal of medicinal chemistry, Mar-10, Volume: 54, Issue:5
Ethanesulfohydroxamic acid ester prodrugs of nonsteroidal anti-inflammatory drugs (NSAIDs): synthesis, nitric oxide and nitroxyl release, cyclooxygenase inhibition, anti-inflammatory, and ulcerogenicity index studies.
AID162644Inhibitory activity against prostaglandin G/H synthase 22000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID1864956Antiinflammatory activity in mouse infected with Candida albicans ATCC SC5314 assessed as reduction in MMP-9 expression in spleen in presence of fluconazole by hematoxylin staining based inverted microscopic analysis
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1817489Anti-inflammatory activity in C57BL/6J mouse model of carrageenan-induced paw edema assessed as reduction in paw edema at 50 mg/kg, po measured after 72 hrs
AID251770Inhibition of lipopolysaccharide-induced PGE-2 production at 10e-5 M2005Journal of medicinal chemistry, Jun-30, Volume: 48, Issue:13
2-Arylpropionic CXC chemokine receptor 1 (CXCR1) ligands as novel noncompetitive CXCL8 inhibitors.
AID631592Mean residence time in Kunming mouse plasma at dose equivalent to 10 mg/kg, iv of naproxen administered as single dose2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
AID459781Binding affinity to beta-amyloid plaques2010Bioorganic & medicinal chemistry, Feb, Volume: 18, Issue:3
Novel anilinophthalimide derivatives as potential probes for beta-amyloid plaque in the brain.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID197730Lysozyme-conjugated prodrugs: in vitro stability in buffered plasma at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID1864906Inhibition of COX-1 (unknown origin) using arachidonic acid as substrate preincubated for 10 mins followed by substrate addition and measured after 2 mins by immunoassay
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.
AID1273102Cytotoxicity against human HCT116 cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID166555The compound was tested for inhibition of translocation in SAR in RBL-2H3 cells1992Journal of medicinal chemistry, Jul-10, Volume: 35, Issue:14
5-lipoxygenase: properties, pharmacology, and the quinolinyl(bridged)aryl class of inhibitors.
AID130472Carrageenan-induced edema was determined value for oral administration1982Journal of medicinal chemistry, Dec, Volume: 25, Issue:12
Synthesis and antiinflammatory activity of hexahydrothiopyrano[4,3-c]pyrazoles and related analogues.
AID130471Carrageenan-induced edema was determined value for intraperitoneal administration1982Journal of medicinal chemistry, Dec, Volume: 25, Issue:12
Synthesis and antiinflammatory activity of hexahydrothiopyrano[4,3-c]pyrazoles and related analogues.
AID189991Anti-inflammatory activity by rat acute gastric irritation assay, activity is expressed as Ulcerogenic dose (UD50).1995Journal of medicinal chemistry, Apr-28, Volume: 38, Issue:9
Synthesis and antiinflammatory activity of certain 5,6,7,8-tetrahydroquinolines and related compounds.
AID1273101Cytotoxicity against human MCF7 cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID1077773Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw volume at 80 mg/kg through gavage administered 1 hr prior to carrageenan-challenge measured after 4 hrs (Rvb = 1.1 +/- 0.1 mL)
AID42809Compound was evaluated for in vitro inhibition of [Fe(2+)]/ascorbate-induced oxidation of bovine heart membranes(antioxidant BHMLO); not determined1999Journal of medicinal chemistry, Jan-28, Volume: 42, Issue:2
Novel esters and amides of nonsteroidal antiinflammatory carboxylic acids as antioxidants and antiproliferative agents.
AID1501460Drug metabolism assessed as CYP2C9 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
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.
AID1698002Intrinsic clearance in cryopreserved human hepatocytes at 1 uM measured up to 120 mins by LC-MS/MS analysis
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
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?
AID1195156Gastrointestinal toxicity in Swiss albino mouse assessed as ulcer index at 100 mg/kg, po measured after 2 hrs2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
AID21264Effective permeability measured in human.1998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID633796Inhibition of ovine COX1 assessed as PGF2alpha production by enzyme immunoassay2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Fragment-based design, docking, synthesis, biological evaluation and structure-activity relationships of 2-benzo/benzisothiazolimino-5-aryliden-4-thiazolidinones as cycloxygenase/lipoxygenase inhibitors.
AID1273103Cytotoxicity against human Mahlavu cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID1628932Selectivity ratio of IC50 for human recombinant AKR1C2 to IC50 for human recombinant AKR1C32016Journal of medicinal chemistry, 08-25, Volume: 59, Issue:16
Discovery of (R)-2-(6-Methoxynaphthalen-2-yl)butanoic Acid as a Potent and Selective Aldo-keto Reductase 1C3 Inhibitor.
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.
AID1271588Binding affinity to equine serum albumin by isothermal titration calorimetric analysis2016Journal of medicinal chemistry, Jan-14, Volume: 59, Issue:1
Structural Insights into the Competitive Binding of Diclofenac and Naproxen by Equine Serum Albumin.
AID625277FDA Liver Toxicity Knowledge Base Benchmark Dataset (LTKB-BD) drugs of less concern for DILI2011Drug discovery today, Aug, Volume: 16, Issue:15-16
FDA-approved drug labeling for the study of drug-induced liver injury.
AID377723Antiinflammatory activity in mouse assessed as inhibition of phorbol myristyl palmitate-induced ear lobe edema at 0.1 umol/ear after 24 hrs relative to control2006Journal of natural products, Jul, Volume: 69, Issue:7
Chamazulene carboxylic acid and matricin: a natural profen and its natural prodrug, identified through similarity to synthetic drug substances.
AID404480Inhibition of PGF2alpha production in mouse MC9 cells2008Journal of medicinal chemistry, Jun-26, Volume: 51, Issue:12
Indole cytosolic phospholipase A2 alpha inhibitors: discovery and in vitro and in vivo characterization of 4-{3-[5-chloro-2-(2-{[(3,4-dichlorobenzyl)sulfonyl]amino}ethyl)-1-(diphenylmethyl)-1H-indol-3-yl]propyl}benzoic acid, efipladib.
AID176213Effective dose was determined in vivo in male Dawley rats by rat carrageenan-induced foot pad edema assay1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Synthesis and biological evaluation of the 1,5-diarylpyrazole class of cyclooxygenase-2 inhibitors: identification of 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benze nesulfonamide (SC-58635, celecoxib).
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.
AID275274Inhibition of carrageenan-induced paw edema in Sprague-Dawley rat at 10 mg/kg, po2007Journal of medicinal chemistry, Jan-11, Volume: 50, Issue:1
Synthesis and biological evaluation of quinoline salicylic acids as P-selectin antagonists.
AID723699Inhibition of soybean lipoxygenase assessed as inhibition of sodium linolate conversion to 13-hydroperoxylinoleic acid after 4 mins by spectrophotometry2013Bioorganic & medicinal chemistry, Jan-15, Volume: 21, Issue:2
Synthesis and biological evaluation of some 5-arylidene-2-(1,3-thiazol-2-ylimino)-1,3-thiazolidin-4-ones as dual anti-inflammatory/antimicrobial agents.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID376411Inhibition of sheep COX1 at 2.52 ug/mL1999Journal of natural products, Nov, Volume: 62, Issue:11
Phenolic glycosides from Dirca palustris.
AID15711Calculated partition coefficient (clogP)1998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID587449Inhibition of human recombinant COX-22011Journal of medicinal chemistry, Mar-10, Volume: 54, Issue:5
Ethanesulfohydroxamic acid ester prodrugs of nonsteroidal anti-inflammatory drugs (NSAIDs): synthesis, nitric oxide and nitroxyl release, cyclooxygenase inhibition, anti-inflammatory, and ulcerogenicity index studies.
AID677462Dissociation constant, pKa of the compound2012European journal of medicinal chemistry, Jul, Volume: 53Self-organizing molecular field analysis of NSAIDs: assessment of pharmacokinetic and physicochemical properties using 3D-QSPkR approach.
AID235404Therapeutic ratio was determined for intraperitoneal administration1982Journal of medicinal chemistry, Dec, Volume: 25, Issue:12
Synthesis and antiinflammatory activity of hexahydrothiopyrano[4,3-c]pyrazoles and related analogues.
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.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID178488Antiinflammatory activity against trypsin hyperalgesia in rat at peroral dose of compound2003Journal of medicinal chemistry, Jan-30, Volume: 46, Issue:3
Indanylidenes. 2. Design and synthesis of (E)-2-(4-chloro-6-fluoro-1-indanylidene)-N-methylacetamide, a potent antiinflammatory and analgesic agent without centrally acting muscle relaxant activity.
AID1221791Cytotoxicity against human hepatocytes assessed as decrease in cell viability at 1 mM measured at 6 hrs by MTT assay in presence of acyl glucuronidation inhibitor (-)-borneol2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID6861Inhibitory activity against 5-lipoxygenase catalysis (5-LO) in sonicated rat basophilic leukemia cell lysate1997Journal of medicinal chemistry, Feb-28, Volume: 40, Issue:5
Nonsteroidal anti-inflammatory drugs as scaffolds for the design of 5-lipoxygenase inhibitors.
AID1148676Antiinflammatory activity in Wistar rat assessed as inhibition of cotton pellet-induced granuloma formation at 30 mg/kg, po after 5 days relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
4-(6-Methoxy-2-naphthyl)butan-2-one and related analogues, a novel structural class of antiinflammatory compounds.
AID227718Binding energy by using the equation deltaG obsd = -RT ln KD1984Journal of medicinal chemistry, Dec, Volume: 27, Issue:12
Functional group contributions to drug-receptor interactions.
AID132615The compound was tested for reduction in phenylquinone-induced abdominal constriction1998Journal of medicinal chemistry, Mar-26, Volume: 41, Issue:7
New cyclooxygenase-2/5-lipoxygenase inhibitors. 2. 7-tert-butyl-2,3-dihydro-3,3-dimethylbenzofuran derivatives as gastrointestinal safe antiinflammatory and analgesic agents: variations of the dihydrobenzofuran ring.
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.
AID703844Inhibition of 5-lipoxygenase in A23187-stimulated human neutrophils assessed as inhibition of enzyme product formation by RP-HPLC analysis2012Journal of medicinal chemistry, Oct-25, Volume: 55, Issue:20
Modified acidic nonsteroidal anti-inflammatory drugs as dual inhibitors of mPGES-1 and 5-LOX.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID26576pKa value of the compound. (extrapolated values)1998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
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.
AID681849TP_TRANSPORTER: inhibition of Digoxin uptake (Digoxin: 0.05 uM, Naproxen: 1000 uM) in Oatp2-expressing LLC-PK1 cells2002Pharmaceutical research, Feb, Volume: 19, Issue:2
Comparative inhibitory effects of different compounds on rat oatpl (slc21a1)- and Oatp2 (Slc21a5)-mediated transport.
AID1501906Inhibition of human COX2 expressed in insect cells using arachidonic acid as substrate pretreated for 3 mins followed by substrate addition measured immediately2017Journal of natural products, 09-22, Volume: 80, Issue:9
Lipid Peroxidation and Cyclooxygenase Enzyme Inhibitory Compounds from Prangos haussknechtii.
AID1136195Antiinflammatory activity in rat arthritis model assessed as inhibition of Freund's adjuvant-induced swelling compound administered orally bid for 17 days starting on day 1 of challenge measured on day 18 relative to indomethacin1978Journal of medicinal chemistry, Oct, Volume: 21, Issue:10
Synthesis and antiinflammatory activity of 6,11-dihydro-11-oxodibenzo[b,e]thiepinalkanoic acids and related compounds.
AID1293294Antiproliferative activity against human HT-29 cells assessed as reduction in cell viability after 24 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID67725-lipoxygenase inhibitory activity against rat polymorphonuclear leucocytes from female wistar rat, by using 5-HETE.1995Journal of medicinal chemistry, Apr-28, Volume: 38, Issue:9
Synthesis and antiinflammatory activity of certain 5,6,7,8-tetrahydroquinolines and related compounds.
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.
AID1323834Displacement of [3H]rosiglitazone from recombinant human C-terminal His-tagged MitoNEET cytosolic domain (32 to 108 residues) expressed in Escherichia coli BL21 by scintillation proximity assay2016Bioorganic & medicinal chemistry letters, 11-01, Volume: 26, Issue:21
Identification of small molecules that bind to the mitochondrial protein mitoNEET.
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.
AID404304Effect on human MRP2-mediated estradiol-17-beta-glucuronide transport in Sf9 cells inverted membrane vesicles relative to control2008Journal of medicinal chemistry, Jun-12, Volume: 51, Issue:11
Prediction and identification of drug interactions with the human ATP-binding cassette transporter multidrug-resistance associated protein 2 (MRP2; ABCC2).
AID1636357Drug activation in human Hep3B cells assessed as human CYP3A4-mediated drug metabolism-induced cytotoxicity measured as decrease in cell viability at 300 uM pre-incubated with BSO for 18 hrs followed by incubation with compound for 3 hrs in presence of NA2016Bioorganic & medicinal chemistry letters, 08-15, Volume: 26, Issue:16
Development of a cell viability assay to assess drug metabolite structure-toxicity relationships.
AID1628931Inhibition of human recombinant AKR1C2 using S-tetralol as substrate assessed as reduction in NADP+-dependent S-tetralol oxidation preincubated for 10 mins followed by protein addition by fluorometric assay2016Journal of medicinal chemistry, 08-25, Volume: 59, Issue:16
Discovery of (R)-2-(6-Methoxynaphthalen-2-yl)butanoic Acid as a Potent and Selective Aldo-keto Reductase 1C3 Inhibitor.
AID1128731Inhibition of squalene synthase in rat liver microsomes assessed as decrease in conversion of [3H]FPP to squalene2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
AID263720Inhibition of beta amyloid protein 42 in SH-SY5Y cell lines overexpressing SPA4CT at 300 uM2006Bioorganic & 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.
AID237416Distribution coeeficient for the compound at pH7.4 (Log D7.4) 2004Journal of medicinal chemistry, Jul-29, Volume: 47, Issue:16
Contribution of ionization and lipophilicity to drug binding to albumin: a preliminary step toward biodistribution prediction.
AID1384712Binding affinity to Influenza A virus nucleoprotein by surface plasmon resonance analysis2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID266761Effective permeability coefficient in 100% silicon membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1733446Cytotoxicity against human MCF7 cells assessed as reduction in cell viability after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry, 05-01, Volume: 37Design and synthesis of novel (S)-Naproxen hydrazide-hydrazones as potent VEGFR-2 inhibitors and their evaluation in vitro/in vivo breast cancer models.
AID160746Inhibitory concentration against Prostaglandin H2 synthase 1 (PGHS-1) from ram seminal vesicle1996Journal of medicinal chemistry, Sep-27, Volume: 39, Issue:20
1-substituted 4-aryl-5-pyridinylimidazoles: a new class of cytokine suppressive drugs with low 5-lipoxygenase and cyclooxygenase inhibitory potency.
AID703401Inhibition of human recombinant N-terminal His6-tagged AKR1C2 expressed in Escherichia coli BL21(DE3) cells using 8-Acetyl-2,3,5,6-tetrahydro-1H,4H-11-oxa-3a-aza-benzo[de]anthracen-10-one as substrate after 1 hr by fluorimetric analysis2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
3-(3,4-Dihydroisoquinolin-2(1H)-ylsulfonyl)benzoic Acids: highly potent and selective inhibitors of the type 5 17-β-hydroxysteroid dehydrogenase AKR1C3.
AID24420Partition coefficient (logP)1998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID193992Gastrointestinal tolerability was evaluated in rats and compound dose that causes lethality was reported.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Nonsteroidal antiinflammatory agents. 14. Synthesis and pharmacological profile of 6-chloro-5-(cyclopentylmethyl)indan-1-carboxylic acid.
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]
AID227925The compound was estimated for biosensor analysis2000Journal of medicinal chemistry, May-18, Volume: 43, Issue:10
Biosensor analysis of the interaction between immobilized human serum albumin and drug compounds for prediction of human serum albumin binding levels.
AID287970Effect on iPGJ2 level in LPS-induced mouse RAW264.7 cells at 10 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
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.
AID604744Displacement of radiolabeled dansylsarcosine from fatty acid containing human serum albumin site 2 in phosphate buffer at pH 7.4 at 12 uM by fluorescence spectroscopy2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
A combined spectroscopic and crystallographic approach to probing drug-human serum albumin interactions.
AID1273105Cytotoxicity against human SNU475 cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID1211796Intrinsic clearance in cryopreserved human HepaRG cells assessed per 10'6 cells by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID540219Volume of distribution at steady state in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1864913Toxicity in Candida albicans ATCC SC5314 infected-mouse assessed as effect on body weight at 10 ug per 20 g, ip administered on day 2, 4, 6, 8, 10 and 12 and measured on day 14 in presence of fluconazole
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID185568Percent inhibition was determined in vivo in male Dawley rats at a dose of 10 mg/kg by rat carrageenan-induced hyperalgesia assay1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Synthesis and biological evaluation of the 1,5-diarylpyrazole class of cyclooxygenase-2 inhibitors: identification of 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benze nesulfonamide (SC-58635, celecoxib).
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.
AID1397088Inhibition of ovine COX1 assessed as reduction in PGH2 production by enzyme immunoassay2018Bioorganic & medicinal chemistry, 08-07, Volume: 26, Issue:14
Synthesis and biological properties of aryl methyl sulfones.
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.
AID1195147Analgesic activity in Swiss albino mouse assessed as latancy of withdrawing tail at 100 mg/kg, po measured after 2 hrs by tail flick test relative to control2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
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.
AID235599Ratio of MED GI erosion to ED30 for carrageenan rat paw was determined1987Journal of medicinal chemistry, May, Volume: 30, Issue:5
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acids. The 6-substituted compounds.
AID113098Analgesic activity in mice by phenyl quinone-induced writhing assay with respect to aspirin.1987Journal of medicinal chemistry, May, Volume: 30, Issue:5
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acids. The 6-substituted compounds.
AID266768Membrane permeability, CA(t)/CD(0) in 100% silicon membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1384750Cytotoxicity against MDCK cells assessed as reduction in cell viability after 24 to 72 hrs by MTT assay2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1628930Inhibition of human recombinant AKR1C3 using S-tetralol as substrate assessed as reduction in NADP+-dependent S-tetralol oxidation preincubated for 10 mins followed by protein addition by fluorometric assay2016Journal of medicinal chemistry, 08-25, Volume: 59, Issue:16
Discovery of (R)-2-(6-Methoxynaphthalen-2-yl)butanoic Acid as a Potent and Selective Aldo-keto Reductase 1C3 Inhibitor.
AID190165Ulcerogenic dose that produced gastric lesions, ulcers and/or hemorrhage in 50% of the animals tested1981Journal of medicinal chemistry, May, Volume: 24, Issue:5
Effect of structural change on acute toxicity and antiinflammatory activity in a series of imidazothiazoles and thiazolobenzimidazoles.
AID378690Inhibition of PGHS1 assessed as conversion of arachidonic acid to prostaglandin1999Journal of natural products, Feb, Volume: 62, Issue:2
Antioxidant and antiinflammatory activities of anthocyanins and their aglycon, cyanidin, from tart cherries.
AID310932Permeability across human Skin2007Journal of medicinal chemistry, Feb-22, Volume: 50, Issue:4
In silico and in vitro filters for the fast estimation of skin permeation and distribution of new chemical entities.
AID299742Toxicity assessed as ulcerogenic activity in rat at 90 mg/kg, po2007Bioorganic & medicinal chemistry letters, Aug-15, Volume: 17, Issue:16
Synthesis and pharmacological evaluation of condensed heterocyclic 6-substituted-1,2,4-triazolo[3,4-b]-1,3,4-thiadiazole derivatives of naproxen.
AID1221799Genotoxicity in HEK293 cells expressing UGT1A3 assessed as DNA strand breaks at 1 mM after 24 hrs by comet assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1864963Immunostimulatory activity in mouse infected with Candida albicans ATCC SC5314 assessed as increase in CD3+ expression level in spleen in presence of fluconazole by immunohistochemical analysis
AID178647Antiinflammatory activity was evaluated in an carrageenan edema (acute inflammation) test, after administering compound orally in rats.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Nonsteroidal antiinflammatory agents. 14. Synthesis and pharmacological profile of 6-chloro-5-(cyclopentylmethyl)indan-1-carboxylic acid.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID173359Hypolipidemic action at 500 uM/kg was determined as reduction in low density lipoprotein in rat plasma2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID710670Analgesic activity in rat SNL neuropathic pain model assessed as reversal of mechanical allodynia at 10 mg/kg, po after 1 hr2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Aminopiperidine sulfonamide Cav2.2 channel inhibitors for the treatment of chronic pain.
AID177221In vivo inhibition of carrageenan-induced air pouch in rats2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID402404Ratio of IC50 for COX2 to IC50 for COX11998Journal of natural products, Oct, Volume: 61, Issue:10
Ursolic acid from Plantago major, a selective inhibitor of cyclooxygenase-2 catalyzed prostaglandin biosynthesis.
AID1733447Cytotoxicity against human MDA-MB-231 cells assessed as reduction in cell viability at 200 to 400 uM after 48 hrs by MTT assay2021Bioorganic & medicinal chemistry, 05-01, Volume: 37Design and synthesis of novel (S)-Naproxen hydrazide-hydrazones as potent VEGFR-2 inhibitors and their evaluation in vitro/in vivo breast cancer models.
AID1195040Antinociceptive activity against CD-1 mouse assessed as licking of hind paw or jumping at 100 mg/kg, po after 90 mins2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Synthesis, antinociceptive and anti-inflammatory effects of porphyrins.
AID631665Tmax in Kunming mouse brain at dose equivalent to 10 mg/kg, iv of naproxen administered as single dose2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
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]
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.
AID197598Lysozyme-conjugated prodrugs: in vitro stability at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID604741Displacement of radiolabeled warfarin from fatty acid-free human serum albumin site 1 in phosphate buffer at pH 7.4 at 12 uM by fluorescence spectroscopy2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
A combined spectroscopic and crystallographic approach to probing drug-human serum albumin interactions.
AID169240Incidence of melena defecation was recorded 24 hrs of last treatment given once daily for 4 days; Positive2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID1293295Antiproliferative activity against human HT-29 cells assessed as reduction in cell viability after 48 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID1864902Antifungal activity against fluconazole- resistant Candida albicans 901 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID197729Lysozyme-conjugated prodrugs: in vitro stability at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID618052Binding affinity to amyloid beta fibrils2011Bioorganic & medicinal chemistry letters, Sep-15, Volume: 21, Issue:18
Novel imaging agents for β-amyloid plaque based on the N-benzoylindole core.
AID299740Analgesic activity in rat at 30 mg/kg, po2007Bioorganic & medicinal chemistry letters, Aug-15, Volume: 17, Issue:16
Synthesis and pharmacological evaluation of condensed heterocyclic 6-substituted-1,2,4-triazolo[3,4-b]-1,3,4-thiadiazole derivatives of naproxen.
AID1628937Inhibition of COX2 (unknown origin) using arachidonic acid as substrate assessed as reduction in PGH2 conversion to PGG2 by measuring TMPD oxidation preincubated for 5 mins followed by substrate/TMPD addition measured for 5 mins by colorimetric assay2016Journal of medicinal chemistry, 08-25, Volume: 59, Issue:16
Discovery of (R)-2-(6-Methoxynaphthalen-2-yl)butanoic Acid as a Potent and Selective Aldo-keto Reductase 1C3 Inhibitor.
AID377721Antiinflammatory activity in mouse assessed as inhibition of phorbol myristyl palmitate-induced ear lobe edema2006Journal of natural products, Jul, Volume: 69, Issue:7
Chamazulene carboxylic acid and matricin: a natural profen and its natural prodrug, identified through similarity to synthetic drug substances.
AID1221772Cytotoxicity against HEK293 cells expressing UGT1A4 assessed as decrease in cell viability at 1 mM by MTT assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
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.
AID1175391Inhibition of human TRPV1 overexpressed in BEAS-2B cells assessed as residual activity at 250 uM after 30 mins by Fluo-4 AM fluorescence assay2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Inhibition of FAAH, TRPV1, and COX2 by NSAID-serotonin conjugates.
AID1175141Cmax in Sprague-Dawley rat at 10 mg/kg, po after 8 hrs2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
AID1211795Dissociation constant, pKa of the compound2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID131340Dose giving one-half of average maximal [40%] response in phenylquinone writhing assay1981Journal of medicinal chemistry, May, Volume: 24, Issue:5
Effect of structural change on acute toxicity and antiinflammatory activity in a series of imidazothiazoles and thiazolobenzimidazoles.
AID1753655Cytotoxicity against human BGC-823 cells assessed as reduction in cell viability measured upto 72 hrs by MTT assay2021European journal of medicinal chemistry, Jun-05, Volume: 218New organoselenides (NSAIDs-Se derivatives) as potential anticancer agents: Synthesis, biological evaluation and in silico calculations.
AID1135112Antiinflammatory activity in rabbit assessed as inhibition of edema at 200 ug per site by reversed passive arthus test1977Journal of medicinal chemistry, May, Volume: 20, Issue:5
Synthesis and antiinflammatory activity of cis-4,5,6,7,8,8a,9-hexahydro-alpha-methyl-5H-fluorene-2-acetic acid.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1272494Anti-inflammatory activity in rat assessed as reduction of carrageenan-induced paw edema at 150 umol/kg, ip after 3.5 hrs relative to control2016Bioorganic & medicinal chemistry letters, Feb-01, Volume: 26, Issue:3
Amides of non-steroidal anti-inflammatory drugs with thiomorpholine can yield hypolipidemic agents with improved anti-inflammatory activity.
AID1223483Unbound fraction in iv dosed human plasma2012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Prediction of in vivo hepatic clearance and half-life of drug candidates in human using chimeric mice with humanized liver.
AID257049Inhibition of recombinant human AKR1C32005Bioorganic & 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.
AID1293300Antiproliferative activity against human PANC1 cells assessed as reduction in cell viability after 24 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID1273090Inhibition of COX in human Mahlavu cells after 48 hrs by fluorometric assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID234213Therapeutic ratio of MED GI erosion to that of ED30 of rat paw1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-6-(methylthio)-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-ca rboxyl ic acids and 1-methyl-4-(methylthio)-5-aroylpyrrole-2-acetic acids.
AID171864Anti-inflammatory activity by rat carrageenan edema assay. (3h edema).1995Journal of medicinal chemistry, Apr-28, Volume: 38, Issue:9
Synthesis and antiinflammatory activity of certain 5,6,7,8-tetrahydroquinolines and related compounds.
AID197600Lysozyme-conjugated prodrugs: in vitro stability in rat cortical homogenate at pH 51992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
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.
AID197602Lysozyme-conjugated prodrugs: in vitro stability in rat cortical homogenate at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID751348Antiinflammatory activity in Duncan Hartley guinea pig assessed as Inhibition of carrageenan-induced PGE2 production at 10 mg/kg, po2013Bioorganic & medicinal chemistry letters, Feb-15, Volume: 23, Issue:4
Discovery and SAR of PF-4693627, a potent, selective and orally bioavailable mPGES-1 inhibitor for the potential treatment of inflammation.
AID1221828Activity of human UGT1A3 expressed in HEK293 cells assessed as enzyme-mediated naproxen acyl-beta-D-glucuronide formation at 1 mM measured at 24 hrs by LC-MS/MS analysis2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID24202Distribution coefficient in octanol/water at pH 5.51998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID1148682Antiinflammatory activity in rat assessed as inhibition of carrageenan-induced paw edema at 6 mg/kg, po relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
4-(6-Methoxy-2-naphthyl)butan-2-one and related analogues, a novel structural class of antiinflammatory compounds.
AID197601Lysozyme-conjugated prodrugs: in vitro stability at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID633797Inhibition of human recombinant COX-2 assessed as PGF2alpha production at 200 uM by enzyme immunoassay2012European journal of medicinal chemistry, Jan, Volume: 47, Issue:1
Fragment-based design, docking, synthesis, biological evaluation and structure-activity relationships of 2-benzo/benzisothiazolimino-5-aryliden-4-thiazolidinones as cycloxygenase/lipoxygenase inhibitors.
AID1175140Cmax in Sprague-Dawley rat at 10 mg/kg, po after 4 hrs2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
AID724443Inhibition of ovine COX12013Bioorganic & medicinal chemistry letters, Jan-01, Volume: 23, Issue:1
Hybrid fluorescent conjugates of COX-2 inhibitors: search for a COX-2 isozyme imaging cancer biomarker.
AID631626Metabolic stability in Kunming mouse plasma assessed as compound hydrolysis at 10 mg/kg, iv by HPLC analysis2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
AID527616Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 300 umol/kg, ip after 3.5 hrs2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Design of more potent squalene synthase inhibitors with multiple activities.
AID260543Anti-inflammatory activity against paw edema induced by carrageenan in fischer rat at 300 umol/kg, ip2006Bioorganic & medicinal chemistry letters, Feb-15, Volume: 16, Issue:4
Synthesis and pharmacochemical study of novel polyfunctional molecules combining anti-inflammatory, antioxidant, and hypocholesterolemic properties.
AID260554Increase in paw weight in Fischer rats at 300 umol/kg, ip2006Bioorganic & medicinal chemistry letters, Feb-15, Volume: 16, Issue:4
Synthesis and pharmacochemical study of novel polyfunctional molecules combining anti-inflammatory, antioxidant, and hypocholesterolemic properties.
AID418092Toxicity in carrageenan treated Albino mouse liver assessed as cholestasis at 30 mg/kg, po administered 1 hr before carrageenan challenge measured after 4 hrs by hematoxilen eosine staining2009Bioorganic & medicinal chemistry letters, Apr-01, Volume: 19, Issue:7
Benzophenone-N-ethyl piperidine ether analogues--synthesis and efficacy as anti-inflammatory agent.
AID1223482Ratio of drug level in blood to plasma in iv dosed human2012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Prediction of in vivo hepatic clearance and half-life of drug candidates in human using chimeric mice with humanized liver.
AID176799In vivo activity in hyperalgesia models.2000Journal of medicinal chemistry, Aug-10, Volume: 43, Issue:16
Selective cyclooxygenase-2 inhibitors: heteroaryl modified 1,2-diarylimidazoles are potent, orally active antiinflammatory agents.
AID631640AUC (0 to t) in Kunming mouse brain at dose equivalent to 10 mg/kg, iv of naproxen administered as single dose2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
AID1628938Selectivity ratio of IC50 for inhibition of COX1 in ram seminal vesicles to IC50 for human recombinant AKR1C32016Journal of medicinal chemistry, 08-25, Volume: 59, Issue:16
Discovery of (R)-2-(6-Methoxynaphthalen-2-yl)butanoic Acid as a Potent and Selective Aldo-keto Reductase 1C3 Inhibitor.
AID189983Gastrointestinal tolerability was evaluated under acute conditions, in rats. The ulcerogenic dose was reported.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Nonsteroidal antiinflammatory agents. 14. Synthesis and pharmacological profile of 6-chloro-5-(cyclopentylmethyl)indan-1-carboxylic acid.
AID1695485Antiinflammatory activity in mouse model of xylene-induced ear swelling assessed as inhibition of swelling by measuring weight of the ear at 150 mg/kg, ig pretreated for 90 mins followed by xylene challenge and measured after 30 mins relative to control2020RSC medicinal chemistry, Jul-01, Volume: 11, Issue:7
A practical synthesis of amino limonin/deoxylimonin derivatives as effective mitigators against inflammation and nociception.
AID1221774Cytotoxicity against HEK293 cells expressing UGT1A4 assessed as decrease in cell viability by measuring intracellular ATP content at 1 mM by CellTiter-Glo luminescent assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1663614Anticancer activity against human HCT15 cells assessed as cell growth inhibition measured after 48 hrs by MTT assay2020Bioorganic & medicinal chemistry letters, 07-15, Volume: 30, Issue:14
Synthesis and anticancer activity of open-resorcinarene conjugates.
AID1293301Antiproliferative activity against human PANC1 cells assessed as reduction in cell viability after 48 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID6711Inhibition activity against 5-lipoxygenase in Human whole blood (HWBL) stimulated with calcium ionophore (A23187) and LTB4 measured by enzyme immunoassay; No data1997Journal of medicinal chemistry, Feb-28, Volume: 40, Issue:5
Nonsteroidal anti-inflammatory drugs as scaffolds for the design of 5-lipoxygenase inhibitors.
AID18861GOF value represents multisets of log P data1998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID239884pKa value of the compound2004Journal of medicinal chemistry, Jul-29, Volume: 47, Issue:16
Contribution of ionization and lipophilicity to drug binding to albumin: a preliminary step toward biodistribution prediction.
AID624607Specific activity of expressed human recombinant UGT1A32000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID190379Ulcerogenic activity administered once daily at 1350 uM/kg for 4 days was determined as no of animals showing perforating ulcers2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID181152Hemoglobin levels in the different assays ranged from 11.5-14.7 g/dl.2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID1128712Antioxidant activity in rat liver microsome membrane assessed as inhibition of lipid peroxidation after 45 mins by TBARS-based spectrophotometric assay2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
AID1273106Cytotoxicity against human HepG2 cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID429543Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 40 mg/kg, po administered 30 mins before carrageenan challenge measured after 5 hrs2009Bioorganic & medicinal chemistry, May-15, Volume: 17, Issue:10
Chlorzoxazone esters of some non-steroidal anti-inflammatory (NSAI) carboxylic acids as mutual prodrugs: design, synthesis, pharmacological investigations and docking studies.
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.
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.
AID81327Inhibition of proliferation measured by inhibition of [3H]thymidine incorporation by HMVEC-L cells1999Journal of medicinal chemistry, Jan-28, Volume: 42, Issue:2
Novel esters and amides of nonsteroidal antiinflammatory carboxylic acids as antioxidants and antiproliferative agents.
AID177520In vivo inhibition of pyresis in rats2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID166554The compound was tested for inhibition LTC4 synthesis1992Journal of medicinal chemistry, Jul-10, Volume: 35, Issue:14
5-lipoxygenase: properties, pharmacology, and the quinolinyl(bridged)aryl class of inhibitors.
AID1916995Antiinflammatory activity against xylene-induced ear swelling ICR mouse model assessed as swelling rate at 100 mg/kg, IG measured after 1 hr (Activity = 58.21 +/- 12.79%)2022Journal of medicinal chemistry, 11-10, Volume: 65, Issue:21
Discovery of the First Selective IDO2 Inhibitor As Novel Immunotherapeutic Avenues for Rheumatoid Arthritis.
AID346087Inhibition of IgE-specific antigen-induced LBT4 release in rat MC9 cells2009Journal of medicinal chemistry, Feb-26, Volume: 52, Issue:4
Reactions of functionalized sulfonamides: application to lowering the lipophilicity of cytosolic phospholipase A2alpha inhibitors.
AID715644Gastrointestinal toxicity in Wistar albino rat assessed as ulcer index at 45 mg/kg, po after 12 hrs2012European journal of medicinal chemistry, Nov, Volume: 57Synthesis and pharmacological evaluation of pyrazolo[4,3-c]cinnoline derivatives as potential anti-inflammatory and antibacterial agents.
AID177016Antiinflammatory activity was determined by inhibition of carrageenan-induced edema in rat paw with respect to phenylbutazone1987Journal of medicinal chemistry, May, Volume: 30, Issue:5
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acids. The 6-substituted compounds.
AID178668Antiinflammatory activity was determined to inhibit adjuvant-induced arthritis in rats with respect to naproxen1987Journal of medicinal chemistry, May, Volume: 30, Issue:5
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acids. The 6-substituted compounds.
AID1864900Antifungal activity against fluconazole- resistant Candida albicans 632 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID1221811Activity of human UGT1A4 expressed in HEK293 cells assessed as enzyme-mediated naproxen acyl-beta-D-glucuronide formation at 1 mM measured at 24 hrs by LC-MS/MS analysis2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID1864925Toxicity in mouse infected with Candida albicans assessed as ALT level in plasma at 10 ug per 20 g, ip administered on day 2, 4, 6, 8, 10 and 12 and measured on day 14 in presence of fluconazole (Rvb = 43.6 +/- 4.4 IU/L)
AID1323835Displacement of [3H]rosiglitazone from recombinant human C-terminal His-tagged MitoNEET cytosolic domain (32 to 108 residues) expressed in Escherichia coli BL21 by Cheng-Prusoff analysis2016Bioorganic & medicinal chemistry letters, 11-01, Volume: 26, Issue:21
Identification of small molecules that bind to the mitochondrial protein mitoNEET.
AID1195149Analgesic activity in Swiss albino mouse assessed as time of licking paws at 100 mg/kg, po measured after 2 hrs by tail flick test relative to control2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
AID1195151Antiinflammatory activity in Swiss albino mouse assessed as inhibition of carrageenan-induced paw edema at 100 mg/kg, po administered 1 hr prior to carrageenan challenge measured after 2 hrs relative to control2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID377727Antiinflammatory activity in mouse assessed as inhibition of phorbol myristyl palmitate-induced ear lobe edema at 1 umol/ear after 48 hrs relative to control2006Journal of natural products, Jul, Volume: 69, Issue:7
Chamazulene carboxylic acid and matricin: a natural profen and its natural prodrug, identified through similarity to synthetic drug substances.
AID197599Lysozyme-conjugated prodrugs: in vitro stability at pH 51992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID1384719Antiviral activity against Influenza A virus (A/WSN/1933(H1N1)) infected in MDCK cells at MOI of 2 assessed as decrease in viral load after 18 hrs by immunofluorescence analysis2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1697999Dissociation constant, acidic pKa of compound measured up to 18 mins by capillary electrophoresis
AID414503Antiinflammatory activity in Albino mouse assessed as inhibition of carrageenan-induced foot paw edema at 30 mg/kg, po administered 1 hr before carrageenan challenge measured after 2 hrs2009Bioorganic & medicinal chemistry letters, Apr-01, Volume: 19, Issue:7
Benzophenone-N-ethyl piperidine ether analogues--synthesis and efficacy as anti-inflammatory agent.
AID173360Hypolipidemic action at 500 uM/kg was determined as reduction in total cholesterol in rat plasma2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID1273107Cytotoxicity against human Hep3B cells assessed as growth inhibition after 72 hrs by sulforhodamine B assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID197597Lysozyme-conjugated prodrugs: in vitro stability at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID1211798Intrinsic clearance in human using well stirred liver model by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1530538Anti-inflammatory activity in rat assessed as inhibition of carrageenan-induced paw edema relative to control2019European journal of medicinal chemistry, Jan-01, Volume: 161Naphthalene, a versatile platform in medicinal chemistry: Sky-high perspective.
AID1367476Analgesic activity in Dunkin-Hartley guinea pig assessed as reduction in LPS-induced thermal hyperalgesia at 10 mg/kg, po pretreated for 1 hr followed by LPS-challenge measured after 4.5 hrs by plantar test relative to control2017Bioorganic & medicinal chemistry letters, 12-01, Volume: 27, Issue:23
Discovery of furan and dihydrofuran-fused tricyclic benzo[d]imidazole derivatives as potent and orally efficacious microsomal prostaglandin E synthase-1 (mPGES-1) inhibitors: Part-1.
AID1293297Antiproliferative activity against human MDA-MB-231 cells assessed as reduction in cell viability after 24 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID266766Dissociation constant, pKa of the compound2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1148679Antiinflammatory activity in Wistar rat assessed as inhibition of cotton pellet-induced granuloma formation at 3 mg/kg, po after 5 days relative to control1978Journal of medicinal chemistry, Dec, Volume: 21, Issue:12
4-(6-Methoxy-2-naphthyl)butan-2-one and related analogues, a novel structural class of antiinflammatory compounds.
AID197595Lysozyme-conjugated prodrugs: in vitro stability at pH 51992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID183344Compound was tested in vivo for antiinflammatory activity against chronic adjuvant arthritic rat by therapeutic inhibition 2 degree paw after peroral administration of 25 mg/kg of dose1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID724444Inhibition of human recombinant COX22013Bioorganic & medicinal chemistry letters, Jan-01, Volume: 23, Issue:1
Hybrid fluorescent conjugates of COX-2 inhibitors: search for a COX-2 isozyme imaging cancer biomarker.
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.
AID177358In vivo inhibition of adjuvant arthritis in rats2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 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.
AID1864907Inhibition of COX-2 (unknown origin) using arachidonic acid as substrate preincubated for 10 mins followed by substrate addition and measured after 2 mins by immunoassay
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?
AID631591AUC (0 to t) in Kunming mouse plasma at dose equivalent to 10 mg/kg, iv of naproxen administered as single dose2011European journal of medicinal chemistry, Sep, Volume: 46, Issue:9
Design, synthesis and biological evaluation of brain-specific glucosyl thiamine disulfide prodrugs of naproxen.
AID1175392Inhibition of human TRPV1 overexpressed in BEAS-2B cells assessed as residual activity at 50 uM after 30 mins by Fluo-4 AM fluorescence assay2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Inhibition of FAAH, TRPV1, and COX2 by NSAID-serotonin conjugates.
AID1273091Inhibition of COX in human HuH7 cells after 48 hrs by fluorometric assay2016Bioorganic & medicinal chemistry, Feb-15, Volume: 24, Issue:4
Novel triazolothiadiazines act as potent anticancer agents in liver cancer cells through Akt and ASK-1 proteins.
AID1390355Analgesic activity in Dunkin-Hartley guinea pig MIA-induced osteoarthritic pain model assessed as reversal of incapacitance at 30 mg/kg, po administered on day 3 measured at 6 to 7 hrs relative to control
AID287965Effect on iPGE2 level in LPS-induced mouse RAW264.7 cells at 2 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID197728Lysozyme-conjugated prodrugs: in vitro stability in lysosomal lysate at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
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.
AID1150602Ratio of ED50 for ulcerogenicity in 24-hrs starved Charles-River rat to ED50 for chronic antiinflammatory activity against adjuvant-induced arthritis in rat1976Journal of medicinal chemistry, Jun, Volume: 19, Issue:6
Cycloalkanoindoles. 1. Syntheses and antiinflammatory actions of some acidic tetrahydrocarbazoles, cyclopentindoles, and cycloheptindoles.
AID624619Specific activity of expressed human recombinant UGT2B72000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID177223Inhibition of carrageenan paw edema in rats2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID171370Inhibition of paw swelling relative to the tebufelone in rat. Value was reported as Carrageenan paw edema index1998Journal of medicinal chemistry, Aug-27, Volume: 41, Issue:18
New cyclooxygenase-2/5-lipoxygenase inhibitors. 3. 7-tert-butyl-2, 3-dihydro-3,3-dimethylbenzofuran derivatives as gastrointestinal safe antiinflammatory and analgesic agents: variations at the 5 position.
AID112732Antiinflammatory activity, administered ip at 150 uM/kg dose was determined against carrageenan-induced mice paw edema model2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID399406Selectivity ratio of IC50 for sheep placental cotyledons COX2 to IC50 for bovine seminal microsomal COX1 preincubated for 10 mins1998Journal of natural products, Jan, Volume: 61, Issue:1
Development of a radiochemical cyclooxygenase-1 and -2 in vitro assay for identification of natural products as inhibitors of prostaglandin biosynthesis.
AID390724Inhibition of HSL in Wistar rat isolated fat cells at 10 uM by spectrophotometric assay2008Journal of medicinal chemistry, Oct-23, Volume: 51, Issue:20
Combining ligand-based pharmacophore modeling, quantitative structure-activity relationship analysis and in silico screening for the discovery of new potent hormone sensitive lipase inhibitors.
AID1195146Analgesic activity in Swiss albino mouse assessed as latancy of withdrawing tail at 50 mg/kg, po measured after 2 hrs by tail flick test relative to control2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
AID1195155Gastrointestinal toxicity in Swiss albino mouse assessed as ulcer index at 50 mg/kg, po measured after 2 hrs2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Novel thiazolo[3,2-b]-1,2,4-triazoles derived from naproxen with analgesic/anti-inflammatory properties: Synthesis, biological evaluation and molecular modeling studies.
AID183349Compound was tested in vivo for antiinflammatory activity against chronic adjuvant arthritic rat by therapeutic inhibition 2 degree paw after peroral administration of 3 mg/kg of dose1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID229958IC50 ratio measured as the IC50 values of COX-1 to that of COX-2.1995Journal of medicinal chemistry, Sep-29, Volume: 38, Issue:20
Antiinflammatory 4,5-diarylpyrroles. 2. Activity as a function of cyclooxygenase-2 inhibition.
AID527609Inhibition of soybean lipoxygenase measured for 6 mins2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
Design of more potent squalene synthase inhibitors with multiple activities.
AID604742Displacement of radiolabeled dansylsarcosine from fatty acid-free human serum albumin site 2 in phosphate buffer at pH 7.4 at 12 uM by fluorescence spectroscopy2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
A combined spectroscopic and crystallographic approach to probing drug-human serum albumin interactions.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1175131AUC in Sprague-Dawley rat at 10 mg/kg, po2014Bioorganic & medicinal chemistry letters, Dec-15, Volume: 24, Issue:24
Gastric-sparing nitric oxide-releasable 'true' prodrugs of aspirin and naproxen.
AID1864910Antifungal actvity against Candida albicans ATCC SC5314 infected in mouse assessed as reduction in infection at 10 ug per 20 g, ip administered on day 2, 4, 6, 8, 10 and 12 and measured on day 14 in presence of fluconazole
AID1864923Toxicity in mouse infected with Candida albicans assessed as AST level in plasma at 10 ug per 20 g, ip administered on day 2, 4, 6, 8, 10 and 12 and measured on day 14 in presence of fluconazole (Rvb = 74.9 +/- 6.7 IU/L)
AID287971Effect on iPGJ2 level in LPS-induced mouse RAW264.7 cells at 50 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID624606Specific activity of expressed human recombinant UGT1A12000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID162666Tested for inhibitory activity against Prostaglandin G/H synthase 2 from human1995Journal of medicinal chemistry, Sep-29, Volume: 38, Issue:20
Antiinflammatory 4,5-diarylpyrroles. 2. Activity as a function of cyclooxygenase-2 inhibition.
AID1384727Selectivity index, ratio of CC50 for human A549 cells to IC50 for Influenza A virus (A/Udorn/1972 (H3N2)) after 18 hrs2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1221815Cytotoxicity against HEK293 cells expressing UGT1A3 assessed as decrease in cell viability at 1 mM by MTT assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID723695Competitive inhibition of human recombinant COX2 assessed as inhibition of PGF2a production at 200 uM by enzyme immunoassay2013Bioorganic & medicinal chemistry, Jan-15, Volume: 21, Issue:2
Synthesis and biological evaluation of some 5-arylidene-2-(1,3-thiazol-2-ylimino)-1,3-thiazolidin-4-ones as dual anti-inflammatory/antimicrobial agents.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID736209Antiinflammatory activity in SKH2 mouse assessed as reduction in carrageenan-induced paw edema at 0.3 mmol/kg, ip after carrageenan challenge measured after 3.5 hrs relative to control2013Journal of medicinal chemistry, Apr-25, Volume: 56, Issue:8
New multifunctional Di-tert-butylphenoloctahydro(pyrido/benz)oxazine derivatives with antioxidant, antihyperlipidemic, and antidiabetic action.
AID767618Antinociceptive activity in po dosed Albino-Swiss mouse assessed as acetic acid-induced abdominal writhing compound administered 30 mins prior challenge measured over 30 mins post acetic acid challenge2013Bioorganic & medicinal chemistry, Oct-01, Volume: 21, Issue:19
High analgesic and anti-inflammatory in vivo activities of six new hybrids NSAIAs tetrahydropyran derivatives.
AID429542Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 40 mg/kg, po administered 30 mins before carrageenan challenge measured after 4 hrs2009Bioorganic & medicinal chemistry, May-15, Volume: 17, Issue:10
Chlorzoxazone esters of some non-steroidal anti-inflammatory (NSAI) carboxylic acids as mutual prodrugs: design, synthesis, pharmacological investigations and docking studies.
AID1211794Fraction unbound in blood (not specified)2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID624615Specific activity of expressed human recombinant UGT2B102000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID196180Effect on perforated ulcers(PU) at the dose of 50 mg/kg2000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID1221792Cytotoxicity against human hepatocytes assessed as decrease in cell viability at 1 mM measured at 6 hrs by MTT assay in absence of acyl glucuronidation inhibitor (-)-borneol2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID190376Concentration at which gastric damage will occur was determined in rat1997Journal of medicinal chemistry, Apr-25, Volume: 40, Issue:9
Synthesis and biological evaluation of the 1,5-diarylpyrazole class of cyclooxygenase-2 inhibitors: identification of 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benze nesulfonamide (SC-58635, celecoxib).
AID1077804Cytotoxicity against human MCF7 cells assessed as growth inhibition after 24 hrs by MTT assay
AID604748Binding affinity to fatty acid-free human serum albumin by equilibrium dialysis2010Bioorganic & medicinal chemistry, Nov-01, Volume: 18, Issue:21
A combined spectroscopic and crystallographic approach to probing drug-human serum albumin interactions.
AID703402Inhibition of human recombinant N-terminal His6-tagged AKR1C1 expressed in Escherichia coli BL21(DE3) cells using 8-Acetyl-2,3,5,6-tetrahydro-1H,4H-11-oxa-3a-aza-benzo[de]anthracen-10-one as substrate after 1 hr by fluorimetric analysis2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
3-(3,4-Dihydroisoquinolin-2(1H)-ylsulfonyl)benzoic Acids: highly potent and selective inhibitors of the type 5 17-β-hydroxysteroid dehydrogenase AKR1C3.
AID1501471Drug metabolism assessed as UGT2B7 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID1384711Stabilization of Influenza A virus nucleoprotein assessed as melting temperature at 5 to 15 uM measured for 10 mins2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID405576Inhibition of ovine COX1 at 100 uM2008Journal of natural products, Jun, Volume: 71, Issue:6
Cyclooxygenase (COX)-1 and -2 inhibitory labdane diterpenes from Crassocephalum mannii.
AID178754Inhibitory activity in the adjuvant induced arthritis model of chronic inflammation in rat1997Journal of medicinal chemistry, May-23, Volume: 40, Issue:11
1,2-Diarylimidazoles as potent, cyclooxygenase-2 selective, and orally active antiinflammatory agents.
AID1128714Antioxidant activity assessed as DPPH radical scavenging activity after 30 mins2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
AID1501470Drug metabolism assessed as UGT1A10 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID160868Inhibition of prostaglandin G/H synthase pathway in rat polymorphonuclear assay by ability to inhibit formation of TXB2 at 10 uM.1995Journal of medicinal chemistry, Apr-28, Volume: 38, Issue:9
Synthesis and antiinflammatory activity of certain 5,6,7,8-tetrahydroquinolines and related compounds.
AID715646Induction of lipid peroxidation in Wistar albino rat assessed as Malondialdehyde level per 100 mg of tissue at 45 mg/kg, po after 12 hrs (Rvb = 3.29 +/- 0.19 nmol/100 mg tissue)2012European journal of medicinal chemistry, Nov, Volume: 57Synthesis and pharmacological evaluation of pyrazolo[4,3-c]cinnoline derivatives as potential anti-inflammatory and antibacterial agents.
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.
AID266767Membrane retention in 100% silicon membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID540218Clearance in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
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.
AID1501459Drug metabolism assessed as CYP1A2 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID305922Drug level in mouse skin2007Bioorganic & medicinal chemistry letters, Mar-01, Volume: 17, Issue:5
N-Alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) prodrugs of carboxylic acid containing drugs.
AID173361Hypolipidemic action at 500 uM/kg was determined as reduction in triglycerides in rat plasma2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID1864898Antifungal activity against fluconazole- resistant Candida albicans CaR assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID197727Lysozyme-conjugated prodrugs: in vitro stability at pH 7.41992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID1698004Fraction unbound in cynomolgus monkey plasma
AID1663611Anticancer activity against human U251 cells assessed as cell growth inhibition measured after 48 hrs by MTT assay2020Bioorganic & medicinal chemistry letters, 07-15, Volume: 30, Issue:14
Synthesis and anticancer activity of open-resorcinarene conjugates.
AID1198256Antiproliferative activity against human U373MG cells assessed as effect on cell number at 1 nM to 10 uM incubated for 1 to 6 days by trypan blue dye exclusion dye based inverted microscopy2015European journal of medicinal chemistry, Mar-26, Volume: 93Effect of new hybrids based on 5,16-pregnadiene scaffold linked to an anti-inflammatory drug on the growth of a human astrocytoma cell line (U373).
AID703399Inhibition of human recombinant N-terminal His6-tagged AKR1C4 expressed in Escherichia coli BL21(DE3) cells using 8-Acetyl-2,3,5,6-tetrahydro-1H,4H-11-oxa-3a-aza-benzo[de]anthracen-10-one as substrate after 1 hr by fluorimetric analysis2012Journal of medicinal chemistry, Sep-13, Volume: 55, Issue:17
3-(3,4-Dihydroisoquinolin-2(1H)-ylsulfonyl)benzoic Acids: highly potent and selective inhibitors of the type 5 17-β-hydroxysteroid dehydrogenase AKR1C3.
AID1733458Induction of morphological changes in human MDA-MB-231 cells assessed as nuclear condensation at IC50 concentration after 48 hrs by DAPI staining based fluorescent microscopic analysis2021Bioorganic & medicinal chemistry, 05-01, Volume: 37Design and synthesis of novel (S)-Naproxen hydrazide-hydrazones as potent VEGFR-2 inhibitors and their evaluation in vitro/in vivo breast cancer models.
AID1384739Antiviral activity against Influenza A virus (A/Puerto Rico/8/1934(H1N1)) infected in C57BL/6J mouse assessed as recovery of weight loss at 1 mg/mouse/day, ip qd treated up to day 2 starting at 5 to 10 mins post infection measured up to day 12 relative to2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID173209Gastrointestinal tolerability was evaluated in rats and amount blood loss was reported.1984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Nonsteroidal antiinflammatory agents. 14. Synthesis and pharmacological profile of 6-chloro-5-(cyclopentylmethyl)indan-1-carboxylic acid.
AID156203Binding to POPC/GMI liposomes using biosensor system2000Journal of medicinal chemistry, Jun-01, Volume: 43, Issue:11
SPR biosensor studies of the direct interaction between 27 drugs and a liposome surface: correlation with fraction absorbed in humans.
AID681160TP_TRANSPORTER: inhibition of Adefovir uptake in OAT1-expressing CHO cells2000The Journal of pharmacology and experimental therapeutics, Oct, Volume: 295, Issue:1
Nonsteroidal anti-inflammatory drugs efficiently reduce the transport and cytotoxicity of adefovir mediated by the human renal organic anion transporter 1.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID418089Toxicity in carrageenan treated Albino mouse liver assessed as acute hepatitis at 30 mg/kg, po administered 1 hr before carrageenan challenge measured after 4 hrs by hematoxilen eosine staining2009Bioorganic & medicinal chemistry letters, Apr-01, Volume: 19, Issue:7
Benzophenone-N-ethyl piperidine ether analogues--synthesis and efficacy as anti-inflammatory agent.
AID243647In vitro inhibitory activity against ovine cyclooxygenase-1 (COX-1) at 200 uM; Inactive2004Journal of medicinal chemistry, Sep-23, Volume: 47, Issue:20
Novel cyclooxygenase-1 inhibitors discovered using affinity fingerprints.
AID160899Concentration required to inhibit 50% activity of prostaglandin synthetase was determined in vitro in mouse brain microsomes1991Journal of medicinal chemistry, Mar, Volume: 34, Issue:3
Antinociceptive (aminoalkyl)indoles.
AID402402Inhibition of COX2-catalyzed prostaglandin biosynthesis after 10 mins of preincubation1998Journal of natural products, Oct, Volume: 61, Issue:10
Ursolic acid from Plantago major, a selective inhibitor of cyclooxygenase-2 catalyzed prostaglandin biosynthesis.
AID624608Specific activity of expressed human recombinant UGT1A42000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID128016Compound was tested for % reduction in phenylquinone-induced abdominal constriction (PAC) at po (peroral) dose of 70 mg/kg in mice1998Journal of medicinal chemistry, Mar-26, Volume: 41, Issue:7
New cyclooxygenase-2/5-lipoxygenase inhibitors. 1. 7-tert-buty1-2,3-dihydro-3,3-dimethylbenzofuran derivatives as gastrointestinal safe antiinflammatory and analgesic agents: discovery and variation of the 5-keto substituent.
AID399404Inhibition of bovine seminal microsomal COX1 assessed as PGE2 production preincubated for 10 mins1998Journal of natural products, Jan, Volume: 61, Issue:1
Development of a radiochemical cyclooxygenase-1 and -2 in vitro assay for identification of natural products as inhibitors of prostaglandin biosynthesis.
AID1077769Antiinflammatory activity in carrageenan-induced Wistar rat model assessed as inhibition of PGE2 level at 80 mg/kg through gavage administered 1 hr prior to carrageenan-challenge measured after 4 hrs (Rvb = 95 +/- 7 pg/mL)
AID710661Antinociceptive activity in Cav2.2 expressing wild type mouse assessed as reversal of complete Freund's adjuvant-induced pain at 30 mg/kg, po after 1 hr2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Aminopiperidine sulfonamide Cav2.2 channel inhibitors for the treatment of chronic pain.
AID3642The compound was tested for inhibition of isolated 5-Lipoxygenase1992Journal of medicinal chemistry, Jul-10, Volume: 35, Issue:14
5-lipoxygenase: properties, pharmacology, and the quinolinyl(bridged)aryl class of inhibitors.
AID287969Effect on iPGJ2 level in LPS-induced mouse RAW264.7 cells at 2 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID429540Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 40 mg/kg, po administered 30 mins before carrageenan challenge measured after 2 hrs2009Bioorganic & medicinal chemistry, May-15, Volume: 17, Issue:10
Chlorzoxazone esters of some non-steroidal anti-inflammatory (NSAI) carboxylic acids as mutual prodrugs: design, synthesis, pharmacological investigations and docking studies.
AID1211791Fraction unbound in human hepatocytes2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1211793Lipophilicity, log P of the compound2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1753654Cytotoxicity against human Caco2 cells assessed as reduction in cell viability measured upto 72 hrs by MTT assay2021European journal of medicinal chemistry, Jun-05, Volume: 218New organoselenides (NSAIDs-Se derivatives) as potential anticancer agents: Synthesis, biological evaluation and in silico calculations.
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.
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.
AID197726Lysozyme-conjugated prodrugs: in vitro stability in lysosomal lysate at pH 51992Journal of medicinal chemistry, Apr-03, Volume: 35, Issue:7
Low molecular weight proteins as carriers for renal drug targeting. Preparation of drug-protein conjugates and drug-spacer derivatives and their catabolism in renal cortex homogenates and lysosomal lysates.
AID184532Mortality caused by the compound in rats after administration at 1350 uM/kg for 4 days2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
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
AID22293Delta logD (logD6.5 - logD7.4)2000Journal of medicinal chemistry, Jun-29, Volume: 43, Issue:13
QSAR model for drug human oral bioavailability.
AID1211792Hepatic clearance in human2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID1698007Ratio of drug level in human blood to plasma administered through iv dosing by LC-MS/MS analysis
AID404479Inhibition of LTB4 production in mouse MC9 cells2008Journal of medicinal chemistry, Jun-26, Volume: 51, Issue:12
Indole cytosolic phospholipase A2 alpha inhibitors: discovery and in vitro and in vivo characterization of 4-{3-[5-chloro-2-(2-{[(3,4-dichlorobenzyl)sulfonyl]amino}ethyl)-1-(diphenylmethyl)-1H-indol-3-yl]propyl}benzoic acid, efipladib.
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?
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]
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.
AID1384721Cytotoxicity against MDCK cells assessed as reduction in cell viability after 48 hrs by trypan blue staining based method2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID131339Dose giving one-half of average maximal [40%] response in carrageenan assay1981Journal of medicinal chemistry, May, Volume: 24, Issue:5
Effect of structural change on acute toxicity and antiinflammatory activity in a series of imidazothiazoles and thiazolobenzimidazoles.
AID1384749Antiviral activity against Influenza A virus (A/Udorn/1972 (H3N2)) infected in MDCK cells at MOI of 2 assessed as decrease in viral load after 18 hrs by crystal violet staining based plaque assay2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID183221Compound was tested in vivo for antiinflammatory activity against chronic adjuvant arthritic rat by therapeutic inhibition 2 degree paw after peroral administration of 1 mg/kg of dose1986Journal of medicinal chemistry, Jun, Volume: 29, Issue:6
Antiinflammatory activity of substituted 6-hydroxypyrimido[2,1-f]purine-2,4,8(1H,3H,9H)-triones. Atypical nonsteroidal antiinflammatory agents.
AID24265Ability to undergo in vitro ester hydrolysis in 80% human plasma ( pH of 7.4) at 37 degree Celsius expressed as half life of methyl ester hydrolysis1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
Esters of N,N-disubstituted 2-hydroxyacetamides as a novel highly biolabile prodrug type for carboxylic acid agents.
AID1384726Cytotoxicity against human A549 cells assessed as reduction in cell viability after 48 hrs by MTT assay2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID1293303Antiproliferative activity against human UACC-903 cells assessed as reduction in cell viability after 24 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID377725Antiinflammatory activity in mouse assessed as inhibition of phorbol myristyl palmitate-induced ear lobe edema at 1 umol/ear after 6 hrs relative to control2006Journal of natural products, Jul, Volume: 69, Issue:7
Chamazulene carboxylic acid and matricin: a natural profen and its natural prodrug, identified through similarity to synthetic drug substances.
AID129290Antiinflammatory activity was assessed from the ability to inhibit cotton pellet granuloma in mice1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-6-(methylthio)-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-ca rboxyl ic acids and 1-methyl-4-(methylthio)-5-aroylpyrrole-2-acetic acids.
AID1384742Antiviral activity against Influenza A virus (A/Puerto Rico/8/1934(H1N1)) infected in C57BL/6J mouse assessed as survival at 1 mg/mouse/day, ip qd treated up to day 2 starting at 5 to 10 mins post infection measured at day 12 relative to control2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
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.
AID24204Distribution coefficient in octanol/water at pH 7.41998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID377724Antiinflammatory activity in mouse assessed as inhibition of phorbol myristyl palmitate-induced ear lobe edema at 0.1 umol/ear after 48 hrs relative to control2006Journal of natural products, Jul, Volume: 69, Issue:7
Chamazulene carboxylic acid and matricin: a natural profen and its natural prodrug, identified through similarity to synthetic drug substances.
AID178548Compound was tested for its analgesic activity in phenylquinone-induced abdominal constriction assay(PAC)1998Journal of medicinal chemistry, Aug-27, Volume: 41, Issue:18
New cyclooxygenase-2/5-lipoxygenase inhibitors. 3. 7-tert-butyl-2, 3-dihydro-3,3-dimethylbenzofuran derivatives as gastrointestinal safe antiinflammatory and analgesic agents: variations at the 5 position.
AID33556The ability concentration.)2000Journal of medicinal chemistry, May-18, Volume: 43, Issue:10
Biosensor analysis of the interaction between immobilized human serum albumin and drug compounds for prediction of human serum albumin binding levels.
AID171368Carrageenan paw edema index (CPE index) as ratio of the reduction in paw volume relative to tebufelone at a po (peroral) dose of 50 mg/kg.1998Journal of medicinal chemistry, Mar-26, Volume: 41, Issue:7
New cyclooxygenase-2/5-lipoxygenase inhibitors. 1. 7-tert-buty1-2,3-dihydro-3,3-dimethylbenzofuran derivatives as gastrointestinal safe antiinflammatory and analgesic agents: discovery and variation of the 5-keto substituent.
AID178669Antiinflammatory activity was determined to inhibit cotton pellet granuloma in rats with respcet to Indomethacin1987Journal of medicinal chemistry, May, Volume: 30, Issue:5
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-carboxylic acids. The 6-substituted compounds.
AID178492Antiinflammatory activity in the rat foot edema at the dose of 3.2-100 mg/kg po1990Journal of medicinal chemistry, Jul, Volume: 33, Issue:7
1,2-Dihydro-1-oxopyrrolo[3,2,1-kl]phenothiazine-2-carboxamides and congeners, dual cyclooxygenase/5-lipoxygenase inhibitors with antiinflammatory activity.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
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.
AID587448Inhibition of ovine COX-12011Journal of medicinal chemistry, Mar-10, Volume: 54, Issue:5
Ethanesulfohydroxamic acid ester prodrugs of nonsteroidal anti-inflammatory drugs (NSAIDs): synthesis, nitric oxide and nitroxyl release, cyclooxygenase inhibition, anti-inflammatory, and ulcerogenicity index studies.
AID1223475Elimination half life in chimeric mouse with humanized liver at 3 mg/kg, iv by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Prediction of in vivo hepatic clearance and half-life of drug candidates in human using chimeric mice with humanized liver.
AID266770Membrane permeability, CA(t)/CD(0) in 100% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1221794Cellular uptake in human hepatocytes at 1 mM measured at 6 hrs by LC-MS/MS analysis in presence of acyl glucuronidation inhibitor (-)-borneol2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
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.
AID1128738In vivo antidyslipidemic activity against Triton WR 1339-induced hyperlipidemic Wistar rat model assessed as decrease in LDL-cholesterol level in plasma at 56 umol/kg, ip administered as single dose 1 hr after Triton WR 1339 challenge measured after 24 hr2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1501472Drug metabolism assessed as UGT2B15 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID12234881-Octanol-water distribution coefficient, log D of the compound at pH 7.42012Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 40, Issue:2
Predicting phenolic acid absorption in Caco-2 cells: a theoretical permeability model and mechanistic study.
AID624612Specific activity of expressed human recombinant UGT1A92000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID680471TP_TRANSPORTER: inhibition of E217betaG uptake (E217betaG: 0.1 uM, Naproxen: 1000 uM) in Oatp1-expressing LLC-PK1 cells2002Pharmaceutical research, Feb, Volume: 19, Issue:2
Comparative inhibitory effects of different compounds on rat oatpl (slc21a1)- and Oatp2 (Slc21a5)-mediated transport.
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.
AID1698001Lipophilicity, log D of the compound at pH 7.4 by by shake flask method
AID1188962Aqueous solubility of the compound in H2O after 24 hrs incubation at 30 degC by LCMS analysis2014ACS medicinal chemistry letters, Aug-14, Volume: 5, Issue:8
An uncharged oxetanyl sulfoxide as a covalent modifier for improving aqueous solubility.
AID1384714Inhibition of nucleoprotein/polymerase acidic protein (1 to 27 residues) interaction in Influenza A virus (A/WSN/1933 (H1N1)) infected in MDCK cells by Western blot analysis2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID399405Inhibition of sheep placental cotyledons COX2 assessed as PGE2 production preincubated for 10 mins1998Journal of natural products, Jan, Volume: 61, Issue:1
Development of a radiochemical cyclooxygenase-1 and -2 in vitro assay for identification of natural products as inhibitors of prostaglandin biosynthesis.
AID1515605Anti-inflammatory activity in C57BL/6 mouse assessed as inhibition of carrageenan-induced hind paw edema treated immediately after carrageenan challenge measured after 3.5 hrs relative to control2019ACS medicinal chemistry letters, Jan-10, Volume: 10, Issue:1
Optimizing the Pharmacological Profile of New Bifunctional Antihyperlipidemic/Antioxidant Morpholine Derivatives.
AID171369Carrageenan paw edema index (CPE index) as ratio of the reduction in paw volume of tested compound relative to the compound tebufelone at peroral dose of 50 mg/kg.1998Journal of medicinal chemistry, Mar-26, Volume: 41, Issue:7
New cyclooxygenase-2/5-lipoxygenase inhibitors. 2. 7-tert-butyl-2,3-dihydro-3,3-dimethylbenzofuran derivatives as gastrointestinal safe antiinflammatory and analgesic agents: variations of the dihydrobenzofuran ring.
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.
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.
AID1501462Drug metabolism assessed as CYP2D6 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID1663617Cytotoxicity against African green monkey COS7 cells assessed as cell growth inhibition measured after 48 hrs by MTT assay2020Bioorganic & medicinal chemistry letters, 07-15, Volume: 30, Issue:14
Synthesis and anticancer activity of open-resorcinarene conjugates.
AID299743Effect on lipid peroxidation in rat gastric mucosa assessed as malondialdehyde level per 100 mg of tissue2007Bioorganic & medicinal chemistry letters, Aug-15, Volume: 17, Issue:16
Synthesis and pharmacological evaluation of condensed heterocyclic 6-substituted-1,2,4-triazolo[3,4-b]-1,3,4-thiadiazole derivatives of naproxen.
AID1221778Cytotoxicity against mock transfected HEK293 cells assessed as decrease in cell viability by measuring intracellular ATP content at 1 mM by CellTiter-Glo luminescent assay2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID266765Effective permeability coefficient in 70% silicon-30% IPM membrane2006Journal of medicinal chemistry, Jun-29, Volume: 49, Issue:13
Parallel artificial membrane permeability assay: a new membrane for the fast prediction of passive human skin permeability.
AID1077765Prodrug conversion in carrageenan-induced Wistar rat model assessed as sulfide species in serum at 80 mg/kg through gavage administered 1 hr prior to carrageenan-challenge
AID67735-lipoxygenase inhibitory activity against rat polymorphonuclear leucocytes from female wistar rat, by using LTB4.1995Journal of medicinal chemistry, Apr-28, Volume: 38, Issue:9
Synthesis and antiinflammatory activity of certain 5,6,7,8-tetrahydroquinolines and related compounds.
AID1211797Intrinsic clearance in cryopreserved human hepatocytes cells assessed per 10'6 cells by LC-MS/MS method2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
Comparison of cryopreserved HepaRG cells with cryopreserved human hepatocytes for prediction of clearance for 26 drugs.
AID724441Selectivity index, ratio of IC50 for ovine COX1 to IC50 for human recombinant COX22013Bioorganic & medicinal chemistry letters, Jan-01, Volume: 23, Issue:1
Hybrid fluorescent conjugates of COX-2 inhibitors: search for a COX-2 isozyme imaging cancer biomarker.
AID305923Permeability across hairless mouse skin from isopropyl myristate2007Bioorganic & medicinal chemistry letters, Mar-01, Volume: 17, Issue:5
N-Alkyl-N-alkyloxycarbonylaminomethyl (NANAOCAM) prodrugs of carboxylic acid containing drugs.
AID429538Antiinflammatory activity in Wistar rat assessed as inhibition of carrageenan-induced paw edema at 40 mg/kg, po administered 30 mins before carrageenan challenge measured after 0.5 hrs2009Bioorganic & medicinal chemistry, May-15, Volume: 17, Issue:10
Chlorzoxazone esters of some non-steroidal anti-inflammatory (NSAI) carboxylic acids as mutual prodrugs: design, synthesis, pharmacological investigations and docking studies.
AID1384746Antiviral activity against Influenza A virus (A/Puerto Rico/8/1934(H1N1)) infected in C57BL/6J mouse assessed as decrease in viral load in bronchoalveolar lavage at 1 mg/mouse/day, ip qd treated up to day 2 starting at 5 to 10 mins post infection relative2018Journal of medicinal chemistry, 08-23, Volume: 61, Issue:16
From Naproxen Repurposing to Naproxen Analogues and Their Antiviral Activity against Influenza A Virus.
AID189990Gastrointestinal tolerability was evaluated under chronic conditions, in rats. The ulcerogenic dose was reported; 5-101984Journal of medicinal chemistry, Mar, Volume: 27, Issue:3
Nonsteroidal antiinflammatory agents. 14. Synthesis and pharmacological profile of 6-chloro-5-(cyclopentylmethyl)indan-1-carboxylic acid.
AID1128735Inhibition of soybean lipoxygenase using sodium linoleate as substrate measured for 6 mins2014Journal of medicinal chemistry, Mar-27, Volume: 57, Issue:6
Design of novel potent antihyperlipidemic agents with antioxidant/anti-inflammatory properties: exploiting phenothiazine's strong antioxidant activity.
AID1864884Antifungal activity against Candida tropicalis ATCC 1369 assessed as fungal growth inhibition measured after 72 hrs in presence of fluconazole by double dilution method
AID1660991Binding affinity to human DHFR at 5 mM in presence of MFM by NMR spectroscopy2020Journal of medicinal chemistry, 08-13, Volume: 63, Issue:15
The Structural Basis for Nonsteroidal Anti-Inflammatory Drug Inhibition of Human Dihydrofolate Reductase.
AID1851152Antinociceptive activity in UV burn-induced thermal hyperalgesia mouse model assessed as reduction in latency time at 30 mg/kg, po relative to control2022Bioorganic & medicinal chemistry letters, 10-01, Volume: 73Discovery of pyridyl urea sulfonamide inhibitors of Na
AID1698010Hepatic clearance in human administered through iv dosing
AID1733459Induction of morphological changes in human MDA-MB-231 cells assessed as DNA fragmentation at IC50 concentration after 48 hrs by DAPI staining based fluorescent microscopic analysis2021Bioorganic & medicinal chemistry, 05-01, Volume: 37Design and synthesis of novel (S)-Naproxen hydrazide-hydrazones as potent VEGFR-2 inhibitors and their evaluation in vitro/in vivo breast cancer models.
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]
AID1753656Cytotoxicity against human MCF7 cells assessed as reduction in cell viability measured upto 72 hrs by MTT assay2021European journal of medicinal chemistry, Jun-05, Volume: 218New organoselenides (NSAIDs-Se derivatives) as potential anticancer agents: Synthesis, biological evaluation and in silico calculations.
AID184650Chronic gastrointestinal erosive activity in rats1989Journal of medicinal chemistry, Jun, Volume: 32, Issue:6
Synthesis and antiinflammatory and analgesic activity of 5-aroyl-6-(methylthio)-1,2-dihydro-3H-pyrrolo[1,2-a]pyrrole-1-ca rboxyl ic acids and 1-methyl-4-(methylthio)-5-aroylpyrrole-2-acetic acids.
AID1293299Antiproliferative activity against human MDA-MB-231 cells assessed as reduction in cell viability after 72 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID1293302Antiproliferative activity against human PANC1 cells assessed as reduction in cell viability after 72 hrs by MTT assay2016Journal of medicinal chemistry, Mar-10, Volume: 59, Issue:5
Design, Synthesis, and Biological Evaluation of Novel Selenium (Se-NSAID) Molecules as Anticancer Agents.
AID1221789Cytotoxicity against human hepatocytes assessed as decrease in cell viability by measuring intracellular ATP content at 1 mM measured at 6 hrs by CellTiter-Glo luminescent assay in presence of acyl glucuronidation inhibitor (-)-borneol2011Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 39, Issue:1
Toxicological evaluation of acyl glucuronides of nonsteroidal anti-inflammatory drugs using human embryonic kidney 293 cells stably expressing human UDP-glucuronosyltransferase and human hepatocytes.
AID678719Metabolic stability in human liver microsomes assessed as medium signal/noise ratio (S/N of 10 to 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.
AID162632Inhibition activity against recombinant human Prostaglandin G/H synthase 21997Journal of medicinal chemistry, Feb-28, Volume: 40, Issue:5
Nonsteroidal anti-inflammatory drugs as scaffolds for the design of 5-lipoxygenase inhibitors.
AID1698011Fraction unbound in human plasma
AID287967Effect on iPGE2 level in LPS-induced mouse RAW264.7 cells at 50 uM by ELISA2007Bioorganic & medicinal chemistry, May-15, Volume: 15, Issue:10
Potential anti-inflammatory actions of the elmiric (lipoamino) acids.
AID24448Partition coefficient value and its ionic species.1998Journal of medicinal chemistry, Dec-03, Volume: 41, Issue:25
Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically derived parameters. A multivariate data analysis approach.
AID161654Inhibitory activity against prostaglandin G/H synthase 12000Journal of medicinal chemistry, Jan-27, Volume: 43, Issue:2
Synthesis and biological evaluation of 3,4-diaryloxazolones: A new class of orally active cyclooxygenase-2 inhibitors.
AID1501469Drug metabolism assessed as UGT1A9 (unknown origin)-mediated metabolite formation2017European journal of medicinal chemistry, Oct-20, Volume: 1391-Aryl-1H- and 2-aryl-2H-1,2,3-triazole derivatives blockade P2X7 receptor in vitro and inflammatory response in vivo.
AID624611Specific activity of expressed human recombinant UGT1A82000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID1077805Cytotoxicity against human Jurkat cells assessed as growth inhibition after 24 hrs by MTT assay
AID540220Clearance in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID171180Body weight change after once daily administration for 4 days in rats was determined2004Bioorganic & medicinal chemistry letters, Jul-16, Volume: 14, Issue:14
Synthesis and pharmacological evaluation of amide conjugates of NSAIDs with L-cysteine ethyl ester, combining potent antiinflammatory and antioxidant properties with significantly reduced gastrointestinal toxicity.
AID1132609Antiinflammatory activity in Wistar rat mycobacterial adjuvant-induced arthritis model assessed as inhibition of swelling at 30 mg/kg/day, po measured on day 14 relative to control1978Journal of medicinal chemistry, May, Volume: 21, Issue:5
Synthesis and antiinflammatory activity of 6-oxo-1-(beta-D-ribofuranosyl)nocotinic acid and related derivatives.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1745845Primary qHTS for Inhibitors of ATXN expression
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
AID1345284Human COX-1 (Cyclooxygenase)1997Journal of medicinal chemistry, Feb-28, Volume: 40, Issue:5
Nonsteroidal anti-inflammatory drugs as scaffolds for the design of 5-lipoxygenase inhibitors.
AID1345206Human COX-2 (Cyclooxygenase)1997Journal of medicinal chemistry, Feb-28, Volume: 40, Issue:5
Nonsteroidal anti-inflammatory drugs as scaffolds for the design of 5-lipoxygenase inhibitors.
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.
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.
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.
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.
AID1802657Caspase Catalytic Activity Assay from Article 10.1016/j.chembiol.2017.02.003: \\Non-steroidal Anti-inflammatory Drugs Are Caspase Inhibitors.\\2017Cell chemical biology, Mar-16, Volume: 24, Issue:3
Non-steroidal Anti-inflammatory Drugs Are Caspase Inhibitors.
AID977611Experimentally measured binding affinity data (Kd) for protein-ligand complexes derived from PDB2014Proteins, Sep, Volume: 82, Issue:9
Structural studies of bovine, equine, and leporine serum albumin complexes with naproxen.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,325)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901011 (23.38)18.7374
1990's722 (16.69)18.2507
2000's1024 (23.68)29.6817
2010's1250 (28.90)24.3611
2020's318 (7.35)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 103.41

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 Index103.41 (24.57)
Research Supply Index8.63 (2.92)
Research Growth Index4.62 (4.65)
Search Engine Demand Index280.29 (26.88)
Search Engine Supply Index2.89 (0.95)

This Compound (103.41)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials1,057 (23.23%)5.53%
Reviews278 (6.11%)6.00%
Case Studies415 (9.12%)4.05%
Observational6 (0.13%)0.25%
Other2,795 (61.42%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (282)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain [NCT03404206]Phase 4387 participants (Actual)Interventional2018-02-12Completed
Open Label Randomised,Two-treatment,Two-period,Two-sequence,Single-dose, Crossover,Comparative Bioequivalence Study of Naproxen Sodium 550 mg Tablets With ANAPROX® DS 550 mg Tablets in Healthy,Adult, Human Subjects Under Fasting Conditions [NCT01052129]Phase 126 participants (Actual)Interventional2006-05-31Completed
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fasting Conditions. [NCT01131728]Phase 126 participants (Actual)Interventional2004-07-31Completed
A Double Blind, Randomised, Placebo Controlled Methodological Cross-over Study to Investigate the Senstivity of a Novel Study Design and Endpoints to Treatment Effects of Naproxen in Osteoarthritis [NCT01231490]Phase 253 participants (Actual)Interventional2008-09-30Completed
Oral Naproxen Versus Oral Tramadol for Analgesia After Cesarean Delivery - A Randomized Controlled Trial [NCT01165814]120 participants (Actual)Interventional2006-08-31Completed
A Multicenter, Double-blind, Double-dummy, Randomized, Single-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine [NCT04384367]Phase 31,664 participants (Anticipated)Interventional2022-12-30Recruiting
A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects [NCT01154790]Phase 1120 participants (Actual)Interventional2010-06-30Completed
Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-see for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-controlled Study With 12 Months Follow-up [NCT00826462]Phase 4177 participants (Actual)Interventional2009-03-31Completed
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 Phase 2a, Proof of Concept, Randomized, Double-Blind, Placebo-Controlled Clinical Trial, to Evaluate the Efficacy and Safety of MK-7264 in Women With Moderate to Severe Endometriosis-Related Pain [NCT03654326]Phase 2187 participants (Actual)Interventional2018-09-11Completed
A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale [NCT03570554]Phase 241 participants (Actual)Interventional2018-06-29Completed
Post Implantation Syndrome and Administration on NSAIDs in Patients Undergoing Endovascular Repair of an Abdominal Aortic Aneurysm Under General Anesthesia [NCT03727412]186 participants (Anticipated)Interventional2018-08-01Recruiting
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of V120083 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee [NCT03028870]Phase 2291 participants (Actual)Interventional2017-03-14Completed
The Effect of Turmeric on New Onset Primary Dysmenorrhea [NCT04183556]90 participants (Actual)Interventional2019-11-15Completed
A Double-Blind, Controlled Study to Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects [NCT03291418]Phase 1/Phase 2258 participants (Actual)Interventional2017-09-08Completed
IL-7 and IL-7R Expression in Peripheral Blood Mononuclear Cells, Peripheral Blood Monocytes or Differentiated Macrophages of Rheumatoid Arthritis Patients With Active vs. Inactive Disease Treated With DMARD and/or CIMZIA [NCT02451748]Phase 432 participants (Actual)Interventional2015-08-31Completed
Impact of Migraine on Work Productivity in Patients Treated With a Combination Product Containing Sumatriptan and Naproxen Sodium or Triptan Monotherapy [NCT01381497]1 participants (Actual)Observational2010-03-31Completed
A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip [NCT03161093]Phase 33,307 participants (Actual)Interventional2017-08-17Completed
A Phase 1 Ascending Single and Multiple Oral Dose Study to Assess the Safety and Tolerability, Including Gastrointestinal Safety, Pharmacokinetics and Pharmacodynamics of ASP7657 in Caucasian Healthy Male and Female Subjects, Including a Food Effect Cohor [NCT02108548]Phase 189 participants (Actual)Interventional2014-04-30Terminated(stopped due to Gastrointestinal safety findings)
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
A Phase I, Open-label, Randomised, 3-way Crossover Study to Demonstrate Bioequivalence of a Single Oral Dose of Naproxen Administered as VIMOVO Manufactured at AstraZeneca AB Compared to That of VIMOVO Manufactured by Patheon Pharmaceuticals and a Markete [NCT01331993]Phase 136 participants (Actual)Interventional2011-09-30Completed
A Phase Ib Biomarker Trial of Naproxen in Patients at Risk for DNA Mismatch Repair Deficient Colorectal Cancer [NCT02052908]Phase 181 participants (Actual)Interventional2014-01-27Completed
A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of a Single Oral Dose of VIMOVO (250 mg Naproxen/20 mg Esomeprazole)in Healthy Adult Subjects [NCT01358383]Phase 128 participants (Actual)Interventional2011-05-31Completed
A Double-Blind, Randomized, Placebo-and Active-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Subjects With Osteoarthritis [NCT01343303]Phase 143 participants (Actual)Interventional2011-03-31Completed
Study of the Efficacy of Co-administration of an NSAID With a Dopamine Agonist in the Alleviation of Acute Cutaneous Inflammatory Pain in Healthy Subjects [NCT02116790]Phase 20 participants (Actual)Interventional2014-05-31Withdrawn
A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data [NCT01381523]1 participants (Actual)Observational2010-11-30Completed
A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg QD And Naproxen 500mg BID In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan [NCT00648258]Phase 3130 participants (Actual)Interventional2003-07-31Completed
Phase I, Open-label, Randomized, 2-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Naprosyn E Under Fasting and Fed Conditions in Healthy Volunteers [NCT00907400]Phase 148 participants (Anticipated)Interventional2009-05-31Completed
A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Trial to Determine the Dose of Caffeine in a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain [NCT04132336]Phase 2193 participants (Actual)Interventional2019-11-12Completed
Changes in mRNA Expression Following Exposure to Naproxen [NCT01090596]48 participants (Actual)Interventional2007-04-30Completed
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Tolerability of TREXIMA* (Sumatriptan Succinate/Naproxen Sodium) for a Single Moderate or Severe Headache in Adults Diagnosed With Probable Migraine Without [NCT00387881]Phase 3679 participants (Actual)Interventional2006-09-30Completed
The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain [NCT02255955]Phase 475 participants (Anticipated)Interventional2014-10-31Not yet recruiting
Randomized, Double-blind and Placebo-controlled Evaluation of Efficacy and Safety of Naproxen Sodium and Codeine Phosphate Combination in Osteoarthritis [NCT02501564]Phase 4135 participants (Actual)Interventional2013-05-31Completed
Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal [NCT02494856]Phase 450 participants (Actual)Interventional2014-10-31Completed
Eliminating Narcotic Prescriptions From Outpatient Minimally Invasive Gynecologic Surgery: a Randomized Controlled Trial [NCT04837014]88 participants (Anticipated)Interventional2022-07-04Recruiting
A Phase 2a Randomized, Double-blinded, Double Dummy, Placebo And Active Controlled, Two-way Cross-over, Flare-enriched Multi-centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A Fatty Acid Amide Hydrolase [NCT00981357]Phase 276 participants (Actual)Interventional2009-11-30Completed
A Double-Blind, Randomized, Active Comparator Study of LT-NS001 Versus Naprosyn for Seven Days in Healthy Subjects With Endoscopic Evaluation [NCT00750243]Phase 1120 participants (Actual)Interventional2008-09-30Completed
[NCT02408978]Phase 10 participants Interventional2015-05-31Completed
"An Open-label, Randomized, Single-dose, Two-treatment, Crossover Bioequivalence Study Comparing a Novel Naproxen Sodium 275 mg Film-coated Tablet (BILIM ILAC SANAYII VE TICARET A.S., TURKEY) and Nalgesin® 275 mg Naproxen Sodium Film-coated Tablet (JSC KR [NCT03697889]Phase 128 participants (Actual)Interventional2018-12-03Completed
NSAIDs vs. Coxibs in the Presence of Aspirin: Effects on Platelet Function, Endothelial Function, and Biomarkers of Inflammation in Subjects With Rheumatoid Arthritis and Increased Cardiovascular Risk or Cardiovascular Disease [NCT03699293]Phase 430 participants (Anticipated)Interventional2018-09-22Recruiting
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Safety and Tolerability Trial of Naproxen Sodium/ Diphenhydramine Combination in an OTC Population [NCT01365052]Phase 3326 participants (Actual)Interventional2011-05-31Completed
Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study [NCT02665286]Phase 4240 participants (Actual)Interventional2016-03-31Completed
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
Project 1: Program on Genetic and Dietary Predictors of Drug Response in Rural and AI/AN Populations (Naproxen Study) [NCT04449471]Phase 430 participants (Anticipated)Interventional2016-01-12Recruiting
Study to Assess the Comparative Bioavailability and Pharmacokinetics of Naproxen From OXP005 Tablets (Test) And Naprosyn® Tablets (Reference) in Normal, Healthy, Adult Subjects [NCT02351024]Phase 10 participants Interventional2015-02-28Completed
A Prospective, Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center, Interventional Study to Compare Gastro-protective Effect and Pain Relief Effect of Naxozol Compared to Celecoxib in Patients With Osteoarthritis [NCT02355236]Phase 4106 participants (Anticipated)Interventional2015-02-28Recruiting
Effect of Repeated Oral Doses of BI 1060469, BI 1021958 and Active Controls, Cimetidine and Naproxen, on Measured GFR Via Renal Clearance of Iohexol in Healthy Male Subjects (a Phase I Study; Single-blind, Randomized, Placebo-controlled Within BI Groups a [NCT02202512]Phase 153 participants (Actual)Interventional2014-09-30Completed
A Phase 1, Single-Center, Randomized, Parallel-group, Placebo- and Naproxen- Controlled, Double-blind Study to Evaluate the Effect of Naproxcinod 750 mg Bid Administered for 8 Days on the Renal Hemodynamics, Natriuretic and Renin Responses to a Single Bol [NCT00909519]Phase 131 participants (Actual)Interventional2009-01-31Completed
Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea [NCT05900336]Phase 470 participants (Anticipated)Interventional2024-01-01Not 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
Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial [NCT04875702]650 participants (Anticipated)Interventional2023-11-15Not yet recruiting
Double-blind, Phase III Study to Evaluate Gastroprotection Obtained by the Use of Rebamipide 300 mg (2x Daily) and Rabeprazole 20 mg/Day (1x Daily) Associated or Not to Prevent Naproxen (1100 mg/Day)-Induced Gastric Lesions for 7 Days. [NCT03658473]Phase 332 participants (Actual)Interventional2014-11-12Completed
Adding Diazepam to Standard Management of Acute, Non-radicular Low Back Pain. An Emergency Department Based Randomized Comparative Effectiveness Study [NCT02646124]Phase 2/Phase 3114 participants (Actual)Interventional2015-06-30Completed
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 NSAID Pain Protocol Provides Adequate Pain Relief in Ankle Fractures Treated Operatively [NCT02281968]Phase 40 participants (Actual)Interventional2014-12-31Withdrawn
Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial [NCT02604550]Phase 4115 participants (Actual)Interventional2015-11-30Completed
Double-blind Study to Compare Efficacy and Safety of Meloxicam 7.5 mg and 15 mg vs. Naproxen Sodium 1100 mg in the Symptomatic Treatment of Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis Over a Period of 5 Days [NCT02183038]Phase 2390 participants (Actual)Interventional1998-07-31Completed
Evaluation of CGRP, Estrogen, Cortisol, VIP, α-Amylase, PGE2, PGI2 and ß-Endorphin Levels in Saliva of Menstrual Migraine Patients Before and After Treatment With Treximet™ [NCT01329562]Phase 441 participants (Actual)Interventional2011-05-31Completed
A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee [NCT01102660]Phase 2172 participants (Actual)Interventional2010-05-31Completed
A Phase 2a, Randomized, Double-blind, Placebo- and Naproxen Controlled, Parallel-group Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee [NCT02611466]Phase 2215 participants (Actual)Interventional2016-02-16Completed
A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea [NCT03448536]Phase 4201 participants (Actual)Interventional2018-04-05Completed
[NCT01178203]Phase 1/Phase 20 participants Interventional2010-07-31Completed
Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial [NCT05154682]Phase 3200 participants (Anticipated)Interventional2021-11-30Enrolling by invitation
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Naproxen Sodium 220 mg + Pseudoephedrine HCL 120 mg ER Tablets and Aleve Cold and Sinus® Under Fed Conditions. [NCT01131767]Phase 126 participants (Actual)Interventional2004-07-31Completed
Clinical Trial To Evaluate Pharmacokinetic Interactions and Safety Between JP-1366 and Aceclofenac, Meloxicam, and Naproxen in Korean Healthy Volunteers and Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian [NCT05181124]Phase 188 participants (Actual)Interventional2021-03-05Completed
An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fasted Conditions [NCT03396250]Phase 136 participants (Actual)Interventional2018-02-12Completed
Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis? A Randomized-single Blind Study. [NCT03794219]80 participants (Actual)Interventional2019-01-07Completed
A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers [NCT04490434]Phase 1110 participants (Anticipated)Interventional2020-06-19Recruiting
Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection [NCT04325633]Phase 330 participants (Actual)Interventional2020-04-24Terminated(stopped due to Stop inclusions for insufficient recruitment)
A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) W [NCT00504127]Phase 31,020 participants (Actual)Interventional2007-04-30Completed
A Single Center Randomized Open-Label Two Arm Crossover Study of Subject Productivity Improvement and Satisfaction With Migraine Treatment Using Treximet vs Usual Triptan [NCT01086358]Phase 460 participants (Actual)Interventional2009-09-30Completed
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
Evaluation of the Effect of Different Acupuncture Dose on Premenstrual Syndrome and the Relationship Between Premenstrual Syndrome and TCM Syndrome Complex [NCT04296422]105 participants (Anticipated)Interventional2019-01-01Enrolling by invitation
BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN: A Partially-Blind Randomized Clinical Trial of Placebo and Chronic Back Pain [NCT02013427]Phase 482 participants (Actual)Interventional2014-10-31Completed
A Randomized, Double-Blind, Placebo And Active Controlled Methodology Study Investigating The Effects Of Tramadol And Naproxen On The Pain Thresholds Of Patients With Severe Pain Due To Osteoarthritis Of The Thumb [NCT00743587]Phase 136 participants (Actual)Interventional2008-09-30Completed
Investigations of Naproxen Treatment Effects in Pre-clinical Alzheimer's Disease (INTREPAD) [NCT02702817]Phase 2200 participants (Actual)Interventional2012-08-01Completed
A Single Center, Double-blind, Placebo-controlled Phase I Single-dose Cross-over Study in Healthy Subjects to Investigate the Inhibitory Effect of CG100649, Celecoxib, Naproxen, and Acetazolamide on the Activity of Cyclooxygenases (COX-1, COX-2) and Carbo [NCT00780325]Phase 126 participants (Actual)Interventional2008-10-31Terminated(stopped due to A total of three parts were planned for this study. The sponsor funded only Part 1, so that neither Part 2 nor Part 3 of this study has been conducted.)
A Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Subjects With Rheumatoid Ar [NCT00626275]Phase 246 participants (Actual)Interventional2007-10-31Completed
A Single Centre, Two Treatment, Two Period, Two Sequence, Randomized Crossover Steady-state Relative Bioavailability Study of Naproxen in Two Tablet Formulations Given Twice Daily (PN 400 Tablets Containing 500 mg of Naproxen Plus 20 mg of Esomeprazole Ve [NCT00992381]Phase 124 participants (Anticipated)Interventional2009-09-30Completed
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)
Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth With Irreversible Pulpitis [NCT04947566]Phase 4116 participants (Actual)Interventional2019-09-02Completed
Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion [NCT02769247]160 participants (Actual)Interventional2014-06-30Completed
A Double-Blind, Placebo-Controlled, 4-Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics at Two Dose Levels of JMI-001 in Comparison With Fexofenadine and Naproxen Administered in Conjunction With Alcohol. [NCT03183297]Phase 148 participants (Anticipated)Interventional2017-08-31Not yet recruiting
6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study Evaluate Gastric Ulcer Incidence Following Administration of PN400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-associated Ulcers [NCT00527787]Phase 3434 participants (Actual)Interventional2007-09-30Completed
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain [NCT03697720]Phase 426 participants (Actual)Interventional2018-05-09Completed
A Parallel Two Arm, Double Blinded Placebo Study, Examining the Efficacy of Sumatriptan With Naprosyn in the Treatment of Migraine With Aura [NCT00893594]30 participants (Anticipated)Interventional2010-10-31Recruiting
Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study [NCT05851976]Phase 4120 participants (Anticipated)Interventional2023-10-04Recruiting
Phase I, Open-label, Randomized, 3-way Crossover Study to Assess Relative Bioavailability of Single Oral Dose of Naproxen as PN400 Compared to Naproxen as Proxen S and Naprosyn E in Healthy Volunteers [NCT00761501]Phase 138 participants (Anticipated)Interventional2008-09-30Completed
Demonstration of OTC Naproxen Sodium's (Aleve's) Anti-inflammatory Action in Dental Implant Surgery Patients [NCT04694300]Phase 432 participants (Actual)Interventional2021-02-07Completed
A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing [NCT00778193]Phase 4125 participants (Actual)Interventional2007-10-31Completed
Phase 3. Efficacy of Flavocoxid Compared With Naproxen in Subjects With Moderate-severe Osteoarthritis (OA) of the Knee [NCT00790985]223 participants (Actual)Interventional2008-01-31Completed
Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fasting Conditions [NCT00804401]Phase 134 participants (Actual)Interventional2004-06-30Completed
A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED) [NCT00449787]Phase 4401 participants (Actual)Interventional2007-03-31Completed
A Double-Blind,Randomized, Placebo Controlled, Parallel Group, Multi-Center Study of Flavocoxid (Limbrel) Versuss Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee [NCT00928837]350 participants (Actual)Interventional2006-03-31Completed
A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea [NCT00092729]Phase 3129 participants (Actual)Interventional2002-06-07Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Pregabalin and Naproxen Sodium on Postoperative Pain After Bunionectomy [NCT00601458]Phase 1100 participants (Actual)Interventional2007-07-31Completed
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial [NCT00602420]Phase 3510 participants (Actual)Interventional2008-06-30Completed
Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations [NCT00692055]Phase 130 participants (Actual)Interventional2008-06-30Completed
A 12-Week, Phase 1, Multicenter, Double-Blind, Randomized, Dose Ranging, Forced Titration, Naproxen-Controlled, Parallel-Group, Pharmacodynamic Study, to Assess the Effects Different Doses of Naproxcinod and Naproxen on Arterial Blood Pressure as Measured [NCT00662610]Phase 1120 participants (Anticipated)Interventional2008-03-31Completed
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee [NCT00652808]Phase 3265 participants (Actual)Interventional2004-05-31Completed
A 12-month, Phase 3, Open-label, Multi-center Study to Evaluate the Long-term Safety of PN400 in Subjects Who Are at Risk for Developing NSAID-associated Ulcers [NCT00527904]Phase 3239 participants (Actual)Interventional2007-03-31Completed
A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen [NCT00346216]Phase 424,081 participants (Actual)Interventional2006-10-04Completed
The Sumatriptan and Naratriptan Pregnancy Registry [NCT01059604]868 participants (Actual)Observational [Patient Registry]2001-12-31Completed
Study TXA107977, a Long-Term Safety Study of a Combination Product Containing Sumatriptan Succinate and Naproxen Sodium for the Treatment of Migraine in Adolescents [NCT00488514]Phase 3656 participants (Actual)Interventional2007-07-13Completed
An Open Label, Randomized, Two-Way Crossover Trial to Compare the Pharmacokinetic Parameters of an Extended- Release Naproxen Sodium Tablet Relative to Naprelan® Tablets Following Single Dose Administration Under Fasted Conditions [NCT00969449]Phase 128 participants (Actual)Interventional2009-04-30Completed
A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain [NCT03566979]Phase 3501 participants (Actual)Interventional2018-08-13Completed
Symptomatic Management of Lyme Arthritis [NCT04038346]Phase 3300 participants (Anticipated)Interventional2019-10-01Recruiting
A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE [NCT00863304]Phase 3849 participants (Actual)Interventional2009-06-09Completed
A Study To Determine The Ability Of FMRI To Detect And Quantify The Effect Of Naproxen On Osteoarthritis Of The Hand [NCT00830050]Early Phase 124 participants (Actual)Interventional2010-07-31Completed
Infliximab as First Line Therapy in Patients With Early Active Axial Spondyloarthritis Trial [NCT00844805]Phase 3158 participants (Actual)Interventional2009-09-30Completed
A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month Treatment of Subjects With Osteoarthritis of the Knee [NCT00643799]Phase 4586 participants (Actual)Interventional2004-03-31Completed
Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA [NCT00652925]Phase 3225 participants (Actual)Interventional2002-10-31Completed
Evaluation of a Behavioral Program for Migraineurs in the Emergency Department. [NCT02643719]0 participants (Actual)Interventional2015-12-31Withdrawn(stopped due to Study team missed continuing review and study lapsed with out recruiting any subjects.)
An Open-Label, Repeat Dose Study Of The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months [NCT00442221]Phase 3500 participants Interventional2004-05-31Completed
A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE [NCT00830063]Phase 3832 participants (Actual)Interventional2009-05-05Completed
TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents [NCT00843024]Phase 3589 participants (Actual)Interventional2008-12-31Completed
A Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Trial Assessing the Analgesic Efficacy of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet in Postsurgical Dental Pain [NCT00720057]Phase 3312 participants (Actual)Interventional2008-06-30Completed
A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima* (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migra [NCT00240617]Phase 3623 participants (Actual)Interventional2005-10-31Completed
A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis. [NCT00807846]Phase 4201 participants (Actual)Interventional2009-09-30Completed
An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting [NCT00751400]Phase 3497 participants (Actual)Interventional2008-07-31Completed
Randomized, 2-Way Crossover, Bioequivalence Study of Two Oral Formulations of Naproxen 500 mg Tablets Administered as 1 x 500 mg Tablet in Healthy Subjects Under Fed Conditions [NCT00803764]Phase 134 participants (Actual)Interventional2004-06-30Completed
Assessment of the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet Treatment on Blood Pressure When Administered Intermittently for Six Months for the Acute Treatment of Migraine Attacks, With or [NCT00792636]Phase 4407 participants (Actual)Interventional2008-11-30Completed
A Randomized, Open-Label, 4-Way Crossover Study to Evaluate Naproxen and Esomeprazole Plasma Levels in Healthy Subjects Following Oral Administration of PN 400, Enteric-Coated Naproxen 500mg Plus Enteric-Coated Esomeprazole 20mg, Enteric-Coated Naproxen 5 [NCT00749385]Phase 140 participants (Actual)Interventional2008-08-31Completed
PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-AND ACTIVE CONTROLLED, MULTICENTER, PARALLEL GROUP PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF RN624 IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN [NCT00584870]Phase 2220 participants (Actual)Interventional2007-07-05Completed
A Phase 2 Randomized, Double-Blinded, Double-Dummy, Placebo And Active Controlled Two Cohort Two-Way Cross-Over, Multi-Centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A 5-Lipoxygenase (5-Lox) Inhibitor [NCT01147458]Phase 2190 participants (Actual)Interventional2010-07-31Terminated(stopped due to See termination reason in detailed description.)
Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (R [NCT00650455]Phase 4489 participants (Actual)Interventional2003-02-28Completed
An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volun [NCT00665743]Phase 130 participants (Anticipated)Interventional2008-03-31Completed
An Open Label, Randomised Two Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration Under Fed Conditions. [NCT00818415]Phase 132 participants (Actual)Interventional2008-11-30Completed
A RANDOMIZED, DOUBLE-BLIND, MULTI-DOSE, ACTIVE- AND PLACEBO-CONTROLLED, MULTI-CENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH CHRONIC LOW BACK PAIN [NCT00876187]Phase 21,359 participants (Actual)Interventional2009-06-15Completed
A Pilot Four-Way Crossover Bioequivalence Trial of Sustained Release Forms of Naproxen Versus Aleve Tablets in Healthy Adult Subjects in a Fasted State [NCT02549469]Phase 132 participants (Actual)Interventional2007-03-31Completed
Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones: A Randomized Control Study [NCT02786446]135 participants (Actual)Interventional2015-07-31Completed
Treximet in the Treatment of Chronic Migraine [NCT01090050]Phase 456 participants (Actual)Interventional2010-09-30Completed
A Single-centre, Randomised, Double-blind, Placebo-controlled, Two-part Study to Assess Safety, Tolerability, Pharmacokinetics of Orally Administered AZD1386 [NCT00945178]Phase 111 participants (Actual)Interventional2009-08-31Terminated(stopped due to The study was terminated due to results in another study (NCT00878501).)
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2) [NCT00382993]Phase 3169 participants (Actual)Interventional2006-12-31Completed
A Multicenter, National, Double-blind, Randomized Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg Relative to Efficacy and Safety of Each Monotherapy for the Acute Treatment of Migraine [NCT01390324]Phase 30 participants (Actual)Interventional2011-12-31Withdrawn
N of 1 Pilot Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis [NCT05430230]Phase 420 participants (Anticipated)Interventional2022-08-24Recruiting
Mechanistic Characterization of Uterine Pain (MCUP) to Improve Diagnosis and Treatment for Dysmenorrhea [NCT04145518]Phase 4214 participants (Anticipated)Interventional2019-10-25Recruiting
A Phase 1 Study to Assess the Pharmacokinetics of Nitrates and Gamma-Hydroxybutyric Acid (GHB) After Oral Administration of Therapeutic and Supratherapeutic Doses of Naproxcinod in Healthy Male Subjects [NCT01404598]Phase 124 participants (Actual)Interventional2010-01-31Completed
A Phase I, Open-Label, Randomized 3-Period Crossover Study in Healthy Male Subjects to Evaluate the Pharmacodynamic Interactions Between YM150 on Naproxen at Steady-State [NCT01409603]Phase 126 participants (Actual)Interventional2010-01-31Completed
A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction [NCT00659490]Phase 2151 participants (Actual)Interventional2008-02-29Completed
An Open Label, Randomized, Two-Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration in Healthy Adult Subjects [NCT00751556]Phase 132 participants (Actual)Interventional2008-02-29Completed
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo Controlled and Active-controlled, Parallel-group Study Evaluating the Analgesic Efficacy and Safety of VM902A in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee [NCT02847702]Phase 275 participants (Actual)Interventional2016-08-31Terminated(stopped due to Company decision)
A Comparative Bioavailability Study of Naproxen Delayed-Release Tablets, 375mg. [NCT00959439]Phase 134 participants (Actual)Interventional2002-03-31Completed
Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) [NCT00007189]Phase 32,625 participants Interventional2001-01-31Completed
A Multicenter, Randomized, Placebo And Active-Controlled Study Of The Effect Of CJ-023,423 On The Incidence Gastroduodenal Endoscopic Ulcers In Healthy Subjects [NCT00392080]Phase 1340 participants (Anticipated)Interventional2006-11-30Completed
[NCT00536068]11 participants (Actual)Interventional2006-08-31Completed
A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the [NCT00541489]Phase 3800 participants (Anticipated)Interventional2007-06-30Completed
A Double-blind, Placebo-controlled Investigation of Inter-individual Variability in Pharmacologic Response to Non-steroidal Anti-inflammatory Drugs [NCT02502006]Phase 116 participants (Actual)Interventional2015-11-30Terminated(stopped due to Funding was not available to complete enrollment)
A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2) [NCT00383162]Phase 3173 participants (Actual)Interventional2006-11-30Completed
Open Label Randomised,Two-treatment,Two-period,Two-sequence,Single-dose, Crossover,Comparative Bioequivalence Study of Naproxen Sodium 550 mg Tablets With ANAPROX® DS 550 mg Tablets in Healthy,Adult, Human Subjects Under Fed Conditions [NCT01052792]Phase 126 participants (Actual)Interventional2006-05-31Completed
A Double-Blind, Double-Dummy, Randomized, Active-Comparator, Non-Inferiority Study of LT-NS001 Versus Naprosyn® for Twelve Weeks in Osteoarthritis Patients to Compare Endoscopic Gastric Ulcer Rates [NCT01063920]Phase 2/Phase 3534 participants (Anticipated)Interventional2010-02-28Completed
Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment [NCT01471899]Phase 378 participants (Actual)Interventional2013-03-31Completed
A Phase 1 Study to Evaluate the Potential Two-Way Pharmacokinetic Interaction Between Lesinurad and Naproxen and Between Lesinurad and Indomethacin in Healthy Adult Male Subjects [NCT01884272]Phase 124 participants (Actual)Interventional2013-06-30Completed
A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migrai [NCT00240630]Phase 3646 participants (Actual)Interventional2005-10-31Completed
Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery [NCT01952652]Phase 461 participants (Actual)Interventional2013-01-31Completed
Local Anesthesia and Analgesics in Post-Operative Endodontic Pain [NCT01982799]0 participants (Actual)Interventional2014-02-28Withdrawn(stopped due to Not enough funding)
Effect of Metamizole on Renal Function in Salt-depleted Healthy Subjects Single-center, Randomized, Open, Controlled Parallel-group Study to Investigate the Effects of Oral Metamizole or Naproxen on Renal Function in Healthy Male Salt-depleted Subjects [NCT01995006]Phase 115 participants (Actual)Interventional2014-01-31Completed
Ictal and Interictal Inflammatory Markers in Migraine [NCT01138150]Phase 436 participants (Actual)Interventional2009-09-30Completed
Effectiveness of Naproxen for the Prevention of Heterotopic Ossification After Complex Elbow Trauma: a Prospective Randomized Trial [NCT00586365]Phase 40 participants (Actual)Interventional2007-10-31Withdrawn(stopped due to Too difficult to satisfy all the inclusion criteria.)
A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee [NCT01688934]Phase 2230 participants (Actual)Interventional2012-09-30Completed
A Double-blind, Randomized, Placebo and Naproxen Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386, in Patients Undergoing Impacted Mandibular Third Molar Extraction [NCT00672646]Phase 2103 participants (Actual)Interventional2008-04-30Completed
A Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Analgesic Effects of Naproxen and Ultracet in a Walking Model of Osteoarthritis Knee Pain [NCT00772967]Phase 122 participants (Actual)Interventional2008-06-30Completed
A Randomized, Double-Blind, Placebo-Controlled Clinical Study of Single Doses of JNJ-39439335 Versus Single and Multiple Doses of Naproxen Versus Placebo in the Treatment of Painful Osteoarthritis of the Knee: Focus on Treatment Effects and Methodological [NCT00933582]Phase 133 participants (Actual)Interventional2009-08-31Completed
An Open Label, Single Dose, Randomised, Parallel Group Pharmacokinetic Study to Evaluate a Combination Product Containing Naproxen Sodium and Sumatriptan in Adolescent Subjects With Migraine and Healthy Adult Subjects Administered at Three Doses. [NCT00989625]Phase 150 participants (Actual)Interventional2008-11-04Completed
An Open Label, Randomized, Two-Way Crossover Study to Determine the Bioavailability of a Single, Oral Dose of an Extended Release Naproxen Sodium Tablet Under Fasting and Fed Conditions [NCT00692016]Phase 132 participants (Actual)Interventional2008-01-31Completed
Naproxen for Acute Pain After Surgery: A Randomized, Placebo-Controlled Trial [NCT00615875]Phase 424 participants (Anticipated)Interventional2008-03-31Not yet recruiting
A Phase III, Two-Part, Randomized, Double-Blind, Active Comparator-Controlled, Multicenter Clinical Trial to Study the Relative Efficacy and Tolerability of Two Doses of MK-0663/Etoricoxib in Patients With Ankylosing Spondylitis [NCT01208207]Phase 31,015 participants (Actual)Interventional2010-09-27Completed
Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination Therapy vs. Oseltamivir Alone for Hospitalised Paediatric Influenza Patients [NCT04315194]54 participants (Actual)Observational [Patient Registry]2017-12-18Completed
A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis [NCT01165307]Phase 477 participants (Actual)Interventional2009-08-31Completed
Elderly Back Pain: Comparing Chiropractic to Medical Care [NCT00602901]Phase 2240 participants (Actual)Interventional2004-07-31Completed
A Randomized, Double Blind, Placebo and Naproxen Controlled, Multi-center, Study to Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Kn [NCT01160822]Phase 2169 participants (Actual)Interventional2010-04-30Completed
Correlation Between Acute Analgesia and Long-Term Function Following Ankle [NCT02667730]Phase 4160 participants (Anticipated)Interventional2015-06-30Recruiting
A 16-week, Phase 1, Multicenter, Double-Blind, Randomized, Naproxen and Ibuprofen-controlled, Parallel-Group Pharmacological Study, to Assess the Effect of Naproxcinod (375mg and750mg, Bid) Compared to Doses of Naproxen (250mg and 500mg, Bid) and to Ibupr [NCT00662896]Phase 1300 participants (Anticipated)Interventional2008-03-31Completed
"An Open-label Study to Evaluate Completeness of Response Following Treatment With Treximet™ for Migraine" [NCT00893737]Phase 4147 participants (Actual)Interventional2009-06-30Completed
301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Fo [NCT00542555]Phase 3918 participants (Actual)Interventional2005-12-31Completed
A Randomized, Double-blind, Single Migraine Attack, Placebo -Controlled, Patallel-group Multicenter Study to Evaluate the Efficacy and Tolerability or Trexima (Sumatriptan Succinate/Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pai [NCT00329459]Phase 3320 participants (Actual)Interventional2006-05-31Completed
A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi Center Study of Flavocoxid ( Limbrel) vs Naproxen in Subjects With Moderate-Severe Osteoarthritis of the Knee [NCT00435292]350 participants (Actual)Interventional2006-04-30Completed
A Double-Blind, Placebo-Controlled, Phase 2B Study to Assess the Efficacy and Safety of a 14-Day Dosing Regimen of 3 Doses of ATB-346 Versus Placebo, Orally Administered Once Daily to Patients Diagnosed With Osteoarthritis of the Knee [NCT03978208]Phase 2381 participants (Actual)Interventional2019-03-29Completed
An Evaluation of Treximet in the Treatment of Acute Migraine Headache: A Placebo-Controlled, Double-Blind, Crossover Study, Assessing Cognitive Function. [NCT00837044]30 participants (Anticipated)Interventional2009-02-28Recruiting
A Phase 1, Open-label, Fixed-sequence, 2-way Drug Interaction Study to Evaluate the Effect of Naproxen on the Pharmacokinetics of LC350189 and the Effect of LC350189 on the Pharmacokinetics of Naproxen in Healthy Subjects [NCT04139824]Phase 124 participants (Actual)Interventional2020-01-22Completed
A Proof-of-Concept, Randomized, Double Blind, Placebo and Active Control, 3-Period, Crossover Design Study Assessing NEO6860 in Patients With Pain Associated With Osteoarthritis of the Knee [NCT02712957]Phase 254 participants (Actual)Interventional2016-03-31Completed
A Random Controlled Trial a Comprehensive Migraine Intervention at the Time of Discharge From the Emergency Department After Treatment for Acute Migraine [NCT01071317]Phase 450 participants (Actual)Interventional2010-02-28Completed
A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Naproxen Table 500 mg Twice Daily in the Treatment of Chin [NCT00157872]Phase 4150 participants Interventional2004-01-07Completed
Effect of Preoperative Tramadol and Naproxen Sodium on Efficacy of Local Anesthesia and Post-operative Pain in Patients With Symptomatic Irreversible Pulpitis [NCT05982392]Phase 2/Phase 347 participants (Actual)Interventional2023-03-01Completed
A Phase 2, Single-center, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Study of a Single Dose of IW-6118, in Patients Undergoing Third Molar Extraction [NCT01107236]Phase 290 participants (Actual)Interventional2010-06-30Completed
Evaluation of the Efficacy of Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction [NCT01053507]Phase 423 participants (Actual)Interventional2010-05-31Terminated(stopped due to Enrollment rate was slower than anticipated.)
A Randomized, Double-Blind, Parallel Group Study To Compare The 7-Day Gastrointestinal Safety of 2 Doses of PLA-695 To That Of Placebo And Naproxen [NCT00366262]Phase 10 participants Interventional2006-06-30Completed
A Phase III, Multicenter, National, Open, Randomized, Parallel and Comparative Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg for the Acute Treatment of Migraine. [NCT01726920]Phase 30 participants (Actual)Interventional2014-07-31Withdrawn(stopped due to Due to budget limitations, the company decided to withdraw this study.)
Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's [NCT00447759]Phase 47,297 participants (Actual)Interventional2007-06-30Completed
TreximetTM in the Prevention and Modification of Disease Progression in Migraine [NCT01300546]Phase 440 participants (Actual)Interventional2010-12-31Completed
The Efficacy and Safety of Derris Scandens Benth Extract and Naproxen for Therapy of Patients With Knee Osteoarthritis [NCT00503828]Phase 3120 participants (Actual)Interventional2007-07-31Completed
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome [NCT05411718]Phase 240 participants (Anticipated)Interventional2023-03-21Recruiting
Study to Evaluate Arthroplasty Specimens in the Phase 3 Fasinumab Program for Osteoarthritis of the Knee and Hip [NCT03949673]Phase 223 participants (Actual)Interventional2019-04-08Terminated(stopped due to Lack of enrollment)
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
Effectiveness of Paracervical Block in Endometrial Sampling Procedures for Pain Control: A Randomized Controlled Clinical Trial [NCT04572828]120 participants (Actual)Interventional2020-09-28Completed
Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level [NCT05629494]Phase 4398 participants (Anticipated)Interventional2022-09-27Recruiting
Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate Efficacy & Safety of ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents [NCT01016678]Phase 2/Phase 3104 participants (Actual)Interventional2010-03-31Completed
Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment [NCT01471886]Phase 383 participants (Actual)Interventional2013-03-31Completed
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
Phase 1 Study of Low Level Laser Therapy Versus Naproxen [NCT01659372]Phase 140 participants (Anticipated)Interventional2012-06-30Recruiting
A Double-Blind, Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy Opf Trexima in the Acute Treatment of Migraine Headaches [NCT00433732]Phase 31,400 participants Interventional2004-08-31Completed
A Double-Blind Multicenter, Randomized, Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches [NCT00434083]Phase 31,200 participants Interventional2004-07-31Completed
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
A Multicenter, Randomized, Active-Controlled Comparison Study of the Incidence of Gastroduodenal Ulcers Associated With Celecoxib and Low Dose ASA Versus Naproxen and Low Dose ASA in Healthy Subjects (50-75 Years of Age) [NCT00137033]Phase 4605 participants Interventional2004-09-30Completed
A Double-blind Randomized Comparison of Celecoxib Plus Esomeprazole Versus Naproxen Plus Esomeprazole for Prevention of Recurrent Ulcer Bleeding in Patients With Arthritis and Cardiothrombotic Diseases (NSAID#8 Study) [NCT00153660]Phase 3514 participants (Actual)Interventional2005-06-30Completed
An Open Label, Single Dose, Parallel Group Study to Evaluate Absorption and Transit Characteristics of TREXIMA and RELPAX in Patients Inside and Outside of an Acute Migraine Attack. [NCT00385008]Phase 320 participants (Actual)Interventional2006-09-13Completed
A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage [NCT01139190]Phase 277 participants (Actual)Interventional2010-07-31Completed
A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of Lansoprazole 30 mg QD and Naproxen 500 mg BID Versus Celecoxib 200 mg QD in Risk Reduction of Non Steroidal Anti-Inflammatory-Associated Ulcers in Osteoarthritis Subjects Taki [NCT00175032]Phase 31,045 participants (Actual)Interventional2003-07-31Completed
Double-Blind, Randomized, Placebo-Controlled Trial of Naproxen Sodium for the Treatment of Obsessive Compulsive Symptoms in Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infections (PANDAS) [NCT04015596]Phase 470 participants (Anticipated)Interventional2020-10-20Recruiting
Efficacy and Safety of Etoricoxib-tramadol 120mg/100mg on Acute Pain After Impacted Lower Third Molar Extraction: A Double Blind Randomized Controlled Trial [NCT05995912]Phase 258 participants (Actual)Interventional2021-09-29Completed
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic Interaction Between Tegoprazan and Non-steroidal Anti-inflammatory Drugs (NSAIDs) After Multiple Oral Dosing in Healthy Male Volunteers [NCT04639804]Phase 160 participants (Actual)Interventional2020-06-06Completed
6-Month, Phase 3, Randomized, Double-blind, Parallel-group, Controlled, Multi-center Study Evaluate Gastric Ulcer Incidence Following Administration of PN400 or Naproxen in Subjects Who Are at Risk for Developing NSAID-associated Ulcers [NCT01129011]Phase 3420 participants (Actual)Interventional2007-09-30Completed
A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep [NCT01280591]Phase 3712 participants (Actual)Interventional2010-10-31Completed
Effects of Nigella Sativa Oil on Pain Intensity and Physical Functions in Patients With Knee Osteoarthritis: A Randomized Controlled Trial [NCT05541185]75 participants (Actual)Interventional2021-02-15Completed
Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow [NCT01525043]Phase 478 participants (Actual)Interventional2012-02-29Completed
A Multicenter, Randomized, Double-Blind, Parallel Group Trial Assessing the Efficacy and Safety of Naproxen Sodium and Diphenhydramine Combination in Postsurgical Dental Pain With Phase Advanced Sleep [NCT01495858]Phase 3267 participants (Actual)Interventional2011-12-31Completed
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
A Randomized, Double-Blind, Placebo-controlled Cross-over, Exploratory Trial of Naproxen to Evaluate Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee [NCT01557816]70 participants (Anticipated)Interventional2011-12-31Recruiting
A 12 Week Double-blind Randomized Trial, With a 12 Week Open-label Extension, to Investigate the Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With Juvenile Rheum [NCT00034853]Phase 3180 participants (Anticipated)Interventional2000-12-31Completed
Effects of Naproxen on Physical Performance [NCT00410995]Phase 440 participants Interventional2004-05-31Terminated(stopped due to Study never initiated.)
Parallel Study, Double-blind, Randomized, to Compare the Safety of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients. [NCT01670552]Phase 3490 participants (Actual)Interventional2016-02-17Completed
Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial [NCT00222976]Phase 460 participants (Anticipated)Interventional2006-09-30Completed
Ibuprofen 600 Mg Extended Release (er) Single-dose Dental Pain Study [NCT00913627]Phase 2196 participants (Actual)Interventional2009-05-07Completed
Double-blind Trial on the Gastrointestinal Integrity Evaluation After Daily Naproxen 1100 mg + Rebamipide 200mg for 7 Days Versus Naproxen 1100mg + Placebo for 7 Days [NCT02632812]Phase 124 participants (Actual)Interventional2014-10-31Completed
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 One Year Double-blind Trial to Investigate the Efficacy and Safety of Meloxicam Oral Suspension 0.25mg/kg and 0.125 mg/kg Administered Once Daily in Comparison to Naproxen Oral Suspension 5mg/kg Administered Twice Daily in Children With Juvenile Rheumat [NCT00279747]Phase 3226 participants Interventional2000-09-30Completed
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicenter Study Of CE-224,535 In Subjects With Osteoarthritic Pain Of The Knee [NCT00418782]Phase 2212 participants (Actual)Interventional2007-01-31Terminated(stopped due to Results of interim analysis indicate lack of efficacy when compared to placebo.)
Influence of Naproxen on Heterotropic Bone Formation Following Hip Arthroscopy [NCT01539447]Early Phase 1108 participants (Actual)Interventional2012-01-31Completed
Safety, Efficacy and Acceptability of Flavocoxid (Limbrel) Compared With Naproxen in Subjects With Osteoarthritis of the Knee. A Pilot Study [NCT00303017]60 participants (Actual)Interventional2006-03-31Completed
A Randomized, Double-blind, Single Migraine Attack, Placebo-controlled, Parallel-group Multicenter Study to Evaluate the Efficacy and Tolerability of Trexima (Sumatriptan Succinate.Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain [NCT00329355]Phase 3351 participants (Actual)Interventional2006-05-31Completed
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
A Bioavailability Study of Naproxen Sodium and Diphenhydramine Hydrochloride Under Fasting Conditions and Naproxen Sodium and Diphenhydramine Hydrochloride Combination Under Fasting and Fed Conditions [NCT01666678]Phase 132 participants (Actual)Interventional2012-01-31Completed
An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID [NCT01427803]Phase 3778 participants (Actual)Interventional2011-09-30Completed
A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars [NCT01229228]Phase 2254 participants (Actual)Interventional2010-10-31Completed
Treximet ™ Pharmacy Budget Impact Model Database Validation Study [NCT01332500]61,737 participants (Actual)Observational2009-07-31Completed
A Randomized, Double-Blind, Placebo Controlled Trial to Assess the Analgesic Efficacy and Safety of Extended Release Naproxen Sodium Tablets in Postsurgical Dental Pain [NCT01389284]Phase 3300 participants (Actual)Interventional2011-06-30Completed
A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic [NCT01383486]Phase 3253 participants (Actual)Interventional2011-07-31Completed
Brain Mechanisms For Clinical Placebo in Chronic Pain: A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain [NCT02986334]Phase 494 participants (Actual)Interventional2016-08-31Completed
Randomized Controlled Trial for Corticosteroids Versus NSAIDs With or Without Adjunctive Atorvastatin for the Treatment for Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome [NCT01442428]Phase 2/Phase 30 participants (Actual)Interventional2014-01-31Withdrawn(stopped due to 2011 Thailand flooding led to loss of GMP pharmacy, project delays, and further regulatory challenges.)
A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA) [NCT01544114]Phase 446 participants (Actual)Interventional2012-04-30Completed
A Randomized Double-blind Placebo Study to Determine the Effectiveness of Theramine and a Low Dose Naproxen on the Management of Chronic Back Pain [NCT01468025]Phase 3127 participants (Actual)Interventional2009-02-28Completed
Clinical Pharmacokinetics of Cytochrome P450: Influence on the Pharmacokinetics of Naproxen (CYP2C8 and CYP2C9) and Associated Naproxen-esomeprazole (CYP2C19) [NCT03092193]Phase 48 participants (Actual)Interventional2017-03-01Completed
"A Single-Dose Crossover Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adult Volunteers in the Fasted State" [NCT00966641]Phase 1/Phase 234 participants (Actual)Interventional2009-08-31Completed
A Global Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Osteoarthritis Pain of the Knee [NCT01207115]Phase 2322 participants (Actual)Interventional2010-09-30Completed
Effect of Electroacupuncture Versus Phonophoresis on Refractory Pain in Juvenile Rheumatoid Arthritis [NCT05504382]42 participants (Anticipated)Interventional2022-08-01Recruiting
A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain [NCT01118273]Phase 4162 participants (Actual)Interventional2008-01-31Completed
A Phase 2, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout and Moderate Renal Impairment [NCT02128490]Phase 2189 participants (Actual)Interventional2014-05-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks. [NCT04948164]Phase 3240 participants (Anticipated)Interventional2018-08-01Recruiting
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure [NCT05463367]Phase 280 participants (Anticipated)Interventional2021-01-01Recruiting
Novel Non-opioid Post-surgical Pain Treatment in Females [NCT05087914]Phase 260 participants (Anticipated)Interventional2021-11-01Recruiting
The Effect of Intensive Urate Lowering Therapy (ULT) With Febuxostat in Comparison With Allopurinol on Cardiovascular Risk in Patients With Gout Using Surrogate Markers: a Randomized, Controlled Trial [NCT02500641]Phase 4196 participants (Actual)Interventional2015-08-17Completed
The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection [NCT01612975]Phase 27 participants (Actual)Interventional2014-04-30Terminated(stopped due to Recruitment futile)
Different Analgesics Prior to IUD Insertion: Is There Any Evidence? [NCT02522130]200 participants (Anticipated)Interventional2015-07-31Recruiting
A Multi-Center, Double-Blinded, Randomized, Phase IV 6-Month Pilot Study to Compare Bleeding Patterns, Satisfaction and Quality of Life Among New Copper 380A IUD Users Treated With Naproxen Sodium (440mg Twice Daily) Versus Placebo [NCT02519231]Phase 434 participants (Actual)Interventional2016-02-29Completed
Multi-centre, Open-label, Active-comparator, Pragmatic Clinical Trial of Low-dose Colchicine Versus Naproxen in Patients With Acute Gout. [NCT01994226]Phase 4399 participants (Actual)Interventional2014-01-31Completed
An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017 [NCT01939002]Phase 3251 participants (Actual)Interventional2013-11-30Completed
Naproxen for Pain Control With Intrauterine Device Insertion: A Randomized Double-Blind Placebo Controlled Trial [NCT02388191]119 participants (Actual)Interventional2015-04-30Completed
A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulce [NCT00367211]Phase 3400 participants Interventional2006-09-30Completed
A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interactions and Safety After Co-administration of Ilaprazole and NSAID in Healthy Adults [NCT05237297]Phase 172 participants (Actual)Interventional2022-02-17Completed
MAST Trial: Multi-modal Analgesic Strategies in Trauma [NCT03472469]Phase 41,561 participants (Actual)Interventional2018-04-02Completed
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer [NCT00383487]Phase 220 participants (Actual)Interventional2005-03-31Terminated(stopped due to Extreme toxicity)
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease [NCT00004845]Phase 2/Phase 30 participants InterventionalCompleted
Randomized, Controlled, Double-blind, Placebo-controlled, Multi-center Hypothesis-finding Trial to Compare the Efficacy and Safety of a 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel and Placebo in the Treatment of Acute Soft Tissue Injuries of [NCT05026320]Phase 276 participants (Actual)Interventional2021-08-08Completed
A Phase 3, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout [NCT02139046]Phase 31,790 participants (Actual)Interventional2014-04-30Completed
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
Efficacy of Multimodal Analgesia Following Hip Arthroscopy [NCT03351439]100 participants (Actual)Interventional2018-04-06Completed
A Randomized, Open Label, Parallel Group Study to Investigate the Effects on Serum Thromboxane by the Addition of Naproxen Sodium to Aspirin Therapy Versus Aspirin Therapy Alone [NCT02229461]Phase 1117 participants (Actual)Interventional2015-02-28Completed
NSAIDs in Sciatica (NIS), an Investigator Initiated Randomised Placebo Controlled Trial of Naproxen [NCT03347929]Phase 4123 participants (Actual)Interventional2017-11-30Completed
A Randomized, Controlled Trial of Oral Naproxen and Transdermal Estradiol for Prevention of Unscheduled Bleeding in New Users of Levonorgestrel Intrauterine Contraception [NCT00789802]129 participants (Actual)Interventional2008-11-30Completed
A Randomized, Double-Blind, Single-Dose, Parallel, Placebo-Controlled Pivotal Trial to Confirm the Efficacy of a Fixed Dose Combination Tablet of Naproxen Sodium and Caffeine to Effectively Alleviate Postsurgical Dental Pain [NCT05485805]Phase 3528 participants (Anticipated)Interventional2022-09-21Recruiting
Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa [NCT01951105]Phase 472 participants (Actual)Interventional2015-02-24Completed
Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial [NCT02463552]50 participants (Actual)Interventional2015-05-31Completed
A Randomized, Double Blind, Placebo- And Active-controlled, 4 Week, Multi-center, Parallel Group Study Assessing The Analgesic Effect, Safety And Tolerability Of Pf-06372865 In Subjects With Chronic Low Back Pain Using Naproxen As Positive Control [NCT02262754]Phase 2302 participants (Actual)Interventional2014-10-31Completed
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? [NCT02307305]Phase 2168 participants (Anticipated)Interventional2014-08-31Recruiting
An Open Label Crossover Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions [NCT03424135]Phase 160 participants (Actual)Interventional2018-03-02Completed
The Effect of NSAIDs in the Early Phase of Achilles Tendinopathy [NCT03401177]70 participants (Actual)Interventional2018-01-15Completed
Inflammation and Daily Life Study [NCT03771612]Early Phase 170 participants (Actual)Interventional2022-02-09Completed
A Phase 1, Single-Center, Randomized, Placebo-Controlled, Ascending Single-Dose Study of the Pharmacokinetics, Safety, and Tolerability of Oral XG005 in Healthy Volunteers [NCT04499209]Phase 150 participants (Actual)Interventional2017-10-16Completed
Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim [NCT01712009]Phase 2600 participants (Actual)Interventional2012-11-01Completed
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
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00346216 (4) [back to overview]The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
NCT00346216 (4) [back to overview]Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)
NCT00346216 (4) [back to overview]The First Occurrence of a Major Adverse Cardiovascular Events (MACE)
NCT00346216 (4) [back to overview]The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)
NCT00382993 (19) [back to overview]Rescue Medication Use During 0 - 24 Hours Post-Dose
NCT00382993 (19) [back to overview]Sustained Complete Pain/Symptom-Free
NCT00382993 (19) [back to overview]Migraine Headache Pain Free at 2 Hours Post-Dose
NCT00382993 (19) [back to overview]Sustained Freedom From Migraine
NCT00382993 (19) [back to overview]Recurrence of Any Migraine Headache Pain
NCT00382993 (19) [back to overview]Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
NCT00382993 (19) [back to overview]Sustained Freedom From Migraine-Associated Nausea
NCT00382993 (19) [back to overview]Sustained Freedom From Migraine-Associated Phonophobia
NCT00382993 (19) [back to overview]Sustained Freedom From Migraine-Associated Neck Pain
NCT00382993 (19) [back to overview]Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose
NCT00382993 (19) [back to overview]Sustained Freedom From Migraine-Associated Sinus Pain
NCT00382993 (19) [back to overview]Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00382993 (19) [back to overview]Sustained Freedom From Migraine-Associated Photophobia
NCT00382993 (19) [back to overview]Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
NCT00382993 (19) [back to overview]Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00382993 (19) [back to overview]Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00382993 (19) [back to overview]Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00382993 (19) [back to overview]Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00382993 (19) [back to overview]Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Sustained Freedom From Migraine-Associated Photophobia
NCT00383162 (19) [back to overview]Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose
NCT00383162 (19) [back to overview]Recurrence of Any Migraine Headache Pain
NCT00383162 (19) [back to overview]Sustained Freedom From Migraine-Associated Sinus Pain
NCT00383162 (19) [back to overview]Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose
NCT00383162 (19) [back to overview]Rescue Medication Used up to 24 Hours Post-dose
NCT00383162 (19) [back to overview]Pain-Free Assessment at 2 Hours Post-dose
NCT00383162 (19) [back to overview]Sustained Complete Pain/Symptom-Free
NCT00383162 (19) [back to overview]Sustained Freedom From Migraine
NCT00383162 (19) [back to overview]Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose
NCT00383162 (19) [back to overview]Sustained Freedom From Migraine-Associated Nausea
NCT00383162 (19) [back to overview]Sustained Freedom From Migraine-Associated Neck Pain
NCT00383162 (19) [back to overview]Sustained Freedom From Migraine-Associated Phonophobia
NCT00385008 (15) [back to overview]Tmax for Eletriptan
NCT00385008 (15) [back to overview]Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine
NCT00385008 (15) [back to overview]Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine
NCT00385008 (15) [back to overview]Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet
NCT00385008 (15) [back to overview]Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet
NCT00385008 (15) [back to overview]Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan
NCT00385008 (15) [back to overview]Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan
NCT00385008 (15) [back to overview]Time of Maximal Drug Concentration (Tmax) for Sumatriptan and Naproxen
NCT00385008 (15) [back to overview]Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan
NCT00385008 (15) [back to overview]Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan
NCT00385008 (15) [back to overview]Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00385008 (15) [back to overview]Mean Area Under the Drug Concentration Time Curve (AUC) From Time of Dosing Through 2 Hour Post-dose [AUC (0-2)], Through 24 Hour [AUC (0-24)] and AUC From Time of Dosing Extrapolated to Infinity [AUC (0-inf)] for Sumatriptan and Naproxen
NCT00385008 (15) [back to overview]Maximum Observed Drug Concentration (Cmax) for Sumatriptan and Naproxen
NCT00385008 (15) [back to overview]Cmax for Eletriptan
NCT00385008 (15) [back to overview]Mean AUC (0-inf) and AUC (0-2) for Eletriptan
NCT00387881 (9) [back to overview]Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.
NCT00387881 (9) [back to overview]Sustained Headache Relief 2-24 Hours After Treatment
NCT00387881 (9) [back to overview]Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment
NCT00387881 (9) [back to overview]Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment
NCT00387881 (9) [back to overview]Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours
NCT00387881 (9) [back to overview]Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment
NCT00387881 (9) [back to overview]Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score
NCT00387881 (9) [back to overview]Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment
NCT00387881 (9) [back to overview]Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment
NCT00449787 (3) [back to overview]Patient Satisfaction
NCT00449787 (3) [back to overview]Numerical Rating Scale
NCT00449787 (3) [back to overview]Headache-related Functional Disability
NCT00488514 (27) [back to overview]Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator
NCT00488514 (27) [back to overview]Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit
NCT00488514 (27) [back to overview]Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12
NCT00488514 (27) [back to overview]Number of Migraine Attacks Rated With the Indicated Pain Severity
NCT00488514 (27) [back to overview]Mean Weight for All Study Participants at the Indicated Time Points
NCT00488514 (27) [back to overview]Mean Height for All Study Participants at the Indicated Time Points
NCT00488514 (27) [back to overview]Mean Heart Rate for All Study Participants at the Indicated Time Points
NCT00488514 (27) [back to overview]Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12
NCT00488514 (27) [back to overview]Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points
NCT00488514 (27) [back to overview]Mean Blood Pressure for All Study Participants at the Indicated Time Points
NCT00488514 (27) [back to overview]Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month
NCT00488514 (27) [back to overview]Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting
NCT00488514 (27) [back to overview]Number of Treated Migraine Attacks
NCT00488514 (27) [back to overview]Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet
NCT00488514 (27) [back to overview]Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet
NCT00488514 (27) [back to overview]Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet
NCT00488514 (27) [back to overview]Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet
NCT00488514 (27) [back to overview]Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet
NCT00488514 (27) [back to overview]Number of Participants With the Indicated Drug-related Adverse Events
NCT00488514 (27) [back to overview]Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit
NCT00488514 (27) [back to overview]Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet
NCT00488514 (27) [back to overview]Number of Participants With Any Adverse Event Categorized Over Time
NCT00488514 (27) [back to overview]Number of Participants With Any Adverse Event Categorized by Severity
NCT00488514 (27) [back to overview]Number of Participants With Any Adverse Event Categorized by Participant Race
NCT00488514 (27) [back to overview]Number of Participants With Any Adverse Event Categorized by Participant Gender
NCT00488514 (27) [back to overview]Number of Participants With Any Adverse Event Categorized by Participant Age
NCT00488514 (27) [back to overview]Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit
NCT00527787 (9) [back to overview]The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment
NCT00527787 (9) [back to overview]Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales
NCT00527787 (9) [back to overview]Number of Participants With Gastric Ulcer Confirmed by Endoscopy
NCT00527787 (9) [back to overview]Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit
NCT00527787 (9) [back to overview]The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers
NCT00527787 (9) [back to overview]The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer
NCT00527787 (9) [back to overview]Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales
NCT00527787 (9) [back to overview]Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire
NCT00527787 (9) [back to overview]Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales
NCT00527904 (1) [back to overview]Number of Subjects Monitored for Long-term Safety of PN 400
NCT00584870 (22) [back to overview]Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12
NCT00584870 (22) [back to overview]Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12
NCT00584870 (22) [back to overview]Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6
NCT00584870 (22) [back to overview]Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
NCT00584870 (22) [back to overview]Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6
NCT00584870 (22) [back to overview]Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12
NCT00584870 (22) [back to overview]Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
NCT00584870 (22) [back to overview]Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
NCT00584870 (22) [back to overview]Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less
NCT00584870 (22) [back to overview]Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12
NCT00584870 (22) [back to overview]Number of Participants With Chronic Low Back Pain (CLBP) Response
NCT00584870 (22) [back to overview]Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication
NCT00584870 (22) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
NCT00584870 (22) [back to overview]Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score
NCT00584870 (22) [back to overview]Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12
NCT00584870 (22) [back to overview]Number of Participants Who Discontinued the Study Due to Lack of Efficacy
NCT00584870 (22) [back to overview]Time to Discontinuation Due to Lack of Efficacy
NCT00584870 (22) [back to overview]Number of Participants With Anti-Drug Antibody (ADA)
NCT00584870 (22) [back to overview]Amount of Rescue Medication Taken
NCT00584870 (22) [back to overview]Duration of Rescue Medication Use
NCT00584870 (22) [back to overview]Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12
NCT00584870 (22) [back to overview]Number of Participants Who Used Rescue Medications
NCT00601458 (2) [back to overview]Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery
NCT00601458 (2) [back to overview]Time to First Request of PCA Hydromorphone
NCT00602420 (1) [back to overview]Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.
NCT00626275 (13) [back to overview]Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain
NCT00626275 (13) [back to overview]Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain
NCT00626275 (13) [back to overview]Part B: Percentage of Participants Using Rescue Medication
NCT00626275 (13) [back to overview]Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period
NCT00626275 (13) [back to overview]Part A: Mean Peak Difference in ELEPI According to the NPRS Scale
NCT00626275 (13) [back to overview]Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing
NCT00626275 (13) [back to overview]Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) Lower-Extremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing
NCT00626275 (13) [back to overview]"Part B: The Mean of Daily Average Now Lower Extremity Pain Intensity (LEPI) Score During the 2-Week Period"
NCT00626275 (13) [back to overview]Part B: Mean Daily LEPI Scores for Weeks 1 and 2
NCT00626275 (13) [back to overview]Part B: Participants' Global Evaluation of Study Medication
NCT00626275 (13) [back to overview]Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2
NCT00626275 (13) [back to overview]Part A: Percentage of Participants in Each Treatment Group Achieving a 25%, 50%, or 75% Reduction From Baseline in Evoked Lower Extremity Pain Intensity Scores
NCT00626275 (13) [back to overview]Part A: Participant's Global Evaluation of Study Medication
NCT00659490 (22) [back to overview]Time to Max Deterioration in VAMS Stimulated
NCT00659490 (22) [back to overview]Maximum Deterioration in VAMS Sedated
NCT00659490 (22) [back to overview]Time to Max Deterioration in VAMS Sedated
NCT00659490 (22) [back to overview]Time to Max Deterioration in VAMS High
NCT00659490 (22) [back to overview]Time to Max Deterioration in VAMS Down
NCT00659490 (22) [back to overview]Time to Max Deterioration in VAMS Anxious
NCT00659490 (22) [back to overview]Pain at Rescue Medication
NCT00659490 (22) [back to overview]Pain at Jaw Movement AUC0-8h
NCT00659490 (22) [back to overview]Pain at Jaw Movement AUC0-4h
NCT00659490 (22) [back to overview]Pain at Jaw Movement at Time of First Rescue Medication
NCT00659490 (22) [back to overview]Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)
NCT00659490 (22) [back to overview]Pain Area Under the Curve 0-8h (AUC0-8h)
NCT00659490 (22) [back to overview]Number of Patients Requesting Rescue Medication
NCT00659490 (22) [back to overview]Mean Pain Based on a VAS Scale
NCT00659490 (22) [back to overview]Mean Pain at Jaw Movement
NCT00659490 (22) [back to overview]Maximum Pain Based on VAS Scale
NCT00659490 (22) [back to overview]Maximum Pain at Jaw Movement
NCT00659490 (22) [back to overview]Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated
NCT00659490 (22) [back to overview]Maximum Deterioration in VAMS Anxious
NCT00659490 (22) [back to overview]Maximum Deterioration in VAMS Down
NCT00659490 (22) [back to overview]Maximum Deterioration in VAMS High
NCT00659490 (22) [back to overview]Time to First Intake of Rescue Medication.
NCT00672646 (6) [back to overview]VAS Pain Intensity at Rescue Intake
NCT00672646 (6) [back to overview]VAS Pain on Jaw Movement at Rescue Intake
NCT00672646 (6) [back to overview]Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
NCT00672646 (6) [back to overview]Time to First Perceptible Pain Relief
NCT00672646 (6) [back to overview]Time to First Meaningful Pain Relief
NCT00672646 (6) [back to overview]Sum of Pain Intensity Difference in Percent (SPID%)
NCT00720057 (6) [back to overview]Summed Pain Intensity Difference (SPID)
NCT00720057 (6) [back to overview]Time to Onset of Effect
NCT00720057 (6) [back to overview]Time to First Use of Rescue Medication
NCT00720057 (6) [back to overview]Global Assessment of the Investigational Product as a Pain Reliever
NCT00720057 (6) [back to overview]Total Pain Relief (TOTPAR)
NCT00720057 (6) [back to overview]Summed Pain Intensity Difference at Specific Time Intervals
NCT00751400 (10) [back to overview]Average Daily Dose
NCT00751400 (10) [back to overview]Number of Total Dosing Occasions Per Subject
NCT00751400 (10) [back to overview]Dosing Occasions With One and More Than One Tablet Taken
NCT00751400 (10) [back to overview]Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days
NCT00751400 (10) [back to overview]Number of Dosing Occasions Per Subject That Exceeded 660 mg
NCT00751400 (10) [back to overview]Number of Subjects With and Without More Than 660 mg at Least Once
NCT00751400 (10) [back to overview]Number of Subjects With and Without More Than One Tablet Taken Per Dose
NCT00751400 (10) [back to overview]Number of Subjects With and Without Next Dose Less Than 22 Hours Later
NCT00751400 (10) [back to overview]Use Days With One or More Misuse Occasions
NCT00751400 (10) [back to overview]Use Days With and Without Next Dose Less Than 22 Hours Later
NCT00772967 (4) [back to overview]Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1
NCT00772967 (4) [back to overview]Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3
NCT00772967 (4) [back to overview]Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1
NCT00772967 (4) [back to overview]Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3
NCT00789802 (3) [back to overview]Number of Bleeding and Spotting Days
NCT00789802 (3) [back to overview]Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups
NCT00789802 (3) [back to overview]Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.
NCT00790985 (1) [back to overview]Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.
NCT00792636 (15) [back to overview]Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure
NCT00792636 (15) [back to overview]Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month
NCT00792636 (15) [back to overview]Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan
NCT00792636 (15) [back to overview]Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure
NCT00792636 (15) [back to overview]Number of Participants Withdrawn From the Study Due to Blood Pressure Changes
NCT00792636 (15) [back to overview]Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen
NCT00792636 (15) [back to overview]Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements
NCT00792636 (15) [back to overview]Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements
NCT00792636 (15) [back to overview]Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study
NCT00792636 (15) [back to overview]Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg
NCT00792636 (15) [back to overview]Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen
NCT00792636 (15) [back to overview]Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen
NCT00792636 (15) [back to overview]Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses
NCT00792636 (15) [back to overview]Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine
NCT00792636 (15) [back to overview]Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month
NCT00807846 (14) [back to overview]Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit
NCT00807846 (14) [back to overview]Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
NCT00807846 (14) [back to overview]Change From Baseline in DBP at Week 4.
NCT00807846 (14) [back to overview]Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
NCT00807846 (14) [back to overview]Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
NCT00807846 (14) [back to overview]Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
NCT00807846 (14) [back to overview]Change From Baseline to Week 2 in SBP.
NCT00807846 (14) [back to overview]Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
NCT00807846 (14) [back to overview]Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
NCT00807846 (14) [back to overview]Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
NCT00807846 (14) [back to overview]Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit
NCT00807846 (14) [back to overview]Change From Baseline in SBP at Week 4.
NCT00807846 (14) [back to overview]Change From Baseline in DBP at Week 6/Final Visit
NCT00807846 (14) [back to overview]Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Pain Free Function Index of Everyday Activities
NCT00826462 (33) [back to overview]Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]Maximum Grip Strength Ratio
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]Pain as Recorded by the Study Doctors on a 100 mm VAS-scale
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Dorsiflexion of Wrist
NCT00826462 (33) [back to overview]Treatment Success - Event Rates in Each Group
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]Pain-free Grip Strength Ratio
NCT00826462 (33) [back to overview]No Pain on Three Point Likert Scale on Isometric Extension of Third Finger
NCT00826462 (33) [back to overview]Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors
NCT00830063 (39) [back to overview]Time to Discontinuation Due to Lack of Efficacy
NCT00830063 (39) [back to overview]Percentage of Participants Who Used Rescue Medication
NCT00830063 (39) [back to overview]Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
NCT00830063 (39) [back to overview]Number of Participants With Positive Anti-Drug Antibody (ADA) Level
NCT00830063 (39) [back to overview]Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Number of Days Participants Used Rescue Medication
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
NCT00830063 (39) [back to overview]Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
NCT00830063 (39) [back to overview]Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Amount of Rescue Medication Taken
NCT00830063 (39) [back to overview]Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Number of Participants With Laboratory Test Abnormalities
NCT00830063 (39) [back to overview]Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities
NCT00830063 (39) [back to overview]Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
NCT00830063 (39) [back to overview]Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00830063 (39) [back to overview]Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
NCT00843024 (17) [back to overview]Number of Participants Sustained Phonophobia-free From 2-24 Hours
NCT00843024 (17) [back to overview]Number of Participants Sustained Photophobia-free From 2-24 Hours
NCT00843024 (17) [back to overview]Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
NCT00843024 (17) [back to overview]Mean Body Mass Index of Participants at Baseline Categorized by Age Group
NCT00843024 (17) [back to overview]Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
NCT00843024 (17) [back to overview]Number of Participants Who Were Pain Free at 2 Hours Post-dose
NCT00843024 (17) [back to overview]Number of Participants Sustained Pain-free From 2-24 Hours
NCT00843024 (17) [back to overview]Number of Participants Sustained Nausea-free From 2-24 Hours
NCT00843024 (17) [back to overview]Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
NCT00843024 (17) [back to overview]Number of Participants Photophobia-free at 2 Hours Post-dose
NCT00843024 (17) [back to overview]Number of Participants Phonophobia-free at 2 Hours Post-dose
NCT00843024 (17) [back to overview]Number of Participants Pain-free at 1 Hour Post-dose
NCT00843024 (17) [back to overview]Number of Participants of the Indicated Race Categorized by Age Group
NCT00843024 (17) [back to overview]Number of Participants Nausea-free at 2 Hours Post-dose
NCT00843024 (17) [back to overview]Number of Female and Male Participants Categorized by Age Group
NCT00843024 (17) [back to overview]Mean Weight of Participants at Baseline Categorized by Age Group
NCT00843024 (17) [back to overview]Mean Age of Participants at Baseline Categorized by Age Group
NCT00844805 (17) [back to overview]Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28
NCT00844805 (17) [back to overview]Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52
NCT00844805 (17) [back to overview]Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28
NCT00844805 (17) [back to overview]Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52
NCT00844805 (17) [back to overview]Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase
NCT00844805 (17) [back to overview]Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase
NCT00844805 (17) [back to overview]Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase
NCT00844805 (17) [back to overview]Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28
NCT00844805 (17) [back to overview]Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase
NCT00844805 (17) [back to overview]Change From Baseline in the Sacroiliac Overall Score at Week 28
NCT00844805 (17) [back to overview]Change From Baseline in the Sacroiliac Overall Score at Week 52
NCT00844805 (17) [back to overview]Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28
NCT00844805 (17) [back to overview]Change From Baseline of Berlin MRI Spine Overall Score at Week 52
NCT00844805 (17) [back to overview]Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase
NCT00844805 (17) [back to overview]Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase
NCT00844805 (17) [back to overview]Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28
NCT00844805 (17) [back to overview]Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52
NCT00863304 (35) [back to overview]Percentage of Participants Who Used Rescue Medication
NCT00863304 (35) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00863304 (35) [back to overview]Number of Participants With Positive Anti-Drug Antibody (ADA) Level
NCT00863304 (35) [back to overview]Number of Participants With Abnormal Physical Examinations Findings
NCT00863304 (35) [back to overview]Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCT00863304 (35) [back to overview]Duration of Rescue Medication Use
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Amount of Rescue Medication Taken
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24
NCT00863304 (35) [back to overview]Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Time to Discontinuation Due to Lack of Efficacy
NCT00863304 (35) [back to overview]Number of Participants With Laboratory Test Abnormalities
NCT00863304 (35) [back to overview]Number of Participants With Adverse Events Associated With Vital Sign Measurements
NCT00863304 (35) [back to overview]Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
NCT00863304 (35) [back to overview]Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00863304 (35) [back to overview]Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00863304 (35) [back to overview]Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00863304 (35) [back to overview]Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
NCT00863304 (35) [back to overview]Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Plasma Concentration of Tanezumab
NCT00876187 (19) [back to overview]Total Nerve Growth Factor (NGF) Concentration
NCT00876187 (19) [back to overview]Amount of Rescue Medication Taken
NCT00876187 (19) [back to overview]Number of Participants Who Developed Anti-Tanezumab Antibodies
NCT00876187 (19) [back to overview]Time to Discontinuation Due to Lack of Efficacy
NCT00876187 (19) [back to overview]Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF
NCT00876187 (19) [back to overview]Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16
NCT00876187 (19) [back to overview]Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24
NCT00876187 (19) [back to overview]Duration of Rescue Medication Use
NCT00876187 (19) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00876187 (19) [back to overview]Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF)
NCT00876187 (19) [back to overview]Percentage of Participants Who Used Rescue Medications
NCT00876187 (19) [back to overview]Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
NCT00893737 (3) [back to overview]Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)
NCT00893737 (3) [back to overview]Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan
NCT00893737 (3) [back to overview]Change in Scores From Completeness of Response Survey (CORS)
NCT00913627 (17) [back to overview]Participant Global Evaluation of Study Medication at 24 Hours
NCT00913627 (17) [back to overview]Participant Global Evaluation of Study Medication at 12 Hours
NCT00913627 (17) [back to overview]Pain Relief Combined With Pain Intensity Difference (PRID) Score
NCT00913627 (17) [back to overview]Pain Intensity Difference (PID) Score
NCT00913627 (17) [back to overview]Percentage of Participants With Treatment Failure
NCT00913627 (17) [back to overview]Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)
NCT00913627 (17) [back to overview]Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)
NCT00913627 (17) [back to overview]Time to Treatment Failure
NCT00913627 (17) [back to overview]Time to Meaningful Pain Relief
NCT00913627 (17) [back to overview]Peak Pain Relief Score
NCT00913627 (17) [back to overview]Time to First Perceptible Pain Relief
NCT00913627 (17) [back to overview]Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief
NCT00913627 (17) [back to overview]Percentage of Participants Achieving Meaningful Pain Relief
NCT00913627 (17) [back to overview]Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8)
NCT00913627 (17) [back to overview]Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID)
NCT00913627 (17) [back to overview]Time-weighted Sum of Pain Relief Scores (TOTPAR)
NCT00913627 (17) [back to overview]Pain Relief (PR) Score
NCT00966641 (1) [back to overview]Area Under the Curve of Plasma Naproxen From 0 to t
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 of Papilledema Grade on Fundus Photography
NCT01003639 (4) [back to overview]Mean Change in Perimetric Mean Deviation
NCT01016678 (3) [back to overview]Number of Participants With 2-hour Pain Free Active Study Drug
NCT01016678 (3) [back to overview]Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention
NCT01016678 (3) [back to overview]Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose
NCT01053507 (5) [back to overview]Change in Number of Associated Headache Symptoms
NCT01053507 (5) [back to overview]Headache Days
NCT01053507 (5) [back to overview]Headache Impact Test-6 (HIT-6) Score
NCT01053507 (5) [back to overview]Mental Efficiency Workload Test (MEWT) Performance Index
NCT01053507 (5) [back to overview]Migraine Specific Quality of Life Questionnaire (MSQ)
NCT01071317 (4) [back to overview]Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale
NCT01071317 (4) [back to overview]Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale
NCT01071317 (4) [back to overview]Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale
NCT01071317 (4) [back to overview]Number of Participants Who Returned to the Emergency Department for Management of Headache
NCT01086358 (4) [back to overview]Workplace Productivity and Activity Impairment Scale (WPAI).
NCT01086358 (4) [back to overview]Lost Workplace Productivity
NCT01086358 (4) [back to overview]Lost Activity Time
NCT01086358 (4) [back to overview]Favorable Response on Migraine-ACT
NCT01090050 (8) [back to overview]Percent Change of Doses of Study Medication
NCT01090050 (8) [back to overview]Migraine Headache Duration From Time of Treatment to Pain Free
NCT01090050 (8) [back to overview]Migraine Headache Days With Greater Than 50% Reduction
NCT01090050 (8) [back to overview]Migraine Disability Assessment(MIDAS)Questionnaire Total Score
NCT01090050 (8) [back to overview]Compliance With Lifestyle Changes
NCT01090050 (8) [back to overview]Percent Change of Migraine Headache Days Compared to Baseline
NCT01090050 (8) [back to overview]Migraine Headache Duration From Onset to Pain Free
NCT01090050 (8) [back to overview]Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline
NCT01118273 (26) [back to overview]Change From Baseline in Categorical Pain Rating Scale Score
NCT01118273 (26) [back to overview]Sleep Efficiency Measured by Actigraphy
NCT01118273 (26) [back to overview]Sleep Latency Measured by Actigraphy
NCT01118273 (26) [back to overview]Sleep Quality Index
NCT01118273 (26) [back to overview]Time to Rescue Medication
NCT01118273 (26) [back to overview]Total Sleep Time by Subject Assessment
NCT01118273 (26) [back to overview]Total Sleep Time Measured by Actigraphy
NCT01118273 (26) [back to overview]Total Wake Time Measured by Actigraphy
NCT01118273 (26) [back to overview]Wake After Sleep Onset (WASO) Measured by Actigraphy
NCT01118273 (26) [back to overview]Wake Episode Measured by Actigraphy
NCT01118273 (26) [back to overview]Cumulative Proportion of Participants Taking Rescue Medication by Hour
NCT01118273 (26) [back to overview]Global Assessment of Study Medication as a Pain Reliever
NCT01118273 (26) [back to overview]Global Assessment of Study Medication as a Sleep-aid
NCT01118273 (26) [back to overview]Karolinska Sleep Diary - Calmness of Sleep
NCT01118273 (26) [back to overview]Karolinska Sleep Diary - Ease of Awakening
NCT01118273 (26) [back to overview]Karolinska Sleep Diary - Easiness to Fall Asleep
NCT01118273 (26) [back to overview]Karolinska Sleep Diary - Premature Awakening
NCT01118273 (26) [back to overview]Karolinska Sleep Diary - Sleep Quality
NCT01118273 (26) [back to overview]Karolinska Sleep Diary - Sufficient Sleep
NCT01118273 (26) [back to overview]Karolinska Sleep Diary - Well Rested
NCT01118273 (26) [back to overview]Number of Times Participants Took Rescue Medication
NCT01118273 (26) [back to overview]Overall Rating of Pain Relief
NCT01118273 (26) [back to overview]Overall Rating of Severity in Categorical Pain Rating Scale Score
NCT01118273 (26) [back to overview]Overall Rating of Severity in Visual Analog Scale (VAS) Score
NCT01118273 (26) [back to overview]Change From Baseline in Visual Analog Scale (VAS) Score
NCT01118273 (26) [back to overview]Activity Mean Measured by Actigraphy
NCT01129011 (9) [back to overview]Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales
NCT01129011 (9) [back to overview]Number of Participants With Gastric Ulcer Confirmed by Endoscopy
NCT01129011 (9) [back to overview]The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment
NCT01129011 (9) [back to overview]The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer
NCT01129011 (9) [back to overview]The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers
NCT01129011 (9) [back to overview]Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales
NCT01129011 (9) [back to overview]Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit
NCT01129011 (9) [back to overview]Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire
NCT01129011 (9) [back to overview]Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales
NCT01138150 (8) [back to overview]Change in the Total Serum Adiponectin (T-ADP)
NCT01138150 (8) [back to overview]High Molecular Weight (HMW)-Adiponectin (ADP)
NCT01138150 (8) [back to overview]High Molecular Weight (HMW): T-ADP
NCT01138150 (8) [back to overview]Leptin
NCT01138150 (8) [back to overview]Low Molecular Weight (LMW)-ADP
NCT01138150 (8) [back to overview]Low Molecular Weight (LMW):Total (T)-ADP
NCT01138150 (8) [back to overview]Middle Molecular Weight (MMW)-ADP
NCT01138150 (8) [back to overview]Resistin
NCT01139190 (1) [back to overview]Degree of GI Injury at Day 15
NCT01147458 (10) [back to overview]WOMAC Total Score
NCT01147458 (10) [back to overview]WOMAC Stiffness Domain Score
NCT01147458 (10) [back to overview]WOMAC Physical Function Domain Score
NCT01147458 (10) [back to overview]Rescue Medication Use
NCT01147458 (10) [back to overview]Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2
NCT01147458 (10) [back to overview]Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1
NCT01147458 (10) [back to overview]Daily Diary Pain Score During Week 1 of Each Treatment Period
NCT01147458 (10) [back to overview]Plasma Concentration of PF-04191834
NCT01147458 (10) [back to overview]Daily Diary Pain Score During Week 2 of Each Treatment Period
NCT01147458 (10) [back to overview]Importance Weighted Total WOMAC Score
NCT01160822 (24) [back to overview]Part B: Proportion of Participants Who Used Rescue Analgesic During Study
NCT01160822 (24) [back to overview]Part B: Physician's Global Assessment of Response to Treatment at Week 4
NCT01160822 (24) [back to overview]Part B: Physician's Global Assessment of Response to Treatment at Week 8
NCT01160822 (24) [back to overview]Part B: Physician's Global Assessment of Response to Treatment at Week 2
NCT01160822 (24) [back to overview]Patient's Global Assessment of Response to Treatment at Week 2
NCT01160822 (24) [back to overview]Part B: Physician's Global Assessment of Response to Treatment at Day 4
NCT01160822 (24) [back to overview]Apparent Clearance of Canakinumab From Plasma (CL/F)
NCT01160822 (24) [back to overview]Apparent Volume of Distribution During Terminal Phase (Vz/F)
NCT01160822 (24) [back to overview]Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)
NCT01160822 (24) [back to overview]Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)
NCT01160822 (24) [back to overview]Maximum Observed Plasma Concentration of Canakinumab (Cmax)
NCT01160822 (24) [back to overview]Patient's Global Assessment of Response to Treatment on Day 4
NCT01160822 (24) [back to overview]Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)
NCT01160822 (24) [back to overview]Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale
NCT01160822 (24) [back to overview]Terminal Phase Half-life (t1/2) of Canakinumab
NCT01160822 (24) [back to overview]Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)
NCT01160822 (24) [back to overview]Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)
NCT01160822 (24) [back to overview]Part A: Number of Participants With Intolerance Events
NCT01160822 (24) [back to overview]Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)
NCT01160822 (24) [back to overview]Patient's Global Assessment of Response to Treatment at Week 8
NCT01160822 (24) [back to overview]Patient's Global Assessment of Response to Treatment at Week 4
NCT01160822 (24) [back to overview]Part B: Physician's Global Assessment of Response to Treatment at Week 12
NCT01160822 (24) [back to overview]Patient's Global Assessment of Response to Treatment at Week 12
NCT01160822 (24) [back to overview]Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales
NCT01165307 (12) [back to overview]Direct Medical Costs
NCT01165307 (12) [back to overview]Quality of Life Score Using the Short Form-12 (SF-12) Health Survey
NCT01165307 (12) [back to overview]Subject Satisfaction at 12 Months
NCT01165307 (12) [back to overview]Change in Ferritin From Baseline
NCT01165307 (12) [back to overview]Change in Hemoglobin
NCT01165307 (12) [back to overview]Ferritin at 12 Months
NCT01165307 (12) [back to overview]Hemoglobin at 12 Months
NCT01165307 (12) [back to overview]Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).
NCT01165307 (12) [back to overview]Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)
NCT01165307 (12) [back to overview]Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )
NCT01165307 (12) [back to overview]Bleeding Pattern at 12 Months
NCT01165307 (12) [back to overview]Indirect Medical Costs
NCT01208207 (5) [back to overview]Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen
NCT01208207 (5) [back to overview]Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg
NCT01208207 (5) [back to overview]Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen
NCT01208207 (5) [back to overview]Number of Participants Discontinuing Study Treatment Due to an Adverse Event
NCT01208207 (5) [back to overview]Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)
NCT01229228 (1) [back to overview]Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
NCT01280591 (21) [back to overview]Karolinska Sleep Diary - Calmness of Sleep
NCT01280591 (21) [back to overview]Karolinska Sleep Diary - Ease of Awakening
NCT01280591 (21) [back to overview]Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night
NCT01280591 (21) [back to overview]Karolinska Sleep Diary - Premature Awakening
NCT01280591 (21) [back to overview]Karolinska Sleep Diary - Sleep Quality
NCT01280591 (21) [back to overview]Karolinska Sleep Diary - Sufficient Sleep
NCT01280591 (21) [back to overview]Karolinska Sleep Diary - Well Rested
NCT01280591 (21) [back to overview]Overall Rating of Pain Relief
NCT01280591 (21) [back to overview]Time to Rescue Medication
NCT01280591 (21) [back to overview]Subjective Sleep Questionnaire - Time to Fall Asleep Last Night
NCT01280591 (21) [back to overview]Sleep Latency Measured by Actigraphy
NCT01280591 (21) [back to overview]Subjective Sleep Questionnaire - Quality of Your Sleep Last Night
NCT01280591 (21) [back to overview]Wake Time After Sleep Onset (WASO) Measured by Actigraphy
NCT01280591 (21) [back to overview]Global Assessment of Investigational Product as a Sleep Aid
NCT01280591 (21) [back to overview]Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed
NCT01280591 (21) [back to overview]Karolinska Sleep Diary - Easiness to Fall Asleep
NCT01280591 (21) [back to overview]Change From Baseline in Pain Intensity
NCT01280591 (21) [back to overview]Sleep Efficiency Measured by Actigraphy
NCT01280591 (21) [back to overview]Cumulative Proportion of Subjects Taking Rescue Medication by Hour
NCT01280591 (21) [back to overview]Global Assessment of Investigational Product as a Pain Reliever
NCT01280591 (21) [back to overview]Total Sleep Time Measured by Actigraphy
NCT01300546 (12) [back to overview]Migraine Disability Assessment Test (MIDAS)
NCT01300546 (12) [back to overview]Compliance With Lifestyle Changes
NCT01300546 (12) [back to overview]Percent Change of Headache Days Compared to Baseline
NCT01300546 (12) [back to overview]Percent Change of Doses of Study Medication
NCT01300546 (12) [back to overview]Headache Days With Greater Than 50% Reduction
NCT01300546 (12) [back to overview]Migraine Attacks
NCT01300546 (12) [back to overview]Migraine Attacks With 50% Reduction
NCT01300546 (12) [back to overview]Percent Change in Headache Days All Treatment Periods Compared to Baseline
NCT01300546 (12) [back to overview]Migraine Severity
NCT01300546 (12) [back to overview]Migraine Duration From Time of Treatment to Pain Free
NCT01300546 (12) [back to overview]Migraine Duration From Onset to Pain Free
NCT01300546 (12) [back to overview]Doses of Study Medication
NCT01329562 (18) [back to overview]Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
NCT01329562 (18) [back to overview]Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
NCT01329562 (18) [back to overview]CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
NCT01329562 (18) [back to overview]CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
NCT01329562 (18) [back to overview]CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
NCT01329562 (18) [back to overview]Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.
NCT01329562 (18) [back to overview]Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders
NCT01329562 (18) [back to overview]α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
NCT01329562 (18) [back to overview]α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
NCT01329562 (18) [back to overview]α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders
NCT01329562 (18) [back to overview]CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders
NCT01329562 (18) [back to overview]α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.
NCT01329562 (18) [back to overview]Time to Pain-Free in Responders vs Non-Responders
NCT01329562 (18) [back to overview]Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment
NCT01329562 (18) [back to overview]Time to Pain Free
NCT01329562 (18) [back to overview]Migraine Recurrence Responders vs Non-Responders
NCT01329562 (18) [back to overview]Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders
NCT01329562 (18) [back to overview]Migraine Recurrence
NCT01332500 (6) [back to overview]Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
NCT01332500 (6) [back to overview]Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
NCT01332500 (6) [back to overview]Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis
NCT01332500 (6) [back to overview]Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis
NCT01332500 (6) [back to overview]Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis
NCT01332500 (6) [back to overview]Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis
NCT01365052 (5) [back to overview]Treatment Compliance - Duration of Exposure to Treatment in Days
NCT01365052 (5) [back to overview]Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
NCT01365052 (5) [back to overview]Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product
NCT01365052 (5) [back to overview]Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product
NCT01365052 (5) [back to overview]Treatment Compliance - Number of Capsules Taken
NCT01374269 (62) [back to overview]Medical Consultations.
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]Missing Workdays
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]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]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]Quality of Life, Bodily Pain
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]Quality of Life, Emotional Performance.
NCT01374269 (62) [back to overview]Quality of Life, Emotional Performance.
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]Quality of Life, General Health Perceptions.
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, 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]Quality of Life, Social Function.
NCT01374269 (62) [back to overview]Quality of Life, Social Function.
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, Vitality.
NCT01374269 (62) [back to overview]Quality of Life, Vitality.
NCT01374269 (62) [back to overview]Quality of Life, Vitality.
NCT01374269 (62) [back to overview]Relapses of Lumbar Pain
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]Roland-Morris Questionnaire
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]Visual Analogue Scale of Pain
NCT01374269 (62) [back to overview]Medical Consultations.
NCT01374269 (62) [back to overview]Medical Consultations.
NCT01374269 (62) [back to overview]Quality of Life, Mental Health.
NCT01383486 (3) [back to overview]The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
NCT01383486 (3) [back to overview]The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours
NCT01383486 (3) [back to overview]The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
NCT01389284 (9) [back to overview]Summed, Time-weighted Pain Intensity Differences (SPID)
NCT01389284 (9) [back to overview]Summed, Time-weighted Total Pain Relief Scores (TOTPARs)
NCT01389284 (9) [back to overview]Pain Relief From Initial Dose
NCT01389284 (9) [back to overview]Median Time to First Intake of Rescue Medication
NCT01389284 (9) [back to overview]Number of Times the Participants Took Rescue Medication Over the 24-hour Period
NCT01389284 (9) [back to overview]Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)
NCT01389284 (9) [back to overview]Cumulative Percentage of Participants Who Took Rescue Medication
NCT01389284 (9) [back to overview]Global Assessment of the Investigational Product as a Pain Reliever
NCT01389284 (9) [back to overview]Pain Intensity Differences (PIDs) by Time From Initial Dose
NCT01427803 (9) [back to overview]Non-therapeutic Reasons for Misuse
NCT01427803 (9) [back to overview]Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken
NCT01427803 (9) [back to overview]Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day
NCT01427803 (9) [back to overview]Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
NCT01427803 (9) [back to overview]Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days
NCT01427803 (9) [back to overview]Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
NCT01427803 (9) [back to overview]Percentage of Dosing Occasions Where More Than One Tablet Was Taken
NCT01427803 (9) [back to overview]Estimated Percentage of Misuse for Non-Therapeutic Reasons
NCT01427803 (9) [back to overview]Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
NCT01495858 (25) [back to overview]Global Assessment of Investigational Product as a Pain Reliever
NCT01495858 (25) [back to overview]Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2
NCT01495858 (25) [back to overview]Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2
NCT01495858 (25) [back to overview]Total Sleep Time Measured by Actigraphy
NCT01495858 (25) [back to overview]Time to Rescue Medication
NCT01495858 (25) [back to overview]Karolinska Sleep Diary - Easiness to Fall Asleep
NCT01495858 (25) [back to overview]Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night
NCT01495858 (25) [back to overview]Subjective Sleep Questionnaire - Quality of Your Sleep Last Night
NCT01495858 (25) [back to overview]Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed
NCT01495858 (25) [back to overview]Sleep Latency Measured by Actigraphy
NCT01495858 (25) [back to overview]Sleep Efficiency Measured by Actigraphy
NCT01495858 (25) [back to overview]Change From Baseline in Pain Intensity
NCT01495858 (25) [back to overview]Karolinska Sleep Diary - Premature Awakening
NCT01495858 (25) [back to overview]Karolinska Sleep Diary - Ease of Awakening
NCT01495858 (25) [back to overview]Overall Rating of Pain Relief
NCT01495858 (25) [back to overview]Karolinska Sleep Diary - Well Rested
NCT01495858 (25) [back to overview]Karolinska Sleep Diary - Sufficient Sleep
NCT01495858 (25) [back to overview]Karolinska Sleep Diary - Sleep Quality
NCT01495858 (25) [back to overview]Subjective Sleep Questionnaire - Time to Fall Asleep Last Night
NCT01495858 (25) [back to overview]Karolinska Sleep Diary - Calmness of Sleep
NCT01495858 (25) [back to overview]Global Assessment of Investigational Product as a Sleep Aid
NCT01495858 (25) [back to overview]Cumulative Proportion of Participants Taking Rescue Medication by Hour
NCT01495858 (25) [back to overview]Wake Time After Sleep Onset (WASO) Measured by Actigraphy
NCT01495858 (25) [back to overview]Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2
NCT01495858 (25) [back to overview]Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2
NCT01544114 (6) [back to overview]PK of Naproxen: Trough Plasma Concentrations
NCT01544114 (6) [back to overview]Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug
NCT01544114 (6) [back to overview]PK of Esomeprazole: Oral Volume of Distribution (V/F)
NCT01544114 (6) [back to overview]PK of Esomeprazole: Oral Plasma Clearance (CL/F)
NCT01544114 (6) [back to overview]Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])
NCT01544114 (6) [back to overview]PK of Esomeprazole: Absorption Rate Constant (Ka)
NCT01587274 (1) [back to overview]Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire
NCT01712009 (7) [back to overview]Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles
NCT01712009 (7) [back to overview]Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles
NCT01712009 (7) [back to overview]Percentage of Participants With Bone Pain (All Grades) in Cycle 1
NCT01712009 (7) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01712009 (7) [back to overview]Mean Patient-reported Bone Pain by Cycle and Across Cycles
NCT01712009 (7) [back to overview]Maximum Patient-reported Bone Pain by Cycle and Across Cycles
NCT01712009 (7) [back to overview]Area Under the Curve (AUC) for Patient-reported Bone Pain
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms
NCT01939002 (31) [back to overview]Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population
NCT01939002 (31) [back to overview]Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population
NCT01939002 (31) [back to overview]Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population
NCT01939002 (31) [back to overview]Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS
NCT01939002 (31) [back to overview]Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population
NCT01939002 (31) [back to overview]Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population
NCT01939002 (31) [back to overview]Summary of Average Duration of FLS in the First 8 Weeks of Treatment
NCT01939002 (31) [back to overview]Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms
NCT01939002 (31) [back to overview]Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment
NCT01939002 (31) [back to overview]Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment
NCT01939002 (31) [back to overview]Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment
NCT01939002 (31) [back to overview]Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment
NCT01939002 (31) [back to overview]Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment
NCT01939002 (31) [back to overview]Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks
NCT01939002 (31) [back to overview]Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks
NCT01939002 (31) [back to overview]Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs
NCT01939002 (31) [back to overview]Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period
NCT01939002 (31) [back to overview]Summary of Average Duration of FLS in the 48 Weeks of Treatment
NCT01939002 (31) [back to overview]Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms
NCT01939002 (31) [back to overview]Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population
NCT01939002 (31) [back to overview]Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing
NCT01939002 (31) [back to overview]Antibody Data in the Overall Population: IFN β-1a Antibody Screening
NCT01939002 (31) [back to overview]Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing
NCT01939002 (31) [back to overview]Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms
NCT01951105 (2) [back to overview]Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment
NCT01951105 (2) [back to overview]Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale
NCT01994226 (1) [back to overview]Change in Pain Intensity
NCT02013427 (1) [back to overview]Change in Pain Assessed by Visual Analogue Scale (VAS)
NCT02128490 (3) [back to overview]Percentage of Participants With at Least One Gout Flare Requiring Treatment
NCT02128490 (3) [back to overview]Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
NCT02128490 (3) [back to overview]Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
NCT02139046 (3) [back to overview]Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3
NCT02139046 (3) [back to overview]Percentage of Participants With at Least One Gout Flare Requiring Treatment
NCT02139046 (3) [back to overview]Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3
NCT02229461 (4) [back to overview]Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration
NCT02229461 (4) [back to overview]Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
NCT02229461 (4) [back to overview]Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration
NCT02229461 (4) [back to overview]Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration
NCT02262754 (23) [back to overview]Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline
NCT02262754 (23) [back to overview]Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4
NCT02262754 (23) [back to overview]Number of Participants Using Rescue Medication
NCT02262754 (23) [back to overview]Number of Days Participants Used the Rescue Medication
NCT02262754 (23) [back to overview]Chronic Low Back Pain (CLBP) Responder Index Analysis
NCT02262754 (23) [back to overview]Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4
NCT02262754 (23) [back to overview]Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3
NCT02262754 (23) [back to overview]Number of Participants With Vital Sign Abnormalities
NCT02262754 (23) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4
NCT02262754 (23) [back to overview]Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4
NCT02262754 (23) [back to overview]Amount of Rescue Medication Used by the Participants
NCT02262754 (23) [back to overview]Time to Withdrawal Due to Lack of Efficacy
NCT02262754 (23) [back to overview]Number of Participants With Laboratory Abnormalities
NCT02262754 (23) [back to overview]Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit
NCT02262754 (23) [back to overview]Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
NCT02262754 (23) [back to overview]Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4
NCT02262754 (23) [back to overview]Number of Participants With Electrocardiogram (ECG) Abnormalities
NCT02262754 (23) [back to overview]Plasma Concentration of PF-06372865
NCT02262754 (23) [back to overview]Plasma Concentration of Naproxen
NCT02262754 (23) [back to overview]Number of Participants Withdrawn Due to Lack of Efficacy
NCT02262754 (23) [back to overview]Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4
NCT02262754 (23) [back to overview]Patient Global Impression of Change (PGI-C) Score
NCT02262754 (23) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02388191 (5) [back to overview]Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)
NCT02388191 (5) [back to overview]Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)
NCT02388191 (5) [back to overview]Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
NCT02388191 (5) [back to overview]Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
NCT02388191 (5) [back to overview]Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
NCT02500641 (1) [back to overview]Pulse Wave Velocity
NCT02502006 (7) [back to overview]Mean Arterial Pressure
NCT02502006 (7) [back to overview]Diastolic Blood Pressure
NCT02502006 (7) [back to overview]Systolic Blood Pressure
NCT02502006 (7) [back to overview]COX-2 Activity ex Vivo
NCT02502006 (7) [back to overview]COX-1 Activity in Vivo
NCT02502006 (7) [back to overview]COX-2 Activity in Vivo
NCT02502006 (7) [back to overview]COX-1 Activity ex Vivo
NCT02519231 (2) [back to overview]Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle
NCT02519231 (2) [back to overview]Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month
NCT02604550 (10) [back to overview]Total Hours of Sleep
NCT02604550 (10) [back to overview]Number of Percocet Tablets Consumed
NCT02604550 (10) [back to overview]Pain Score
NCT02604550 (10) [back to overview]Patient-Reported Vomiting
NCT02604550 (10) [back to overview]Time to Straight Less Raise
NCT02604550 (10) [back to overview]"Percent of Patients Rating Their Satisfaction as Excellent or Good"
NCT02604550 (10) [back to overview]Patient-Reported Constipation
NCT02604550 (10) [back to overview]Patient-Reported Itching
NCT02604550 (10) [back to overview]Patient-Reported Nausea
NCT02604550 (10) [back to overview]Patient-Reported Sedation
NCT02632812 (6) [back to overview]Prostaglandin Level (PGE2 Quantification)
NCT02632812 (6) [back to overview]Presence of H. Pylori by Biopsy
NCT02632812 (6) [back to overview]Histopathological Score
NCT02632812 (6) [back to overview]Number of Adverse Events
NCT02632812 (6) [back to overview]Endoscopic Score - Modified Lanza Score
NCT02632812 (6) [back to overview]Endoscopic Score - Cryer Score
NCT02646124 (4) [back to overview]Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
NCT02646124 (4) [back to overview]Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours
NCT02646124 (4) [back to overview]Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale
NCT02646124 (4) [back to overview]Participants Satisfied With Treatment
NCT02665286 (4) [back to overview]Cases of Moderate or Severe LBP
NCT02665286 (4) [back to overview]Functional Impairment as Measured on the Roland Morris Disability Questionnaire
NCT02665286 (4) [back to overview]Medications--Patient Self Report of Medication Use
NCT02665286 (4) [back to overview]Patient Satisfaction With Treatment
NCT02769247 (5) [back to overview]Paragard vs Mirena IUD
NCT02769247 (5) [back to overview]Pain Control With IUD Insertion
NCT02769247 (5) [back to overview]Physician Perceived Pain Control During IUD Insertion
NCT02769247 (5) [back to overview]Perceived Pain 30 Days Post Insertion
NCT02769247 (5) [back to overview]Patient Satisfaction With IUD
NCT02986334 (1) [back to overview]Percent Change in Pain Assessed by Visual Analogue Scale (VAS)
NCT03028870 (18) [back to overview]"Average Daily Pain Right Now Score Collected by e-Diary"
NCT03028870 (18) [back to overview]Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale
NCT03028870 (18) [back to overview]Patient Global Impression of Change (PGIC)
NCT03028870 (18) [back to overview]Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)
NCT03028870 (18) [back to overview]Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score
NCT03028870 (18) [back to overview]Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score
NCT03028870 (18) [back to overview]Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)
NCT03028870 (18) [back to overview]Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary
NCT03028870 (18) [back to overview]Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary
NCT03028870 (18) [back to overview]European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status
NCT03028870 (18) [back to overview]Supplemental Analgesic Medication Use
NCT03028870 (18) [back to overview]Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score
NCT03028870 (18) [back to overview]"Daily Average Pain Over the Last 24 Hours Score at Week 4"
NCT03028870 (18) [back to overview]"Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4"
NCT03028870 (18) [back to overview]Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score
NCT03028870 (18) [back to overview]Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale
NCT03028870 (18) [back to overview]"Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale"
NCT03028870 (18) [back to overview]Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale
NCT03161093 (49) [back to overview]Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2
NCT03161093 (49) [back to overview]Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1
NCT03161093 (49) [back to overview]Number of Participants With AA (as Confirmed by Adjudication) - Year 2
NCT03161093 (49) [back to overview]Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
NCT03161093 (49) [back to overview]Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
NCT03161093 (49) [back to overview]Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
NCT03161093 (49) [back to overview]Number of Treatment Emergent Adverse Events (TEAEs) - Year 1
NCT03161093 (49) [back to overview]Number of TEAEs - Year 2
NCT03161093 (49) [back to overview]Number of TEAEs - Year 1 and Year 2
NCT03161093 (49) [back to overview]Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1
NCT03161093 (49) [back to overview]Number of Participants With DA (as Confirmed by Adjudication) - Year 2
NCT03161093 (49) [back to overview]Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
NCT03161093 (49) [back to overview]Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2
NCT03161093 (49) [back to overview]Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2
NCT03161093 (49) [back to overview]Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2
NCT03161093 (49) [back to overview]Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1
NCT03161093 (49) [back to overview]Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2
NCT03161093 (49) [back to overview]Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2
NCT03161093 (49) [back to overview]Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1
NCT03161093 (49) [back to overview]Number of Participants With Any Type of All-Cause JR in Year 2
NCT03161093 (49) [back to overview]Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1
NCT03161093 (49) [back to overview]Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen
NCT03161093 (49) [back to overview]Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen
NCT03161093 (49) [back to overview]Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
NCT03161093 (49) [back to overview]Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
NCT03161093 (49) [back to overview]Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen
NCT03161093 (49) [back to overview]Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
NCT03161093 (49) [back to overview]Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
NCT03404206 (3) [back to overview]Total Pain Relief (TOTPAR)
NCT03404206 (3) [back to overview]Time to First Use of Rescue Medication
NCT03404206 (3) [back to overview]Sum of Pain Intensity Difference (SPID)
NCT03448536 (10) [back to overview]TOTPAR Over 0-6 Hours
NCT03448536 (10) [back to overview]TOTPAR 6-12 Hours
NCT03448536 (10) [back to overview]Pain Relief Scores at Each Evaluation
NCT03448536 (10) [back to overview]Pain Intensity Difference (PID) Scores at Each Evaluation
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]Time to First Intake of Rescue Medication
NCT03448536 (10) [back to overview]Summed Pain Intensity Difference (SPID) Over 0-12 Hours
NCT03448536 (10) [back to overview]Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours
NCT03448536 (10) [back to overview]SPID Over 6-12 Hours
NCT03472469 (10) [back to overview]Number of Intensive Care Unti (ICU) Days
NCT03472469 (10) [back to overview]Number of Participants With Any Opioid-related Complications
NCT03472469 (10) [back to overview]Pain as Assessed by Score on the Numeric Rating Scale (NRS)
NCT03472469 (10) [back to overview]Pharmacy Costs
NCT03472469 (10) [back to overview]Number of Hospital Days
NCT03472469 (10) [back to overview]Number of Participants Discharged From the Hospital With an Opioid Prescription
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
NCT03472469 (10) [back to overview]Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
NCT03566979 (2) [back to overview]Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments
NCT03566979 (2) [back to overview]Time to Confirmed Perceptible Pain Relief
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
NCT03570554 (3) [back to overview]Change From Baseline in Brief Arthritis Stiffness Scale (BASS) Score at Day 4
NCT03654326 (5) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
NCT03654326 (5) [back to overview]Percentage of Participants Who Experienced an Adverse Event
NCT03654326 (5) [back to overview]Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2
NCT03654326 (5) [back to overview]Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2
NCT03654326 (5) [back to overview]Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2
NCT03697720 (2) [back to overview]Change in Menstrual Pain
NCT03697720 (2) [back to overview]Change in Participant Bladder Pain Sensitivity From Baseline
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]Participant's Global Evaluation of Study Medication OR Overall Impression of Study Medication According to Participant's Global Evaluation
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 Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 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 8 Hours (SPID 0-8)
NCT03879408 (9) [back to overview]Pain Relief (PAR) Scores at Individual Timepoints
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 8 Hours (TOTPAR 0-8)
NCT03949673 (3) [back to overview]Number of Participants by Degree of Cartilage Loss
NCT03949673 (3) [back to overview]Number of Participants by Degree of Synovial Lymphocytic Inflammation
NCT03949673 (3) [back to overview]Number of Participants by Degree of Bony Changes
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
NCT04132336 (12) [back to overview]Total Pain Relief (TOTPAR) From 0 to 2, 4 and 12 Hours Post-dose
NCT04132336 (12) [back to overview]Number of Participants With Adverse Events
NCT04132336 (12) [back to overview]The Cumulative Percentage of Participants Taking Rescue Medication
NCT04132336 (12) [back to overview]Sum of Pain Intensity Differences (SPIDs) From 0 to 2, 4 and 12 Hours Post-dose
NCT04132336 (12) [back to overview]Pain Relief Score at Each Evaluation
NCT04132336 (12) [back to overview]Total Pain Relief (TOTPAR) Over 8 Hours
NCT04132336 (12) [back to overview]Time to First Use of Rescue Medication
NCT04132336 (12) [back to overview]The Number of Participants With Clinically Significant Changes in Physical Examinations and Vital Signs
NCT04132336 (12) [back to overview]Pain Intensity Difference (PID) at Each Evaluation
NCT04132336 (12) [back to overview]Peak Pain Relief Score
NCT04132336 (12) [back to overview]Peak Pain Intensity Difference (PID)
NCT04132336 (12) [back to overview]Sum of Pain Intensity Difference (SPID) Over 8 Hours
NCT04307940 (9) [back to overview]Amount 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]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]Time to First Use of Rescue Medication
NCT04307940 (9) [back to overview]Sum of Pain Intensity Difference Over 6 Hours (SPID 0-6)
NCT04307940 (9) [back to overview]Duration of Pain at Least Half Gone Over 12 Hours
NCT04307940 (9) [back to overview]Total Pain Relief Over 12 Hours (TOTPAR 0-12)

The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).

APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology). (NCT00346216)
Timeframe: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months

,,
InterventionPercentage of Partcipants (Number)
ITT (N = 8072, 8040, 7969)MITT (N = 8030, 7990, 7933)
Celecoxib2.31.7
Ibuprofen2.71.9
Naproxen2.51.8

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Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)

"VAS question How much pain do you have was graded on a scale from 0 to 100 with 0 indicating No pain and 100 indicating Worst possible pain." (NCT00346216)
Timeframe: ITT and MITT Population - Baseline to 42 months

,,
InterventionNumber of participants (Mean)
Baseline (ITT) N= 8014, 8001, 7928Change-Baseline to Mon1 (ITT) N=7382, 7379, 7325Change-Baseline to Mon2 (ITT) N=7180, 7090, 7149Change-Baseline to Mon4 (ITT) N=6777, 6696, 6740Change-Baseline to Mon8 (ITT) N=6230, 6137, 6159Change-Baseline to Mon12 (ITT) N=5792, 5696, 5846Change-Baseline to Mon18 (ITT) N=5310, 5181. 5246Change-Baseline to Mon24 (ITT) N=4818, 4776, 4785Change-Baseline to Mon30 (ITT) N=4140, 4069, 4086Change-Baseline to Mon36 (ITT) N=3692, 3627, 3635Change-Baseline to Mon42 (ITT) N=3469, 3406, 3439Baseline (MITT) N=7974, 7954, 7894Change-Baseline to Mon1 MITT N=7372, 7367, 7321Change-Baseline to Mon2 MITT N=7170, 7078, 7142Change-Baseline to Mon4 MITT N=6772, 6686, 6732Change-Baseline to Mon8 MITT N=6224, 6128, 6155Change-Baseline to Mon12 MITT N=5787, 5689, 5844Change-Baseline to Mon18 MITT N=5305, 5175, 5242Change-Baseline to Mon24 MITT N=4815, 4769, 4782Change-Baseline to Mon30 MITT N=4139, 4067, 4085Change-Baseline to Mon36 MITT N=3691, 3623, 3635Change-Baseline to Mon42 MITT N=3468, 3404, 3438
Celecoxib54.0-8.2-10.5-11.4-11.7-11.0-11.3-11.3-10.5-10.1-11.454.0-8.2-10.5-11.4-11.7-11.0-11.3-11.4-10.5-10.2-11.4
Ibuprofen54.1-9.0-10.6-11.7-12.1-11.6-11.3-11.5-11.2-10.7-11.154.1-9.0-10.6-11.7-12.1-11.6-11.3-11.5-11.2-10.7-11.1
Naproxen54.1-9.9-11.1-12.3-12.1-11.9-11.7-11.4-11.3-11.6-12.154.1-9.9-11.1-12.3-12.1-11.9-11.7-11.3-11.3-11.6-12.1

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The First Occurrence of a Major Adverse Cardiovascular Events (MACE)

MACE defined as the composite of CV death (including hemorrhagic death), non-fatal MI, non-fatal stroke, hospitalization for UA, revascularization or hospitalization for TIA (NCT00346216)
Timeframe: ITT Population - 30 months; MITT Population - 42 months

,,
InterventionPercentage of Participants (Number)
ITT (N = 8072, 8040, 7969)MITT (N = 8030, 7990, 7933)
Celecoxib4.23.1
Ibuprofen4.83.6
Naproxen4.33.2

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The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)

CSGIE include: Gastroduodenal (GD) hemorrhage, Gastric outlet obstruction, Gastroduodenal, small bowel or large bowel perforation, Large bowel hemorrhage, Small bowel hemorrhage, Acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage, Symptomatic gastric or duodenal ulcer (NCT00346216)
Timeframe: ITT Population - 30 months; MITT Population - 42 months

,,
InterventionPercentage of Participants (Number)
ITT (N = 8072, 8040, 7969)MITT (N = 8030, 7990, 7933)
Celecoxib0.70.3
Ibuprofen0.90.7
Naproxen0.70.7

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Rescue Medication Use During 0 - 24 Hours Post-Dose

A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label). (NCT00382993)
Timeframe: 0-24 Hours Post-Dose

InterventionParticipants (Number)
Placebo72
Sumatriptan/Naproxen Sodium29

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Sustained Complete Pain/Symptom-Free

Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication. (NCT00382993)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo7
Sumatriptan/Naproxen Sodium30

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Migraine Headache Pain Free at 2 Hours Post-Dose

Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time. (NCT00382993)
Timeframe: 2 Hours Post-Dose

InterventionParticipants (Number)
Placebo19
Sumatriptan/Naproxen Sodium59

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Sustained Freedom From Migraine

Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication. (NCT00382993)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo8
Sumatriptan/Naproxen Sodium34

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Recurrence of Any Migraine Headache Pain

Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours. (NCT00382993)
Timeframe: 24 hours and 48 hours

,
InterventionParticipants (Number)
Recurrence by 24 hours post-doseRecurrence by 48 hours post-dose
Placebo56
Sumatriptan/Naproxen Sodium1313

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Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose

Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose. (NCT00382993)
Timeframe: 2 - 24 Hours Post-Dose

InterventionParticipants (Number)
Placebo10
Sumatriptan/Naproxen Sodium41

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Sustained Freedom From Migraine-Associated Nausea

Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose. (NCT00382993)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo38
Sumatriptan/Naproxen Sodium79

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Sustained Freedom From Migraine-Associated Phonophobia

Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose. (NCT00382993)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo30
Sumatriptan/Naproxen Sodium68

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Sustained Freedom From Migraine-Associated Neck Pain

Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose. (NCT00382993)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo29
Sumatriptan/Naproxen Sodium65

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Migraine Headache Pain Free at 0.5, 1, 4, and 8 Hours Post-Dose

Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time. (NCT00382993)
Timeframe: 0.5, 1, 4, and 8 Hours Post-Dose

,
InterventionParticipants (Number)
Pain Free at 0.5 Hour Post-DosePain Free at 1 Hour Post-DosePain Free at 4 Hours Post-DosePain Free at 8 Hours Post-Dose
Placebo3122332
Sumatriptan/Naproxen Sodium3338388

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Sustained Freedom From Migraine-Associated Sinus Pain

Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose. (NCT00382993)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo44
Sumatriptan/Naproxen Sodium75

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Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose

"Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment. Complete pain/symptom-free was defined as migraine-free, neck pain-free, and sinus pain free." (NCT00382993)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Complete Pain/Symptom-BaselineComplete Pain/Symptom-2 Hours Post-DoseComplete Pain/Symptom-4 Hours Post-DoseComplete Pain/Symptom-8 Hours Post-Dose
Placebo132121114106
Sumatriptan/Naproxen Sodium134947058

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Sustained Freedom From Migraine-Associated Photophobia

Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose. (NCT00382993)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo23
Sumatriptan/Naproxen Sodium65

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Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose

Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment. (NCT00382993)
Timeframe: 2, 4 , and 8 hours post-dose

,
InterventionParticipants (Number)
Migraine-Free at 2 Hours Post-DoseMigraine-Free at 4 Hours Post-DoseMigraine-Free at 8 Hours Post-Dose
Placebo152030
Sumatriptan/Naproxen Sodium467683

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Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had sinus pain at the time of assessment. (NCT00382993)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Migraine-Assoc Sinus Pain at BaselineMigraine-Assoc Sinus Pain at 2 Hours Post-DoseMigraine-Assoc Sinus Pain at 4 Hours Post-DoseMigraine-Assoc Sinus Pain at 8 Hours Post-Dose
Placebo47403627
Sumatriptan/Naproxen Sodium56412720

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Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had photophobia (sensitivity to light) at the time of assessment. (NCT00382993)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Migraine Assoc Photophobia-BaselineMigraine Assoc Photophobia 2 Hours Post-DoseMigraine Assoc Photophobia 4 Hours Post-DoseMigraine Assoc Photophobia 8 Hours Post-Dose
Placebo100846951
Sumatriptan/Naproxen Sodium101483125

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Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had phonophobia (sensitivity to noise) at the time of assessment. (NCT00382993)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Migraine Assoc Phonophobia-BaselineMigraine Assoc Phonophobia 2 Hours Post-DoseMigraine Assoc Phonophobia 4 Hours Post-DoseMigraine Assoc Phonophobia 8 Hours Post-Dose
Placebo75685642
Sumatriptan/Naproxen Sodium80422720

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Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of Participants with neck pain at the time of assessment. (NCT00382993)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Migraine-Assoc Neck Pain at BaselineMigraine-Assoc Neck Pain at 2 Hours Post-DoseMigraine-Assoc Neck Pain at 4 Hours Post-DoseMigraine-Assoc Neck Pain at 8 Hours Post-Dose
Placebo81716551
Sumatriptan/Naproxen Sodium75523829

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Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present. (NCT00382993)
Timeframe: Baseline, 2, 4, and 8 hours

,
InterventionParticipants (Number)
Migraine Associated Nausea at BaselineMigraine Associated Nausea 2 Hours Post-DoseMigraine Associated Nausea 4 Hours Post-DoseMigraine Associated Nausea 8 Hours Post-Dose
Placebo40433527
Sumatriptan/Naproxen Sodium48331814

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Migraine-Associated Neck Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of Participants with neck pain at the time of assessment. (NCT00383162)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Baseline2 hours post-dose4 hours post-dose8 hours post-dose
Placebo65544637
Sumatriptan-Naproxen Sodium82544031

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Migraine-Associated Phonophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had phonophobia (sensitivity to noise) at the time of assessment. (NCT00383162)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Baseline2 hours post-dose4 hours post-dose8 hours post-dose
Placebo82735644
Sumatriptan-Naproxen Sodium86473124

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Migraine-Associated Photophobia Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had photophobia (sensitivity to light) at the time of assessment. (NCT00383162)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Baseline2 hours post-dose4 hours post-dose8 hours post-dose
Placebo98866548
Sumatriptan-Naproxen Sodium95573327

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Migraine-Associated Sinus Pain Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had sinus pain at the time of assessment. (NCT00383162)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Baseline2 hours post-dose4 hours post-dose8 hours post-dose
Placebo58523935
Sumatriptan-Naproxen Sodium61312019

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Migraine-Associated Nausea Assessed at Baseline, 2, 4, and 8 Hours Post-dose

Number of participants who had nausea at the time of assessment. Resolution of an associated symptom was defined as a migraine headache symptom that was present at the time of treatment that was not present post-dose. Symptom resolution was defined only among subjects who treated while their symptom was present. (NCT00383162)
Timeframe: Baseline, 2, 4, and 8 hours

,
InterventionParticipants (Number)
Baseline2 hours post-dose4 hours post-dose8 hours post-dose
Placebo45422924
Sumatriptan-Naproxen Sodium48392014

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Sustained Freedom From Migraine-Associated Photophobia

Sustained Freedom from Migraine-Associated Photophobia was defined as the absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo23
Sumatriptan-Naproxen Sodium59

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Migraine-Free Assessment at 2, 4, and 8 Hours Post-dose

Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea and vomiting) at the time of the assessment. (NCT00383162)
Timeframe: 2, 4 , and 8 hours post-dose

,
InterventionParticipants (Number)
2 hours post-dose4 hours post-dose8 hours post-dose
Placebo193029
Sumatriptan-Naproxen Sodium477280

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Pain-Free Assessment at 1/2, 1, 4, 8 Hours Post-dose

Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time. (NCT00383162)
Timeframe: 1/2, 1, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
1/2 hour post-dose1 hour post-dose4 hours post-dose8 hours post-dose
Placebo2133032
Sumatriptan-Naproxen Sodium6268088

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Recurrence of Any Migraine Headache Pain

Recurrence is defined as the return of any migraine headache pain during the specified post-dose period, following a pain-free response at 2 hours. (NCT00383162)
Timeframe: 24 hours and 48 hours

,
InterventionParticipants (Number)
Recurrence by 24 hours post-doseRecurrence by 48 hours post-dose
Placebo1213
Sumatriptan-Naproxen Sodium1111

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Sustained Freedom From Migraine-Associated Sinus Pain

Sustained Freedom from Migraine-Associated Sinus Pain was defined as the absence of sinus pain from 2 to 24 hours post-dose. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo34
Sumatriptan-Naproxen Sodium76

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Complete Pain/Symptom-Free Assessed at Baseline, 2, 4, and 8 Hours Post-dose

"Number of participants who were completely symptom-free (migraine-free plus neck and sinus pain-free) at time of assessment.Complete pain/symptom-free was defined as migraine-free, neck pain-free, and sinus pain free." (NCT00383162)
Timeframe: Baseline, 2, 4, and 8 hours post-dose

,
InterventionParticipants (Number)
Baseline2 hours post-dose4 hours post-dose8 hours post-dose
Placebo133117107106
Sumatriptan-Naproxen Sodium136927362

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Rescue Medication Used up to 24 Hours Post-dose

A rescue medication was defined as an additional medication taken for the treatment of migraine headache pain symptoms associated with the attack. Allowed were a single dose of either: sumatriptan (50mg or 100mg), OR naproxen sodium (max 550mg), OR, an over-the-counter pain-reliever (per label). (NCT00383162)
Timeframe: Dosing to 24 hours post-dose

InterventionParticipants (Number)
Placebo84
Sumatriptan-Naproxen Sodium40

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Pain-Free Assessment at 2 Hours Post-dose

Participants rated their pain severity using a four point scale where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain. Pain-free was a rating of 0 (no pain) at the specified time. (NCT00383162)
Timeframe: 2 hours post-dose

InterventionParticipants (Number)
Placebo23
Sumatriptan-Naproxen Sodium54

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Sustained Complete Pain/Symptom-Free

Sustained Complete Pain/Symptom-Free was defined as completely symptom-free (migraine-free plus neck and sinus pain-free) at 2 hours and sustained from 2 to 24 hours without the use of rescue medication. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo9
Sumatriptan-Naproxen Sodium30

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Sustained Freedom From Migraine

Migraine-free was defined as pain-free with no traditional migraine-associated symptoms (i.e.,photophobia, phonophobia, nausea). Sustained migraine-free was defined as migraine-free at 2 hours and sustained from 2 to 24 hours post dose without the use of rescue medication. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo11
Sumatriptan-Naproxen Sodium32

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Sustained Freedom From Migraine Pain Between 2-24 Hours Post-dose

Sustained freedom from migraine pain was defined as having no pain at 2 hours post-dose without the use of rescue medication; and without the recurrence of any pain or the use of any rescue medication 2 to 24 hours post-dose. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo10
Sumatriptan-Naproxen Sodium36

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Sustained Freedom From Migraine-Associated Nausea

Sustained Freedom from Migraine-Associated Nausea was defined as the absence of nausea from 2 to 24 hours post-dose. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo38
Sumatriptan-Naproxen Sodium70

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Sustained Freedom From Migraine-Associated Neck Pain

Sustained Freedom from Migraine-Associated Neck Pain was defined as the absence of neck pain from 2 to 24 hours post-dose. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo33
Sumatriptan-Naproxen Sodium63

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Sustained Freedom From Migraine-Associated Phonophobia

Sustained Freedom from Migraine-Associated Phonophobia was defined as the absence of phonophobia (sensitivity to noise) from 2 to 24 hours post-dose. (NCT00383162)
Timeframe: 2 - 24 hours post-dose

InterventionParticipants (Number)
Placebo31
Sumatriptan-Naproxen Sodium66

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Tmax for Eletriptan

Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction. (NCT00385008)
Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.

Interventionhr (Median)
Non-migraineMigraine
Relpax (Eletriptan 40 mg)2.5002.000

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Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine

Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administered (For 30 days)

Interventionhr (Median)
Sumatriptan, Non-migraineSumatriptan, MigraineNaproxen, Non-migraineNaproxen, Migraine
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)4.3654.3504.5104.350

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Time to First Appearance of Sumatriptan, Naproxen and Eletriptan at the Proximal Small Intestine

Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administered (For 30 days)

Interventionhr (Median)
Eletriptan, Non-migraineEletriptan, Migraine
Relpax (Eletriptan 40 mg)5.5305.810

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Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet

Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administered (For 30 days)

Interventionhr (Median)
Sumatriptan, Non-migraineSumatriptan, MigraineNaproxen, Non-migraineNaproxen, Migraine
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)0.0500.0501.1251.250

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Time to Complete Dispersion of the Sumatriptan and Naproxen Portions of the TREXIMA Tablet and of the Relpax Tablet

Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administered (For 30 days)

Interventionhr (Median)
Eletriptan, Non-migraineEletriptan, Migraine
Relpax (Eletriptan 40 mg)0.6000.670

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Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan

Scintigraphic images were analyzed in a time-lapse format and regions of interest were drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with pharmacokinetic (PK) blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administration (For 30 days)

Interventionhours (hr) (Median)
10% gastric emptying, Eletriptan, Non-migraine10% gastric emptying, Eletriptan, Migraine50% gastric emptying, Eletriptan, Non-migraine50% gastric emptying, Eletriptan, Migraine90% gastric emptying, Eletriptan, Non-migraine90% gastric emptying, Eletriptan, MigraineComplete gastric emptying, Eletriptan,Non-migraineComplete gastric emptying, Eletriptan, Migraine
Relpax (Eletriptan 40 mg)0.4000.4100.5900.8902.5902.4903.7653.510

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Time to 10%, 50%, 90% and Complete Gastric Empting of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan

Scintigraphic images were analyzed in a time-lapse format and regions of interest were drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with pharmacokinetic (PK) blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administration (For 30 days)

Interventionhours (hr) (Median)
10% gastric emptying, Sumatriptan, Non-migraine10% gastric emptying, Sumatriptan, Migraine10% gastric emptying, Naproxen, Non-migraine10% gastric emptying, Naproxen, Migraine50% gastric emptying, Sumatriptan, Non-migraine50% gastric emptying, Sumatriptan, Migraine50% gastric emptying, Naproxen, Non-migraine50% gastric emptying, Naproxen, Migraine90% gastric emptying, Sumatriptan, Non-migraine90% gastric emptying, Sumatriptan, Migraine90% gastric emptying, Naproxen, Non-migraine90% gastric emptying, Naproxen, MigraineComplete gastric emptying,Sumatriptan,Non-migraineComplete gastric emptying, Sumatriptan, MigraineComplete gastric emptying, Naproxen, Non-migraineComplete gastric emptying, Naproxen, Migraine
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)0.1000.1301.1951.3000.6751.0702.2602.3103.0203.4404.2904.0104.5054.0004.7604.500

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Time of Maximal Drug Concentration (Tmax) for Sumatriptan and Naproxen

Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction. (NCT00385008)
Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.

Interventionhr (Median)
Sumatriptan, Non-migraineSumatriptan, MigraineNaproxen, Non-migraineNaproxen, Migraine
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)2.0001.5004.504.00

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Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan

Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administered (For 30 days)

Interventionhr (Median)
Sumatriptan, Non-MigraineSumatriptan, MigraineNaproxen, Non-MigraineNaproxen, Migraine
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)2.8952.9902.5502.230

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Small Intestine Transit and Residence (Time to 50% Through Intestine) of the Radioactive Markers Representing Sumatriptan, Naproxen and Eletriptan

Scintigraphic images were analyzed in a time-lapse format and regions of interest were to be drawn to include the stomach and small intestine. Images were recorded in a supine position and a series of 3 to 60 consecutive anterior scintigraphic images, each 1 minute in duration, were recorded using a clinical grade gamma camera. After this initial continuous imaging sequence, additional images were recorded to coincide with PK blood sampling times as necessary to monitor the tablet disintegration and transit time through the intestines. Prior to ingesting the radiolabeled dosage forms, two external markers (2-3 microcuries of indium-111 or technetium-99m) were placed on each participant to facilitate consistent positioning underneath the gamma camera. The first marker was placed on the right side of the participant's chest (approximately at the fifth intercostal rib) and a second marker was placed on the hip bone (approximately the left anterior superior ileac spine). (NCT00385008)
Timeframe: Day 1 of each treatment administered (For 30 days)

Interventionhr (Median)
Eletriptan, Non-MigraineEletriptan, Migraine
Relpax (Eletriptan 40 mg)4.3354.140

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Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. (NCT00385008)
Timeframe: Up to Day 30

,
InterventionParticipants (Count of Participants)
Any AEsAny SAEs
Relpax (Eletriptan 40 mg)30
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)80

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Mean Area Under the Drug Concentration Time Curve (AUC) From Time of Dosing Through 2 Hour Post-dose [AUC (0-2)], Through 24 Hour [AUC (0-24)] and AUC From Time of Dosing Extrapolated to Infinity [AUC (0-inf)] for Sumatriptan and Naproxen

Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction. (NCT00385008)
Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.

Interventionmicrogram*hr per mL (µg*hr/mL) (Geometric Mean)
AUC (0-24), Sumatriptan, Non-migraineAUC (0-24), Sumatriptan, MigraineAUC (0-inf), Sumatriptan, Non-migraineAUC (0-inf), Sumatriptan, MigraineAUC (0-2), Sumatriptan, Non-migraineAUC (0-2), Sumatriptan, MigraineAUC (0-24), Naproxen, Non-migraineAUC (0-24), Naproxen, MigraineAUC (0-inf), Naproxen, Non-migraineAUC (0-inf), Naproxen, MigraineAUC (0-2), Naproxen, Non-migraineAUC (0-2), Naproxen, Migraine
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)231.526165.707231.999158.03665.15654.884570.54627.06901.13978.3923.1624.38

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Maximum Observed Drug Concentration (Cmax) for Sumatriptan and Naproxen

Following TREXIMA administration, 6 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12, 24, 48, 72 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction. (NCT00385008)
Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12, 24, 48 and 72 hours post-dose for each treatment administered.

Interventionnanograms per milliliter (ng/mL) (Geometric Mean)
Sumatriptan, Non-migraineSumatriptan, MigraineNaproxen, Non-migraineNaproxen, Migraine
TREXIMA (Sumatriptan 85 mg + Naproxen 500 mg)49.90045.67646.3456.36

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Cmax for Eletriptan

Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction. (NCT00385008)
Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.

Interventionng/mL (Geometric Mean)
Non-migraineMigraine
Relpax (Eletriptan 40 mg)80.24691.323

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Mean AUC (0-inf) and AUC (0-2) for Eletriptan

Following Relpax administration, 8 mL blood sample was collected at pre-dose and then at 5, 10 , 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, and 75 minutes. Then at 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour and at 8, 10, 12 hour post-dose for each treatment administered. All available plasma supernatant was withdrawn from the precipitated blood fraction. (NCT00385008)
Timeframe: Pre-dose and then at 5 minute intervals through 60 minutes, at 75 minutes, every 30 minutes from 90 minutes through 6 hours, and at 8, 10, 12 hours post-dose for each treatment administered.

Interventionµg*hr/mL (Geometric Mean)
AUC (0-inf), Non-migraineAUC (0-inf), MigraineAUC (0-2), Non-migraineAUC (0-2), Migraine
Relpax (Eletriptan 40 mg)540.669570.86070.24978.092

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Pain-Free at 2 Hours Post-dose and Sustained Pain-Free From 2-24 Hours Post-dose.

Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine. (NCT00387881)
Timeframe: 2 hours through 24 hours after Treatment

,
InterventionParticipants (Number)
Pain-Free (2 hours)Sustained Pain-Free (2-24 hours)
Placebo2520
Sumatriptan/Naproxen6454

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Sustained Headache Relief 2-24 Hours After Treatment

Sustained pain relief was defined as having pain relief (mild or no pain) at 2 hours w/o any moderate or severe pain during 2-24 hour period post-treatment, without rescue medication. (NCT00387881)
Timeframe: 2-24 hours after treatment

InterventionParticipants (Number)
Placebo77
Sumatriptan/Naproxen110

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Subjects Who Used Rescue Medication From 0 - 24 Hours After Treatment

Rescue medication defined as additional medication (i.e. sumatriptan/naproxen sodium as open-label rescue or other medication as permitted per protocol), taken by subject for the treatment of headache pain or other symptoms associated with the headache attack. (NCT00387881)
Timeframe: 0 - 24 hours after treatment

InterventionParticipants (Number)
Placebo101
Sumatriptan/Naproxen61

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Intermediate Sustained Pain Relief: Post-dose at Intervals of 2-4 Hours and 1-2 Hours After Treatment

Intermediate sustained pain relief was defined as achieving headache pain relief (from moderate or severe pain at baseline to mild or no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours). (Intermediate=Intermed.) (NCT00387881)
Timeframe: 1-2, and 2- 4 hours after treatment

,
InterventionParticipants (Number)
Intermed. Sustained Pain Relief, 2-4 hrs post-doseIntermed. Sustained Pain Relief, 1-2 hrs post-dose
Placebo9267
Sumatriptan/Naproxen11884

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Intermediate Sustained Pain-Free: Post-dose at Intervals of 2-4 Hours and 1-2 Hours

Intermediate sustained pain free was defined as achieving headache pain-free (moderate or severe pain to no pain) prior to the specified timepoint (1 or 2 hours) and maintaining it to the specified timepoint (2-4 hours).(Intermediate=Intermed.) (NCT00387881)
Timeframe: 1-2 and 2-4 hours after treatment

,
InterventionParticipants (Number)
Intermed. Sustained Pain-free, 2-4 hrs post-doseIntermed. Sustained Pain-free, 1-2 hrs post-dose
Placebo2211
Sumatriptan/Naproxen6123

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Incidence of Headache Associated: Neck Pain, Sinus Pain, Photophobia, Phonophobia, Nausea at Time Intervals of 4 and 2 Hours After Treatment

Neck pain, sinus pain, photophobia, phonophobia and nausea are considered headache-associated symptoms.(Headache-associated=Headache-Assoc.) (NCT00387881)
Timeframe: 2 and 4 hours after treatment

,
InterventionParticipants (Number)
Headache-Assoc. Neck Pain at 4 hoursHeadache-Assoc. Neck Pain at 2 hoursHeadache-Assoc. Sinus Pain at 4 hoursHeadache-Assoc. Sinus Pain at 2 hoursHeadache-Assoc. Photophobia at 4 hoursHeadache-Assoc. Photophobia at 2 hoursHeadache-Assoc. Phonophobia at 4 hoursHeadache-Assoc. Phonophobia at 2 hoursHeadache-Assoc. Nausea at 4 hoursHeadache-Assoc. Nausea at 2 hours
Placebo93688849876083538237
Sumatriptan/Naproxen63594936604659545136

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Medication Satisfaction: Mean Patient Perception of Migraine (PPMQ-R) Subscale Score

Patient Perception of Migraine Questionnaire-Revised(PPMQ-R) evaluates subject satisfaction with treatment 24 hours post-dose using validated questions. Questions are analyzed on 4 subscale scores (efficacy, functionality, ease-of-use, and tolerability) and total score. Scores range from 0-100, with the higher scores indicating better satisfaction. (NCT00387881)
Timeframe: 0 - 24 hours after treatment

,
InterventionScore in scale (Mean)
Efficacy Adjusted MeanFunctionality Adjusted MeanEase-of-Use Adjusted MeanBothersome-of-Side Effects Adjusted MeanTotal Score adjusted Mean
Placebo5356849464
Sumatriptan/Naproxen6770889175

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Headache Relief at 4, 2, 1 and 0.5 Hours After Treatment

Pain relief was defined as reduction of headache pain from a baseline severity of moderate or severe to none or mild at the given time. (NCT00387881)
Timeframe: 0.5, 1, 2, and 4 hours after treatment

,
InterventionParticipants (Number)
Headache relief at 4 hoursHeadache relief at 2 hoursHeadache relief at 1 hourHeadache relief at 0.5 hour
Placebo1081137339
Sumatriptan/Naproxen1531248541

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Freedom From Headache Pain at 0.5, 1, and 4 Hours After Treatment

Pain-Free is defined as post-treatment headache pain severity of none in subjects who have not used rescue medication prior to or at the time of the assessment. (NCT00387881)
Timeframe: 0.5, 1, and 4 hours after Treatment

,
InterventionParticipants (Number)
Pain-free at 4 hoursPain-free at 1 hourPain-free at 0.5 hour
Placebo60166
Sumatriptan/Naproxen105235

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Patient Satisfaction

"At the 48 hour assessment, patients were asked, The next time you go to an emergency room with a headache, do you want to receive the same medication. This outcome tabulates the number of affirmative responses." (NCT00449787)
Timeframe: 48 hours after ER discharge

Interventionparticipants (Number)
Sumatriptan69
Naproxen68

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Numerical Rating Scale

"Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable.~Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief" (NCT00449787)
Timeframe: Baseline, two hours

Interventionunits on a scale (Mean)
Sumatriptan4.1
Naproxen4.3

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Number of Participants With Abnormal Electrocardiogram Findings at Screening and at the Final Visit as Assessed by the Investigator

The number of participants with an electrocardiogram (ECG) status of normal, abnormal, clinically significant (CS), or not clinically significant (NCS), as determined by the Investigator, was reported. Specific definitions of ECG categorizations were not provided; investigators were expected to apply reasonable standards of clinical judgment. Normal, all ECG parameters within accepted normal ranges; abnormal, ECG finding(s) outside of normal ranges; CS, ECG with a CS abnormality that meets exclusion criteria; NCS, ECG with an abnormality not CS or meeting exclusion criteria per investigator. (NCT00488514)
Timeframe: Screening and Final Visit (up to Month 12)

,,
Interventionparticipants (Number)
Screening, normal, n=284, 337, 621Screening, abnormal, NCS, n=284, 337, 621Screening, abnormal, CS, n=284, 337, 621Final Visit, Normal, n=248, 294, 542Final Visit, abnormal, NCS, n=248, 294, 542Final Visit, abnormal, CS, n=248, 294, 542
12-14 Years224600196520
12-17 Years49412704161260
15-17 Years270670220740

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Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionnaire-Revised (PPMQ-R) at the Screening Visit

"The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7)." (NCT00488514)
Timeframe: Screening

,,
Interventionparticipants (Number)
Overall Efficacy, Very SatisfiedOverall Efficacy, SatisfiedOverall Efficacy, Somewhat SatisfiedOverall Efficacy, NeutralOverall Efficacy, Somewhat DissatisfiedOverall Efficacy, DissatisfiedOverall Efficacy, Very DissatisfiedSide Effects, Very SatisfiedSide Effects, SatisfiedSide Effects, Somewhat SatisfiedSide Effects, NeutralSide Effects, Somewhat DissatisfiedSide Effects, DissatisfiedSide Effects, Very DissatisfiedOverall Treatment Satisfaction, Very SatisfiedOverall Treatment Satisfaction, SatisfiedOverall Treatment Satisfaction, Somewhat SatisfiedOverall Treatment Satisfaction, NeutralTreatment Satisfaction, Somewhat DissatisfiedOverall Treatment Satisfaction, DissatisfiedOverall Treatment Satisfaction, Very Dissatisfied
12 Month Completer Population1154721512825050263662411705616993
6 Month Completer Population22102113302322489874569136730113943513238
ITT Population3616319267494312135166771272918115019216467314315

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Number of Participants Categorized by Response to Each of the 3 Global Satisfaction Questions From the Patient Perception Migraine Questionaire-Revised (PPMQ-R) at Month 12

"The PPMQ-R is a fully validated 32-item questionnaire assessing participant satisfaction with acute migraine medication and includes 3 questions that assess satisfaction with respect to efficacy, side effects, and overall satisfaction (i.e., How effective the medication is overall, side effects of the medication, overall satisfaction with the medication). Each item is rated on a 7-point scale ranging from very satisfied (1) to very dissatisfied (7)." (NCT00488514)
Timeframe: End of Study/Month 12

,,
Interventionparticipants (Number)
Overall Efficacy, Very SatisfiedOverall Efficacy, SatisfiedOverall Efficacy, Somewhat SatisfiedOverall Efficacy, NeutralOverall Efficacy, Somewhat DissatisfiedOverall Efficacy, DissatisfiedOverall Efficacy, Very DissatisfiedSide Effects, Very SatisfiedSide Effects, SatisfiedSide Effects, Somewhat SatisfiedSide Effects, NeutralSide Effects, Somewhat DissatisfiedSide Effects, DissatisfiedSide Effects, Very DissatisfiedOverall Treatment Satisfaction, Very SatisfiedOverall Treatment Satisfaction, SatisfiedOverall Treatment Satisfaction, Somewhat SatisfiedOverall Treatment Satisfaction, NeutralTreatment Satisfaction, Somewhat DissatisfiedOverall Treatment Satisfaction, DissatisfiedOverall Treatment Satisfaction, Very Dissatisfied
12 Month Completer Population48461231004240146332514762301
6 Month Completer Population5963165100495121107426461105301
ITT Population66752072105561241112537176136311

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Number of Migraine Attacks Rated With the Indicated Pain Severity

The number of migraine attacks treated at the mild, moderate, or severe intensity were counted. Pain severity was assessed by participants based on a scale of 0-3: 0=no pain, 1=mild, 2= moderate, 3=severe. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventiontreated migraine attacks (Number)
No painMildModerateSevere
12 Month Completer Population0100925351686
6 Month Completer Population0137335552385
ITT Population0161941322759

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Mean Weight for All Study Participants at the Indicated Time Points

(NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

,,
Interventionkilograms (Mean)
Screening, n=285, 337, 622Month 3, n=270, 306, 576Month 6, n=223, 248, 471Month 9, n=197, 220, 417Month 12, n=178, 198, 376
12-14 Years57.0258.0160.2061.2462.92
12-17 Years62.1962.5863.5764.2365.25
15-17 Years66.5766.6166.6166.9067.35

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Mean Height for All Study Participants at the Indicated Time Points

(NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

,,
Interventioncentimeters (Mean)
Screening, n=285, 337, 622Month 3, n=271, 308, 579Month 6, n=224, 249, 473Month 9, n=198, 221, 419Month 12, n=178, 198, 376
12-14 Years160.2161.3162.6163.8165.3
12-17 Years163.9164.5165.1165.8166.7
15-17 Years167.0167.3167.3167.6167.9

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Mean Heart Rate for All Study Participants at the Indicated Time Points

A sitting heart rate was measured once for each participant at each visit. (NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

,,
Interventionbeats per minute (Mean)
Screening, n=284, 336, 620Month 3, n=266, 305, 571Month 6, n=221, 247, 468Month 9, n=198, 221, 419Month 12, n=178, 198, 376
12-14 Years75.876.977.576.976.8
12-17 Years7.4376.276.476.175.7
15-17 Years73.075.675.475.474.7

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Mean Change From Baseline in the Migraine Specific Quality of Life (QOL) Questionnaire for Adolescents (MSQ-A) Score at Months 3, 6, 9, and 12

The MSQ-A consists of 14 items measuring how migraines affect QOL: Role Function (RF)-Restrictive (items 1-7) and RF-Preventative (items 8-11), examining the degree to which performance of daily activities is limited or interrupted, respectively, by migraine; RF-Emotional (items 12-14, examining frustration/helplessness due to migraine). Dimensions (dim.) are scored independently. The 14 items are reverse coded onto a 1-6 scale; dim. are then created by summing specific item scores and transforming raw total score onto a 0-100 scale. For each dim., higher scores indicate better health status. (NCT00488514)
Timeframe: Baseline and Months 3, 6, 9, and 12

,
Interventionpoints on a scale (Mean)
Role restrictive, Month 3, n=457, 160Role restrictive, Month 6, n=366, 160Role restrictive, Month 9, n=315, 148Role restrictive, Month 12, n=291, 153Role preventative, Month 3, n=457, 160Role preventative, Month 6, n=366, 160Role preventative, Month 9, n=315, 148Role preventative, Month 12, n=291, 153Role emotional , Month 3, n=457, 160Role emotional, Month 6, n=366, 160Role emotional, Month 9, n=315, 148Role emotional, Month 12, n=291, 153
12 Month Completer Population9.08.29.011.59.68.38.28.47.97.29.07.1
ITT Population10.110.513.715.77.96.89.49.87.16.610.511.4

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Mean Body Mass Index (BMI) for All Study Participants at the Indicated Time Points

BMI = (Weight in kilograms)/(height in centimeters/100)^2 (NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

,,
Interventionkilograms per meters squared (Mean)
Screening, n=285, 337, 622Month 3, n=270, 306, 576Month 6, n=223, 248, 471Month 9, n= 197, 220, 417Month 12, n=178, 198, 376
12-14 Years22.0122.0922.5422.5822.81
12-17 Years22.9722.9523.1723.2023.33
15-17 Years23.7723.7123.7423.7423.79

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Mean Blood Pressure for All Study Participants at the Indicated Time Points

At each visit, a participant's blood pressure was taken three times. The average of the three readings was then calculated for each participant at each visit (mean blood pressure). The outcome measure represents the average of the mean blood pressure of all of the study participants. SBP, systolic blood pressure; DBP, diastolic blood pressure. (NCT00488514)
Timeframe: Screening and Months 3, 6, 9, and 12

,,
Interventionmillimeters of mercury (mmHg) (Mean)
SBP, Screening, n=285, 337, 622SBP, Month 3, n=270, 308, 578SBP, Month 6, n=224, 249, 473SBP, Month 9, n=198, 221, 419SBP, Month 12, n=178, 198, 376DBP, Screening, n=285, 337, 622DBP, Month 3, n=270, 308, 578DBP, Month 6, n=224, 249, 473DBP, Month 9, n=198, 221, 419DBP, Month 12, n=178, 198, 376
12-14 Years107.4107.2109.2109.6111.066.265.766.165.666.6
12-17 Years108.9109.3110.6111.2111.567.767.167.367.368.3
15-17 Years110.2111.1112.0112.7112.169.068.468.468.969.9

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Average Number of Headaches, Migraine Attacks, and Treated Migraine Attacks Per Month

The average number of headaches (non-migraine and migraine attacks), migraine attacks, and treated migraine attacks per month was calculated for each participant, based on their time in the study. The outcome measure represents the average of the mean number of the headaches, migraine headaches, and treated migraines per month of the study participants in the 6 Month, 12 Month, and ITT Populations. A treated attack is defined as a migraine treated with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionevents (Mean)
HeadachesMigrainesTreated migraine attacks
12 Month Completer Population3.92.62.4
6 Month Completer Population3.32.21.9
ITT Population3.01.81.5

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Number of Treated Migraine Attacks With Photophobia, Phonophobia, Nausea, Neck Pain, Sinus Pain, and Vomiting

The number of treated migraine attacks with the reported migraine-associated symptoms of photophobia, phonophobia, nausea, neck pain, sinus pain, and vomiting were counted. Photophobia: sensitivity to light; phonophobia: sensitivity to sound. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventiontreated migraine attacks (Number)
PhotophobiaPhonophobiaNauseaNeck painSinus painVomiting
12 Month Completer Population40643725217321721424375
6 Month Completer Population56085221312030502052555
ITT Population65286063369035402428682

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Number of Treated Migraine Attacks

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, or prohibited medications, was summarized. Rescue medication was additional medication taken within 24 hours of Combination Tablet. Prohibited medications: ergot, opioid, barbiturate, 5-HT1 agonist, long-acting non-steroidal anti-inflammatory drug (NSAID), short-acting NSAID-containing compound, analgesic, anti-emetic, monoamine oxidase inhibitors, St. John's Wort, angiotensin-converting enzyme inhibitor, Angiotensin II receptor blockers, anti-coagulant, anti-platelet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Interventiontreated migraine attacks (Number)
All MigrainesMigraines Without Rescue MedicationMigraines Without Rescue or Prohibited Medication
85 mg Sumatriptan/500 mg Naproxen Sodium851777917657

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Number of Treated Attacks Classified as Migraine Pain-Free Within 4 Hours That Were Also Pain Free Within 2 Hours of Dosing With the Combination Tablet

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Interventiontreated migraine attacks (Number)
All MigrainesMigraines Without Rescue MedicationMigraines Without Rescue or Prohibited Medication
85 mg Sumatriptan/500 mg Naproxen Sodium362335983596

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Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 4 Hours of Dosing With a Combination Tablet

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 4 hours after the participant was dosed with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Interventiontreated migraine attacks (Number)
All MigrainesMigraines Without Rescue MedicationMigraines Without Rescue or Prohibited Medication
85 mg Sumatriptan/500 mg Naproxen Sodium507650205017

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Number of Treated Attacks Classified as Migraine Pain-Free (MPF) Within 24 Hours of Dosing With the Combination Tablet

The number of migraine attacks eligible for evaluation, not associated with rescue medication use, and not associated with either rescue medication use or prohibited medications were counted. Migraine Pain Free was defined as the migraine attack ending <= 24 hours after the participant was dosed with the Combination Tablet. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Interventiontreated migraine attacks (Number)
All MigrainesMigraines Without Rescue MedicationMigraines Without Rescue or Prohibited Medication
85 mg Sumatriptan/500 mg Naproxen Sodium640061426052

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Number of Total Migraines Headaches and Migraines Treated With the Combination Tablet

The total number of migraine headaches and the number of migraine headaches treated with the Combination Tablet during the study were summarized. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionmigraine attacks (Number)
Total MigrainesTreated Migraines
12 Month Completer Population58515234
6 Month Completer Population82907318
ITT Population99378517

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Number of Tablets Taken, After Which at Least One Adverse Event Occurred Within 3 or 5 Days of Dosing With That Combination Tablet

The number of events that occurred within 3 or 5 days of dosing with the combination tablet on a per tablet basis. A total of 8413, 5876, and 9989 tablets were taken by the 6 Month Completer, 12 Month Completer, and the Safety Populations, respectively. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventiontablets (Number)
Number of tablets with an AE within 3 daysNumber of tablets with an AE within 5 days
12 Month Completer Population667706
6 Month Completer Population917970
Safety Population11161178

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Number of Participants With Hematocrit and Hemoglobin Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit

"A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: hemoglobin, 12-17 years old (y): 120-160 grams (g)/L; hematocrit (expressed as the percentage of blood occupied by red blood cells), 12-17 y: 0.360-0.490." (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionparticipants (Number)
Hemoglobin, normal to high, n=318,176, 546Hemoglobin, normal to low, n=318,176, 546Hematocrit, normal to high, n=318,176, 546Hematocrit, normal to low, n=318,176, 546
12 Month Completer Population06010
6 Month Completer Population610217
Safety Population920429

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Number of Participants With Any Adverse Event That Occurred Within 3 or 5 Days of the First Dose of the Combination Tablet

The number of participants with adverse events that occurred within 3 or 5 days of their first dose of the Combination Tablet was recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionparticipants (Number)
Within 3 daysWithin 5 days
12 Month Completer Population3535
6 Month Completer Population6666
Safety Population128130

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Number of Participants With Any Adverse Event Categorized Over Time

The number of participants with an adverse event occurring in either the first six months of the study (months 0-6; <=194 days) or the second six months of the study (months 6-12; =>194 days until end of study) was recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionparticipants (Number)
First six months of studySecond six months of study
12 Month Completer Population11285
6 Month Completer Population208143
Safety Population348191

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Number of Participants With Any Adverse Event Categorized by Severity

The number of participants with at least one mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities), moderate (an event that is sufficiently discomforting to interfere with normal everyday activities), or severe adverse event (an event that prevents normal everyday activities) was recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionparticipants (Number)
MildModerateSevere
12 Month Completer Population437214
6 Month Completer Population7414024
Safety Population12722044

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Number of Participants With Any Adverse Event Categorized by Participant Race

"The number of participants with any adverse event was categorized by race. The category Other captures : American Indian or Alaskan Native; Asian, Native Hawaiian, or Other Pacific Islander; African American/African Heritage and Asian; African American/African Heritage and White; and American Indian or Alaskan Native and White." (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Interventionparticipants (Number)
CaucasianAfrican AmericanOther
85 mg Sumatriptan/500 mg Naproxen Sodium3443514

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Number of Participants With Any Adverse Event Categorized by Participant Gender

The number of participants with adverse events by gender is recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

Interventionparticipants (Number)
FemaleMale
85 mg Sumatriptan/500 mg Naproxen Sodium238155

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Number of Participants With Any Adverse Event Categorized by Participant Age

The number of participants with any adverse event by age group (12-14 and 15-17 years) is recorded. (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionparticipants (Number)
Ages 12-14Ages 15-17
12 Month Completer Population5773
6 Month Completer Population104135
Safety Population175218

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Number of Participants With Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine, Potassium, and Blood Urea Nitrogen (BUN) Values of Interest That Shifted From Normal at Baseline to Abnormal at the End of Study Visit

"A shift from normal to low, for example, indicates that a value was normal at baseline but low at the end of study visit. The value ranges were determined by the central laboratory. Reference ranges: ALT, 12 years old (y): 0-45 Units/liter (U/L), >13 y: 0-48 U/L; AST, 12 y: 0-42 U/L, >13 y 0-42 U/L; creatinine, 12 y: 27-88 micromoles/liter (UMOL/L), >13 y: 44-124 UMOL/L; potassium, 12 y: 3.5-5.5 millimoles/liter (MMOL/L), >13 y: 3.5-5.3 MMOL/L; BUN, 12-17 y: 24-101 milligrams (mg)/deciliter (dL)." (NCT00488514)
Timeframe: Baseline through End of Study (up to Month 12)

,,
Interventionparticipants (Number)
ALT, normal to high, n=330, 179, 565ALT, normal to low, n=330, 179, 565AST, normal to high, n=329, 179, 562AST, normal to low, n=329, 179, 562Creatinine, normal to high, n=330, 179, 565Creatinine, normal to low, n=330, 179, 565Potassium, normal to high, n=329, 179, 562Potassium, normal to low, n=329, 179, 562BUN, normal to high, n=330, 179, 565BUN, normal to low, n=330, 179, 565
12 Month Completer Population1010010200
6 Month Completer Population2010021302
Safety Population3030024619

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The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment

The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period (NCT00527787)
Timeframe: 6 months

InterventionParticipants (Number)
PN400 (VIMOVO)1
Naproxen11

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Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales

"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47" (NCT00527787)
Timeframe: baseline to 6 Months

InterventionUnits on SODA Subscale (Least Squares Mean)
PN400 (VIMOVO)-6
Naproxen0

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Number of Participants With Gastric Ulcer Confirmed by Endoscopy

The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached. (NCT00527787)
Timeframe: 6 months

InterventionParticipants (Number)
PN400 (VIMOVO)9
Naproxen50

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Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit

"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck." (NCT00527787)
Timeframe: 6 months

Interventionparticipants (Number)
PN400 (VIMOVO)140
Naproxen65

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The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers

The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort (NCT00527787)
Timeframe: 6 months

InterventionParticipants (Number)
PN400 (VIMOVO)114
Naproxen149

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The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer

The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period (NCT00527787)
Timeframe: 6 Months

InterventionParticipants (Number)
PN400 (VIMOVO)7
Naproxen26

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Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales

Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35. (NCT00527787)
Timeframe: baseline to 6 Months

InterventionUnits on SODA Subscale (Least Squares Mean)
PN400 (VIMOVO)-2.2
Naproxen-0.5

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Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire

"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group." (NCT00527787)
Timeframe: change from baseline at 6 Months

InterventionParticipants (Number)
PN400 (VIMOVO)93
Naproxen52

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Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales

Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23 (NCT00527787)
Timeframe: baseline to 6 Months

InterventionUnits on SODA Subscale (Least Squares Mean)
PN400 (VIMOVO)3.4
Naproxen0.9

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Number of Subjects Monitored for Long-term Safety of PN 400

Incidence of adverse events and monitoring vital signs, clinical laboratory values, physical exams, ECG. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared. Treatment-emergent AEs were also summarized by maximum severity, by quartile of number of doses taken and by treatment window. (NCT00527904)
Timeframe: 12 months

Interventionparticipants (Number)
PN400 (VIMOVO)239

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Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. (NCT00584870)
Timeframe: Baseline, Week 1, 2, 4, 8, 12

,,
Interventionunits on a scale (Mean)
Change at Week 1Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen-2.18-2.40-2.57-2.79-2.88
Placebo-1.34-1.92-2.23-2.48-2.68
Tanezumab-2.41-2.25-3.39-3.74-3.45

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Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12

The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions (Q) 1-4 assessed the magnitude of pain (Q1 for worst pain, Q2 for least pain, Q3 for average pain, Q4 for pain right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. Question 5 consisted of 7 sub-items (A to G; general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain score, each ranging from 0 (no pain) to 10 (pain as bad as you can imagine), with lower scores indicating less pain. (NCT00584870)
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12

,,
Interventionunits on a scale (Mean)
Baseline: Worst PainBaseline: Average PainChange at Week 1: Worst PainChange at Week 1: Average PainChange at Week 2: Worst PainChange at Week 2: Average PainChange at Week 4: Worst PainChange at Week 4: Average PainChange at Week 6: Worst PainChange at Week 6: Average PainChange at Week 8: Worst PainChange at Week 8: Average PainChange at Week 12: Worst PainChange at Week 12: Average Pain
Naproxen7.026.18-2.40-2.02-2.67-2.20-2.57-2.37-2.87-2.45-2.89-2.44-2.93-2.45
Placebo7.296.54-1.88-1.46-2.28-2.22-2.47-2.61-2.29-2.65-2.90-2.80-2.83-2.88
Tanezumab6.895.99-2.54-2.09-2.21-1.97-3.54-2.99-3.67-3.29-3.85-3.26-3.40-3.00

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Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. (NCT00584870)
Timeframe: Baseline, Week 6

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 6
Naproxen6.65-2.69
Placebo6.67-2.16
Tanezumab6.48-3.58

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Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Time to achieve >=30% or >=50% sustained reduction from baseline (i.e. reduction from baseline in daily average LBPI score that was maintained for a total of 4 consecutive days) was summarized using the Kaplan-Meier estimates of the median time to 30% and 50% response. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. (NCT00584870)
Timeframe: Randomization to Last Study Visit (up to 16 weeks)

,,
Interventiondays (Median)
Time to >=30% reductionTime to >=50% reduction
Naproxen741
Placebo1765
Tanezumab818

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Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with cumulative reduction (as percent) (greater than 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in Average LBPI score from Baseline at Week 6 were reported, participants (%) are reported more than once in categories specified. (NCT00584870)
Timeframe: Week 6

,,
InterventionParticipants (Count of Participants)
Greater than 0% reductionGreater than or equal to (>=)10% reduction>=20% reduction>=30% reduction>=40% reduction>=50% reduction>=60% reduction>=70% reduction>=80% reduction>=90% reduction100% reduction
Naproxen7772645041302616953
Placebo3429211312875310
Tanezumab797568655850402516106

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Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12

The mBPI-sf was a self-administered questionnaire used to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1 to 4 assessed the magnitude of pain (worst, least, average, right now) on an 11-point NRS ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 consisted of 7 sub-items (general activity [GA], mood, walking ability [WA], normal work [NW], relations with other people, sleep, enjoyment of life) which measured the level of interference of pain on daily functions. Each sub-item was assessed on an 11-point NRS ranging from 0 (did not interfere) to 10 (completely interfere). The response from 7 sub-items of question 5 were averaged to obtain pain interference composite score (CS), range: 0 to 10 (higher score=more interference). (NCT00584870)
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12

,,
Interventionunits on a scale (Mean)
Baseline: CSBaseline: GABaseline: WABaseline: NWBaseline: SleepChange at Week 1: CSChange at Week 1: GAChange at Week 1: WAChange at Week 1: NWChange at Week 1: SleepChange at Week 2: CSChange at Week 2: GAChange at Week 2: WAChange at Week 2: NWChange at Week 2: SleepChange at Week 4: CSChange at Week 4: GAChange at Week 4: WAChange at Week 4: NWChange at Week 4: SleepChange at Week 6: CSChange at Week 6: GAChange at Week 6: WAChange at Week 6: NWChange at Week 6: SleepChange at Week 8: CSChange at Week 8: GAChange at Week 8: WAChange at Week 8: NWChange at Week 8: SleepChange at Week 12: CSChange at Week 12: GAChange at Week 12: WAChange at Week 12: NWChange at Week 12: Sleep
Naproxen5.435.835.255.895.75-2.51-2.51-2.04-2.40-2.87-2.82-2.94-2.48-3.02-2.88-2.52-2.58-2.09-2.63-2.63-2.84-2.97-2.48-2.95-2.99-3.01-3.14-2.62-3.24-3.51-2.84-3.01-2.54-2.97-3.33
Placebo5.295.495.155.806.20-2.07-1.88-2.17-2.22-2.27-2.70-2.58-2.64-2.92-3.19-2.72-2.36-2.81-2.81-3.08-2.76-2.68-2.39-2.87-3.03-3.04-2.93-2.87-3.33-3.33-2.74-2.92-2.04-3.17-3.08
Tanezumab4.815.554.465.155.69-2.52-3.10-2.35-2.75-2.73-2.17-2.61-1.87-2.45-2.41-3.13-3.62-2.87-3.55-3.54-3.25-3.65-3.11-3.55-3.92-3.19-3.72-3.05-3.62-3.47-3.08-3.45-2.78-3.36-3.58

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Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Number of participants with >=30% and >=50% reduction from Baseline in daily average LBPI score were reported. (NCT00584870)
Timeframe: Weeks 1, 2, 4, 6, 8, 12

,,
InterventionParticipants (Count of Participants)
Week 1: >=30% reductionWeek 1: >=50% reductionWeek 2: >=30% reductionWeek 2: >=50% reductionWeek 4: >=30% reductionWeek 4: >=50% reductionWeek 6: >=30% reductionWeek 6: >=50% reductionWeek 8: >=30% reductionWeek 8: >=50% reductionWeek 12: >=30% reductionWeek 12: >=50% reduction
Naproxen452648315028503051334530
Placebo8514716101381892012
Tanezumab462842286243655066495943

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Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain) with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants with >=30% or >=50% reduction from baseline in daily average LBPI score that was maintained for a minimum duration of 4 consecutive days were reported. (NCT00584870)
Timeframe: Week 12

,,
InterventionParticipants (Count of Participants)
>=30% reduction>=50% reduction
Naproxen6050
Placebo2620
Tanezumab7162

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Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Participants were classified as responders if average LBPI score was 2 or less, and as non-responders if average LBPI score was greater than (>) 2. Participants with average LBPI score of 2 or less were reported. (NCT00584870)
Timeframe: Week 1, 2, 4, 6, 8, 12

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 4Week 6Week 8Week 12
Naproxen131919212521
Placebo246586
Tanezumab182027333226

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Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12

"Patient's global assessment of low back pain scale assessed participants overall impression of disease activity. Participants answered: Considering all the ways your low back pain affects you, how are you doing today? Participants responded using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). Participants who reported a change of -4, -3, -2, -1, 0, 1, 2, 3, 4 from Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) score at specified weeks were presented." (NCT00584870)
Timeframe: Week 1, 2, 4, 6, 8, 12

,,
InterventionParticipants (Count of Participants)
Week 1: Change= -4Week 1: Change= -3Week 1: Change= -2Week 1: Change= -1Week 1: Change= 0Week 1: Change= 1Week 1: Change= 2Week 1: Change= 3Week 1: Change= 4Week 2: Change= -4Week 2: Change= -3Week 2: Change= -2Week 2: Change= -1Week 2: Change= 0Week 2: Change= 1Week 2: Change= 2Week 2: Change= 3Week 2: Change= 4Week 4: Change= -4Week 4: Change= -3Week 4: Change= -2Week 4: Change= -1Week 4: Change= 0Week 4: Change= 1Week 4: Change= 2Week 4: Change= 3Week 4: Change= 4Week 6: Change= -4Week 6: Change= -3Week 6: Change= -2Week 6: Change= -1Week 6: Change= 0Week 6: Change= 1Week 6: Change= 2Week 6: Change= 3Week 6: Change= 4Week 8: Change= -4Week 8: Change= -3Week 8: Change= -2Week 8: Change= -1Week 8: Change= 0Week 8: Change= 1Week 8: Change= 2Week 8: Change= 3Week 8: Change= 4Week 12: Change= -4Week 12: Change= -3Week 12: Change= -2Week 12: Change= -1Week 12: Change= 0Week 12: Change= 1Week 12: Change= 2Week 12: Change= 3Week 12: Change= 4
Naproxen0218332641001417302361001218322042000722182071000517251941000615211411000
Placebo0161417300004517820000561573000035121010000261444000042971100
Tanezumab112423252100121626246100102230140000222520151000022323111000111422201000

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Number of Participants With Chronic Low Back Pain (CLBP) Response

Participants were considered as CLBP responders if they had achieved a reduction of >=30% in daily average LBPI score from baseline, an increase of >=30% in patient's global assessment of low back pain (disease activity) from baseline, and no worsening (increase) in RMDQ total score from baseline at specified week. Daily average low back pain assessed on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Patient's global assessment of low back pain assessed using a 5-point Likert scale with a score of 1 being the best (very good) and a score of 5 being the worst (very poor). RMDQ: low back pain-specific, participant administered questionnaire consisted of 24 statements and participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. Total RMDQ score was calculated as sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability. (NCT00584870)
Timeframe: Weeks 1, 2, 4, 6, 8, 12

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 4Week 6Week 8Week 12
Naproxen303431393630
Placebo691191412
Tanezumab333251504838

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Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication

"Participants answered: In all ways, how would you rate your overall response to the study medication today? Participants responded using a 4-point Likert scale where 1 = poor, 2 = fair, 3 = good and 4 = excellent. Higher score indicated better overall response to the treatment." (NCT00584870)
Timeframe: Week 1, 2, 4, 6, 8, 12

,,
InterventionParticipants (Count of Participants)
Week 1: PoorWeek 1: FairWeek 1: GoodWeek 1: ExcellentWeek 2: PoorWeek 2: FairWeek 2: GoodWeek 2: ExcellentWeek 4: PoorWeek 4: FairWeek 4: GoodWeek 4: ExcellentWeek 6: PoorWeek 6: FairWeek 6: GoodWeek 6: ExcellentWeek 8: PoorWeek 8: FairWeek 8: GoodWeek 8: ExcellentWeek 12: PoorWeek 12: FairWeek 12: GoodWeek 12: Excellent
Naproxen13223217161434181516272111232318924191915171817
Placebo121114361115481013585144671346657
Tanezumab7162926101731194530291102232182032692123

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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Week 16) that were absent before treatment or that worsened relative to pretreatment state. (NCT00584870)
Timeframe: Baseline up to 28 days after last dose of study treatment (up to Week 16)

,,
InterventionParticipants (Count of Participants)
AEsSAEs
Naproxen542
Placebo270
Tanezumab500

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Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score

Total duration of response was defined as the total number of days with >=30% or >=50% reduction from baseline in the daily average LBPI score. Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. (NCT00584870)
Timeframe: Week 1 up to Week 12

,,
Interventiondays (Least Squares Mean)
Total duration for >=30% reductionTotal duration for >=50% reduction
Naproxen38.8127.58
Placebo33.1322.08
Tanezumab43.9133.21

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Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), with lower scores indicating less pain. Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. Change from baseline was calculated as the average of each specified week interval (Week 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12) values minus the baseline value. (NCT00584870)
Timeframe: Baseline, Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, 5 to 12

,,
Interventionunits on a scale (Mean)
Change over Weeks 1 to 4Change over Weeks 1 to 8Change over Weeks 1 to 12Change over Weeks 5 to 8Change over Weeks 5 to 12
Naproxen-2.35-2.47-2.52-2.66-2.68
Placebo-1.83-1.97-2.06-2.38-2.46
Tanezumab-2.59-2.86-2.92-3.56-3.48

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Number of Participants Who Discontinued the Study Due to Lack of Efficacy

(NCT00584870)
Timeframe: Baseline up to Week 12

InterventionParticipants (Count of Participants)
Tanezumab7
Naproxen14
Placebo8

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Time to Discontinuation Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. Median was not estimable if the percentage of participants who discontinued due to lack of efficacy was below 50%. (NCT00584870)
Timeframe: Baseline up to Week 12

Interventiondays (Median)
TanezumabNA
NaproxenNA
PlaceboNA

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Number of Participants With Anti-Drug Antibody (ADA)

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). (NCT00584870)
Timeframe: Baseline up to Week 12

InterventionParticipants (Count of Participants)
Tanezumab0

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Amount of Rescue Medication Taken

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen (in mg) in each particular week was summarized. (NCT00584870)
Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

,,
Interventionmg (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Naproxen2039.82327.62208.32475.02318.82227.31873.32212.32319.42513.92166.72253.5
Placebo2451.22225.02565.82434.22444.42573.52393.91924.21406.31534.51375.01722.2
Tanezumab2545.53221.62703.72220.82073.32062.51854.22134.31772.71851.61992.21828.1

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Duration of Rescue Medication Use

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. The number of days of rescue medication use during the particular week were summarized. (NCT00584870)
Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

,,
Interventiondays (Median)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Naproxen110.5211111100
Placebo11.52211110001
Tanezumab222100.5000.500.50

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Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12

Roland-Morris Disability Questionnaire: low back pain-specific, participant administered questionnaire that assessed how well participants with low back pain were able to function with regard to daily activities. The questionnaire consisted of 24 statements and the participants were instructed to put a mark next to each appropriate statement if it described their pain on the day of assessment. The number of statements marked were added up by the clinician. Total RMDQ score was calculated as the sum of number of statements checked. Total possible score ranged from 0 to 24, with higher scores indicated greater disability. (NCT00584870)
Timeframe: Baseline, Week 1, 2, 4, 6, 8, 12

,,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 4Change at Week 6Change at Week 8Change at Week 12
Naproxen12.36-3.69-4.04-4.00-4.69-5.17-5.10
Placebo13.68-3.76-4.08-4.31-4.55-5.60-4.67
Tanezumab12.33-5.21-5.17-7.24-7.88-7.93-7.12

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Number of Participants Who Used Rescue Medications

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 2000 mg per day up to 3 days per week could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized. (NCT00584870)
Timeframe: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Naproxen504942494642383938413133
Placebo292724282120171912141316
Tanezumab616554403736343133303230

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Total Patient Controlled Analgesic (PCA) Hydromorphone Consumption Over the 24 Hours Post-surgery

Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg. (NCT00601458)
Timeframe: First 24 hours following surgery

Interventionmilligrams (Geometric Mean)
Pregabalin 300 mg2.94
Naproxen Sodium 550 mg2.07
Placebo5.96

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Time to First Request of PCA Hydromorphone

Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg. (NCT00601458)
Timeframe: First 24 hours following surgery

InterventionHours (Median)
Pregabalin 300 mg7.3
Naproxen Sodium 550 mg9.1
Placebo5.8

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Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.

Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days. (NCT00602420)
Timeframe: From baseline through day 5

Intervention(Pain Scale Score)*Days (Mean)
Naproxen6.04
Placebo7.71

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Part A: Pain Intensity Score (NPRS Score) for Overall Pain, for Lower Extremity Pain, and for Evoked (by Treadmill Walking) Lower Extremity Pain

"Overall Pain Intensity (OPI), Now Lower Extremity Pain Intensity (LEPI), and Evoked Lower Extremity Pain Intensity (ELEPI) were assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours (hr) after dosing. At 15 minutes before dosing, during Period 1 only, participants were also asked to assess their average LEPI over the last 24 hours as a baseline measurement. Now LEPI was assessed at 15 minutes before dosing for baseline and at the 1-, 2-, 3-, 4-, 5-, 6-, and 12-hour time points. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then (after the Now LEPI assessment) he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI." (NCT00626275)
Timeframe: Baseline up to 12 hours post dose

,,
Interventionunits on a scale (Mean)
ELEPI, BaselineELEPI, 2 hr Post DoseELEPI, 4 hr Post DoseELEPI, 6 hr Post DoseLEPI, BaselineLEPI, 1 hr Post DoseLEPI, 2 hr Post DoseLEPI, 3 hr Post DoseLEPI, 4 hr Post DoseLEPI, 5 hr Post DoseLEPI, 6 hr Post DoseLEPI, 12 hr Post DoseOPI, BaselineOPI, 6 hr Post DoseOPI, 12 hr Post Dose
ADL5859 - 200 mg (Part A)6.3635.455.004.955.685.344.914.734.704.734.774.765.774.914.89
Naproxen - 500 mg (Part A)6.204.714.244.005.785.004.334.043.933.983.893.786.134.043.73
Placebo (Part A)6.365.475.164.936.185.385.244.674.764.714.495.116.204.805.03

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Part A: Pain Intensity Difference Between Baseline and the Value at Each Scheduled Time Point for Overall Pain

Overall Pain Intensity (OPI) was assessed by the participant using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. OPI was assessed at 15 minutes before dosing for baseline and at 6 and 12 hours after dosing. Difference = predose (baseline) OPI score - OPI score 6 and 12 hours post dose. (NCT00626275)
Timeframe: Baseline, 6 and 12 hours post dose

,,
Interventionunits on a scale (Mean)
Change From Baseline 6 Hours Post DoseChange From Baseline 12 Hours Post Dose
ADL5859 - 200mg (Part A)0.860.92
Naproxen - 500 mg (Part A)2.093.73
Placebo (Part A)1.401.16

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Part B: Percentage of Participants Using Rescue Medication

The percentage of participants who took at least 1 dose of rescue medication during 2-week treatment period of Part B is presented. (NCT00626275)
Timeframe: Baseline through Week 2

InterventionPercentage of Participants (Number)
Placebo (Part B)45.8
ADL5859 - 100 mg (Part B)40.0

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Part B: Mean Daily Average Overall Pain Intensity Scores Over Week 1, Over Week 2, and Over a 2-Week Period

During Part B, participants returned to the clinic for 2 additional visits at approximately weekly intervals for assessments of Overall Pain Index (OPI). Participants rated their OPI on an 11-point Numeric Pain Rating Scale (NPRS) with 0 indicating No Pain and 10 indicating Worst possible pain (NCT00626275)
Timeframe: Baseline through Week 1, Week 1 through Week 2, and Baseline through Week 2

,
Interventionunits on a scale (Mean)
Change from Baseline to Week 1Change from Week 1 to Week 2Change from Baseline to Week 2
ADL5859 - 100 mg (Part B)4.264.064.21
Placebo (Part B)4.264.334.33

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Part A: Mean Peak Difference in ELEPI According to the NPRS Scale

Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point NPRS. Participants were asked to rate their lower extremity pain on an 11 point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Peak ELEPID was defined as the maximum of ELEPIDs recorded at 2, 4, and 6 hours post dose. Difference = predose (baseline) NPRS score - peak NPRS score up to 6 hours post dose. (NCT00626275)
Timeframe: Baseline, Up to 6 hours post dose

Interventionunits on a scale (Mean)
Placebo (Part A)1.82
Naproxen - 500 mg (Part A)2.49
ADL5859 - 200 mg (Part A)1.84

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Part A: Average Difference Between Baseline and Postdose Evoked Lower Extremity Pain Over the 4 Hours After Dosing

Evoked Lower Extremity Pain Intensity (ELEPI) was assessed using the 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. Approximately 1 hour before dosing and approximately 45 minutes before the 2-, 4-, and 6-hour time points, the participant rested for 45 minutes, then he or she started a treadmill walk at 15 minutes before dosing for baseline and at the 2-, 4-, and 6-hour time points, and then assessed ELEPI. Difference = predose (baseline) ELEPI score - ELEPI score 4 hours post dose. (NCT00626275)
Timeframe: Baseline, 4 hours post dose

Interventionunits on a scale (Mean)
Placebo (Part A)1.04
Naproxen - 500 mg (Part A)1.72
ADL5859 - 200 mg (Part A)1.14

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Part A: Average Difference Between Baseline and Post Dose Evoked (by Treadmill Walking) Lower-Extremity Pain Intensity Scores (AELEPID) Over the 6 Hours After Dosing

"Approximately 1 hour before baseline and again approximately 45 minutes before the 2-, 4-, and 6-hour time points, participants rested for 45 minutes, then they started the treadmill walk at 15 minutes before baseline and at the 2-, 4-, and 6-hour time points. After the treadmill walk, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. The average difference between baseline and 6 hours post dose evoked lower-extremity pain intensity scores (AELEPID-6) is presented for each treatment group. Difference = predose (baseline) NPRS score - NPRS score 6 hours post dose.~Least square (LS) means and standard errors (SE) were calculated from an analysis-of-covariance (ANCOVA) model with fixed effects for sequence, treatment, period, predose evoked lower extremity pain intensity as a covariate, and a random effect for participant nested within sequence." (NCT00626275)
Timeframe: Baseline through 6 hours post dose

Interventionunits on a scale (Least Squares Mean)
Placebo (Part A)1.12
Naproxen - 500 mg (Part A)1.95
ADL5859 - 200 mg (Part A)1.20

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"Part B: The Mean of Daily Average Now Lower Extremity Pain Intensity (LEPI) Score During the 2-Week Period"

"Participants assessed their Now LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11-point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken.~LS means and SE were calculated from an analysis-of-covariance model with effect for treatment and baseline Now LEPI (before dosing for Treatment Period 1 of Part A) as a covariate. Participants with no postbaseline assessments were excluded from the baseline summary." (NCT00626275)
Timeframe: Baseline through 2 Weeks

Interventionunits on a scale (Least Squares Mean)
Placebo (Part B)4.23
ADL5859 - 100 mg (Part B)4.21

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Part B: Mean Daily LEPI Scores for Weeks 1 and 2

"Participants assessed their Now LEPI 3 times each day (morning, midday, and evening at approximately 10 AM, 2 PM, and 8 PM) and before taking any rescue medication. At each time point, participants were asked to rate their lower extremity pain on an 11 point Numeric Pain Rating Scale (NPRS), with 0 indicating No Pain and 10 indicating Worst Possible Pain. If a scheduled pain assessment was taken within 4 hours of rescue medication, the observed pain score was replaced by the pain score obtained right before the rescue medication was taken." (NCT00626275)
Timeframe: Baseline through Week 1 and Week 1 through Week 2

,
Interventionunits on a scale (Mean)
Over Week 1Over Week 2
ADL5859 - 100 mg (Part B)4.174.13
Placebo (Part B)4.284.23

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Part B: Participants' Global Evaluation of Study Medication

"For Part B, each participant's global evaluation (overall impression) of study medication was obtained at each weekly visit. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from excellent to poor. Participant counts per score were reported at Week 1 (Day 7) and Week 2 (Day 14)." (NCT00626275)
Timeframe: Up to Week 1 and Week 2

,
InterventionParticipants (Number)
Week 1 - Excellent (n=23, 20)Week 1 - Very good (n=23, 20)Week 1 - Good (n=23, 20)Week 1 - Fair (n=23, 20)Week 1 - Poor (n=23, 20)Week 2 - Excellent (n=24, 19)Week 2 - Very Good (n=24, 19)Week 2 - Good (n=24, 19)Week 2 - Fair (n=24, 19)Week 2 - Poor (n=24, 19)
ADL5859 - 100 mg (Part B)3744244353
Placebo (Part B)2566425755

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Part B: Mean Daily Average LEPI Scores Over the Last 24 Hours at Week 1 and Week 2

Each day during Part B, participants rated their Lower Extremity Pain Intensity over the last 24 hours on an 11-point NPRS, with 0 indicating No Pain and 10 indicating Worst Possible Pain (NCT00626275)
Timeframe: Week 1 and Week 2

,
Interventionunits on a scale (Mean)
Week 1Week 2
ADL5859 - 100 mg (Part B)4.264.25
Placebo (Part B)4.664.57

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Part A: Percentage of Participants in Each Treatment Group Achieving a 25%, 50%, or 75% Reduction From Baseline in Evoked Lower Extremity Pain Intensity Scores

Percentage was measured by identifying the number of participants who achieved the desired percentage Reduction From Baseline in ELEPI Score at either 2, 4, and 6 hours post dose and was divided the by the number of total participants in the given group and then multiplied by 100 to equate to a percentage. (NCT00626275)
Timeframe: Up to 2, 4, and 6 hours post dosing

,,
InterventionPercentage of Participants (Number)
2 Hours Post-Dose, 25% Reduction4 Hours Post-Dose, 25% Reduction6 Hours Post-Dose, 25% Reduction2 Hours Post-Dose, 50% Reduction4 Hours Post-Dose, 50% Reduction6 Hours Post-Dose, 50% Reduction2 Hours Post-Dose, 75% Reduction4 Hours Post-Dose, 75% Reduction6 Hours Post-Dose, 75% Reduction
ADL5859 - 200 mg (Part A)22.736.445.54.515.918.206.86.8
Naproxen - 500 mg (Part A)46.760.064.424.431.133.36.78.911.1
Placebo (Part A)28.940.042.24.422.226.7006.7

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Part A: Participant's Global Evaluation of Study Medication

"For each treatment period during Part A, each participant's global evaluation (overall impression) of study medication was obtained 6 hours after dosing. Scores were recorded on the Case Report Form (CRF) on a 5 point scale ranging from excellent to poor. Participant counts per score were reported once in Part A." (NCT00626275)
Timeframe: 6 hours post dose during Treatment Periods 1, 2, and 3 of Part A

,,
Interventionparticipants (Number)
ExcellentVery GoodGoodFairPoor
ADL5859 - 200 mg (Part A)1812158
Naproxen - 500 mg (Part A)6121593
Placebo (Part A)1915128

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Time to Max Deterioration in VAMS Stimulated

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

InterventionMinutes (Mean)
AZD1940143
Placebo163
Naproxen213

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Maximum Deterioration in VAMS Sedated

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionmm (Mean)
AZD194033
Placebo21
Naproxen24

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Time to Max Deterioration in VAMS Sedated

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionminutes (Mean)
AZD1940190
Placebo221
Naproxen227

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Time to Max Deterioration in VAMS High

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionminutes (Mean)
AZD1940115
Placebo191
Naproxen193

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Time to Max Deterioration in VAMS Down

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionminutes (Mean)
AZD1940227
Placebo262
Naproxen349

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Time to Max Deterioration in VAMS Anxious

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionminutes (Mean)
AZD1940126
Placebo167
Naproxen212

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Pain at Rescue Medication

"Pain at time of first rescue medication (VAS 0-100mm). Only patients taking rescue are included in analysis. Observed case.~Pain at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)." (NCT00659490)
Timeframe: At time of first rescue medication taken before 8 hours after end of surgery

Interventionmm (Mean)
AZD194073
Placebo70
Naproxen47

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Pain at Jaw Movement AUC0-8h

Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-8h (from end of surgery) of VAS pain at jaw movement (0-100mm, 0 = no pain - 100 = worst pain imaginable) (NCT00659490)
Timeframe: 0-8h from end of surgery to 8 hours post surgery

Interventionmm*h (Mean)
AZD1940342
Placebo337
Naproxen135

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Pain at Jaw Movement AUC0-4h

Area under the Visual Analogue Scale (VAS, 0-100 mm) of jaw movement versus time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Area under the curve 0-4h (from end of surgery) of VAS pain at jaw movement (0-100mm0 = no pain - 100 = worst pain imaginable). (NCT00659490)
Timeframe: 0-4h after end of surgery to 4 hours post surgery

Interventionmm*h (Mean)
AZD1940142
Placebo138
Naproxen53

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Pain at Jaw Movement at Time of First Rescue Medication

"Pain at jaw movement at time of first rescue medication (VAS 0-100mm). Observed case.~Pain at jaw movement at time of first rescue medication (VAS 0-100mm, 0 = no pain - 100 = worst pain imaginable)." (NCT00659490)
Timeframe: At time of first rescue medication (before 8 hours after end on surgery)

Interventionmm (Mean)
AZD194067
Placebo65
Naproxen53

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Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)

Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-4h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. (NCT00659490)
Timeframe: 0-4h (from end of surgery to 4 hours post surgery)

Interventionmm*h (Mean)
AZD1940145
Placebo143
Naproxen54

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Pain Area Under the Curve 0-8h (AUC0-8h)

Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. (NCT00659490)
Timeframe: 0-8 h(from end of surgery to 8 hours post surgery)

Interventionmm*h (Mean)
AZD1940355
Placebo356
Naproxen129

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Number of Patients Requesting Rescue Medication

Observed case. (NCT00659490)
Timeframe: End of surgery up to 8hours following surgery

InterventionParticipants (Number)
AZD194037
Placebo43
Naproxen7

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Mean Pain Based on a VAS Scale

Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) versus time curve divided by time.Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable) (NCT00659490)
Timeframe: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)

Interventionmm (Mean)
AZD194031
Placebo29
Naproxen13

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Mean Pain at Jaw Movement

Calculated as the area under the Visual Analogue Pain Scale (0-100 mm) of jaw movement versus time curve divided by time. Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable. Mean Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable ). (NCT00659490)
Timeframe: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)

Interventionmm (Mean)
AZD194032
Placebo28
Naproxen14

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Maximum Pain Based on VAS Scale

"Maximum pain recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum pain VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)" (NCT00659490)
Timeframe: From end of surgery to 8h or time first intake of rescue medication (whichever came first)

Interventionmm (Mean)
AZD194066
Placebo65
Naproxen33

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Maximum Pain at Jaw Movement

"Maximum pain at jaw movement recorded on a Visual Analogue Scale, VAS (0-100mm). Observed case.~Maximum Pain at jaw movement VAS (0-100mm, 0 = no pain - 100 = worst pain imaginable)" (NCT00659490)
Timeframe: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)

Interventionmm (Mean)
AZD194063
Placebo63
Naproxen33

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Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionmm (Mean)
AZD194022
Placebo26
Naproxen28

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Maximum Deterioration in VAMS Anxious

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionmm (Mean)
AZD194020
Placebo15
Naproxen13

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Maximum Deterioration in VAMS Down

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionmm (Mean)
AZD194020
Placebo25
Naproxen24

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Maximum Deterioration in VAMS High

Subjective qualities of mood in the subject are measured by letting the subject rate their subjective experiences of a number of adjectives using a series of visual analogue scales. Subjects are required to rate on 100-mm lines the extent to which they felt each adjective at a given time point from 'not at all' on the left end of the scale to 'extremely' on the right end of the scale. The VAMS commonly used in studies with cannabinoids consists of six adjectives and visual analogue scales: stimulated; high (as in drug high, elated); anxious; sedated; down (as in moody, depressed) and hungry. (NCT00659490)
Timeframe: Between dosing and 12h post-dose

Interventionmm (Mean)
AZD194030
Placebo12
Naproxen20

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Time to First Intake of Rescue Medication.

(NCT00659490)
Timeframe: From end of surgery to 8 hours following surgery

InterventionHours (Mean)
AZD19403.8
Placebo3.7
Naproxen4.7

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VAS Pain Intensity at Rescue Intake

0 = 'No pain' 100 ='Worst pain imaginable' (NCT00672646)
Timeframe: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product

Interventionunits on a VAS scale (Median)
AZD138661.0
Naproxen69.0
Placebo70.5

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VAS Pain on Jaw Movement at Rescue Intake

0 = 'No pain' 100 ='Worst pain imaginable' (NCT00672646)
Timeframe: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product

InterventionUnits on a VAS scale (Median)
AZD138665.0
Naproxen81.0
Placebo73.5

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Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)

0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately. (NCT00672646)
Timeframe: Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.

,,
Interventionunits on VAS scale (Median)
Just before dosing15 minutes30 minutes45 minutes1 hour1 hour 15 minutes1 hour 30 minutes1 hour 45 minutes2 hours2 hours 30 minutes3 hours4 hours5 hours6 hours7 hours8 hours
AZD1386503330.528.531.535.54150.550.530.524.51419141514
Naproxen48546161524638352826211810764
Placebo46.54547515553445037232014.514131411.5

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Time to First Perceptible Pain Relief

First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours. (NCT00672646)
Timeframe: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

Interventionhour (Median)
AZD13860.3
Naproxen0.8
Placebo1.3

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Time to First Meaningful Pain Relief

First meaningful pain relief is the time when the participant's pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours. (NCT00672646)
Timeframe: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

Interventionhour (Median)
AZD13868.0
Naproxen4.2
Placebo8.0

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Sum of Pain Intensity Difference in Percent (SPID%)

Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI). (NCT00672646)
Timeframe: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

Interventionpercentage of pain intensity change * h (Median)
AZD138635.5
Naproxen171.8
Placebo-7.5

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Summed Pain Intensity Difference (SPID)

Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values over 0-24 and 16-24 hours, respectively. (NCT00720057)
Timeframe: 0 to 24 hours post dose

,
Interventionunits on a scale (Mean)
SPID 0-24SPID16-24
Naproxen Sodium ER (BAYH6689)25.98.8
Placebo-3.1-1.0

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Time to Onset of Effect

"Time to onset of effect is defined as the time to meaningful pain relief, provided that the subjects experienced both perceptible and meaningful pain relief. Perceptible pain relief was defined as when the subject first began to feel any pain-relieving effect from the investigational product. Meaningful pain relief was defined as when the subject felt the degree of pain relief was meaningful to them." (NCT00720057)
Timeframe: from postdose to onset of first perceptible and meaningful pain relief for up to 6 hours

Interventionhours (Median)
Naproxen Sodium ER (BAYH6689)1.37
Placebo4.13

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Time to First Use of Rescue Medication

Time to first use of rescue medication was estimated using the Kaplan-Meier method and analyzed by a Log rank test stratified by trial site and baseline pain intensity (PI). The outcome measure is time to first use of rescue medication. The criteria are if adequate pain relief is not achieved, then subjects are permitted to take rescue medication. (NCT00720057)
Timeframe: postdose to first use of rescue medication

Interventionhours (Median)
Naproxen Sodium ER (BAYH6689)22.27
Placebo1.90

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Global Assessment of the Investigational Product as a Pain Reliever

Categorical Scale: Poor (0), Fair (1), Good (2), Very Good (3), Excellent (4). (NCT00720057)
Timeframe: at 24 hours postdose or immediately before first use of rescue medication

Interventionunits on a scale (Mean)
Naproxen Sodium ER (BAYH6689)2.3
Placebo0.6

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Total Pain Relief (TOTPAR)

Pain relief categorical rating scale - no relief (0), a little relief (1), some relief (2), a lot of relief (3), or complete relief (4) was used for all pain relief assessments postdose. Time weighted total pain relief (TOTPAR) was 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. (NCT00720057)
Timeframe: 0-24 hours post dose

,
Interventionunits on a scale (Mean)
TOTPAR 0 - 6 hoursTOTPAR 0 - 12 hoursTOTPAR 0 - 16 hoursTOTPAR 0 - 24 hoursTOTPAR 16 - 24 hours
Naproxen Sodium ER (BAYH6689)12.725.534.151.317.2
Placebo3.15.57.210.93.7

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Summed Pain Intensity Difference at Specific Time Intervals

Categorical pain intensity scale - no pain (0), mild pain (1), moderate pain (2), or severe pain (3) was used for all pain intensity assessments postdose. Time-weighted Sum Pain Intensity Difference (SPID) was calculated by multiplying the Pain Intensity Difference (PID) score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values for 0-6, 0-12, 0-16 hour intervals, respectively. (NCT00720057)
Timeframe: 0-16 hours post dose

,
Interventionunits on a scale (Mean)
SPID 0 - 6SIPD 0 - 12SIPD 0 - 16
Naproxen Sodium ER (BAYH6689)6.212.717.1
Placebo-0.4-1.4-2.0

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Average Daily Dose

(NCT00751400)
Timeframe: 1 month

Interventionmg (Mean)
Naproxen Sodium ER (BAYH6689)722

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Number of Total Dosing Occasions Per Subject

Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. (NCT00751400)
Timeframe: 1 month

Interventiondosing occasions (Mean)
Naproxen Sodium ER (BAYH6689)5.5

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Dosing Occasions With One and More Than One Tablet Taken

Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. (NCT00751400)
Timeframe: 1 month

Interventiondosing occasions (Number)
only one tablet takenmore than one tablet taken
Naproxen Sodium ER (BAYH6689)250066

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Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days

This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing (NCT00751400)
Timeframe: 1 month

Interventionparticipants (Number)
not more than 10 consecutive daysmore than 10 consecutive days
Naproxen Sodium ER (BAYH6689)376109

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Number of Dosing Occasions Per Subject That Exceeded 660 mg

Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. (NCT00751400)
Timeframe: 1 month

Interventiondosing occasions (Mean)
Naproxen Sodium ER (BAYH6689)0.6

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Number of Subjects With and Without More Than 660 mg at Least Once

This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion). (NCT00751400)
Timeframe: 1 month

Interventionparticipants (Number)
not more than 660 mgmore than 660 mg at least once
Naproxen Sodium ER (BAYH6689)344123

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Number of Subjects With and Without More Than One Tablet Taken Per Dose

(NCT00751400)
Timeframe: 1 month

Interventionparticipants (Number)
never took more than one tablet per dosetook more than one tablet per dose
Naproxen Sodium ER (BAYH6689)44027

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Use Days With One or More Misuse Occasions

Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data. (NCT00751400)
Timeframe: 1 month

Interventiondays (Number)
use days without a misuse occasionuse days with a misuse occasion
Naproxen Sodium ER (BAYH6689)2112294

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Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes,rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over a 20 minute high-paced treadmill walk at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 1 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 1

Interventionunits on a scale (Least Squares Mean)
Placebo0.150
Naproxen-0.508
Ultracet-1.00

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Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over a 20 minute high-paced treadmill walk, at 5 hrs post-dose. A high-paced walk is the highest pace that can be walked safely for at least 5 minutes that is at a 10-30% higher rate than a self-paced walk. The difference between the TWA (0-20 minutes) PI determined at baseline, and the TWA (0-20 minutes) PI of the high-paced walk on Day 3 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 3

Interventionunits on a scale (Least Squares Mean)
Placebo-0.234
Naproxen-1.11
Ultracet-1.30

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Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following the first treatment on Day 1, PI was similarly measured over 20 minute self-paced walks at 2, 4, and 6 hrs post-dose . The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the three TWA (0-20 minutes)PI from the self-paced walks on Day 1 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 1

Interventionunits on a scale (Least Squares Mean)
Placebo-0.438
Naproxen-0.956
Ultracet-1.47

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Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3

Baseline measurements of participant-specific knee PI were gathered pre-dose on Day 1 from the briskest possible self-pace constant walks on a treadmill over the course of a 20 minute interval. Over this interval PI readings were taken at time points 0,3,6,9,12,15,18 and 20 minutes, rated on an 11-point numeric rating scale (NRS), with 0: No Pain - 10: Worst Pain You Can Imagine. Following a single treatment on Day 3, PI was similarly measured over 20 minute self paced walks at 4 and 6 hrs post-dose. The difference between the TWA (0-20 minutes) PI determined at baseline, and the average of the two TWA (0-20 minutes) PI from the self-paced walks on Day 3 is reported as units on a scale. (NCT00772967)
Timeframe: Baseline and Day 3

Interventionunits on a scale (Least Squares Mean)
Placebo-0.927
Naproxen-1.54
Ultracet-1.73

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Number of Bleeding and Spotting Days

The median number of bleeding and spotting days reported at 12 weeks. (NCT00789802)
Timeframe: 12 weeks

InterventionDAYS (Median)
Oral Naproxen27.5
Oral Placebo32
Transdermal Estradiol44

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Continuation Rates of the LNG-IUC at the End of the 12 Week Between the 3 Study Groups

To compare continuation rates of the LNG-IUC at the end of the 12 week between the 3 study groups (NCT00789802)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Oral Naproxen34
Oral Placebo35
Transdermal Estradiol37

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Number of Bleeding Days Observed in Women With a LNG-IUC Treated With Naproxen, Estradiol and Placebo.

Median number of bleeding days observed in women with a LNG-IUC treated with naproxen, estradiol and placebo at 16 weeks. (NCT00789802)
Timeframe: 16 weeks

Interventiondays (Median)
Transdermal Estradiol35
Oral Naproxen53
Oral Placebo38

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Western Ontario and McMaster Universities Arthritis (WOMAC) Composite Score: Percent Change From Baseline to Week 12.

"WOMAC is a composite of subscales: pain - 5 questions, stiffness - 2 questions, physical function - 17 questions. Subject answers each question as none=0, slight=1, moderate=2, very=3 and extreme=4 of pain, stiffness and difficulty of function. Scores for each subscale are summed, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Individual question scores are then summed to form a raw score ranging from 0 (worst) to 96 (best). Raw scores are normalized by multiplying each score by 100/96. This produces a reported WOMAC Score of between 0 (worst) to 100 (best).The higher the score of the units on the scale, the better the outcome.~For each individual subject, the percent change from baseline to Week 12 in the WOMAC composite score is calculated as 100 x (week 12 minus baseline)/baseline. The higher the percent change, the better the outcome. The percent changes from baseline to Week 12 are then compared between Flavocoxid and Naproxen." (NCT00790985)
Timeframe: As measured at Baseline and Week 12

Interventionpercentage of change (Mean)
Naproxen85.75
Flavocoxid 500 mg69.97

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Time to the First Day With an Average Diastolic Blood Pressure Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure

Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. (NCT00792636)
Timeframe: Baseline to End of Study (6-month study duration)

Interventiondays (Median)
Sumatriptan/Naproxen51
Sumatriptan50.5
Naproxen26

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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, With <6, 6-10, >=6, 10-14, and >14 Doses Per Month

The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 10-14 and the >14 doses/month groups due to lack of convergence. (NCT00792636)
Timeframe: Baseline and Month 6

InterventionmmHg (Least Squares Mean)
Systolic,<6 doses per monthSystolic, 6-10 doses per monthSystolic, >=6 doses per monthDiastolic,<6 doses per monthDiastolic, 6-10 doses per monthDiastolic, >=6 doses per month
Sumatriptan/Naproxen-1.6-4.6-4.3-1.0-3.7-3.5

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Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Sumatriptan

The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). (NCT00792636)
Timeframe: Baseline and Month 6

,
InterventionmmHg (Mean)
Systolic, Baseline, n=120, 109Systolic, Month 6, n=48, 42Systolic, Change from Baseline, n=47, 41Diastolic, Baseline, n=120, 109Diastolic, Month 6, n=48, 42Diastolic, Change from Baseline, n=47, 41
Sumatriptan110.8109.4-2.875.773.9-1.6
Sumatriptan/Naproxen111.7107.1-2.976.073.0-2.1

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Time to the First Day With an Average Systolic Blood Pressure Increase of >=5 mmHg From the Baseline Systolic Blood Pressure

Kaplan-Meier curves for the distribution of time to the first day with an average diastolic BP increase of >=3 mmHg from the baseline diastolic BP during each calendar day were calculated and graphed for each treatment group. Only valid BP measurements were included and were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. (NCT00792636)
Timeframe: Baseline to End of Study (6-month study duration)

Interventiondays (Median)
Sumatriptan/Naproxen42.5
Sumatriptan32.5
Naproxen18.5

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Number of Participants Withdrawn From the Study Due to Blood Pressure Changes

The number of participants withdrawn from the study due to protocol-defined blood pressure changes were summarized for each treatment group. Defined blood pressure changes included (1) monthly average BP ≥140 mmHg systolic or >=90 mmHg diastolic and confirmed in clinic, (2) monthly average BP increase of >=30 mmHg systolic or >=20 mmHg from in-clinic screening and confirmed in clinic, and (3) systolic >=140 mmHg or diastolic >=90 mmHg on consecutive clinic visits >=2 weeks apart. (NCT00792636)
Timeframe: Baseline to End of Study (6-month study duration)

Interventionparticipants (Number)
Sumatriptan/Naproxen1
Sumatriptan0
Naproxen0

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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan and Naproxen

The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). (NCT00792636)
Timeframe: Baseline and Month 6

,
InterventionmmHg (Mean)
Systolic, Baseline, n=109, 115Systolic, Month 6, n=42, 37Systolic, Change from Baseline, n=41, 36Diastolic, Baseline, n=109, 115Diastolic, Month 6, n=42, 37Diastolic, Change from Baseline, n=41, 36
Naproxen110.1108.2-1.874.774.3-0.6
Sumatriptan110.8109.4-2.875.773.9-1.6

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Number of Participants With an Increase of >=5 mmHg From the Baseline Systolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements

The number of participants with an increase of >=5 mmHg from the baseline systolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. (NCT00792636)
Timeframe: Baseline to End of Study (6-month study duration)

Interventionparticipants (Number)
Sumatriptan/Naproxen53
Sumatriptan57
Naproxen63

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Number of Participants With an Increase of >=3 mmHg From the Baseline Diastolic Blood Pressure for the Average of Any Given Two-day Consecutive Collection of Blood Pressure Measurements

The number of participants with an increase of >=3 mmHg from the baseline diastolic blood pressure for the average of any given two-day consecutive collection of valid blood pressure measurements during the study were summarized. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. (NCT00792636)
Timeframe: Baseline to End of Study (6-month study duration)

Interventionparticipants (Number)
Sumatriptan/Naproxen72
Sumatriptan65
Naproxen77

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Number of Participants With a Consecutive 2-day Average Systolic Blood Pressure of >=140 mmHg During the Study

The number of participants with any valid two-day consecutive average systolic blood pressure measurement of >=140 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. (NCT00792636)
Timeframe: Baseline to End of Study (6-month study duration)

Interventionparticipants (Number)
Sumatriptan/Naproxen2
Sumatriptan2
Naproxen3

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Number of Participants With a Consecutive 2-day Average Diastolic Blood Pressure of >=90 mmHg

The number of participants with any valid two-day consecutive average diastolic blood pressure measurement of >=90 mmHg was calculated. Valid blood pressure measurements were defined as follows: must be taken at least 24 hours following last dose of investigational product used to treat an individual migraine, must be taken no later than 96 hours after last dose of investigational product used to treat an individual migraine, must be taken prior to the onset of a subsequent individual migraine. (NCT00792636)
Timeframe: Baseline to End of Study (6-month study duration)

Interventionparticipants (Number)
Sumatriptan/Naproxen10
Sumatriptan11
Naproxen11

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Treatment Difference in Systolic and Diastolic Blood Pressure Mean Changes From Baseline at 6 Months Between Sumatriptan/Naproxen and Naproxen

The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). (NCT00792636)
Timeframe: Baseline and Month 6

,
InterventionmmHg (Mean)
Systolic, Baseline, n=120, 115Systolic, Month 6, n=48, 37Systolic, Change from Baseline, n=47, 36Diastolic, Baseline, n=120, 115Diastolic, Month 6, n=48, 37Diastolic, Change from Baseline, n=47, 36
Naproxen110.1108.2-1.874.774.3-0.6
Sumatriptan/Naproxen111.7107.1-2.976.073.0-2.1

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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen

The calculation of baseline and post-baseline mean blood pressure (BP) (either systolic or diastolic) for each month (30-day period) is the average of all valid Telephonic Self-Measured Blood Pressure (T-SMBP) measurements. T-SMBP technology is a method that allows the participant to self-measure BP outside the clinic using a BP monitor and transfer the data from their home to a central server. Change from baseline was calculated as the Month 6 value minus the Baseline value. Least squares mean and confidence intervals were based on mixed model repeated measures analysis (MMRM). (NCT00792636)
Timeframe: Baseline and Month 6

Interventionmillimeters of mercury (mmHg) (Mean)
Systolic, Baseline, n=120Systolic, Month 6, n=48Systolic, Change from Baseline, n=47Diastolic, Baseline, n=120Diastolic, Month 6, n=48Diastolic, Change from Baseline, n=47
Sumatriptan/Naproxen111.7107.1-2.976.073.0-2.1

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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating With <30 Total Doses, 30-60 Total Doses, >=30, 60-90 Total Doses, and >90 Total Doses

The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis. Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals (CIs) were based on MMRM analysis. LSMeans and CIs were not calculated for the 60-90 and the >90 total dose groups due to lack of convergence. (NCT00792636)
Timeframe: Baseline and Month 6

InterventionmmHg (Least Squares Mean)
Systolic, <30 total dosesSystolic, 30-60 total dosesSystolic, >=30 total dosesDiastolic, <30 total dosesDiastolic, 30-60 total dosesDiastolic, >=30 total doses
Sumatriptan/Naproxen-1.2-3.4-3.7-0.6-3.3-3.6

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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <1.3 Times Per Migraine, 1.3-1.7 Times Per Migraine, and >1.7 Times Per Migraine

The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. (NCT00792636)
Timeframe: Baseline and Month 6

InterventionmmHg (Least Squares Mean)
Systolic, <1.3 doses per migraineSystolic, 1.3-1.7 doses per migraineSystolic, >1.7 doses per migraineDiastolic, <1.3 doses per migraineDiastolic, 1.3-1.7 doses per migrainesDiastolic, >1.7 doses per migraine
Sumatriptan/Naproxen-0.3-2.7-3.8-0.4-0.9-3.2

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Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Month 6 for Sumatriptan/Naproxen for the ITT Subpopulation of Participants Treating, on Average, <4 Migraines, 4-6 Migraines, >=4 Migraines, and >6 Migraines Per Month

The calculation of baseline and post-baseline mean BP (either systolic or diastolic) for each month (30-day period) is the average of all valid T-SMBP measurements. The subgrouping of the ITT population was created and examined to demonstrate the robustness of the results for the primary analysis.Descriptive statistics were calculated for baseline, month 6, and change from baseline to month 6. LSMeans and corresponding confidence intervals were based on MMRM analysis. LSMeans and corresponding confidence intervals were not calculated for > 6 migraines/month group due to lack of convergence. (NCT00792636)
Timeframe: Baseline and Month 6

InterventionmmHg (Least Squares Mean)
Systolic, <4 migraines per monthSystolic, 4-6 migraines per monthSystolic, >=4 migraines per monthDiastolic, <4 migraines per monthDiastolic, 4-6 migraines per monthDiastolic, >=4 migraines per month
Sumatriptan/Naproxen-2.0-3.3-3.7-1.2-5.3-4.1

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Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit

Ambulatory BP measurements were obtained from 24 participants (in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. (NCT00807846)
Timeframe: 6 weeks/Final Visit

Interventionbpm (beats per minute) (Mean)
Celecoxib2.5
Naproxen3.7

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Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.

Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'. (NCT00807846)
Timeframe: 6 weeks

Interventionmm (Least Squares Mean)
Celecoxib-12.990
Naproxen-12.588

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Change From Baseline in DBP at Week 4.

Value at 4 weeks minus value at baseline. (NCT00807846)
Timeframe: 4 weeks

InterventionmmHg (Least Squares Mean)
Celecoxib-0.628
Naproxen-0.848

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Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.

The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor. (NCT00807846)
Timeframe: 6 weeks

Interventionmm (millimeter) (Least Squares Mean)
Celecoxib-10.581
Naproxen-13.614

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Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.

Value at 2 weeks minus value at baseline. (NCT00807846)
Timeframe: 2 weeks

InterventionmmHg (Least Squares Mean)
Celecoxib-1.346
Naproxen-0.139

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Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit

Value at 6 weeks minus value at baseline. (NCT00807846)
Timeframe: 6 Weeks/Final Visit

InterventionmmHg (millimeter of mercury) (Least Squares Mean)
Celecoxib0.366
Naproxen-0.734

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Change From Baseline to Week 2 in SBP.

Value at 2 weeks minus value at baseline. (NCT00807846)
Timeframe: 2 weeks

InterventionmmHg (Least Squares Mean)
Celecoxib-0.202
Naproxen-1.290

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Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.

The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor. (NCT00807846)
Timeframe: Week 6/Final Visit

InterventionParticipants (Number)
Celecoxib47
Naproxen54

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Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.

Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'. (NCT00807846)
Timeframe: Week 6/Final Visit

InterventionParticipants (Number)
Celecoxib33
Naproxen45

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Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)

A summary of ABPM 24-hour averages for SBP and DBP are presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002). (NCT00807846)
Timeframe: 6 weeks/Final Visit

,
InterventionmmHg (Mean)
SBPDBP
Celecoxib2.40.9
Naproxen1.90.3

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Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit

Ambulatory BP measurements were obtained from 24 participants(in addition to the BP measurements obtained by the cuff technique) participating in the exploratory 24-hour ABPM sub-study. BP was monitored by a 24 hour Ambulatory BP device provided by a central vendor. (NCT00807846)
Timeframe: 6 weeks/Final Visit

,
InterventionmmHg (Mean)
SBPDBP
Celecoxib2.40.9
Naproxen-1.7-1.1

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Change From Baseline in SBP at Week 4.

Value at 4 weeks minus value at baseline. (NCT00807846)
Timeframe: 4 weeks

InterventionmmHg (Least Squares Mean)
Celecoxib-0.170
Naproxen-2.007

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Change From Baseline in DBP at Week 6/Final Visit

Value at 6 weeks/Final Visit minus value at baseline. (NCT00807846)
Timeframe: 6 weeks

InterventionmmHg (Least Squares Mean)
Celecoxib-0.535
Naproxen-0.356

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Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)

A summary of ABPM 24-hour averages for heart rate is presented in this Outcome Measure. One of the participant in the Naproxen ABPM Arm had clinically implausible high BP values at Baseline. Due to the low number of participants in each Arm (12 and 11) these values had a significant impact on the mean baseline values for the Naproxen Arm. As a result, an additional sensitivity analysis was conducted, excluding this participant (Participant ID 10031002). (NCT00807846)
Timeframe: 6 weeks/Final Visit

Interventionbpm (Mean)
Celecoxib2.5
Naproxen3.3

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 52 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy53
Placebo Injection in Combination With Physical Therapy76
Control Group: Wait-and-see Treatment63

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 6 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy44
Placebo Injection in Combination With Physical Therapy16
Control Group: Wait-and-see Treatment17

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy43
Placebo Injection in Combination With Physical Therapy35
Control Group: Wait-and-see Treatment36

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy37
Placebo Injection in Combination With Physical Therapy32
Control Group: Wait-and-see Treatment34

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 26 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy82
Placebo Injection in Combination With Physical Therapy76
Control Group: Wait-and-see Treatment74

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer . Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 6 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy58
Placebo Injection in Combination With Physical Therapy50
Control Group: Wait-and-see Treatment57

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy2.78
Placebo Injection in Combination With Physical Therapy4.40
Control Group: Wait-and-see Treatment4.82

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 52 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy1.64
Placebo Injection in Combination With Physical Therapy1.03
Control Group: Wait-and-see Treatment1.40

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 26 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy2.97
Placebo Injection in Combination With Physical Therapy1.83
Control Group: Wait-and-see Treatment2.00

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 6 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy87
Placebo Injection in Combination With Physical Therapy80
Control Group: Wait-and-see Treatment74

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy28
Placebo Injection in Combination With Physical Therapy17
Control Group: Wait-and-see Treatment16

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Affected Function on 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy25
Placebo Injection in Combination With Physical Therapy45
Control Group: Wait-and-see Treatment38

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Pain Free Function Index of Everyday Activities

Pain free function Index ( 0 - 8 ; 0: full function, 8 no function). Does the patient have pain on 8 every-day activities (dressing, eating, washing, household tasks, opening doors, carrying objects, with work, at sports). Recording a 0 on a complaint listed signifies full function, recording a 1 signifies no function. Thus the more activities with no function the higher score and the higher impairment. (NCT00826462)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Corticosteroid Injection in Combination With Physical Therapy3.42
Placebo Injection in Combination With Physical Therapy3.62
Control Group: Wait-and-see Treatment3.37

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Affected Function on a 100 mm VAS-scale as Recorded by the Study Doctors

To what extent is the use of the elbow affected registered on 100 mm VAS-scale. 0 mm represents use not affected. 100 mm signifies maximum affected function. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy16
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment10

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Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 12 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy83
Placebo Injection in Combination With Physical Therapy88
Control Group: Wait-and-see Treatment89

[back to top]

Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 26 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy89
Placebo Injection in Combination With Physical Therapy99
Control Group: Wait-and-see Treatment99

[back to top]

Maximum Grip Strength Ratio

Maximum grip strength registered with hand held dynamometer. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain hampers the application of grip force to a larger degree signifying a more severe condition. A ratio approaching 1 signifies a milder complaint where grip strength is not hampered by pain. (NCT00826462)
Timeframe: 52 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy96
Placebo Injection in Combination With Physical Therapy102
Control Group: Wait-and-see Treatment104

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 12 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy22
Placebo Injection in Combination With Physical Therapy12
Control Group: Wait-and-see Treatment17

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 26 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy19
Placebo Injection in Combination With Physical Therapy29
Control Group: Wait-and-see Treatment38

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Pain as Recorded by the Study Doctors on a Visual Analog Scale (VAS Scale)

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy29
Placebo Injection in Combination With Physical Therapy45
Control Group: Wait-and-see Treatment44

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy38
Placebo Injection in Combination With Physical Therapy21
Control Group: Wait-and-see Treatment19

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale (Visual Analog Scale).

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 12 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy41
Placebo Injection in Combination With Physical Therapy33
Control Group: Wait-and-see Treatment33

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 6 weeks

Interventionpercentage of participants (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy3
Control Group: Wait-and-see Treatment8

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Pain as Recorded by the Study Doctors on a 100 mm VAS-scale

Pain in elbow as recorded by the study doctors on a 100 mm VAS-scale (Visual Analog Scale). The scale runs from 0 mm (no pain) to 100 mm (maximum pain), higher scores means worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy19
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment13

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Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 6 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy32
Placebo Injection in Combination With Physical Therapy50
Control Group: Wait-and-see Treatment51

[back to top]

Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 52 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy20
Placebo Injection in Combination With Physical Therapy9
Control Group: Wait-and-see Treatment12

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No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 12 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy24
Control Group: Wait-and-see Treatment22

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No Pain on Three Point Likert Scale on Dorsiflexion of Wrist

"Percentage of patients reporting no pain on dorsiflexion of wrist on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 52 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy60
Control Group: Wait-and-see Treatment50

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Treatment Success - Event Rates in Each Group

Unadjusted event rates of treatment success, defined as participants rating themselves 'much improved' or 'completely recovered' on a six point scale. Percentage with 99% confidence interval. (NCT00826462)
Timeframe: 6 - 52 weeks

,,
Interventionpercentage of participants (Number)
6 weeks12 weeks26 weeks52 weeks
Control Group: Wait-and-see Treatment15486778
Corticosteroid Injection in Combination With Physical Therapy59424275
Placebo Injection in Combination With Physical Therapy24456978

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Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side.Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 52 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy100
Placebo Injection in Combination With Physical Therapy90
Control Group: Wait-and-see Treatment91

[back to top]

Pain-free Grip Strength Ratio

Pain free grip strength registered with hand held dynamometer 30 31. Mean of three measurements as ratio of affected to unaffected side. Strength registered in kg. A ratio closer to zero signifies that pain occurs at the application of a small force signifying a more severe condition. A ratio approaching 1 signifies a milder complaint. (NCT00826462)
Timeframe: 12 weeks

InterventionRatio x 100 (Mean)
Corticosteroid Injection in Combination With Physical Therapy64
Placebo Injection in Combination With Physical Therapy55
Control Group: Wait-and-see Treatment63

[back to top]

No Pain on Three Point Likert Scale on Isometric Extension of Third Finger

"Percentage of patients reporting no pain on isometric extension of third finger on a three-point Likert scale on dorsiflexion of wrist. Scale: No pain - some pain - definite pain." (NCT00826462)
Timeframe: 26 weeks

Interventionpercentage of patients (Number)
Corticosteroid Injection in Combination With Physical Therapy31
Placebo Injection in Combination With Physical Therapy53
Control Group: Wait-and-see Treatment58

[back to top]

Overall Complaint on 100 mm VAS-scale as Recorded by the Study Doctors

Overall complaint registered on VAS-scale as recorded by study doctors. 0 mm represents no overall complaint. 100 mm signifies maximum overall complaint. Higher scores mean a worse outcome. (NCT00826462)
Timeframe: 26 weeks

Interventionmm (Mean)
Corticosteroid Injection in Combination With Physical Therapy36
Placebo Injection in Combination With Physical Therapy19
Control Group: Wait-and-see Treatment18

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Time to Discontinuation Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. (NCT00830063)
Timeframe: Baseline up to Week 16

Interventiondays (Median)
PlaceboNA
Tanezumab 5 mg + PlaceboNA
Tanezumab 10 mg + PlaceboNA
Naproxen + PlaceboNA

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Percentage of Participants Who Used Rescue Medication

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized. (NCT00830063)
Timeframe: Week 2, 4, 8, 12, 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo49.747.040.032.036.0
Placebo62.559.553.542.540.5
Tanezumab 10 mg + Placebo58.638.933.030.525.1
Tanezumab 5 mg + Placebo47.335.335.829.426.9

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Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT00830063)
Timeframe: Day 1 (Baseline) up to Week 24

,,,
InterventionParticipants (Count of Participants)
Adverse EventsSerious Adverse Events
Naproxen + Placebo1045
Placebo998
Tanezumab 10 mg + Placebo1226
Tanezumab 5 mg + Placebo1077

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Number of Participants With Positive Anti-Drug Antibody (ADA) Level

Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: tanezumab 5 mg + placebo and tanezumab 10 mg + placebo. Results with titer value >= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive. (NCT00830063)
Timeframe: Baseline, Week 8, 16, 24

,
InterventionParticipants (Count of Participants)
BaselineWeek 8Week 16Week 24
Tanezumab 10 mg + Placebo1001
Tanezumab 5 mg + Placebo1101

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Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)

"Participants answered: Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today? Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported." (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo25.522.019.518.019.5
Placebo11.09.09.512.513.5
Tanezumab 10 mg + Placebo16.830.028.624.819.8
Tanezumab 5 mg + Placebo17.829.729.231.725.2

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Number of Days Participants Used Rescue Medication

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized. (NCT00830063)
Timeframe: Week 2, 4, 8, 12, 16

,,,
Interventiondays (Median)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo00000
Placebo11100
Tanezumab 10 mg + Placebo10000
Tanezumab 5 mg + Placebo00000

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.02-2.81-2.92-2.72-2.91-2.73
Placebo7.04-1.69-1.81-1.95-2.18-2.07
Tanezumab 10 mg + Placebo7.04-2.98-3.95-4.00-4.05-3.91
Tanezumab 5 mg + Placebo7.17-2.63-3.42-3.57-3.99-3.73

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.02-2.81-2.87-2.60-2.62-2.31
Placebo7.04-1.69-1.76-1.77-1.82-1.72
Tanezumab 10 mg + Placebo7.04-2.98-3.84-3.68-3.46-3.16
Tanezumab 5 mg + Placebo7.17-2.63-3.40-3.42-3.73-3.33

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo6.86-2.66-2.93-2.83-2.95
Placebo6.85-1.92-2.02-2.13-2.31
Tanezumab 10 mg + Placebo6.86-2.80-3.73-3.77-3.79
Tanezumab 5 mg + Placebo6.86-2.44-3.07-3.27-3.61

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo-2.66-2.90-2.70-2.66
Placebo-1.92-1.92-1.96-1.93
Tanezumab 10 mg + Placebo-2.80-3.63-3.50-3.32
Tanezumab 5 mg + Placebo-2.44-3.07-3.18-3.46

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00830063)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Naproxen + Placebo6.86-2.42
Placebo6.85-1.88
Tanezumab 10 mg + Placebo6.86-2.91
Tanezumab 5 mg + Placebo6.86-3.18

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo7.18-3.12-3.32-3.26-3.34
Placebo7.21-2.34-2.53-2.62-2.80
Tanezumab 10 mg + Placebo7.25-2.95-4.14-4.24-4.21
Tanezumab 5 mg + Placebo7.30-2.61-3.58-3.73-4.07

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo-3.12-3.28-3.13-2.98
Placebo-2.34-2.36-2.35-2.24
Tanezumab 10 mg + Placebo-2.95-3.99-3.89-3.65
Tanezumab 5 mg + Placebo-2.61-3.59-3.63-3.89

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. (NCT00830063)
Timeframe: Baseline (Day 1), Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Naproxen + Placebo7.18-2.82
Placebo7.21-2.23
Tanezumab 10 mg + Placebo7.25-3.27
Tanezumab 5 mg + Placebo7.30-3.55

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.04-3.05-3.35-3.23-3.40-3.28
Placebo7.22-2.40-2.58-2.71-2.87-2.84
Tanezumab 10 mg + Placebo7.08-2.96-4.02-4.11-4.01-3.77
Tanezumab 5 mg + Placebo7.16-2.52-3.53-3.65-3.94-3.71

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.04-3.05-3.30-3.05-2.98-2.72
Placebo7.22-2.40-2.36-2.41-2.28-2.26
Tanezumab 10 mg + Placebo7.08-2.96-3.89-3.80-3.50-3.10
Tanezumab 5 mg + Placebo7.16-2.52-3.49-3.52-3.73-3.39

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo8.30-3.24-3.39-3.25-3.06-2.93
Placebo8.24-2.19-2.18-2.15-2.14-2.21
Tanezumab 10 mg + Placebo8.15-3.10-4.18-3.98-3.79-3.38
Tanezumab 5 mg + Placebo8.29-2.86-3.61-3.65-4.01-3.61

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.02-2.86-3.06-2.94-3.06-2.96
Placebo7.03-1.99-2.13-2.23-2.44-2.37
Tanezumab 10 mg + Placebo7.05-2.91-3.94-4.00-4.02-3.82
Tanezumab 5 mg + Placebo7.11-2.56-3.36-3.52-3.89-3.67

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.02-2.86-3.02-2.81-2.75-2.52
Placebo7.03-1.99-2.02-2.03-2.00-1.95
Tanezumab 10 mg + Placebo7.05-2.91-3.82-3.70-3.48-3.12
Tanezumab 5 mg + Placebo7.11-2.56-3.35-3.41-3.69-3.35

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Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)

SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life. (NCT00830063)
Timeframe: Baseline, Week 12, 16

,,,
Interventionunits on a scale (Mean)
Baseline: Domain 1Change at Week 12:Domain 1Change at Week 16:Domain 1Baseline: Domain 2Change at Week 12:Domain 2Change at Week 16:Domain 2Baseline: Domain 3Change at Week 12:Domain 3Change at Week 16:Domain 3Baseline: Domain 4Change at Week 12:Domain 4Change at Week 16:Domain 4Baseline: Domain 5Change at Week 12:Domain 5Change at Week 16:Domain 5Baseline: Domain 6Change at Week 12:Domain 6Change at Week 16:Domain 6Baseline: Domain 7Change at Week 12:Domain 7Change at Week 16:Domain 7Baseline: Domain 8Change at Week 12:Domain 8Change at Week 16:Domain 8Baseline: MCAChange at Week 12: MCAChange at Week 16: MCABaseline: PCAChange at Week 12: PCAChange at Week 16: PCA
Naproxen + Placebo65.164.124.2331.9312.6911.8045.4413.0312.5934.0214.9314.5051.847.196.2267.949.448.8171.544.884.9274.912.562.590.240.110.11-1.860.590.56
Placebo66.034.133.6130.4510.159.8043.6210.7710.0533.7213.6711.5353.094.394.3669.289.057.2970.696.034.9076.062.941.930.310.150.10-1.920.470.45
Tanezumab 10 mg + Placebo67.643.233.4734.5317.4715.4846.5017.5717.2333.7221.0719.1952.326.968.3569.868.488.7972.946.065.5774.483.663.560.250.070.10-1.780.770.73
Tanezumab 5 mg + Placebo67.196.334.7632.6918.4517.1444.2120.0019.0433.6523.0821.1651.0010.299.2068.5311.8212.1371.529.008.9175.803.463.210.260.160.17-1.850.880.80

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Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)

SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life. (NCT00830063)
Timeframe: Baseline, Week 12, 16

,,,
Interventionunits on a scale (Mean)
Baseline: Domain 1Change at Week 12:Domain 1Change at Week 16:Domain 1Baseline: Domain 2Change at Week 12:Domain 2Change at Week 16:Domain 2Baseline: Domain 3Change at Week 12:Domain 3Change at Week 16:Domain 3Baseline: Domain 4Change at Week 12:Domain 4Change at Week 16:Domain 4Baseline: Domain 5Change at Week 12:Domain 5Change at Week 16:Domain 5Baseline: Domain 6Change at Week 12:Domain 6Change at Week 16:Domain 6Baseline: Domain 7Change at Week 12:Domain 7Change at Week 16:Domain 7Baseline: Domain 8Change at Week 12:Domain 8Change at Week 16:Domain 8Baseline: MCAChange at Week 12: MCAChange at Week 16: MCABaseline: PCAChange at Week 12: PCAChange at Week 16: PCA
Naproxen + Placebo65.164.123.6231.9312.6911.0845.4413.0311.6934.0214.9313.1951.847.195.6667.949.448.0071.544.884.6274.912.562.310.240.110.10-1.860.590.51
Placebo66.034.133.4230.4510.158.7443.6210.779.6433.7213.6711.2353.094.393.9869.289.056.9770.696.034.6176.062.941.660.310.150.09-1.920.470.42
Tanezumab 10 mg + Placebo67.643.233.3134.5317.4713.9446.5017.5715.1033.7221.0716.7652.326.967.5269.868.487.4372.946.064.2174.483.662.970.250.070.06-1.780.770.66
Tanezumab 5 mg + Placebo67.196.334.0332.6918.4515.3844.2120.0017.3333.6523.0818.9951.0010.298.8368.5311.8211.6371.529.008.4675.803.463.210.260.160.19-1.850.880.71

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Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities

Criteria for potential clinical concern in ECG parameters are: Criterion 1= maximum QTcB interval (Bazett's correction) in range of 450 millisecond (msec) to less than 480 msec, Criterion 2= maximum QTcB interval in range of 480 msec to less than 500 msec, Criterion 3= maximum QTcB interval >= 500 msec; Criterion 4= maximum QTcF interval (Fridericia's correction) in range of 450 msec to less than 480 msec, Criterion 5= maximum QTcF interval in range of 480 msec to less than 500 msec, Criterion 6= maximum QTcF interval >= 500 msec, Criterion 7= maximum QTcB interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 8= maximum QTcB interval increase >=60 msec, Criterion 9= maximum QTcF interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 10= maximum QTcF interval increase >=60 msec. (NCT00830063)
Timeframe: Day 1 (Baseline) up to Week 24

,,,
InterventionParticipants (Count of Participants)
Criterion 1Criterion 2Criterion 3Criterion 4Criterion 5Criterion 6Criterion 7Criterion 8Criterion 9Criterion 10
Naproxen + Placebo4511920271211
Placebo35811311292132
Tanezumab 10 mg + Placebo38531322283211
Tanezumab 5 mg + Placebo39301630252181

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Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

"Participants answered: Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today? Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition." (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo-0.89-0.89-0.77-0.73
Placebo-0.53-0.52-0.52-0.53
Tanezumab 10 mg + Placebo-0.68-1.07-0.96-0.83
Tanezumab 5 mg + Placebo-0.69-1.02-0.95-0.98

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Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)

"Participants answered: Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today? Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition." (NCT00830063)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Naproxen + Placebo3.44-0.70
Placebo3.41-0.53
Tanezumab 10 mg + Placebo3.39-0.74
Tanezumab 5 mg + Placebo3.41-0.87

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Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24

NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items from both the left and right side, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicate increased impairment. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16, 24

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 24
Naproxen + Placebo1.43-0.20-0.25-0.27-0.25-0.34-0.34
Placebo1.55-0.14-0.02-0.12-0.17-0.11-0.13
Tanezumab 10 mg + Placebo1.140.14-0.16-0.00-0.12-0.21-0.21
Tanezumab 5 mg + Placebo1.75-0.37-0.50-0.51-0.42-0.50-0.51

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Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo6.69-2.39-2.40-2.49-2.67-2.60
Placebo6.43-1.25-1.33-1.45-1.68-1.67
Tanezumab 10 mg + Placebo6.60-2.09-2.96-3.13-3.20-2.96
Tanezumab 5 mg + Placebo6.51-1.84-2.58-2.66-3.03-2.79

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Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo6.70-2.39-2.33-2.42-2.30-2.21
Placebo6.46-1.23-1.34-1.48-1.53-1.44
Tanezumab 10 mg + Placebo6.58-2.08-2.91-2.92-2.79-2.48
Tanezumab 5 mg + Placebo6.51-1.80-2.46-2.52-2.82-2.54

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Amount of Rescue Medication Taken

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized. (NCT00830063)
Timeframe: Week 2, 4, 8, 12, 16

,,,
Interventionmg (Mean)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo2025.132210.001987.501800.001872.50
Placebo3512.503492.503320.002857.502860.00
Tanezumab 10 mg + Placebo2546.801795.571423.651504.931458.13
Tanezumab 5 mg + Placebo2644.281773.631684.081238.811427.86

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Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)

"Participants answered: Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today? Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported." (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo25.522.520.020.522.5
Placebo11.09.010.014.516.0
Tanezumab 10 mg + Placebo16.831.531.529.124.6
Tanezumab 5 mg + Placebo17.829.729.733.727.7

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Number of Participants With Laboratory Test Abnormalities

Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20). (NCT00830063)
Timeframe: Day 1 (Baseline) up to Week 24

InterventionParticipants (Count of Participants)
Placebo146
Tanezumab 5 mg + Placebo155
Tanezumab 10 mg + Placebo139
Naproxen + Placebo162

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Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities

Assessment of the clinical significance of vital sign changes was done per investigator judgment. Changes in vital signs determined to be clinically significant by the investigator were reported as adverse events. (NCT00830063)
Timeframe: Day 1 (Baseline) up to Week 24

InterventionParticipants (Count of Participants)
Placebo2
Tanezumab 5 mg + Placebo0
Tanezumab 10 mg + Placebo2
Naproxen + Placebo3

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Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure. (NCT00830063)
Timeframe: Week 2, 4, 8, 12, 16

,,,
Interventionpercentage of participants (Number)
Week 2: >=30 percent reductionWeek 2: >=50 percent reductionWeek 4: >=30 percent reductionWeek 4: >=50 percent reductionWeek 8: >=30 percent reductionWeek 8: >=50 percent reductionWeek 12: >=30 percent reductionWeek 12: >=50 percent reductionWeek 16: >=30 percent reductionWeek 16: >=50 percent reduction
Naproxen + Placebo60.544.562.548.562.546.058.046.555.541.5
Placebo46.729.647.230.744.731.744.232.742.731.2
Tanezumab 10 mg + Placebo58.441.672.860.970.360.465.857.959.452.0
Tanezumab 5 mg + Placebo52.036.165.852.068.353.069.357.465.852.0

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Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported. (NCT00830063)
Timeframe: Baseline up to Week 16

,,,
Interventionpercentage of participants (Number)
Greater than (>) 0 percent>=10 percent>=20 percent>=30 percent>=40 percent>=50 percent>=60 percent>=70 percent>=80 percent>=90 percent100 percent
Naproxen + Placebo71.568.062.055.550.041.535.526.018.011.04.0
Placebo57.354.350.842.736.731.227.622.114.68.03.0
Tanezumab 10 mg + Placebo69.366.364.459.456.452.047.037.625.217.87.4
Tanezumab 5 mg + Placebo73.371.868.365.860.452.049.539.129.218.88.4

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Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported. (NCT00830063)
Timeframe: Baseline up to Week 16

,,,
Interventionpercentage of participants (Number)
>0 percent>=10 percent>=20 percent>=30 percent>=40 percent>=50 percent>=60 percent>=70 percent>=80 percent>=90 percent100 percent
Naproxen + Placebo91.583.073.065.557.047.541.030.021.513.05.0
Placebo82.475.466.854.345.737.731.724.615.69.03.5
Tanezumab 10 mg + Placebo92.186.182.273.368.361.954.543.628.719.87.9
Tanezumab 5 mg + Placebo87.683.277.773.366.355.953.041.629.719.38.9

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Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)

A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure. (NCT00830063)
Timeframe: Weeks 2, 4, 8, 12, 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo67.069.567.062.561.0
Placebo55.353.350.348.750.3
Tanezumab 10 mg + Placebo69.876.272.866.863.9
Tanezumab 5 mg + Placebo61.972.372.870.866.3

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Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)

A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure. (NCT00830063)
Timeframe: Week 2, 4, 8, 12, 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo67.070.570.069.070.0
Placebo55.356.356.360.861.8
Tanezumab 10 mg + Placebo69.881.281.780.280.2
Tanezumab 5 mg + Placebo61.973.876.777.275.2

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Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure. (NCT00830063)
Timeframe: Week 2, 4, 8, 12, 16

,,,
Interventionpercentage of participants (Number)
Week 2: >=30 percent reductionWeek 2: >=50 percent reductionWeek 4: >=30 percent reductionWeek 4: >=50 percent reductionWeek 8: >=30 percent reductionWeek 8: >=50 percent reductionWeek 12: >=30 percent reductionWeek 12: >=50 percent reductionWeek 16: >=30 percent reductionWeek 16: >=50 percent reduction
Naproxen + Placebo60.544.563.549.565.048.064.551.065.547.5
Placebo46.729.651.332.751.835.256.839.754.337.7
Tanezumab 10 mg + Placebo58.441.676.763.478.265.377.264.973.361.9
Tanezumab 5 mg + Placebo52.036.166.852.071.355.073.859.973.355.9

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain. (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo8.30-3.24-3.44-3.40-3.46-3.48
Placebo8.24-2.19-2.30-2.38-2.61-2.65
Tanezumab 10 mg + Placebo8.15-3.10-4.33-4.36-4.35-4.10
Tanezumab 5 mg + Placebo8.29-2.86-3.65-3.81-4.25-3.99

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Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

"Participants answered: Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today? Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition." (NCT00830063)
Timeframe: Baseline, Week 2, 4, 8, 12

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo3.44-0.89-0.91-0.81-0.82
Placebo3.41-0.53-0.54-0.56-0.63
Tanezumab 10 mg + Placebo3.39-0.68-1.10-1.05-0.98
Tanezumab 5 mg + Placebo3.41-0.69-1.01-0.96-1.01

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Number of Participants Sustained Phonophobia-free From 2-24 Hours

Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication. (NCT00843024)
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=144, 96, 96, 15112-14 years, n=71, 43, 46, 6515-17 years, n=73, 53, 50, 86
Placebo472720
Sumatriptan 10 mg/ Naproxen 60 mg482424
Sumatriptan 30 mg/ Naproxen 180 mg513120
Sumatriptan 85 mg/ Naproxen 500 mg793643

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Number of Participants Sustained Photophobia-free From 2-24 Hours

Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication. (NCT00843024)
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=144, 96, 96, 15112-14 years, n=71, 43, 46, 6515-17 years, n=73, 53, 50, 86
Placebo442519
Sumatriptan 10 mg/ Naproxen 60 mg482127
Sumatriptan 30 mg/ Naproxen 180 mg432122
Sumatriptan 85 mg/ Naproxen 500 mg753540

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Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose

Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive. (NCT00843024)
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=145, 96, 97, 15212-14 years, n=71, 43, 46, 6515-17 years, n=74, 53, 51, 87
Placebo472126
Sumatriptan 10 mg/ Naproxen 60 mg1459
Sumatriptan 30 mg/ Naproxen 180 mg16610
Sumatriptan 85 mg/ Naproxen 500 mg211011

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Mean Body Mass Index of Participants at Baseline Categorized by Age Group

The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2). (NCT00843024)
Timeframe: Baseline

InterventionKilograms per meters squared (kg/m^2) (Mean)
12 to 14 Years Age Group22.6
15 to 17 Years Age Group24.6

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Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points

Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment. (NCT00843024)
Timeframe: Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, 1 hour, n=145, 96, 96, 152Total Population, 2 hours, n=145, 96, 96, 152Total Population, 3 hours, n=145, 96, 96, 152Total Population, 4 hours, n=145, 96, 96, 152Total Population, 8 hours, n=145, 96, 96, 152Total Population, 12 hours, n=145, 96, 96, 152Total Population, 18 hours, n=145, 96, 96, 152Total Population, 24 hours, n=145, 96, 96, 15212-14 years, 1 hour, n=71, 43, 46, 6512-14 years, 2 hours, n=71, 43, 46, 6512-14 years, 3 hours, n=71, 43, 46, 6512-14 years, 4 hours, n=71, 43, 46, 6512-14 years, 8 hours, n=71, 43, 46, 6512-14 years, 12 hours, n=71, 43, 46, 6512-14 years, 18 hours, n=71, 43, 46, 6512-14 years, 24 hours, n=71, 43, 46, 6515-17 years, 1 hour, n=74, 53, 50, 8715-17 years, 2 hours, n=74, 53, 50, 8715-17 years, 3 hours, n=74, 53, 50, 8715-17 years, 4 hours, n=74, 53, 50, 8715-17 years, 8 hours, n=74, 53, 50, 8715-17 years, 12 hours, n=74, 53, 50, 8715-17 years, 18 hours, n=74, 53, 50, 8715-17 years, 24 hours, n=74, 53, 50, 87
Placebo2102934454850521411142010212216182025282930
Sumatriptan 10 mg/ Naproxen 60 mg006691113140011444500555799
Sumatriptan 30 mg/ Naproxen 180 mg0611131515151701244446059911111111
Sumatriptan 85 mg/ Naproxen 500 mg23151620202223017810101010228810101213

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Number of Participants Who Were Pain Free at 2 Hours Post-dose

Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose. (NCT00843024)
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=142, 96, 97, 15012-14 years, n=70, 43, 46, 6515-17 years, n=72, 53, 51, 85
Placebo14104
Sumatriptan 10 mg/ Naproxen 60 mg281810
Sumatriptan 30 mg/ Naproxen 180 mg261313
Sumatriptan 85 mg/ Naproxen 500 mg361719

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Number of Participants Sustained Pain-free From 2-24 Hours

Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication. (NCT00843024)
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=142, 96, 97, 15012-14 years, n=70, 43, 46, 6515-17 years, n=72, 53, 51, 85
Placebo13103
Sumatriptan 10 mg/ Naproxen 60 mg23149
Sumatriptan 30 mg/ Naproxen 180 mg241212
Sumatriptan 85 mg/ Naproxen 500 mg351718

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Number of Participants Sustained Nausea-free From 2-24 Hours

Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication. (NCT00843024)
Timeframe: 2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=144, 95, 96, 15112-14 years, n=71, 43, 46, 6515-17 years, n=73, 52, 50, 86
Placebo683929
Sumatriptan 10 mg/ Naproxen 60 mg673136
Sumatriptan 30 mg/ Naproxen 180 mg643331
Sumatriptan 85 mg/ Naproxen 500 mg944351

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Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline

The number of participants receiving double-blind treatment were reported according to age. (NCT00843024)
Timeframe: Baseline

,,,
InterventionParticipants (Number)
12-14 years15-17 years
Placebo7174
Sumatriptan 10 mg/ Naproxen 60 mg4353
Sumatriptan 30 mg/ Naproxen 180 mg4651
Sumatriptan 85 mg/ Naproxen 500 mg6587

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Number of Participants Photophobia-free at 2 Hours Post-dose

The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed. (NCT00843024)
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=144, 96, 96, 15112-14 years, n=71, 43, 46, 6515-17 years, n=73, 53, 50, 86
Placebo593326
Sumatriptan 10 mg/ Naproxen 60 mg572928
Sumatriptan 30 mg/ Naproxen 180 mg472423
Sumatriptan 85 mg/ Naproxen 500 mg894148

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Number of Participants Phonophobia-free at 2 Hours Post-dose

The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed. (NCT00843024)
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=144, 96, 96, 15112-14 years, n=71, 43, 46, 6515-17 years, n=73, 53, 50, 86
Placebo603426
Sumatriptan 10 mg/ Naproxen 60 mg593247
Sumatriptan 30 mg/ Naproxen 180 mg553322
Sumatriptan 85 mg/ Naproxen 500 mg904149

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Number of Participants Pain-free at 1 Hour Post-dose

Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose. (NCT00843024)
Timeframe: 1 hour after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=142, 96, 97, 15012-14 years, n=70, 43, 46, 6515-17 years, n=72, 53, 51, 85
Placebo642
Sumatriptan 10 mg/ Naproxen 60 mg972
Sumatriptan 30 mg/ Naproxen 180 mg624
Sumatriptan 85 mg/ Naproxen 500 mg1147

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Number of Participants of the Indicated Race Categorized by Age Group

The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups. (NCT00843024)
Timeframe: Baseline

,
InterventionParticipants (Number)
African American/African HeritageAmerican Indian or Alaska NativeAsianNative Hawaiian or other Pacific IslanderWhiteAfrican American/African Heritage and WhiteAmerican Indian or Alaska Native and WhiteAsian and Native Hawaiian/other Pacific IslanderAsian and WhiteNative Hawaiian/ other Pacific Islander and WhiteMissing
12 to 14 Years Age Group31121181240201
15 to 17 Years Age Group32020216441321

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Number of Participants Nausea-free at 2 Hours Post-dose

The number of participants who did not have nausea at 2 hours post dose was analzyed. (NCT00843024)
Timeframe: 2 hours after single dose of double-blind treatment (Randomization through Week 13)

,,,
Interventionparticipants (Number)
Total Population, n=144, 95, 96, 15112-14 years, n=71, 43, 46, 6515-17 years, n=73, 52, 50, 86
Placebo1015546
Sumatriptan 10 mg/ Naproxen 60 mg783642
Sumatriptan 30 mg/ Naproxen 180 mg743836
Sumatriptan 85 mg/ Naproxen 500 mg1064759

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Number of Female and Male Participants Categorized by Age Group

The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups. (NCT00843024)
Timeframe: Baseline

,
InterventionParticipants (Number)
FemaleMale
12 to 14 Years Age Group114111
15 to 17 Years Age Group17392

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Mean Weight of Participants at Baseline Categorized by Age Group

The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. (NCT00843024)
Timeframe: Baseline

InterventionKilograms (kg) (Mean)
12 to 14 Years Age Group58.7
15 to 17 Years Age Group69.6

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Mean Age of Participants at Baseline Categorized by Age Group

The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. (NCT00843024)
Timeframe: Baseline

InterventionYears (Mean)
12 to 14 Years Age Group13.1
15 to 17 Years Age Group16.1

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Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 28

"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0." (NCT00844805)
Timeframe: Week 28

InterventionParticipants (Number)
Infliximab + Naproxen19
Placebo + Naproxen0

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Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine and Sacroiliac Joint at Treatment Week 52

"MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active spinal inflammatory lesions was defined as a Berlin MRI Score = 0.~Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0." (NCT00844805)
Timeframe: Week 52

InterventionParticipants (Number)
Naproxen1
No Treatment1

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Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 28

MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0. (NCT00844805)
Timeframe: Week 28

InterventionParticipants (Number)
Infliximab + Naproxen63
Placebo + Naproxen23

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Number of Participants With Complete Absence of Active Inflammatory Lesions at the Spine at Treatment Week 52

MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions was defined as a Berlin MRI Score = 0. (NCT00844805)
Timeframe: Week 52

InterventionParticipants (Number)
Naproxen20
No Treatment16

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Percentage of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Treatment Phase

ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation). (NCT00844805)
Timeframe: Week 52

InterventionPercentage of Participants (Number)
Infliximab + Naproxen40
Placebo + Naproxen55

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Percentage of Participants That Achieved ASAS-20 Response at Week 28 in the Treatment Phase

"ASAS-20 response was defined as ≥20% improvement in response according to following criteria:~• An improvement of ≥20% from baseline and an absolute improvement from~baseline of ≥10 mm in at least 3 of the following 4 domains (patient global assessment, pain, function,and inflammation)~• Absence of deterioration from baseline (≥20% and an absolute change of~≥10 mm) in the potential remaining domain." (NCT00844805)
Timeframe: Week 28

InterventionPercentage of Participants (Number)
Infliximab + Naproxen85
Placebo + Naproxen37

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Percentage of Participants That Achieved ASAS-40 Response at Week 28 in the Treatment Phase

ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS-40 response was defined as ASAS achieving ≥40% improvement in 3 of the 4 domains (patient global assessment, total back pain, function, and inflammation), with an absolute improvement of ≥20 mm and no deterioration in the remaining domain. (NCT00844805)
Timeframe: Week 28

InterventionPercentage of Participants (Number)
Infliximab + Naproxen79
Placebo + Naproxen29

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Number of Participants Achieving the Assessment in Ankylosing Spondylitis (ASAS) Partial Remission Criteria at Week 28

ASAS domains were measured on a visual analog scale (VAS) of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation). (NCT00844805)
Timeframe: Week 28

,
InterventionParticipants (Number)
Achieved Partial RemissionDid Not Achieve Partial Remission
Infliximab + Naproxen6540
Placebo + Naproxen1833

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Number of Participants Maintaining the ASAS Partial Remission Criteria at Week 52 By Treatment Assignment in the Follow-Up Phase

ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worst situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation). (NCT00844805)
Timeframe: Week 52

,
InterventionParticipants (Number)
Achieved Partial RemissionDid Not Achieve Partial Remission
Naproxen1921
No Treatment1624

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Change From Baseline in the Sacroiliac Overall Score at Week 28

Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. (NCT00844805)
Timeframe: Baseline, Week 28

InterventionUnits on a Scale (Median)
Infliximab + Naproxen-2.0
Placebo + Naproxen-3.0

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Change From Baseline in the Sacroiliac Overall Score at Week 52

Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. (NCT00844805)
Timeframe: Baseline, Week 28

InterventionUnits on a Scale (Median)
Naproxen1.1
No Treatment1.0

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Change From Baseline of Berlin Magnetic Resonance Imaging (MRI) Spine Overall Score at Week 28

MRI scans (T1 for chronic changes and short tau inversion recovery [STIR] for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. (NCT00844805)
Timeframe: Baseline, Week 28

InterventionUnits on a Scale (Median)
Infliximab + Naproxen-0.5
Placebo + Naproxen0.0

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Change From Baseline of Berlin MRI Spine Overall Score at Week 52

MRI scans (T1 for chronic changes and STIR for active changes) of the whole spine was performed to determine the Berlin MRI Spine Score. The Berlin MRI scoring for the spine was assessed on a scale of 0 (best) to 3 (worst) for a maximum total score of 69, with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. (NCT00844805)
Timeframe: Baseline, Week 52

InterventionUnits on a Scale (Median)
Naproxen0.0
No Treatment0.0

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Median Duration of Maintaining ASAS Partial Remission in the Follow-Up Phase

ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria is defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation). (NCT00844805)
Timeframe: Week 52

InterventionWeeks (Median)
Naproxen23.00
No Treatment12.57

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Number of Participants Who Achieved ASAS Partial Remission That Experienced Disease Flare With Naproxen Maintenance Treatment in the Follow-Up Phase

"The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) employs a VAS of 0mm (best) to 100mm (worst). Disease flare was defined as reaching a BASDAI of ≥30 mm during two consecutive visits after Week 28 until Week 52.~ASAS domains were measured on a VAS of 0 to 100 mm (with 0 being the very best situation and 100 being the very worse situation). ASAS partial remission criteria was defined as reaching ≤20 mm in all 4 ASAS domains (i.e., patient global assessment, total back pain, function, and inflammation)." (NCT00844805)
Timeframe: Week 52

InterventionParticipants (Number)
Naproxen1
No Treatment3

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Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 28

Each sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active inflammatory lesions at the sacroiliac joints was defined as a Score = 0. (NCT00844805)
Timeframe: Week 28

InterventionParticipants (Number)
Infliximab + Naproxen29
Placebo + Naproxen3

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Number of Participants With Complete Absence of Active Inflammatory Lesions at the Sacroiliac Joint at Treatment Week 52

EaEach sacroiliac joint was divided into four quadrants. An activity score of 0 (best) to 3 (worst) was assessed for every quadrant of the left and right sacroiliac joint separately for a total maximum score of 24, with with 0 = no inflammatory lesions; 1 = minor bone marrow edema; 2 = moderate bone marrow edema; 3 = major bone marrow edema; or N = non readable. Complete absence of active sacroiliac inflammatory lesions was defined as a Score = 0. (NCT00844805)
Timeframe: Week 52

InterventionParticipants (Number)
Naproxen3
No Treatment4

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Percentage of Participants Who Used Rescue Medication

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized. (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo46.636.535.433.530.1
Placebo61.652.547.842.737.4
Tanezumab 10 mg + Placebo68.945.637.933.533.5
Tanezumab 5 mg + Placebo63.347.138.933.233.2

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT00863304)
Timeframe: Baseline (Day 1) up to Week 24

,,,
InterventionParticipants (Count of Participants)
AEsSAEs
Naproxen + Placebo1109
Placebo854
Tanezumab 10 mg + Placebo1014
Tanezumab 5 mg + Placebo1013

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Number of Participants With Positive Anti-Drug Antibody (ADA) Level

Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: Tanezumab 5 mg + Placebo and Tanezumab 10 mg + Placebo. Results with titer value >= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive. (NCT00863304)
Timeframe: Baseline, Weeks 8, 16, and 24

,
InterventionParticipants (Count of Participants)
BaselineWeek 8Week 16Week 24
Tanezumab 10 mg + Placebo1000
Tanezumab 5 mg + Placebo0100

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Number of Participants With Abnormal Physical Examinations Findings

Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Criteria for abnormal physical findings were based on investigator's discretion. (NCT00863304)
Timeframe: Baseline (Day 1)

,,,
InterventionParticipants (Count of Participants)
AbdomenEarsExtremitiesEyesGeneralHeadHeartLungsMusculoskeletalNeckNoseSkinThroatThyroid
Naproxen + Placebo15633151788188203433
Placebo1954091467587723161
Tanezumab 10 mg + Placebo117296355181413132
Tanezumab 5 mg + Placebo121147111236389402312

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Number of Participants With Abnormal Electrocardiogram (ECG) Findings

All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as treatment related adverse events were presented. Relatedness to treatment was assessed by investigator. (NCT00863304)
Timeframe: Baseline (Day 1) up to Week 24

,,,
InterventionParticipants (Count of Participants)
QRS complex abnormalT wave abnormalT wave inversionBradycardiaVentricular extrasystoles
Naproxen + Placebo00000
Placebo00000
Tanezumab 10 mg + Placebo01111
Tanezumab 5 mg + Placebo10000

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Duration of Rescue Medication Use

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized. (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventiondays (Median)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo00000
Placebo11000
Tanezumab 10 mg + Placebo20000
Tanezumab 5 mg + Placebo20000

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo6.96-2.45-2.51-2.32-2.41-2.24
Placebo7.19-1.54-1.69-1.74-1.72-1.74
Tanezumab 10 mg + Placebo7.11-2.39-3.10-2.90-3.06-2.95
Tanezumab 5 mg + Placebo7.07-2.52-3.18-3.31-3.21-3.17

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Amount of Rescue Medication Taken

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized. (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionmg (Mean)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo2069.711713.941956.941851.671827.75
Placebo3967.983392.163329.273055.833155.34
Tanezumab 10 mg + Placebo3325.242648.062274.271963.592014.56
Tanezumab 5 mg + Placebo3661.842442.312024.042012.021968.75

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo-2.52-2.58-2.56-2.70-2.60
Placebo-1.60-1.84-1.92-2.03-2.08
Tanezumab 10 mg + Placebo-2.33-3.05-3.10-3.36-3.30
Tanezumab 5 mg + Placebo-2.34-3.09-3.13-3.36-3.38

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, and 12

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo6.95-2.52-2.55-2.40-2.47
Placebo7.04-1.60-1.77-1.76-1.71
Tanezumab 10 mg + Placebo7.09-2.33-2.94-2.83-2.95
Tanezumab 5 mg + Placebo6.83-2.34-3.04-3.00-3.06

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. (NCT00863304)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Naproxen + Placebo6.95-2.25
Placebo7.04-1.75
Tanezumab 10 mg + Placebo7.09-2.86
Tanezumab 5 mg + Placebo6.83-3.01

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.22-3.03-3.05-2.82-2.80-2.64
Placebo7.36-2.14-2.18-2.23-2.21-2.19
Tanezumab 10 mg + Placebo7.23-2.44-3.26-3.00-3.20-2.95
Tanezumab 5 mg + Placebo7.16-2.64-3.38-3.29-3.34-3.22

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, and 12

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo-2.92-2.98-2.85-2.78
Placebo-2.11-2.29-2.23-2.12
Tanezumab 10 mg + Placebo-2.42-3.27-3.06-3.24
Tanezumab 5 mg + Placebo-2.64-3.48-3.46-3.40

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00863304)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at week 16
Naproxen + Placebo7.30-2.61
Placebo7.41-2.14
Tanezumab 10 mg + Placebo7.37-3.03
Tanezumab 5 mg + Placebo7.27-3.32

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo8.24-2.93-3.07-2.88-2.84-2.61
Placebo8.33-1.97-2.19-2.12-2.05-2.06
Tanezumab 10 mg + Placebo8.22-2.64-3.35-3.30-3.38-3.11
Tanezumab 5 mg + Placebo8.05-2.84-3.54-3.44-3.43-3.33

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo7.30-2.92-3.04-3.05-3.12-3.07
Placebo7.41-2.11-2.42-2.48-2.58-2.64
Tanezumab 10 mg + Placebo7.37-2.42-3.35-3.39-3.73-3.58
Tanezumab 5 mg + Placebo7.27-2.64-3.57-3.59-3.79-3.80

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [worst stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at week 2Change at week 4Change at week 8Change at week 12Change at week 16
Naproxen + Placebo7.07-2.63-2.68-2.52-2.56-2.37
Placebo7.21-1.75-1.92-1.91-1.85-1.88
Tanezumab 10 mg + Placebo7.19-2.38-3.11-2.94-3.08-2.94
Tanezumab 5 mg + Placebo7.06-2.50-3.23-3.26-3.22-3.17

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Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition." (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo-0.88-0.86-0.78-0.78-0.79
Placebo-0.52-0.55-0.52-0.59-0.55
Tanezumab 10 mg + Placebo-0.60-0.92-0.88-0.88-0.89
Tanezumab 5 mg + Placebo-0.65-0.91-0.92-0.95-0.90

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Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition." (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, and 12

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen + Placebo-0.88-0.85-0.71-0.65
Placebo-0.52-0.55-0.51-0.55
Tanezumab 10 mg + Placebo-0.60-0.93-0.85-0.80
Tanezumab 5 mg + Placebo-0.65-0.90-0.91-0.85

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Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)

"PGA of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition." (NCT00863304)
Timeframe: Baseline, Week 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Naproxen + Placebo3.48-0.66
Placebo3.46-0.49
Tanezumab 10 mg + Placebo3.40-0.80
Tanezumab 5 mg + Placebo3.36-0.80

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Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24

NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 122 (maximum impairment), higher scores indicated increased impairment. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo1.14-0.08-0.18-0.17-0.28-0.30
Placebo1.52-0.22-0.26-0.31-0.29-0.52
Tanezumab 10 mg + Placebo0.920.00-0.26-0.190.10-0.13
Tanezumab 5 mg + Placebo1.38-0.21-0.13-0.15-0.32-0.25

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Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)

Participants assessed their average daily pain score in the index hip/knee using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. A weekly mean was calculated using the daily index hip/knee pain scores within each specified study week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score. (NCT00863304)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 16

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen + Placebo-2.02-2.11-2.01-2.02-1.82
Placebo-1.11-1.43-1.39-1.52-1.60
Tanezumab 10 mg + Placebo-1.70-2.46-2.37-2.36-2.18
Tanezumab 5 mg + Placebo-1.75-2.34-2.33-2.39-2.38

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Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)

The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life. (NCT00863304)
Timeframe: Baseline, Weeks 12, and 16

,,,
Interventionunits on a scale (Mean)
Change at Week 12: MCAChange at Week 16: MCAChange at Week 12: PCAChange at Week 16: PCA
Naproxen + Placebo0.010.100.580.52
Placebo0.010.070.430.39
Tanezumab 10 mg + Placebo0.090.120.770.66
Tanezumab 5 mg + Placebo0.100.160.830.76

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Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)

The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum), where higher score indicated a better health related quality of life. (NCT00863304)
Timeframe: Baseline, Weeks 12, and 16

,,,
Interventionunits on a scale (Mean)
Change at Week 12: General HealthChange at Week 16: General HealthChange at Week 12: Physical FunctionChange at Week 16: Physical FunctionChange at Week 12: Role PhysicalChange at Week 16: Role PhysicalChange at Week 12: Bodily PainChange at Week 16: Bodily PainChange at Week 12:VitalityChange at Week 16:VitalityChange at Week 12: Social FunctionChange at Week 16: Social FunctionChange at Week 12: Role EmotionalChange at Week 16: Role EmotionalChange at Week 12: Mental HealthChange at Week 16: Mental Health
Naproxen + Placebo3.053.1211.7811.2213.2211.4815.0613.954.376.797.247.721.753.713.092.89
Placebo1.111.439.458.8010.628.8511.1310.333.854.754.135.443.473.791.421.59
Tanezumab 10 mg + Placebo4.023.4118.4015.9316.6615.2220.4017.546.526.978.077.308.417.933.333.52
Tanezumab 5 mg + Placebo3.515.0218.5717.2619.4317.9521.8919.739.059.5510.1210.008.028.493.173.74

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Time to Discontinuation Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. (NCT00863304)
Timeframe: Baseline up to Week 16

Interventiondays (Median)days (Mean)
PlaceboNA
Tanezumab 5 mg + PlaceboNA
Tanezumab 10 mg + PlaceboNA
Naproxen + PlaceboNA
Placebo87.78
Tanezumab 5 mg + Placebo80.12
Tanezumab 10 mg + Placebo84.62
Naproxen + Placebo72.87

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Number of Participants With Laboratory Test Abnormalities

Laboratory values: hematology (hemoglobin; hematocrit; red blood cell count [less than {<}0.8* lower limit of normal [LLN], platelets <0.5* LLN,>1.75* upper limit of normal (ULN), white blood cell count<0.6* LLN, >1.5* ULN, liver function (total bilirubin>1.5* ULN, aspartate aminotransferase; alanine aminotransferase; gamma-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase>3.0* ULN, total protein; albumin<0.8* LLN; >1.2* ULN), renal function (blood urea nitrogen; creatinine>1.3* ULN, uric acid>1.2* ULN), lipids (cholesterol, triglycerides >1.3*ULN), electrolytes (sodium<0.95* LLN, >1.05* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate<0.9* LLN, >1.1* ULN), chemistry (glucose <0.6*LLN, >1.5*ULN; creatine kinase >2.0*ULN), urinalysis (specific gravity <1.003, >1.030; pH<4.5, >8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase>=1). (NCT00863304)
Timeframe: Baseline (Day 1) up to Week 24

InterventionParticipants (Count of Participants)
Placebo145
Tanezumab 5 mg + Placebo145
Tanezumab 10 mg + Placebo144
Naproxen + Placebo164

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Number of Participants With Adverse Events Associated With Vital Sign Measurements

Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant vital signs (based on the investigator's judgment) considered as adverse events were reported. (NCT00863304)
Timeframe: Baseline (Day 1) up to Week 24

InterventionParticipants (Count of Participants)
Placebo3
Tanezumab 5 mg + Placebo6
Tanezumab 10 mg + Placebo5
Naproxen + Placebo6

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Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported. (NCT00863304)
Timeframe: Baseline up to Week 16

,,,
Interventionpercentage of participants (Number)
>0% reduction>=10% reduction>=20% reduction>=30% reduction>=40% reduction>=50% reduction>=60% reduction>=70% reduction>=80% reduction>=90% reduction=100% reduction
Naproxen + Placebo67.161.455.151.743.541.132.923.719.39.23.4
Placebo54.151.244.539.233.529.726.819.613.48.62.4
Tanezumab 10 mg + Placebo64.961.557.252.947.644.738.929.322.613.95.8
Tanezumab 5 mg + Placebo71.669.766.462.156.951.744.538.923.713.36.2

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Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported. (NCT00863304)
Timeframe: Baseline up to Week 16

,,,
Interventionpercentage of participants (Number)
>0% reduction>=10% reduction>=20% reduction>=30% reduction>=40% reduction>=50% reduction>=60% reduction>=70% reduction>=80% reduction>=90% reduction=100% reduction
Naproxen + Placebo85.075.465.758.950.746.937.726.621.710.64.3
Placebo81.372.759.348.840.735.429.220.613.99.12.9
Tanezumab 10 mg + Placebo86.579.872.664.456.351.044.232.224.514.96.3
Tanezumab 5 mg + Placebo89.683.478.771.164.558.849.842.225.614.26.2

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Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure. (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo68.669.669.668.164.3
Placebo49.848.853.153.655.0
Tanezumab 10 mg + Placebo55.365.966.869.768.8
Tanezumab 5 mg + Placebo59.774.474.973.574.9

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Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure. (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo68.667.164.358.953.1
Placebo49.845.946.942.642.6
Tanezumab 10 mg + Placebo55.363.960.659.655.8
Tanezumab 5 mg + Placebo59.772.572.064.564.9

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Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

"PGA of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported." (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo23.221.715.515.019.3
Placebo13.412.412.412.912.4
Tanezumab 10 mg + Placebo16.826.426.922.122.6
Tanezumab 5 mg + Placebo14.724.226.523.221.8

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Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

"PGA of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported." (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen + Placebo23.222.217.417.921.3
Placebo13.412.912.413.913.4
Tanezumab 10 mg + Placebo16.826.928.825.526.0
Tanezumab 5 mg + Placebo14.724.627.025.624.6

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Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure. (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionpercentage of participants (Number)
Week 2: >=30 percent reductionWeek 2: >=50 percent reductionWeek 4: >=30 percent reductionWeek 4: >=50 percent reductionWeek 8: >=30 percent reductionWeek 8: >=50 percent reductionWeek 12: >=30 percent reductionWeek 12: >=50 percent reductionWeek 16:>=30 percent reductionWeek 16:>=50 percent reduction
Naproxen + Placebo56.537.258.540.660.944.458.045.958.946.9
Placebo43.126.349.335.945.535.948.837.848.835.4
Tanezumab 10 mg + Placebo45.228.459.645.261.547.165.953.864.451.0
Tanezumab 5 mg + Placebo50.237.070.153.170.656.471.658.371.158.8

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Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure. (NCT00863304)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionpercentage of participants (Number)
Week 2: >=30 percent reductionWeek 2: >=50 percent reductionWeek 4: >=30 percent reductionWeek 4: >=50 percent reductionWeek 8: >=30 percent reductionWeek 8: >=50 percent reductionWeek 12: >=30 percent reductionWeek 12: >=50 percent reductionWeek 16: >=30 percent reductionWeek 16: >=50 percent reduction
Naproxen + Placebo56.537.257.039.157.541.152.741.551.741.1
Placebo43.126.346.434.039.732.140.232.139.229.7
Tanezumab 10 mg + Placebo45.228.458.244.254.842.856.348.652.944.7
Tanezumab 5 mg + Placebo50.237.068.751.768.254.064.053.162.151.7

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Plasma Concentration of Tanezumab

Analysis was done by setting concentration values below the lower limit of quantification (LLOQ) to zero. (NCT00876187)
Timeframe: Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit

,,
Interventionnanogram per milliliter (Mean)
Baseline: pre-doseBaseline: 1 hr post-doseWeek 4Week 8: pre-doseWeek 8: 1 hr post-doseWeek 16Week 24
Tanezumab 10 mg60.23544105.46983.377442.8434637.82531.014636.217
Tanezumab 20 mg40.93968460.141983.721081.699161.841393.401222.17
Tanezumab 5 mg70.76271944.46472.248240.4052026.01239.804276.991

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Total Nerve Growth Factor (NGF) Concentration

(NCT00876187)
Timeframe: Baseline (pre-dose and 1 hour [hr] post-dose); Any time point at Week 4 Visit; Week 8 (pre-dose and 1 hr post-dose); Any time point at Week 16 Visit, at Week 24 Visit

,,,,
Interventionpicogram per mL (Mean)
Baseline: pre-doseBaseline: 1 hr post-doseWeek 4Week 8: pre-doseWeek 8: 1 hr post-doseWeek 16Week 24
Naproxen 500 mg35.5040.3038.1741.4769.74135.1738.77
Placebo34.6537.9092.33126.66124.7141.96226.61
Tanezumab 10 mg55.66113.333981.73624.73950.94490.53549.5
Tanezumab 20 mg61.79126.504456.74238.64929.15842.24420.3
Tanezumab 5 mg44.3896.763217.62671.72943.53263.02602.0

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Amount of Rescue Medication Taken

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. (NCT00876187)
Timeframe: Week 2, 4, 8, 12, 16

,,,,
Interventionmg per week (Mean)
Week 2Week 4Week 8Week 12Week 16
Naproxen 500 mg3350.522680.892477.892455.782448.98
Placebo4168.123547.832910.872619.572523.91
Tanezumab 10 mg3952.222583.622829.352511.952250.85
Tanezumab 20 mg4306.902688.362558.222351.032369.86
Tanezumab 5 mg4305.193252.162633.622256.472140.09

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Number of Participants Who Developed Anti-Tanezumab Antibodies

Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point. (NCT00876187)
Timeframe: Baseline (Day 1), Week 8, 16, 24

,,
InterventionParticipants (Count of Participants)
BaselineWeek 8Week 16Week 24
Tanezumab 10 mg1011
Tanezumab 20 mg0011
Tanezumab 5 mg0000

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Time to Discontinuation Due to Lack of Efficacy

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method. (NCT00876187)
Timeframe: Baseline up to Week 16

Interventiondays (Median)
PlaceboNA
Tanezumab 5 mgNA
Tanezumab 10 mgNA
Tanezumab 20 mgNA
Naproxen 500 mgNA

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Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Pain Interference Index, Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 2, 4, 8, 12 and 16: BOCF

BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure pain interference (PI) on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes); higher score = greater impairment. The 7 items in Q5 averaged to obtain pain interference index (function composite score), range: 0 (no interference) to 10 (complete interference); higher score = greater impairment. (NCT00876187)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,,
Interventionunits on a scale (Mean)
Change at Week 2: Pain Interference IndexChange at Week 4: Pain Interference IndexChange at Week 12: Pain Interference IndexChange at Week 16: Pain Interference IndexChange at Week 8: Pain Interference IndexChange at Week 2: General ActivityChange at Week 4: General ActivityChange at Week 8: General ActivityChange at Week 12: General ActivityChange at Week 16: General ActivityChange at Week 2: Walking AbilityChange at Week 4: Walking AbilityChange at Week 8: Walking AbilityChange at Week 12: Walking AbilityChange at Week 16: Walking AbilityChange at Week 2: Normal WorkChange at Week 4: Normal WorkChange at Week 8: Normal WorkChange at Week 12: Normal WorkChange at Week 16: Normal WorkChange at Week 2: Pain Interference with SleepChange at Week 4: Pain Interference with SleepChange at Week 8: Pain Interference with SleepChange at Week 12: Pain Interference with SleepChange at Week 16: Pain Interference with Sleep
Naproxen 500 mg-1.75-2.01-1.81-1.59-1.71-1.92-2.08-1.77-1.90-1.65-1.73-2.00-1.72-1.80-1.53-1.67-2.03-1.76-1.85-1.65-2.2-2.2-1.9-2.0-1.8
Placebo-1.33-1.48-1.38-1.32-1.33-1.30-1.33-1.36-1.43-1.34-1.29-1.48-1.24-1.28-1.17-1.33-1.59-1.31-1.43-1.27-1.4-1.6-1.4-1.5-1.4
Tanezumab 10 mg-1.97-2.40-2.21-2.02-2.15-2.20-2.64-2.27-2.39-2.20-1.83-2.32-2.01-2.13-1.91-2.01-2.49-2.25-2.35-2.09-2.0-2.6-2.4-2.4-2.3
Tanezumab 20 mg-1.81-2.63-2.38-2.17-2.37-2.06-2.90-2.53-2.62-2.26-1.81-2.58-2.36-2.34-2.14-2.01-2.79-2.58-2.57-2.40-1.7-2.7-2.4-2.5-2.3
Tanezumab 5 mg-1.59-1.99-1.62-1.52-1.65-1.72-2.17-1.70-1.76-1.68-1.59-1.91-1.62-1.63-1.49-1.75-2.03-1.72-1.76-1.55-1.7-2.3-1.9-1.8-1.7

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Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score for Worst and Average Pain at Week 2, 4, 8, 12, 16: Baseline Observation Carried Forward (BOCF)

BPI-sf: self-report questionnaire rated on an 11-point scale, consists of 5 questions to assess severity and impact of pain on daily functions. Question 1-4 (Q1-Q4) measure severity of pain (worst, least, average, right now), each question ranging between 0 (no pain) to 10 (pain as bad as you can imagine). Question 5 (Q5) consists of 7 items which measure level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life), each item ranging from 0 (does not interfere) to 10 (completely interferes). Results are reported for worst and average pain, each with a score range: 0 (no pain) and 10 (pain as bad as you can imagine), higher scores indicated worse pain. (NCT00876187)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,,
Interventionunits on a scale (Mean)
Baseline: Worst PainBaseline: Average PainChange at Week 2: Worst PainChange at Week 2: Average PainChange at Week 4: Worst PainChange at Week 4: Average PainChange at Week 8: Worst PainChange at Week 8: Average PainChange at Week 12: Worst PainChange at Week 12: Average PainChange at Week 16: Worst PainChange at Week 16: Average Pain
Naproxen 500 mg7.286.27-1.97-1.57-2.16-1.77-1.98-1.61-2.13-1.73-1.94-1.66
Placebo7.276.22-1.63-1.16-1.63-1.19-1.54-1.19-1.63-1.32-1.55-1.20
Tanezumab 10 mg7.046.08-2.19-1.69-2.57-2.09-2.35-1.98-2.53-2.13-2.20-1.89
Tanezumab 20 mg7.366.35-2.08-1.65-2.88-2.32-2.55-2.18-2.70-2.26-2.36-2.03
Tanezumab 5 mg7.106.25-1.76-1.43-2.21-1.88-1.94-1.78-1.99-1.75-1.75-1.58

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Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 16: Baseline Observation Carried Forward (BOCF)

Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Overall possible score range for daily average LBPI at specified visit was 0= no pain to 10= worst possible pain, where higher scores indicated higher pain intensity. (NCT00876187)
Timeframe: Baseline, Week 16

,,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 16
Naproxen 500 mg6.77-1.70
Placebo6.71-1.25
Tanezumab 10 mg6.57-2.02
Tanezumab 20 mg6.74-2.19
Tanezumab 5 mg6.62-1.55

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Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. (NCT00876187)
Timeframe: Baseline, Week 2, 4, 8, 12

,,,,
Interventionunits on scale (Mean)
Change at Week 2Change at Week 4Change at Week 8Change at Week 12
Naproxen 500 mg-1.85-2.05-1.82-1.93
Placebo-1.29-1.50-1.40-1.49
Tanezumab 10 mg-1.83-2.47-2.23-2.27
Tanezumab 20 mg-1.68-2.44-2.32-2.37
Tanezumab 5 mg-1.48-1.94-1.82-1.92

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Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

"Participants answered: Considering all ways your low back pain affects you, how are you doing today? Participants rated their condition using scale assessing symptoms and limitations to carry out normal daily activities. Score range:1 to 5. 1: Very Good (No symptoms and limitations); 2: Good (Mild symptoms and no limitations); 3: Fair (Moderate symptoms and some limitations); 4: Poor (Severe symptoms and inability to carry out most activities); 5: Very Poor (Very severe, intolerable symptoms and inability to carry all activities)." (NCT00876187)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen 500 mg3.35-0.59-0.67-0.54-0.59-0.49
Placebo3.41-0.55-0.53-0.52-0.48-0.42
Tanezumab 10 mg3.33-0.66-0.77-0.71-0.73-0.63
Tanezumab 20 mg3.36-0.62-0.84-0.78-0.74-0.67
Tanezumab 5 mg3.41-0.62-0.78-0.66-0.69-0.59

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Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

RMDQ: back-specific, participant administered questionnaire that assesses how well participants with low back pain were able to function with regard to daily activities. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement if it describes his/her functional ability on the day of assessment. The number of statements marked are added up by the clinician. Total RMDQ score is calculated as the sum of number of statements marked. Total possible RMDQ score: 0 (best functioning) to 24 (worst functioning), with higher scores indicated greater disability. (NCT00876187)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16
Naproxen 500 mg12.86-2.28-2.39-2.27-2.44-2.08
Placebo12.79-1.68-1.85-1.86-1.91-1.76
Tanezumab 10 mg12.98-2.59-3.45-2.93-3.16-3.20
Tanezumab 20 mg13.00-2.39-3.35-3.47-3.26-2.82
Tanezumab 5 mg12.24-2.47-2.81-2.62-2.23-2.27

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Change From Baseline in Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) at Week 8 and 16

WPAI:SHP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Four scores are derived as percent: activity impairment (AI), impairment while working (IW), overall work impairment (OWI), work time missed (WTM). Each of 4 scores expressed as impairment percentages with a total possible score range of 0 to 100, high percentage= more impairment, less productivity. (NCT00876187)
Timeframe: Baseline, Week 8, 16

,,,,
Interventionpercentage of impairment (Mean)
Baseline: Activity ImpairmentBaseline: Impairment While WorkingBaseline: Overall Work ImpairmentBaseline: Work Time MissedChange at Week 8: Activity ImpairmentChange at Week 8: Impairment While WorkingChange at Week 8: Overall Work ImpairmentChange at Week 8: Work Time MissedChange at Week 16: Activity ImpairmentChange at Week 16: Impairment While WorkingChange at Week 16:Overall Work ImpairmentChange at Week 16:Work Time Missed
Naproxen 500 mg59.9748.908.303.26-18.53-16.70-4.58-1.74-24.28-21.05-6.68-2.30
Placebo58.7749.196.291.97-14.58-14.790.430.58-22.50-20.60-2.52-0.79
Tanezumab 10 mg59.3249.157.512.02-24.96-21.98-3.83-0.38-29.95-27.65-3.92-0.24
Tanezumab 20 mg60.8149.6210.713.82-27.08-19.21-6.64-2.15-31.79-24.57-7.71-2.98
Tanezumab 5 mg55.1545.176.683.17-15.80-10.750.080.16-19.45-15.22-1.72-0.09

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Change From Baseline Neuropathy Impairment Score (NIS) at Week 8, 16 and 24

NIS is a standardized instrument used to evaluate signs of peripheral neuropathy in participants. NIS is the sum of scores of 37 items, from both the left and right side of following 4 domains: cranial nerves (5 items), muscle weakness (19 items), reflexes (5 items) and sensation (8 items). Each of 24 items related to cranial nerves and muscle weakness, scored from 0 (normal) to 4 (paralysis); higher scores indicated higher abnormality/impairment. Each of 13 items related to reflexes and sensation, scored as 0 (normal), 1 (decreased) and 2 (absent); higher scores indicated lesser reflexes and sensation. For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. (NCT00876187)
Timeframe: Baseline, Week 8, 16, 24

,,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 8Change at Week 16Change at Week 24
Naproxen 500 mg1.02-0.06-0.18-0.48
Placebo0.97-0.15-0.30-0.74
Tanezumab 10 mg1.03-0.090.050.10
Tanezumab 20 mg1.31-0.380.02-0.46
Tanezumab 5 mg1.16-0.41-0.27-0.15

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Duration of Rescue Medication Use

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. (NCT00876187)
Timeframe: Week 2, 4, 8, 12, 16

,,,,
Interventiondays/week (Median)
Week 2Week 4Week 8Week 12Week 16
Naproxen 500 mg1.01.00.00.00.0
Placebo2.02.01.00.00.0
Tanezumab 10 mg2.01.01.00.00.0
Tanezumab 20 mg2.01.00.00.00.0
Tanezumab 5 mg2.01.00.00.00.0

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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial. (NCT00876187)
Timeframe: Baseline up to Week 24

,,,,
InterventionParticipants (Count of Participants)
AEsSAEs
Naproxen 500 mg1425
Placebo1205
Tanezumab 10 mg1713
Tanezumab 20 mg1903
Tanezumab 5 mg1414

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Number of Participants With Chronic Low Back Pain (CLBP) Responder Index: Baseline Observation Carried Forward (BOCF)

Chronic Low Back Pain (CLBP) Responder Index: A response was defined as reduction of at least 30% in mean daily average LBPI from baseline to a specified week, decrease of at least 30% in PGA of low back pain from baseline to the specified week and no worsening (increase) in RMDQ total score from baseline to the specified week. Participants who were responders were reported. (NCT00876187)
Timeframe: Week 2, 4, 8, 12, 16

,,,,
Interventionparticipants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen 500 mg6979648363
Placebo3852404544
Tanezumab 10 mg771149610490
Tanezumab 20 mg8011310310589
Tanezumab 5 mg4870626052

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Number of Participants With Cumulative Reduction From Baseline at Week 16 in Daily Average Low Back Pain Intensity (LBPI) Score : Baseline Observation Carried Forward (BOCF)

Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. Participants with specified reduction (as percent) from baseline at Week 16 are reported. (NCT00876187)
Timeframe: Baseline, Week 16

,,,,
InterventionParticipants (Count of Participants)
Greater than (>) 0%Greater than or equal to (>=)10%>= 20%>= 30%>= 40%>= 50%>= 60%>= 70%>= 80%>= 90%= 100%
Naproxen 500 mg1601461281119278603726169
Placebo103907862533931221285
Tanezumab 10 mg171159136123112947862453020
Tanezumab 20 mg1741621451371201048054402616
Tanezumab 5 mg12111199836459422924129

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Percentage of Participants Who Used Rescue Medications

In case of inadequate pain relief for CLBP or for non-CLBP related pain, acetaminophen up to 3000 mg per day up to 3 days per week could be taken as rescue medication. (NCT00876187)
Timeframe: Week 2, 4, 8, 12, 16

,,,,
Interventionpercentage of participants (Number)
Week 2Week 4Week 8Week 12Week 16
Naproxen 500 mg60.853.248.344.641.2
Placebo70.363.954.840.442.6
Tanezumab 10 mg74.154.350.945.143.0
Tanezumab 20 mg73.453.447.638.738.0
Tanezumab 5 mg69.753.949.640.541.4

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Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Daily average back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive voice response system (IVRS). The participant described the chronic low back pain (CLBP) during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5 days prior to randomization (initial pain assessment period). Post-baseline value was calculated as mean of the scores over the 7-day period prior to and including the post-baseline visit. (NCT00876187)
Timeframe: Baseline, Week 2, 4, 8, 12, 16

,,,,
Interventionpercentage of participants (Number)
Week 2: >=30% reductionWeek 2: >=50% reductionWeek 4: >=30% reductionWeek 4: >=50% reductionWeek 8: >=30% reductionWeek 8: >=50% reductionWeek 12: >=30% reductionWeek 12: >=50% reductionWeek 16: >=30% reductionWeek 16: >=50% reduction
Naproxen 500 mg39.024.442.025.839.722.742.730.837.626.4
Placebo27.411.333.916.532.218.731.322.227.017.0
Tanezumab 10 mg42.419.354.235.648.132.548.136.341.731.9
Tanezumab 20 mg41.022.052.535.950.835.350.540.046.435.3
Tanezumab 5 mg32.820.743.528.943.125.442.731.035.825.4

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Paired T-test Indicating Greater Subject Satisfaction With Treximet Over Usual Pre-study Triptan as Determined by the Revised Patient Perception of Migraine Questionnaire (PPMQ-R)

Scores calculated for (1) Efficacy (2) Functionality (3) Ease of use (4) Cost. Higher score represents better treatment satisfaction. (NCT00893737)
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

InterventionUnits on a scale (Mean)
EfficacyFunctionalityEase of UseCost
Treximet8.6113.862.767.28

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Percent of Participants Reporting Treximet Provides Therapeutic Advantage Over Usual Pre-study Triptan

CORS completed at Visit 1 regarding participant pre-study triptan and at Visit 2 regarding Treximet taken in study. Areas of therapeutic advantage evaluated: How often does 1 dose completely relieve (1) headache pain (2) neck/shoulder pain (3) nausea (4) light sensitivity (5) sound sensitivity (6) irritability. How quickly can/do you (1) concentrate or think clearly (2) resume normal activities (3) function normally (4) feel completely normal. How confident are you that (1) one dose will completely relieve migraine within 2 hours (2) once relieved, migraine will not return within 24 hours. (NCT00893737)
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

InterventionPercent of Participants (Number)
How often 1 dose relieves headache painHow often 1 dose relieves neck/shoulder painHow often 1 dose relieves nauseaHow often 1 dose relieves light sensitivityHow often 1 dose relieves sound sensitivityHow often 1 dose relieves irritabilityHow quickly can you concentrate or think clearlyHow quickly can you resume normal activitiesHow quickly can you function normallyHow quickly do you feel completely normalConfidence 1 dose will relieve migraine in 2 hoursConfidence migraine will not return in 24 hours
Treximet425243424536313232363338

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Change in Scores From Completeness of Response Survey (CORS)

"CORS scores for Pain (0-4), Associated Symptoms (0-4), Limbic/Affective Symptoms (0-5), and Speed of Return to Functionality (1-5), represent outcome measures that are relevant to patients. Higher scores represent better treatment efficacy.~The analysis compares CORS scores for usual triptan (pre-study) versus (vs.) Treximet (study medication)." (NCT00893737)
Timeframe: Visit 1 (screening) and Visit 2 (study completion following 2-month treatment period)

InterventionUnits on a scale (Mean)
Pain ScoreAssociated Symptoms ScoreLimbic Symptoms ScoreFunctionality Score
Treximet0.170.070.030.10

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Participant Global Evaluation of Study Medication at 24 Hours

Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5). (NCT00913627)
Timeframe: 24 hours

,,,
Interventionparticipants (Number)
Very poorPoorFairGoodVery goodExcellent
Ibuprofen IR/ER (Roller Compaction)212141716
Ibuprofen IR/ER (Wet Granulation)203102318
Naproxen714171910
Placebo2041310

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Participant Global Evaluation of Study Medication at 12 Hours

Participant rated global evaluation of study medication; results reported by evaluation categories and included very poor (0), poor (1), fair (2), good (3), very good (4), and excellent (5). (NCT00913627)
Timeframe: 12 hours

,,,
Interventionparticipants (Number)
Very poorPoorFairGoodVery goodExcellent
Ibuprofen IR/ER (Roller Compaction)213112016
Ibuprofen IR/ER (Wet Granulation)20492813
Naproxen71818159
Placebo2041220

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Pain Relief Combined With Pain Intensity Difference (PRID) Score

PRID=PID+PR, where PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline and could range from -1 to 3. Baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated improvement. PR: 5-point categorical pain relief scale (None [0], A Little [1], Some [2], A Lot [3], Complete [4]). PRID score could range from -1 to 7 where higher scores indicated better pain relief and decrease in pain intensity. (NCT00913627)
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours

,,,
Interventionunits on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours11 hours12 hours13 hours14 hours16 hours24 hours
Ibuprofen IR/ER (Roller Compaction)0.451.422.492.983.644.174.754.984.874.604.454.303.893.773.703.703.683.433.232.81
Ibuprofen IR/ER (Wet Granulation)0.381.162.252.983.794.254.684.734.754.754.664.254.184.214.143.953.633.453.022.68
Naproxen0.331.091.742.483.143.293.673.673.593.623.413.413.163.163.212.932.982.972.932.97
Placebo-0.070.070.210.310.340.550.550.660.720.790.790.720.660.550.550.520.620.690.550.76

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Pain Intensity Difference (PID) Score

"PID based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). PID score derived by subtracting postdose score from baseline score and could range from -1 to 3. A baseline pain intensity score of at least 2 was required for study enrollment. Higher positive PID values indicated greater improvement (decrease in pain intensity)." (NCT00913627)
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours

,,,
Interventionunits on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours11 hours12 hours13 hours14 hours16 hours24 hours
Ibuprofen IR/ER (Roller Compaction)0.090.400.770.941.251.511.701.811.741.621.511.471.341.261.231.261.251.151.080.89
Ibuprofen IR/ER (Wet Granulation)0.090.340.701.001.291.481.641.661.681.661.641.481.411.451.431.381.231.181.020.91
Naproxen0.050.290.530.811.051.051.241.241.221.221.121.141.001.021.030.950.950.930.950.97
Placebo-0.14-0.14-0.10-0.10-0.070.000.000.030.070.070.070.070.00-0.03-0.03-0.030.000.03-0.030.07

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Percentage of Participants With Treatment Failure

Treatment failure defined as use of rescue medication or discontinuation due to lack of efficacy. (NCT00913627)
Timeframe: 8, 9, 10, 11, and 12 hours

,,,
Interventionpercentage of participants (Number)
8 hours9 hours10 hours11 hours12 hours
Ibuprofen IR/ER (Roller Compaction)11.311.317.020.820.8
Ibuprofen IR/ER (Wet Granulation)12.512.512.514.317.9
Naproxen24.125.927.627.632.8
Placebo82.882.882.882.882.8

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Time-weighted Sum of Pain Intensity Difference Score From 8 to 12 Hours (SPID 8-12)

"PID score based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity)." (NCT00913627)
Timeframe: 8 to 12 hours post dose

Interventionunits on a scale (Mean)
Placebo-0.03
Ibuprofen IR/ER (Roller Compaction)6.57
Ibuprofen IR/ER (Wet Granulation)7.14
Naproxen5.14

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Time-weighted Sum of Pain Intensity Difference Score From 0 to 12 Hours (SPID 0-12)

"Pain intensity difference (PID) score based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -12 to 36 where higher positive values indicated improvement (decrease in pain intensity)." (NCT00913627)
Timeframe: Baseline (0 hour) to 12 hours post dose

Interventionunits on a scale (Mean)
Placebo0.05
Ibuprofen IR/ER (Roller Compaction)16.87
Ibuprofen IR/ER (Wet Granulation)17.34
Naproxen12.66

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Time to Treatment Failure

Time to first rescue medication or discontinuation due to lack of efficacy (NCT00913627)
Timeframe: Baseline to 24 hours

Interventionhours (Median)
Placebo1.7
Ibuprofen IR/ER (Roller Compaction)NA
Ibuprofen IR/ER (Wet Granulation)NA
NaproxenNA

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Time to Meaningful Pain Relief

Participants evaluated the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief, defined as relief from the pain that is considered meaningful to the participant. (NCT00913627)
Timeframe: Baseline to 6 hours

Interventionminutes (Median)
PlaceboNA
Ibuprofen IR/ER (Roller Compaction)59.7
Ibuprofen IR/ER (Wet Granulation)76.7
Naproxen84.1

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Peak Pain Relief Score

"Maximum PR score over the scheduled pain relief assessments. PR score based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief)." (NCT00913627)
Timeframe: Baseline to 12 hours

Interventionunits on a scale (Mean)
Placebo1.00
Ibuprofen IR/ER (Roller Compaction)3.42
Ibuprofen IR/ER (Wet Granulation)3.39
Naproxen3.05

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Time to First Perceptible Pain Relief

"Time to first perceptible relief (confirmed by meaningful relief) was defined as the elapsed time from dosing until the participant depresses the first stopwatch labelled first perceptible relief, if the participant also depressed the second stopwatch labelled as meaningful relief by 6 hours. If the confirmation was not achieved, the participant was censored at 6 hours. Perceptible relief defined as when participant first begins to feel any pain relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she has currently." (NCT00913627)
Timeframe: Baseline to 6 hours

Interventionminutes (Median)
PlaceboNA
Ibuprofen IR/ER (Roller Compaction)29.4
Ibuprofen IR/ER (Wet Granulation)29.4
Naproxen32.1

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Percentage of Participants Achieving First Perceptible Relief Confirmed by Meaningful Relief

The elapsed time from dosing until the participant indicated first perceptible relief, provided the participant also indicated achieving meaningful relief. Perceptible relief defined as when participant first begins to feel any pain-relieving effect whatsoever of the drug. Does not necessarily mean the participant feels completely better, but when the participant first feels any difference in the pain he/she currently has now. (NCT00913627)
Timeframe: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes

,,,
Interventionpercentage of participants (Number)
15 minutes30 minutes45 minutes60 minutes90 minutes120 minutes180 minutes240 minutes300 minutes360 minutes
Ibuprofen IR/ER (Roller Compaction)17.052.864.281.183.083.083.083.083.083.0
Ibuprofen IR/ER (Wet Granulation)19.655.473.283.987.591.191.191.191.191.1
Naproxen8.639.756.965.572.472.472.472.472.472.4
Placebo3.43.46.913.813.813.813.813.813.813.8

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Percentage of Participants Achieving Meaningful Pain Relief

Participants evaluated the time to first perceptible pain relief by depressing a stopwatch at the moment they first began to experience perceptible relief and the time to meaningful relief by depressing a second stopwatch at the moment they first began to experience meaningful relief defined as relief from the pain that is considered meaningful to the participant. (NCT00913627)
Timeframe: 15, 30, 45, 60, 90, and 120 minutes and every 60 minutes up to 360 minutes

,,,
Interventionpercentage of participants (Number)
15 minutes30 minutes45 minutes60 minutes90 minutes120 minutes180 minutes240 minutes300 minutes360 minutes
Ibuprofen IR/ER (Roller Compaction)1.99.428.350.964.271.779.283.083.083.0
Ibuprofen IR/ER (Wet Granulation)0.010.728.639.357.171.482.189.391.191.1
Naproxen1.73.413.831.050.056.963.867.269.072.4
Placebo0.00.03.43.43.46.910.310.310.313.8

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Time-weighted Sum of Pain Intensity Difference From 0 to 4 Hours (SPID 0-4) and 4 to 8 Hours (SPID 4-8)

"Time-weighted sum of PID score. PID based on 4-point categorical pain intensity rating scale. Participants asked, How much pain do you have at this time? Range of scale: None (0), Mild (1), Moderate (2), Severe (3). SPID score derived by adding the time-weighted sums of PID scores over the time interval. Scores could range from -4 to 12 where higher positive values indicated improvement (decrease in pain intensity)." (NCT00913627)
Timeframe: 0 to 4 hours and 4 to 8 hours

,,,
Interventionunits on a scale (Mean)
SPID 0-4SPID 4-8
Ibuprofen IR/ER (Roller Compaction)5.448.15
Ibuprofen IR/ER (Wet Granulation)5.228.13
Naproxen3.965.95
Placebo-0.120.31

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Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores (SPRID)

Time-weighted sum of PRID score where PRID=PID+PR. PID: 4-point categorical pain intensity difference scale, 0 (none) to 3 (severe), score derived by subtracting postdose score from baseline, ranged from -1 to 3. Baseline pain intensity score of at least 2 required for enrollment. Higher positive PID values = improvement. PR: 5-point categorical pain relief scale None (0), A Little (1), Some (2), A Lot (3) or Complete (4). SPRID 0-4, SPRID 4-8, and SRID 8-12 scores ranged from -4 to 28, SPRID 0-12 ranged from -12 to 84, higher scores = greater improvement. (NCT00913627)
Timeframe: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours

,,,
Interventionunits on a scale (Mean)
SPRID 0-4SPRID 4-8SPRID 8-12SPRID 0-12
Ibuprofen IR/ER (Roller Compaction)15.4823.2119.3648.76
Ibuprofen IR/ER (Wet Granulation)15.1223.1420.7350.01
Naproxen11.9717.7115.8638.45
Placebo1.783.693.007.09

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Time-weighted Sum of Pain Relief Scores (TOTPAR)

"TOTPAR based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None (0), A Little (1), Some (2), A Lot (3) or Complete (4). Higher scores indicated improvement (better pain relief). For time-weighted sum of pain relief scores from 0 to 4 hours (TOTPAR 0-4), from 4 to 8 hours (TOTPAR 4-8), and from 8 to 12 hours (TOTPAR 8-12): range of scores 0 (worst) to 16 (best). TOTPAR 0-12 range of scores 0 (worst) to 48 (best)." (NCT00913627)
Timeframe: 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 0 to 12 hours

,,,
Interventionunits on a scale (Mean)
TOTPAR 0-4TOTPAR 4-8TOTPAR 8-12TOTPAR 0-12
Ibuprofen IR/ER (Roller Compaction)10.0415.0612.7931.89
Ibuprofen IR/ER (Wet Granulation)9.9015.0213.5932.67
Naproxen8.0111.7610.7225.79
Placebo1.913.383.037.04

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Pain Relief (PR) Score

"PR score based on 5-point categorical pain relief scale. Participants asked, How much relief do you have from your starting pain? Range of scale: None [0], A Little [1], Some [2], A Lot [3] or Complete [4]. Higher scores indicated improvement (better pain relief)." (NCT00913627)
Timeframe: 15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, and 24 hours

,,,
Interventionunits on a scale (Mean)
15 minutes30 minutes45 minutes60 minutes90 minutes2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours11 hours12 hours13 hours14 hours16 hours24 hours
Ibuprofen IR/ER (Roller Compaction)0.361.021.722.042.402.663.063.173.132.982.942.832.552.512.472.432.432.282.151.92
Ibuprofen IR/ER (Wet Granulation)0.290.821.551.982.502.773.043.073.073.093.022.772.772.772.712.572.392.272.001.77
Naproxen0.280.791.211.672.092.242.432.432.362.402.292.282.162.142.171.982.032.031.982.00
Placebo0.070.210.310.410.410.550.550.620.660.720.720.660.660.590.590.550.620.660.590.69

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Area Under the Curve of Plasma Naproxen From 0 to t

Blood samples for evaluation of PK variables were collected over a 48-hour period after drug administration. (NCT00966641)
Timeframe: 30 minutes prior to administration; 30, 60, and 90 minutes post drug administration; and 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, and 48 hours post drug administration.

Interventionmin×μg/mL (Mean)
PL 310067763.0
Naproxen69427.9

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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 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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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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Number of Participants With 2-hour Pain Free Active Study Drug

All data was collected and measured from self-reported patient diaries (NCT01016678)
Timeframe: 3 years

,,,
InterventionParticipants (Number)
Pain Free at 2 hours post dose for Active TreatmenPain Free at 2 Hours Post Dose for Placebo
Migraine Attack 1352
Migraine Attack 2232
Migraine Attack 3213
Migraine Attack 4246

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Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention

All data was collected and measured from self-reported patient diaries (NCT01016678)
Timeframe: 3 years

Interventionpercentage of attacks (Number)
Active Drug32
Placebo18

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Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose

All data was collected and measured from self-reported patient diaries (NCT01016678)
Timeframe: 3 years

Interventionpercentage of attacks (Number)
Active Drug86
Placebo78

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Change in Number of Associated Headache Symptoms

Change in number of associated headache symptoms at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm. Associated headache symptoms measured included number of incidences of: sleeplessness, difficulty thinking, and bodily pain. (NCT01053507)
Timeframe: Day 0, Day 30

,
Interventionchange in number of symptoms (Mean)
Change in SleeplessnessChange in Difficulty ThinkingChange in Bodily Pain
Placebo-2.300.00-3.80
Treximet2.430.14-1.71

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Headache Days

Change in number of headache days at Day 0 vs. Day 30 in Treximet arm vs. Placebo arm. (NCT01053507)
Timeframe: Day 0, Day 30

Interventiondays (Mean)
Treximet-3.00
Placebo-0.30

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Headache Impact Test-6 (HIT-6) Score

The Headache Impact Test-6 (HIT-6) scale measures the impact of headache symptoms on subject's life. Possible scores range from 36 to 78. Score of 48 or less indicates headache has little impact on life. Score of 60-78 indicative of very severe impact. (NCT01053507)
Timeframe: Day 0, Day 30

,
Interventionunits on a scale (Mean)
Day 0Day 30
Placebo61.9161.91
Treximet59.4358.57

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Mental Efficiency Workload Test (MEWT) Performance Index

The Mental Efficiency Workload Test (MEWT) performance index is a scale with minimum and maximum values of 1 to 10, 1 indicates the poorest level and 10 indicates the best level of cognitive functioning. (NCT01053507)
Timeframe: Day 0, Day 30

,
Interventionunits on a scale (Mean)
Day 0Day 30
Placebo3.43.11
Treximet3.103.17

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Migraine Specific Quality of Life Questionnaire (MSQ)

The Migraine-Specific Quality of Life Questionnaire (MSQ) is a scale that measures the impact of migraine across three aspects: role function-restrictive (RR), role function-preventive (RP), and emotional function (EF). Possible scores on each subscale range from a 0 to 100 scale such that higher scores indicate better quality of life. (NCT01053507)
Timeframe: Day 0, Day 30

,
Interventionunits on a scale (Mean)
Day 0 - Role Function-Restrictive ScoreDay 30 - Role Function-Restrictive ScoreDay 0 - Role Function-Preventive ScoreDay 30 - Role Function-Preventive ScoreDay 0 - Emotional Function ScoreDay 30 - Emotional Function Score
Placebo45.7150.3968.6469.5550.9157.58
Treximet6059.5979.29806065.03

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Number of Participants Who Report They Are Comfortable With Disease Management, as Measured by a Three-item Likert Scale

Participants were asked to describe themselves as very comfortable, somewhat comfortable, or uncomfortable. Reported here are those who were very comfortable (NCT01071317)
Timeframe: 1 month after study enrollment

InterventionParticipants (Count of Participants)
Comprehensive Care10
Typical Care6

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Migraine Functional Impairment as Measured by Score on the Headache Impact Test 6 (HIT6) Scale

This is a standardized instrument commonly used in migraine research. Participants answer 6 Likert questions about the impact of migraine on their daily life. A score of 36, the lowest possible score, indicates minimal functional impairment. A score of 78, the highest possible score, indicates substantial functional impairment (NCT01071317)
Timeframe: 1 month after study enrollment

Interventionunits on a scale (Mean)
Comprehensive Care59
Typical Care56

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Number of Participants Who Report Satisfaction With Treatment, as Measured by a Three Item Likert Scale

Participants could report that they were completely satisfied, mostly satisfied or unsatisfied. Reported here are the number who were unsatisfied. (NCT01071317)
Timeframe: 1 month after study enrollment

InterventionParticipants (Count of Participants)
Comprehensive Care4
Typical Care4

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Number of Participants Who Returned to the Emergency Department for Management of Headache

We report the number of patient who returned to the emergency department for management of headache (NCT01071317)
Timeframe: 1 month after study enrollment

InterventionParticipants (Count of Participants)
Comprehensive Care1
Typical Care3

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Workplace Productivity and Activity Impairment Scale (WPAI).

The primary outcome measure was lost productivity (workplace productivity + non-workplace activity time) as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time. (NCT01086358)
Timeframe: 6 months

Interventionhours (Mean)
Arm 1 - Triptan4.15
Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm2.44

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Lost Workplace Productivity

This outcome measure was lost workplace productivity as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time. (NCT01086358)
Timeframe: 6 months

Interventionhours (Mean)
Arm 1 - Triptan2.25
Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm1.23

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Lost Activity Time

This outcome measure was lost activity time as measured by a variant of the Work Productivity and Activity Impairment Scale (WPAI) at 6 months.The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The unit of analysis is hours lost. The higher the score the greater impact on productivity. The range depends on the length of the attack, but in the sample among all observed attacks, lost work productivity ranged from 0-10.5 hours, while lost non-workplace activity time ranged from 0 to 8.95 hours. The total lost productivity is the sum of lost work productivity and lost non-workplace activity time. (NCT01086358)
Timeframe: 6 Months

Interventionhours (Mean)
Arm 1 - Triptan1.89
Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm1.22

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Favorable Response on Migraine-ACT

The Migraine-ACT is a 4-item scale with yes/no responses. A score of 3 or more is considered favorable. The primary efficacy dataset included the 37 patients that completed both phases of the study and uses the last observed headache. The Migraine-ACT is reported as a binary measure (3 or more positive responses). The outcome presented included the percentage with a score of 3 or more, and the Odds ratio comparing the two treatments. (NCT01086358)
Timeframe: 6 months

Interventionpercentage of favorable responses (Mean)
Arm 1 - Triptan46
Arm 2 - Sumatriptan/Naproxen Sodium (Treximet) Arm71

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Percent Change of Doses of Study Medication

"Comparing the number of doses of study medication taken during Baseline Period(days 1-30) of triptans(Group A) and non-steroidal anti-inflammatory drugs(NSAIDS)(Group B)to the number of doses of study medication taken during Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~e.g.Percent change=[(number of doses of study medication during Treatment Period Month 3(days 91-120)-number of doses of study medication during Baseline(days 1-30)/number of doses of study medication during Baseline(days 1-30)]*100%)." (NCT01090050)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.

,
Interventionpercent doses of study medication (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium825.6239.8135.6
Sumatriptan/Naproxen Sodium173.840.140.0

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Migraine Headache Duration From Time of Treatment to Pain Free

"Comparing mean migraine duration from time of treatment to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from time of treatment to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from time of treatment to pain free during Baseline(days 1-30)/mean duration from time of treatment to pain free during Baseline(days 1-30)]*100%)" (NCT01090050)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.

,
Interventionpercent hours of migraine duration (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium24.5828.4523.15
Sumatriptan/Naproxen Sodium176.70175.78151.12

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Migraine Headache Days With Greater Than 50% Reduction

Number of subjects with at least 50% reduction in number of migraine headache days reported in Baseline vs. Treatment Period months 1(days 31-60), 2(days 61-90), and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. (NCT01090050)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 92, and 121 respectively.

,
Interventionparticipants (Number)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium434
Sumatriptan/Naproxen Sodium303

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Migraine Disability Assessment(MIDAS)Questionnaire Total Score

"Change in Migraine Disability Assessment (MIDAS) total score (effect migraine headaches have on subjects daily function) from Baseline (Day 31) to 3 months after Baseline to end of Treatment Period Month 3(Day 121) following final dose of study medication in the Sumatriptan/Naproxen Sodium arm vs. the Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present." (NCT01090050)
Timeframe: Baseline MIDAS collected at Day 31, Post final dose study at Day 121.

,
Interventionscores on a scale (Mean)
Day 31Day 121
Naproxen Sodium81.216.4
Sumatriptan/Naproxen Sodium76.656.3

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Compliance With Lifestyle Changes

Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Lower scores indicate a better outcome. Higher scores indicate a worse outcome. (NCT01090050)
Timeframe: Day 121

InterventionUnits on a scale (Mean)
Sumatriptan/Naproxen Sodium2.00
Naproxen Sodium2.40

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Percent Change of Migraine Headache Days Compared to Baseline

Comparing the number of migraine headache days during Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days 91-120 in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%) (NCT01090050)
Timeframe: Day 121 (following 30 day Baseline Period and Treatment Period days 91-120.

Interventionpercent migraine headache days per month (Mean)
Sumatriptan/Naproxen Sodium-8.06
Naproxen Sodium-56.37

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Migraine Headache Duration From Onset to Pain Free

"Comparing mean migraine duration from onset to pain free from Baseline Period (Days 1-30), to each of the Treatment Period Months 1(days 31-60), 2(days 61-90), and 3(days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from each Treatment Period month compared to Baseline. The following formula was used for each treatment period month calculation.~e.g. Percent change=[(mean migraine duration from onset to pain free during Treatment Period Month 3(days 91-120)-mean migraine duration from onset to pain free during Baseline(days 1-30)/mean duration from onset to pain free during Baseline(days 1-30)]*100%)" (NCT01090050)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121 respectively.

,
Interventionpercent hours of migraine duration (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium26.3728.9119.65
Sumatriptan/Naproxen Sodium167.83176.18151.49

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Percent Change of Migraine Headache Days in All Treatment Periods Compared to Baseline

"Comparing number of migraine headache days from Baseline to Treatment Period Months 1, 2, and 3 in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Comparing the number of migraine headache days reported from Baseline Period days 1-30 to number of migraine headache days reported in Treatment Period days Months 1(days 31-60), 2(days 61-90),and 3(days 91-120)in the Sumatriptan/Naproxen Sodium arm versus (vs.) Naproxen Sodium arm. Each treatment period month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation.~e.g. percent change=[(total headache days during Treatment Period Month 3(days 91-120)-total headache days during Baseline(days 1-30)/total headache days during Baseline(days 1-30)]*100%)" (NCT01090050)
Timeframe: Baseline Period (days 1-30) collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121, respectively.

,
Interventionpercent migraine headache days per month (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium-61.55-45.42-56.37
Sumatriptan/Naproxen Sodium-26.22-2.96-8.06

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Change From Baseline in Categorical Pain Rating Scale Score

Subjects responded to question, 'My pain at this time is' with following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). Subjects completed this question at baseline (post-dental surgery) and after sleep period. The following measure is the change in pain rating from baseline. (NCT01118273)
Timeframe: Baseline and up to 10 hours

InterventionScores on a scale (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg-1.2
Naproxen Sodium 440 mg (BAYH6689)-1.0
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg-1.2
Naproxen Sodium 220 mg (BAYH6689)-0.7
DPH 50mg0.3
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg-0.9

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Sleep Efficiency Measured by Actigraphy

Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01118273)
Timeframe: Up to 10 hours

InterventionPercentage of sleep time (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg57.24
Naproxen Sodium 440 mg (BAYH6689)51.49
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg68.87
Naproxen Sodium 220 mg (BAYH6689)52.09
DPH 50mg12.85
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg56.70

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Sleep Latency Measured by Actigraphy

Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Sleep latency was defined as minutes to sleep onset since dosing, where sleep onset was the first 20-minute block with 19 minutes of sleep. For subjects who had not achieved sleep onset (e.g., due to taking rescue medication before achieving sleep onset), sleep latency was considered as censored at the time of wakening. (NCT01118273)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg29.17
Naproxen Sodium 440 mg (BAYH6689)32.81
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg46.77
Naproxen Sodium 220 mg (BAYH6689)31.58
DPH 50mg41.05
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg36.38

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Sleep Quality Index

Sleep Quality Index is the mean score of items, 'sleep quality', 'calm sleep', 'ease falling asleep', and 'slept throughout' on the Karolinska Sleep Diary, ranges from 1 (worst possible) to 5 (best possible). (NCT01118273)
Timeframe: Up to 10 hours

InterventionScores on a scale (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg3.49
Naproxen Sodium 440 mg (BAYH6689)2.89
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg3.40
Naproxen Sodium 220 mg (BAYH6689)3.12
DPH 50mg2.96
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg3.37

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Time to Rescue Medication

"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the time to taking rescue medication from the time the subject took study treatment." (NCT01118273)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mgNA
Naproxen Sodium 440 mg (BAYH6689)NA
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mgNA
Naproxen Sodium 220 mg (BAYH6689)NA
DPH 50mgNA
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mgNA

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Total Sleep Time by Subject Assessment

Subject responded to: Please estimate the number of hours and minutes you think that you slept. (NCT01118273)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg306.32
Naproxen Sodium 440 mg (BAYH6689)309.97
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg339.08
Naproxen Sodium 220 mg (BAYH6689)309.23
DPH 50mg160.49
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg299.58

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Total Sleep Time Measured by Actigraphy

"Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as awake from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero." (NCT01118273)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg339.80
Naproxen Sodium 440 mg (BAYH6689)304.60
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg413.89
Naproxen Sodium 220 mg (BAYH6689)308.89
DPH 50mg76.35
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg335.68

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Total Wake Time Measured by Actigraphy

Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01118273)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg253.72
Naproxen Sodium 440 mg (BAYH6689)290.03
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg180.21
Naproxen Sodium 220 mg (BAYH6689)285.62
DPH 50mg518.58
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg255.20

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Wake After Sleep Onset (WASO) Measured by Actigraphy

Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. WASO was defined as minutes of awake during the period of sleep onset and offset, where sleep onset is the first 20-minute block with 19 minutes of sleep. (NCT01118273)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg139.96
Naproxen Sodium 440 mg (BAYH6689)190.91
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg75.66
Naproxen Sodium 220 mg (BAYH6689)145.67
DPH 50mg428.34
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg129.02

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Wake Episode Measured by Actigraphy

Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Wake Episodes - # of blocks of continuous wake epochs (defined as 2 or more consecutive epochs scored as wake that ends when there is at least one epoch scored as sleep subsequent to the start of the wake epochs). (NCT01118273)
Timeframe: Up to 10 hours

InterventionWake episodes (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg8.38
Naproxen Sodium 440 mg (BAYH6689)10.86
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg13.26
Naproxen Sodium 220 mg (BAYH6689)9.89
DPH 50mg5.84
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg11.98

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Cumulative Proportion of Participants Taking Rescue Medication by Hour

"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the proportion of subjects who rescued in the study." (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 hour2 hours3 hours4 hours5 hours6 hours7 hours8 hours9 hours10 hours
DPH 50mg4172021242525252525
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg07777910101111
Naproxen Sodium 220 mg (BAYH6689)19910111213131313
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg0555567788
Naproxen Sodium 440 mg (BAYH6689)391111111112121212
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg26810111111111112

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Global Assessment of Study Medication as a Pain Reliever

Subject responded to question, 'How would you rating this study medication you received as a pain-reliever?' with the following choices: Poor (0), Fair(1), Good(2), Very Good(3), Excellent(4) (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
PoorFairGoodVery goodExcellent
DPH 50mg157500
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg554112
Naproxen Sodium 220 mg (BAYH6689)64791
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg25497
Naproxen Sodium 440 mg (BAYH6689)47745
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg167112

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Global Assessment of Study Medication as a Sleep-aid

Subject rating of following question with 0 being poor to 4 being excellent: How would you rate the study medication you received as a sleep aid? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
PoorFairGoodVery goodExcellent
DPH 50mg67320
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg06970
Naproxen Sodium 220 mg (BAYH6689)46631
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg23783
Naproxen Sodium 440 mg (BAYH6689)64741
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg14854

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Karolinska Sleep Diary - Calmness of Sleep

Subject rating of following question with 1 being very restless and 5 being very calm: How calm was your sleep? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 = Very restless2 = Rather restless3 = Neither restless nor calm4 = Rather calm5 = Very calm
DPH 50mg17361
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg07582
Naproxen Sodium 220 mg (BAYH6689)15761
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg163121
Naproxen Sodium 440 mg (BAYH6689)27463
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg015160

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Karolinska Sleep Diary - Ease of Awakening

Subject rating of following question with 1 being very difficult to 5 being very easy: Ease of awakening? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50mg01395
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg004144
Naproxen Sodium 220 mg (BAYH6689)111152
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg02588
Naproxen Sodium 440 mg (BAYH6689)10786
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg011155

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Karolinska Sleep Diary - Easiness to Fall Asleep

Subject rating of following question with 1 being very difficult to 5 being very easy: How easy was it to fall asleep? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50mg16740
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg05791
Naproxen Sodium 220 mg (BAYH6689)35372
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg121181
Naproxen Sodium 440 mg (BAYH6689)531121
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg031081

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Karolinska Sleep Diary - Premature Awakening

Subject rating of following question with 1 being woke up much too early to 3 being no: Premature awakening? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 = Woke up much too early2 = Woke up somewhat too early3 = No
DPH 50mg864
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg5134
Naproxen Sodium 220 mg (BAYH6689)677
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg2129
Naproxen Sodium 440 mg (BAYH6689)6106
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg589

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Karolinska Sleep Diary - Sleep Quality

Subject rating of following question with 1 being very poor and 5 being very good: How was your sleep? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 = Very poor2 = Rather poor3 = Neither poor nor good4 = Rather good5 = Very good
DPH 50mg15390
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg011092
Naproxen Sodium 220 mg (BAYH6689)12791
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg123143
Naproxen Sodium 440 mg (BAYH6689)401152
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg126112

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Karolinska Sleep Diary - Sufficient Sleep

Subject rating of following question with 1 being no, definitely too little to 5 being yes, definitely enough: Did you get enough (sufficient) sleep? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 = No, definitely too little2 = No, much too little3 = No, somewhat too little4 = Yes, almost enough5 = Yes, definitely enough
DPH 50mg24840
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg116122
Naproxen Sodium 220 mg (BAYH6689)114104
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg023144
Naproxen Sodium 440 mg (BAYH6689)43483
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg144103

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Karolinska Sleep Diary - Well Rested

Subject rating of following question with 1 being not rested at all to 3 being completely rested: Well-rested? (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
1 = Not rested at all2 = Somewhat unrested3 = Completely rested
DPH 50mg3141
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg1174
Naproxen Sodium 220 mg (BAYH6689)0128
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg0149
Naproxen Sodium 440 mg (BAYH6689)4144
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg1138

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Number of Times Participants Took Rescue Medication

"Subjects were allowed to rescue and take a non-study pain reliever if the pain was not tolerable. This measure represents for the number of times rescue medication was taken by a subject." (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
0123
DPH 50mg22230
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg161100
Naproxen Sodium 220 mg (BAYH6689)141300
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg19800
Naproxen Sodium 440 mg (BAYH6689)151200
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg151200

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Overall Rating of Pain Relief

"Subjects responded to question, Overall, the relief from my starting pain was by checking one of the following choices: no relief (0), a little relief (1), some relief (2), a lot of relief (3), complete relief (4)." (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionParticipants (Number)
No reliefA little reliefSome reliefA lot reliefComplete relief
DPH 50mg119520
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg425133
Naproxen Sodium 220 mg (BAYH6689)634113
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg235134
Naproxen Sodium 440 mg (BAYH6689)347103
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg148122

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Overall Rating of Severity in Categorical Pain Rating Scale Score

Subject responded to question, 'My pain at this time is' by selecting one of the following choices: no pain (0), mild pain (1), moderate pain (2), or severe pain (3). (NCT01118273)
Timeframe: Up to 10 hours

,,,,,
InterventionScores on a scale (Mean)
BaselinePost-Baseline
DPH 50mg2.372.67
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg2.221.41
Naproxen Sodium 220 mg (BAYH6689)2.481.78
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg2.481.26
Naproxen Sodium 440 mg (BAYH6689)2.481.48
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg2.441.26

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Overall Rating of Severity in Visual Analog Scale (VAS) Score

Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain. (NCT01118273)
Timeframe: At 10 hours

,,,,,
InterventionScores on a scale (Mean)
BaselinePost-Baseline
DPH 50mg79.1584.26
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg73.1138.19
Naproxen Sodium 220 mg (BAYH6689)73.7048.59
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg78.1930.33
Naproxen Sodium 440 mg (BAYH6689)77.2640.30
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg76.1132.11

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Change From Baseline in Visual Analog Scale (VAS) Score

Subjects completed the VAS scale at baseline (post-dental surgery) and after completion of the sleep period. Subjects marked a line on a 100-mm scale to indicate the severity of pain they are experiencing from 0 being no pain to 100 being worse possible pain.This measure indicates the change in pain severity rating on the VAS scale from baseline. (NCT01118273)
Timeframe: Baseline and up to 10 hours

InterventionScores on a scale (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg-44.04
Naproxen Sodium 440 mg (BAYH6689)-36.65
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg-47.26
Naproxen Sodium 220 mg (BAYH6689)-25.89
DPH 50mg6.00
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg-35.89

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Activity Mean Measured by Actigraphy

Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. Activity mean - average movement per minute. (NCT01118273)
Timeframe: Up to 10 hours

InterventionMovement per minute (Least Squares Mean)
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg42.09
Naproxen Sodium 440 mg (BAYH6689)48.48
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg26.73
Naproxen Sodium 220 mg (BAYH6689)52.36
DPH 50mg72.43
Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg41.14

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Mean Change From Baseline on Satisfaction of the Severity of Dyspepsia Assessment (SODA) Subscales

Mean Change in Satisfaction on SODA Assessment. Questions/statements to rate about satisfaction/dissatisfaction with their present level of abdominal discomfort. Question 1: 4-point scale range 0 (extremely unhappy) to 4 (extremely happy), statement 2 (I feel satisfied with my health with regard to abdominal discomfort) & statement 3 (I am pleased because my abdominal discomfort seems under control) on a 5 point scale (definitely true to definitely false) & question 4 rated how pleased subjects were with abdominal discomfort on a 10 point scale. Total satisfaction composite range: 2-23 (NCT01129011)
Timeframe: baseline to 6 Months

InterventionUnits on SODA Subscale (Least Squares Mean)
PN400 (VIMOVO)1.9
Naproxen0.5

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Number of Participants With Gastric Ulcer Confirmed by Endoscopy

The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached. (NCT01129011)
Timeframe: 6 months

InterventionParticipants (Number)
PN400 (VIMOVO)15
Naproxen51

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The Number of Participants Developing Duodenal Ulcers Throughout 6 Months of Treatment

The Number of Participants Developing Duodenal Ulcers at any time during the 6 Months of the treatment period (NCT01129011)
Timeframe: 6 months

InterventionParticipants (Number)
PN400 (VIMOVO)2
Naproxen12

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The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events or to Duodenal Ulcer

The Number of Participants Discontinuing from the Study Due to non-steroidal antiinflammatory drug (NSAID)-Associated Upper GI Adverse Events or to Duodenal Ulcer during the treatment period (NCT01129011)
Timeframe: 6 Months

InterventionParticipants (Number)
PN400 (VIMOVO)10
Naproxen25

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The Number of Participants With Pre-Specified NSAID-Associated Upper GI Adverse Events or Duodenal Ulcers

The Number of Participants with Pre-Specified non-steroidal antiinflammatory drug (NSAID)-Associated Upper Gastrointestinal (UGI) Adverse Events or Duodenal Ulcers after 6 months of treatment. Pre-specified UGI adverse events typically associated with NSAID use include dyspepsia, abdominal pain, gastritis, erosive esophagitis, duodenitis, abdominal discomfort (NCT01129011)
Timeframe: 6 months

InterventionParticipants (Number)
PN400 (VIMOVO)114
Naproxen151

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Mean Change From Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales

"Mean Change from Baseline on Pain Intensity of the Severity of Dyspepsia Assessment (SODA) Subscales. There are 6 questions about abdominal pain during the past 7 days: q 1-5 on average: 1. rate with a number between 0 (no pain) and 100 (pain as bad as it could be), 2. rate with a number between 0 (no discomfort) and 10 (discomfort as bad as it can be), 3. on a scale of 5 (from none to excriciating), 4. on 100 mm VAS, 5. on a scale of 4 and 6. worst abdominal pain scale 0 (no discomfort) and 10 (discomfort as bad as it can be). Total composite possible range for pain intensity is: 2-47" (NCT01129011)
Timeframe: Baseline to 6 Months

InterventionUnits on SODA Subscale (Least Squares Mean)
PN400 (VIMOVO)-3
Naproxen0

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Heartburn Symptom Resolution, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit

"Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were:~none: no symptoms~mild: awareness of symptom, but easily tolerated~moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep)~severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck." (NCT01129011)
Timeframe: 6 months

Interventionparticipants (Number)
PN400 (VIMOVO)102
Naproxen62

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Improvement From Baseline in Upper Abdominal Pain and Discomfort Scores at 6 Months, Based on the Overall Treatment Evaluation for Dyspepsia Questionnaire

"Improvement from baseline in Upper Abdominal Pain and Discomfort scores at 6 months, based on the overall Treatment Evaluation for Dyspepsia Questionnaire. Subjects were asked: since treatment started, has there been any change in your upper abdominal pain and/or discomfort? Answers would be better/about the same/worse. Participants with the response better (instead of about the same or worse), are tabulated by treatment group." (NCT01129011)
Timeframe: change from baseline at 6 Months

InterventionParticipants (Number)
PN400 (VIMOVO)79
Naproxen63

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Mean Change From Baseline on Non-Pain Symptoms of the Severity of Dyspepsia Assessment (SODA) Subscales

Change from Baseline of Non-Pain Symptoms on the SODA Assessment. There are 7 categories about the non-pain symptoms: burping/beching, heartburn, bloating, passing gas, sour taste, nausea and bad breath. For each of these categories, subjects were to rate during the past seven days, on average, the severity on a 5 point scale ranging from no problem to very severe problem. The scores are combined into a single composite score. The total possible range of the non-pain symptoms subscale is: 7-35. (NCT01129011)
Timeframe: baseline to 6 Months

InterventionUnits on SODA Subscale (Least Squares Mean)
PN400 (VIMOVO)-1.1
Naproxen0.1

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Change in the Total Serum Adiponectin (T-ADP)

Change in total serum adiponectin after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Interventionug/mL (Mean)
Treatment Responders 30 Minutes After Treatment-0.96
Treatment Non-Responders 30 Minutes After Treatment0.25
Treatment Responders 60 Minutes After Treatment-0.97
Treatment Non-Responders 60 Minutes After Treatment0.29
Treatment Responders 120 Minutes After Treatment-0.98
Treatment Non-Responders0.24

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High Molecular Weight (HMW)-Adiponectin (ADP)

serum HMW-ADP levels after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Interventionug/mL (Mean)
Treatment Responders 120 Minutes After Treatment-0.24
Treatment Non Responders 120 Minutes After Treatment-0.08
Treatment Responders 30 Minutes After Treatment-0.23
Treatment Non-Responders 30 Minutes After Treatment-0.14
Treatment Non-Responders 60 Minutes After Treatment-0.24
Treatment Responders 60 Minutes After Treatment-0.21

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High Molecular Weight (HMW): T-ADP

serum HMW:T-ADP levels after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes, 60 minutes, 120 minutes after treatment

Interventionratio (Mean)
Treatment Responders 120 Minutes After Treatment-0.04
Treatment Non Responders 120 Minutes After Treatment0.01
Treatment Responders 30 Minutes After Treatment-0.02
Treatment Non-Responders 30 Minutes After Treatment0.01
Treatment Non-Responders 60 Minutes After Treatment0.01
Treatment Responders 60 Minutes After Treatment-0.02

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Leptin

serum leptin levels after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Interventionug/mL (Mean)
Treatment Responders 120 Minutes After Treatment0.71
Treatment Non Responders 120 Minutes After Treatment0.89
Treatment Responders 30 Minutes After Treatment0.28
Treatment Non-Responders 30 Minutes After Treatment0.84
Treatment Non-Responders 60 Minutes After Treatment1.00
Treatment Responders 60 Minutes After Treatment0.02

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Low Molecular Weight (LMW)-ADP

serum LMW-ADP levels after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Interventionug/mL (Mean)
Treatment Responders 120 Minutes After Treatment0.32
Treatment Non Responders 120 Minutes After Treatment-0.43
Treatment Responders 30 Minutes After Treatment0.15
Treatment Non-Responders 30 Minutes After Treatment-0.25
Treatment Non-Responders 60 Minutes After Treatment-0.45
Treatment Responders 60 Minutes After Treatment0.11

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Low Molecular Weight (LMW):Total (T)-ADP

serum LMW:T-ADP levels after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Interventionratio (Mean)
Treatment Responders 120 Minutes After Treatment0.04
Treatment Non Responders 120 Minutes After Treatment-0.04
Treatment Responders 30 Minutes After Treatment-0.01
Treatment Non-Responders 30 Minutes After Treatment0.02
Treatment Non-Responders 60 Minutes After Treatment-0.04
Treatment Responders 60 Minutes After Treatment0.01

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Middle Molecular Weight (MMW)-ADP

serum MMW-ADP levels after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Interventionug/mL (Mean)
Treatment Responders 120 Minutes After Treatment-0.02
Treatment Non Responders 120 Minutes After Treatment0.02
Treatment Responders 30 Minutes After Treatment-0.03
Treatment Non-Responders 30 Minutes After Treatment-0.02
Treatment Non-Responders 60 Minutes After Treatment0.16
Treatment Responders 60 Minutes After Treatment-0.03

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Resistin

serum resistin levels after treatment in responders and non responders (NCT01138150)
Timeframe: 30 minutes after treatment, 60 minutes after treatment, 120 minutes after treatment

Interventionug/mL (Mean)
Treatment Responders 120 Minutes After Treatment-0.95
Treatment Non Responders 120 Minutes After Treatment-0.97
Treatment Responders 30 Minutes After Treatment-1
Treatment Non-Responders 30 Minutes After Treatment-0.88
Treatment Non-Responders 60 Minutes After Treatment-1.36
Treatment Responders 60 Minutes After Treatment-0.79

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Degree of GI Injury at Day 15

"Degree of mucosal injury was assessed by endoscopy, with the following scoring system:~Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer" (NCT01139190)
Timeframe: 15 days

,
Interventionparticipants (Number)
Gastroduodenal Score of 3 or HigherGastroduodenal Score of 2 or Less
Naproxen2013
PL31002311

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WOMAC Total Score

The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance. (NCT01147458)
Timeframe: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

,,,
InterventionUnits on a scale (Mean)
Period 1 BaselinePeriod 1 End of TreatmentPeriod 2 BaselinePeriod 2 End of Treatment
Naproxen Followed by PF-04191834 + Naproxen54.845.450.340.6
PF-04191834 + Naproxen Followed by Naproxen52.943.545.135.4
PF-04191834 Followed by Placebo53.750.046.439.4
Placebo Followed by PF-0419183456.049.944.242.6

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WOMAC Stiffness Domain Score

The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness. (NCT01147458)
Timeframe: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

,,,
InterventionUnits on a scale (Mean)
Period 1 BaselinePeriod 1 End of TreatmentPeriod 2 BaselinePeriod 2 End of Treatment
Naproxen Followed by PF-04191834 + Naproxen4.84.04.43.6
PF-04191834 + Naproxen Followed by Naproxen4.73.83.92.9
PF-04191834 Followed by Placebo4.84.44.23.3
Placebo Followed by PF-041918345.04.43.93.5

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WOMAC Physical Function Domain Score

The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function. (NCT01147458)
Timeframe: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

,,,
InterventionUnits on a scale (Mean)
Period 1 BaselinePeriod 1 End of TreatmentPeriod 2 BaselinePeriod 2 End of Treatment
Naproxen Followed by PF-04191834 + Naproxen38.732.035.628.7
PF-04191834 + Naproxen Followed by Naproxen37.430.831.625.0
PF-04191834 Followed by Placebo37.735.432.627.9
Placebo Followed by PF-0419183439.735.731.630.8

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Rescue Medication Use

Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week. (NCT01147458)
Timeframe: Day -7 (Visit 2) up to 28-day follow-up (Visit 10)

,,,
InterventionNumber of pills (Mean)
Period 1Period 2
Naproxen Followed by PF-04191834 + Naproxen1073.7932.7
PF-04191834 + Naproxen Followed by Naproxen1210.2980.8
PF-04191834 Followed by Placebo1096.11100.0
Placebo Followed by PF-041918341114.51078.1

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Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2

The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain. (NCT01147458)
Timeframe: Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)

,,,
InterventionUnits on a scale (Mean)
BaselineChange from Baseline
Naproxen Followed by PF-04191834 + Naproxen10.2-2.1
PF-04191834 + Naproxen Followed by Naproxen9.7-1.5
PF-04191834 Followed by Placebo9.7-1.8
Placebo Followed by PF-041918348.6-0.6

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Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1

The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain. (NCT01147458)
Timeframe: Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)

,,,
InterventionUnits on a scale (Mean)
BaselineChange from Baseline
Naproxen Followed by PF-04191834 + Naproxen11.1-1.6
PF-04191834 + Naproxen Followed by Naproxen10.8-1.9
PF-04191834 Followed by Placebo11.3-1.2
Placebo Followed by PF-0419183411.5-1.6

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Daily Diary Pain Score During Week 1 of Each Treatment Period

The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible). (NCT01147458)
Timeframe: 4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits

,,,
InterventionUnits on a scale (Mean)
Baseline of Period 1Week 1 of Period 1Baseline of Period 2Week 1 of Period 2
Naproxen Followed by PF-04191834 + Naproxen6.75.65.65.0
PF-04191834 + Naproxen Followed by Naproxen6.45.45.44.7
PF-04191834 Followed by Placebo6.56.25.15.1
Placebo Followed by PF-041918346.96.54.84.8

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Plasma Concentration of PF-04191834

(NCT01147458)
Timeframe: Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43

,
Interventionng/mL (Mean)
Period 1 Day 1 Post-dosePeriod 1 Day 8 Pre-dosePeriod 1 Day 8 Post-dosePeriod 1 Day 15 Pre-dosePeriod 1 Day 15 Post-dosePeriod 2 Day 29 Post-dosePeriod 2 Day 36 Pre-dosePeriod 2 Day 36 Post-dosePeriod 2 Day 43 Pre-dosePeriod 2 Day 43 Post-dose
PF-04191834 600 mg BID121.5623.5511.01007797.5122.1581.2550.4137.9127.5
PF-04191834 600 mg BID + Naproxen 500 mg BID214.811551117843.0736.0137.31141115412711181

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Daily Diary Pain Score During Week 2 of Each Treatment Period

The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible). (NCT01147458)
Timeframe: Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2

,,,
InterventionUnits on a scale (Mean)
Baseline of Period 1Week 2 of Period 1Baseline of Period 2Week 2 of Period 2
Naproxen Followed by PF-04191834 + Naproxen6.75.65.64.8
PF-04191834 + Naproxen Followed by Naproxen6.45.35.44.4
PF-04191834 Followed by Placebo6.55.85.14.8
Placebo Followed by PF-041918346.95.84.84.5

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Importance Weighted Total WOMAC Score

Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance. (NCT01147458)
Timeframe: Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2

,,,
InterventionUnits on a scale (Mean)
Period 1 BaselinePeriod 1 End of TreatmentPeriod 2 BaselinePeriod 2 End of Treatment
Naproxen Followed by PF-04191834 + Naproxen20.116.618.414.9
PF-04191834 + Naproxen Followed by Naproxen19.415.916.613.0
PF-04191834 Followed by Placebo19.718.317.014.4
Placebo Followed by PF-0419183420.518.216.215.6

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Part B: Proportion of Participants Who Used Rescue Analgesic During Study

Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication. (NCT01160822)
Timeframe: Day 4, Weeks 1, 2, 4, 8 and 12

,,
Interventionproportion of participants (Number)
Day 4Week 1Week 2Week 4Week 8Week 12
Part B: Canakinumab0.270.450.520.550.570.62
Part B: Naproxen0.190.230.330.430.590.70
Part B: Placebo0.300.470.570.600.690.75

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Part B: Physician's Global Assessment of Response to Treatment at Week 4

The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 4

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab4151451
Part B: Naproxen9211240
Part B: Placebo5201131

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Part B: Physician's Global Assessment of Response to Treatment at Week 8

The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 8

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab5131071
Part B: Naproxen9161350
Part B: Placebo3221120

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Part B: Physician's Global Assessment of Response to Treatment at Week 2

The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 2

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab7151062
Part B: Naproxen1520940
Part B: Placebo5201342

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Patient's Global Assessment of Response to Treatment at Week 2

Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 2

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab5121392
Part B: Naproxen11191251
Part B: Placebo6161452

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Part B: Physician's Global Assessment of Response to Treatment at Day 4

The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Day 4

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab8111643
Part B: Naproxen6211371
Part B: Placebo7181432

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Apparent Clearance of Canakinumab From Plasma (CL/F)

(NCT01160822)
Timeframe: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.

InterventionmL/hr (Mean)
Part A: Canakinumab 150 mg9.58
Part A: Canakinumab 300 mg9.66
Part A: Canakinumab 600 mg13.3
Part B: Canakinumab8.65

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Apparent Volume of Distribution During Terminal Phase (Vz/F)

(NCT01160822)
Timeframe: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.

InterventionmL (Mean)
Part A: Canakinumab 150 mg7320
Part A: Canakinumab 300 mg8060
Part A: Canakinumab 600 mg8930
Part B: Canakinumab8910

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Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)

(NCT01160822)
Timeframe: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.

Interventionµg*day/mL (Mean)
Part A: Canakinumab 150 mg16900
Part A: Canakinumab 300 mg32400
Part A: Canakinumab 600 mg49300
Part B: Canakinumab78300

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Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)

(NCT01160822)
Timeframe: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.

Interventionµg*day/mL (Mean)
Part A: Canakinumab 150 mg16900
Part A: Canakinumab 300 mg30700
Part A: Canakinumab 600 mg56100
Part B: Canakinumab71900

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Maximum Observed Plasma Concentration of Canakinumab (Cmax)

(NCT01160822)
Timeframe: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.

Interventionµg/mL (Mean)
Part A: Canakinumab 150 mg23.0
Part A: Canakinumab 300 mg34.8
Part A: Canakinumab 600 mg65.5
Part B: Canakinumab77.8

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Patient's Global Assessment of Response to Treatment on Day 4

Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Day 4

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab6141156
Part B: Naproxen4201662
Part B: Placebo8161352

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Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)

"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.~Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects." (NCT01160822)
Timeframe: Baseline and Day 4

Interventionunits on a scale (Mean)
Part B: Canakinumab-26.7
Part B: Placebo-26.5
Part B: Naproxen-27.6

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Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale

"The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.~Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects." (NCT01160822)
Timeframe: Baseline and Week 4

Interventionunits on a scale (Mean)
Part B: Canakinumab-3.5
Part B: Placebo-4.0
Part B: Naproxen-4.5

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Terminal Phase Half-life (t1/2) of Canakinumab

The time it takes for the concentration level of canakinumab to fall to 50% of the original value. (NCT01160822)
Timeframe: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.

Interventionhours (Mean)
Part A: Canakinumab 150 mg539
Part A: Canakinumab 300 mg578
Part A: Canakinumab 600 mg474
Part B: Canakinumab736

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Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)

(NCT01160822)
Timeframe: Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.

Interventionhours (Median)
Part A: Canakinumab 150 mg96.2
Part A: Canakinumab 300 mg86.7
Part A: Canakinumab 600 mg144
Part B: Canakinumab95.9

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Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)

"After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).~Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects." (NCT01160822)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12
Part B: Canakinumab-25.6-26.2-25.1
Part B: Naproxen-36.1-33.0-27.8
Part B: Placebo-31.1-30.9-32.1

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Part A: Number of Participants With Intolerance Events

An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. (NCT01160822)
Timeframe: Baseline to Day 3

Interventionparticipants (Number)
Part A: Canakinumab 150 mg0
Part A: Canakinumab 300 mg0
Part A: Canakinumab 600 mg0
Part A: Placebo0

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Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)

A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). (NCT01160822)
Timeframe: Baseline, Day 4, Weeks 1, 2, 4, 8 and 12

,,
Interventionpercentage of participants (Number)
Day 4 [N=42, 44, 48]Week 1 [N=42, 44, 48]Week 2 [N=41, 44, 48]Week 4 [N=39, 40, 46]Week 8 [N=36, 38, 43]Week 12 [N=35, 37, 41]
Part B: Canakinumab50.040.546.351.352.848.6
Part B: Naproxen47.956.362.571.755.853.7
Part B: Placebo43.245.543.255.050.051.4

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Patient's Global Assessment of Response to Treatment at Week 8

Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 8

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab591192
Part B: Naproxen1018951
Part B: Placebo519851

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Patient's Global Assessment of Response to Treatment at Week 4

Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 4

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab5151081
Part B: Naproxen9181342
Part B: Placebo6161062

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Part B: Physician's Global Assessment of Response to Treatment at Week 12

The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 12

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab513692
Part B: Naproxen1015871
Part B: Placebo7161220

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Patient's Global Assessment of Response to Treatment at Week 12

Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor. (NCT01160822)
Timeframe: Week 12

,,
Interventionparticipants (Number)
ExcellentGoodAcceptablePoorVery poor
Part B: Canakinumab4127111
Part B: Naproxen7151351
Part B: Placebo8131420

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Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales

"The WOMAC consists of 3 subscales:~The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.~The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.~The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.~Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects." (NCT01160822)
Timeframe: Baseline and Weeks 4, 8 and 12

,,
Interventionunits on a scale (Mean)
Pain at Week 8Pain at Week 12Stiffness at Week 4Stiffness at Week 8Stiffness at Week 12Function at Week 4 [N=38, 39, 43]Function at Week 8 [N=35, 36, 41]Function at Week 12 [N= 33, 36, 39]
Part B: Canakinumab-3.7-3.2-1.3-1.3-1.1-14.1-13.7-13.4
Part B: Naproxen-4.6-4.0-1.9-2.0-1.4-16.2-16.1-14.4
Part B: Placebo-4.2-4.5-1.5-1.5-1.7-15.9-14.9-16.5

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Direct Medical Costs

Direct Medical Costs consisted of two categories: primarily hospital billed services, and primarily physician billed services. Primary hospital billed services were as defined by Medicare billing practice. (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

,
Interventiondollars (Mean)
Primarily hospital billed servicesPrimarily physician billed services
Medical Therapy13001601
Radiofrequency Endometrial Ablation34941837

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Quality of Life Score Using the Short Form-12 (SF-12) Health Survey

Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 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. Improvement was defined as a change of ≥ 6 points. (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

,
Interventionunits on a scale (Mean)
SF-12 Physical ScaleSF-12 Mental Scale
Medical Therapy54.249.8
Radiofrequency Endometrial Ablation54.553.8

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Subject Satisfaction at 12 Months

Subject satisfaction was ascertained by asking study participants to choose from one of four categories relating to their general satisfaction with treatment: totally satisfied, generally satisfied, acceptable improvement in symptoms, or unacceptable treatment. (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

,
Interventionparticipants (Number)
Totally satisfiedGenerally satisfiedAcceptable improvementUnacceptable
Medical Therapy12421
Radiofrequency Endometrial Ablation30100

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Change in Ferritin From Baseline

(NCT01165307)
Timeframe: Measured at 12 months following initial treatment

Interventionug/L (Median)
Medical Therapy4.0
Radiofrequency Endometrial Ablation10.0

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Change in Hemoglobin

(NCT01165307)
Timeframe: baseline, 12 months

Interventiong/dL (Median)
Medical Therapy0.0
Radiofrequency Endometrial Ablation0.5

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Ferritin at 12 Months

(NCT01165307)
Timeframe: Measured at 12 months following initial treatment

Interventionug/L (Median)
Medical Therapy25.0
Radiofrequency Endometrial Ablation26.5

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Hemoglobin at 12 Months

(NCT01165307)
Timeframe: Measured at 12 months following initial treatment

Interventiong/dL (Median)
Medical Therapy13.2
Radiofrequency Endometrial Ablation13.4

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Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).

The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation. (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

Interventionunits on a scale (Median)
Medical Therapy15
Radiofrequency Endometrial Ablation0

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Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)

The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 100 mm in length. Possible scores range from 0 (no pain) to 100 (worst possible pain). The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

Interventionmm (Median)
Medical Therapy0.4
Radiofrequency Endometrial Ablation0.0

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Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )

The MMAS questionnaire captures the subjective consequences of menorrhagia on six domains: practical difficulties; social life; psychological wellbeing; physical health; work routine; and family life. Each of the six domains has four statements that represent four levels of response. Respondents indicate the statement that best matches their feelings for each domain. The statement scores derive from a weighting of the domains and a weighting of the statements in level of severity by women in the original study. Scores range from 0 (worst possible state in all domains) to 100 (best possible state in all domains). (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

Interventionunits on a scale (Median)
Medical Therapy100
Radiofrequency Endometrial Ablation100

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Bleeding Pattern at 12 Months

"The menstruation pattern of the subjects was evaluated. A bleeding episode was defined as any set of one or more bleeding days bounded at each end by two or more bleeding-free days. The bleeding pattern was analyzed using a 90 day reference period and divided into groups, (based on World Health Organization (WHO) classification of clinically important bleeding patterns). The groups are Amenorrhea (no bleeding during the reference period); Infrequent bleeding (fewer than 3 bleeding episodes); Irregular bleeding (between 3 and 5 episodes with less than 3 bleeding-free intervals of length 14 days or more); Prolonged bleeding (1 or more bleeding episodes lasting 14 days or more); Eumenorrhea normal pattern (none of the above patterns)." (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

,
Interventionparticipants (Number)
AmenorrheaIrregular/Infrequent bleedingProlonged bleedingEumenorrhea
Medical Therapy5428
Radiofrequency Endometrial Ablation16609

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Indirect Medical Costs

Indirect cost A refers to cost of sanitary products and lack of activity, indirect cost B refers to cost of sanitary products and reduced work days, and indirect cost C refers to cost of sanitary products, lack of activity, and reduced work days. (NCT01165307)
Timeframe: Measured at 12 months following initial treatment

,
Interventiondollars (Mean)
Indirect costs AIndirect costs BIndirect costs C
Medical Therapy741264968
Radiofrequency Endometrial Ablation12427138

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Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Naproxen

Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. (NCT01208207)
Timeframe: Baseline and up to Week 6

Interventionmm VAS (Least Squares Mean)
Etoricoxib 90 mg-31.23
Naproxen 1000 mg-30.59

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Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 90 mg vs. Etoricoxib 60 mg

Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. (NCT01208207)
Timeframe: Baseline and up to Week 6

Interventionmm VAS (Least Squares Mean)
Etoricoxib 90 mg-30.51
Etoricoxib 60 mg-28.94

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Time-Weighted Average Change From Baseline in the Spinal Pain Intensity in Study Part 1: Etoricoxib 60 mg vs. Naproxen

Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. The time-weighted average change is calculated by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average. (NCT01208207)
Timeframe: Baseline and up to Week 6

Interventionmm VAS (Least Squares Mean)
Etoricoxib 60 mg-29.00
Naproxen 1000 mg-30.59

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Number of Participants Discontinuing Study Treatment Due to an Adverse Event

(NCT01208207)
Timeframe: Up to 26 weeks

InterventionParticipants (Number)
Etoricoxib 60 mg (Part I)22
Etoricoxib 90 mg (Part I)2
Naproxen 1000 mg (Part I)6
Etoricoxib 60 mg / 60 mg (Part II)3
Etoricoxib 60 mg / 90 mg (Part II)9
Etoricoxib 90 mg / 90 mg (Part II)4
Naproxen 1000 mg (Part II)2

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Average Change From Week 6 in the Spinal Pain Intensity Over Weeks 10 and 12 in Study Part 2: Etoricoxib 60/90 mg vs. Etoricoxib 60mg (Non-responders From Part I)

Spinal Pain Intensity is measured using a visual analog scale (VAS) from 0-100 mm with a lower value representing a better response. Average change from Week 6 in Spinal Pain Intensity (VAS) over Weeks 10 and 12 is calculated as the average Spinal pain Intensity (VAS) value over Weeks 10 and 12 minus the Spinal Pain Intensity (VAS) at Week 6. (NCT01208207)
Timeframe: Week 6 to Week 10 and Week 12

Interventionmm VAS (Least Squares Mean)
Etoricoxib 60 mg/ 90 mg-9.97
Etoricoxib 60 mg / 60 mg-7.26

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Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0

"Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours.~Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max~The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60." (NCT01229228)
Timeframe: Over 0 to 12 Hours

Interventionunits on a scale (Least Squares Mean)
Naproxen Test (Lower Dose)25.868
Naproxen Test (Upper Dose)31.948
Naprosyn 250 mg24.373
Naprosyn 500 mg28.549
Placebo9.531

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Karolinska Sleep Diary - Calmness of Sleep

Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very restless2 = Rather restless3 = Neither restless nor calm4 = Rather calm5 = Very calm
DPH 50 mg51610123
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)829396826
Naproxen Sodium 440 mg (BAYH6689)748426122
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)835377632

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Karolinska Sleep Diary - Ease of Awakening

Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg01101520
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)04249448
Naproxen Sodium 440 mg (BAYH6689)12338856
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)07289855

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Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night

Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) (NCT01280591)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)6.2
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)5.8
Naproxen Sodium 440 mg (BAYH6689)5.5
DPH 50 mg4.4

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Karolinska Sleep Diary - Premature Awakening

Subjects responded to the following question: Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Woke up much too early2 = Woke up somewhat too early3 = No
DPH 50 mg23176
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)545957
Naproxen Sodium 440 mg (BAYH6689)658035
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)407771

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Karolinska Sleep Diary - Sleep Quality

Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very poor2 = Rather poor3 = Neither poor nor good4 = Rather good5 = Very good
DPH 50 mg31013182
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)524526821
Naproxen Sodium 440 mg (BAYH6689)539695512
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)323468234

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Karolinska Sleep Diary - Sufficient Sleep

Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = No, definitely too little2 = No, much too little3 = No, somewhat too little4 = Yes, almost enough5 = Yes, definitely enough
DPH 50 mg1081495
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)2124405233
Naproxen Sodium 440 mg (BAYH6689)1822565826
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)714378446

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Karolinska Sleep Diary - Well Rested

Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Not rested at all2 = Somewhat unrested3 = Completely rested
DPH 50 mg8317
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)219554
Naproxen Sodium 440 mg (BAYH6689)1611648
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)910079

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Overall Rating of Pain Relief

"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)." (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
0 = No relief1 = A little relief2 = Some relief3 = A lot of relief4 = Complete relief
DPH 50 mg7911183
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)894295329
Naproxen Sodium 440 mg (BAYH6689)688246240
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)444326558

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Time to Rescue Medication

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)NA
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)NA
Naproxen Sodium 440 mg (BAYH6689)NA
DPH 50 mg113.5

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Subjective Sleep Questionnaire - Time to Fall Asleep Last Night

Subjects responded to Estimate of how long it took to fall asleep (minutes) (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)40.0
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)40.7
Naproxen Sodium 440 mg (BAYH6689)53.4
DPH 50 mg42.4

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Sleep Latency Measured by Actigraphy

Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)25.50
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)30.25
Naproxen Sodium 440 mg (BAYH6689)25.75
DPH 50 mg41.50

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Subjective Sleep Questionnaire - Quality of Your Sleep Last Night

Subjects responded to Quality of sleep (10-point scale, where 1 was poor and 10 was excellent) (NCT01280591)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)6.4
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)5.9
Naproxen Sodium 440 mg (BAYH6689)5.4
DPH 50 mg4.9

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Wake Time After Sleep Onset (WASO) Measured by Actigraphy

WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)143.7
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)230.9
Naproxen Sodium 440 mg (BAYH6689)214.0
DPH 50 mg431.4

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Global Assessment of Investigational Product as a Sleep Aid

The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4). (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg39670
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)1029472613
Naproxen Sodium 440 mg (BAYH6689)295137177
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)839584912

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Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed

Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes) (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)73.8
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)75.3
Naproxen Sodium 440 mg (BAYH6689)103.5
DPH 50 mg81.7

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Karolinska Sleep Diary - Easiness to Fall Asleep

Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5) (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg8161093
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)1145574215
Naproxen Sodium 440 mg (BAYH6689)1259554113
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)841576220

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Change From Baseline in Pain Intensity

Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain (NCT01280591)
Timeframe: Baseline and up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)-1.2
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)-0.7
Naproxen Sodium 440 mg (BAYH6689)-0.9
DPH 50 mg0.1

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Sleep Efficiency Measured by Actigraphy

Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionPercent of sleep time during in-bed time (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)71.0
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)56.3
Naproxen Sodium 440 mg (BAYH6689)59.3
DPH 50 mg23.6

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Cumulative Proportion of Subjects Taking Rescue Medication by Hour

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01280591)
Timeframe: Up to 10 hours

,,,
Interventionparticipants (Number)
≤ 60 minutes≤ 120 minutes≤ 180 minutes≤ 240 minutes≤ 300 minutes≤ 360 minutes≤ 420 minutes≤ 480 minutes≤ 540 minutes≤ 600 minutes
DPH 50 mg0536670747677787878
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)1365057656978838789
Naproxen Sodium 440 mg (BAYH6689)0274147505562636768
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)0182325293436394243

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Global Assessment of Investigational Product as a Pain Reliever

The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4). (NCT01280591)
Timeframe: Up to 10 hours

,,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg45970
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)216354825
Naproxen Sodium 440 mg (BAYH6689)015365634
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)29436448

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Total Sleep Time Measured by Actigraphy

Total time time was measured as total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01280591)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)426.2
Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)337.7
Naproxen Sodium 440 mg (BAYH6689)355.8
DPH 50 mg141.4

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Migraine Disability Assessment Test (MIDAS)

"Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability No subscales are present." (NCT01300546)
Timeframe: Baseline MIDAS collected at Day 31, Post final dose study medication MIDAS collected at Day 121.

,
Interventionscores on a scale (Mean)
Baseline Day 31Day 121
Naproxen Sodium22.624.1
Sumatriptan/Naproxen Sodium28.727.9

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Compliance With Lifestyle Changes

Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. (NCT01300546)
Timeframe: Day 121

Interventionscores on a scale (Mean)
Sumatriptan/Naproxen Sodium2.33
Naproxen Sodium2.43

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Percent Change of Headache Days Compared to Baseline

Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%). (NCT01300546)
Timeframe: Day 121 (following 30 day Baseline Period and Treatment Period Days 91-120)

Interventionpercent change of headache days (Mean)
Sumatriptan/Naproxen Sodium-13.50
Naproxen Sodium-36.50

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Percent Change of Doses of Study Medication

% change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)]*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline. (NCT01300546)
Timeframe: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionpercent change of study medication (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium160.876.4112.7
Sumatriptan/Naproxen Sodium130.8114.996.1

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Headache Days With Greater Than 50% Reduction

Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. (NCT01300546)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionparticipants (Number)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium336
Sumatriptan/Naproxen Sodium123

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Migraine Attacks

Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)]*100%). (NCT01300546)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionpercent change of migraine attacks (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium-12.23-9.03-39.12
Sumatriptan/Naproxen Sodium-4.35-2.88-8.63

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Migraine Attacks With 50% Reduction

Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm (NCT01300546)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionparticipants (Number)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium106
Sumatriptan/Naproxen Sodium324

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Percent Change in Headache Days All Treatment Periods Compared to Baseline

Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)]*100%). (NCT01300546)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionpercent change of migraine headache days (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium-26.86-21.44-36.50
Sumatriptan/Naproxen Sodium-1.70-4.39-13.50

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Migraine Severity

Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)]*100%). (NCT01300546)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionpercent change of migraine severity (Mean)
2 hours after treatment for Baseline to Month 12 hours after treatment for Baseline to Month 22 hours after treatment for Baseline to Month 3
Naproxen Sodium11.780.3332.62
Sumatriptan/Naproxen Sodium-17.84-36.71-55.60

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Migraine Duration From Time of Treatment to Pain Free

"% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.~Percent change=[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)]*100%)." (NCT01300546)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionpercent change of migraine duration (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium-14.91-25.5273.42
Sumatriptan/Naproxen Sodium150.1092.73114.10

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Migraine Duration From Onset to Pain Free

Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)]*100%). (NCT01300546)
Timeframe: Baseline Period collected at Day 31, Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventionpercent change of migraine duration (Mean)
Baseline to Treatment Period Month 1Baseline to Treatment Period Month 2Baseline to Treatment Period Month 3
Naproxen Sodium-14.92-26.3570.84
Sumatriptan/Naproxen Sodium72.0435.8661.96

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Doses of Study Medication

Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. (NCT01300546)
Timeframe: Treatment Period Months 1, 2, and 3 collected at Days 61, 91, and 121.

,
Interventiondoses of study medication (Mean)
Treatment Period Month 1Treatment Period Month 2Treatment Period Month 3
Naproxen Sodium9.368.868.50
Sumatriptan/Naproxen Sodium11.0010.2810.28

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Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days

,,
Interventionpg/mL (Mean)
VIP Migraine Onset (n=10,7,6)VIP Migraine Headache Free (n=9,4,6)VIP 24 Hours Migraine Headache Free (n=10,7,5)PGE2 Migraine Onset (n=10,7,6)PGE2 Migraine Headache Free (n=10,4,6)PGE2 24 Hours Migraine Headache Free (n=10,7,7)Cortisol Migraine Onset (n=8,7,6)Cortisol Migraine Headache Free (n=10,3,5)Cortisol 24 Hours Migraine Headache Free(n=10,6,6)PGI2 Migraine Onset (n=10,7,6)PGI2 Migraine Headache Free (n=10,4,6)PGI2 24 Hours Migraine Headache Free (n=10,7,7)Estradiol Migraine Onset (n=9,7,6)Estradiol Migraine Headache Free (n=9,5,4)Estradiol 24 Hours Migraine Headache Free(n=6,7,6)
Placebo105.28964.41059.97.568.3510.461084.51490.921031.16108.23115.6397.6937.7548.8321.34
Treximet Non-Responder948.97643.01174.211.7210.2112.651508.972042.871621.38186.17176.37295.0742.8126.5881.38
Treximet Responder1251.141409.751480.7914.137.8713.43952.52592.35863.09134.40154.16154.1044.8956.5934.86

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Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache.

,
Interventionpg/mL (Mean)
VIP Migraine Onset (n=10,7,6)VIP Migraine Headache Free (n=9,4,7)VIP 24 Hours Migraine Headache Free (n=10,7,6)PGE2 Migraine Onset (n=10,7,6)PGE2 Migraine Headache Free (n=10,4,6,)PGE2 24 Hours Migraine Headache Free (n=10,7,7)Cortisol Migraine Onset (n=8,7,6)Cortisol Migraine Headache Free (n=10,3,6)Cortisol 24 Hours Migraine Headache Free(n=10,6,6)PGI2 Migraine Onset (n=10,7,6)PGI2 Migraine Headache Free (n=10,4,6)PGI2 24 Hours Migraine Headache Free (n=10,7,7)Estradiol Migraine Onset (n=9,7,6)Estradiol Migraine Headache Free (n=9,4,5,)Estradiol 24 Hours Migraine Headache Free(n=6,7,5)
Placebo1052.8964.41059.97.568.3510.461084.51490.921031.16108.23115.6397.6937.0548.8321.34
Treximet1111.31949.71353.0413.029.2713.041209.341498.921271.4158.29167.48224.5843.9339.9256.33

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CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

"CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headache

,
Interventionpmol/mg (Mean)
CGRP Baseline (n=10, 14)CGRP Migraine Onset (n=10, 13)CGRP 2 Hours Post Treatment (n=9, 14)
Placebo18.5522.2814.92
Treximet15.0327.8221.38

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CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

"CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache

,
Interventionpmol/mg (Mean)
CGRP Migraine Onset (n=10,7,6)CGRP Migraine Headache Free (n=9,4,6)CGRP 24 Hours Migraine Headache Free (n=9,7,7)
Placebo22.2822.5529.37
Treximet28.8232.2632.15

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CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

"CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline to 24 hours post headache gone for 1 menstrual migraine.

,,
Interventionpmol/mg (Mean)
CGRP Migraine Onset (n=10,7,6)CGRP Migraine Headache Free (n=9,4,6)CGRP 24 Hours Migraine Headache Free (n=9,7,7)
Placebo22.2822.5529.37
Treximet Non-Responder33.7620.7835.87
Treximet Responder22.7449.4828.43

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Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.

"Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point." (NCT01329562)
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free

,
Interventionpg/mL (Mean)
Urine Pre-Cycle Day 1 (n=3, 6)Urine Pre-Cycle Day 2 (n=6, 8)Urine Pre-Cycle Day 3 (n=8, 6)Urine Pre-Cycle Day 4 (n=9, 10)Urine Migraine Headache Free (n=11, 13Saliva Pre-Cycle Day 1 (n=1, 4)Saliva Pre-Cycle Day 2 (n=2, 6)Saliva Pre-Cycle Day 3 (n=8, 10)Saliva Pre-Cycle Day 4 (n=6, 9)Saliva Migraine Headache Free (n=8, 6)
Placebo2442.444333.923582.923232.102398.5541.7563.4546.4755.8654.93
Treximet3090.922616.645089.633141.512989.7243.3341.8773.0841.7251.32

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Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders

"Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From mid luteal phase and for the duration of 1 menstrual migraine until headache free.

,,
Interventionpg/mL (Mean)
Urine Pre-Cycle Day 1 (n=3,2,4)Urine Pre-Cycle Day 2 (n=6,3,5)Urine Pre-Cycle Day 3 (n=8,2,5)Urine Pre-Cycle Day 4 (n=9,5,5)Urine Migraine Headache Free (n=10,7,7)Saliva Pre-Cycle Day 1 (n=1,0,4)Saliva Pre-Cycle Day 2 (n=2,2,4)Saliva Pre-Cycle Day 3 (n=8,4,7)Saliva Pre-Cycle Day 4 (n=8,5,4)Saliva Migraine Headache Free (n=8,3,4)
Placebo2442.444333.923582.923232.102398.5541.7563.4546.4755.8654.93
Treximet Non-Responder3687.073661.525629.714266.023373.4043.3347.3667.7654.2233.22
Treximet Responder1898.63875.343739.442016.992542.09NA30.8981.0531.7175.45

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α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment for 1 menstrual migraine headache

,
InterventionU/L (Mean)
α-Amylase Baseline (n=10, 14)α-Amylase Migraine Onset (n=10, 13)α-Amylase 2 Hours Post Treatment (n=9, 14)
Placebo109280.50100956.70102449.80
Treximet99626.6198853.32103594.90

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α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders

"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headache.

,,
InterventionU/L (Mean)
α-Amylase Baseline (n=10,7,7)α-Amylase Migraine Onset (n=10,7,6)α-Amylase 2 Hours Post Treatment (n=9,7,7)
Placebo109280.50100956.7102449.88
Treximet Non-Responder101250.5493456.77103662.4
Treximet Responder98002.68103478.94103527.5

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α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders

"α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline from 24 hours post migraine gone for 1 menstrual migraine.

,,
InterventionU/L (Mean)
α-amylase Migraine Onset (n=10,7,6)α-amylase Migraine Headache Free (n=9,7,7)α-amylase 24 Hours Migraine Headache Free(n=10,4,6
Placebo100956.7102908.61100354.3
Treximet Non-Responder93456.77103031.44101559.9
Treximet Responder103478.9498720.95102475.8

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CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders

"CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.

,,
Interventionpmol/mg (Mean)
CGRP Baseline (n=10,7,7)CGRP Migraine Onset (n=10,7,6)CGRP 2 Hours Post Treatment (n=9,7,7)
Placebo18.5522.2814.92
Treximet Non-Responder17.8033.7621.67
Treximet Responder12.2722.7421.08

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α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.

"α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure." (NCT01329562)
Timeframe: From baseline to 24 hours post headache gone for 1 menstrual migraine headache

,
InterventionU/L (Mean)
α-Amylase Migraine Onset (n=10,7,6)α-Amylase Migraine Headache Free (n=10,4,6)α-Amylase 24 Hours Migraine Headache Free(n=10,7,7
Placebo100956.70102908.61100354.00
Treximet98853.32101307.25102017.80

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Time to Pain-Free in Responders vs Non-Responders

"Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.~0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From the onset of 1 menstrual migraine headache until pain-free.

Interventionhours (Mean)
Placebo7.64
Treximet Responder3.13
Treximet Non-Responder4.68

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Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment

"Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes." (NCT01329562)
Timeframe: From Baseline until 2 hours post treatment of 1 menstrual migraine headache

,
Interventionpg/mL (Mean)
VIP Baseline (n=10, 14)VIP Migraine Onset (n=10, 13)VIP 2 Hours Post Treatment (n=9, 13)PGE2 Baseline (n=10, 14)PGE2 Migraine Onset (n=10, 13)PGE2 2 Hours Post Treatment (n=9, 14)Cortisol Baseline (n=10, 13)Cortisol Migraine Onset (n=8, 13)Cortisol 2 Hours Post Treatment (n=8, 10)PGI2 Baseline (n=10, 14)PGI2 Migraine Onset (n=10, 13)PGI2 2 Hours Post Treatment (n=9, 14)Estradiol Baseline (n=10, 13)Estradiol Migraine Onset (n=9, 13)Estradiol 2 Hours Post Treatment (n=9,14)
Placebo763.61052.81130.449.257.568.291064.141084.852011.45109.51108.2397.5863.3741.6854.07
Treximet1149.51111.31933.7712.6513.027.991040.491209.34418.48160.27158.29201.6062.6143.9341.66

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Time to Pain Free

"Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe." (NCT01329562)
Timeframe: From onset of 1 menstrual migraine headache until pain free.

Interventionhours (Mean)
Placebo7.64
Treximet3.90

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Migraine Recurrence Responders vs Non-Responders

"Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.~0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From the onset of 1 menstrual migraine until 24 hours post treatment.

Interventionparticipants (Number)
Placebo1
Treximet Responder2
Treximet Non-Responder0

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Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders

"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria." (NCT01329562)
Timeframe: From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.

,,
Interventionpg/mL (Mean)
VIP Baseline (n=10,7,7)VIP Migraine Onset (n=10,7,6)VIP 2 Hours Post Treatment (n=9,7,6,)PGE2 Baseline (n=10,7,7)PGE2 Migraine Onset (n=10,7,6)PGE2 2 Hours Post Treatment (n=9,7,7)Cortisol Baseline (n=10,6,7)Cortisol Migraine Onset (n=8,7,6)Cortisol 2 Hours Post Treatment (n=8,6,4)PGI2 Baseline (n=10,7,7)PGI2 Migraine Onset (n=10,7,6)PGI2 2 Hours Post Treatment (n=9,7,7)Estradiol Baseline (n=9,7,6)Estradiol Migraine Onset (n=8,7,6)Estradiol 2 Hours Post Treatment (n=8,7,7)
Placebo763.61052.81130.449.257.568.291064.141084.52011.45109.51108.2397.5863.3737.0554.07
Treximet Non-Responder885.0948.17414.011.0111.729.151254.531508.97322.72177.54186.17247.6366.6842.8146.68
Treximet Responder1414.01251.141320.1414.2914.136.83790.77952.52482.32142.99134.40155.5649.6044.8936.64

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Migraine Recurrence

"Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe." (NCT01329562)
Timeframe: From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.

Interventionparticipants (Number)
Placebo0
Treximet2

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Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis

"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)." (NCT01332500)
Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)

,
Interventiontablets per participant (Mean)
TriptansNon-steroidal anti-inflammatory drugsOpioidsErgotsOther
Switch - Oral Triptan24.422.987.40.11.3
Switch - Sumatriptan/Naproxen Sodium24.420.988.40.01.4

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Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis

"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)." (NCT01332500)
Timeframe: 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)

,
Interventiontablets per participant (Mean)
TriptansNon-steroidal anti-inflammatory drugsOpioidsErgotsOther
Naïve - Oral Triptan18.421.580.10.11.4
Naïve - Sumatriptan/Naproxen Sodium17.719.275.80.11.5

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Treatment Compliance - Duration of Exposure to Treatment in Days

(NCT01365052)
Timeframe: 10 days after randomization

InterventionDays (Mean)
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)9.9
Placebo9.8

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Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product

Please see further details in AE section (NCT01365052)
Timeframe: 10 days after randomization

InterventionPercentage of participants (Number)
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)0
Placebo0

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Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product

(NCT01365052)
Timeframe: 10 days after randomization

InterventionPercentage of participants (Number)
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)1.8
Placebo3.7

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Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product

Please see further details in Adverse Events (AE) section (NCT01365052)
Timeframe: 10 days after randomization

InterventionPercentage of participants (Number)
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)39.6
Placebo45.0

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Treatment Compliance - Number of Capsules Taken

(NCT01365052)
Timeframe: 10 days after randomization

InterventionCapsules (Mean)
Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)20.1
Placebo19.9

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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

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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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Missing Workdays

This result shows the average of the number of missed work days. (NCT01374269)
Timeframe: 24 weeks

InterventionDays (Mean)
Excercise0.2
NSAID0.2

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Missing Workdays

This result shows the average of the number of missed work days. (NCT01374269)
Timeframe: 4 weeks

InterventionDays (Mean)
Excercise0.0
NSAID0.3

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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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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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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

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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: 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

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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: 24 weeks

Interventionunits on a scale (Mean)
Excercise2.3
NSAID3.1

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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: 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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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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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: 12 weeks

Interventionunits on a scale (Mean)
Excercise91.2
NSAID82.4

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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

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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: 4 weeks

Interventionunits on a scale (Mean)
Excercise82.5
NSAID84.7

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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: At the beginning

Interventionunits on a scale (Mean)
Excercise67.2
NSAID63.4

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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, 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

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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: 4 weeks

Interventionunits on a scale (Mean)
Excercise66.3
NSAID67.1

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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: At the beginning

Interventionunits on a scale (Mean)
Excercise64.3
NSAID64.7

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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

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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: 24 weeks

Interventionunits on a scale (Mean)
Excercise78.5
NSAID76.9

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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

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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

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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: 24 weeks

Interventionunits on a scale (Mean)
Excercise84.1
NSAID82.6

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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: 4 weeks

Interventionunits on a scale (Mean)
Excercise75.8
NSAID70.3

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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: At the beginning

Interventionunits on a scale (Mean)
Excercise64.6
NSAID66.5

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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

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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

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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

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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

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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

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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

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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

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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

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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: 12 weeks

Interventionunits on a scale (Mean)
Excercise67.5
NSAID66.6

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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: 24 weeks

Interventionunits on a scale (Mean)
Excercise70.3
NSAID62.8

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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

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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: At the beginning

Interventionunits on a scale (Mean)
Excercise55.5
NSAID55.3

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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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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

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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: 24 weeks

Interventionunits on a scale (Mean)
Excercise2.3
NSAID2.5

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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: 4 weeks

Interventionunits on a scale (Mean)
Excercise4.2
NSAID4.6

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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: At the beginning

Interventionunits on a scale (Mean)
Excercise6.9
NSAID7.7

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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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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

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Medical Consultations.

This result shows, the total number of participants received additional medical consultations. (NCT01374269)
Timeframe: 12 weeks

Interventionparticipants (Number)
Excercise1
NSAID6

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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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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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The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours

In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score NCT01383486)
Timeframe: Up to 14 days

InterventionPercentage of participants (Number)
Naproxen Sodium ER (BAY H6689) or Advil IR64.5

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The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours

(NCT01383486)
Timeframe: Within 24 hours of their selection decision taken up to 14 days

InterventionPercentage of participants (Number)
Naproxen Sodium ER (BAY H6689) or Advil IR71.5

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The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours

Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B). (NCT01383486)
Timeframe: up to 14 days

InterventionPercentage of participants (Number)
Naproxen Sodium ER (BAY H6689) or Advil IR72.0

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Summed, Time-weighted Pain Intensity Differences (SPID)

Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. (NCT01389284)
Timeframe: 0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose

,,
InterventionScore on the scale (Mean)
From 0 to 6 hours, LS MeanFrom 0 to 8 hours, LS MeanFrom 0 to 12 hours, LS MeanFrom 0 to 16 hours, LS MeanFrom 16 to 24 hours, LS Mean
Naproxen Sodium ER (BAYH6689)5.37.010.914.78.5
Naproxen Sodium IR (Aleve, BAYH6689)5.36.910.915.08.6
Placebo-0.5-0.8-0.9-1.00.4

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Summed, Time-weighted Total Pain Relief Scores (TOTPARs)

TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24. (NCT01389284)
Timeframe: 0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose

,,
InterventionScore on the scale (Mean)
From 0 to 6 hoursFrom 0 to 8 hoursFrom 0 to 12 hoursFrom 0 to 16 hoursFrom 0 to 24 hoursFrom 16 to 24 hours
Naproxen Sodium ER (BAYH6689)13.117.426.535.554.519.0
Naproxen Sodium IR (Aleve, BAYH6689)12.816.826.435.855.119.4
Placebo4.76.19.713.421.88.4

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Pain Relief From Initial Dose

Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief (NCT01389284)
Timeframe: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose

,,
InterventionScore on the scale (Mean)
0.25 hours0.5 hours0.75 hours1 hour2 hours3 hours4 hours5 hours6 hours8 hours12 hours16 hours20 hours24 hours
Naproxen Sodium ER (BAYH6689)0.91.52.02.22.32.32.42.32.22.12.32.22.32.4
Naproxen Sodium IR (Aleve, BAYH6689)0.81.31.72.02.32.42.22.22.22.02.42.32.32.5
Placebo0.60.80.90.90.80.70.90.90.80.80.91.01.01.2

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Median Time to First Intake of Rescue Medication

Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group. (NCT01389284)
Timeframe: Up to 24 hours postdose

InterventionHours (Median)
Naproxen Sodium ER (BAYH6689)NA
Naproxen Sodium IR (Aleve, BAYH6689)NA
Placebo2.9

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Number of Times the Participants Took Rescue Medication Over the 24-hour Period

(NCT01389284)
Timeframe: 24 hours postdose

InterventionRescue medication intakes (Mean)
Naproxen Sodium ER (BAYH6689)0.5
Naproxen Sodium IR (Aleve, BAYH6689)0.6
Placebo1.4

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Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)

SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief. (NCT01389284)
Timeframe: From 0 to 24 hours post-dose

InterventionScore on the scale (Mean)
Naproxen Sodium ER (BAYH6689)23.2
Naproxen Sodium IR (Aleve, BAYH6689)23.6
Placebo-0.6

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Cumulative Percentage of Participants Who Took Rescue Medication

(NCT01389284)
Timeframe: At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose

,,
InterventionPercentage of participants (Number)
0.25 hours0.5 hours0.75 hours1 hour2 hours3 hours4 hours5 hours6 hours8 hours12 hours16 hours20 hours24 hours
Naproxen Sodium ER (BAYH6689)00.00.00.07.512.516.718.320.020.822.525.026.726.7
Naproxen Sodium IR (Aleve, BAYH6689)00.00.00.07.513.316.720.023.325.025.827.527.527.5
Placebo00.00.00.030.050.055.058.360.063.366.766.766.766.7

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Global Assessment of the Investigational Product as a Pain Reliever

Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent (NCT01389284)
Timeframe: 24 hours postdose or immediately before the first intake of rescue medication

,,
InterventionParticipants (Number)
0 - Poor1 - Fair2 - Good3 - Very good4 - Excellent
Naproxen Sodium ER (BAYH6689)1614223335
Naproxen Sodium IR (Aleve, BAYH6689)1812204327
Placebo3455124

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Pain Intensity Differences (PIDs) by Time From Initial Dose

Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe (NCT01389284)
Timeframe: At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose

,,
InterventionScore on the scale (Mean)
0.25 hours, LS Mean0.5 hours, LS Mean0.75 hours, LS Mean1 hours, LS Mean2 hours, LS Mean3 hours, LS Mean4 hours, LS Mean5 hours, LS Mean6 hours, LS Mean8 hours, LS Mean12 hours, LS Mean16 hours, LS Mean20 hours, LS Mean24 hours, LS Mean
Naproxen Sodium ER (BAYH6689)1.91.71.41.21.21.21.21.31.31.31.21.21.21.1
Naproxen Sodium IR (Aleve, BAYH6689)2.01.71.51.41.21.21.21.21.31.41.21.21.11.1
Placebo2.01.92.02.12.32.32.32.32.32.32.22.22.22.1

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Non-therapeutic Reasons for Misuse

Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse. (NCT01427803)
Timeframe: 28 days

InterventionParticipants (Number)
Naproxen Sodium ER (BAYH6689)52

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Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken

Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions. (NCT01427803)
Timeframe: 28 days

InterventionPercentage of participants (Number)
Naproxen Sodium ER (BAYH6689)19.7

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Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day

Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day. (NCT01427803)
Timeframe: 28 days

InterventionPercentage of participants (Number)
Naproxen Sodium ER (BAYH6689)4.8

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Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days

Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course. (NCT01427803)
Timeframe: 28 days

InterventionPercentage of participants (Number)
Naproxen Sodium ER (BAYH6689)14.9

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Percentage of Dosing Occasions Where More Than One Tablet Was Taken

Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions. (NCT01427803)
Timeframe: 28 days

InterventionPercentage of dosing occasions (Number)
Naproxen Sodium ER (BAYH6689)5.4

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Estimated Percentage of Misuse for Non-Therapeutic Reasons

The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons. (NCT01427803)
Timeframe: 28 days

InterventionPercentage of Participants (Number)
Naproxen Sodium ER (BAYH6689)6.5

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Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course

"This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by use day. A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive evaluable days." (NCT01427803)
Timeframe: 28 days

InterventionPercentage of participants (Number)
Naproxen Sodium ER (BAYH6689)5

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Global Assessment of Investigational Product as a Pain Reliever

The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4). (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg15391
Naproxen Sodium 440 mg (BAYH6689)13253812
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)14224018

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Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2

(NCT01495858)
Timeframe: Baseline and day 2

InterventionBeats/min (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)1.0
Naproxen Sodium 440 mg (BAYH6689)-0.1
DPH 50 mg4.7

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Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2

(NCT01495858)
Timeframe: Baseline and Day 2

InterventionmmHg (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)0.7
Naproxen Sodium 440 mg (BAYH6689)-0.2
DPH 50 mg2.1

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Total Sleep Time Measured by Actigraphy

Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)418.66
Naproxen Sodium 440 mg (BAYH6689)392.38
DPH 50 mg206.61

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Time to Rescue Medication

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)NA
Naproxen Sodium 440 mg (BAYH6689)NA
DPH 50 mg146.50

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Karolinska Sleep Diary - Easiness to Fall Asleep

Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg9614123
Naproxen Sodium 440 mg (BAYH6689)833272311
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)329223612

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Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night

Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing) (NCT01495858)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)6.6
Naproxen Sodium 440 mg (BAYH6689)5.7
DPH 50 mg4.6

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Subjective Sleep Questionnaire - Quality of Your Sleep Last Night

Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent. (NCT01495858)
Timeframe: Up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)6.5
Naproxen Sodium 440 mg (BAYH6689)5.8
DPH 50 mg4.9

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Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed

Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes) (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)111.1
Naproxen Sodium 440 mg (BAYH6689)144.8
DPH 50 mg98.4

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Sleep Latency Measured by Actigraphy

Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Median)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)23.50
Naproxen Sodium 440 mg (BAYH6689)16.75
DPH 50 mg27.50

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Sleep Efficiency Measured by Actigraphy

Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionPercent of sleep time during in-bed time (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)69.777
Naproxen Sodium 440 mg (BAYH6689)65.396
DPH 50 mg34.436

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Change From Baseline in Pain Intensity

Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain (NCT01495858)
Timeframe: Baseline and up to 10 hours

InterventionScores on a scale (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)2.4
Naproxen Sodium 440 mg (BAYH6689)2.4
DPH 50 mg2.5

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Karolinska Sleep Diary - Premature Awakening

Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Woke up much too early2 = Woke up somewhat too early3 = No
DPH 50 mg211112
Naproxen Sodium 440 mg (BAYH6689)315219
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)244533

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Karolinska Sleep Diary - Ease of Awakening

Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very difficult2 = Rather difficult3 = Neither difficult nor easy4 = Rather easy5 = Very easy
DPH 50 mg0251423
Naproxen Sodium 440 mg (BAYH6689)30165330
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)01175628

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Overall Rating of Pain Relief

"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)." (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
0 = No relief1 = A little relief2 = Some relief3 = A lot of relief4 = Complete relief
DPH 50 mg354582
Naproxen Sodium 440 mg (BAYH6689)303153721
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)245104721

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Karolinska Sleep Diary - Well Rested

Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Not rested at all2 = Somewhat unrested3 = Completely rested
DPH 50 mg131714
Naproxen Sodium 440 mg (BAYH6689)95538
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)75342

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Karolinska Sleep Diary - Sufficient Sleep

Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = No, definitely too little2 = No, much too little3 = No, somewhat too little4 = Yes, almost enough5 = Yes, definitely enough
DPH 50 mg1368116
Naproxen Sodium 440 mg (BAYH6689)1010273421
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)28185222

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Karolinska Sleep Diary - Sleep Quality

Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very poor2 = Rather poor3 = Neither poor nor good4 = Rather good5 = Very good
DPH 50 mg9119123
Naproxen Sodium 440 mg (BAYH6689)322313610
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)11233479

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Subjective Sleep Questionnaire - Time to Fall Asleep Last Night

Subjects responded to Estimate of how long it took to fall asleep (minutes) (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)39.5
Naproxen Sodium 440 mg (BAYH6689)40.2
DPH 50 mg40.0

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Karolinska Sleep Diary - Calmness of Sleep

Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5) (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
1 = Very restless2 = Rather restless3 = Neither restless nor calm4 = Rather calm5 = Very calm
DPH 50 mg5175134
Naproxen Sodium 440 mg (BAYH6689)32924424
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)12618489

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Global Assessment of Investigational Product as a Sleep Aid

The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4). (NCT01495858)
Timeframe: Up to 10 hours

,,
InterventionParticipants (Number)
0 = Poor1 = Fair2 = Good3 = Very good4 = Excellent
DPH 50 mg17281
Naproxen Sodium 440 mg (BAYH6689)132424135
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)212372311

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Cumulative Proportion of Participants Taking Rescue Medication by Hour

If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded (NCT01495858)
Timeframe: Up to 10 hours

,,
Interventionparticipants (Number)
≤ 60 minutes≤ 120 minutes≤ 180 minutes≤ 240 minutes≤ 300 minutes≤ 360 minutes≤ 420 minutes≤ 480 minutes≤ 540 minutes≤ 600 minutes
DPH 50 mg0212932333435353535
Naproxen Sodium 440 mg (BAYH6689)1121317232526283030
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)091415161721222424

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Wake Time After Sleep Onset (WASO) Measured by Actigraphy

WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. (NCT01495858)
Timeframe: Up to 10 hours

InterventionMinutes (Least Squares Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)155.25
Naproxen Sodium 440 mg (BAYH6689)180.08
DPH 50 mg364.83

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Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2

(NCT01495858)
Timeframe: Baseline and day 2

InterventionmmHg (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)-1.3
Naproxen Sodium 440 mg (BAYH6689)-0.6
DPH 50 mg2.2

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Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2

(NCT01495858)
Timeframe: Baseline and day 2

InterventionBreaths/min (Mean)
Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)-1.4
Naproxen Sodium 440 mg (BAYH6689)-1.2
DPH 50 mg-0.3

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PK of Naproxen: Trough Plasma Concentrations

Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant. (NCT01544114)
Timeframe: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose

,,
Interventionµg/mL (Geometric Mean)
Month 1Month 3
VIMOVO 250 mg/20 mg63.0963.16
VIMOVO 375 mg/20 mg19.2933.91
VIMOVO 500 mg/20 mg40.7140.69

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Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug

An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity. (NCT01544114)
Timeframe: SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.

,,,
Interventionparticipants (Number)
Any TEAEMild TEAEModerate TEAESevere TEAEAny related TEAEAny SAEAny related SAEAny TEAE leading to deathAny TEAE leading to DC of study drugAny related TEAE leading to DC of study drug
Total37181811111043
VIMOVO 250 mg/20 mg4130100011
VIMOVO 375 mg/20 mg16961611011
VIMOVO 500 mg/20 mg17890400021

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PK of Esomeprazole: Oral Volume of Distribution (V/F)

(NCT01544114)
Timeframe: pre-dose, and up to 3 hours post-dose

InterventionL (Geometric Mean)
VIMOVO 250 mg/20 mg28
VIMOVO 375 mg/20 mg61
VIMOVO 500 mg/20 mg57
Total55

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PK of Esomeprazole: Oral Plasma Clearance (CL/F)

(NCT01544114)
Timeframe: pre-dose, and up to 3 hours post-dose

InterventionL/h (Geometric Mean)
VIMOVO 250 mg/20 mg27
VIMOVO 375 mg/20 mg44
VIMOVO 500 mg/20 mg47
Total43

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Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])

(NCT01544114)
Timeframe: pre-dose, and up to 3 hours post-dose

Interventionhr*µmol/L (Geometric Mean)
VIMOVO 250 mg/20 mg2.2
VIMOVO 375 mg/20 mg1.3
VIMOVO 500 mg/20 mg1.2
Total1.3

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PK of Esomeprazole: Absorption Rate Constant (Ka)

(NCT01544114)
Timeframe: pre-dose, and up to 3 hours post-dose

Interventionh^-1 (Geometric Mean)
VIMOVO 250 mg/20 mg2.8
VIMOVO 375 mg/20 mg2.6
VIMOVO 500 mg/20 mg4.1
Total3.3

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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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Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles

Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)

,,
Interventionpercentage of participants (Number)
Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD34.736.238.061.0
Naproxen 500 mg BID34.434.140.259.2
No Prophylaxis34.333.940.763.4

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Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles

Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling. (NCT01712009)
Timeframe: Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)

,,
Interventionpercentage of participants (Number)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD4.50.00.00.04.5
Naproxen 500 mg BID3.11.71.10.64.1
No Prophylaxis4.71.11.81.95.8

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Percentage of Participants With Bone Pain (All Grades) in Cycle 1

Bone pain data were captured as part of standard adverse event (AE) reporting. (NCT01712009)
Timeframe: Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)

Interventionpercentage of participants (Number)
No Prophylaxis46.6
Naproxen 500 mg BID40.3
Loratadine 10 mg QD42.5

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Number of Participants With Adverse Events (AEs)

"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.~The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies." (NCT01712009)
Timeframe: From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.

,,
Interventionparticipants (Number)
Any adverse eventWorst grade of ≥ 2Worst grade of ≥ 3Worst grade of ≥ 4Serious adverse eventsFatal adverse eventsAE leading to discontinuation from studySAE leading to discontinuation from studyAny adverse event related to IPSAE related to IPAE related to IP leading to discontinuation of IPSAE related to IP leading to discontinuation of IPAny adverse event related to pegfilgrastimSAE related to pegfilgrastimAE related to / leading to discontinuation of PegSAE related to / leading to discontinuation of Peg
Loratadine 10 mg QD1941686320140327000105160
Naproxen 500 mg BID1921697330300533019196030
No Prophylaxis188164741834031000087461

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Mean Patient-reported Bone Pain by Cycle and Across Cycles

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

,,
Interventionunits on a scale (Least Squares Mean)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across all Cycles (n=191, 196, 200)
Loratadine 10 mg QD1.71.41.41.31.5
Naproxen 500 mg BID1.81.31.31.21.5
No Prophylaxis2.21.71.61.71.9

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Maximum Patient-reported Bone Pain by Cycle and Across Cycles

Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

,,
Interventionunits on a scale (Least Squares Mean)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD3.02.62.52.14.1
Naproxen 500 mg BID3.32.42.22.14.2
No Prophylaxis3.93.02.72.84.7

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Area Under the Curve (AUC) for Patient-reported Bone Pain

Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle. (NCT01712009)
Timeframe: Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)

,,
Interventionunits on a scale * days (Least Squares Mean)
Cycle 1 (n=191, 196, 200)Cycle 2 (n=178, 180, 193)Cycle 3 (n=165, 176, 188)Cycle 4 (n=162, 169, 179)Across All Cycles (n=191, 196, 200)
Loratadine 10 mg QD7.05.96.15.66.3
Naproxen 500 mg BID7.75.65.55.26.6
No Prophylaxis9.37.36.87.28.0

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Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

Interventionunits on a scale (Mean)
Convenience at 4WRI; n=194Change at Week 4; n=185Change at Week 12; n=175Change at Week 24; n=167Change at Week 36; n =162Change at Week 48; n=153Change at Early Termination; n=26
Overall Population66.66518.70318.1218.41918.70419.5887.808

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Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

Interventionunits on a scale (Mean)
Global Satisfaction at 4WRI; n=194Change at Week 4; n=185Change at Week 12; n=175Change at Week 24; n=167Change at Week 36; n =162Change at Week 48; n=153Change at Early Termination; n=26
Overall Population75.9856.7897.3547.5759.1798.556-38.538

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Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

Interventionunits on a scale (Mean)
Side Effects at 4WRI; n=194Change at Week 4; n=185Change at Week 12; n=175Change at Week 24; n=167Change at Week 36; n=162Change at Week 48; n=153Change at Early Termination; n=26
Overall Population85.176.0655.1092.9583.371.418-18.731

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Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Week 4

,
Interventionunits on a scale (Mean)
Convenience at 4WRI; n=100, 94Change at Week 4; n=95, 90
BIIB017 Plus Current FLS Therapy65.9419.768
BIIB017 Plus Naproxen67.43617.578

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Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Week 4

,
Interventionunits on a scale (Mean)
Effectiveness at 4WRI; n=100, 94Change at Week 4; n=95, 90
BIIB017 Plus Current FLS Therapy75.160.979
BIIB017 Plus Naproxen72.5-6.356

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Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Week 4

,
Interventionunits on a scale (Mean)
Global Satisfaction at 4WRI; n=100, 94Change at Week 4; n=95, 90
BIIB017 Plus Current FLS Therapy75.868.663
BIIB017 Plus Naproxen76.1174.811

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Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Week 4

,
Interventionunits on a scale (Mean)
Side Effects at 4WRI; n=100, 94Change at Week 4; n=95, 90
BIIB017 Plus Current FLS Therapy83.788.579
BIIB017 Plus Naproxen86.6493.411

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Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population

Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in. (NCT01939002)
Timeframe: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination

Interventiondays (Mean)
Days in 4WRI; n=123Change at Week 12; n=106Change at Week 24; n=99Change at Week 36; n=96Change at Week 48; n =95Change at Early Termination; n=15
Overall Population0.0160.0570.06100.1370

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Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population

Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in. (NCT01939002)
Timeframe: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination

Interventiondays (Mean)
Days in 4WRI; n=123Change at Week 12; n=106Change at Week 24; n=99Change at Week 36; n=96Change at Week 48; n =95Change at Early Termination; n=15
Overall Population0.0160.0190.02-0.0210.1260.2

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Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population

Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in. (NCT01939002)
Timeframe: Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination

Interventiondays (Mean)
Days in 4WRI; n=123Change at Week 12; n=106Change at Week 24; n=99Change at Week 36; n=96Change at Week 48; n=95Change at Early Termination; n=15
Overall Population4.691-0.019-0.081-0.0520.0320.2

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Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population

Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only. (NCT01939002)
Timeframe: Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination

Interventionunits on a scale (Mean)
Baseline; n=194Change at Week 12; n=174Change at Week 48; n=153Change Early Termination; n=26
Overall Population0.830.0290.150.346

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Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population

The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in. (NCT01939002)
Timeframe: 4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)

Interventionunits on a scale (Mean)
Effectiveness at 4WRI; n=194Change at Week 4; n=185Change at Week 12; n=175Change at Week 24; n=167Change at Week 36; n =162Change at Week 48; n=153Change at Early Termination; n=26
Overall Population73.871-2.589-1.2740.3411.8642.863-17.308

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Summary of Average Duration of FLS in the First 8 Weeks of Treatment

Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks. (NCT01939002)
Timeframe: 4-week run-in period, first 8 weeks of treatment

,,
Interventionhours (Median)
Average duration in 4WRI; n=88, 86, 174Average duration in F8W; n=91, 83, 174Change from 4WRI to F8W; n=85, 78, 163
BIIB017 Plus Current FLS Therapy16182.1
BIIB017 Plus Naproxen12.8183.8
Overall Population13.75183

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Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms

The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks. (NCT01939002)
Timeframe: 4-week run-in period, 48 weeks of treatment

,,
Interventionunits on a scale (Mean)
Severity of FLS in 4WRISeverity of FLS in 48WMean Change from 4WRI to 48W
BIIB017 Plus Current FLS Therapy1.21.280.08
BIIB017 Plus Naproxen1.050.98-0.07
Overall Population1.131.140.01

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Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment

Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks. (NCT01939002)
Timeframe: 4-week run-in period, first 8 weeks of treatment

,,
Interventionunits on a scale (Mean)
Effectiveness in 4WRI; n=91, 86, 177Effectiveness in F8W; n=96, 91, 187Change from 4WRI to F8W; n=87, 83, 170
BIIB017 Plus Current FLS Therapy64.569.6956.525
BIIB017 Plus Naproxen66.39874.2535.694
Overall Population65.42271.9136.119

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Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment

Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks. (NCT01939002)
Timeframe: 4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment

,,
Interventionpercentage of participants (Number)
4WRIF8W48W
BIIB017 Plus Current FLS Therapy889195
BIIB017 Plus Naproxen91.588.394.7
Overall Population89.789.794.8

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Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment

Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks. (NCT01939002)
Timeframe: 4-week run-in period, first 8 weeks of treatment

,,
Interventionunits on a scale (Mean)
Satisfaction in 4WRI; n=91, 86, 177Satisfaction in F8W; n=96, 91, 187Change from 4WRI to F8W; n=87, 83, 170
BIIB017 Plus Current FLS Therapy68.65471.1533.715
BIIB017 Plus Naproxen72.77874.6840.759
Overall Population70.65872.8712.272

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Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment

Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks. (NCT01939002)
Timeframe: 4-week run-in period, 48 weeks of treatment

,,
Interventionunits on a scale (Mean)
Satisfaction in 4WRI; n=91, 86, 177Satisfaction in 48W; n=99, 94, 193Change from 4WRI to 48W; n=90, 86, 176
BIIB017 Plus Current FLS Therapy68.65472.1924.607
BIIB017 Plus Naproxen72.77876.0612.274
Overall Population70.65874.0763.467

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Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment

Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks. (NCT01939002)
Timeframe: 4-week run-in period, 48 weeks of treatment

,,
Interventionunits on a scale (Mean)
Effectiveness in 4WRI; n=91, 86, 177Effectiveness in 48W; n=99, 94, 193Change from 4WRI to 48W; n=90, 86, 176
BIIB017 Plus Current FLS Therapy64.570.5476.803
BIIB017 Plus Naproxen66.39875.4168.042
Overall Population65.42272.9187.408

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Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks

Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks. (NCT01939002)
Timeframe: 4-week run-in period, 48 weeks of treatment

,,
Interventionpercentage of participants (Number)
With FLS in 4WRI / With FLS during 48WWith FLS in 4WRI / Without FLS during 48WWithout FLS in 4WRI / With FLS during 48WWithout FLS in 4WRI / Without FLS during 48W
BIIB017 Plus Current FLS Therapy86.002.009.003.00
BIIB017 Plus Naproxen87.234.267.451.06
Overall Population86.603.098.252.06

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Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks

Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks. (NCT01939002)
Timeframe: 4-week run-in period, first 8 weeks of treatment

,,
Interventionpercentage of participants (Number)
With FLS in 4WRI / With FLS during F8WWith FLS in 4WRI / Without FLS during F8WWithout FLS in 4WRI / With FLS during F8WWithout FLS in 4WRI / Without FLS during F8W
BIIB017 Plus Current FLS Therapy85.003.006.006.00
BIIB017 Plus Naproxen82.988.515.323.19
Overall Population84.025.675.674.64

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Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs

An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions. (NCT01939002)
Timeframe: Day 1 to Week 52

,
Interventionparticipants (Number)
Any eventModerate or severe eventSevere eventRelated eventSerious eventDiscontinuations due to AEsTreatment discontinuation due to FLS eventTreatment discontinuation due to ISR eventsStudy discontinuation due to an event
BIIB017 Plus Current FLS Therapy93547804143513
BIIB017 Plus Naproxen906012716132313

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Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period

Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in. (NCT01939002)
Timeframe: Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)

,,
Interventionhours (Mean)
Average duration in 4WRI; n=88, 86, 174Average duration in L4W; n=87, 83, 170Change from 4WRI to L4W; n=80, 77, 157
BIIB017 Plus Current FLS Therapy16.06718.0572.612
BIIB017 Plus Naproxen14.91515.8920.943
Overall Population15.497171.793

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Summary of Average Duration of FLS in the 48 Weeks of Treatment

Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks. (NCT01939002)
Timeframe: 4-week run-in period, 48 weeks of treatment

,,
Interventionhours (Median)
Average duration in 4WRI; n=88, 86, 174Average duration in 48W; n=95, 89, 184Change from 4WRI to 48W; n=86, 82, 168
BIIB017 Plus Current FLS Therapy1616.752.82
BIIB017 Plus Naproxen12.816.962
Overall Population13.7516.962.16

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Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms

The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose. (NCT01939002)
Timeframe: during the first 8 weeks of treatment

Interventionpercentage of participants (Number)
BIIB017 Plus Current FLS Therapy13
BIIB017 Plus Naproxen7.4

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Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population

The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose. (NCT01939002)
Timeframe: during the first 8 weeks of treatment

Interventionpercentage of participants (Number)
Overall Population10.3

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Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing

The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only. (NCT01939002)
Timeframe: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)

Interventionparticipants (Number)
Baseline: Positive; n=201Baseline: Negative; n=201Any post-baseline visit: Positive; n=198Any post-baseline visit: Negative; n=198Week 12: Positive; n=182Week 12: Negative; n=182Week 24: Positive; n=173Week 24: Negative; n=173Week 36: Positive; n=168Week 36: Negative; n=168Week 48/EW: Positive; n=193Week 48/EW: Negative; n=193Negative at BL with ≥ 1 positive post-BL; n=192
Overall Population7194819661763170116731904

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Antibody Data in the Overall Population: IFN β-1a Antibody Screening

The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only. (NCT01939002)
Timeframe: Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)

Interventionparticipants (Number)
Baseline: Positive; n=199Baseline: Negative; n=199Any post-baseline visit: Positive; n=198Any post-baseline visit: Negative; n=198Week 12: Positive; n=183Week 12: Negative; n=183Week 24: Positive; n=171Week 24: Negative; n=171Week 36: Positive; n=167Week 36: Negative; n=167Week 48/EW: Positive; n=193Week 48/EW: Negative; n=193Negative at BL with ≥ 1 positive post-BL; n=174
Overall Population22177351782615722149181492516813

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Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing

The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only. (NCT01939002)
Timeframe: Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)

Interventionparticipants (Number)
Baseline: Positive; n=22Baseline: Negative; n=22Any post-baseline visit: Positive; n=35Any post-baseline visit: Negative; n=35Week 12: Positive; n=26Week 12: Negative; n=26Week 24: Positive; n=22Week 24: Negative; n=22Week 36: Positive; n=18Week 36: Negative; n=18Week 48/EW: Positive; n=25Week 48/EW: Negative; n=25Negative at BL with ≥ 1 positive post-BL; n=7
Overall Population14817201511111111712131

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Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms

The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks. (NCT01939002)
Timeframe: 4-week run-in period, first 8 weeks of treatment

,,
Interventionunits on a scale (Mean)
Severity of FLS in 4WRISeverity of FLS in F8WMean Change from 4WRI to F8W
BIIB017 Plus Current FLS Therapy1.1981.3110.113
BIIB017 Plus Naproxen1.051.036-0.013
Overall Population1.1261.1780.052

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Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment

Residual pain is computed based on pain ratings from the week prior to treatment and last week of study participation (at ~6months) (NCT01951105)
Timeframe: 6 months

Intervention% residual pain (Mean)
Carbidopa/Levodopa & Naproxen (Males)62.97
Carbidopa/Levodopa & Naproxen (Females)9.48
Placebo & Naproxen (Males)37.96
Placebo & Naproxen (Females)45.23
Observation (Males)85.55
Observation (Females)48.84

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Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale

Primary outcome is 20% reduction in pain intensity at p<0.1 based on pain ratings during 1 week prior to treatment and last week of study participation (at ~6months) (NCT01951105)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Observation5
Carbidopa/Levodopa & Naproxen15
Placebo & Naproxen21

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Change in Pain Intensity

Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome (NCT01994226)
Timeframe: Days 0-7

Interventionunits on a scale (Mean)
Low-dose Colchicine3.5
Naproxen3.8

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Change in Pain Assessed by Visual Analogue Scale (VAS)

"The primary outcome was changes (% change) in self-reported pain levels using VAS - from 0 (no pain) to 10 (worst imaginable pain).~Results are presented as largest percentage (%) change in pain before and after the interventions (baseline and post-intervention, 6 weeks).~Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline." (NCT02013427)
Timeframe: 6 weeks

Interventionpercentage of change in pain (Mean)
Observational-0.03
Naproxen & Omeprazole-0.10
Placebo Only-0.21

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Percentage of Participants With at Least One Gout Flare Requiring Treatment

"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare." (NCT02128490)
Timeframe: Baseline to Month 3

Interventionpercentage of participants (Number)
Placebo10.5
Febuxostat IR 40 mg40.5
Febuxostat XR 40 mg23.1
Febuxostat IR 80 mg37.8
Febuxostat XR 80 mg42.1

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Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3

(NCT02128490)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0
Febuxostat IR 40 mg13.5
Febuxostat XR 40 mg35.9
Febuxostat IR 80 mg40.5
Febuxostat XR 80 mg44.7

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Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3

(NCT02128490)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0
Febuxostat IR 40 mg32.4
Febuxostat XR 40 mg53.8
Febuxostat IR 80 mg59.5
Febuxostat XR 80 mg55.3

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Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3

(NCT02139046)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0.6
Febuxostat IR 40 mg40.3
Febuxostat XR 40 mg48.2
Febuxostat IR 80 mg57.7
Febuxostat XR 80 mg61.1

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Percentage of Participants With at Least One Gout Flare Requiring Treatment

"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare." (NCT02139046)
Timeframe: Baseline to Month 3

Interventionpercentage of participants (Number)
Placebo20.7
Febuxostat IR 40 mg21.0
Febuxostat XR 40 mg22.8
Febuxostat IR 80 mg27.2
Febuxostat XR 80 mg26.6

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Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3

(NCT02139046)
Timeframe: Month 3

Interventionpercentage of participants (Number)
Placebo0.3
Febuxostat IR 40 mg15.7
Febuxostat XR 40 mg25.9
Febuxostat IR 80 mg42.6
Febuxostat XR 80 mg50.1

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Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration

Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. (NCT02229461)
Timeframe: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)

,,,,,
Interventionpercentage (Mean)
Day 7 at 1 hourDay 7 at 3 hourDay 7 at 6 hourDay 7 at 12 hourDay 7 at 18 hourDay 7 at 24 hourDay 16 at 1 hourDay 16 at 3 hourDay 16 at 6 hourDay 16 at 12 hourDay 16 at 18 hourDay 17 at 1 hourDay 17 at 3 hourDay 17 at 6 hourDay 17 at 12 hourDay 17 at 18 hourDay 17 at 24 hourDay 19 at 1 hourDay 19 at 3 hourDay 19 at 6 hourDay 19 at 12 hourDay 19 at 18 hourDay 19 at 24 hour
Group 1-IR ASA Co-administered With Naproxen Sodium99.8699.8499.6999.5999.1899.0199.0698.8097.6996.5994.1995.7195.4993.5592.5489.4489.0598.3598.5298.2697.6797.2197.04
Group 2-IR ASA 30 Min After Naproxen Sodium99.8399.7999.6799.4899.1899.5598.3897.6796.2692.7192.2394.6392.7990.9191.1587.1983.6797.8997.9097.4396.9096.2996.16
Group 3-IR ASA 8 Hours After Naproxen Sodium99.6999.5499.4499.1299.7697.7898.3298.0297.4096.3195.6895.5696.4395.6494.1394.2390.3998.8999.0598.9898.7798.5297.98
Group 4-IR ASA Only99.6799.6699.4899.3198.8698.7199.7199.6899.5599.4299.0199.7099.6899.5299.3098.9598.7099.6999.6499.5099.2698.8898.49
Group 5-IR ASA 30 Min Before Naproxen Sodium99.9199.8699.7599.6899.3999.2399.2899.1998.4397.8496.4597.4296.9695.3194.7493.4291.4098.1698.2797.8497.3396.6296.01
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid99.8499.8099.7099.6399.7099.8098.8198.5397.5195.3897.7396.9595.9293.9192.6088.1484.2794.0694.4493.2592.0090.9490.67

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Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration

Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. (NCT02229461)
Timeframe: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19

,,,,,
Interventionpercentage (Mean)
Day 7 at 1 hourDay 7 at 3 hourDay 7 at 6 hourDay 7 at 12 hourDay 7 at 18 hourDay 7 at 24 hourDay 16 at 1 hourDay 16 at 3 hourDay 16 at 6 hourDay 16 at 12 hourDay 16 at 18 hourDay 16 at 24 hourDay 17 at 1 hourDay 17 at 3 hourDay 17 at 6 hourDay 17 at 12 hourDay 17 at 18 hourDay 17 at 24 hourDay 19 at 1 hourDay 19 at 3 hourDay 19 at 6 hourDay 19 at 12 hourDay 19 at 18 hourDay 19 at 24 hour
Group 1-IR ASA Co-administered With Naproxen Sodium98.8497.8297.9597.7597.8596.6298.0693.0393.5589.5586.6186.4286.1985.4582.9083.4985.7779.5592.6891.0390.5791.5991.2093.76
Group 2-IR ASA 30 Min After Naproxen Sodium98.8298.2598.5797.9296.0998.2695.4989.2588.6285.6384.4172.6679.9990.1684.7781.2278.3479.0689.6592.0491.4989.2593.5090.93
Group 3-IR ASA 8 Hours After Naproxen Sodium97.5997.7298.3796.6698.7998.8989.5592.6290.4088.7682.1477.7186.1492.6083.0886.5086.5375.6795.3293.6892.3595.1894.8593.66
Group 4-IR ASA Only98.3497.6197.2997.4996.2995.0498.9997.3798.5097.4295.6995.7898.7298.0197.3497.4695.4797.2398.0597.8298.2496.9196.2496.63
Group 5-IR ASA 30 Min Before Naproxen Sodium99.4098.9599.0698.5497.9798.1396.7396.1795.5692.3093.2888.4993.7588.5292.3992.4285.7092.0794.3994.5393.7292.8492.7496.14
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid98.6797.6897.9398.3697.8798.4494.9590.6291.2789.4591.0386.8790.0083.9485.8282.1370.9081.3479.3679.8281.1480.6685.6781.67

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Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration

Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores. (NCT02229461)
Timeframe: At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19

,,,,,
Interventionpercentage (Mean)
Day 7 at 1 hourDay 7 at 3 hourDay 7 at 6 hourDay 7 at 12 hourDay 7 at 18 hourDay 7 at 24 hourDay 16 at 1 hourDay 16 at 3 hourDay 16 at 6 hourDay 16 at 12 hourDay 16 at 18 hourDay 16 at 24 hourDay 17 at 1 hourDay 17 at 3 hourDay 17 at 6 hourDay 17 at 12 hourDay 17 at 18 hourDay 17 at 24 hourDay 19 at 1 hourDay 19 at 3 hourDay 19 at 6 hourDay 19 at 12 hourDay 19 at 18 hourDay 19 at 24 hour
Group 1-IR ASA Co-administered With Naproxen Sodium58.60-121.7661.7436.4162.3680.6068.9675.2574.4579.8873.8667.4776.2378.4876.4683.1782.3078.6664.0669.1860.961.0869.6989.86
Group 2-IR ASA 30 Min After Naproxen Sodium12.7812.861.7028.5425.2746.3124.1551.2261.2070.9874.0764.2656.7746.1669.1686.4068.6570.8441.1048.5150.2133.4374.5580.90
Group 3-IR ASA 8 Hours After Naproxen Sodium5.5510.80-3.29-17.9511.9641.2929.2533.1262.3211.1635.4315.96-452.4821.7437.52-24.7231.9653.2421.4623.6451.5936.9215.4129.02
Group 4-IR ASA Only87.7379.1678.2080.8178.5089.1286.1285.9281.3681.3885.1985.2583.5383.4883.4886.0083.7185.4383.9781.6282.9884.4591.1283.67
Group 5-IR ASA 30 Min Before Naproxen Sodium64.1475.8973.6976.0238.5877.6162.6783.5182.5579.5171.9373.7382.1375.1574.6182.3771.3582.1381.0578.0170.8744.9788.4382.63
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid30.4518.9926.9117.11-151.0644.0245.1237.0981.0753.0471.6451.4033.6448.2752.0367.5541.5187.0243.9214.8558.6413.1784.4671.27

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Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration

Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated. (NCT02229461)
Timeframe: At hour 24 on Day 16 post treatment

Interventionpercentage (Mean)
Group 1-IR ASA Co-administered With Naproxen Sodium93.09
Group 2-IR ASA 30 Min After Naproxen Sodium87.71
Group 3-IR ASA 8 Hours After Naproxen Sodium92.87
Group 4-IR ASA Only98.72
Group 5-IR ASA 30 Min Before Naproxen Sodium95.35
Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid95.65

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Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline

Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported. (NCT02262754)
Timeframe: Baseline up to Week 4

,,
Interventionparticipants (Number)
>=30 percent response>=50 percent response
Naproxen3112
PF-06372865249
Placebo2511

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Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4

Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported. (NCT02262754)
Timeframe: Week 4

,,
Interventionparticipants (Number)
PoorFairGoodExcellent
Naproxen5143715
PF-063728651118368
Placebo826288

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Number of Participants Using Rescue Medication

Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported. (NCT02262754)
Timeframe: Week 1, 2, 3, 4

,,
Interventionparticipants (Number)
Week 1 (n= 74, 74, 74)Week 2 (n= 67, 72, 72)Week 3 (n= 63, 69, 71)Week 4 (59, 66, 67)
Naproxen34302722
PF-0637286535323127
Placebo34262523

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Number of Days Participants Used the Rescue Medication

The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary. (NCT02262754)
Timeframe: Week 1, 2, 3, 4

,,
Interventiondays (Mean)
Week 1 (n= 74, 74, 74)Week 2 (n= 67, 72, 72)Week 3 (n= 63, 69, 71)Week 4 (59, 66, 67)
Naproxen1.71.61.51.4
PF-063728651.71.81.41.4
Placebo1.71.61.91.4

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Chronic Low Back Pain (CLBP) Responder Index Analysis

Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week. (NCT02262754)
Timeframe: Week 1, 2, 3, 4

,,
Interventionparticipants (Number)
Week 1Week 2Week 3Week 4
Naproxen8111419
PF-0637286508811
Placebo05129

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Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4

Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain. (NCT02262754)
Timeframe: Baseline, Week 1, 2, 3, 4

,,
Interventionunits on a scale (Least Squares Mean)
Change at Week 1 (n= 73, 73, 73)Change at Week 2 (n= 66, 71, 72)Change at Week 3 (n= 62, 67, 71)Change at Week 4 (n= 58, 65, 65)
Naproxen-0.34-0.39-0.43-0.54
PF-06372865-0.19-0.28-0.31-0.21
Placebo-0.20-0.24-0.45-0.33

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Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3

Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability. (NCT02262754)
Timeframe: Baseline, Week 1, 2, 3

,,
Interventionunits on a scale (Mean)
Baseline (n= 74, 74, 74)Change at week 1 (n= 73, 73, 73)Change at week 2 (n= 66, 71, 72)Change at week 3 (n= 62, 67, 71)
Naproxen8.5-1.2-1.6-2.0
PF-063728659.4-0.5-1.3-1.3
Placebo9.8-0.4-0.7-1.0

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Number of Participants With Vital Sign Abnormalities

Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg. (NCT02262754)
Timeframe: Baseline up to Follow-up (44 days)

,,
Interventionparticipants (Number)
Supine SBP: <90 mmHgSupine DBP: <50 mmHgSupine pulse rate: <40 bpmSupine pulse rate: >120 bpmMaximum increase in Supine SBP: >=30 mmHgMaximum increase in Supine DBP: >=20 mmHgMaximum decrease in Supine SBP: >=30 mmHgMaximum decrease in Supine DBP: >=20 mmHg
Naproxen00001443
PF-0637286511000369
Placebo00005613

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4

This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall. (NCT02262754)
Timeframe: Baseline, Week 2, Week 4

,,
Interventionunits on a scale (Mean)
Total recall score: at Baseline (n= 74,74,74)Total recall score: Change at Week 2 (n= 66,72,71)Total recall score: Change at Week 4 (n= 56,66,66)Delayed Recall Score: at Baseline (n= 74,74,74)Delayed Recall Score:Change at Week 2 (n=66,72,71)Delayed Recall Score:Change at Week 4 (n=56,65,66)
Naproxen24.46-0.300.118.59-0.060.41
PF-0637286522.920.570.688.31-0.57-0.28
Placebo24.470.741.438.590.180.57

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Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4

Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. (NCT02262754)
Timeframe: Baseline, Week 1, 2, 3, 4

,,
Interventionunits on a scale (Least Squares Mean)
Change at week 1 (n= 74, 74, 74)Change at week 2 (n= 65, 70, 72)Change at week 3 (n= 62, 69, 70)Change at week 4 (n= 59, 64, 66)
Naproxen-0.70-1.17-1.39-1.58
PF-06372865-0.41-0.98-1.09-1.14
Placebo-0.50-0.93-1.12-1.22

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Amount of Rescue Medication Used by the Participants

The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule. (NCT02262754)
Timeframe: Week 1, 2, 3, 4

,,
Interventionmg (Mean)
Week 1 (n= 72, 70, 74)Week 2 (n= 65, 68, 72)Week 3 (n= 61, 65, 71)Week 4 (n= 58, 62, 67)
Naproxen2064.51920.51740.51489.2
PF-063728651621.81594.11416.91348.8
Placebo1388.91030.81172.11101.7

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Time to Withdrawal Due to Lack of Efficacy

"Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as Insufficient Clinical Response. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization." (NCT02262754)
Timeframe: Baseline up to Week 4

Interventiondays (Median)
PlaceboNA
PF-06372865NA
NaproxenNA

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Number of Participants With Laboratory Abnormalities

Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20). (NCT02262754)
Timeframe: Baseline up to 28 days after the last dose of study treatment (Day 56)

Interventionparticipants (Number)
Placebo26
PF-0637286544
Naproxen41

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Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit

PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit. (NCT02262754)
Timeframe: End of treatment (Day 30), follow-up (Day 44)

Interventionunits on a scale (Least Squares Mean)
Placebo-0.11
PF-06372865-0.34
Naproxen0.01

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Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4

Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability. (NCT02262754)
Timeframe: Baseline, Week 4

Interventionunits on a scale (Mean)
Placebo-1.00
PF-06372865-1.64
Naproxen-2.43

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Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4

Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week. (NCT02262754)
Timeframe: Baseline, Week 4

Interventionunits on a scale (Mean)
Placebo-1.19
PF-06372865-1.03
Naproxen-1.45

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Number of Participants With Electrocardiogram (ECG) Abnormalities

Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction). (NCT02262754)
Timeframe: Baseline up to Follow-up (44 days)

,,
Interventionparticipants (Number)
Max. PR Interval: >=300 msec (n=72, 74, 72)Max. QRS Complex: >=140 msec (n=72, 74, 72)Max. QTCF Interval: 450 to <480 msec (n=72,74,72)Max. QTCF Interval: 480 to <500 msec (n=72,74,72)Max. QTCF Interval: >=500 msec (n=72, 74, 72)Max. PR Interval IFB: >=25 or 50% (n=72, 74, 71)Max. QRS Complex IFB: >=50% (n=72, 74, 72)Max. QTCF Interval IFB: 30 to<60 msec (n=72,74,72)Max. QTCF Interval IFB: >=60 msec (n=72,74,72)
Naproxen012000100
PF-06372865001100041
Placebo001001133

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Plasma Concentration of PF-06372865

Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL). (NCT02262754)
Timeframe: Baseline, Week 1, 2, 3, 4

Interventionng/mL (Mean)
Baseline (n= 73)Week 1 (n= 74)Week 2 (n= 72)Week 3 (n= 71)Week 4 (n= 65)
PF-06372865NA15.5747.5146.6548.24

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Plasma Concentration of Naproxen

Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL. (NCT02262754)
Timeframe: Baseline, Week 1, 2, 3, 4

Interventionng/mL (Mean)
Baseline (n= 73)Week 1 (n= 74)Week 2 (n= 72)Week 3 (n= 71)Week 4 (n= 65)
Naproxen317.068150678306714065650

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Number of Participants Withdrawn Due to Lack of Efficacy

Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported. (NCT02262754)
Timeframe: Baseline up to Week 4

Interventionparticipants (Number)
Placebo2
PF-063728650
Naproxen1

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Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4

Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. (NCT02262754)
Timeframe: Baseline, Week 1, 2, 3, 4

,,
Interventionpercent change (Mean)
Change at week 1 (n= 74, 74, 74)Change at week 2 (n= 65, 70, 72)Change at week 3 (n= 62, 69, 70)Change at week 4 (n= 59, 64, 66)
Naproxen-10.601-17.682-22.204-23.906
PF-06372865-5.830-15.467-17.167-17.072
Placebo-7.453-15.190-19.100-20.958

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Patient Global Impression of Change (PGI-C) Score

PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening. (NCT02262754)
Timeframe: Week 1, 2, 3, 4

,,
Interventionunits on a scale (Least Squares Mean)
Week 1 (n= 73, 73, 73)Week 2 (n= 66, 71, 72)Week 3 (n= 62, 67, 71)Week 4 (n= 58, 65, 65)
Naproxen2.952.832.632.61
PF-063728653.153.042.942.93
Placebo3.323.123.013.04

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The 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 or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. (NCT02262754)
Timeframe: Baseline up to 28 days after the last dose of study treatment (Day 56)

,,
Interventionparticipants (Number)
AEsSAEs
Naproxen282
PF-06372865341
Placebo261

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Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)

"Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure." (NCT02388191)
Timeframe: Immediately after tenaculum is placed on cervix

Interventionunits on a scale (Median)
Naproxen Sodium37.3
Placebo31.8

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Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)

"Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure." (NCT02388191)
Timeframe: Immediately after uterine sounding

Interventionunits on a scale (Median)
Naproxen Sodium59.8
Placebo58

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Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)

"Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure." (NCT02388191)
Timeframe: Immediately after IUD insertion is complete

Interventionunits on a scale (Median)
Naproxen Sodium69
Placebo66

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Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

"Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure." (NCT02388191)
Timeframe: Five minutes after IUD insertion is complete

Interventionunits on a scale (Median)
Naproxen Sodium16.5
Placebo26

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Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

"Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure." (NCT02388191)
Timeframe: Fifteen minutes after IUD insertion is complete

Interventionunits on a scale (Median)
Naproxen Sodium12.8
Placebo24

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Pulse Wave Velocity

Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment. (NCT02500641)
Timeframe: 36 weeks of treatment

Interventionm/s (Mean)
Febuxostat 80/120 mg/Day9.0
Allopurinol 100 up to 600 mg/Day9.05

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Mean Arterial Pressure

Blood pressure was measured over 12 hours using an automatic ambulatory blood pressure monitor. (NCT02502006)
Timeframe: 12 hours

Interventionmm Hg (Mean)
Celecoxib90.4
Naproxen92.9
Placebo89.7

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Diastolic Blood Pressure

Blood pressure was measured over 12 hours using an automatic ambulatory blood pressure monitor. (NCT02502006)
Timeframe: 12 hours

Interventionmm Hg (Mean)
Celecoxib74.8
Naproxen76.6
Placebo89.7

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Systolic Blood Pressure

Blood pressure was measured over 12 hours using an automatic ambulatory blood pressure monitor. (NCT02502006)
Timeframe: 12 hours

Interventionmm Hg (Mean)
Celecoxib123.0
Naproxen127.1
Placebo124.1

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COX-2 Activity ex Vivo

COX-2 activity was assessed ex vivo using a whole blood assay. Prostaglandin E2 concentrations in LPS-treated plasma were quantified before, and 0.5, 1, 2, 4, 8, and 12 h after treatment and expressed as AUC over the 12 hour dosing interval. (NCT02502006)
Timeframe: 12 hours

Interventionng*h/ml (Mean)
Celecoxib87.86
Naproxen54.71
Placebo154.1

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COX-1 Activity in Vivo

COX-1 activity was measured in vivo by quantifying the urinary metabolite of thromboxane A2 before, and 1, 2, 4, 8, and 12 h after treatment, normalized to urinary creatinine and expressed as AUC over the 12 hour dosing interval. (NCT02502006)
Timeframe: 12 hours

Interventionng*h/mg creatinine (Mean)
Celecoxib8.018
Naproxen2.907
Placebo9.509

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COX-2 Activity in Vivo

COX-2 activity was measured in vivo by quantifying the urinary metabolite of prostaglandin I2 before, and 1, 2, 4, 8, and 12 h after treatment, normalized to urinary creatinine and expressed as AUC over the 12 hour dosing interval. (NCT02502006)
Timeframe: 12 hours

Interventionng*h/mg creatinine (Mean)
Celecoxib1.610
Naproxen1.253
Placebo2.413

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COX-1 Activity ex Vivo

COX-1 activity was measured ex vivo using a whole blood assay. Thromboxane A2 serum concentrations were quantified before, and 0.5, 1, 2, 4, 8, and 12 h after treatment and expressed as AUC over the 12 hour dosing interval. (NCT02502006)
Timeframe: 12 hours

Interventionng*h/ml (Mean)
Celecoxib2869
Naproxen115.7
Placebo3135

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Mean Days of Bleeding and Spotting, Spotting Only and Bleeding Only for the 84 Day Treatment Cycles and Last 28 Day Post-treatment Cycle

Number of bleeding and spotting, spotting only and bleeding only days given as mean. We calculated the mean difference and 95% confidence interval between the two treatment groups and provided the p-value of means. (NCT02519231)
Timeframe: 4 months

,
Interventiondays (Mean)
Bleeding or spotting days first 84 daysBleeding or spotting days last 28 daysBleeding only days first 84 daysBleeding only days last 28 daysSpotting only days first 84 daysSpotting only days last 28 days
Placebo23.09.615.56.67.53.0
Treatment29.29.315.74.813.54.5

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Percentage Reporting Moderate-heavy/Heavy Menses, Often/Always Menstrual Cramping and 7 or More Days of Menstrual Bleeding for the 84-day Treatment Months and 28-day Post-treatment Month

Percentage reporting moderate-heavy/heavy menses, often/always menstrual cramping and 7 or more days of menstrual bleeding during the first 84 days and the last 28 days. We also report % difference and p-value between the two treatment groups. (NCT02519231)
Timeframe: 4 months

,
InterventionParticipants (Count of Participants)
Month 1 : Moderate heavy or heavy bleedingMonth 1 : Menstrual bleeding length 7+ daysMonth 1 : Often/always crampingMonth 1 : Unexpected bleedingMonth 2 : Moderate heavy or heavy bleedingMonth 2 : Menstrual bleeding length 7+ daysMonth 2 : Often/always crampingMonth 2 : Unexpected bleedingMonth 3 : Moderate heavy or heavy bleedingMonth 3 : Menstrual bleeding length 7+ daysMonth 3 : Often/always crampingMonth 3 : Unexpected bleedingMonth 4 : Moderate heavy or heavy bleedingMonth 4 : Menstrual bleeding length 7+ daysMonth 4 : Often/always crampingMonth 4 : Unexpected bleeding
Placebo7555851775155616
Treatment7816481766117635

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Total Hours of Sleep

The total hours of sleep first postoperative night, between 0 to 12 hours. (NCT02604550)
Timeframe: First Postoperative Night (up to 12 hours)

Interventionhours (Mean)
Femoral Nerve Block6.3
Adductor Canal Block5.8

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Number of Percocet Tablets Consumed

Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms, (NCT02604550)
Timeframe: Post surgery, Day 0 to Day 6

,
Interventioncount of tablets (Mean)
Day of surgery (Day 0)Post-surgery Day 1Post-surgery Day 2Post-surgery Day 3Post-surgery Day 4Post-surgery Day 5Post-surgery Day 6
Adductor Canal Block2.44.73.62.21.21.40.4
Femoral Nerve Block2.04.63.72.31.10.60.3

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Pain Score

Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry. (NCT02604550)
Timeframe: Post-surgery (day of surgery to 6 days post-surgery)

,
Interventionunits on a scale (Mean)
Recovery room dischargeDay of surgery, eveningPost-surgery Day 1 - MorningPost-surgery Day 1 - AfternoonPost-surgery Day 1 - EveningPost-surgery Day 2 - MorningPost-surgery Day 2 - AfternoonPost-surgery Day 2 - EveningPost-surgery Day 3 - MorningPost-surgery Day 3 - AfternoonPost-surgery Day 3 - EveningPost-surgery Day 4 - MorningPost-surgery Day 4 - AfternoonPost-surgery Day 4 - EveningPost-surgery Day 5 - MorningPost-surgery Day 5 - AfternoonPost-surgery Day 5 - EveningPost-surgery Day 6 - MorningPost-surgery Day 6 - AfternoonPost-surgery Day 6 - Evening
Adductor Canal Block4.05.15.75.06.05.34.64.54.03.43.73.02.73.33.13.33.33.13.22.8
Femoral Nerve Block4.13.95.75.15.55.44.54.34.23.84.03.53.24.03.73.63.43.73.22.7

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Patient-Reported Vomiting

Total occurrences of patient-reported vomiting post-surgery. (NCT02604550)
Timeframe: Post-Surgery (up to 6 days)

Interventionoccurrence of vomiting (Number)
Femoral Nerve Block1
Adductor Canal Block1

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Time to Straight Less Raise

The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery. (NCT02604550)
Timeframe: Post-Surgery (up to 6 days)

Interventionhours (Mean)
Femoral Nerve Block31.7
Adductor Canal Block16.4

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"Percent of Patients Rating Their Satisfaction as Excellent or Good"

Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery. (NCT02604550)
Timeframe: 2 Weeks Post-Surgery

Interventionpercentage of participants (Number)
Femoral Nerve Block39
Adductor Canal Block64

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Patient-Reported Constipation

Total occurrences of patient-reported constipation post-surgery. (NCT02604550)
Timeframe: Post-Surgery (up to 6 days)

Interventionoccurrence of constipation (Number)
Femoral Nerve Block2
Adductor Canal Block1

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Patient-Reported Itching

Total occurrences of patient-reported itching post-surgery. (NCT02604550)
Timeframe: Post-Surgery (up to 6 days)

Interventionoccurrence of itching (Number)
Femoral Nerve Block2
Adductor Canal Block1

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Patient-Reported Nausea

Total occurrences of patient-reported nausea post-surgery. (NCT02604550)
Timeframe: Post-Surgery (up to 6 days)

Interventionoccurrence of nausea (Number)
Femoral Nerve Block3
Adductor Canal Block2

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Patient-Reported Sedation

Total occurrences of patient-reported feelings of sedation post-surgery. (NCT02604550)
Timeframe: Post-Surgery (up to 6 days)

Interventionoccurrence of sedation (Number)
Femoral Nerve Block0
Adductor Canal Block0

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Prostaglandin Level (PGE2 Quantification)

Tissue prostaglandin concentration quantified by enzyme-linked immunosorbent assay (ELISA) using Cayman Chemical Monoclonal Prostaglandin E2 EIA Kit (item number 514010) (NCT02632812)
Timeframe: 8 days

,
Interventionpg/mL (mean tissue PGE2 concentration) (Mean)
Basal PGE2 concentrationEnd of treatment PGE2 concentration
Placebo & Naproxen1005241
Rebamipide & Naproxen999168

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Presence of H. Pylori by Biopsy

Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori) (NCT02632812)
Timeframe: 8 days

,
Interventionparticipants (Number)
Basal endoscopyEnd of treatment endoscopy
Placebo & Naproxen56
Rebamipide & Naproxen56

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Histopathological Score

"Histopathologic grade score developed for microscopic injury evaluation 0 = Normal gastric mucosa or mild chronic inflammation~= Chronic gastritis without activity~= Chronic gastritis with activity on antrum~= Chronic gastritis with activity on the body~= Chronic gastritis with activity on antrum and on the body" (NCT02632812)
Timeframe: 8 days

,
InterventionHistopathologic grade score (Median)
Basal endoscopyEnd of treatment endoscopy
Placebo & Naproxen11
Rebamipide & Naproxen11

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Number of Adverse Events

(NCT02632812)
Timeframe: 60 days

Interventionadverse events (Number)
Rebamipide & Naproxen7
Placebo & Naproxen7

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Endoscopic Score - Modified Lanza Score

"Modified Lanza score according to gastroduodenal mucosal injury:~0 = No hemorrhage or erosion observed~= One or two hemorrhages or erosions observed in one gastric area~= Three to five hemorrhages or erosions observed in one gastric area~= Hemorrhages or erosions observed in two gastric areas, six or more hemorrhages or erosions observed in one gastric area, with the total number not exceeding ten in the entire stomach~= Hemorrhages or erosions observed in three or more gastric areas; eleven or more hemorrhages or erosions observed widely in the entire stomach~= Ulcer" (NCT02632812)
Timeframe: 8 days

InterventionModified Lanza score (Median)
Rebamipide & Naproxen3.5
Placebo & Naproxen4

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Endoscopic Score - Cryer Score

"Cryer score according to gastroduodenal mucosal injury:~0 = Normal or erythema~= Any amount of submucosal hemorrhage or edema without erosions~= 1 erosion +- submucosal hemorrhage or edema~= 2-4 erosions +- submucosal hemorrhage or edema~= 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema~= Multiple ulcers +- submucosal hemorrhage or edema - Ulcer" (NCT02632812)
Timeframe: 8 days

InterventionCryer score (Median)
Rebamipide & Naproxen4
Placebo & Naproxen4

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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." (NCT02646124)
Timeframe: Between baseline and one week after emergency department discharge

Interventionunits on a scale (Mean)
Diazepam11
Placebo11

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Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale

Patients with moderate or serve pain. Worst Lower Back Pain (LBP) over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. (NCT02646124)
Timeframe: 1 week after discharge from emergency department

InterventionParticipants (Count of Participants)
Diazepam18
Placebo12

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Participants Satisfied With Treatment

"Participants who answered Yes when asked the question Do you want to receive the same combination of medications during a subsequent visit to the ER?" (NCT02646124)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Diazepam44
Placebo37

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Cases of Moderate or Severe LBP

Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none (NCT02665286)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Placebo34
Orphenadrine26
Methocarbamol31

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Functional Impairment as Measured on the Roland Morris Disability Questionnaire

"Change in Roland Morris Disability Questionnaire between baseline and 1 week.~The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment." (NCT02665286)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Placebo10.9
Orphenadrine9.4
Methocarbamol8.1

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Medications--Patient Self Report of Medication Use

Participants still using medication such as analgesics for LBP after treatment (NCT02665286)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Placebo42
Orphenadrine40
Methocarbamol50

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Patient Satisfaction With Treatment

The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention. (NCT02665286)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Placebo51
Orphenadrine53
Methocarbamol51

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Paragard vs Mirena IUD

difference in pain ratings during IUD insertion as assessed by visual analog scale by both patient (0-10 with 10 being the most pain, 0 no pain) within 30 minutes post insertion classified by IUD type. This measure is made to address whether type of IUD affected pain perception. (NCT02769247)
Timeframe: visual analog scale as assessed by patient and physician both within 30 minutes post insertion

Interventionunits on a scale (Mean)
Mirena3.02
Paragard IUD3.49

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Pain Control With IUD Insertion

visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain (NCT02769247)
Timeframe: within 30 minutes after IUD insertion

Interventionunits on a scale (Mean)
Placebo3.606
Naproxen/Normal Saline3.088
Placebo Oral Medication/Lidocaine2.83
Naproxen/Lidocaine3.382

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Physician Perceived Pain Control During IUD Insertion

visual analog scale (0-3) as assessed by physician within 30 minutes after IUD insertion Scale is from a minimum of 0, with maximum of 3 with higher scores denoting more pain (NCT02769247)
Timeframe: within 30 minutes after IUD insertion

Interventionunits on a scale (Mean)
Placebo.59
Naproxen/Normal Saline.48
Placebo Oral Medication/Lidocaine.56
Naproxen/Lidocaine.77

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Perceived Pain 30 Days Post Insertion

survey patient 30 days later to determine her recollection of pain during insertion (0-10); 10 being the most pain. One patient had no IUD initially inserted and was not included; each arm had patients lost to follow up (3 in placebo arm, 2 in naproxen arm, 4 in placebo/oral medication arm). (NCT02769247)
Timeframe: 30 days post IUD insertion

Interventionunits on a scale (Mean)
Placebo3.12
Naproxen/Normal Saline2.97
Placebo Oral Medication/Lidocaine3.2
Naproxen/Lidocaine3.04

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Patient Satisfaction With IUD

Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied. (NCT02769247)
Timeframe: 30 days post insertion

Interventionunits on a scale (Mean)
Placebo4.423
Naproxen/Normal Saline4.325
Placebo Oral Medication/Lidocaine4.264
Naproxen/Lidocaine4.358

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Percent Change in Pain Assessed by Visual Analogue Scale (VAS)

"Self-report pain using a VAS scale (0-10) : 0 represents no pain and 10 the worst imaginable pain.~Results are presented as percentage (%) change in pain before and after the intervention (baseline and post-intervention, 12 weeks).~Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline." (NCT02986334)
Timeframe: 12 weeks

Interventionpercentage of pain change (Mean)
No Treatment Intervention-0.0145
Active Treatment Intervention-0.2082
Placebo Treatment Intervention-0.1109

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"Average Daily Pain Right Now Score Collected by e-Diary"

Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen6.5906.000
Placebo6.4815.833
V120083 30 mg6.1046.366
V120083 60 mg6.7377.269

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Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale

The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen9.95.5
Placebo10.16.8
V120083 30 mg10.27.0
V120083 60 mg9.67.2

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Patient Global Impression of Change (PGIC)

"The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding very much improved and much improved was summarized by treatment group." (NCT03028870)
Timeframe: 4 Weeks

,,,
InterventionParticipants (Count of Participants)
Total Subjects Completing PGICSubjects Responding 'Very Much' / 'Much' Improved
Naproxen7638
Placebo7218
V120083 30 mg7225
V120083 60 mg6527

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Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)

Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment. (NCT03028870)
Timeframe: Baseline up to 4 Weeks

,,,
InterventionParticipants (Count of Participants)
Suicidal ideationSuicidal behaviorSuicidal ideation or behaviorSelf-injurious behavior without suicidal intent
Naproxen0000
Placebo0000
V120083 30 mg0000
V120083 60 mg0000

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Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score

The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen5.7473.510
Placebo5.8014.308
V120083 30 mg5.7844.139
V120083 60 mg5.7394.135

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Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score

The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen4.7182.070
Placebo4.2782.634
V120083 30 mg4.6182.847
V120083 60 mg4.3482.679

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Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)

The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen56.028.5
Placebo53.135.7
V120083 30 mg55.536.5
V120083 60 mg53.435.3

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Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary

"The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).~The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state." (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen32.34839.372
Placebo33.76237.826
V120083 30 mg31.68935.515
V120083 60 mg31.62936.277

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Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary

"The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).~The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state." (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen60.45060.921
Placebo59.45060.948
V120083 30 mg59.24859.596
V120083 60 mg59.76659.560

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European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status

"EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)." (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
Baseline VAS ScoreWeek 4 VAS Score
Naproxen75.483.7
Placebo74.681.4
V120083 30 mg73.277.0
V120083 60 mg72.977.4

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Supplemental Analgesic Medication Use

The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group. (NCT03028870)
Timeframe: Up to 28 days

InterventionSupplemental Analgesic Tablets (Mean)
V120083 30 mg0.779
V120083 60 mg0.686
Naproxen0.378
Placebo0.670

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Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score

Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder. (NCT03028870)
Timeframe: Week 4

,,,
Interventionscore on a scale (Mean)
Week 4 change from baseline - HADS-AWeek 4 change from baseline - HADS-D
Naproxen-0.4-0.2
Placebo-0.6-0.1
V120083 30 mg-0.50.3
V120083 60 mg-0.30.6

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"Daily Average Pain Over the Last 24 Hours Score at Week 4"

At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine. (NCT03028870)
Timeframe: Week 4

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen6.13.6
Placebo5.94.4
V120083 30 mg5.94.2
V120083 60 mg5.94.3

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"Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4"

"A subject's response to treatment was defined as the percentage reduction from the baseline average pain over the last 24 hours score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having > 0 % reduction; non-responders were defined as having ≤ 0% reduction." (NCT03028870)
Timeframe: Week 4

,,,
InterventionParticipants (Count of Participants)
Responder - YesResponder - No
Naproxen5719
Placebo4232
V120083 30 mg4628
V120083 60 mg4225

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Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score

The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen47.626.8
Placebo49.633.1
V120083 30 mg49.335.8
V120083 60 mg48.935.5

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Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale

The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen4.22.6
Placebo4.53.1
V120083 30 mg4.63.2
V120083 60 mg4.53.3

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"Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale"

Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine. (NCT03028870)
Timeframe: Weeks 1, 2 and 4

,,,
Interventionscore on a scale (Mean)
BaselineWeek 1 change from baselineWeek 2 change from baselineWeek 4 change from baseline
Naproxen6.469-1.655-2.255-2.741
Placebo6.543-0.977-1.593-1.952
V120083 30 mg6.242-0.920-1.653-1.959
V120083 60 mg6.431-0.860-1.336-1.803

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Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale

The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68. (NCT03028870)
Timeframe: 4 Weeks

,,,
Interventionscore on a scale (Mean)
BaselineWeek 4
Naproxen33.618.7
Placebo35.123.2
V120083 30 mg34.625.6
V120083 60 mg34.825.0

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Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2

(NCT03161093)
Timeframe: Day 1 through week 104E

InterventionParticipants (Count of Participants)
Placebo19
Naproxen47
Fasinumab 1 mg SC Q8W44
Fasinumab 1 mg SC Q4W100

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Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1

(NCT03161093)
Timeframe: Baseline to Week 52

InterventionParticipants (Count of Participants)
Placebo4
Naproxen27
Fasinumab 1 mg SC Q8W40
Fasinumab 1 mg SC Q4W102

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Number of Participants With AA (as Confirmed by Adjudication) - Year 2

(NCT03161093)
Timeframe: First dose of study drug in Year 2 through week 104E

InterventionParticipants (Count of Participants)
Placebo2
Naproxen7
Fasinumab 1 mg SC Q8W11
Fasinumab 1 mg SC Q4W53

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Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2

(NCT03161093)
Timeframe: Day 1 through week 104E (Extension)

InterventionParticipants (Count of Participants)
Placebo6
Naproxen33
Fasinumab 1 mg SC Q8W50
Fasinumab 1 mg SC Q4W152

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Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.76
Fasinumab 1 mg SC Q8W-1.90

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Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.60
Fasinumab 1 mg SC Q4W-2.07

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Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Naproxen-2.00
Fasinumab 1 mg SC Q4W-2.07

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Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Placebo-1.91
Fasinumab 1 mg SC Q8W-2.09

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Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

InterventionScore on a scale (Least Squares Mean)
Placebo-1.46
Fasinumab 1 mg SC Q4W-2.30

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Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionPercentage of participants (Number)
Placebo43.9
Fasinumab 1 mg SC Q4W56.2

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Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Week 16

InterventionPercentage of participants (Number)
Naproxen50.5
Fasinumab 1 mg SC Q4W56.2

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Number of Treatment Emergent Adverse Events (TEAEs) - Year 1

(NCT03161093)
Timeframe: Baseline to Week 52

InterventionEvents (Number)
Placebo1063
Naproxen3641
Fasinumab 1 mg SC Q8W1985
Fasinumab 1 mg SC Q4W3901

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Number of TEAEs - Year 2

(NCT03161093)
Timeframe: First dose of study drug in Year 2 through week 104E

InterventionEvents (Number)
Year 2 Naproxen973
Year 2 Fasinumab 1 mg SC Q8W277
Year 2 Fasinumab 1 mg SC Q4W808

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Number of TEAEs - Year 1 and Year 2

(NCT03161093)
Timeframe: Day 1 through week 104E

InterventionEvents (Number)
Placebo1317
Naproxen4348
Fasinumab 1 mg SC Q8W2271
Fasinumab 1 mg SC Q4W4712

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Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1

(NCT03161093)
Timeframe: Baseline to Week 52

InterventionParticipants (Count of Participants)
Placebo0
Naproxen1
Fasinumab 1 mg SC Q8W2
Fasinumab 1 mg SC Q4W7

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Number of Participants With DA (as Confirmed by Adjudication) - Year 2

(NCT03161093)
Timeframe: First dose of study drug in Year 2 through week 104E

InterventionParticipants (Count of Participants)
Placebo0
Naproxen0
Fasinumab 1 mg SC Q8W0
Fasinumab 1 mg SC Q4W4

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Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionPercentage of participants (Number)
Placebo53.9
Fasinumab 1 mg SC Q8W52.3

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Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2

(NCT03161093)
Timeframe: Day 1 through week 104E

InterventionParticipants (Count of Participants)
Placebo0
Naproxen1
Fasinumab 1 mg SC Q8W2
Fasinumab 1 mg SC Q4W11

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Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2

(NCT03161093)
Timeframe: First dose of study drug in Year 2 through week 104E

InterventionParticipants (Count of Participants)
Year 2 Naproxen0
Year 2 Fasinumab 1 mg SC Q8W0
Year 2 Fasinumab 1 mg SC Q4W0

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Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2

(NCT03161093)
Timeframe: Day 1 through week 104E

InterventionParticipants (Count of Participants)
Placebo1
Naproxen0
Fasinumab 1 mg SC Q8W0
Fasinumab 1 mg SC Q4W0

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Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1

(NCT03161093)
Timeframe: Baseline to Week 52

InterventionParticipants (Count of Participants)
Placebo1
Naproxen0
Fasinumab 1 mg SC Q8W0
Fasinumab 1 mg SC Q4W0

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Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2

(NCT03161093)
Timeframe: First dose of study drug in Year 2 through week 104E

InterventionParticipants (Count of Participants)
Year 2 Naproxen16
Year 2 Fasinumab 1 mg SC Q8W6
Year 2 Fasinumab 1 mg SC Q4W12

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Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2

(NCT03161093)
Timeframe: Day 1 through week 104E

InterventionParticipants (Count of Participants)
Placebo23
Naproxen51
Fasinumab 1 mg SC Q8W35
Fasinumab 1 mg SC Q4W82

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Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1

(NCT03161093)
Timeframe: Baseline to Week 52

InterventionParticipants (Count of Participants)
Placebo18
Naproxen43
Fasinumab 1 mg SC Q8W29
Fasinumab 1 mg SC Q4W70

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Number of Participants With Any Type of All-Cause JR in Year 2

(NCT03161093)
Timeframe: First dose of study drug in Year 2 through week 104E

InterventionParticipants (Count of Participants)
Year 2 Naproxen22
Year 2 Fasinumab 1 mg SC Q8W12
Year 2 Fasinumab 1 mg SC Q4W33

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Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1

(NCT03161093)
Timeframe: Baseline to Week 52

InterventionParticipants (Count of Participants)
Placebo12
Naproxen33
Fasinumab 1 mg SC Q8W31
Fasinumab 1 mg SC Q4W67

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Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Placebo-0.64
Fasinumab 1 mg SC Q4W-0.92

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Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Placebo-0.79
Fasinumab 1 mg SC Q8W-0.77

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Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen

The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Naproxen-0.82
Fasinumab 1 mg SC Q8W-0.77

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Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen

The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Naproxen-0.78
Fasinumab 1 mg SC Q4W-0.92

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Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo

The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Placebo-0.60
Fasinumab 1 mg SC Q4W-0.79

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Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo

The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor). (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Placebo-0.74
Fasinumab 1 mg SC Q8W-0.75

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Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Placebo-1.82
Fasinumab 1 mg SC Q4W-2.49

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Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Placebo-2.09
Fasinumab 1 mg SC Q8W-2.19

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Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Placebo-1.71
Fasinumab 1 mg SC Q4W-2.42

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Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 36, 40 and 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.57
Fasinumab 1 mg SC Q4W-2.06

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Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 36, 40 and 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.69
Fasinumab 1 mg SC Q8W-1.80

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Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

InterventionScore on a scale (Least Squares Mean)
Placebo-1.73
Fasinumab 1 mg SC Q8W-2.11

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Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Mean)
Naproxen-2.42
Fasinumab 1 mg SC Q4W-2.88

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Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Naproxen-2.41
Fasinumab 1 mg SC Q8W-2.53

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Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Naproxen-2.15
Fasinumab 1 mg SC Q4W-2.20

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Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.69
Fasinumab 1 mg SC Q4W-2.20

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Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.77
Fasinumab 1 mg SC Q8W-1.99

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Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 36, 40 and 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.50
Fasinumab 1 mg SC Q4W-1.99

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Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 36, 40 and 44

InterventionScore on a scale (Least Squares Mean)
Placebo-1.62
Fasinumab 1 mg SC Q8W-1.69

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Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

InterventionScore on a scale (Least Squares Mean)
Placebo-1.37
Fasinumab 1 mg SC Q4W-2.25

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Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to average score across weeks 4, 8, 12 and 16

InterventionScore on a scale (Least Squares Mean)
Placebo-1.61
Fasinumab 1 mg SC Q8W-2.04

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Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Naproxen-1.98
Fasinumab 1 mg SC Q4W-2.42

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Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. (NCT03161093)
Timeframe: Baseline to Week 16

InterventionScore on a scale (Least Squares Mean)
Naproxen-2.04
Fasinumab 1 mg SC Q8W-2.09

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Total Pain Relief (TOTPAR)

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. (NCT03404206)
Timeframe: Up to 24 hours

InterventionScores on a scale * hours (Mean)
Naproxen Sodium (Aleve, BAY117031)47.16
Ibuprofen (Advil)28.96
Placebo13.40

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Time to First Use of Rescue Medication

Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment. (NCT03404206)
Timeframe: Up to 24 hours

,,
Interventionhours (Number)
Minimum25th Percentile50th Percentile75th PercentileMaximum
Ibuprofen (Advil)1.228.26710.53314.11718.28
Naproxen Sodium (Aleve, BAY117031)1.2211.017NANA22.17
Placebo1.182.1172.53312.10021.75

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Sum of Pain Intensity Difference (SPID)

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 sum of 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. (NCT03404206)
Timeframe: Up to 24 hours

InterventionScores on a scale * hours (Mean)
Naproxen Sodium (Aleve, BAY117031)83.29
Ibuprofen (Advil)48.54
Placebo9.96

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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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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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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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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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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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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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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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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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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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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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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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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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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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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 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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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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Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments

Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported. (NCT03566979)
Timeframe: Up to 45 minutes after dosing

,
InterventionPercentage of Participants (Number)
45 minutes after dosing44 minutes after dosing43 minutes after dosing42 minutes after dosing41 minutes after dosing40 minutes after dosing39 minutes after dosing38 minutes after dosing37 minutes after dosing36 minutes after dosing35 minutes after dosing34 minutes after dosing33 minutes after dosing32 minutes after dosing31 minutes after dosing30 minutes after dosing29 minutes after dosing28 minutes after dosing27 minutes after dosing26 minutes after dosing25 minutes after dosing24 minutes after dosing23 minutes after dosing22 minutes after dosing21 minutes after dosing20 minutes after dosing19 minutes after dosing18 minutes after dosing17 minutes after dosing16 minutes after dosing15 minutes after dosing14 minutes after dosing13 minutes after dosing
Placebo27.625.925.925.925.925.925.925.924.124.124.124.124.122.420.720.719.019.019.019.017.217.217.217.217.217.217.217.217.212.112.18.68.6
Test Naproxen Sodium Tablet (440 mg)84.984.984.284.284.284.284.284.284.284.283.682.982.281.680.374.371.769.169.167.867.865.863.261.857.953.950.747.445.442.132.223.017.1

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Time to Confirmed Perceptible Pain Relief

Minutes until confirmed first perceptible pain relief was 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 first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. (NCT03566979)
Timeframe: 12 hours

InterventionMinutes (Median)
PlaceboNA
Test Naproxen Sodium Tablet (440 mg)18.7
Commercial Naproxen Sodium Tablets (440 mg)23.5
Commercial Naproxen Sodium Liquid Gel Capsules (440 mg)28.1

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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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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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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. (NCT03654326)
Timeframe: Up to approximately 8 weeks

InterventionPercentage of Participants (Number)
Gefapixant3.2
Placebo0.0

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Percentage of Participants Who Experienced an Adverse Event

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, this analysis included AEs reported up to 14 days after end of study intervention. (NCT03654326)
Timeframe: Up to approximately 10 weeks

InterventionPercentage of Participants (Number)
Gefapixant53.2
Placebo35.5

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Change From Baseline in Average Daily Pelvic Pain Score During Treatment Cycle 2

Pelvic pain (cyclic pain associated with menses, and non-cyclic pain not associated with menses) severity score was measured using a 0-10 numeric rating scale (NRS), with 0 representing no pain and 10 representing extremely severe pain. The averages of the daily pelvic pain scores (cyclic and non-cyclic, combined) entered in participants' electronic diaries (eDiaries) were calculated for Baseline and Treatment Cycle 2 (approximately Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline. (NCT03654326)
Timeframe: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

InterventionScores on a Scale (Least Squares Mean)
Gefapixant-2.2
Placebo-1.7

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Change From Baseline in Average Daily Non-Cyclic Pelvic Pain Score During Treatment Cycle 2

Non-cyclic pelvic pain (not associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the non-cyclic daily pelvic pain scores entered in participants' eDiaries was calculated for the Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates decrease in pain severity from baseline. (NCT03654326)
Timeframe: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

InterventionScores on a Scale (Least Squares Mean)
Gefapixant-2.3
Placebo-1.8

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Change From Baseline in Average Daily Cyclic Pelvic Pain Score During Treatment Cycle 2

Cyclic pelvic pain (associated with menses) severity score was measured using a 0-10 NRS, with 0 representing no pain and 10 representing extremely severe pain. The average of the daily cyclic pelvic pain scores entered in participants' eDiaries was calculated for Baseline and Treatment Cycle 2 (Week 4 to Week 8). A negative change indicates a decrease in pain severity from baseline. (NCT03654326)
Timeframe: Baseline and Treatment Cycle 2 (Week 4 to Week 8; each cycle is approximately 28 days)

InterventionScores on a Scale (Least Squares Mean)
Gefapixant-2.0
Placebo-1.3

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Change in Menstrual Pain

Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score. (NCT03697720)
Timeframe: 6-8 months

Interventionscore on a scale (Mean)
Primary Dysmenorrhea4.1

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Change in Participant Bladder Pain Sensitivity From Baseline

Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure. (NCT03697720)
Timeframe: 6-8 months

Interventionscore on a scale (Mean)
Primary Dysmenorrhea10.7

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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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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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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 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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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 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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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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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 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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Number of Participants by Degree of Cartilage Loss

Microscopic articular features including degree of cartilage were evaluated and scored (Superficial Fibrillation, Deep fissuring, Loss to Tide Mark, Loss to Exposed Bone). (NCT03949673)
Timeframe: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

,,
InterventionParticipants (Count of Participants)
Superficial FibrillationDeep fissuringLoss to Tide MarkLoss to Exposed Bone
Fasinumab2029
Non-steroidal Anti-inflammatory Drug (NSAID)1013
Placebo0101

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Number of Participants by Degree of Synovial Lymphocytic Inflammation

Inflammatory cells including lymphocytes, mast cells, neutrophils, and eosinophils were scored by presence and degree (None present, Slight/Mild, Moderate, Marked/Band). (NCT03949673)
Timeframe: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

,,
InterventionParticipants (Count of Participants)
None presentSlight/MildModerateMarked/Band
Fasinumab3532
Non-steroidal Anti-inflammatory Drug (NSAID)2210
Placebo0020

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Number of Participants by Degree of Bony Changes

Microscopic articular features including degree of bony changes were evaluated and scored (Normal, Sclerosis [Lamellar/Mixed], Subarticular Fracture/Collapse). (NCT03949673)
Timeframe: Up to 24 weeks from the last dose of study drug in the parent study, an average of approximately 3 months

,,
InterventionParticipants (Count of Participants)
NormalSclerosis (Lamellar/Mixed)Subarticular Fracture/Collapse
Fasinumab175
Non-steroidal Anti-inflammatory Drug (NSAID)122
Placebo110

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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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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: 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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Total Pain Relief (TOTPAR) From 0 to 2, 4 and 12 Hours Post-dose

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 0-2 ranges from 0 to 8, TOTPAR 0-4 ranges from 0 to 16, and TOTPAR 0-12 ranges from 0 to 48. A higher value indicates more pain relief (NCT04132336)
Timeframe: Up to 2 hours, 4 hours and 12 hours post dose

,,,,,,
InterventionScores on a scale*hours (Mean)
TOTPAR 0-2TOTPAR 0-4TOTPAR 0-12
Caffeine1.663.5910.28
Naproxen Sodium3.527.8622.95
Naproxen Sodium/Caffeine-Dose 14.8310.2728.20
Naproxen Sodium/Caffeine-Dose 24.7710.2928.26
Naproxen Sodium/Caffeine-Dose 34.228.8425.13
Naproxen Sodium/Caffeine-Dose 43.979.2828.72
Placebo1.062.448.44

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Number of Participants With Adverse Events

(NCT04132336)
Timeframe: Up to 5 days post dose

InterventionParticipants (Count of Participants)
Naproxen Sodium/Caffeine-Dose 16
Naproxen Sodium/Caffeine-Dose 23
Naproxen Sodium/Caffeine-Dose 31
Naproxen Sodium/Caffeine-Dose 42
Naproxen Sodium3
Caffeine5
Placebo4

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The Cumulative Percentage of Participants Taking Rescue Medication

(NCT04132336)
Timeframe: Up to 12 hours post dose

,,,,,,
InterventionPercentage of participants (Number)
0.5 Hours Post-Dose1 Hour Post-Dose1.5 Hours Post-Dose2 Hours Post-Dose3 Hours Post-Dose4 Hours Post-Dose5 Hours Post-Dose6 Hours Post-Dose7 Hours Post-Dose8 Hours Post-Dose9 Hours Post-Dose10 Hours Post-Dose11 Hours Post-Dose12 Hours Post-Dose
Caffeine0037.55056.356.362.568.868.868.868.868.868.875.0
Naproxen Sodium000015.618.818.821.921.921.928.131.334.434.4
Naproxen Sodium/Caffeine-Dose 1000003.19.49.412.515.621.925.025.025.0
Naproxen Sodium/Caffeine-Dose 2003.23.26.56.56.59.79.79.725.825.825.829.0
Naproxen Sodium/Caffeine-Dose 3003.13.16.39.415.618.821.921.925.028.128.128.1
Naproxen Sodium/Caffeine-Dose 400003.13.13.16.36.39.49.415.615.618.8
Placebo0025.037.556.368.868.868.868.875.075.075.075.075.0

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Sum of Pain Intensity Differences (SPIDs) From 0 to 2, 4 and 12 Hours Post-dose

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 0-2 ranges from -20 to 20, SPID 0-4 ranges from -40 to 40 and SPID 0-12 ranges from -120 to 120. A higher value indicates a better pain reduction. (NCT04132336)
Timeframe: Up to 2 hours, 4 hours and 12 hours post dose

,,,,,,
InterventionScores on a scale*hours (Mean)
SPID 0-2SPID 0-4SPID 0-12
Caffeine2.134.5012.44
Naproxen Sodium6.0514.3343.08
Naproxen Sodium/Caffeine-Dose 18.3018.0250.58
Naproxen Sodium/Caffeine-Dose 28.6819.2652.45
Naproxen Sodium/Caffeine-Dose 37.1715.5844.80
Naproxen Sodium/Caffeine-Dose 46.9217.0552.45
Placebo1.162.591.15

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Pain Relief Score at Each Evaluation

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) (NCT04132336)
Timeframe: Up to 12 hours post dose

,,,,,,
InterventionScores on a scale (Mean)
0.5 Hours Post-Dose1 Hours Post-Dose1.5 Hours Post-Dose2 Hours Post-Dose3 Hours Post-Dose4 Hours Post-Dose5 Hours Post-Dose6 Hours Post-Dose7 Hours Post-Dose8 Hours Post-Dose9 Hours Post-Dose10 Hours Post-Dose11 Hours Post-Dose12 Hours Post-Dose
Caffeine0.60.90.90.80.91.00.90.90.90.80.90.90.80.8
Naproxen Sodium1.01.82.02.22.12.22.22.12.12.01.91.81.41.6
Naproxen Sodium/Caffeine-Dose 11.62.42.82.82.82.72.62.42.32.12.22.22.12.2
Naproxen Sodium/Caffeine-Dose 21.52.32.82.92.82.72.62.62.52.32.12.01.91.9
Naproxen Sodium/Caffeine-Dose 31.52.22.32.42.42.32.32.22.12.12.01.81.92.0
Naproxen Sodium/Caffeine-Dose 40.92.02.42.62.62.72.72.72.52.42.32.32.42.2
Placebo0.40.60.60.50.60.80.80.80.80.70.80.80.80.8

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Total Pain Relief (TOTPAR) Over 8 Hours

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 8 hours ranges from 0 to 32, a higher value indicates more pain relief. (NCT04132336)
Timeframe: Up to 8 hours post dose

InterventionScores on a scale*hours (Mean)
Naproxen Sodium/Caffeine-Dose 119.58
Naproxen Sodium/Caffeine-Dose 220.26
Naproxen Sodium/Caffeine-Dose 317.41
Naproxen Sodium/Caffeine-Dose 419.53
Naproxen Sodium16.27
Caffeine7.03
Placebo5.44

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Time to First Use of Rescue Medication

(NCT04132336)
Timeframe: Up to 12 hours post dose

Interventionhours (Median)
Naproxen Sodium/Caffeine-Dose 1NA
Naproxen Sodium/Caffeine-Dose 2NA
Naproxen Sodium/Caffeine-Dose 3NA
Naproxen Sodium/Caffeine-Dose 4NA
Naproxen SodiumNA
Caffeine2.083
Placebo2.125

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The Number of Participants With Clinically Significant Changes in Physical Examinations and Vital Signs

(NCT04132336)
Timeframe: Up to 5 days post dose

InterventionParticipants (Count of Participants)
Naproxen Sodium/Caffeine-Dose 10
Naproxen Sodium/Caffeine-Dose 20
Naproxen Sodium/Caffeine-Dose 30
Naproxen Sodium/Caffeine-Dose 40
Naproxen Sodium0
Caffeine0
Placebo0

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Pain Intensity Difference (PID) at Each Evaluation

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 (NCT04132336)
Timeframe: Up to 12 hours post dose

,,,,,,
InterventionScores on a scale (Mean)
0.5 Hours Post-Dose1 Hour Post-Dose1.5 Hours Post-Dose2 Hours Post-Dose3 Hours Post-Dose4 Hours Post-Dose5 Hours Post-Dose6 Hours Post-Dose7 Hours Post-Dose8 Hours Post-Dose9 Hours Post-Dose10 Hours Post-Dose11 Hours Post-Dose12 Hours Post-Dose
Caffeine0.81.21.21.11.11.31.11.11.10.91.11.10.80.8
Naproxen Sodium1.52.93.74.14.04.34.13.93.93.73.63.33.13.1
Naproxen Sodium/Caffeine-Dose 12.34.24.95.15.04.84.74.64.34.03.83.83.83.8
Naproxen Sodium/Caffeine-Dose 22.64.25.15.55.45.25.04.84.54.23.83.73.53.6
Naproxen Sodium/Caffeine-Dose 32.13.74.34.34.34.14.03.83.83.73.63.43.63.5
Naproxen Sodium/Caffeine-Dose 41.43.44.24.85.05.15.04.94.74.34.24.14.24.0
Placebo0.50.60.70.50.60.91.01.00.80.70.80.90.90.9

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Peak Pain Relief Score

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). At each post-dose time point, participants check the appropriate box (from 0 to 4) on the Categorical Pain Relief Rating Scale to indicate the relief from starting pain at the post dose time points. (NCT04132336)
Timeframe: Up to 12 hours post dose

InterventionScores on a scale (Mean)
Naproxen Sodium/Caffeine-Dose 13.3
Naproxen Sodium/Caffeine-Dose 23.2
Naproxen Sodium/Caffeine-Dose 33.0
Naproxen Sodium/Caffeine-Dose 43.1
Naproxen Sodium2.6
Caffeine1.6
Placebo1.3

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Peak Pain Intensity Difference (PID)

Pain intensity is measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). Participants circle a number (from 0 to 10) on the Numerical Rating Scale to indicate the severity the pain they are experiencing at baseline and at each post dose time point. 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). (NCT04132336)
Timeframe: Up to 12 hours post dose

InterventionScores on a scale (Mean)
Naproxen Sodium/Caffeine-Dose 16.0
Naproxen Sodium/Caffeine-Dose 26.2
Naproxen Sodium/Caffeine-Dose 35.9
Naproxen Sodium/Caffeine-Dose 46.3
Naproxen Sodium5.3
Caffeine2.7
Placebo2.3

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Sum of Pain Intensity Difference (SPID) Over 8 Hours

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 8 hours ranges from -80 to 80. A higher value indicates a better pain reduction. (NCT04132336)
Timeframe: Up to 8 hours post dose

InterventionScores on a scale*hours (Mean)
Naproxen Sodium/Caffeine-Dose 135.45
Naproxen Sodium/Caffeine-Dose 237.87
Naproxen Sodium/Caffeine-Dose 330.70
Naproxen Sodium/Caffeine-Dose 436.02
Naproxen Sodium29.95
Caffeine8.75
Placebo6.03

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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 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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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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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 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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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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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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