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oxycodone

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Description

Oxycodone: A semisynthetic derivative of CODEINE. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

oxycodone : A semisynthetic opioid of formula C18H21NO4 that is derived from thebaine. It is a moderately potent opioid analgesic, generally used for relief of moderate to severe pain. [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 CID5284603
CHEMBL ID656
CHEBI ID7852
SCHEMBL ID2737
MeSH IDM0015664

Synonyms (119)

Synonym
AC-16043
oxycodonum
14-hydroxy-3-methoxy-17-methyl-4,5alpha-epoxymorphinan-6-one
oxicodona
CHEBI:7852 ,
(5alpha)-14-hydroxy-17-methyl-3-(methyloxy)-4,5-epoxymorphinan-6-one
endine (australia)
hsdb 3142
oxycone
endone
codeinone, 7,8-dihydro-14-hydroxy-
morphinan-6-one, 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methyl-
supendol [canada]
morphinan-6-one, 4,5-alpha-epoxy-14-hydroxy-3-methoxy-17-methyl-
brn 0043446
oxycodonum [inn-latin]
einecs 200-960-2
ossicodone [dcit]
nsc 19043
pancodone retard (united kingdom)
oxycodone [usan:inn:ban]
oxanest
oxicodona [inn-spanish]
eubine [france]
morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, (5alpha)-
oxycontin
oxycodeinon
eucodalum
14-hydroxydihydrocodeinone
codeinone,8-dihydro-14-hydroxy-
dihydrone
nsc19043
nsc-19043
wln: t b6566 b6/co 4abbc r bx fv ho pn ght&&ttj cq jo1 p1
morphinan-6-one,5.alpha.-epoxy-14-hydroxy-3-methoxy-17-methyl-
4ah-8,5-bcd]furan-5(6h)-one, 7,7a,8,9-tetrahydro-7a-hydroxy-3-methoxy-12-methyl-
diphydrone
dihydro-14-hydroxycodeinone
codeinone, dihydrohydroxy-
(-)-14-hydroxydihydrocodeinone
percobarb
(-)-oxycodone
morphinan-6-one,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, (5.alpha.)-
dihydrohydroxycodeinone
dihydroxycodeinone
oxicon
oxycodeinone
oxycodon
codeinone, dihydro-14-hydroxy-
D05312
oxycodone (usan/inn)
C08018
oxycodone
76-42-6
4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
DB00497
4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
pavinal
CHEMBL656 ,
pf-00345439
xtampza
pti 821
remoxy
pti-821
ids-no-002
n02aa05
oxymorphone 3-methyl ether
oxycodone cii
dihydrohydroxycondeinone
supendol
apo-oxycodone cr
oxyneo
unii-cd35pmg570
oxyir
oxyfast
avridi
pancodone retard
ossicodone
xtampza er
cd35pmg570 ,
bdbm50370595
oxycodone [mi]
oxycodone cii [usp-rs]
oxycodone [mart.]
oxycodone [orange book]
(5.alpha.)-4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
oxycodone [hsdb]
hydrocodone hydrogen tartrate 2.5-hydrate impurity d [ep impurity]
oxycodone [who-dd]
oxycodone [vandf]
oxycodone [inn]
oxycodone [usan]
(4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one
gtpl7093
BRUQQQPBMZOVGD-XFKAJCMBSA-N
SCHEMBL2737
(5-alpha)-4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
DTXSID5023407 ,
(1s,5r,13r,17s)-17-hydroxy-10-methoxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one
oxycodone 0.1 mg/ml in methanol
oxycodone 1.0 mg/ml in methanol
pf06
(4r,4as,7ar,12bs)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one
Q407535
oxicodone
dtxcid903407
oxycodone (mart.)
oxycodone cii (usp-rs)
hydrocodone hydrogen tartrate 2.5-hydrate impurity d (ep impurity)
supendol (canada)
xtampzaer
oxycodonum (latin)
eubine (france)
oxycodone sr
oxycodonum (inn-latin)
(5alpha)-4,5-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one
oxicodona (inn-spanish)
OOX ,
14-hydroxy-3-methoxy-17-methyl-5beta-4,5-epoxymorphinan-6-one

Research Excerpts

Toxicity

Oxycodone in spinal block prolongs analgesia period, does not cause serious adverse effects and seems to be safe and effective opioid for patients undergoing THA.

ExcerptReferenceRelevance
"Approximately equianalgesic oral doses of codeine, an oxycodone compound resembling Percodan, and pentazocine were compared for adverse effects in a double-blind, randomized study of four doses of each drug given over two days to 247 postsurgical patients with pain."( Adverse effects of commonly ordered oral narcotics.
Hopper, M; Kantor, TG; Laska, E, 1981
)
0.26
" The incidence of adverse effects was similar in all groups; serious adverse effects did not occur."( The safety and efficacy of intrabursal oxycodone and bupivacaine in analgesia after shoulder surgery.
Kirvelä, O; Muittari, P,
)
0.13
" There were no significant differences in adverse effects (P=."( Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain.
Babul, N; Belzile, M; Bruera, E; Darke, A; Fainsinger, R; Ford, I; Harsanyi, Z; Pituskin, E, 1998
)
0.3
"Controlled-release oxycodone is as safe and effective as controlled-release morphine in the treatment of cancer pain."( Randomized, double-blind, cross-over trial comparing safety and efficacy of oral controlled-release oxycodone with controlled-release morphine in patients with cancer pain.
Babul, N; Belzile, M; Bruera, E; Darke, A; Fainsinger, R; Ford, I; Harsanyi, Z; Pituskin, E, 1998
)
0.3
"To assess the effect of opioid substitution (substituting one member of the opioid class for another) on the incidence and severity of adverse effects in palliative care patients who experience unacceptable, refractory adverse effects when taking an opioid drug."( Opioid substitution to reduce adverse effects in cancer pain management.
Ashby, MA; Jackson, KA; Martin, P, 1999
)
0.3
" 49 substitutions were for adverse effects."( Opioid substitution to reduce adverse effects in cancer pain management.
Ashby, MA; Jackson, KA; Martin, P, 1999
)
0.3
"We found that the incidence and severity of adverse effects differed between opioids in the same patient."( Opioid substitution to reduce adverse effects in cancer pain management.
Ashby, MA; Jackson, KA; Martin, P, 1999
)
0.3
" The most common adverse events were constipation, nausea, pruritus, somnolence, and dizziness."( Efficacy and safety of controlled-release versus immediate-release oxycodone: randomized, double-blind evaluation in patients with chronic back pain.
Fleischmann, R; Hale, ME; Iwan, T; Kaiko, RF; Lacouture, PG; Salzman, R; Swanton, RE; Wild, J, 1999
)
0.3
"To determine whether the use of diclofenac ophthalmic solution is a safe and effective analgesic in the treatment of traumatic corneal abrasions in the emergency department."( Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions.
Allegra, JR; Eskin, B; Nashed, AH; Szucs, PA, 2000
)
0.31
" The outcome measurements were improvement in NPIS score 2 hours after treatment, use of oxycodone-acetaminophen, and occurrence of any adverse effects."( Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions.
Allegra, JR; Eskin, B; Nashed, AH; Szucs, PA, 2000
)
0.31
"Diclofenac ophthalmic solution appears to be a safe and effective analgesic in the treatment of traumatic corneal abrasions in the ED."( Safety and efficacy of diclofenac ophthalmic solution in the treatment of corneal abrasions.
Allegra, JR; Eskin, B; Nashed, AH; Szucs, PA, 2000
)
0.31
"Tramadol, a weak opioid mu-receptor agonist, may have a favourable potency and side effect profile for intravenous patient-controlled analgesia (PCA)."( Efficacy and side effects of tramadol versus oxycodone for patient-controlled analgesia after maxillofacial surgery.
Rosenberg, PH; Silvasti, M; Svartling, N; Tarkkila, P; Tuominen, M, 1999
)
0.3
" The review suggested that immediate-release and controlled-release preparations of oxycodone have similar efficacy and comparable side effect profiles."( Safety and efficacy of controlled-release oxycodone: a systematic literature review.
Karbowicz, SH; Rischitelli, DG, 2002
)
0.31
"In all, 28 of 33 patients (85%) completed the study; discontinuations were for adverse events (N=3), patient choice (N=1), and lack of effectiveness (N =1)."( Effectiveness and safety of new oxycodone/acetaminophen formulations with reduced acetaminophen for the treatment of low back pain.
Domingos, J; Galer, BS; Gammaitoni, AR; Lacouture, P; Schlagheck, T, 2003
)
0.32
" Opioid-related adverse events, similar among groups, were generally mild or moderate."( The efficacy and safety of oral immediate-release oxymorphone for postsurgical pain.
Ahdieh, H; Gimbel, J, 2004
)
0.32
" Adverse events for the active drugs were similar; the most frequent were constipation and sedation."( Efficacy and safety of oxymorphone extended release in chronic low back pain: results of a randomized, double-blind, placebo- and active-controlled phase III study.
Dvergsten, C; Gimbel, J; Hale, ME, 2005
)
0.33
" The occurrence of adverse events and changes in laboratory tests were evaluated as safety variables."( Efficacy, safety and pharmacokinetic study of a novel fentanyl-containing matrix transdermal patch system in Japanese patients with cancer pain.
Hanaoka, K; Hosokawa, T; Ishida, T; Kitajima, T; Mashimo, S; Miyazaki, T; Namiki, A; Nogami, S; Ogawa, S, 2008
)
0.35
" A total of 316 adverse events occurred in 78 (90."( Efficacy, safety and pharmacokinetic study of a novel fentanyl-containing matrix transdermal patch system in Japanese patients with cancer pain.
Hanaoka, K; Hosokawa, T; Ishida, T; Kitajima, T; Mashimo, S; Miyazaki, T; Namiki, A; Nogami, S; Ogawa, S, 2008
)
0.35
" The patch tested was well tolerated and its use did not result in any increased incidence of adverse drug reactions over those commonly found with opioid analgesics."( Efficacy, safety and pharmacokinetic study of a novel fentanyl-containing matrix transdermal patch system in Japanese patients with cancer pain.
Hanaoka, K; Hosokawa, T; Ishida, T; Kitajima, T; Mashimo, S; Miyazaki, T; Namiki, A; Nogami, S; Ogawa, S, 2008
)
0.35
" One week later on administration, no significant adverse effects were found in the serology, conscious level, and subjective symptoms of nausea and vomiting."( [Efficacy and safety of continuous subcutaneous injection of the compound oxycodone in cancer pain management: the first 4-year audit].
Hasegawa, T; Hisada, A; Matoba, M; Nozaki, Y; Yoshimoto, T, 2009
)
0.35
" A data overview demonstrates the efficacy and tolerability of PR oxycodone/naloxone in the management of severe chronic pain without the burden of severe gastrointestinal adverse events."( Combined oral prolonged-release oxycodone and naloxone in opioid-induced bowel dysfunction: review of efficacy and safety data in the treatment of patients experiencing chronic pain.
Clemens, KE; Mikus, G, 2010
)
0.36
" Adverse events in both extension phases were consistent with those associated with opioid therapy; no additional safety concerns were observed."( Long-term efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of non-cancer chronic pain.
Dürr, H; Hakl, M; Hopp, M; Hrib, R; Lejcko, J; Leyendecker, P; Meissner, W; Reimer, K; Sandner-Kiesling, A; Sevcik, P; Tarau, L; Uhl, R, 2010
)
0.36
" (1) The adverse effects caused by the prior opioids improved in more than half of the patients, and worsened in none."( [Efficacy and safety of compound oxycodone injection for cancer pain relief-a multicenter survey of prescriptions].
Hasegawa, T; Hisada, A; Matoba, M; Murakami, S; Tomiyasu, S; Yomiya, K; Yoshimoto, T, 2010
)
0.36
"4% (299/342) of patients reported at least one treatment-emergent adverse event (TEAE); incidences of gastrointestinal-related TEAEs were 26."( Efficacy and safety of Tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: a randomized, double-blind, placebo- and active-controlled phase III
Afilalo, M; Etropolski, MS; Haeussler, J; Kelly, K; Kuperwasser, B; Lange, B; Okamoto, A; Rauschkolb, C; Steup, A; Van Hove, I, 2010
)
0.36
" Safety evaluations included adverse events (AEs), vital signs, and clinical laboratory assessments."( Efficacy and safety of oxycodone HCl/niacin tablets for the treatment of moderate-to-severe postoperative pain following bunionectomy surgery.
Clark, FJ; Daniels, SE; Golf, M; Singla, S; Spivey, RJ, 2011
)
0.37
" Adverse events were also recorded."( The efficacy and safety of fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic pain.
Ashburn, MA; Messina, J; Slevin, KA; Xie, F, 2011
)
0.37
" Adverse events with both study drugs were generally typical of opioids, and the majority occurred during titration."( The efficacy and safety of fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic pain.
Ashburn, MA; Messina, J; Slevin, KA; Xie, F, 2011
)
0.37
"Safety and tolerability assessments included adverse events (AEs), laboratory tests, vital signs, physical examinations, and electrocardiograms."( Long-term safety of Remoxy® (extended-release oxycodone) in patients with moderate to severe chronic osteoarthritis or low back pain.
Friedmann, N; Klutzaritz, V; Webster, L, 2011
)
0.37
" Incidences of treatment-emergent adverse events were 56% during the open-label period, and 59, 77, and 73% for the BTDS 5, BTDS 20, and oxycodone 40 mg/day treatment groups, respectively, during the double-blind phase."( Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study.
Hale, M; Landau, C; Munera, C; Ripa, S; Steiner, D, 2011
)
0.37
"Remoxy significantly improved analgesia among patients with moderate to severe chronic osteoarthritic pain with an adverse event profile similar to other opioids."( Efficacy and safety of an extended-release oxycodone (Remoxy) formulation in patients with moderate to severe osteoarthritic pain.
Friedmann, N; Klutzaritz, V; Webster, L,
)
0.13
" The objective was to assess side effect frequency, degree of bother, and impact on health-related quality of life (HRQoL)."( Oxycodone-related side effects: impact on degree of bother, adherence, pain relief, satisfaction, and quality of life.
Ackerman, SJ; Anastassopoulos, KP; Benson, C; Chow, W; Kim, MS; Tapia, C,
)
0.13
" This raises a question about the unmet need for pain medications with improved side effect profiles."( Oxycodone-related side effects: impact on degree of bother, adherence, pain relief, satisfaction, and quality of life.
Ackerman, SJ; Anastassopoulos, KP; Benson, C; Chow, W; Kim, MS; Tapia, C,
)
0.13
" There was a 50-75 percent reduction in moderate to severe adverse events (AEs) commonly associated with opioids (ie, nausea, vomiting, and dizziness) in the MoxDuo 6 mg/4 mg group when compared with its morphine-equivalent dose groups."( Analgesic and adverse effects of a fixed-ratio morphine-oxycodone combination (MoxDuo) in the treatment of postoperative pain.
Kelen, R; Richards, P; Riff, D; Stern, W,
)
0.13
" No serious adverse effects associated with bowel stimulation were reported."( Safety and efficacy of immediate postoperative feeding and bowel stimulation to prevent ileus after major gynecologic surgical procedures.
Fanning, J; Hojat, R, 2011
)
0.37
"Immediate postoperative feeding and bowel stimulation is a safe and effective approach to preventing ileus in patients who undergo major gynecologic surgical procedures."( Safety and efficacy of immediate postoperative feeding and bowel stimulation to prevent ileus after major gynecologic surgical procedures.
Fanning, J; Hojat, R, 2011
)
0.37
" Overall, rates of adverse drug reactions were similar."( A randomized, double-blind, active-controlled, double-dummy, parallel-group study to determine the safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate/severe, chronic cancer pain.
Ahmedzai, SH; Bar-Sela, G; Bosse, B; Hopp, M; Leyendecker, P; Nauck, F, 2012
)
0.38
"To provide family physicians with a practical clinical summary of the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, developed by the National Opioid Use Guideline Group."( Canadian guideline for safe and effective use of opioids for chronic noncancer pain: clinical summary for family physicians. Part 1: general population.
Kahan, M; Mailis-Gagnon, A; Srivastava, A; Wilson, L, 2011
)
0.37
"To determine the efficacy and adverse reactions of OxyContin® administered by rectal route in advanced cancer patients."( Clinical observations on safety and efficacy of OxyContin® administered by rectal route in treating cancer related pain.
Huang, XE; Li, CG; Li, Y; Lu, YY, 2011
)
0.37
"OxyContin admistered by rectal route is safe for advanced cancer patients with satisfactory pain control effects, thus deserving further clinical observation."( Clinical observations on safety and efficacy of OxyContin® administered by rectal route in treating cancer related pain.
Huang, XE; Li, CG; Li, Y; Lu, YY, 2011
)
0.37
" Pain intensity on a numeric rating scale, percentage of patients with each degree of pain, quality of life, adverse reactions, analgesic costs, and hospital stays were evaluated and compared among the three groups."( Liver cancer: effects, safety, and cost-effectiveness of controlled-release oxycodone for pain control after TACE.
Kan, Z; Shi, P; Wang, J; Yan, Z; Zhou, B, 2012
)
0.38
" No significant difference was observed in quality of life and adverse events between the treated groups and the placebo group."( Liver cancer: effects, safety, and cost-effectiveness of controlled-release oxycodone for pain control after TACE.
Kan, Z; Shi, P; Wang, J; Yan, Z; Zhou, B, 2012
)
0.38
" The aim of the present study was to evaluate the results from randomized controlled trials investigating the relative amount of adverse effects using tapentadol or oxycodone for the treatment of pain."( [Undesired side effects of tapentadol in comparison to oxycodone. A meta-analysis of randomized controlled comparative studies].
Dinges, G; Koch, T; Kranke, P; Merker, M; Morin, AM, 2012
)
0.38
" The incidences of typical adverse side effects of opioid-based analgesic therapy (e."( [Undesired side effects of tapentadol in comparison to oxycodone. A meta-analysis of randomized controlled comparative studies].
Dinges, G; Koch, T; Kranke, P; Merker, M; Morin, AM, 2012
)
0.38
"The results show that using tapentadol significantly reduces the risk of the typical opioid-based adverse effects compared with oxycodone while providing equivalent analgesic treatment."( [Undesired side effects of tapentadol in comparison to oxycodone. A meta-analysis of randomized controlled comparative studies].
Dinges, G; Koch, T; Kranke, P; Merker, M; Morin, AM, 2012
)
0.38
"Although opioids are widely accepted as standard therapy for treating acute postoperative pain, the frequent occurrence of adverse events (AEs) and the substantial burden on the patient and the costs of care are a barrier to optimal dosing and adherence to prescribed treatment."( Efficacy and safety of dual-opioid therapy in acute pain.
Webster, L, 2012
)
0.38
"It has been confirmed by several clinical trials that the fentanyl patch causes less adverse events than sustained-release oral morphine, and after rotation."( [A pilot study of the reduced effects of adverse events caused by oral morphine and oxycodone after rotating to fentanyl patch in patients with metastatic breast cancer].
Fujii, S; Ikeda, M; Koike, Y; Kubo, S; Kurebayashi, J; Mizutou, A; Nakashima, K; Nomura, T; Oota, Y; Saitou, W; Seki, M; Shiiki, S; Shimo, T; Sonoo, H; Tanaka, K; Yamamoto, Y; Yamashita, T, 2012
)
0.38
"We prospectively investigated the reduced effects of adverse events caused by sustained-release oral morphine and controlled-release oxycodone after rotating to the fentanyl patch in patients with metastatic breast cancer."( [A pilot study of the reduced effects of adverse events caused by oral morphine and oxycodone after rotating to fentanyl patch in patients with metastatic breast cancer].
Fujii, S; Ikeda, M; Koike, Y; Kubo, S; Kurebayashi, J; Mizutou, A; Nakashima, K; Nomura, T; Oota, Y; Saitou, W; Seki, M; Shiiki, S; Shimo, T; Sonoo, H; Tanaka, K; Yamamoto, Y; Yamashita, T, 2012
)
0.38
" Those experiencing adverse events from oral morphine or oral oxycodone were administered a fentanyl patch."( [A pilot study of the reduced effects of adverse events caused by oral morphine and oxycodone after rotating to fentanyl patch in patients with metastatic breast cancer].
Fujii, S; Ikeda, M; Koike, Y; Kubo, S; Kurebayashi, J; Mizutou, A; Nakashima, K; Nomura, T; Oota, Y; Saitou, W; Seki, M; Shiiki, S; Shimo, T; Sonoo, H; Tanaka, K; Yamamoto, Y; Yamashita, T, 2012
)
0.38
"This study suggested that the fentanyl patch can reduce adverse events caused by sustained-release oral morphine as well as controlled-release oral oxycodone."( [A pilot study of the reduced effects of adverse events caused by oral morphine and oxycodone after rotating to fentanyl patch in patients with metastatic breast cancer].
Fujii, S; Ikeda, M; Koike, Y; Kubo, S; Kurebayashi, J; Mizutou, A; Nakashima, K; Nomura, T; Oota, Y; Saitou, W; Seki, M; Shiiki, S; Shimo, T; Sonoo, H; Tanaka, K; Yamamoto, Y; Yamashita, T, 2012
)
0.38
"5%) rated tolerability as "good" or "very good" at Week 52; few patients discontinued treatment because of an adverse event (1."( Sustained safety and efficacy of once-daily hydromorphone extended-release (OROS® hydromorphone ER) compared with twice-daily oxycodone controlled-release over 52 weeks in patients with moderate to severe chronic noncancer pain.
Binsfeld, H; Richarz, U; Sabatowski, R; Szczepanski, L; Waechter, S, 2013
)
0.39
"To understand the relationship between the risk of opioid-related gastrointestinal adverse effects (AEs) and exposure to tapentadol and oxycodone as well as its active metabolite, oxymorphone, using pharmacokinetic/pharmacodynamic models."( Pharmacokinetic and pharmacodynamic modeling of opioid-induced gastrointestinal side effects in patients receiving tapentadol IR and oxycodone IR.
Etropolski, M; Lin, R; Nandy, P; Okamoto, A; Upmalis, D; Xu, XS, 2012
)
0.38
" Common adverse events, which occurred in 91."( Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients.
Bae, SH; Cho, YY; Hyun, MS; Kim, JY; Kim, MK; Lee, KH; Lee, SA; Lee, WS; Park, KU; Ryoo, HM; Song, HS,
)
0.13
"4%) reported experiencing at least 1 side effect with 77."( Economic study on the impact of side effects in patients taking oxycodone controlled-release for noncancer pain.
Ackerman, SJ; Anastassopoulos, KP; Baik, R; Biondi, D; Chow, W; Kim, MS; Tapia, CI, 2012
)
0.38
" Respondents who reported higher levels of side-effect bother also reported greater MRU, resulting in increased payer costs."( Economic study on the impact of side effects in patients taking oxycodone controlled-release for noncancer pain.
Ackerman, SJ; Anastassopoulos, KP; Baik, R; Biondi, D; Chow, W; Kim, MS; Tapia, CI, 2012
)
0.38
" Moderate to severe gastrointestinal adverse events occurred in 50% of patients in the oxycodone/acetaminophen group compared with 15% of the equianalgesic morphine/oxycodone group."( Comparison of the efficacy and safety of dual-opioid treatment with morphine plus oxycodone versus oxycodone/acetaminophen for moderate to severe acute pain after total knee arthroplasty.
Gimbel, JS; Kelen, R; Minkowitz, HS; Richards, P; Stern, W, 2013
)
0.39
" The primary endpoint was a ≥1/3 reduction in pain (NRS); secondary endpoints included the time to analgesia and adverse effects."( Randomised phase II trial (NCT00637975) evaluating activity and toxicity of two different escalating strategies for pregabalin and oxycodone combination therapy for neuropathic pain in cancer patients.
Bianchi, A; Bramati, A; Carbone, C; Farina, G; Febbraro, A; Ganzinelli, M; Garassino, MC; Gentili, M; Iorno, V; La Verde, N; Marabese, M; Moretti, A; Piva, S; Spagnoletti, I; Torri, V, 2013
)
0.39
" Given its tricyclic properties, serotonin syndrome is a potential side effect of this drug."( Neuropsychiatric side effects of cyclobenzaprine.
Sederholm, B; Shprecher, D; Sloan, CT, 2013
)
0.39
" Safety assessments included adverse events, vital signs, pulse oximetry (SpO2), and electrocardiograms."( Pharmacokinetics, tolerability, and safety of intranasal administration of reformulated OxyContin(®) tablets compared with original OxyContin (®) tablets in healthy adults.
Apseloff, G; Colucci, SV; Harris, SC; Perrino, PJ, 2013
)
0.39
", adverse events, vital signs, laboratory tests) were assessed to 24 hours postdose."( Abuse potential, pharmacokinetics, pharmacodynamics, and safety of intranasally administered crushed oxycodone HCl abuse-deterrent controlled-release tablets in recreational opioid users.
Bartlett, C; Colucci, SV; Harris, SC; Perrino, PJ; Sellers, EM; Shram, MJ; Smith, I, 2014
)
0.4
" Treatment-emergent adverse events were comparable between treatment groups."( Safety and efficacy of once-daily hydromorphone extended-release versus twice-daily oxycodone hydrochloride controlled-release in chinese patients with cancer pain: a phase 3, randomized, double-blind, multicenter study.
Han, J; Hou, Y; Richards, HM; Shen, W; Yu, L; Yu, S, 2014
)
0.4
" Adverse events (AEs) and discontinuations were recorded in each study; pooled results were analyzed by treatment group."( Safety and tolerability of tapentadol extended release in moderate to severe chronic osteoarthritis or low back pain management: pooled analysis of randomized controlled trials.
Etropolski, M; Flügel, M; Häufel, T; Kuperwasser, B; Lange, B; Laschewski, F; Rauschkolb, C, 2014
)
0.4
" The difference in adverse events (AEs) between the two treatments did not reach significance, as 19."( Clinical evaluation of the first oxycodone once daily prolonged release tablet in moderate to severe chronic pain: a randomized, double-blind, multicenter, cross-over, non-inferiority study to investigate efficacy and safety in comparison with an establis
Janecki, M; Lux, EA; Maritz, MA, 2014
)
0.4
"Treatment-emergent adverse events, physical examinations, vital sign measurements, and clinical laboratory testing were assessed throughout the study."( Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery.
Barrett, T; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.4
" Adverse events occurred during the OLE in 64 patients (43."( Assessment of the safety and efficacy of extended-release oxycodone/acetaminophen, for 14 days postsurgery.
Barrett, T; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.4
"Number and type of adverse events (AEs) and drugrelated AEs, including assessments of withdrawal (Clinical Opiate Withdrawal Scale; COWS), pharmacokinetics, efficacy, and aberrant behaviors (Current Opioid Misuse Measure)."( A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
Arora, S; Clemmer, R; Goli, V; Hudson, JD; Meisner, P; Michael, D; Pixton, GC; Setnik, B; Sommerville, KW,
)
0.13
"Repeat dosing of ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of both opioid-experienced and opioid-naïve patients."( A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
Arora, S; Clemmer, R; Goli, V; Hudson, JD; Meisner, P; Michael, D; Pixton, GC; Setnik, B; Sommerville, KW,
)
0.13
"Historically, chronic pain generally went under-treated for a variety of objective and subjective reasons, including difficulty to objectively diagnose and manage over a long period of time, potential serious adverse effects of commonly available medications, and patient, healthcare and societal concerns over opioid medications."( Long-term efficacy, safety and tolerability of Remoxy for the management of chronic pain.
Pergolizzi, JV; Raffa, RB; Taylor, R; Zampogna, G, 2015
)
0.42
" We assessed the frequency and intensity of adverse effects, the intensity of postoperative pain by a verbal numeric scale and the use of rescue analgesia from 12 hours after administration of the drug and between 7 and 13 days after the last oxycodone dose."( Safety and tolerability of controlled-release oxycodone on postoperative pain in patients submitted to the oncologic head and neck surgery.
Carvalho, AC; Cavalcanti, IL; Figueiredo, NV; Migon, RN; Musauer, MG; Rodrigues, VS; Vane, LA,
)
0.13
"The most common adverse events were nausea, vomiting, dizziness, pruritus, insomnia, constipation and urinary retention, most mild."( Safety and tolerability of controlled-release oxycodone on postoperative pain in patients submitted to the oncologic head and neck surgery.
Carvalho, AC; Cavalcanti, IL; Figueiredo, NV; Migon, RN; Musauer, MG; Rodrigues, VS; Vane, LA,
)
0.13
"Controlled release oxycodone showed to be safe and well tolerated and caused a significant decrease in post-operative pain."( Safety and tolerability of controlled-release oxycodone on postoperative pain in patients submitted to the oncologic head and neck surgery.
Carvalho, AC; Cavalcanti, IL; Figueiredo, NV; Migon, RN; Musauer, MG; Rodrigues, VS; Vane, LA,
)
0.13
" The primary outcome was the percentage of patients without adverse event-related study discontinuations who presented with a combination of a ≥50% improvement of pain intensity, disability and quality-of-life and a ≤50% worsening of bowel function at study end."( Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine for the treatment of chronic low back pain: results of a 12 week prospective, randomized, open-label blinded endpoint streamlined study with prolonged-release preparations.
Mueller-Schwefe, GH; Ueberall, MA, 2015
)
0.42
"0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE)."( A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment.
Bass, A; Bramson, C; Hale, ME; Malhotra, BK; Meisner, P; Pixton, G; Rauck, RL; Setnik, B; Sommerville, KW; Wilson, JG; Wolfram, G, 2015
)
0.42
" Xtampza ER had an adverse event profile consistent with other opioids and was well tolerated; no new safety concerns were identified."( A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain.
Brown, RH; Fleming, AB; Katz, N; Kopecky, EA; O'Connor, M, 2015
)
0.42
" However, due to the concerns of adverse reactions, drug interactions, and addiction, clinicians frequently hesitate to prescribe opioids."( Is oxycodone/naloxone effective and safe in managing chronic pain of a fragile elderly patient with multiple skin ulcers of the lower limbs? A case report.
Francis, M; Guerriero, F; Maurizi, N; Perna, S; Ricevuti, G; Rollone, M; Rondanelli, M; Sgarlata, C, 2015
)
0.42
" The most common treatment-emergent adverse events (incidence ≥10%; n = 1154) were headache (13."( Long-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial.
Arsenault, P; Buynak, R; Etropolski, M; Heisig, F; Rappaport, SA; Rauschkolb, C; Rod, K, 2015
)
0.42
" Additionally, those patients administered epidural oxycodone had lower pain scores, needed less rescue analgesics and had fewer adverse effects compared with intravenous administration."( Cytotoxicity of Oxycodone and Morphine in Human Neuroblastoma and Mouse Motoneuronal Cells: A Comparative Approach.
Kokki, H; Kokki, M; Litmala, O; Pasanen, M; Pesonen, M; Vehviläinen, P, 2016
)
0.43
" At each visit, pain intensity, modifications of therapy and adverse drug reactions (ADRs) were recorded."( Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV 'real life' trial on the variability of response to opioids.
Apolone, G; Azzarello, G; Bandieri, E; Caraceni, A; Cavanna, L; Corli, O; Crispino, C; Di Gregorio, R; Dragani, TA; Floriani, I; Galli, F; Gamucci, T; Greco, MT; Iorno, V; Kaasa, S; Lipari, G; Luzzani, M; Montanari, M; Pacchioni, M; Pavesi, L; Reale, C; Roberto, A; Valenti, D, 2016
)
0.43
"The main findings were the similarity in pain control, response rates and main adverse reactions among opioids."( Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV 'real life' trial on the variability of response to opioids.
Apolone, G; Azzarello, G; Bandieri, E; Caraceni, A; Cavanna, L; Corli, O; Crispino, C; Di Gregorio, R; Dragani, TA; Floriani, I; Galli, F; Gamucci, T; Greco, MT; Iorno, V; Kaasa, S; Lipari, G; Luzzani, M; Montanari, M; Pacchioni, M; Pavesi, L; Reale, C; Roberto, A; Valenti, D, 2016
)
0.43
" As cardiovascular safety data are lacking, we assessed disproportionate reporting of adverse cardiac events associated with naloxone across large, international pharmacovigilance systems."( Cardiovascular disorders associated with naloxone monotherapy and in fixed-dose combination with opioids: Data from international safety surveillance.
Haigney, MC; Kao, D; Krantz, MJ; Mehler, PS; Sandhu, A, 2016
)
0.43
"Post-marketing data from the World Health Organization (WHO) and FDA Adverse Events Reporting System (FAERS) were evaluated for naloxone and the synthetic opioids oxycodone and tilidine."( Cardiovascular disorders associated with naloxone monotherapy and in fixed-dose combination with opioids: Data from international safety surveillance.
Haigney, MC; Kao, D; Krantz, MJ; Mehler, PS; Sandhu, A, 2016
)
0.43
"In total, 14,827,374 million adverse drug event reports were reviewed."( Cardiovascular disorders associated with naloxone monotherapy and in fixed-dose combination with opioids: Data from international safety surveillance.
Haigney, MC; Kao, D; Krantz, MJ; Mehler, PS; Sandhu, A, 2016
)
0.43
"Available pharmacovigilance data do not suggest disproportionate reporting of adverse cardiovascular events for opioid antagonists used to treat OIC."( Cardiovascular disorders associated with naloxone monotherapy and in fixed-dose combination with opioids: Data from international safety surveillance.
Haigney, MC; Kao, D; Krantz, MJ; Mehler, PS; Sandhu, A, 2016
)
0.43
"The adverse events (AEs) of oxycodone in cancer-related pain were controversial, so we conducted a meta-analysis to determine it."( The Adverse Events of Oxycodone in Cancer-Related Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Huang, L; Jin, SH; Liu, Y; Ma, H; Tian, X; Yue, GJ; Zeng, XT; Zhou, JG, 2016
)
0.43
" HYD demonstrated a safety profile typical of µ opioids; nausea, constipation, vomiting, and dizziness were the most frequently reported opioid-related adverse events during the study."( Effectiveness and Safety of Once-Daily Extended-Release Hydrocodone in Individuals Previously Receiving Immediate-Release Oxycodone for Chronic Pain.
He, E; Kowalski, M; Pergolizzi, J, 2018
)
0.48
" The safety profile was consistent with the application method and known side-effect profile of oxycodone and naltrexone."( Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.
Gavin, PD; Schlagheck, T; Shakib, S; Simon, LS; Smith, AJ, 2017
)
0.46
" Adverse events were consistent with the known effects of OXN PR and no new safety concerns emerged."( Long-term efficacy and safety of oxycodone-naloxone prolonged-release formulation (up to 180/90 mg daily) - results of the open-label extension phase of a phase III multicenter, multiple-dose, randomized, controlled study.
Bosse, B; Dupoiron, D; Ellery, A; Hopp, M; Kremers, W; Loewenstein, O; Stachowiak, A, 2017
)
0.46
"2% for tapentadol PR); time to treatment discontinuation due to an adverse event was significantly shorter for oxycodone CR (p < 0."( Efficacy and safety of tapentadol prolonged release for moderate-to-severe chronic osteoarthritis knee pain: a pooled analysis of two double-blind, randomized, placebo- and oxycodone controlled release-controlled studies.
Dubois, C; Elling, C; Lange, B; von Zabern, D, 2017
)
0.46
" Pain scores, adverse events, and length of stay were recorded."( Intrathecal Morphine and Oral Analgesics Provide Safe and Effective Pain Control After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis.
Abbott, MD; Burke, MC; Caird, MS; Farley, FA; Gibbons, KM; Holman, AE; Hong, RA; Li, Y; Robbins, CB, 2018
)
0.48
" Adverse events occurred at similar rates in both groups."( Intrathecal Morphine and Oral Analgesics Provide Safe and Effective Pain Control After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis.
Abbott, MD; Burke, MC; Caird, MS; Farley, FA; Gibbons, KM; Holman, AE; Hong, RA; Li, Y; Robbins, CB, 2018
)
0.48
"ITM and oral analgesics provide safe and effective pain control after PSF for AIS."( Intrathecal Morphine and Oral Analgesics Provide Safe and Effective Pain Control After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis.
Abbott, MD; Burke, MC; Caird, MS; Farley, FA; Gibbons, KM; Holman, AE; Hong, RA; Li, Y; Robbins, CB, 2018
)
0.48
" Of the 26 patients ≥65 years old randomized to continue oxycodone DETERx during the double-blind maintenance phase, 18 (69%) completed the study; only two patients (8%) in the oxycodone DETERx group discontinued due to adverse events."( Tolerability, Safety, and Effectiveness of Oxycodone DETERx in Elderly Patients ≥65 Years of Age with Chronic Low Back Pain: A Randomized Controlled Trial.
Kopecky, EA; Lagasse, S; O'Connor, M; Vaughn, B, 2017
)
0.46
" Thus, patients with cancer are commonly on medications, such as antifungals, that have the potential to interact with opioids, causing adverse effects."( Oxycodone-induced neurotoxicity secondary to concurrent voriconazole use in a patient with cancer.
Alghothani, L; Gustin, J,
)
0.13
" 1) Opioid overdose is a common complication of abuse, so it is desirable for an opioid vaccine to block the toxic as well as the addictive effects of opioids."( Safety and efficacy of an oxycodone vaccine: Addressing some of the unique considerations posed by opioid abuse.
Baruffaldi, F; Carroll, FI; Comer, SD; Langston, TL; Laudenbach, M; Navarro, HA; Pentel, PR; Peterson, SJ; Pravetoni, M; Raleigh, MD; Runyon, SP; Winston, S, 2017
)
0.46
"3%) patients reported adverse events."( Efficacy and safety of oxycodone/naloxone as add-on therapy to gabapentin or pregabalin for the management of chemotherapy-induced peripheral neuropathy in Korea.
Jin, JY; Kang, JH; Kim, BS; Ko, YH; Kwon, JH; Park, HJ; Park, SY; Woo, IS, 2018
)
0.48
" All adverse events during the hospital stay were recorded."( A prospective, randomized, open label, controlled study investigating the efficiency and safety of 3 different methods of rectus sheath block analgesia following midline laparotomy.
Anttila, M; Eskelinen, M; Hautajärvi, H; Kinnunen, M; Kokki, H; Kokki, M; Lehtonen, M; Purdy, M, 2018
)
0.48
" No serious or unexpected adverse events were reported."( A prospective, randomized, open label, controlled study investigating the efficiency and safety of 3 different methods of rectus sheath block analgesia following midline laparotomy.
Anttila, M; Eskelinen, M; Hautajärvi, H; Kinnunen, M; Kokki, H; Kokki, M; Lehtonen, M; Purdy, M, 2018
)
0.48
" The majority of adverse effects were moderate or mild and recovered with no sequelae."( Efficacy and Safety of Oxycodone Injection for Relieving Cancer Pain: A Study in Japan Consisting of Two Open Trials for Intravenous and Subcutaneous Administration.
Hojo, M; Kokubun, H; Matoba, M; Ryu, E; Tomiyasu, S; Yoshimoto, T, 2018
)
0.48
"Our objective was to assess the effect of sublingual fentanyl tablets (SFTs) on pain relief, quality of life, and adverse effects in patients with cancer pain, according to cancer stage and background opioid regimen."( Efficacy and Safety of Sublingual Fentanyl Tablets in Breakthrough Cancer Pain Management According to Cancer Stage and Background Opioid Medication.
Coma, J; De Sanctis, V; Estivill, P; Ferreras, J; Folch, J; Fuentes, J; Guitart, J; Jiménez, AJ; Moya, J; Rodelas, F; Salazar, R; Sanz, A; Tomás, A; Vargas, MI, 2018
)
0.48
" The efficacy and safety of SFTs were evaluated, recording pain intensity (PI), onset of pain relief, and adverse events (AEs)."( Efficacy and Safety of Sublingual Fentanyl Tablets in Breakthrough Cancer Pain Management According to Cancer Stage and Background Opioid Medication.
Coma, J; De Sanctis, V; Estivill, P; Ferreras, J; Folch, J; Fuentes, J; Guitart, J; Jiménez, AJ; Moya, J; Rodelas, F; Salazar, R; Sanz, A; Tomás, A; Vargas, MI, 2018
)
0.48
" Adverse events occurred in 83."( A randomized, double-blind, non-inferiority study of hydromorphone hydrochloride immediate-release tablets versus oxycodone hydrochloride immediate-release powder for cancer pain: efficacy and safety in Japanese cancer patients.
Aruga, E; Inoue, S; Saito, Y; Takahashi, H; Tsuneto, S; Uemori, M, 2018
)
0.48
" However, if the opioid analgesic could be limited to a single drug, we hypothesized that the risk of adverse drug interactions could be reduced, with fewer adverse effects."( Oxycodone is safe and effective for general anesthesia.
Ellerkmann, RK; Soehle, M; Wirtz, CD; Wirz, S,
)
0.13
" Safety was evaluated by the measurement of hemodynamic changes (blood pressure, heart rate), the detection of pathologic changes in the electrocardiogram, changes of the peripheral oxygen saturation, and by the assessment of adverse effects."( Oxycodone is safe and effective for general anesthesia.
Ellerkmann, RK; Soehle, M; Wirtz, CD; Wirz, S,
)
0.13
" No severe adverse events were recorded."( Oxycodone is safe and effective for general anesthesia.
Ellerkmann, RK; Soehle, M; Wirtz, CD; Wirz, S,
)
0.13
" Our results in nonhuman primates suggest that bifunctional NOP/MOP agonists with the appropriate balance of NOP and MOP agonist activity may provide a dual therapeutic action for safe and effective pain relief and treating prescription opioid abuse."( A bifunctional nociceptin and mu opioid receptor agonist is analgesic without opioid side effects in nonhuman primates.
Czoty, PW; Daga, PR; Ding, H; Kiguchi, N; Kishioka, S; Ko, MC; Lu, JJ; Polgar, WE; Yasuda, D; Zaveri, NT, 2018
)
0.48
" However, although opioids have been appropriately used in Japan, they rarely induce serious adverse events, such as respiratory depression."( Current Status of Adverse Events Related with Opioid Analgesics in Japan: Assessment Based on Japanese Adverse Drug Event Report Database.
Futamura, A; Nakagawa, T; Suga, Y; Sugawara, H; Suzuki, S; Takase, H; Torigoe, K; Uchida, M; Uesawa, Y, 2019
)
0.51
" The mild or moderate adverse effects were similar in 2 groups, while severe adverse effects were only identified in morphine group (P = ."( Efficacy and safety of sustained-release oxycodone compared with immediate-release morphine for pain titration in cancer patients: A multicenter, open-label, randomized controlled trial (SOCIAL).
Guo, Q; Han, F; Lu, L; Pan, H; Pan, J; Qian, S; Shen, P; Shu, Q; Wang, K; Xu, Q; Yang, Z; Zhang, P; Zhou, Y, 2019
)
0.51
" There was no clinically relevant harm with regards to the drop out rate due to adverse and serious adverse events by opioids compared to placebo."( Opioids for chronic non-cancer neuropathic pain. An updated systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks duration.
Häuser, W; Klose, P; Petzke, F; Sommer, C; Welsch, P, 2020
)
0.56
" TAP IR was less likely to have gastrointestinal adverse effects such as nausea and constipation compared with other opioids."( Efficacy and Safety of Tapentadol Immediate Release for Acute Pain: A Systematic Review and Meta-Analysis.
Narayan, SW; Patanwala, AE; Penm, J; Wang, X, 2020
)
0.56
"TAP IR is as effective as other opioids at higher doses for acute pain and is associated with fewer gastrointestinal adverse effects."( Efficacy and Safety of Tapentadol Immediate Release for Acute Pain: A Systematic Review and Meta-Analysis.
Narayan, SW; Patanwala, AE; Penm, J; Wang, X, 2020
)
0.56
"With increased opioid use, drug-drug interactions (DDIs) and associated adverse events are growing among geriatric patients."( The impact of drug interactions on adverse effects of oral oxycodone in male geriatric patients.
Gwak, HS; Kim, JH; Kim, JY; Lee, N; Yee, J, 2020
)
0.56
" Numerous tools and procedural practice guides are available to help facilitate safe prescribing."( How I treat pain in hematologic malignancies safely with opioid therapy.
Gazelka, H; Geyer, HL; Mesa, R, 2020
)
0.56
"To perform the analysis, a comprehensive database consisting of pain relief compounds with information on summary-level of efficacy over time, adverse events and dropout rates was compiled from multiple sources."( Model-based Meta-analysis to Compare Primary Efficacy-endpoint, Efficacy-time Course, Safety, and Tolerability of Opioids Used in the Management of Osteoarthritic Pain in Humans.
Alhaj-Suliman, SO; Milavetz, G; Salem, AK, 2020
)
0.56
" It was also found that gastrointestinal adverse events were the most opioid-associated and dosedependent adverse effects."( Model-based Meta-analysis to Compare Primary Efficacy-endpoint, Efficacy-time Course, Safety, and Tolerability of Opioids Used in the Management of Osteoarthritic Pain in Humans.
Alhaj-Suliman, SO; Milavetz, G; Salem, AK, 2020
)
0.56
" To offer more effective medical interventions to treat or prevent OUD, antiopioid vaccines are in development that reduce the distribution of the targeted opioids to brain and subsequently reduce the associated behavioral and toxic effects."( Combining a Candidate Vaccine for Opioid Use Disorders with Extended-Release Naltrexone Increases Protection against Oxycodone-Induced Behavioral Effects and Toxicity.
Accetturo, C; Pravetoni, M; Raleigh, MD, 2020
)
0.56
" The purpose of this trial was to compare opioid-related adverse events (ORAES) of intravenous oxycodone and morphine after total hip arthroplasty."( Post-operative opioid-related adverse events with intravenous oxycodone compared to morphine: A randomized controlled trial.
Alonso, S; Boisson, C; Cuvillon, P; Kouyoumdjian, P; L'Hermite, J; Langeron, O; Luc Faillie, J; Raux, M; Reubrecht, V; Vialles, N; Zoric, L, 2021
)
0.62
"Opioids are increasingly prescribed and frequently involved in adverse drug events (ADEs)."( Nature of adverse events with opioids in hospitalised patients: a post-hoc analysis of three patient record review studies.
de Bruijne, M; Jongerden, I; Klopotowska, JE; Langelaan, M; Moesker, M; Schutijser, BCFM; Wagner, C, 2020
)
0.56
" Future interventions should focus on safe dosing of opioids when prescribing and administering, especially in elderly patients."( Nature of adverse events with opioids in hospitalised patients: a post-hoc analysis of three patient record review studies.
de Bruijne, M; Jongerden, I; Klopotowska, JE; Langelaan, M; Moesker, M; Schutijser, BCFM; Wagner, C, 2020
)
0.56
"Opioids pose significant increased risk for serious adverse drug events (ADEs)."( Predictors of serious adverse drug events from opioids: Results from the Food and Drug Administration Adverse Events Reporting System.
McDonald, DD; Srisopa, P, 2021
)
0.62
"A post hoc design was used to examine predictors of opioid analgesics ADEs with Food and Drug Administration Adverse Events Reporting System (FAERS) data."( Predictors of serious adverse drug events from opioids: Results from the Food and Drug Administration Adverse Events Reporting System.
McDonald, DD; Srisopa, P, 2021
)
0.62
" The tool focused on pain expectations, multi-modal methods (both pharmacologic and non-pharmacologic) to manage pain, safe storage, and disposal of excess medication."( A Quality Improvement Initiative Addressing Safe Opioid Prescribing and Disposal Postcesarean Delivery.
Genord, C; Loomis, EA; McNaughton, D, 2022
)
0.72
" Pain at rest/motion (based on pain visual analog scale (VAS) score), rescue analgesia consumption, satisfaction level and adverse events were assessed after AKS."( Oxycodone-paracetamol tablet exhibits increased analgesic efficacy for acute postoperative pain, higher satisfaction and comparable safety profiles compared with celecoxib in patients underwent arthroscopic knee surgery.
Di, J; Liu, J; Xing, E; Zhang, Y, 2021
)
0.62
"Acute doses of diazepam or diclazepam result in the accumulation of oxycodone, whereas chronic administration induces the accumulation of oxymorphone, the toxic metabolite."( Metabolic interactions of benzodiazepines with oxycodone ex vivo and toxicity depending on usage patterns in an animal model.
Bazgier, V; Čechová, P; El Balkhi, S; Javellaud, J; Lawson, R; Marquet, P; Otyepka, M; Picard, N; Saint-Marcoux, F; Trouillas, P; Zarrouk, E, 2023
)
0.91
"This cases series demonstrated that regional anesthesia using ultrasonography-guided indwelling popliteal catheters was safe and effective for pain control in CMT patients undergoing outpatient foot and ankle surgery."( Safety and Efficacy of Postoperative Indwelling Popliteal Nerve Catheters for Outpatient Charcot-Marie-Tooth Surgery.
An, T; Kissen, M; Pfeffer, G; Pollock, G; Schwartz, E, 2022
)
0.72
" The incidence of adverse effects was monitored."( Analgesic Efficacy and Safety of Spinal Oxycodone in Total Hip Arthroplasty: A Preliminary Study.
Adamski, M; Bienert, A; Kowalski, G; Leppert, W; Olczak, B; Szkutnik-Fiedler, D; Teżyk, A; Wieczorowska-Tobis, K, 2022
)
0.72
" Regarding adverse effects, one patient had hypotension, one had bradycardia, and one had pruritus."( Analgesic Efficacy and Safety of Spinal Oxycodone in Total Hip Arthroplasty: A Preliminary Study.
Adamski, M; Bienert, A; Kowalski, G; Leppert, W; Olczak, B; Szkutnik-Fiedler, D; Teżyk, A; Wieczorowska-Tobis, K, 2022
)
0.72
"Oxycodone in spinal block prolongs analgesia period, does not cause serious adverse effects and seems to be safe and effective opioid for patients undergoing THA."( Analgesic Efficacy and Safety of Spinal Oxycodone in Total Hip Arthroplasty: A Preliminary Study.
Adamski, M; Bienert, A; Kowalski, G; Leppert, W; Olczak, B; Szkutnik-Fiedler, D; Teżyk, A; Wieczorowska-Tobis, K, 2022
)
0.72
" There was no serious adverse event reported."( Targin®: An effective opiate analgesia with minimal gastrointestinal side effects-An observational study.
Jones, S; Rossaak, J; Smith, M,
)
0.13
" At the same time, the incidence of adverse reactions in the rectal administration group was low."( Meta-analysis of efficacy and safety of sustained release oxycodone hydrochloride rectal administration for moderate to severe pain.
Chen, DD; Chen, HZ; Cheng, TF; Cui, BX; Dai, XJ; Hou, XB; Wang, D; Wang, Y; Wang, YY; Xu, H, 2022
)
0.72
"To quantify the frequency and intensity of adverse events (AEs), commonly known as side effects, experienced by children receiving either ibuprofen or oxycodone for pain management following an acute fracture."( Quantifying the intensity of adverse events with ibuprofen and oxycodone: an observational cohort study.
Ali, S; Carleton, B; Drendel, AL; Gourlay, K; Johnson, DW; Le May, S; Ortiz, S; Rosychuk, RJ; Watts, R; Yukseloglu, A, 2022
)
0.72
" However, the effect of pretreatment with oxycodone on recovery of cognitive function and adverse effects has rarely been studied."( Safety and efficacy of etomidate in combination with oxycodone in painless gastroscopic procedures in the elderly: A prospective randomized controlled trial study.
Li, YP; Zhou, Y, 2023
)
0.91
" Adverse events, including somatic motor reactions, hypotension, bradycardia, myocardial tremor, nausea and vomiting, and injection pain, were also recorded in both groups."( Safety and efficacy of etomidate in combination with oxycodone in painless gastroscopic procedures in the elderly: A prospective randomized controlled trial study.
Li, YP; Zhou, Y, 2023
)
0.91
" Fewer adverse events such as dynamic body reactions, cardiac tremor, nausea and vomiting, and injection pain occurred in the observation group than in the control group (P < ."( Safety and efficacy of etomidate in combination with oxycodone in painless gastroscopic procedures in the elderly: A prospective randomized controlled trial study.
Li, YP; Zhou, Y, 2023
)
0.91
"Etomidate in combination with oxycodone for painless gastroscopic operation in the elderly is a safe and effective anesthetic strategy."( Safety and efficacy of etomidate in combination with oxycodone in painless gastroscopic procedures in the elderly: A prospective randomized controlled trial study.
Li, YP; Zhou, Y, 2023
)
0.91
" The use of opioids is often associated with adverse effects or clinical issues."( Assessment of Neurotoxic Effects of Oxycodone and Naloxone in SH-SY5Y Cell Line.
Almeida, W; da Costa, NS; Galiciolli, MEA; Irioda, AC; Lima, LS; Margarete Cestari, M; Nogara, PA; Oliveira, CS; Pereira, ME, 2023
)
0.91
" We hypothesized that the preoperative administration of a liposomal bupivacaine (LB) supraclavicular nerve block would be safe and effective in controlling postoperative pain."( Safety and Efficacy of Liposomal Bupivacaine Supraclavicular Nerve Blocks in Open Treatment of Distal Radius Fractures: A Perioperative Pain Management Protocol.
Brown, CA; Ghanouni, A; Ghareeb, PA; Payne, SH; Williams, R, 2023
)
0.91
"Liposomal bupivacaine supraclavicular nerve blocks are safe and effective in the treatment of postoperative pain after open reduction internal fixation of DRF."( Safety and Efficacy of Liposomal Bupivacaine Supraclavicular Nerve Blocks in Open Treatment of Distal Radius Fractures: A Perioperative Pain Management Protocol.
Brown, CA; Ghanouni, A; Ghareeb, PA; Payne, SH; Williams, R, 2023
)
0.91
"Central nervous system adverse events (AEs) occur when oxycodone is used in combination with benzodiazepines, antidepressants and anticonvulsants."( Signal mining and analysis for central nervous system adverse events due to taking oxycodone based on FAERS database.
Huang, H; Huang, L; Lu, X; Wang, Z; Wu, X; Xiao, J; Zhang, L, 2023
)
0.91
" Regarding adverse events, nausea occurred in 12."( Comparison of Analgesic Efficacy and Safety of Low-Dose Transdermal Fentanyl and Oral Oxycodone in Opioid-Naïve Patients with Cancer Pain.
Fujimoto, H; Funato, M; Kawana, M; Kiribayashi, M; Kokubun, H; Kondo, M; Kusakabe, A; Miyasato, A; Nagatani, K; Nakamura, K; Ohno, R; Okamoto, K; Onoda, C; Ozeki, A; Suzuki, N, 2023
)
0.91
"Due to concerns over potential interactions between some hepatitis C direct-acting antivirals (DAAs) and opioids, we describe adverse event (AE) reports of concomitant use of opioids and DAAs."( Reported adverse events related to use of hepatitis C virus direct-acting antivirals with opioids: 2017-2021.
Collins, M; Conway, B; Dylla, DE; Khan, T; Marcinak, J; Martinez, A; Saget, B, 2023
)
0.91
"Although opioids have been shown to be effective for cancer pain, opioid-induced adverse events (AEs) are common."( Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study.
Arakawa, S; Chiu, SW; Hiratsuka, Y; Hirayama, H; Inoue, A; Ishiki, H; Kosugi, K; Kubo, E; Matsuda, Y; Miyashita, M; Morita, T; Natsume, M; Nishijima, K; Ouchi, K; Sato, M; Satomi, E; Shigeno, T; Shimizu, M; Shimoda, M; Shimoi, T; Tagami, K; Yamaguchi, T; Yokomichi, N, 2023
)
0.91

Pharmacokinetics

Pharmacokinetic parameters showed that mean values of C(max), AUC(0-t) and AUC (0-∞) of oxycodone were dose dependent, whereas Tmax and t(1/2) were not. Most of the pharmacokinetic changes in oral oxycodones were seen in the elimination phase, with modest effects by itraconazole on its peak concentration.

ExcerptReferenceRelevance
" No differences were found between treatments in mean Cmax and AUC values of oxycodone which varied from 34 to 38 ng ml-1 and from 208 to 245 ng ml-1 h, respectively."( The pharmacokinetics and metabolism of oxycodone after intramuscular and oral administration to healthy subjects.
Kalso, E; Olkkola, KT; Pöyhiä, R; Seppälä, T, 1992
)
0.28
" The mean +/- SD elimination half-life after single-dose administration of intravenous (4."( Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer.
Cramond, T; Leow, KP; Smith, MT; Williams, B, 1992
)
0.28
" AUC values were also calculated for the pharmacodynamic variable "drug effect," scored on a 100 mm visual analog scale."( Pharmacokinetic-pharmacodynamic relationships of controlled-release oxycodone.
Benziger, DP; Burke, BE; Fitzmartin, RD; Goldenheim, PD; Kaiko, RF; Reder, RF, 1996
)
0.29
" Mean elimination half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance."( The pharmacokinetics of oxycodone in uremic patients undergoing renal transplantation.
Kirvela, M; Lindgren, L; Olkkola, KT; Seppala, T, 1996
)
0.29
" The purpose of this investigation was to develop and validate a pharmacokinetic model for CR oxycodone tablets in comparison with IR oxycodone solution."( Characterization and validation of a pharmacokinetic model for controlled-release oxycodone.
Kaiko, RF; Mandema, JW; Oshlack, B; Reder, RF; Stanski, DR, 1996
)
0.29
" Among the reasons for pursuing pharmacokinetic/ pharmacodynamic relationships is the prospect of predicting the time-action characteristics of new therapeutics on the basis of early studies in normals using pharmacodynamic surrogates for analgesia."( Pharmacokinetics and pharmacodynamics of controlled-release opioids.
Kaiko, RF, 1997
)
0.3
"47 l/kg and the terminal elimination half-life 157 +/- 47 min."( Pharmacokinetic comparison of intravenous and intranasal administration of oxycodone.
Kaasalainen, V; Kalso, E; Olkkola, KT; Seppälä, T; Takala, A, 1997
)
0.3
" In addition, pharmacodynamic effects were assessed using both objective and subjective measures for up to 48 hr after dosing."( A pharmacokinetic/pharmacodynamic study of controlled-release oxycodone.
Benziger, DP; Fitzmartin, RD; Grandy, RP; Miotto, J; Swanton, RE; Thomas, GB, 1997
)
0.3
" THe median elimination half-life of oxycodone was 13."( Pharmacokinetics and ventilatory effects of oxycodone before and after liver transplantation.
Höckerstedt, K; Lindgren, L; Olkkola, KT; Seppälä, T; Tallgren, M, 1997
)
0.3
" Plasma opioid concentrations, subjective pharmacodynamic ratings, and psychomotor function were assessed for 24 hours after drug administration."( Effects of blocking CYP2D6 on the pharmacokinetics and pharmacodynamics of oxycodone.
Heiskanen, T; Kalso, E; Olkkola, KT, 1998
)
0.3
"A significant reduction in plasma oxymorphone levels did not substantially alter the pharmacodynamic effects of oxycodone."( Effects of blocking CYP2D6 on the pharmacokinetics and pharmacodynamics of oxycodone.
Heiskanen, T; Kalso, E; Olkkola, KT, 1998
)
0.3
"93), Cmax (7."( Lack of interaction between levofloxacin and oxycodone: pharmacokinetics and drug disposition.
Fitzgerald, JF; Grant, EM; Nicolau, DP; Nightingale, C; Quintiliani, R; Zhong, M, 2001
)
0.31
" Oxycodone AUC(0-t), AUC(0-infinity), and Cmax were dose dependent, whereas tma and t(1/2) were not."( Comparison of the pharmacokinetics of oxycodone administered in three Percocet formulations.
Davis, MW; Gammaitoni, AR, 2002
)
0.31
" A comparison is also presented between several methods based on animal pharmacokinetic data, using the same set of proprietary compounds, and it lends further support for the use of this method, as opposed to methods that require the gathering of pharmacokinetic data in laboratory animals."( Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
Gao, F; Lombardo, F; Obach, RS; Shalaeva, MY, 2004
)
0.32
" The time to peak concentration was 2-30 (16) minutes in the intramuscular group, 30-480 (221) minutes in the buccal group and 60-360 (193) minutes in the gastric group."( Pharmacokinetics of oxycodone after intravenous, buccal, intramuscular and gastric administration in children.
Kokki, H; Ojanperä, I; Rasanen, I; Reinikainen, M; Suhonen, P; Vanamo, K, 2004
)
0.32
" Serum APAP concentrations (APAPs) were measured hourly from zero through eight hours and again at 24 hours, and basic noncompartmental pharmacokinetic parameters were compared."( Pharmacokinetic effects of diphenhydramine or oxycodone in simulated acetaminophen overdose.
Goklaney, A; Halcomb, SE; Mullins, ME; Sivilotti, ML, 2005
)
0.33
" Special populations, including children and those with liver/renal failure, have a unique oxycodone pharmacokinetic profile that must be taken into account in order to maximize analgesic efficacy and reduce the risk of adverse events."( The pharmacokinetics of oxycodone.
Kern, SE; Lugo, RA, 2004
)
0.32
"As part of ongoing studies to evaluate the analgesic efficacy and pharmacokinetic properties of combination oxycodone plus ibuprofen in the treatment of moderate to severe acute pain, 2 pharmacokinetic studies were conducted."( Pharmacokinetic properties of combination oxycodone plus racemic ibuprofen: two randomized, open-label, crossover studies in healthy adult volunteers.
Abramowitz, W; Benedek, I; Fiske, W; Kapil, R; Nolting, A; Roy, P, 2004
)
0.32
"The goals of these studies were to compare the pharmacokinetic properties of monotherapy with oxycodone or ibuprofen with those of a tablet formulation of these 2 agents combined (study A), and to determine whether the absorption of the individual agents when given in the combination tablet was affected by the concomitant ingestion of food (study B)."( Pharmacokinetic properties of combination oxycodone plus racemic ibuprofen: two randomized, open-label, crossover studies in healthy adult volunteers.
Abramowitz, W; Benedek, I; Fiske, W; Kapil, R; Nolting, A; Roy, P, 2004
)
0.32
" In both studies, the pharmacokinetic properties (C(max), T(max), t(1/2), AUC(0-4), AUC(0-1), and AUC(0-infinity)) of oxycodone and ibuprofen were derived from plasma drug concentrations."( Pharmacokinetic properties of combination oxycodone plus racemic ibuprofen: two randomized, open-label, crossover studies in healthy adult volunteers.
Abramowitz, W; Benedek, I; Fiske, W; Kapil, R; Nolting, A; Roy, P, 2004
)
0.32
" The pharmacokinetic properties of ibuprofen and oxycodone were not statistically different when administered alone or combined."( Pharmacokinetic properties of combination oxycodone plus racemic ibuprofen: two randomized, open-label, crossover studies in healthy adult volunteers.
Abramowitz, W; Benedek, I; Fiske, W; Kapil, R; Nolting, A; Roy, P, 2004
)
0.32
"The single-dose pharmacokinetic profiles of oxycodone and ibuprofen in these healthy volunteers were similar when these 2 drugs were given as monotherapy or in combination, suggesting bioequivalence."( Pharmacokinetic properties of combination oxycodone plus racemic ibuprofen: two randomized, open-label, crossover studies in healthy adult volunteers.
Abramowitz, W; Benedek, I; Fiske, W; Kapil, R; Nolting, A; Roy, P, 2004
)
0.32
" One barrier to effective pain treatment is understanding the pharmacokinetic behavior of analgesics in this age group."( Population pharmacokinetics of oxycodone in children 6 months to 7 years old.
El-Tahtawy, A; Kokki, H; Reidenberg, BE, 2006
)
0.33
" The samples were analyzed with a liquid chromatography-tandem mass spectrometry method and a population pharmacokinetic model was used to simultaneously fit all the data using NONMEM."( In vivo blood-brain barrier transport of oxycodone in the rat: indications for active influx and implications for pharmacokinetics/pharmacodynamics.
Boström, E; Hammarlund-Udenaes, M; Simonsson, US, 2006
)
0.33
" In the result, pharmacokinetic parameters calculated at CL/F were: 45."( [Pharmacokinetics of controlled-release oxycodone in patients with cancer pain].
Hoka, S; Kokubun, H; Komatsu, T; Matoba, M; Nakamura, K; Yago, K, 2007
)
0.34
" Oral administration of oxycodone to the SD rat is a poor model of the human for the study of the pharmacodynamic effects of oxycodone."( Sex differences in the pharmacokinetics, oxidative metabolism and oral bioavailability of oxycodone in the Sprague-Dawley rat.
Chan, S; Edwards, SR; Smith, MT; Wyse, BD, 2008
)
0.35
" We used HPLC-electrochemical detector (ECD) to determine oxycodone and hydrocotarnine serum concentrations, and used the nonlinear least-squares method (MULTI) for calculation of the pharmacokinetic parameters."( Pharmacokinetics and variation in the clearance of oxycodone and hydrocotarnine in patients with cancer pain.
Fukawa, M; Hoka, S; Kokubun, H; Matoba, M; Yago, K; Yamada, Y, 2007
)
0.34
" This study was carried out to assess the efficacy, safety and pharmacokinetic profiles of a 12."( Efficacy, safety and pharmacokinetic study of a novel fentanyl-containing matrix transdermal patch system in Japanese patients with cancer pain.
Hanaoka, K; Hosokawa, T; Ishida, T; Kitajima, T; Mashimo, S; Miyazaki, T; Namiki, A; Nogami, S; Ogawa, S, 2008
)
0.35
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" This review highlights potential pharmacokinetic (changes in metabolite production, metabolizing enzyme expression, and transporter function) and pharmacodynamic (receptor type, location and functionality; alterations in signaling pathways and cross-tolerance) aspects of opioid tolerance development, and presents several pharmacodynamic modeling strategies that have been used to characterize time-dependent attenuation of opioid analgesia."( Opioid tolerance development: a pharmacokinetic/pharmacodynamic perspective.
Dumas, EO; Pollack, GM, 2008
)
0.35
"The aim of this paper was to report the pharmacokinetic results from a single-dose study and a multiple-dose bioequivalence study of OXN versus separate formulations of oxycodone PR and naloxone PR administered concurrently in healthy subjects."( Single- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/antagonist prolonged-release combination in healthy adult volunteers.
Bailey, P; Grothe, B; Hopp, M; Leyendecker, P; Mundin, G; Reimer, K; Smith, K; Uhl, R, 2008
)
0.35
" The pharmacokinetic properties of the OXN FDC were similar to those of oxycodone PR + naloxone PR given as separate formulations, based on the regulatory definition."( Single- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/antagonist prolonged-release combination in healthy adult volunteers.
Bailey, P; Grothe, B; Hopp, M; Leyendecker, P; Mundin, G; Reimer, K; Smith, K; Uhl, R, 2008
)
0.35
" Plasma concentrations of oxycodone and its oxidative metabolites were measured for 48 hours, and pharmacodynamic effects were evaluated."( Effect of telithromycin on the pharmacokinetics and pharmacodynamics of oral oxycodone.
Grönlund, J; Hagelberg, N; Laine, K; Martikainen, IK; Neuvonen, PJ; Olkkola, KT; Saari, T, 2010
)
0.36
" Plasma concentrations of oxycodone and its oxidative metabolites were measured for 48 h, and pharmacodynamic effects were evaluated."( Effects of itraconazole on the pharmacokinetics and pharmacodynamics of intravenously and orally administered oxycodone.
Grönlund, J; Hagelberg, NM; Laine, K; Neuvonen, M; Neuvonen, PJ; Olkkola, KT; Saari, TI, 2010
)
0.36
" Most of the pharmacokinetic changes in oral oxycodone were seen in the elimination phase, with modest effects by itraconazole on its peak concentration, which was increased by 45% (P=0."( Effects of itraconazole on the pharmacokinetics and pharmacodynamics of intravenously and orally administered oxycodone.
Grönlund, J; Hagelberg, NM; Laine, K; Neuvonen, M; Neuvonen, PJ; Olkkola, KT; Saari, TI, 2010
)
0.36
" We performed a three-way, placebo-controlled, double-blind cross-over study to assess the pharmacokinetic and pharmacodynamic consequences of drug interactions with oxycodone."( Effect of the inhibition of CYP3A4 or CYP2D6 on the pharmacokinetics and pharmacodynamics of oxycodone.
Drewe, J; Hammann, F; Krähenbühl, S; Kummer, O; Moser, C; Schaller, O, 2011
)
0.37
"Inhibition of CYP3A4 by ketoconazole increases the exposure and some pharmacodynamic effects of oxycodone."( Effect of the inhibition of CYP3A4 or CYP2D6 on the pharmacokinetics and pharmacodynamics of oxycodone.
Drewe, J; Hammann, F; Krähenbühl, S; Kummer, O; Moser, C; Schaller, O, 2011
)
0.37
"Oxycodone blood concentrations could be described by a one-compartment model but, given the necessarily short timescale of the study, the concentrations were represented by linear interpolation for subsequent pharmacodynamic models."( A pharmacokinetic and pharmacodynamic study of oral oxycodone in a human experimental pain model of hyperalgesia.
Arendt-Nielsen, L; Christrup, LL; Drewes, AM; Foster, DJ; Olesen, AE; Staahl, C; Upton, R, 2010
)
0.36
" Plasma concentrations of oxycodone and its oxidative metabolites were measured over 48 hours, and pharmacokinetic and pharmacodynamic parameters subsequently evaluated."( Effect of inhibition of cytochrome P450 enzymes 2D6 and 3A4 on the pharmacokinetics of intravenous oxycodone: a randomized, three-phase, crossover, placebo-controlled study.
Grönlund, J; Hagelberg, NM; Laine, K; Neuvonen, PJ; Olkkola, KT; Saari, TI, 2011
)
0.37
" There were no significant sex-related differences in any of the pharmacokinetic parameters."( Elimination of intravenous oxycodone in the elderly: a pharmacokinetic study in postoperative orthopaedic patients of different age groups.
Aantaa, R; Kuusniemi, K; Liukas, A; Neuvonen, M; Neuvonen, PJ; Olkkola, KT; Virolainen, P, 2011
)
0.37
" The pharmacokinetic data of oxycodone available for elderly are limited, and there appear to be only little data on the population pharmacokinetics of oxycodone."( Oxycodone clearance is markedly reduced with advancing age: a population pharmacokinetic study.
Ihmsen, H; Neuvonen, PJ; Olkkola, KT; Saari, TI; Schwilden, H, 2012
)
0.38
" The elimination half-life of oxycodone showed an age-dependent increase."( Oxycodone clearance is markedly reduced with advancing age: a population pharmacokinetic study.
Ihmsen, H; Neuvonen, PJ; Olkkola, KT; Saari, TI; Schwilden, H, 2012
)
0.38
" The aim of this study was to evaluate the influence of cachexia on the pharmacokinetic disposition of and clinical responses to oxycodone in cancer patients."( Impact of cachexia on pharmacokinetic disposition of and clinical responses to oxycodone in cancer patients.
Kagawa, Y; Kawakami, J; Naito, T; Ohnishi, K; Tashiro, M; Yamamoto, K, 2012
)
0.38
" In the study group, maternal pharmacokinetics of oxycodone was measured from plasma concentrations during labour, and neonatal exposure was assessed from umbilical plasma samples using population pharmacokinetic methods."( Intravenous oxycodone for pain relief in the first stage of labour--maternal pharmacokinetics and neonatal exposure.
Franco, MG; Heinonen, S; Kokki, H; Kokki, M; Neuvonen, PJ; Raatikainen, K; Sankilampi, U; Välitalo, P, 2012
)
0.38
"A whole-body physiologically based pharmacokinetic (PBPK) model was developed for the prediction of unbound drug concentration-time profiles in the rat brain, in which drug transfer across the blood-brain barrier (BBB) was treated mechanistically by separating the parameters governing the rate (permeability) of BBB transfer from brain binding."( Development of a physiologically based pharmacokinetic model for the rat central nervous system and determination of an in vitro-in vivo scaling methodology for the blood-brain barrier permeability of two transporter substrates, morphine and oxycodone.
Ball, K; Bouzom, F; Declèves, X; Scherrmann, JM; Walther, B, 2012
)
0.38
" Plasma drug concentration data were used to generate pharmacokinetic models, which were then used to fit the VPTT data using NONMEM(®) VI to generate population pharmacokinetic/pharmacodynamic models."( A population pharmacokinetic and pharmacodynamic study of a peripheral κ-opioid receptor agonist CR665 and oxycodone.
Arendt-Nielsen, L; Drewes, AM; Kell, S; Kristensen, K; Olesen, AE; Staahl, C; Wong, GY, 2013
)
0.39
" Mechanistic pharmacokinetic simulations suggested that the low metabolite ratio was the result of combined poor metabolizer (PM) status of cytochrome P450 (CYP) 2C19 and CYP2D6."( A poor metabolizer of both CYP2C19 and CYP2D6 identified by mechanistic pharmacokinetic simulation in a fatal drug poisoning case involving venlafaxine.
Ahlner, J; Boel, LW; Brock, B; Jornil, J; Nielsen, TS; Rosendal, I; Zackrisson, AL, 2013
)
0.39
" Crushed ORF administration yielded reduced oxycodone Cmax and increased Tmax versus crushed OC and Oxy API."( Abuse potential, pharmacokinetics, pharmacodynamics, and safety of intranasally administered crushed oxycodone HCl abuse-deterrent controlled-release tablets in recreational opioid users.
Bartlett, C; Colucci, SV; Harris, SC; Perrino, PJ; Sellers, EM; Shram, MJ; Smith, I, 2014
)
0.4
"The aim of this study is to evaluate the pharmacokinetic profile of oxycodone and three of its metabolites, noroxycodone, oxymorphone and noroxymorphone after intravenous administration in Chinese patients with pain."( Pharmacokinetics of oxycodone hydrochloride and three of its metabolites after intravenous administration in Chinese patients with pain.
Dong, RH; Gao, HZ; Hao, GT; Li, YY; Liang, YG; Liu, ZY; Qu, HY; Wang, XF; Zhang, LJ; Zhou, HY, 2014
)
0.4
"Pharmacokinetic parameters showed that mean values of C(max), AUC(0-t) and AUC(0-∞) of oxycodone were dose dependent, whereas Tmax and t(1/2) were not."( Pharmacokinetics of oxycodone hydrochloride and three of its metabolites after intravenous administration in Chinese patients with pain.
Dong, RH; Gao, HZ; Hao, GT; Li, YY; Liang, YG; Liu, ZY; Qu, HY; Wang, XF; Zhang, LJ; Zhou, HY, 2014
)
0.4
" Noncompartmental analysis and population pharmacokinetic analysis were performed."( Pharmacokinetics of oxycodone after intravenous and subcutaneous administration in Japanese patients with cancer pain.
Fukumura, K; Hojo, M; Kokubun, H; Matoba, M; Yoshimoto, T, 2014
)
0.4
"The main pharmacokinetic parameters for oxycodone in men (n = 14) and women (n = 10) were as follows: Cmax, 14."( The pharmacokinetics of oral oxycodone in patients after total gastric resection.
Biczysko-Murawa, A; Grabowski, T; Gracz, J; Grześkowiak, E; Karbownik, A; Murawa, D; Murawa, P; Połom, K; Szałek, E; Tezyk, A, 2014
)
0.4
" The 90 % confidence intervals (CIs) for AUC∞ and Cmax ratios of ALO-02 with 20 % ethanol versus water were within 80-125 %; upper 90 % CIs were >125 % for ALO-02 with 40 % ethanol versus water."( Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02).
Bramson, C; Malhotra, BK; Matschke, K; Salageanu, J; Wang, Q, 2015
)
0.42
"Oxycodone exposures (Cmax) were unaffected when ALO-02 was administered with 20 % ethanol but Cmax increased by 37 % with 40 % ethanol versus water."( Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02).
Bramson, C; Malhotra, BK; Matschke, K; Salageanu, J; Wang, Q, 2015
)
0.42
"Mean (SD) oxycodone Cmax values following Remoxy 20-mg administration were 17."( The pharmacokinetics of oxycodone and its metabolites following single oral doses of Remoxy®, an abuse-deterrent formulation of extended-release oxycodone, in patients with hepatic or renal impairment.
de Kater, AW; Friedmann, N; Malhotra, BK; Schoenhard, GL,
)
0.13
"As renal or hepatic function decreased, oxycodone Cmax and AUC(0-t) were up to approximately twofold higher following single, oral doses of extended-release Remoxy."( The pharmacokinetics of oxycodone and its metabolites following single oral doses of Remoxy®, an abuse-deterrent formulation of extended-release oxycodone, in patients with hepatic or renal impairment.
de Kater, AW; Friedmann, N; Malhotra, BK; Schoenhard, GL,
)
0.13
" Primary aims included examination of the plasma and urinary pharmacokinetic profile of once-daily quinine; secondary aims assessed pharmacokinetic/pharmacodynamic interactions with oxycodone (a CYP3A and CYP2D substrate)."( Quinine as a potential tracer for medication adherence: A pharmacokinetic and pharmacodynamic assessment of quinine alone and in combination with oxycodone in humans.
Babalonis, S; Hampson, AJ; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2015
)
0.42
" Crushed Oxycodone DETERx® was bioequivalent to intact Oxycodone DETERx® and exhibited a numerically lower Cmax ."( Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties.
Fleming, AB; Gudin, J; Kopecky, EA; Levy-Cooperman, N, 2015
)
0.42
"These data demonstrate that when crushed and taken orally, Oxycodone DETERx® maintains its EXTENDED-release profile, while crushed OxyContin® shows a pharmacokinetic profile similar to an immediate-release product."( Comparing the Effect of Tampering on the Oral Pharmacokinetic Profiles of Two Extended-Release Oxycodone Formulations with Abuse-Deterrent Properties.
Fleming, AB; Gudin, J; Kopecky, EA; Levy-Cooperman, N, 2015
)
0.42
" In this review, comparative evidence on pharmacokinetic differences between abuse-deterrent and classical formulations of the same opioids is summarized; furthermore, pharmacodynamic differences, with a focus on analgesia and abuse-related symptoms, are addressed."( Abuse-Deterrent Opioid Formulations: Pharmacokinetic and Pharmacodynamic Considerations.
Knothe, C; Lötsch, J; Walter, C, 2016
)
0.43
"For primary pharmacokinetic (PK) assessments, abuse quotient (Cmax/Tmax) was lower with DETERx IN than DETERx PO; both treatments were substantially lower than OXY-IR IN (6."( A Randomized, Double-Blind, Double-Dummy Study to Evaluate the Intranasal Human Abuse Potential and Pharmacokinetics of a Novel Extended-Release Abuse-Deterrent Formulation of Oxycodone.
Fleming, AB; Kopecky, EA; Smith, MD; Webster, LR, 2016
)
0.43
"Pharmacokinetic and pharmacodynamic outcomes suggest that DETERx IN has relatively low HAP; continued research in larger populations is suggested."( A Randomized, Double-Blind, Double-Dummy Study to Evaluate the Intranasal Human Abuse Potential and Pharmacokinetics of a Novel Extended-Release Abuse-Deterrent Formulation of Oxycodone.
Fleming, AB; Kopecky, EA; Smith, MD; Webster, LR, 2016
)
0.43
"The t1/2 and Tmax values for oxycodone were similar for all 3 treatments."( Effect of food on the pharmacokinetics of oxycodone and naltrexone from ALO-02, an extended release formulation of oxycodone with sequestered naltrexone.
Bramson, C; Gandelman, K; Lamson, M; Malhotra, B; Matschke, K; Salageanu, J, 2015
)
0.42
"5 h, mean ± SD, n = 6), resulted in the acetazolamide microdose exhibiting a substantially longer plasma half-life (24."( A Pharmacokinetic Study Examining Acetazolamide as a Novel Adherence Marker for Clinical Trials.
Babalonis, S; Hampson, AJ; Krieter, P; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2016
)
0.43
"In the pharmacokinetic study, patients were administered intravenous oxycodone (0."( Population pharmacokinetics and analgesic potency of oxycodone.
An, SM; Choi, BM; Lee, EK; Lee, SH; Lee, YH; Noh, GJ, 2017
)
0.46
"In the population pharmacokinetic study (n = 54), oxycodone plasma concentration over time was well described by a three-compartment mammillary model."( Population pharmacokinetics and analgesic potency of oxycodone.
An, SM; Choi, BM; Lee, EK; Lee, SH; Lee, YH; Noh, GJ, 2017
)
0.46
" Preterm neonates were found to have the highest pharmacokinetic variability out of the study population."( Maturation of oxycodone pharmacokinetics in neonates and infants: Oxycodone and its metabolites in plasma and urine.
Hautajärvi, H; Heikkinen, M; Hokkanen, J; Kokki, H; Kokki, M; Pitkänen, H; Ranta, VP; Sankilampi, U; Välitalo, P, 2017
)
0.46
"Oxycodone elimination is slower and pharmacokinetic variability more pronounced in neonates when compared to older infants."( Maturation of oxycodone pharmacokinetics in neonates and infants: Oxycodone and its metabolites in plasma and urine.
Hautajärvi, H; Heikkinen, M; Hokkanen, J; Kokki, H; Kokki, M; Pitkänen, H; Ranta, VP; Sankilampi, U; Välitalo, P, 2017
)
0.46
"The aim of the current population pharmacokinetic study was to quantify oxycodone pharmacokinetics in children ranging from preterm neonates to children up to 7 years of age."( Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials.
Hooker, AC; Kokki, H; Kokki, M; Olkkola, KT; Ranta, VP; Välitalo, P, 2017
)
0.46
" A population pharmacokinetic model was built using 781 measurements of oxycodone plasma concentration."( Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials.
Hooker, AC; Kokki, H; Kokki, M; Olkkola, KT; Ranta, VP; Välitalo, P, 2017
)
0.46
" The pharmacokinetic model developed may be used to evaluate different multiple dosing regimens, but the safety of repeated doses should be ensured."( Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials.
Hooker, AC; Kokki, H; Kokki, M; Olkkola, KT; Ranta, VP; Välitalo, P, 2017
)
0.46
"To characterize the pharmacokinetic profile and evaluate the safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM)."( Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.
Gavin, PD; Schlagheck, T; Shakib, S; Simon, LS; Smith, AJ, 2017
)
0.46
" Two separate studies were conducted to assess the pharmacokinetic bioequivalence of a newly formulated oxycodone hydrochloride extended-release tablet to a marketed oxycodone product in Japan under fasting and fed conditions."( Pharmacokinetic Bioequivalence Studies of an Extended-Release Oxycodone Hydrochloride Tablet in Healthy Japanese Subjects Under Fasting and Fed Conditions Without an Opioid Antagonist.
Furuie, H; Ishizuka, H; Kuroda, K; Toyama, K, 2017
)
0.46
" Our aim was to translate a recently published comprehensive CNS physiologically-based pharmacokinetic (PBPK) model from rat to human, and to predict drug concentration-time profiles in multiple CNS compartments on available human data of four drugs (acetaminophen, oxycodone, morphine and phenytoin)."( Prediction of human CNS pharmacokinetics using a physiologically-based pharmacokinetic modeling approach.
Beukers, MW; Danhof, M; de Lange, ECM; Huntjens, DR; Kokki, H; Kokki, M; Krauwinkel, W; Proost, JH; Välitalo, PA; van Hasselt, JGC; Vermeulen, A; Wong, YC; Yamamoto, Y, 2018
)
0.48
"This second pharmacokinetic study demonstrated that Xtampza ER maintains its ER properties after crushing, unlike OxyContin, which failed to retain its ER properties after crushing."( The comparative pharmacokinetics of physical manipulation by crushing of Xtampza
Brennan, MJ; Fleming, AB; Kopecky, EA; Marseilles, A; O'Connor, M, 2017
)
0.46
" The pharmacokinetics including the relatively short half-life of oxycodone in patients with ESRD with or without haemodialysis and the absence of unconjugated active metabolites indicate that oxycodone can be used at usual doses in patients requiring dialysis."( Pharmacokinetics of oxycodone/naloxone and its metabolites in patients with end-stage renal disease during and between haemodialysis sessions.
Amico, P; Dickenmann, M; Duthaler, U; Hammann, F; Haschke, M; Jehle, AW; Kalbermatter, S; Krähenbühl, S; Lenherr, C; Leuppi-Taegtmeyer, A; Liechti, ME; Meyer Zu Schwabedissen, HE; Schmid, Y, 2019
)
0.51
" Most of the basic oxycodone pharmacokinetic (PK) data are from the 1990s and from academic research; however, a lot of additional data have been published over the last 10 years."( Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone.
Kinnunen, M; Kokki, H; Kokki, M; Lammi, P; Piirainen, P, 2019
)
0.51
"Physiologically-based pharmacokinetic (PBPK) modeling offers a unique modality to predict age-specific pharmacokinetics."( Physiologically Based Pharmacokinetic Modeling of Oxycodone in Children to Support Pediatric Dosing Optimization.
Jiang, XH; Song, HX; Tang, SW; Wang, L; Xu, M; Zheng, L, 2019
)
0.51
" This study aimed to investigate the pharmacokinetic properties of the new OTR tablets and evaluate the bioequivalence of oxycodone from OTR and the original extended release (ER) formulation tablets administered with an opioid antagonist in patients with chronic pain."( Pharmacokinetics and Bioequivalence Evaluation of a New Oxycodone Tamper-Resistant Tablet Administered with an Opioid Antagonist in Patients with Chronic Pain.
Hu, C; Luo, Z; Miao, J; Shen, Y; Shu, S; Wang, Y; Zhu, X, 2020
)
0.56
" After a single dose of 40 mg tablets, pharmacokinetic results of the new OTR tablet were found to be similar to those of original extended-release oxycodone tablet."( Pharmacokinetics and Bioequivalence Evaluation of a New Oxycodone Tamper-Resistant Tablet Administered with an Opioid Antagonist in Patients with Chronic Pain.
Hu, C; Luo, Z; Miao, J; Shen, Y; Shu, S; Wang, Y; Zhu, X, 2020
)
0.56
" In this study, a physiologically based pharmacokinetic (PBPK) model was built using GastroPlus™ software for oxycodone, two primary metabolites (noroxycodone, oxymorphone) and one secondary metabolite (noroxymorphone)."( Physiologically based pharmacokinetic modelling of oxycodone drug-drug interactions.
Hautajärvi, H; Heikkinen, AT; Kokki, H; Kokki, M; Ranta, VP; Rinne, V; Rytkönen, J, 2020
)
0.56
" The latter was lower than in the MBMA and explained the slightly longer apparent half-life of oxycodone in the newly collected data."( Oxycodone Effect on Pupil Constriction in Recreational Opioid Users: A Pharmacokinetic/Pharmacodynamic Meta-Analysis Approach.
Buller, S; Dari, A; Freijer, J; Gautrois, M; Rengelshausen, J; Stahlberg, HJ, 2021
)
0.62
" Covariate influences such as age, size, and fat mass on oxycodone pharmacokinetic parameters over the human lifespan are poorly quantified."( Population pharmacokinetics of oxycodone: Premature neonates to adults.
Anderson, BJ; Hannam, JA; Kokki, H; Kokki, M; Morse, JD; Sundermann, M, 2021
)
0.62
" Theory-based allometry was used to scale pharmacokinetic parameters to a 70 kg individual."( Population pharmacokinetics of oxycodone: Premature neonates to adults.
Anderson, BJ; Hannam, JA; Kokki, H; Kokki, M; Morse, JD; Sundermann, M, 2021
)
0.62
" The limited studies that involve pharmacokinetics of the urinary excretion of OC metabolites leave a knowledge gap regarding the excretion of conjugated and minor metabolites, pharmacokinetic differences by formulation, and the impact of CYP2D6 activity on the metabolism and excretion of OC."( Urinary Pharmacokinetics of Immediate and Controlled Release Oxycodone and its Phase I and II Metabolites Using LC-MS-MS.
Chermà, MD; Gréen, H; Jakobsson, G; Kronstrand, R; Swortwood, MJ; Truver, MT, 2023
)
0.91
" This model-based pharmacokinetic (PK)-pharmacodynamic (PD) analysis quantified the impact of age and alcohol use on pupillometry and cold pressor test (CPT) PD based on data from an open-label study of a single, immediate-release 10-mg oral oxycodone in middle-age and older adults (aged 35-85) without severe functional limitations."( Model-Based Analysis of the Influence of Alcohol Use and Age on Pharmacokinetics-Pharmacodynamics of Oral Oxycodone in Middle-Age and Older Community-Dwelling Adults.
Cherrier, MM; Lalovic, BB; Shen, DD; Shireman, L, 2022
)
0.72
" This study aims to characterize the pharmacokinetic profile of oxycodone after intravenous administration and to simulate an appropriate dosage for analgesic efficacy in obese patients."( Population Pharmacokinetics and Dosing Simulations of Intravenous Oxycodone for Perioperative Pain Relief in Adult Surgical Patients with Obesity.
Chaw, SH; Haron, DEBM; Lo, YL; Shariffuddin, II; Yeap, LL, 2023
)
0.91

Compound-Compound Interactions

Oxycodone in combination with propofol can be used safely and effectively for painless gastroscopy, with the advantages of a low Propofol dose, maintenance of hemodynamic stability and few adverse effects.

ExcerptReferenceRelevance
" We evaluated 1014 fatality cases involving oxycodone (OXC) for evidence of enhanced toxicity associated with multiple drug-drug interactions."( Oxycodone involvement in drug abuse deaths. II. Evidence for toxic multiple drug-drug interactions.
Ballina, M; Caplan, YH; Cone, EJ; Fant, RV; Haddox, JD; Reder, RF; Rohay, JM,
)
0.13
" We evaluated 1014 fatality cases involving oxycodone (OXC) for evidence of enhanced toxicity associated with multiple drug-drug interactions."( Oxycodone involvement in drug abuse deaths. II. Evidence for toxic multiple drug-drug interactions.
Ballina, M; Caplan, YH; Cone, EJ; Fant, RV; Haddox, JD; Reder, RF; Rohay, JM, 2004
)
0.32
"This randomized, double-blind, placebo- and active-controlled, parallel-group study was designed to demonstrate the superiority of oxycodone in combination with naloxone in a prolonged release (PR) formulation over placebo with respect to analgesic efficacy."( Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain.
Fleischer, W; Grothe, B; Hermanns, K; Hopp, M; Leyendecker, P; Meissner, W; Reimer, K; Ruckes, C; Szombati, I; Vondrackova, D; Weber, S, 2008
)
0.35
" Overall, the results suggest that several adjuvant analgesics may interact with the BBB transport of oxycodone at relatively high concentrations."( Drug-drug interaction between oxycodone and adjuvant analgesics in blood-brain barrier transport and antinociceptive effect.
Deguchi, Y; Nakazawa, Y; Okura, T; Shimomura, K; Terasaki, T, 2010
)
0.36
"Preclinical and clinical studies have shown that opioids combined with ultra-low-dose naltrexone (NTX) may have increased analgesic potency and have suggested reduced abuse or dependence liability."( Human abuse liability assessment of oxycodone combined with ultra-low-dose naltrexone.
Bigelow, GE; Harrison, JA; Lanier, RK; Strain, EC; Tompkins, DA, 2010
)
0.36
" A high interindividual variability in the activity of these enzymes because of genetic polymorphisms and/or drug-drug interactions is well established."( Genetic polymorphisms and drug interactions modulating CYP2D6 and CYP3A activities have a major effect on oxycodone analgesic efficacy and safety.
Daali, Y; Dayer, P; Desmeules, JA; Eap, CB; Hochstrasser, D; Hopfgartner, G; Rebsamen, MC; Rossier, MF; Samer, CF; Wagner, M, 2010
)
0.36
"6 g/kg), and oxycodone combined with the lower dose and the higher dose of ethanol on separate sessions."( Subjective, psychomotor, and physiological effects of oxycodone alone and in combination with ethanol in healthy volunteers.
Gutierrez, S; Zacny, JP, 2011
)
0.37
"In this study, 10 mg of oral oxycodone combined with a low dose of ethanol generated abuse liability-related effects, but when tested separately, they did not."( Subjective, psychomotor, and physiological effects of oxycodone alone and in combination with ethanol in healthy volunteers.
Gutierrez, S; Zacny, JP, 2011
)
0.37
" Using a double-blind, randomized, crossover design, 16 healthy volunteers were administered (in separate sessions) capsules containing placebo, 75 mg pregabalin, 150 mg pregabalin, 10 mg oxycodone, and 75 mg pregabalin combined with 10 mg oxycodone."( Subjective, psychomotor, and physiological effects of pregabalin alone and in combination with oxycodone in healthy volunteers.
Coalson, DW; Paice, JA; Zacny, JP, 2012
)
0.38
"A mu receptor antagonist combined with oxycodone (OXY) may improve pain control, reduce physical tolerance and withdrawal, minimizing opioid-related bowel dysfunction and act as an abuse deterrent."( Oxycodone combined with opioid receptor antagonists: efficacy and safety.
Davis, M; Gamier, P; Goforth, HW, 2013
)
0.39
" Prolonged-release (PR) naloxone combined with PR OXY demonstrates a consistent reduction in opioid-related bowel dysfunction in multiple randomized controlled trials."( Oxycodone combined with opioid receptor antagonists: efficacy and safety.
Davis, M; Gamier, P; Goforth, HW, 2013
)
0.39
"CYP2D6 drug-drug interactions appear to change effectiveness of commonly prescribed drugs in the ED."( The effect of CYP2D6 drug-drug interactions on hydrocodone effectiveness.
Campbell, J; Hamamura, D; Heard, KJ; Monte, AA; Vasiliou, V; Weinshilboum, RM, 2014
)
0.4
"To observe treatment effects and safety of fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain."( Clinical study on fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain.
Ca, LH; Chang, J; Huang, XE; Huang, XH; Liu, J; Ma, YM; Wei, W; Wu, YJ; Xiao, Y; Zhang, RX, 2014
)
0.4
"Fluvoxamine combined with oxycodone prolonged-release tablets could be more effective in treating patients with cancer pain, and could reduce the dosage of oxycodone prolonged-release tablets and thus be associated with lower side effects, and improved quality of life."( Clinical study on fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain.
Ca, LH; Chang, J; Huang, XE; Huang, XH; Liu, J; Ma, YM; Wei, W; Wu, YJ; Xiao, Y; Zhang, RX, 2014
)
0.4
" The performance of the DRI oxycodone immunoassay was compared with liquid chromatography combined with tandem mass spectrometry (LC/MS/MS) assay."( Comparison of Response of DRI Oxycodone Semiquantitative Immunoassay With True Oxycodone Values Determined by Liquid Chromatography Combined With Tandem Mass Spectrometry: Sensitivity of the DRI Assay at 100 ng/ml Cut-Off and Validity of Semiquantitative
Dasgupta, A; Davis, B; Dixon, RB, 2016
)
0.43
" Oxycodone and noroxycodone parameters (Tmax , Cmax , t1/2 ) were similar with or without quinine present, although drug exposure (AUC) was slightly greater when combined with quinine."( Quinine as a potential tracer for medication adherence: A pharmacokinetic and pharmacodynamic assessment of quinine alone and in combination with oxycodone in humans.
Babalonis, S; Hampson, AJ; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2015
)
0.42
" We evaluated the efficacy and the safety of a prolonged release oral formulation of oxycodone hydrochloride combined with naloxone hydrochloride dehydrate, in a fixed ratio of 2:1 (OXN PR)."( Efficacy and safety profile of prolonged release oxycodone in combination with naloxone (OXN PR) in Parkinson's disease patients with chronic pain.
Dauri, M; Madeo, G; Natoli, S; Pierantozzi, M; Pisani, A; Schirinzi, T; Stefani, A, 2015
)
0.42
" The primary outcome was reporting frequency of the MedDRA System Organ Class (SOC) 'Cardiac Disorders' for naloxone alone and in fixed-dose combination with opioids."( Cardiovascular disorders associated with naloxone monotherapy and in fixed-dose combination with opioids: Data from international safety surveillance.
Haigney, MC; Kao, D; Krantz, MJ; Mehler, PS; Sandhu, A, 2016
)
0.43
"Determine the abuse potential of intravenous oxycodone combined with naltrexone, which represents simulated crushed ALO-02 in solution, compared with intravenous oxycodone in nondependent, recreational opioid users."( Intravenous abuse potential study of oxycodone alone or in combination with naltrexone in nondependent recreational opioid users.
Backonja, M; Bass, A; Malhotra, BK; Matschke, K; Setnik, B; Sommerville, KW; Webster, LR; Wolfram, G, 2016
)
0.43
"Low-dose ropivacaine combined with intrathecal fentanyl can provide adequate anaesthesia with minimal haemodynamic variation."( EFFECT OF PREOPERATIVE INTRAVENOUS OXYCODONE ON LOW-DOSE ROPIVACAINE SPINAL ANESTHESIA COMBINED WITH INTRATHECAL FENTANYL.
Fu, Y; Wang, J; Wang, N; Zhang, S, 2016
)
0.43
"To assess the efficacy of preoperative intravenous oxycodone on transurethral resection of prostate (TURP) under 10 mg ropivacaine spinal anaesthesia combined with intrathecal 25 pg fentanyl."( EFFECT OF PREOPERATIVE INTRAVENOUS OXYCODONE ON LOW-DOSE ROPIVACAINE SPINAL ANESTHESIA COMBINED WITH INTRATHECAL FENTANYL.
Fu, Y; Wang, J; Wang, N; Zhang, S, 2016
)
0.43
" Previous studies showed that opioids combined with gabapentin for management of cancer pain reduced the dosage of opioids."( The research on long-term clinical effects and patients' satisfaction of gabapentin combined with oxycontin in treatment of severe cancer pain.
Chen, DL; Li, YH; Wang, ZJ; Zhu, YK, 2016
)
0.43
" Drug-drug interaction screening tools built into electronic health records and other services identify the interaction as risk of opioid withdrawal rather than hypersensitivity."( Potential drug interaction with opioid agonist in the setting of chronic low-dose opioid antagonist use.
Diaz, CJ; Goode, PA; Leonard, JB; Nair, V; Penoyar, JB, 2017
)
0.46
" We hypothesize that different doses of oxycodone hydrochloride combined with flurbiprofen axetil would generate great results on postoperative intravenous analgesia in lower abdominal patients."( Effect of oxycodone hydrochloride combined with flurbiprofen axetil for intravenous patient-controlled analgesia in lower abdominal patients: A randomized trial.
Fang, J; Lian, Y; Wu, Y; Xiang, X; Yuan, X, 2018
)
0.48
"75 mg/kg oxycodone hydrochloride combined with flurbiprofen axetil can provide safe and effective postoperative analgesia for lower abdominal patients, with fewer adverse reactions."( Effect of oxycodone hydrochloride combined with flurbiprofen axetil for intravenous patient-controlled analgesia in lower abdominal patients: A randomized trial.
Fang, J; Lian, Y; Wu, Y; Xiang, X; Yuan, X, 2018
)
0.48
"DEX combined with oxycodone can improve sleep quality and provide good visceral analgesia."( Effect of Intravenous Oxycodone in Combination With Different Doses of Dexmedetomdine on Sleep Quality and Visceral Pain in Patients After Abdominal Surgery: A Randomized Study.
Bao, C; Chen, Z; Jiang, Z; Song, Q; Wang, H; Zhou, G, 2018
)
0.48
"The primary purpose of this study was to identify the most common drug-drug interactions (DDI'S) in patients prescribed medications upon discharge from the emergency department."( Descriptive study of drug-drug interactions attributed to prescriptions written upon discharge from the emergency department.
Bridgeman, PJ; Jawaro, T; Mele, J; Wei, G, 2019
)
0.51
" The primary endpoint is the identification and characterization of drug-drug interactions caused by discharge prescriptions written by the treating physician."( Descriptive study of drug-drug interactions attributed to prescriptions written upon discharge from the emergency department.
Bridgeman, PJ; Jawaro, T; Mele, J; Wei, G, 2019
)
0.51
"This study was designed to discuss the clinical effects of dexmedetomidine combined with oxycodone patient-controlled intravenous analgesia for patients with laparoscopic radical resection of rectal cancer."( Effect of dexmedetomidine combined with oxycodone patient-controlled intravenous analgesia on the levels of inflammatory cytokine in patients with rectal cancer.
Song, J; Wang, G; Wei, N; Zhang, J, 2019
)
0.51
" This study aimed to investigate the pharmacokinetic properties of the new OTR tablets and evaluate the bioequivalence of oxycodone from OTR and the original extended release (ER) formulation tablets administered with an opioid antagonist in patients with chronic pain."( Pharmacokinetics and Bioequivalence Evaluation of a New Oxycodone Tamper-Resistant Tablet Administered with an Opioid Antagonist in Patients with Chronic Pain.
Hu, C; Luo, Z; Miao, J; Shen, Y; Shu, S; Wang, Y; Zhu, X, 2020
)
0.56
" The model was refined and verified against literature clinical data after oxycodone administration in the absence of drug-drug interactions (DDI)."( Physiologically based pharmacokinetic modelling of oxycodone drug-drug interactions.
Hautajärvi, H; Heikkinen, AT; Kokki, H; Kokki, M; Ranta, VP; Rinne, V; Rytkönen, J, 2020
)
0.56
"With increased opioid use, drug-drug interactions (DDIs) and associated adverse events are growing among geriatric patients."( The impact of drug interactions on adverse effects of oral oxycodone in male geriatric patients.
Gwak, HS; Kim, JH; Kim, JY; Lee, N; Yee, J, 2020
)
0.56
"To compare the therapeutic effects of continuous epidural block combined with drugs and oral drugs alone on postherpetic neuralgia (PHN)."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.62
" Patients in group A had epidural block combined with oral administration of gabapentin and oxycodone-acetaminophen, and patients in group B received oral gabapentin and oxycodone-acetaminophen."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.62
"Both treatments have certain effects on PHN, but epidural block combined with drug therapy is more effective, especially for patients with severe pain, early use can quickly relieve pain."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.62
"In this preliminary study involving healthy participants, paroxetine combined with oxycodone, compared with oxycodone alone, significantly decreased the ventilatory response to hypercapnia on days 1 and 5, whereas quetiapine combined with oxycodone did not cause such an effect."( Effect of Paroxetine or Quetiapine Combined With Oxycodone vs Oxycodone Alone on Ventilation During Hypercapnia: A Randomized Clinical Trial.
Boughner, R; Burkhart, K; Dahan, A; Davis, MC; Florian, J; Ford, K; Gershuny, V; Han, X; Ismaiel, OA; Matta, M; Patel, V; Prentice, K; Racz, R; Rouse, R; Sanabria, C; Shah, A; Stone, M; Strauss, DG; van der Schrier, R; Wang, C; Weaver, J, 2022
)
0.72
" Gabapentin significantly increased drug liking when given in combination with ALC and OXY + ALC (p < 0."( Gabapentin increases the abuse liability of alcohol alone and in combination with oxycodone in participants with co-occurring opioid and alcohol use disorder.
Castillo, F; Comer, SD; Evans, SM; Foltin, RW; Jones, JD; Luba, RR; Mogali, S, 2022
)
0.72
"The aim of this study is to investigate the safety and efficacy of different doses of oxycodone in combination with propofol during painless gastroscopy."( Differential dosing of oxycodone in combination with propofol in diagnostic painless gastroscopy in elderly patients: A prospective randomized controlled trial.
Li, YP; Zhou, Y, 2022
)
0.72
"05 mg/kg oxycodone in combination with propofol can be used safely and effectively for painless gastroscopy, with the advantages of a low propofol dose, maintenance of hemodynamic stability and few adverse effects."( Differential dosing of oxycodone in combination with propofol in diagnostic painless gastroscopy in elderly patients: A prospective randomized controlled trial.
Li, YP; Zhou, Y, 2022
)
0.72
" We conducted a prospective randomized controlled trial to compare etomidate alone with etomidate combined with oxycodone in elderly patients undergoing painless gastroscopy."( Safety and efficacy of etomidate in combination with oxycodone in painless gastroscopic procedures in the elderly: A prospective randomized controlled trial study.
Li, YP; Zhou, Y, 2023
)
0.91
"Etomidate in combination with oxycodone for painless gastroscopic operation in the elderly is a safe and effective anesthetic strategy."( Safety and efficacy of etomidate in combination with oxycodone in painless gastroscopic procedures in the elderly: A prospective randomized controlled trial study.
Li, YP; Zhou, Y, 2023
)
0.91
"To evaluate the adverse effects and particularly the anesthetic effect of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy."( Application of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy.
Cao, Y; Hao, S; Quan, Z; Yao, J; Zhou, C, 2023
)
0.91
"Low-dose etomidate combined with oxycodone and midazolam for endoscopic injection sclerotherapy could reduce the incidence of hypoxia without increasing the incidence of complications."( Application of low-dose etomidate combined with oxycodone and midazolam in endoscopic injection sclerotherapy.
Cao, Y; Hao, S; Quan, Z; Yao, J; Zhou, C, 2023
)
0.91
" More importantly, opioids are often prescribed in combination with multiple other drugs, especially in patient populations who typically are prescribed a large drug regimen."( Hydrocodone, Oxycodone, and Morphine Metabolism and Drug-Drug Interactions.
Coates, S; Lazarus, P, 2023
)
0.91
" Potential drug-drug interactions (DDIs) were assessed by Lexi-Interact ver."( Potential Drug Interactions in Terminally-Ill Cancer Patients, a Report from the Middle East.
Mahzoni, H; Moghaddas, A; Momenzadeh, M; Naghsh, E; Sharifi, M, 2023
)
0.91
" The objective is to investigate the optimal dose of oxycodone for PCIA combined with paravertebral nerve block, to achieve effective multimodal analgesia management in patients undergoing thoracoscopic lung cancer lobectomy."( Effect of oxycodone combined with ultrasound-guided thoracic paravertebral nerve block on postoperative analgesia in patients with lung cancer undergoing thoracoscopic surgery: protocol for a randomised controlled study.
Feng, H; Liu, Z; Shi, P; Su, J; Wang, Y; Wei, X; Wu, G, 2023
)
0.91
" There is a risk of drug-drug interactions involving CYP450 in older adults due to the high prevalence of polypharmacy."( Importance of cytochrome 3A4 and 2D6-mediated drug-drug interactions in oxycodone consumption among older adults hospitalized for hip fracture: a cross-sectional study.
Decaix, T; Gautier, S; Laprévote, O; Pépin, M; Royer, L; Sellier, C; Siguret, V; Teillet, L; Tritz, T, 2023
)
0.91

Bioavailability

Oxycodone displays high bioavailability after oral administration and may be better than morphine in patients with renal impairment. Administration of IRO-A with food suggested increased overall bioavailability relative to fasting conditions.

ExcerptReferenceRelevance
" intramuscular bioavailability of codeine in man."( Analgesic studies of codeine and oxycodone in patients with cancer. I. Comparisons of oral with intramuscular codeine and of oral with intramuscular oxycodone.
Beaver, WT; Houde, RW; Rogers, A; Wallenstein, SL, 1978
)
0.26
" The assay was developed for use in bioavailability studies of therapeutic doses of oxycodone."( Quantitative GLC determination of oxycodone in human plasma.
Renzi, NL; Tam, JN, 1979
)
0.26
" The mean absolute oral bioavailability of oxycodone was 87%, and the mean +/- SD volume of distribution after oral administration was 249."( Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer.
Cramond, T; Leow, KP; Smith, MT; Williams, B, 1992
)
0.28
" First-pass glucuronidation limits systemic bioavailability of oral naloxone."( Treatment of opioid-induced constipation with oral naloxone: a pilot study.
Culpepper-Morgan, JA; Foley, K; Houde, RW; Inturrisi, CE; Kreek, MJ; Marsh, F; Portenoy, RK, 1992
)
0.28
" The assumed oral bioavailability ratios were 44% (group 1, first 10 patients) and 33% (group 2, last 10 patients) for morphine and 66% (group 1) and 50% (group 2) for oxycodone hydrochloride, respectively."( Morphine and oxycodone hydrochloride in the management of cancer pain.
Kalso, E; Vainio, A, 1990
)
0.28
"29) and the mean (+/- SD) absolute bioavailability was 61."( Pharmacokinetics and pharmacodynamics of oxycodone when given intravenously and rectally to adult patients with cancer pain.
Cramond, T; Leow, KP; Smith, MT, 1995
)
0.29
" It is suitable for oral administration due to high bioavailability (60%), and may also be given intramuscularly, intravenously, subcutaneously, and rectally; it is not recommended for spinal administration."( A review of oxycodone's clinical pharmacokinetics and pharmacodynamics.
Kalso, E; Pöyhiä, R; Vainio, A, 1993
)
0.29
"The steady-state bioavailability of a controlled-release (CR) oxycodone tablet was compared with that of an immediate-release (IR) oxycodone solution in a randomized, analytically masked, multiple-dose, crossover study in 24 normal subjects."( Steady-state bioavailability of controlled-release oxycodone in normal subjects.
Benziger, DD; Kaiko, RF; Miotto, JB; Oshlack, B; Reder, RF,
)
0.13
"The effects of a high-fat meal on the bioavailability of oxycodone hydrochloride, administered as a recently developed 40 mg controlled-release (CR) tablet or a 20 mg immediate-release (IR) solution, were evaluated in a randomized crossover study in 22 normal male and female subjects."( Differential effects of food on the bioavailability of controlled-release oxycodone tablets and immediate-release oxycodone solution.
Benziger, DP; Chasin, M; Fitzmartin, RD; Kaiko, RF; Miotto, JB; Reder, RF, 1996
)
0.29
" Absorption rate of the IR solution was best described by a mono-exponential model with a lag time, whereas absorption rate of the CR tablet was best described using a bi-exponential model."( Characterization and validation of a pharmacokinetic model for controlled-release oxycodone.
Kaiko, RF; Mandema, JW; Oshlack, B; Reder, RF; Stanski, DR, 1996
)
0.29
"A single-dose, analytically blinded, randomized, crossover study was conducted in 22 healthy male volunteers to compare the bioavailability of one 20 mg with two 10 mg controlled-release (CR) oxycodone tablets."( A pharmacokinetic/pharmacodynamic study of controlled-release oxycodone.
Benziger, DP; Fitzmartin, RD; Grandy, RP; Miotto, J; Swanton, RE; Thomas, GB, 1997
)
0.3
" The variation in plasma morphine concentrations was higher than that of oxycodone, consistent with the lower bioavailability of morphine."( Morphine or oxycodone in cancer pain?
Heiskanen, TE; Kalso, EA; Ruismäki, PM; Seppälä, TA, 2000
)
0.31
"Previous studies have demonstrated a significant reduction in the oral bioavailability of trovafloxacin and ciprofloxacin when administered concomitantly with an intravenous opiate such as morphine."( Lack of interaction between levofloxacin and oxycodone: pharmacokinetics and drug disposition.
Fitzgerald, JF; Grant, EM; Nicolau, DP; Nightingale, C; Quintiliani, R; Zhong, M, 2001
)
0.31
"Previous studies have demonstrated a significant reduction in the oral bioavailability of trovafloxacin and ciprofloxacin when administered concomitantly with an intravenous opiate, such as morphine."( Minimal interaction between gatifloxacin and oxycodone.
Grant, EM; Nicolau, DR; Nightingale, C; Quintiliani, R, 2002
)
0.31
" Compared with morphine, oxycodone has a higher oral bioavailability and is about twice as potent."( Oxycodone. Pharmacological profile and clinical data in chronic pain management.
Coluzzi, F; Mattia, C,
)
0.13
" The following model adequately describes the population pharmacokinetic profile of oxycodone where absolute bioavailability (F) is estimated for each administration route: CL/F=55x(body weight/70)0."( Population pharmacokinetics of oxycodone in children 6 months to 7 years old.
El-Tahtawy, A; Kokki, H; Reidenberg, BE, 2006
)
0.33
" Using a new, sensitive, and specific liquid chromatography/mass spectrometry (LC/MS) with electrospray ionization detector assay, the absorption bioavailability of sublingual oxycodone was determined in rabbits by comparing plasma concentration after sublingual spray delivery with equivalent intravenous dose."( Effect of pH on sublingual absorption of oxycodone hydrochloride.
Al-Ghananeem, AM; Crooks, PA; Malkawi, AH, 2006
)
0.33
" Oral bioavailability ranges from 60 to 87%, and plasma protein binding is 45%."( Oxycodone: a pharmacological and clinical review.
Espinosa Arranz, E; González Barón, M; Ordóñez Gallego, A, 2007
)
0.34
" Treatments were considered bioequivalent if the 90% CIs for relative bioavailability calculations fell within a predetermined range of 80% to 125%."( Single- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/antagonist prolonged-release combination in healthy adult volunteers.
Bailey, P; Grothe, B; Hopp, M; Leyendecker, P; Mundin, G; Reimer, K; Smith, K; Uhl, R, 2008
)
0.35
" These findings suggest that the coadministration of oxycodone PR and naloxone PR in an FDC would not significantly affect the bioavailability of either of its constituents in these subjects."( Single- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/antagonist prolonged-release combination in healthy adult volunteers.
Bailey, P; Grothe, B; Hopp, M; Leyendecker, P; Mundin, G; Reimer, K; Smith, K; Uhl, R, 2008
)
0.35
" Oxycodone has good oral bioavailability and it produces more predictable plasma concentrations than morphine, which has a poor and more variable bioavailability."( Oxycodone: new 'old' drug.
Hagelberg, NM; Olkkola, KT, 2009
)
0.35
" Oxycodone displays high bioavailability after oral administration and may be better than morphine in patients with renal impairment due to the decreased production of active metabolites."( Role of oxycodone and oxycodone/naloxone in cancer pain management.
Leppert, W,
)
0.13
" The absolute bioavailability of oxycodone was 59 % from oral solutions, 64 % from capsules, and 55 % from controlled-release tablets."( Absorption of different oral dosage forms of oxycodone in the elderly: a cross-over clinical trial in patients undergoing cystoscopy.
Aaltomaa, S; Eskelinen, M; Kokki, H; Kokki, M; Ojanperä, I; Rasanen, I; Välitalo, P, 2012
)
0.38
"Our results indicate that, in the elderly, the bioavailability of the three different oral dosage forms of oxycodone is fairly similar."( Absorption of different oral dosage forms of oxycodone in the elderly: a cross-over clinical trial in patients undergoing cystoscopy.
Aaltomaa, S; Eskelinen, M; Kokki, H; Kokki, M; Ojanperä, I; Rasanen, I; Välitalo, P, 2012
)
0.38
" Moreover, relatively high enteral bioavailability allows an easy switch from one drug formulation to another during the course of pain management."( Oxycodone for the treatment of postoperative pain.
Kokki, H; Kokki, M; Sjövall, S, 2012
)
0.38
"To determine the absolute bioavailability of naloxone from oral doses ranging from 5 mg to 120 mg."( Low absolute bioavailability of oral naloxone in healthy subjects.
Bailey, P; Bell, D; Bond, S; Hopp, M; Mundin, G; Smith, K; Woodward, J, 2012
)
0.38
"The mean oral absolute bioavailability of naloxone in this study was ≤ 2% at doses ranging from 5 mg to 120 mg."( Low absolute bioavailability of oral naloxone in healthy subjects.
Bailey, P; Bell, D; Bond, S; Hopp, M; Mundin, G; Smith, K; Woodward, J, 2012
)
0.38
" Secondary objectives were to assess food effects on the pharmacokinetics of IRO-A tablets, to compare the relative bioavailability of oxycodone in IRO-A tablets versus marketed oxycodone hydrochloride (IRO) tablets under fed conditions and to evaluate the single-dose safety profile of the IRO-A tablets in healthy volunteers pretreated with naltrexone."( Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a sing
Bass, A; Leibowitz, M; Pixton, GC; Rolleri, R; Sommerville, KW; Stark, JG; Zamora, CA, 2012
)
0.38
" Dose proportionality (IRO-A), food effects (IRO-A), and relative bioavailability in a fed state (IRO-A and IRO) were assessed by using bioequivalence criteria (90% CIs between 80% and 125% for C(max) and AUC)."( Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a sing
Bass, A; Leibowitz, M; Pixton, GC; Rolleri, R; Sommerville, KW; Stark, JG; Zamora, CA, 2012
)
0.38
" The bioavailability of oxycodone from IRO-A tablets in the fed state was comparable with IRO tablets based on AUC parameters, although C(max) was ~16."( Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a sing
Bass, A; Leibowitz, M; Pixton, GC; Rolleri, R; Sommerville, KW; Stark, JG; Zamora, CA, 2012
)
0.38
" Administration of IRO-A with food suggested increased overall bioavailability relative to fasting conditions and a reduction in peak systemic exposure of oxycodone that is not expected to be clinically significant."( Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a sing
Bass, A; Leibowitz, M; Pixton, GC; Rolleri, R; Sommerville, KW; Stark, JG; Zamora, CA, 2012
)
0.38
" Their impact on oral pharmacotherapy, including their effect on the bioavailability of oral medications, is poorly understood."( Unpredictable absorption of oral opioid medications in a quadriplegic patient with chronic enterocutaneous fistulas.
Viswesh, VV, 2012
)
0.38
"The rate of absorption of oxycodone from OXN PR tablets correlated well with the in vitro release rates, demonstrating that a Level A IVIVC with internal predictability has been successfully developed for OXN PR tablets."( Validated in vitro/in vivo correlation of prolonged-release oxycodone/naloxone with differing dissolution rates in relation to gastrointestinal transit times.
Hahn, U; Heun, G; Krämer, M; Leuner, C; Mundin, GE; Mysicka, J; Smith, KJ, 2012
)
0.38
" The bioavailability is higher than for morphine and less variable."( Cytochrome P450-mediated changes in oxycodone pharmacokinetics/pharmacodynamics and their clinical implications.
Andersson, ML; Gustafsson, LL; Söderberg Löfdal, KC, 2013
)
0.39
"To assess relative bioavailability of a new generic (test) formulation of oxycodone hydrochloride (HCl) extended release (ER) tablets with that of marketed reference products, OxyContin®, in Canada and USA, in healthy adult subjects under fasting and fed conditions."( Bioequivalence of oxycodone hydrochoride extended release tablets to marketed reference products OxyContin® in Canada and US.
Ducharme, MP; Freeman, JC; Godfrey, AR; Gosai, P; Katikaneni, P; Kumar, KS; Kumar, S; Monif, T; Mudnaik, R, 2013
)
0.39
" Typical population values and between-subject variability (coefficient of variation, percent) for oxycodone clearance and the oral absorption rate constant were 73 L/h (31."( Should the dosage of controlled-release oxycodone in advanced cancer be modified on the basis of patient characteristics?
Anderson, H; Charles, B; George, R; Hardy, J; Norris, R; Tapuni, A, 2014
)
0.4
" The aim of this formulation is to counteract opioid-induced constipation through the local antagonist effect of naloxone in the gut wall, while maintaining analgesia due to the low bioavailability of oral naloxone."( Oxycodone/Naloxone prolonged-release: a review of its use in the management of chronic pain while counteracting opioid-induced constipation.
Burness, CB; Keating, GM, 2014
)
0.4
" To pilot test our hypothesis, we used a mathematical model which postulates that oxycodone's addictive potential is given by: LAP=E/(ka/ke), where LAP represents addictive potential, E represents euphoric potency, ka is the absorption rate constant of drug from the gastrointestinal tract, and ke is the systemic elimination rate constant of drug by all processes responsible for its removal from plasma."( The CYP2D6 gene determines oxycodone's phenotype-specific addictive potential: implications for addiction prevention and treatment.
Boston, RC; Daly, D; Linares, OA; Stefanovski, D, 2014
)
0.4
" The low oral bioavailability (< 2%) of naloxone makes the precipitation of the acute opioid withdrawal symptoms unlikely following oral oxycodone/naloxone exposure."( Oxycodone/naloxone preparation can cause acute withdrawal symptoms when misused parenterally or taken orally.
Graudins, A; Greene, SL; Koutsogiannis, Z; Macleod, D; Robinson, J; Wong, A, 2015
)
0.42
" Under fed conditions, the absorption rate constant of OC and APAP decreased significantly, although there was no effect on CL/F and V/F."( Pooled post hoc analysis of population pharmacokinetics of oxycodone and acetaminophen following a single oral dose of biphasic immediate-release/extended-release oxycodone/acetaminophen tablets.
Devarakonda, K; Franke, RM; Morton, T, 2015
)
0.42
"This study compared the development of tolerance to two orally bioavailable prescription opioids, oxycodone and hydrocodone, to that of morphine, and the reversal of this tolerance by ethanol."( Ethanol Reversal of Tolerance to the Antinociceptive Effects of Oxycodone and Hydrocodone.
Akbarali, HI; Dewey, WL; Henderson, G; Jacob, JC; Poklis, JL, 2017
)
0.46
" Bioavailability of OOD could be classified as comparable to the twice-daily administration of the OTD reference formulation."( Bioavailability of oxycodone after administration of a new prolonged-release once-daily tablet formulation in healthy subjects, in comparison to an established twice-daily tablet
.
Gschwind, YJ; Guth, V; Kovacs, P; Maritz, MA; Rey, H; Scheidel, B; Steigerwald, K, 2017
)
0.46
" As the bioavailability of each opioid has a certain extent of interindividual bioavailability this conversion represents an approximation."( Oral oxycodone for pain after caesarean section: A randomized comparison with nurse-administered IV morphine in a pragmatic study.
Arnelo, C; Blanck, A; Niklasson, B; Öhman, SG; Segerdahl, M, 2015
)
0.42
" In this single-dose pharmacokinetic study, we assessed the relative bioavailability of oxycodone for Oxycodone ARIR and IR oxycodone, and the effect of food on Oxycodone ARIR following oral administration."( Relative Oral Bioavailability of an Abuse-Deterrent, Immediate-Release Formulation of Oxycodone, Oxycodone ARIR in a Randomized Study.
Aigner, S; Iverson, M; Kinzler, ER; Pantaleon, C; Webster, LR, 2019
)
0.51
"This open-label, randomized study in healthy adults compared the relative bioavailability of Oxycodone ARIR 30 mg to IR oxycodone 30 mg under fasted conditions, and Oxycodone ARIR under fed versus fasted conditions."( Relative Oral Bioavailability of an Abuse-Deterrent, Immediate-Release Formulation of Oxycodone, Oxycodone ARIR in a Randomized Study.
Aigner, S; Iverson, M; Kinzler, ER; Pantaleon, C; Webster, LR, 2019
)
0.51
"In this single-dose pharmacokinetic evaluation, fasted Oxycodone ARIR 30 mg had similar bioavailability to and is expected to have the same efficacy and safety profile as IR oxycodone."( Relative Oral Bioavailability of an Abuse-Deterrent, Immediate-Release Formulation of Oxycodone, Oxycodone ARIR in a Randomized Study.
Aigner, S; Iverson, M; Kinzler, ER; Pantaleon, C; Webster, LR, 2019
)
0.51
"Failure to recognize the impact of various situations described throughout this work, including the bioavailability due to loss of oral route, due to pharmacokinetics and pharmacodynamics of the various drugs, either in the context of the impaired metabolism or excretion, or in due to pharmacological interactions, conditions a serious risk of subtreatment of pain and consequent impact in terms of quality of life."( [Opioids for Cancer Pain and its Use under Particular Conditions: A Narrative Review].
Brás, M; Fragoso, M; Vieira, C, 2019
)
0.51
"The objective of this study was to determine the effect of concomitant alcohol intake on the bioavailability of oxycodone from an oxycodone once-daily (OOD) formulation and an oxycodone twice-daily (OTD) formulation."( Once-Daily Oxycodone Prolonged-Release Tablets Are Resistant to Alcohol-Induced Dose Dumping: Results From a Randomized Trial in Healthy Volunteers.
Burger, N; Faulkner, J; Fraser, D; Maritz, MA; Rey, H, 2020
)
0.56
"The new data confirmed the PK profile and the PK/PD relationship identified using the MBMA, resulting in similar parameter estimates except for the intranasal absorption rate constant."( Oxycodone Effect on Pupil Constriction in Recreational Opioid Users: A Pharmacokinetic/Pharmacodynamic Meta-Analysis Approach.
Buller, S; Dari, A; Freijer, J; Gautrois, M; Rengelshausen, J; Stahlberg, HJ, 2021
)
0.62
" However, in patients with hepatic impairment, porto-systemic shunting can increase systemic bioavailability of naloxone, potentially compromising the analgesic efficacy of oral naloxone-oxycodone combinations."( Oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe, chronic cancer pain: Challenges in the context of hepatic impairment.
Aggarwal, G; Ahmedzai, S; Douglas, C; Green, M; Le, BH; Nicoll, A, 2022
)
0.72
"Oxycodone is absorbed in a clinically relevant extent in patients with short bowel syndrome, but bioavailability varies greatly between patients, which shall be taken into consideration."( Oral absorption of oxycodone in patients with short bowel syndrome.
Christrup, LL; Drewes, AM; Hestvang, J; Ladebo, L; Mikkelsen, MS; Olesen, AE; Rasmussen, HH; Vinter-Jensen, L, 2021
)
0.62
" Furthermore, oral bioavailability was 14."( Effect of Roux-en-Y gastric bypass on the pharmacokinetic-pharmacodynamic relationships of liquid and controlled-release formulations of oxycodone.
Abuhelwa, AY; Christrup, LL; Drewes, AM; Foster, DJR; Kongstad, KT; Kroustrup, JP; Ladebo, L; Olesen, AE; Pacyk, GJ, 2021
)
0.62

Dosage Studied

The aim of the study was to evaluate the analgesic/antihyperalgesic efficacy and to establish the dose-response relationship of morphine immediate release (IR) and oxycodone IR in a human experimental algesimetric model. Behaviourally, rats co-administered sub-antinociceptive doses of Oxycodone and morphine were similar to control rats dosed with saline. Rats that received equi-potent doses of either opioid alone were markedly sedated.

ExcerptRelevanceReference
" In the oxycodone group, only two patients (12%) needed maximal dosage (6 x 4 mg), one of them requiring 32 mg of oxycodone."( Comparison of the analgesic dose-effect relationships of nefopam and oxycodone in postoperative pain.
Leander, P; Tammisto, T; Tigerstedt, I, 1979
)
0.26
" The marked interindividual variation observed in the pharmacokinetics and pharmacodynamics of oxycodone in this study supports the need for individualized dosing regimens."( Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer.
Cramond, T; Leow, KP; Smith, MT; Williams, B, 1992
)
0.28
" The mean normalized area under the curve (AUC/D) obtained after intravenous dosing (48."( Comparative oxycodone pharmacokinetics in humans after intravenous, oral, and rectal administration.
Cramond, T; Leow, KP; Smith, MT; Watt, JA; Williams, BE, 1992
)
0.28
"min/ml and with dosing intervals less than 3 hours."( Treatment of opioid-induced constipation with oral naloxone: a pilot study.
Culpepper-Morgan, JA; Foley, K; Houde, RW; Inturrisi, CE; Kreek, MJ; Marsh, F; Portenoy, RK, 1992
)
0.28
" The dosing interval was 5 min, until the patient did not want any further analgesics."( Intravenous morphine and oxycodone for pain after abdominal surgery.
Kalso, E; Linko, K; Onnela, P; Pöyhiä, R; Tammisto, T; Tigerstedt, I, 1991
)
0.28
" However, the effect of differences in dosing protocol on tolerance to opioid analgesics of high or low efficacy has not been addressed."( The effect of intrinsic efficacy on opioid tolerance.
Duttaroy, A; Yoburn, BC, 1995
)
0.29
" At the end of treatment, the pumps and placebos were removed, and 4-24 h later, mice were tested in dose-response studies (tail flick) using the same drug that had been chronically administered."( The effect of intrinsic efficacy on opioid tolerance.
Duttaroy, A; Yoburn, BC, 1995
)
0.29
" The marked interindividual variation observed in the pharmacokinetics and pharmacodynamics of oxycodone in this study emphasizes the need for individualized dosing regimens."( Pharmacokinetics and pharmacodynamics of oxycodone when given intravenously and rectally to adult patients with cancer pain.
Cramond, T; Leow, KP; Smith, MT, 1995
)
0.29
" With the use of the tail flick model, dose-response curves were constructed to codeine, morphine, oxycodone and oxymorphone (the O-demethylated metabolite of oxycodone) in both rat strains."( The influence of pharmacogenetics on opioid analgesia: studies with codeine and oxycodone in the Sprague-Dawley/Dark Agouti rat model.
Bochner, F; Cleary, J; Mikus, G; Somogyi, A, 1994
)
0.29
" In conclusion, ondansetron given prior to anaesthesia in a dosage of 4 mg did not prevent postoperative nausea and vomiting after laparoscopic cholecystectomy."( Antiemetic efficacy of prophylactic ondansetron in laparoscopic cholecystectomy. A randomised, double-blind, placebo-controlled trial.
Koivuranta, MK; Läärä, E; Ryhänen, PT, 1996
)
0.29
" Serial blood samples were collected for 36 h after dosing and analyzed for oxycodone by a validated method using gas chromatography/mass spectrometry."( Differential effects of food on the bioavailability of controlled-release oxycodone tablets and immediate-release oxycodone solution.
Benziger, DP; Chasin, M; Fitzmartin, RD; Kaiko, RF; Miotto, JB; Reder, RF, 1996
)
0.29
" Recently, controlled-release (CR) oxycodone tablets were developed to provide the benefits of twice-a-day dosing to patients treated with oxycodone."( Characterization and validation of a pharmacokinetic model for controlled-release oxycodone.
Kaiko, RF; Mandema, JW; Oshlack, B; Reder, RF; Stanski, DR, 1996
)
0.29
" Medical records were reviewed to determine reasons for opioid dosage escalations."( Codeine and oxycodone use in patients with chronic rheumatic disease pain.
Mahowald, ML; Woods, SR; Ytterberg, SR, 1998
)
0.3
" This patient's clinical course indicates that oral oxycodone can be used safely and to good effect at high dose, that the milligram relative potency ratio for oral oxycodone to parenteral morphine during repeated dosing is 3:1, and suggests that availability of multiple formulations of oxycodone may benefit cancer patients."( The relative potency between high dose oral oxycodone and intravenous morphine: a case illustration.
Doona, M; Walsh, D; Zhukovsky, DS, 1999
)
0.3
" Assessments were made at 30 min, 60 min, then hourly after dosing for 12 h or until remedication."( Relative potency of controlled-release oxycodone and controlled-release morphine in a postoperative pain model.
Brown, J; Clark, P; Curtis, GB; Johnson, GH; Lacouture, PG; O'Callaghan, R; Shi, M; Taylor, R, 1999
)
0.3
" Behaviourally, rats co-administered sub-antinociceptive doses of oxycodone and morphine were similar to control rats dosed with saline, whereas rats that received equi-potent doses of either opioid alone, were markedly sedated."( Co-administration of sub-antinociceptive doses of oxycodone and morphine produces marked antinociceptive synergy with reduced CNS side-effects in rats.
Ross, FB; Smith, MT; Wallis, SC, 2000
)
0.31
" A 34 year-old male patient experienced visual hallucinations and severe tremor after dramatically increasing his dosage of oxycodone while on stable amounts of sertraline and cyclosporin."( Visual hallucination and tremor induced by sertraline and oxycodone in a bone marrow transplant patient.
Flockhart, DA; Rosebraugh, CJ; Woosley, RL; Yasuda, SU, 2001
)
0.31
"1 after titration with IR oxycodone dosed qid."( Double-blind, randomized comparison of the analgesic and pharmacokinetic profiles of controlled- and immediate-release oral oxycodone in cancer pain patients.
Davis, M; Reder, RF; Stambaugh, H; Stambaugh, JE; Stambaugh, MD, 2001
)
0.31
" When initiating treatment, controlled-release preparations of opioids are generally favoured, and are combined with immediate release morphine to prevent or treat 'breakthrough' pain and to enable the optimum opioid dosage to be calculated."( [Treatment of pain in cancer with systemically administered opioids].
de Wit, R; Enting, RH; Lieverse, PJ; Smitt, PA; van der Rijt, CC; Wilms, EB, 2001
)
0.31
" This article will address the safety and efficacy of acetaminophen, aspirin, and ibuprofen independently and in combination with currently available prescription dosage forms with a focus on pharmacology, pharmacotherapeutics, pharmacodynamics, and pharmacokinetics, including drug interactions at the CYP450 system."( Acetaminophen, aspirin, or Ibuprofen in combination analgesic products.
Barkin, RL,
)
0.13
" The reduced dosing frequency makes the oral medication more convenient for patients, making it easier for them to comply with the dosing regimen."( Opioid formulations: tailoring to the needs in chronic pain.
Reder, RF, 2001
)
0.31
"Optimal pharmacologic management of pain requires selection of the appropriate analgesic drug, prescription of the appropriate dose, administration of the analgesic by the appropriate route, scheduling of the appropriate dosing interval, prevention of persistent pain and relief of breakthrough pain, aggressive titration of the dose of the analgesic, prevention, anticipation, and management of analgesic side-effects, use of appropriate co-analgesic drugs, and consideration of sequential trials of opioid analgesics."( Advancement of opioid analgesia with controlled-release oxycodone.
Levy, MH, 2001
)
0.31
" The recommended dosing of the study medications was 1 tablet every 4 to 6 hours, not to exceed 5 tablets per day."( Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of moderate or severe acute low back pain.
Dornseif, BE; Doyle, RT; Morris, E; Palangio, M; Valente, TJ, 2002
)
0.31
" Controlled-release oxycodone has the advantage of less frequent dosing than immediate-release oxycodone; however, other agents may be dosed infrequently at much lower costs."( Safety and efficacy of controlled-release oxycodone: a systematic literature review.
Karbowicz, SH; Rischitelli, DG, 2002
)
0.31
" The new difference CD spectroscopic method can be applied to the selective determination of 6-oxo-morphinans in bulk and dosage forms."( Determination of 6-oxo-morphinans, as the oximes, by difference circular dichroism spectroscopy.
Gergely, A; Horváth, P; Hosztafi, S; Szász, G; Szentesi, A, 2002
)
0.31
"All prior analgesics were discontinued, and oxycodone/acetaminophen was dosed three times a day (TID), titrated to clinically meaningful pain relief."( Effectiveness and safety of new oxycodone/acetaminophen formulations with reduced acetaminophen for the treatment of low back pain.
Domingos, J; Galer, BS; Gammaitoni, AR; Lacouture, P; Schlagheck, T, 2003
)
0.32
"2, on average, provided adequate pain control during the subsequent 12-hour dosing interval and for a maximum of 7 days."( Conversion to oral controlled-release oxycodone from intravenous opioid analgesic in the postoperative setting.
Adler, LJ; Ashburn, MA; Crews, JC; Ginsberg, B; Hord, AH; Laurito, CE; Sinatra, RS, 2003
)
0.32
" The median daily dosage strength of transdermal fentanyl was 75."( Patient-reported utilization patterns of fentanyl transdermal system and oxycodone hydrochloride controlled-release among patients with chronic nonmalignant pain.
Ackerman, SJ; Brennan, M; Mordin, M; Reblando, J; Schein, J; Vallow, S; Xu, X,
)
0.13
"To assess clinical efficacy of controlled-release oxycodone (CRO) 20 mg on a 12-h dosing schedule in this prospective, randomised, placebo-controlled, double-blinded study of 40 ASA physical status I-III women undergoing breast surgery for cancer."( Clinical efficacy of controlled-release oxycodone 20 mg administered on a 12-h dosing schedule on the management of postoperative pain after breast surgery for cancer.
Hundegger, S; Kampe, S; Kaufmann, J; Kiencke, P; Mellinghoff, H; Warm, M, 2004
)
0.32
"The administration of CRO 20 mg on a 12-h dosing schedule halves postoperative IV PCA opioid consumption."( Clinical efficacy of controlled-release oxycodone 20 mg administered on a 12-h dosing schedule on the management of postoperative pain after breast surgery for cancer.
Hundegger, S; Kampe, S; Kaufmann, J; Kiencke, P; Mellinghoff, H; Warm, M, 2004
)
0.32
" The mean daily dosage of oxycodone CR (91."( Establishing the dosage equivalency of oxymorphone extended release and oxycodone controlled release in patients with cancer pain: a randomized controlled study.
Ahdieh, H; Dvergsten, C; Gabrail, NY, 2004
)
0.32
"To determine the dosing of sustained-release oxycodone that is typically prescribed to achieve pain relief in a mixed group of chronic pain patients."( Sustained-release oxycodone dosing survey of chronic pain patients.
Glick, RM; Marcus, DA,
)
0.13
" Total daily dosing for both long- and short-acting opioids were recorded for each patient."( Sustained-release oxycodone dosing survey of chronic pain patients.
Glick, RM; Marcus, DA,
)
0.13
"The prescribed frequency of dosing sustained-release oxycodone determined through clinical practice was twice daily for 33% of patients, with 67% requiring greater than twice daily dosing."( Sustained-release oxycodone dosing survey of chronic pain patients.
Glick, RM; Marcus, DA,
)
0.13
" Patients maintained on every-12-hour dosing were twice as likely to use regularly scheduled, daily, short-acting opioids to achieve pain relief."( Sustained-release oxycodone dosing survey of chronic pain patients.
Glick, RM; Marcus, DA,
)
0.13
" Postoperatively the propacetamol dosage was repeated twice and diclofenac once on the ward."( Propacetamol and diclofenac alone and in combination for analgesia after elective tonsillectomy.
Hiller, A; Savolainen, S; Silvanto, M; Tarkkila, P, 2004
)
0.32
" The median dosing interval was >9."( The efficacy and safety of oral immediate-release oxymorphone for postsurgical pain.
Ahdieh, H; Gimbel, J, 2004
)
0.32
" Long-acting oral opioids supply satisfactory analgesia at more convenient dosing intervals."( Advances in opioid therapy and formulations.
Walsh, D, 2005
)
0.33
" With stable dosing throughout the treatment phase, oxymorphone ER (79."( Efficacy and safety of oxymorphone extended release in chronic low back pain: results of a randomized, double-blind, placebo- and active-controlled phase III study.
Dvergsten, C; Gimbel, J; Hale, ME, 2005
)
0.33
" Oxycodone is available in the United States in oral dosage forms and controlled-release tablets."( The pharmacokinetics of oxycodone.
Kern, SE; Lugo, RA, 2004
)
0.32
" Based on these data, the following primary efficacy end points were determined: total pain relief 6 hours after dosing (TOTPAR6) and sum of pain intensity differences 6 hours after dosing (SPID6)."( Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study.
Newman, K; Pong, A; Singla, N, 2005
)
0.33
" The onset of pain relief occurred within 15 minutes of dosing with all 4 regimens."( Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study.
Newman, K; Pong, A; Singla, N, 2005
)
0.33
" The primary outcome measures were total pain relief through 6 hours after dosing (TOTPAR6), sum of pain intensity differences through 6 hours (SPID6), and adverse events."( Analgesic efficacy and tolerability of oxycodone 5 mg/ibuprofen 400 mg compared with those of oxycodone 5 mg/acetaminophen 325 mg and hydrocodone 7.5 mg/acetaminophen 500 mg in patients with moderate to severe postoperative pain: a randomized, double-blin
Adamson, DN; Christensen, SE; Han, SH; Litkowski, LJ; Newman, KB; Van Dyke, T, 2005
)
0.33
" In this Phase II dose-ranging study, Oxytrex bid demonstrated greater pain relief with a more convenient dosing schedule compared to oxycodone qid."( Adding ultralow-dose naltrexone to oxycodone enhances and prolongs analgesia: a randomized, controlled trial of Oxytrex.
Burns, LH; Butera, PG; Chindalore, VL; Craven, RA; Friedmann, N; Yu, KP, 2005
)
0.33
" Routine dosing of oxycodone in young infants may be dangerous."( Marked variation in oxycodone pharmacokinetics in infants.
Anttila, E; Olkkola, KT; Pokela, ML; Seppälä, T, 2005
)
0.33
" Along these trials, mean daily dosage of oxycodone was approximately 40 mg, with a low incidence of intolerable typical opiate side effects."( Oxycodone. Pharmacological profile and clinical data in chronic pain management.
Coluzzi, F; Mattia, C,
)
0.13
"When opioids are used for postoperative pain control, it is useful to define the dose-response relationship for analgesia and respiratory depression."( Preoperative "fentanyl challenge" as a tool to estimate postoperative opioid dosing in chronic opioid-consuming patients.
Davis, JJ; Dillon, JD; Egan, TD; Hall, RH; Johnson, KB; Niu, SY; Pace, NL; Swenson, JD, 2005
)
0.33
" This model confirms using a weight-based dose for oxycodone without adjustment for age between 6 months and 7 years and is valuable for evaluating dosing schedules and dosing routes."( Population pharmacokinetics of oxycodone in children 6 months to 7 years old.
El-Tahtawy, A; Kokki, H; Reidenberg, BE, 2006
)
0.33
" A sublingual spray dosage form of oxycodone hydrochloride would be a good alternative for fast onset pain management, especially in children."( Effect of pH on sublingual absorption of oxycodone hydrochloride.
Al-Ghananeem, AM; Crooks, PA; Malkawi, AH, 2006
)
0.33
" l-methadone, racemic methadone, and oxycodone had a similar dose-dependent antinociceptive effect, whereas the dose-response curve of morphine was shallower."( Morphine, oxycodone, methadone and its enantiomers in different models of nociception in the rat.
Kalso, E; Kontinen, VK; Kylänlahti, I; Lemberg, K; Viljakka, K; Yli-Kauhaluoma, J, 2006
)
0.33
"Patients were randomized to receive either P-ERMS once-daily (QD) dosing or CRO twice-daily (BID) dosing for a 24-week treatment period."( Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain.
Nicholson, B; Ross, E; Sasaki, J; Weil, A, 2006
)
0.33
" After 24 weeks, all patients on P-ERMS were dosing within the FDA-approved frequencies (65% QD, 35% BID); 56% of patients on CRO dosed BID, but 38% dosed TID and 6% dosed four times daily (QID)."( Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain.
Nicholson, B; Ross, E; Sasaki, J; Weil, A, 2006
)
0.33
"P-ERMS and CRO both relieved chronic nonmalignant pain in this community-based population; however, patients taking P-ERMS dosed in accordance with FDA-approved frequencies (QD/BID); 44% of those taking CRO dosed more frequently (TID/QID)."( Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain.
Nicholson, B; Ross, E; Sasaki, J; Weil, A, 2006
)
0.33
" The shift to the right of the dose-response curves was greater for morphine and oxycodone compared to etorphine and the highest dose of clocinnamox reduced the maximal effect of morphine and oxycodone, but not etorphine."( Opioid agonist efficacy predicts the magnitude of tolerance and the regulation of mu-opioid receptors and dynamin-2.
Kumar, P; Pawar, M; Sirohi, S; Sunkaraneni, S; Walker, EA; Yoburn, BC, 2007
)
0.34
" They received oral OCRT at an initial dosage of 5mg every 12 hours for patients scoring 4-6 and 10mg every 12 hours for patients scoring > or =7."( Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain.
Dai, Y; Dou, C; Guo, Y; Lu, L; Pan, H; Wu, D; Wu, S; Xu, N; Yue, J; Zhang, Y; Zhang, Z, 2007
)
0.34
" The total mean OCRT dosage was 445."( Efficacy and tolerability of oxycodone hydrochloride controlled-release tablets in moderate to severe cancer pain.
Dai, Y; Dou, C; Guo, Y; Lu, L; Pan, H; Wu, D; Wu, S; Xu, N; Yue, J; Zhang, Y; Zhang, Z, 2007
)
0.34
" Oral controlled-release opioid products enable patients to better maintain pain control due to convenient dosing intervals and sustained blood concentration."( [Oxycodone: a strong opioid in the treatment of patients with arthritis].
Anić, B; Bilusić, M; Grazio, S, 2006
)
0.33
" The average wholesale price per dosing unit of each drug during each period studied was obtained from internal databases."( Prescribing patterns and purchasing costs of long-acting opioids over nine years at an academic oncology hospital.
Arbuckle, R; Bruera, E; Curry, EA; Hung, F; Palla, S, 2007
)
0.34
"Lacking enough knowledge of pediatric cancer pain and pediatric dosage form of analgesics, current treatment of pediatric cancer pain in China is unsatisfactory."( [Feasibility to treat pediatric cancer pain with analgesics for adults and their efficacy].
Lin, H; Ling, JY; Luo, WB; Sun, XF; Xia, Y; Zhen, ZJ; Zheng, L, 2007
)
0.34
"Basing on the components and the endurable dosage of each component for children, we formulated the appropriate dosage and usage of a few analgesics (including sustained release tablets of morphine, oxycodone and transdermal fantanyl) available in China, most of which were used in adults."( [Feasibility to treat pediatric cancer pain with analgesics for adults and their efficacy].
Lin, H; Ling, JY; Luo, WB; Sun, XF; Xia, Y; Zhen, ZJ; Zheng, L, 2007
)
0.34
" Dosage was individualized for each patient and up-titrated until effective pain control was achieved."( Oxycodone controlled-release as first-choice therapy for moderate-to-severe cancer pain in Italian patients: results of an open-label, multicentre, observational study.
Aitini, E; Bandieri, E; Calorio, A; Dambrosio, M; Del Prete, S; Endrizzi, L; Garetto, F; Ianniello, GP; Marra, A; Micheletto, G; Nastasi, G; Piantedosi, F; Sabbatini, G; Sidoti, V; Silvestri, B; Spanu, P, 2008
)
0.35
" A dosage increase of oxycodone from 20 to 40 mg bid was required in only one patient with a clavicle fracture."( Use of oxycodone in polytrauma patients: the "Gemelli" experience.
Barbaro, F; Buccelletti, F; Candelli, M; Carbone, L; De Marco, G; Fiore, V; Franceschi, F; Gabrielli, M; Gasbarrini, A; Gasbarrini, G; Gigante, G; Giupponi, B; Mancini, F; Marini, M; Ojetti, V; Pignataro, G; Roccarina, D; Santarelli, L; Silveri, NG; Ursella, S,
)
0.13
" Opioids are often reduced in dosage or even discontinued as a result of impaired bowel function, leading to insufficient pain treatment."( Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain.
Fleischer, W; Grothe, B; Hermanns, K; Hopp, M; Leyendecker, P; Meissner, W; Reimer, K; Ruckes, C; Szombati, I; Vondrackova, D; Weber, S, 2008
)
0.35
" Conclusions This case suggests that, in some circumstances, the opioid blockade may be overcome when naltrexone levels drop towards the end of the dosing interval, producing vulnerability to subsequent naltrexone-induced withdrawal."( Precipitated withdrawal during maintenance opioid blockade with extended release naltrexone.
Fishman, M, 2008
)
0.35
" This phase III, randomized, double-blind, active-controlled study evaluated the tolerability of tapentadol immediate release (IR) and oxycodone IR for low back pain or osteoarthritis pain (hip or knee), using flexible dosing over 90 days."( Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: a randomized, double-blind study.
Hale, M; Lange, C; Okamoto, A; Rauschkolb, C; Upmalis, D, 2009
)
0.35
" Patients in group B who were receiving gabapentin continued this treatment up to a maximum daily dosage of 2400 mg during the observation period."( Adequacy assessment of oxycodone/paracetamol (acetaminophen) in multimodal chronic pain : a prospective observational study.
Bertini, L; Carucci, A; Gatti, A; Mammucari, M; Occhioni, R; Sabato, AF, 2009
)
0.35
" Measurements were performed before dosing and at 30, 60, and 90 min after dosing."( Analgesic efficacy of peripheral kappa-opioid receptor agonist CR665 compared to oxycodone in a multi-modal, multi-tissue experimental human pain model: selective effect on visceral pain.
Arendt-Nielsen, L; Drewes, AM; Kell, S; Menzaghi, F; Olesen, AE; Staahl, C; Wong, GY, 2009
)
0.35
"To assess clinical equivalence of 20 mg controlled-release oxycodone (Oxygesic; Mundipharma, Limburg, Germany) and 200 mg controlled-release tramadol (Tramal long; Grunenthal, Aachen, Germany) on a 12-hour dosing schedule in a randomized, double-blinded study of 54 ASA I-III physical status (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer."( Clinical equivalence of controlled-release oxycodone 20 mg and controlled-release tramadol 200 mg after surgery for breast cancer.
Dagtekin, O; Kampe, S; Landwehr, S; Shaheen, S; Warm, M; Wolter, K, 2009
)
0.35
"Analgesic efficacy of opioids and dosing protocol have been shown to influence analgesic tolerance."( Dosing protocol and analgesic efficacy determine opioid tolerance in the mouse.
Dighe, SV; Madia, PA; Sirohi, S; Walker, EA; Yoburn, BC, 2009
)
0.35
" Dose-response studies were conducted using morphine following treatment."( Dosing protocol and analgesic efficacy determine opioid tolerance in the mouse.
Dighe, SV; Madia, PA; Sirohi, S; Walker, EA; Yoburn, BC, 2009
)
0.35
" These results suggest that opioid analgesic tolerance may be increased when sustained release dosing formulations or continuous infusions are employed clinically."( Dosing protocol and analgesic efficacy determine opioid tolerance in the mouse.
Dighe, SV; Madia, PA; Sirohi, S; Walker, EA; Yoburn, BC, 2009
)
0.35
" Most patients had a clear indication for use of oxycodone and appropriate dosing regimes."( Oxycodone--an audit of its prescription in a local hospital.
Chan, SY; Choo, CY; Ong, CY, 2009
)
0.35
" Patients were then started on open-label pregabalin (75, 150, 300 and 600 mg/day) according to a forced titration dosing regimen, while continuing the same dosage of oxycodone or placebo for 4 weeks."( A randomized, controlled trial of oxycodone versus placebo in patients with postherpetic neuralgia and painful diabetic neuropathy treated with pregabalin.
Duffull, SB; Moore, BJ; Nissen, LM; O'Callaghan, JP; Smith, MT; Zin, CS, 2010
)
0.36
" Also, an analysis of medians was calculated for each of the dosage groupings using Bonett-Price confidence intervals for both raw and adjusted LC-MS-MS values."( Use of an algorithm applied to urine drug screening to assess adherence to an oxycontin regimen.
Couto, JE; Leider, HL; Linden, A; Romney, MC; Webster, L,
)
0.13
" At the scene were numerous bottles of methadone, with the chronic dosage of 240 mg 3 times a day."( Cause of death conundrum with methadone use: a case report.
Benson, BE; Letsky, MC; Seifert, SA; Zumwalt, RE, 2011
)
0.37
" To determine the dosing frequency of sustained-release opioids (morphine, oxycodone, and transdermal fentanyl) and the prevalence of end-of-dose failure in clinical practice, a patient-reported survey was performed."( The dosing frequency of sustained-release opioids and the prevalence of end-of-dose failure in cancer pain control: a Korean multicenter study.
Ahn, JS; Kim, DY; Kim, SY; Ryoo, BY; Shin, DB; Song, HS; Yim, CY, 2010
)
0.36
"8% of these patients took medication earlier than the prescribed dosing schedule."( The dosing frequency of sustained-release opioids and the prevalence of end-of-dose failure in cancer pain control: a Korean multicenter study.
Ahn, JS; Kim, DY; Kim, SY; Ryoo, BY; Shin, DB; Song, HS; Yim, CY, 2010
)
0.36
" End-of-dose failure is suggested to explain increased dosing frequency, and patients reported that adequate pain relief lasted for less time than was stated in the manufacturers' prescription recommendation."( The dosing frequency of sustained-release opioids and the prevalence of end-of-dose failure in cancer pain control: a Korean multicenter study.
Ahn, JS; Kim, DY; Kim, SY; Ryoo, BY; Shin, DB; Song, HS; Yim, CY, 2010
)
0.36
" The treatment started with oxycodone/acetaminophen at the dosage of 5 mg/325 mg, and then the dosage was titrated until the attainment of good pain relief."( Oxycodone/acetaminophen at low dosage: an alternative pain treatment for patients with rheumatoid arthritis.
Biasi, G; Corvetta, A; Di Sabatino, V; Galeazzi, M; Pari, C; Raffaeli, W; Sarti, D,
)
0.13
" Dosage was individualized for each patient and up-titrated over the first week of treatment."( Use of oxycodone controlled-release immediately after NSAIDs: a new approach to obtain good pain control.
Bandieri, E; Costa, G; Fornasier, G; Iorno, V; Micheletto, G; Pastacaldi, G; Pizza, C; Tessaro, L, 2010
)
0.36
" These parameters further improved after 3 months of therapy and remained stable during the follow-up; moreover, an increase of daily dosage of oxycodone was never required."( Oxycodone in the long-term treatment of chronic pain related to scleroderma skin ulcers.
Colaci, M; Ferri, C; Giuggioli, D; Manfredi, A, 2010
)
0.36
" The aim of this review is to outline the pharmacodynamic and pharmacokinetic properties, drug interactions, dosing rules, adverse effects, equianalgesic dose ratio with other opioids and clinical studies of oxycodone in patients with cancer pain."( Role of oxycodone and oxycodone/naloxone in cancer pain management.
Leppert, W,
)
0.13
"randomized, double-blind, placebo-controlled, ascending-dose cohort, dose-response study with flexible dosing."( A double-blind, placebo-controlled study of dual-opioid treatment with the combination of morphine plus oxycodone in patients with acute postoperative pain.
Kelen, R; Richards, P; Stern, W; Webster, L,
)
0.13
" There was a poor correlation between concentrations of both oxycodone and noroxycodone in plasma and saliva over a range of times following dosing (r (2) = 0."( Is saliva a valid substitute for plasma in pharmacokinetic studies of oxycodone and its metabolites in patients with cancer?
Anderson, H; Charles, B; Hardy, J; Norris, R; O'Shea, A, 2012
)
0.38
"8 percent vomiting, which affected adherence to prescribed dosing regimens and, thus, is inversely associated with the level of pain relief."( Oxycodone-related side effects: impact on degree of bother, adherence, pain relief, satisfaction, and quality of life.
Ackerman, SJ; Anastassopoulos, KP; Benson, C; Chow, W; Kim, MS; Tapia, C,
)
0.13
" Simulations of repetitive bolus dosing showed a 20% increase in oxycodone concentration in the elderly."( Oxycodone clearance is markedly reduced with advancing age: a population pharmacokinetic study.
Ihmsen, H; Neuvonen, PJ; Olkkola, KT; Saari, TI; Schwilden, H, 2012
)
0.38
" In elderly patients, dosing should therefore be reduced and carefully titrated to avoid considerable accumulation of oxycodone and potentially hazardous side-effects."( Oxycodone clearance is markedly reduced with advancing age: a population pharmacokinetic study.
Ihmsen, H; Neuvonen, PJ; Olkkola, KT; Saari, TI; Schwilden, H, 2012
)
0.38
"Although opioids are widely accepted as standard therapy for treating acute postoperative pain, the frequent occurrence of adverse events (AEs) and the substantial burden on the patient and the costs of care are a barrier to optimal dosing and adherence to prescribed treatment."( Efficacy and safety of dual-opioid therapy in acute pain.
Webster, L, 2012
)
0.38
"The optimal dosage of the 3-day-type transdermal fentanyl patch was determined by titration of short-acting oral oxycodone."( [Three-day-type transdermal fentanyl patch conversion by rapid titration method with short-acting oral oxycodone for cancer pain].
Fujio, N; Ishikawa, N; Kameyama, M; Watanabe, H; Yamazaki, K, 2012
)
0.38
"To characterize the pharmacokinetics (PK) of oxycodone following intravenous injection and administration of three oral dosage forms (solution, capsule, and controlled-release tablet) in elderly patients (age 76-89 years) undergoing cystoscopy."( Absorption of different oral dosage forms of oxycodone in the elderly: a cross-over clinical trial in patients undergoing cystoscopy.
Aaltomaa, S; Eskelinen, M; Kokki, H; Kokki, M; Ojanperä, I; Rasanen, I; Välitalo, P, 2012
)
0.38
" For intravenous injection we calculated clearance, volume of distribution at steady state, and the half-life of elimination, and for oral dosage forms also the absolute bioavailability."( Absorption of different oral dosage forms of oxycodone in the elderly: a cross-over clinical trial in patients undergoing cystoscopy.
Aaltomaa, S; Eskelinen, M; Kokki, H; Kokki, M; Ojanperä, I; Rasanen, I; Välitalo, P, 2012
)
0.38
"Our results indicate that, in the elderly, the bioavailability of the three different oral dosage forms of oxycodone is fairly similar."( Absorption of different oral dosage forms of oxycodone in the elderly: a cross-over clinical trial in patients undergoing cystoscopy.
Aaltomaa, S; Eskelinen, M; Kokki, H; Kokki, M; Ojanperä, I; Rasanen, I; Välitalo, P, 2012
)
0.38
" The effects of oxycodone (0, 5, and 20 mg/70 kg, orally) were compared, using a within-session cumulative dosing procedure, on the first and fifth days of the 'daily' dosing phase to assess for tolerance; active oxycodone was administered on the second and fourth days of the daily dosing phase."( Effects of repeated oxycodone administration on its analgesic and subjective effects in normal, healthy volunteers.
Comer, SD; Cooper, ZD; Evans, SM; Foltin, RW; Haney, M; Kowalczyk, WJ; Manubay, JM; Saccone, PA; Sullivan, MA; Vosburg, SK, 2012
)
0.38
"" Global assessments of efficacy, dosing convenience, and tolerability were secondary endpoints."( Sustained safety and efficacy of once-daily hydromorphone extended-release (OROS® hydromorphone ER) compared with twice-daily oxycodone controlled-release over 52 weeks in patients with moderate to severe chronic noncancer pain.
Binsfeld, H; Richarz, U; Sabatowski, R; Szczepanski, L; Waechter, S, 2013
)
0.39
"Pharmacokinetic parameters were determined over a 12-hour dosing interval."( Randomized, double-blind, placebo-controlled study of the abuse potential of different formulations of oral oxycodone.
Bath, B; Marmon, T; Medve, RA; Stoddard, GJ; Webster, LR, 2012
)
0.38
"We investigated the safety and efficacy of the bilateral periarticular multimodal drug injection (PMDI) at a reduced dosage in patients undergoing simultaneous bilateral total knee arthroplasty (SBTKA)."( Use of reduced-dose periarticular injection for pain management in simultaneous bilateral total knee arthroplasty.
Chang, CB; Jeon, YT; Kang, YG; Kim, TK; Koh, IJ; Song, J, 2012
)
0.38
"The aim of the study was to evaluate the analgesic/antihyperalgesic efficacy and to establish the dose-response relationship of morphine immediate release (IR) and oxycodone IR in a human experimental algesimetric model."( Dose-response relationship after single oral dose administrations of morphine and oxycodone using laser-evoked potentials on UVB- and capsaicin-irritated skin in healthy male subjects.
Hoeben, E; Mangold, B; Reitmeir, P; Rusch, S; Schaffler, K; Smit, JW; Upmalis, D, 2012
)
0.38
"Of the 35 adults enrolled in the study, 33 completed at least 1 dosing period."( Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a sing
Bass, A; Leibowitz, M; Pixton, GC; Rolleri, R; Sommerville, KW; Stark, JG; Zamora, CA, 2012
)
0.38
" In part 1 of the study, patients were dosed every 5 minutes for the first 65 minutes (up to 13 doses) with study drug, provided that vital signs criteria were met."( Analgesic efficacy and tolerability of intravenous morphine versus combined intravenous morphine and oxycodone in a 2-center, randomized, double-blind, pilot trial of patients with moderate to severe pain after total hip replacement.
Bäthis, H; Böhmer, A; Joppich, R; Kelen, R; Lefering, R; Neugebauer, E; Otto, C; Petzke, F; Richards, P; Stern, W; Treptau, T; Zarghooni, K, 2012
)
0.38
" Two chronic pain patients with loss of pain control following dosage increase in levothyroxine supplementation are presented."( Loss of antinociceptive effectiveness of morphine and oxycodone following titration of levothyroxine: case reports and a brief review of published literature.
Herndon, CM; Kearney, TC; Lindsay, TJ; Matoushek, TA,
)
0.13
" It has also been reported that pregabalin used with oxycodine reveals analgesic effect with smaller dosage than pregabalin alone."( [Case of acute exacerbation of neuropathic cancer pain rapidly relieved by simultaneous oral intake of immediate release oxycodone and pregabalin].
Baba, M; Gomwo, I, 2012
)
0.38
" Sensitivity analyses consider the impact of real-world dosing patterns for LAO on treatment costs."( Clinical simulation model of long-acting opioids for treatment of chronic non-cancer pain in the United States.
Merchant, S; Mody, SH; Neil, N; Ogden, K; Provenzano, D, 2013
)
0.39
" In sensitivity analyses, tapentadol ER becomes a dominant strategy when real-world dosing patterns are considered."( Clinical simulation model of long-acting opioids for treatment of chronic non-cancer pain in the United States.
Merchant, S; Mody, SH; Neil, N; Ogden, K; Provenzano, D, 2013
)
0.39
" When the dosage of morphine may result in unpredictable bioavailability, like in patients with severe hepatic cirrhosis, oxycodone might be beneficial because it has higher and less variability in bioavailability between patients than morphine."( Cytochrome P450-mediated changes in oxycodone pharmacokinetics/pharmacodynamics and their clinical implications.
Andersson, ML; Gustafsson, LL; Söderberg Löfdal, KC, 2013
)
0.39
" The abuse quotient (AQ), calculated as C(max)/t(max), served as an index of the average rate of increase in drug concentration from dosing to t max."( Pharmacokinetics, tolerability, and safety of intranasal administration of reformulated OxyContin(®) tablets compared with original OxyContin (®) tablets in healthy adults.
Apseloff, G; Colucci, SV; Harris, SC; Perrino, PJ, 2013
)
0.39
"In a head-to-head study of up to 10 days in duration, the analgesic efficacy and tolerability of tapentadol immediate release (IR) versus oxycodone IR using a flexible dosing regimen were compared in patients with acute low back pain (LBP) and associated radicular leg pain."( Tapentadol immediate release versus oxycodone immediate release for treatment of acute low back pain.
Benson, C; Biondi, D; Etropolski, M; Moskovitz, B; Rauschkolb, C; Xiang, J,
)
0.13
"This head-to-head study demonstrated that tapentadol IR had comparable analgesic efficacy and overall safety to that of oxycodone IR for the relief of moderate to severe, acute LBP and associated radicular leg pain when using flexible dosing regimens that reflect typical use in clinical practice; however, tapentadol IR demonstrated a better gastrointestinal tolerability profile, particularly for the common opioid-related TEAEs of vomiting and constipation."( Tapentadol immediate release versus oxycodone immediate release for treatment of acute low back pain.
Benson, C; Biondi, D; Etropolski, M; Moskovitz, B; Rauschkolb, C; Xiang, J,
)
0.13
"We conducted a prospective, randomized, cross-sectional study to develop and validate a new model to predict oxycodone in urine that can be used to help evaluate whether patients are complying with their oxycodone dosing regimens."( A new model for using quantitative urine testing as a diagnostic tool for oxycodone treatment and compliance.
Boston, RC; Daly, D; Linares, OA; Stefanovski, D, 2013
)
0.39
" The questions asked were related to whether a narcotic was routinely prescribed for patients who have had impacted teeth removed, the most common drug used, and the dosage and number of tablets prescribed."( Narcotic prescribing habits and other methods of pain control by oral and maxillofacial surgeons after impacted third molar removal.
Abubaker, AO; Laskin, DM; Mutlu, I, 2013
)
0.39
"Most oral and maxillofacial surgeons prescribe analgesic drugs of an appropriate type and dosage and use proper adjunctive pain control measures to supplement these drugs."( Narcotic prescribing habits and other methods of pain control by oral and maxillofacial surgeons after impacted third molar removal.
Abubaker, AO; Laskin, DM; Mutlu, I, 2013
)
0.39
" Dosage of CR oxycodone increased from a mean of 130."( Noninterventional observational study using high-dose controlled-release oxycodone (CR oxycodone) for cancer pain management in outpatient clinics.
Baek, JH; Baek, SK; Cho, DY; Choi, YJ; Kim, SY; Ryoo, HM; Shin, HW; Song, HS; Zang, DY, 2013
)
0.39
" Despite reports that patient characteristics significantly affect oxycodone pharmacokinetics, our results do not support alteration of current prescribing practices for maintenance dosing of Oxycontin® in most patients with advanced cancer."( Should the dosage of controlled-release oxycodone in advanced cancer be modified on the basis of patient characteristics?
Anderson, H; Charles, B; George, R; Hardy, J; Norris, R; Tapuni, A, 2014
)
0.4
" This approach is intended to reduce the opioid subjective rewarding effects such as euphoria which are prominent following swallowing the dosage form without tampering."( Sequestered naltrexone in sustained release morphine or oxycodone - a way to inhibit illicit use?
Pergolizzi, JV; Raffa, RB; Taylor, R, 2014
)
0.4
" Secondary endpoints included SPIDs and total pain relief (TOTPAR) over the dosing intervals; time to perceptible, meaningful, and confirmed pain relief; and the proportion of patients with ≥30% reduction in pain intensity scores."( A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain.
Barrett, T; Giuliani, M; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.4
"OC/APAP ER was efficacious and generally well tolerated in an established model of moderate to severe acute pain, providing an onset of analgesia in approximately 30 minutes and sustained pain relief over the 12 hour dosing period."( A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain.
Barrett, T; Giuliani, M; Kostenbader, K; Singla, N; Sisk, L; Young, J, 2014
)
0.4
" Our hypothesis about oxycodone's addictive potential may provide a unifying approach useful for both personalized medicine dosing and predicting addictive potential of oral drugs in humans, since it is based on both oxycodone's pharmacogenetics and pharmacokinetics."( The CYP2D6 gene determines oxycodone's phenotype-specific addictive potential: implications for addiction prevention and treatment.
Boston, RC; Daly, D; Linares, OA; Stefanovski, D, 2014
)
0.4
"To develop a framework for integrating pharmacogenetics with clinical pharmacokinetics for personalized oxycodone dosing based on a patient's CYP2D6 phenotype."( Personalized oxycodone dosing: using pharmacogenetic testing and clinical pharmacokinetics to reduce toxicity risk and increase effectiveness.
Boston, RC; Daly, D; Linares, AD; Linares, OA; Stefanovski, D, 2014
)
0.4
"Our study shows how clinicians can reduce risk and increase effectiveness for oxycodone dosing by (1) determining the patient's likely metabolic response through testing a patient's CYP2D6 phenotype, and (2) calculating clinical pharmacokinetics specific to the patient's CYP2D6 phenotype to design a personalized oxycodone dosing regimen."( Personalized oxycodone dosing: using pharmacogenetic testing and clinical pharmacokinetics to reduce toxicity risk and increase effectiveness.
Boston, RC; Daly, D; Linares, AD; Linares, OA; Stefanovski, D, 2014
)
0.4
"Personalized oxycodone dosing is a new tool for a clinician treating chronic pain patients requiring oxycodone."( Personalized oxycodone dosing: using pharmacogenetic testing and clinical pharmacokinetics to reduce toxicity risk and increase effectiveness.
Boston, RC; Daly, D; Linares, AD; Linares, OA; Stefanovski, D, 2014
)
0.4
" For constipation, M6G, fentanyl and buprenorphine were full agonists, oxycodone was a partial agonist, morphine produced a bell-shaped dose-response curve, whereas DPDPE and U69,593 were inactive."( In vivo profiling of seven common opioids for antinociception, constipation and respiratory depression: no two opioids have the same profile.
Kuo, A; Meutermans, W; Smith, MT; Wyse, BD, 2015
)
0.42
"Organ-specific OC mass transport kinetics provide new information for OC dosing in pain management."( Organ-specific microcirculatory mass transport of oxycodone in humans: clinical implications for therapeutic use.
Daly, A; Linares, OA; Schiesser, WE, 2015
)
0.42
" Thus, a treatment option with the potential for a reduced dosing frequency exists for health care providers and patients."( Safety and efficacy of once-daily hydromorphone extended-release versus twice-daily oxycodone hydrochloride controlled-release in chinese patients with cancer pain: a phase 3, randomized, double-blind, multicenter study.
Han, J; Hou, Y; Richards, HM; Shen, W; Yu, L; Yu, S, 2014
)
0.4
" In addition, the dynamic changes accompanying repetitive OC dosing suggested that local unbound OC gave rise to both higher extravascular OC content and increased OC spillover."( Oxycodone recycling: a novel hypothesis of opioid tolerance development in humans.
Boston, RC; Fudin, J; Linares, AD; Linares, OA; Schiesser, WE, 2014
)
0.4
" Plasma concentration of oxycodone and its metabolites were measured up to 8 hours after administration as follows: on day 1, CR oxycodone was administered alone; on day 2, CR oxycodone was administered with aprepitant (125 mg, at the same time of oxycodone dosing in the morning)."( Effects of aprepitant on the pharmacokinetics of controlled-release oral oxycodone in cancer patients.
Chayahara, N; Fujiwara, Y; Imamura, Y; Kiyota, N; Minami, H; Mukohara, T; Shimada, T; Toyoda, M, 2014
)
0.4
"In vitro: Mechanical manipulation of dosage forms using common household utensils."( Impact of physical manipulation on in vitro and in vivo release profiles of oxycodone DETERx®: an extended-release, abuse-deterrent formulation.
Fleming, AB; Grima, M; Kopecky, EA; Mayock, SP; Noonan, PK; Saim, S; Varanasi, RK,
)
0.13
" Manipulation of DETERx by crushing (using the most effective method established in vitro) or chewing resulted in bioequivalent plasma concentration-time profiles to the intact dosage form."( Impact of physical manipulation on in vitro and in vivo release profiles of oxycodone DETERx®: an extended-release, abuse-deterrent formulation.
Fleming, AB; Grima, M; Kopecky, EA; Mayock, SP; Noonan, PK; Saim, S; Varanasi, RK,
)
0.13
" In a within-subjects, randomized, double-blind, placebo-controlled, dose-response design, 14 healthy subjects completed a resting-state scan following ingestion of placebo, 10 mg, or 20 mg of oxycodone."( Opioid modulation of resting-state anterior cingulate cortex functional connectivity.
Angstadt, M; de Wit, H; Fitzgerald, DA; Gorka, SM; Phan, KL, 2014
)
0.4
"001; n = 373), using a final average daily dosage of 252."( [Tapentadol prolonged release improves analgesia, functional impairment and quality of life in patients with chronic pain who have previously received oxycodone/naloxone].
Kern, KU; Krings, D; Waldmann-Rex, S, 2014
)
0.4
"Repeat dosing of ALO-02 for up to 12 months is safe and well tolerated in a CNCP population of both opioid-experienced and opioid-naïve patients."( A multicenter, 12-month, open-label, single-arm safety study of oxycodone-hydrochloride/naltrexone-hydrochloride extended-release capsules (ALO-02) in patients with moderate-to-severe chronic noncancer pain.
Arora, S; Clemmer, R; Goli, V; Hudson, JD; Meisner, P; Michael, D; Pixton, GC; Setnik, B; Sommerville, KW,
)
0.13
"Fluvoxamine combined with oxycodone prolonged-release tablets could be more effective in treating patients with cancer pain, and could reduce the dosage of oxycodone prolonged-release tablets and thus be associated with lower side effects, and improved quality of life."( Clinical study on fluvoxamine combined with oxycodone prolonged-release tablets in treating patients with moderate to severe cancer pain.
Ca, LH; Chang, J; Huang, XE; Huang, XH; Liu, J; Ma, YM; Wei, W; Wu, YJ; Xiao, Y; Zhang, RX, 2014
)
0.4
" However, in clinical sites, a higher dosage may be needed due to characteristics of cancer pain."( [Switching from oral oxycodone to oxycodone injection - an investigation into the dosage amount ratio].
Goda, Y; Kamiyama, H; Oda, K, 2015
)
0.42
" The findings of the present study emphasize the potential of oxycodone once-a-day CR tablets for improved patient compliance, safety, and efficacy, which could help researchers to develop new CR dosage forms of oxycodone."( Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets.
Kim, DW; Kim, JY; Lee, M; Lee, SH; Park, CW; Park, ES; Park, J; Rhee, YS; Seo, JW, 2015
)
0.42
" It also allows for convenient dosing before or during surgery, permitting the initiation of effective analgesia in the early phase of the postoperative period."( Perspectives on Intravenous Oxycodone for Control of Postoperative Pain.
Pergolizzi, JV; Raffa, RB; Seow-Choen, F; Taylor, R; Wexner, SD; Zampogna, G, 2016
)
0.43
"During this investigation, nondependent prescription opioid abusers (N=17 completers) were maintained for 2-3weeks on ascending daily doses of PIO (0mg, 15mg, 45mg) prior to completing a laboratory session assessing the aforementioned effects of OXY [using a within-session cumulative dosing procedure (0, 10, and 20mg, cumulative dose=30mg)]."( The effects of pioglitazone, a PPARγ receptor agonist, on the abuse liability of oxycodone among nondependent opioid users.
Ciccocioppo, R; Comer, SD; Jones, JD; Manubay, JM; Metz, VE; Mogali, S; Sullivan, MA, 2016
)
0.43
" These results have important implications for future dosing strategies and may limit the utility of dronabinol as a treatment for opioid withdrawal."( Safety of oral dronabinol during opioid withdrawal in humans.
Babalonis, S; Elayi, SC; Jicha, CJ; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2015
)
0.42
" Subsequently, the dosing regimen was increased to 3 mg/kg twice a day over 10 days, although further marked tolerance did not develop."( Effects of Acute and Repeated Administration of Oxycodone and Naloxone-Precipitated Withdrawal on Intracranial Self-Stimulation in Rats.
Beardsley, PM; Walentiny, DM; Wiebelhaus, JM, 2016
)
0.43
" Because of a previously reported 82% error rate in handwritten discharge narcotic prescriptions, we developed a computerized, web-based, controlled substance prescription writer that includes weight-based dosing logic and alerts to reduce the error rate to (virtually) zero."( An Analysis of 34,218 Pediatric Outpatient Controlled Substance Prescriptions.
George, JA; Hunsberger, J; Lee, BH; Lehmann, CU; Park, PS; Shay, JE; White, ED; Yaster, M, 2016
)
0.43
" The primary outcome will be oxycodone dosage needed to achieve satisfactory analgaesia on day 14."( MAGnesium-oral supplementation to reduce PAin in patients with severe PERipheral arterial occlusive disease: the MAG-PAPER randomised clinical trial protocol.
Bisighini, L; Bonardelli, S; Lamberti, L; Latronico, N; Minelli, C; Rizzo, F; Rizzolo, A; Turin, M; Venturini, MA; Zangrandi, M; Zappa, S, 2015
)
0.42
" The present case indicates that unless opioid side effects improve after dosage reduction, the possibility that they may be withdrawal symptoms should also be considered."( Opioid withdrawal presenting only nausea during tapering of oxycodone after celiac plexus block: a case report.
Koizumi, T; Mamiya, K; Sakamoto, A; Takayama, H, 2016
)
0.43
" The prevalence of opioid abuse via intravenous (IV) injection has led to the development of dosage forms designed to deter abuse using different inactive ingredients and formulation strategies."( In vitro assessment of the potential for abuse via the intravenous route of oxycodone DETERx® microspheres.
Fleming, AB; Grima, MP; Mayock, SP; Scungio, TA,
)
0.13
"The extraction of oxycodone DETERx and two comparators, extended-release oxycodone (oxycodone ER) and immediate-release oxycodone (oxycodone IR), was evaluated in small volumes (5 and 10 mL) of water after manipulation of the dosage forms."( In vitro assessment of the potential for abuse via the intravenous route of oxycodone DETERx® microspheres.
Fleming, AB; Grima, MP; Mayock, SP; Scungio, TA,
)
0.13
" ADFs, therefore, are particularly useful with ER opioid agents, which are designed to produce consistent analgesia over prolonged dosing intervals."( Evaluation of the durability of pain relief throughout a 12 hour dosing interval of a novel, extended-release, abuse-deterrent formulation of oxycodone.
Kopecky, EA; Nalamachu, S; O'Connor, M; Taylor, R; Vaughn, B, 2016
)
0.43
"To evaluate the durability of pain relief of a novel formulation of oxycodone throughout the 12 hour dosing interval."( Evaluation of the durability of pain relief throughout a 12 hour dosing interval of a novel, extended-release, abuse-deterrent formulation of oxycodone.
Kopecky, EA; Nalamachu, S; O'Connor, M; Taylor, R; Vaughn, B, 2016
)
0.43
"The evaluation of dosing patterns indicates that this ER oxycodone capsule formulation has durability of effect over the entire 12-hour dosing interval."( Evaluation of the durability of pain relief throughout a 12 hour dosing interval of a novel, extended-release, abuse-deterrent formulation of oxycodone.
Kopecky, EA; Nalamachu, S; O'Connor, M; Taylor, R; Vaughn, B, 2016
)
0.43
" Analysis was based on 748 Numerical Rating Scale (NRS) scores of pain intensity and 51 observed morphine and oxycodone dosing events."( A Model-Based Approach for Joint Analysis of Pain Intensity and Opioid Consumption in Postoperative Pain.
Christrup, LL; Drewes, AM; Juul, RV; Knøsgaard, KR; Kreilgaard, M; Lund, TM; Olesen, AE; Osther, PJ; Pedersen, KV, 2016
)
0.43
" Plasma samples were analyzed just before dosing through 48 hours postdose for oxycodone, and through 120 hours postdose for naltrexone and its major metabolite, 6-ß-naltrexol."( Effect of food on the pharmacokinetics of oxycodone and naltrexone from ALO-02, an extended release formulation of oxycodone with sequestered naltrexone.
Bramson, C; Gandelman, K; Lamson, M; Malhotra, B; Matschke, K; Salageanu, J, 2015
)
0.42
" Use of conversion tables to guide selection of opioid agonist dosage may compromise patient safety."( Opioid agonist doses for oxycodone and morphine dependence: Findings from a retrospective case series.
Bruno, R; Degenhardt, L; Demirkol, A; Lintzeris, N; Nielsen, S, 2017
)
0.46
" The rate of acetazolamide elimination into urine was followed for several days after dosing cessation."( A Pharmacokinetic Study Examining Acetazolamide as a Novel Adherence Marker for Clinical Trials.
Babalonis, S; Hampson, AJ; Krieter, P; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2016
)
0.43
" For each of 4 consecutive mornings after dosing cessation, the rates of urinary acetazolamide elimination remained quantifiable."( A Pharmacokinetic Study Examining Acetazolamide as a Novel Adherence Marker for Clinical Trials.
Babalonis, S; Hampson, AJ; Krieter, P; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2016
)
0.43
" Patients or caregivers may manipulate extended-release (ER) opioid formulations to facilitate oral dosing due to a lack of therapeutic options that allow for sprinkle or enteral feeding tube administration."( An abuse-deterrent, microsphere-in-capsule formulation of extended-release oxycodone: alternative modes of administration to facilitate pain management in patients with dysphagia.
Fleming, AB; Kopecky, EA; Marseilles, A; McCarberg, BH; O'Connor, M; Thompson, C; Varanasi, RK, 2016
)
0.43
" This study investigated the patterns of opioid prescribing and characterized the dosing and duration of opioid use in patients with noncancer and cancer pain."( Dose and Duration of Opioid Use in Patients with Cancer and Noncancer Pain at an Outpatient Hospital Setting in Malaysia.
Choy, LW; Ismail, CR; Rahman, NA; Zin, CS, 2017
)
0.46
" Previous studies showed that opioids combined with gabapentin for management of cancer pain reduced the dosage of opioids."( The research on long-term clinical effects and patients' satisfaction of gabapentin combined with oxycontin in treatment of severe cancer pain.
Chen, DL; Li, YH; Wang, ZJ; Zhu, YK, 2016
)
0.43
" Fentanyl and ketorolac dose-response relationships were evaluated for selected outcome variables."( Intramuscular Fentanyl and Ketorolac Associated with Superior Pain Control After Pediatric Bilateral Myringotomy and Tube Placement Surgery: A Retrospective Cohort Study.
Cook-Sather, SD; Jantzen, EC; Jawad, AF; Li, Y; Long, AS; Muhly, WT; Polansky, M; Stricker, PA, 2017
)
0.46
"03 mg/kg/infusion) under fixed ratio 1 (FR1), FR2, and FR5 schedules of reinforcement followed by a dose-response study to assess sensitivity to the reinforcing effects of oxycodone."( Oxycodone self-administration in male and female rats.
Chartoff, E; Mavrikaki, M; Page, S; Potter, D; Pravetoni, M, 2017
)
0.46
"Burn victim patients are frequently prescribed opioids at doses that are significantly higher than standard analgesic dosing guidelines, and, even despite an escalation in opioid dosing, many continue to experience pain."( Burn injury decreases the antinociceptive effects of opioids.
Bates, MLS; Eitan, S; Emery, MA; Wellman, PJ, 2017
)
0.46
" The pharmacokinetic model developed may be used to evaluate different multiple dosing regimens, but the safety of repeated doses should be ensured."( Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials.
Hooker, AC; Kokki, H; Kokki, M; Olkkola, KT; Ranta, VP; Välitalo, P, 2017
)
0.46
" Physiologic and opioid agonist effects were assessed during chronic dosing sessions."( Effects of Short-Term Oxycodone Maintenance on Experimental Pain Responses in Physically Dependent Opioid Abusers.
Coe, MA; Lofwall, MR; Nuzzo, PA; Walsh, SL, 2017
)
0.46
" The merits of adopting a different dosage form were also noted."( [Outcomes of an Independent Clinical Study to Compare Branded and Generic Formulations of Sustained-Release Oxycodone].
Aoyama, Y; Nawa, T; Okawa, M; Onodera, Y; Saito, Y; Shimizu, K; Yamamoto, M; Yamamoto, Y, 2017
)
0.46
"159 mg/kg, can be useful to adjust the dosage of IV oxycodone for maintain stable BP during induction of general anesthesia."( Optimal dose of intravenous oxycodone for attenuating hemodynamic changes after endotracheal intubation in healthy patients: A randomized controlled trial.
Baek, CW; Jung, YH; Kang, H; Lee, OH; Lee, SH; Park, YH; Shin, HY; Woo, YC, 2017
)
0.46
" This literature review reveals that variants in ABCB1, OPRM1, and COMT have been replicated for opioid dosing and variants in ABCB1 have been replicated for both treatment response and adverse effects."( Pharmacogenomics and Patient Treatment Parameters to Opioid Treatment in Chronic Pain: A Focus on Morphine, Oxycodone, Tramadol, and Fentanyl.
Hall, C; Hotham, E; Lloyd, RA; Suppiah, V; Williams, M, 2017
)
0.46
" Additional endpoints assessed at every visit were the impact of pain on quality of life (QoL), breakthrough cancer pain (BTCP) episodes, opioid dosage escalation index, bowel dysfunction, safety, and other side effects."( High dosage of a fixed combination oxycodone/naloxone prolonged release: efficacy and tolerability in patients with chronic cancer pain.
Amato, F; Ceniti, S; Consoletti, L; Magaldi, D; Mameli, S; Marcassa, C; Notaro, P; Palmieri, V; Pisanu, GM; Vellucci, R, 2017
)
0.46
" Daily dosage of OXN-PR slightly increased (T0: 81."( High dosage of a fixed combination oxycodone/naloxone prolonged release: efficacy and tolerability in patients with chronic cancer pain.
Amato, F; Ceniti, S; Consoletti, L; Magaldi, D; Mameli, S; Marcassa, C; Notaro, P; Palmieri, V; Pisanu, GM; Vellucci, R, 2017
)
0.46
") dose-dependently decreased oxycodone self-administration, and shifted the oxycodone dose-response curve downward."( The novel dopamine D3 receptor antagonists/partial agonists CAB2-015 and BAK4-54 inhibit oxycodone-taking and oxycodone-seeking behavior in rats.
Bi, GH; Boateng, C; Cao, J; Gao, JT; Gardner, EL; He, Y; Newman, AH; Xi, ZX; You, ZB, 2017
)
0.46
"Plasma profiles of OOD reveal sustained concentrations of oxycodone over the complete dosing interval of 24 hours."( Bioavailability of oxycodone after administration of a new prolonged-release once-daily tablet formulation in healthy subjects, in comparison to an established twice-daily tablet
.
Gschwind, YJ; Guth, V; Kovacs, P; Maritz, MA; Rey, H; Scheidel, B; Steigerwald, K, 2017
)
0.46
"The new 10-mg OOD formulation provides sustained oxycodone plasma concentrations over the dosing interval of 24 hours and is suitable for once-daily administration."( Bioavailability of oxycodone after administration of a new prolonged-release once-daily tablet formulation in healthy subjects, in comparison to an established twice-daily tablet
.
Gschwind, YJ; Guth, V; Kovacs, P; Maritz, MA; Rey, H; Scheidel, B; Steigerwald, K, 2017
)
0.46
" Dissolution was assessed for intact and crushed dosage forms."( In Vitro Drug Release After Crushing: Evaluation of Xtampza
Fleming, AB; Mayock, SP; Saim, S, 2017
)
0.46
"Intact formulations exhibited drug release rates characteristic of 12- or 24-h dosage forms."( In Vitro Drug Release After Crushing: Evaluation of Xtampza
Fleming, AB; Mayock, SP; Saim, S, 2017
)
0.46
" As such, Xtampza ER may be less appealing to abusers and offer a margin of safety for patients who manipulate dosage forms to facilitate swallowing."( In Vitro Drug Release After Crushing: Evaluation of Xtampza
Fleming, AB; Mayock, SP; Saim, S, 2017
)
0.46
" Further research to assess adverse events and other dosing may be warranted."( Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial.
Baer, J; Barnaby, DP; Bijur, PE; Chang, AK; Esses, D, 2017
)
0.46
" Vaccination shifted the dose-response curves to the right, representing protection, for each of these endpoints."( Safety and efficacy of an oxycodone vaccine: Addressing some of the unique considerations posed by opioid abuse.
Baruffaldi, F; Carroll, FI; Comer, SD; Langston, TL; Laudenbach, M; Navarro, HA; Pentel, PR; Peterson, SJ; Pravetoni, M; Raleigh, MD; Runyon, SP; Winston, S, 2017
)
0.46
" Univariate and multivariable regressions were used to examine the influence of dosage strength, drug formulation, and bulk purchasing on street price."( Scoring the best deal: Quantity discounts and street price variation of diverted oxycodone and oxymorphone.
Bau, GE; Dart, RC; Dasgupta, N; Lebin, JA; Murphy, DL; Severtson, SG, 2019
)
0.51
" For a 2-fold increase in dosage strength, there is a 24."( Scoring the best deal: Quantity discounts and street price variation of diverted oxycodone and oxymorphone.
Bau, GE; Dart, RC; Dasgupta, N; Lebin, JA; Murphy, DL; Severtson, SG, 2019
)
0.51
"Haemodialysis performed 6-10 h after dosing removed ∼10% of the administered dose of oxycodone predominantly as unconjugated oxycodone and noroxycodone or conjugated oxymorphone and noroxymorphone."( Pharmacokinetics of oxycodone/naloxone and its metabolites in patients with end-stage renal disease during and between haemodialysis sessions.
Amico, P; Dickenmann, M; Duthaler, U; Hammann, F; Haschke, M; Jehle, AW; Kalbermatter, S; Krähenbühl, S; Lenherr, C; Leuppi-Taegtmeyer, A; Liechti, ME; Meyer Zu Schwabedissen, HE; Schmid, Y, 2019
)
0.51
" Because of its strong analgesic activity and dosage form, fentanyl has become one of the first choices for severe and moderate pain in clinical practice."( Comparison of the use of different analgesics in the course of anesthesia care based on pharmacoeconomics.
Jing, C; Ping, Y; Qing, J, 2018
)
0.48
" The dosage of oxycodone in GG genotype was significantly higher than that in AA genotype and AG genotype (15."( [Relationship of OPRM1 118A/G gene polymorphism and oxycodone analygesic dose in paitents with cancer pain].
Bie, M; Li, X; Lin, T; Song, J; Zhang, C, 2018
)
0.48
" VK4-116 also lowered the break-point (BP) for oxycodone self-administration under a progressive-ratio schedule of reinforcement, shifted the oxycodone dose-response curve downward, and inhibited oxycodone extinction responding and reinstatement of oxycodone-seeking behavior."( Dopamine D
Bi, GH; Cao, J; Gadiano, A; Galaj, E; Gardner, EL; Kumar, V; Newman, AH; Rais, R; Slusher, BS; Xi, ZX; You, ZB, 2019
)
0.51
"001) and significantly decreased sufentanil dosage within 6h ( P= ."( Intra-operative Oxycodone Reduced Postoperative Catheter-Related Bladder Discomfort Undergoing Transurethral Resection Prostate. A Prospective, Double Blind Randomized Study.
Chen, X; Li, J; Liu, S; Weng, C; Xiong, J, 2019
)
0.51
" A strong consensus was achieved regarding which pharmacological treatment (transmucosal fentanyl) and dosing method (start low and go slow) are the most suitable for the older population."( Expert consensus on the management of breakthrough cancer pain in older patients. A Delphi study.
Alarcón, MDL; Cabezón-Gutiérrez, L; Estévez, FV; Jiménez-López, AJ; Martín-Arroyo, JMT; Padrós, MC; Rebollo, MA; Sanz-Yagüe, A, 2019
)
0.51
" A dose-response trend was observed for constipation but not for the other side effects."( Side effects from opioids used for acute pain after emergency department discharge.
Castonguay, V; Chauny, JM; Cournoyer, A; Daoust, R; Lessard, J; Morris, J; Paquet, J; Piette, É; Williamson, D, 2020
)
0.56
" Furthermore, enduring exacerbation of nociceptive hypersensitivity is also observed when the same dosing regimen for either morphine, fentanyl, or oxycodone begins 1 month after nerve injury."( Oxycodone, fentanyl, and morphine amplify established neuropathic pain in male rats.
Ball, JB; Fabisiak, T; Grace, PM; Green-Fulgham, SM; Kwilasz, AJ; Maier, SF; Watkins, LR, 2019
)
0.51
" CYP3A4*1G polymorphism related to postoperative VAS score, medication dosage and prevalence of adverse reactions in sufentanil group (p<0."( Correlation between gene polymorphism and opioid efficacy in patients with gastric or intestinal cancer.
He, XY; Huang, ZK; Pu, J; Wang, N; Yuan, HB, 2019
)
0.51
" All 9 interventions significantly reduced at least one of the following: high-risk agent use including meperidine use by up to 71%; total or daily dosage of opioids at discharge, including median morphine milligram equivalence (MME) from 90 mg to 45 mg per patient; and quantity of medications such as oxycodone supplied to patients, halved in one study from 6,170 expected to 2,932 supplied tablets."( Prescriber Education Interventions to Optimize Opioid Prescribing in Acute Care: A Systematic Review.
Arnold, C; Bui, T; Dooley, M; Hopkins, RE; Magliano, D, 2019
)
0.51
" We sought to evaluate the effectiveness and safety of over the counter dosing of ibuprofen on pain and bleeding rates following ESS."( Effect of Over the Counter Ibuprofen Dosing after Sinus Surgery for Chronic Rhinosinusitis: A Prospective Cohort Pilot Study.
Davis, GE; Humphreys, IM; Miller, C, 2020
)
0.56
"Over the counter dosing of ibuprofen along with acetaminophen may yield better pain control after sinus surgery compared to acetaminophen alone."( Effect of Over the Counter Ibuprofen Dosing after Sinus Surgery for Chronic Rhinosinusitis: A Prospective Cohort Pilot Study.
Davis, GE; Humphreys, IM; Miller, C, 2020
)
0.56
" Moreover, there is scant literature on the efficacy of around-the-clock (ATC) scheduled dosing of opioid analgesia compared to pro re nata (PRN; as-needed) dosing for postpartum pain management."( Scheduled versus as-needed postpartum analgesia and oxycodone utilization.
Blitz, MJ; Marchbein, H; Palleschi, GT; Pappas, K; Prasannan, L; Rochelson, B; Stoffels, GJ, 2022
)
0.72
"Our aim was to determine how inpatient oxycodone use is affected by as-needed compared to ATC scheduled dosing of acetaminophen, ibuprofen, and low-dose oxycodone, with the option to decline any of these medications."( Scheduled versus as-needed postpartum analgesia and oxycodone utilization.
Blitz, MJ; Marchbein, H; Palleschi, GT; Pappas, K; Prasannan, L; Rochelson, B; Stoffels, GJ, 2022
)
0.72
" In month 21 of the 48-month study period, a new institutional protocol for postpartum pain management was implemented which consisted of scheduled dosing of a multimodal analgesic regimen."( Scheduled versus as-needed postpartum analgesia and oxycodone utilization.
Blitz, MJ; Marchbein, H; Palleschi, GT; Pappas, K; Prasannan, L; Rochelson, B; Stoffels, GJ, 2022
)
0.72
"After cesarean delivery, scheduled multimodal analgesia that includes ATC dosing of acetaminophen, ibuprofen, and low-dose oxycodone, with the option to decline any of these medications, does not increase the percentage of women who receive oxycodone or mean oxycodone consumption per inpatient day compared to as-needed analgesia."( Scheduled versus as-needed postpartum analgesia and oxycodone utilization.
Blitz, MJ; Marchbein, H; Palleschi, GT; Pappas, K; Prasannan, L; Rochelson, B; Stoffels, GJ, 2022
)
0.72
" Fast and accurate determination of oxycodone blood concentration would enable personalized dosing and monitoring of the analgesic as well as quick diagnostics of possible overdose in emergency care."( Electrochemical Detection of Oxycodone and Its Main Metabolites with Nafion-Coated Single-Walled Carbon Nanotube Electrodes.
Jiang, H; Kalso, E; Kauppinen, EI; Koskinen, J; Laurila, T; Lilius, T; Mikladal, B; Mynttinen, E; Sainio, S; Varjos, I; Wester, N, 2020
)
0.56
" An efficient and sensitive method to measure multiple serum drugs and metabolites could inform drug dosing in polypharmacy."( Quantification of serum levels in mice of seven drugs (and six metabolites) commonly taken by older people with polypharmacy.
Hilmer, SN; Mach, J; Wang, X, 2021
)
0.62
" Of these, 10 were caused by dosing errors and 4 probably contributed to patients' death."( Nature of adverse events with opioids in hospitalised patients: a post-hoc analysis of three patient record review studies.
de Bruijne, M; Jongerden, I; Klopotowska, JE; Langelaan, M; Moesker, M; Schutijser, BCFM; Wagner, C, 2020
)
0.56
" Future interventions should focus on safe dosing of opioids when prescribing and administering, especially in elderly patients."( Nature of adverse events with opioids in hospitalised patients: a post-hoc analysis of three patient record review studies.
de Bruijne, M; Jongerden, I; Klopotowska, JE; Langelaan, M; Moesker, M; Schutijser, BCFM; Wagner, C, 2020
)
0.56
"This nationwide study aimed to compare use of oxycodone and doctor shopping for oxycodone in 2010 and 2016, and to quantify doctor shopping for oxycodone by sex, age, formulation, and dosage in 2010 and 2016."( Evolution of doctor shopping for oxycodone in the 67 million inhabitants in France as a proxy for potential misuse or abuse.
Lapeyre-Mestre, M; Micallef, J; Pradel, V; Soeiro, T, 2021
)
0.62
" Herein we evaluate the effects of acute and repeated dosing of SR-17018, oxycodone and morphine in additional models of pain-related behaviors."( Comparison of morphine, oxycodone and the biased MOR agonist SR-17018 for tolerance and efficacy in mouse models of pain.
Acevedo-Canabal, A; Bannister, TD; Bohn, LM; Cameron, MD; Grim, TW; Kennedy, NM; Pantouli, F; Schmid, CL, 2021
)
0.62
"Proportions of BZD coprescribing, BZD dosing patterns in matched patients, and the esti-mated number of lives potentially saved by the opioid treatment switch."( Concomitant use of benzodiazepines in chronic pain patients adherent to extended-release tapentadol or oxycodone treatment-A retrospective claims analysis.
DeGeorge, M; Imro, M; Passik, SD; Tatovic, S; Vukicevic, D; Zah, V,
)
0.13
"032 mg/kg/inf) on a fixed ratio 1 (FR1) schedule of reinforcement and (2) compare full dose-response curves for MDPV and oxycodone self-administration under an FR5 schedule of reinforcement."( MDPV "high-responder" rats also self-administer more oxycodone than their "low-responder" counterparts under a fixed ratio schedule of reinforcement.
Gannon, BM; Murnane, KS; Rice, KC, 2021
)
0.62
" High levels of timeout responding were noted in a subset of rats that acquired MDPV self-administration ("high-responders", n = 5), and the FR5 dose-response curve for MDPV was shifted upward for these rats relative to their "low-responder" (n = 6) counterparts."( MDPV "high-responder" rats also self-administer more oxycodone than their "low-responder" counterparts under a fixed ratio schedule of reinforcement.
Gannon, BM; Murnane, KS; Rice, KC, 2021
)
0.62
" The primary endpoint was the total dosage of oxycodone."( Changes of Opioid Consumption After Lumbar Fusion Using Ultrasound-Guided Lumbar Erector Spinae Plane Block: A Randomized Controlled Trial.
Chen, L; Li, J; Wang, M; Wang, X; Wang, Y; Zhu, L, 2021
)
0.62
"In Japan, 14 opioids with a variety of dosage forms, such as oral preparation, injection, transdermal patch, transmucosal and suppository are clinically available as analgesics, and their use properly depends on the type and degree of pain and patient condition."( [Current status and issues in clinical use of opioids].
Nakagawa, T, 2021
)
0.62
" This study was designed to simulate dosing and stock check procedures for oxycodone oral solution, as a sample CD solution, and evaluate where the volume losses that cause discrepancies could arise from."( Reduction of oral liquid controlled drugs discrepancy in day-to-day practice.
Fox, A; Mohanasundaram, S; Roldo, M; Rutter, P; Wood, K, 2021
)
0.62
" These were used to simulate dosing and stock check practices."( Reduction of oral liquid controlled drugs discrepancy in day-to-day practice.
Fox, A; Mohanasundaram, S; Roldo, M; Rutter, P; Wood, K, 2021
)
0.62
"During dosing with tapentadol, gastrointestinal side effects and motility parameters were on placebo level."( Tapentadol results in less deterioration of gastrointestinal function and symptoms than standard opioid therapy in healthy male volunteers.
Drewes, AM; Frøkjaer, JB; Hansen, TM; Krogh, K; Mark, EB; Nedergaard, RB; Nissen, TD; Scott, SM, 2021
)
0.62
" However, optimal dosing is a difficult task as current guidelines are based on an intact gastrointestinal tract."( Oral absorption of oxycodone in patients with short bowel syndrome.
Christrup, LL; Drewes, AM; Hestvang, J; Ladebo, L; Mikkelsen, MS; Olesen, AE; Rasmussen, HH; Vinter-Jensen, L, 2021
)
0.62
" Still, optimal therapeutic dosing must be individualized, and other factors such as those related to malnutrition and motility shall also be taken into consideration."( Oral absorption of oxycodone in patients with short bowel syndrome.
Christrup, LL; Drewes, AM; Hestvang, J; Ladebo, L; Mikkelsen, MS; Olesen, AE; Rasmussen, HH; Vinter-Jensen, L, 2021
)
0.62
" Prescriptions for OC vary based on the dosage and formulation, immediate release (IR) and controlled release (CR)."( Urinary Pharmacokinetics of Immediate and Controlled Release Oxycodone and its Phase I and II Metabolites Using LC-MS-MS.
Chermà, MD; Gréen, H; Jakobsson, G; Kronstrand, R; Swortwood, MJ; Truver, MT, 2023
)
0.91
" During the transition, she experienced some withdrawal in the setting of swallowed buprenorphine/naloxone tablets, which were intended to be dosed sublingually."( Transition from Oxycodone to Buprenorphine/Naloxone in a Hospitalized Patient with Sickle Cell Disease: A Case Report.
DeFries, T; Leyde, S; Pratt, L; Suen, L, 2022
)
0.72
" Thus, in order to adjust the dosage of OXY for well-managed pain relief with less toxicity, we tried establishing and validating a system for measuring plasma concentrations of OXY using liquid chromatography-tandem mass spectrometry (LC-MS/MS)."( Establishment to measure oxycodone in plasma with liquid chromatography-tandem mass spectrometry.
Ito, S; Kitaichi, K; Matsuo, M; Mori, M; Oida, Y; Soda, M; Yamasaki, R, 2022
)
0.72
"En absence de changements cliniques ou biochimiques suggérant une aggravation de la fonction rénale, la cystatine C sérique a été mesurée par dosage immunoturbidimétrique."(
Abbasi, BA; Amaro-Estrada, I; Andreas, NS; Ariga, K; Bedrov, D; Bello, AK; Bouganim, N; Braam, B; Cao, Y; Capasso, R; Caro, AL; Chen, G; Chen, Y; Clark, MK; Cossio-Bayugar, R; Dong, D; Gao, D; Gao, T; Ghimire, A; Gul, F; Hamonic, LN; He, Y; Hill, JP; Hollebeek, LD; Hu, B; Iqbal, J; Jardan, YAB; Jiang, M; Jindal, K; John, B; Khan, I; Khan, M; Klarenbach, S; Kumar, V; Li, J; Li, L; Li, Z; Lin, H; Liu, C; Liu, HF; Liu, J; Liu, L; Liu, Z; Ma, R; Mach, T; Mahmood, T; Marath, U; Mathew, D; Mei, C; Muneer, S; Nakamura, J; Ni, H; Okpechi, IG; Padwal, R; Qi, A; Qin, Y; Renjitha, M; Ringrose, J; Scott-Douglas, N; Shahbaz, A; Shi, L; Shojai, S; Singh, SK; Slabu, D; Song, Y; Srivastava, RK; Sultana, N; Takeyasu, K; Tang, SS; Thompson, S; Tinwala, MM; Trinh, E; Valappil, SP; Wang, L; Wang, T; Wang, Y; Wu, W; Xi, H; Yang, M; Yang, Y; Ye, F; Yin, G; Yin, M; Yin, X; Yuan, XS; Zaidi, D; Zeng, L; Zhang, L; Zhang, Z; Zhang, ZC; Zheng, D, 2022
)
0.72
" The other aim included the average blood pressure, heart rate, surgical pleth index, and bispectral index values fluctuation during the intraoperative period of expanding the medullary cavity, the sufentanil, and remifentanil consumption during the operation, the amount of time the patients stayed in the Postanesthesia Care Unit, the 8 hours, 16 hours, and 24 hours total dosage of oxycodone, the resting and exercise Visual Analog Scale (VAS) pain scores at 8 hours, 16 hours, and 24 hours after surgery, postoperative adverse events, and safety."( Ultrasound-Guided Oblique Sagittal Anterior Quadratus Lumborum Block in Total Hip Arthroplasty: A Randomized Controlled Trial.
Chen, L; Li, H; Ruan, B; Wang, M; Wang, N; Ye, W; Ying, T, 2022
)
0.72
" The trials were short in duration (maximum length was 24 days) and only assessed safety and efficacy of a 12-h dosing interval."( On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data.
Bavli, I; Herder, M; Pappin, J, 2022
)
0.72
" OPRM1 and COMT are receiving increasing attention and have implications for all opioids, with changes in opioid dosage requirements observed but they have not yet been studied widely enough to be considered clinically actionable."( The Role of Pharmacogenomics in Opioid Prescribing.
Philip, J; Rubio, J; Somogyi, AA; Wong, AK, 2022
)
0.72
" This study aims to characterize the pharmacokinetic profile of oxycodone after intravenous administration and to simulate an appropriate dosage for analgesic efficacy in obese patients."( Population Pharmacokinetics and Dosing Simulations of Intravenous Oxycodone for Perioperative Pain Relief in Adult Surgical Patients with Obesity.
Chaw, SH; Haron, DEBM; Lo, YL; Shariffuddin, II; Yeap, LL, 2023
)
0.91
" The intraoperative propofol dosage and the operative time of gastroscopy were recorded."( Differential dosing of oxycodone in combination with propofol in diagnostic painless gastroscopy in elderly patients: A prospective randomized controlled trial.
Li, YP; Zhou, Y, 2022
)
0.72
" ITS analyses showed that immediately postrescheduling, quarterly hydrocodone dispensing decreased by 177M dosage units while codeine, oxycodone, and morphine dispensing increased by 49M, 62M, and 4M dosage units, respectively."( The impact of hydrocodone rescheduling on utilization, abuse, misuse, and overdose deaths.
Ajao, A; Chai, GP; Ding, Y; Gill, R; Karami, S; Major, JM; McAninch, J; Meyer, T; Secora, A; Wong, J; Zhang, D; Zhao, Y, 2023
)
0.91
" Oxycodone increased as first prescribed opioid (from 44% to 85%) whereas tramadol decreased (64-11%), but their dosage remained stable (stronger opioids were preferred by prescribers)."( Out-of-hospital opioid prescriptions after knee and hip arthroplasty: prescribers and the first prescribed opioid.
Bouvy, ML; Dahan, A; Gademan, MGJ; Nelissen, RGHH; Rosendaal, FR; van Brug, HE; van Dorp, ELA; van Steenbergen, LN, 2023
)
0.91
"0-10 mg/kg) were studied in combination with the peak oxycodone dose and a dose on the descending limb of the dose-effect curve; NTX and (±)VK4-40 were also studied at the peak of the PR dose-response curve (N = 4)."( Effects of selective dopamine D3 receptor partial agonist/antagonists on oxycodone self-administration and antinociception in monkeys.
Allen, MI; Banks, ML; Cornelissen, JC; Nader, MA; Newman, AH; Woodlief, K, 2023
)
0.91
" The index of consciousness 2 was utilized to titrate the remifentanil dosage in all patients to ensure sufficient analgesia."( Pre-incisional Preventive Precise Multimodal Analgesia May Enhance the Rehabilitation Process of Acute Postoperative Pain Following Total Laparoscopic Hysterectomy: A Randomized Controlled Trial.
Feng, S; Qi, M; Wan, A; Wang, C; Wang, S; Wang, T; Xiao, W; Yang, S; Yao, D; Zhou, L, 2023
)
0.91
" By combining with clinical data such as age, sex, dosage and duration of medication, the effect of gene polymorphism on the ADR of patients after taking opioid drugs was statistically analysed."( Study on the association between adverse drug reactions to opioids and gene polymorphisms: a case-case-control study.
Fu, Z; Guan, YY; Li, QF; Song, C; Sun, YZ; Yang, J; Zheng, L, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
opioid analgesicA narcotic or opioid substance, synthetic or semisynthetic agent producing profound analgesia, drowsiness, and changes in mood.
mu-opioid receptor agonistA compound that exhibits agonist activity at the mu-opioid receptor.
antitussiveAn agent that suppresses cough. Antitussives have a central or a peripheral action on the cough reflex, or a combination of both. Compare with expectorants, which are considered to increase the volume of secretions in the respiratory tract, so facilitating their removal by ciliary action and coughing, and mucolytics, which decrease the viscosity of mucus, facilitating its removal by ciliary action and expectoration.
[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
organic heteropentacyclic compound
semisynthetic derivativeAny organic molecular entity derived from a natural product by partial chemical synthesis.
[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
Oxycodone Action Pathway3111

Protein Targets (13)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Solute carrier family 22 member 1 Homo sapiens (human)IC50 (µMol)2,003.78000.21005.553710.0000AID1526751
AcetylcholinesteraseElectrophorus electricus (electric eel)IC50 (µMol)76.20000.00000.94539.9400AID514203
Delta-type opioid receptorRattus norvegicus (Norway rat)Ki1.08700.00000.60689.2330AID239360
Mu-type opioid receptorRattus norvegicus (Norway rat)Ki0.04360.00000.38458.6000AID239089
Kappa-type opioid receptorRattus norvegicus (Norway rat)Ki2.65800.00000.18683.9500AID239148
Mu-type opioid receptorHomo sapiens (human)Ki0.01200.00000.419710.0000AID1558955; AID1681778; AID1811101
Kappa-type opioid receptorCavia porcellus (domestic guinea pig)IC50 (µMol)76.20000.00030.71237.0700AID514203
Potassium voltage-gated channel subfamily H member 2Homo sapiens (human)IC50 (µMol)10.00000.00091.901410.0000AID1681774
Sigma non-opioid intracellular receptor 1Homo sapiens (human)Ki10.00000.00000.490110.0000AID1558961; AID1681775; AID1811100
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Kappa-type opioid receptorMus musculus (house mouse)EC50 (µMol)16.00000.00080.80564.8860AID765837
Mu-type opioid receptorHomo sapiens (human)EC50 (µMol)0.13780.00000.32639.4000AID1558957; AID1681777; AID1811102; AID765841
Delta-type opioid receptorHomo sapiens (human)EC50 (µMol)4.00000.00000.43328.3000AID765842
Kappa-type opioid receptorHomo sapiens (human)EC50 (µMol)16.00000.00000.22448.9900AID765840
Mu-type opioid receptorMus musculus (house mouse)EC50 (µMol)0.16000.00020.03930.2030AID765836
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (106)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processSolute carrier family 22 member 1 Homo sapiens (human)
neurotransmitter transportSolute carrier family 22 member 1 Homo sapiens (human)
serotonin transportSolute carrier family 22 member 1 Homo sapiens (human)
establishment or maintenance of transmembrane electrochemical gradientSolute carrier family 22 member 1 Homo sapiens (human)
organic cation transportSolute carrier family 22 member 1 Homo sapiens (human)
quaternary ammonium group transportSolute carrier family 22 member 1 Homo sapiens (human)
prostaglandin transportSolute carrier family 22 member 1 Homo sapiens (human)
monoamine transportSolute carrier family 22 member 1 Homo sapiens (human)
putrescine transportSolute carrier family 22 member 1 Homo sapiens (human)
spermidine transportSolute carrier family 22 member 1 Homo sapiens (human)
acetylcholine transportSolute carrier family 22 member 1 Homo sapiens (human)
dopamine transportSolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine transportSolute carrier family 22 member 1 Homo sapiens (human)
thiamine transportSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transportSolute carrier family 22 member 1 Homo sapiens (human)
epinephrine transportSolute carrier family 22 member 1 Homo sapiens (human)
serotonin uptakeSolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine uptakeSolute carrier family 22 member 1 Homo sapiens (human)
thiamine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
metanephric proximal tubule developmentSolute carrier family 22 member 1 Homo sapiens (human)
purine-containing compound transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
dopamine uptakeSolute carrier family 22 member 1 Homo sapiens (human)
monoatomic cation transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
transport across blood-brain barrierSolute carrier family 22 member 1 Homo sapiens (human)
(R)-carnitine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
acyl carnitine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
spermidine transmembrane transportSolute carrier family 22 member 1 Homo sapiens (human)
cellular detoxificationSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transport across blood-brain barrierSolute carrier family 22 member 1 Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerMu-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled acetylcholine receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
sensory perceptionMu-type opioid receptorHomo sapiens (human)
negative regulation of cell population proliferationMu-type opioid receptorHomo sapiens (human)
sensory perception of painMu-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayMu-type opioid receptorHomo sapiens (human)
behavioral response to ethanolMu-type opioid receptorHomo sapiens (human)
positive regulation of neurogenesisMu-type opioid receptorHomo sapiens (human)
negative regulation of Wnt protein secretionMu-type opioid receptorHomo sapiens (human)
positive regulation of ERK1 and ERK2 cascadeMu-type opioid receptorHomo sapiens (human)
calcium ion transmembrane transportMu-type opioid receptorHomo sapiens (human)
cellular response to morphineMu-type opioid receptorHomo sapiens (human)
regulation of cellular response to stressMu-type opioid receptorHomo sapiens (human)
regulation of NMDA receptor activityMu-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayMu-type opioid receptorHomo sapiens (human)
immune responseDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messengerDelta-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
adult locomotory behaviorDelta-type opioid receptorHomo sapiens (human)
negative regulation of gene expressionDelta-type opioid receptorHomo sapiens (human)
negative regulation of protein-containing complex assemblyDelta-type opioid receptorHomo sapiens (human)
positive regulation of CREB transcription factor activityDelta-type opioid receptorHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylationDelta-type opioid receptorHomo sapiens (human)
response to nicotineDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayDelta-type opioid receptorHomo sapiens (human)
eating behaviorDelta-type opioid receptorHomo sapiens (human)
regulation of mitochondrial membrane potentialDelta-type opioid receptorHomo sapiens (human)
regulation of calcium ion transportDelta-type opioid receptorHomo sapiens (human)
cellular response to growth factor stimulusDelta-type opioid receptorHomo sapiens (human)
cellular response to hypoxiaDelta-type opioid receptorHomo sapiens (human)
cellular response to toxic substanceDelta-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayDelta-type opioid receptorHomo sapiens (human)
immune responseKappa-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
phospholipase C-activating G protein-coupled receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
chemical synaptic transmissionKappa-type opioid receptorHomo sapiens (human)
sensory perceptionKappa-type opioid receptorHomo sapiens (human)
locomotory behaviorKappa-type opioid receptorHomo sapiens (human)
sensory perception of painKappa-type opioid receptorHomo sapiens (human)
adenylate cyclase-inhibiting opioid receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
response to insulinKappa-type opioid receptorHomo sapiens (human)
positive regulation of dopamine secretionKappa-type opioid receptorHomo sapiens (human)
negative regulation of luteinizing hormone secretionKappa-type opioid receptorHomo sapiens (human)
response to nicotineKappa-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor signaling pathwayKappa-type opioid receptorHomo sapiens (human)
maternal behaviorKappa-type opioid receptorHomo sapiens (human)
eating behaviorKappa-type opioid receptorHomo sapiens (human)
response to estrogenKappa-type opioid receptorHomo sapiens (human)
estrous cycleKappa-type opioid receptorHomo sapiens (human)
response to ethanolKappa-type opioid receptorHomo sapiens (human)
regulation of saliva secretionKappa-type opioid receptorHomo sapiens (human)
behavioral response to cocaineKappa-type opioid receptorHomo sapiens (human)
sensory perception of temperature stimulusKappa-type opioid receptorHomo sapiens (human)
defense response to virusKappa-type opioid receptorHomo sapiens (human)
cellular response to lipopolysaccharideKappa-type opioid receptorHomo sapiens (human)
cellular response to glucose stimulusKappa-type opioid receptorHomo sapiens (human)
positive regulation of p38MAPK cascadeKappa-type opioid receptorHomo sapiens (human)
positive regulation of potassium ion transmembrane transportKappa-type opioid receptorHomo sapiens (human)
response to acrylamideKappa-type opioid receptorHomo sapiens (human)
positive regulation of eating behaviorKappa-type opioid receptorHomo sapiens (human)
conditioned place preferenceKappa-type opioid receptorHomo sapiens (human)
neuropeptide signaling pathwayKappa-type opioid receptorHomo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by hormonePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of DNA-templated transcriptionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion homeostasisPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cardiac muscle contractionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of ventricular cardiac muscle cell membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cellular response to xenobiotic stimulusPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane depolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of heart rate by cardiac conductionPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
membrane repolarization during ventricular cardiac muscle cell action potentialPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
positive regulation of potassium ion transmembrane transportPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
negative regulation of potassium ion export across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
potassium ion import across plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
lipid transportSigma non-opioid intracellular receptor 1Homo sapiens (human)
nervous system developmentSigma non-opioid intracellular receptor 1Homo sapiens (human)
G protein-coupled opioid receptor signaling pathwaySigma non-opioid intracellular receptor 1Homo sapiens (human)
regulation of neuron apoptotic processSigma non-opioid intracellular receptor 1Homo sapiens (human)
protein homotrimerizationSigma non-opioid intracellular receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (40)

Processvia Protein(s)Taxonomy
acetylcholine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
neurotransmitter transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
dopamine:sodium symporter activitySolute carrier family 22 member 1 Homo sapiens (human)
norepinephrine:sodium symporter activitySolute carrier family 22 member 1 Homo sapiens (human)
protein bindingSolute carrier family 22 member 1 Homo sapiens (human)
monoamine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
secondary active organic cation transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
organic anion transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
organic cation transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
prostaglandin transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
pyrimidine nucleoside transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
thiamine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
putrescine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
spermidine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
quaternary ammonium group transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
toxin transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
identical protein bindingSolute carrier family 22 member 1 Homo sapiens (human)
xenobiotic transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
(R)-carnitine transmembrane transporter activitySolute carrier family 22 member 1 Homo sapiens (human)
G-protein alpha-subunit bindingMu-type opioid receptorHomo sapiens (human)
G protein-coupled receptor activityMu-type opioid receptorHomo sapiens (human)
beta-endorphin receptor activityMu-type opioid receptorHomo sapiens (human)
voltage-gated calcium channel activityMu-type opioid receptorHomo sapiens (human)
protein bindingMu-type opioid receptorHomo sapiens (human)
morphine receptor activityMu-type opioid receptorHomo sapiens (human)
G-protein beta-subunit bindingMu-type opioid receptorHomo sapiens (human)
neuropeptide bindingMu-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor activityDelta-type opioid receptorHomo sapiens (human)
protein bindingDelta-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled enkephalin receptor activityDelta-type opioid receptorHomo sapiens (human)
neuropeptide bindingDelta-type opioid receptorHomo sapiens (human)
G protein-coupled opioid receptor activityKappa-type opioid receptorHomo sapiens (human)
protein bindingKappa-type opioid receptorHomo sapiens (human)
receptor serine/threonine kinase bindingKappa-type opioid receptorHomo sapiens (human)
dynorphin receptor activityKappa-type opioid receptorHomo sapiens (human)
neuropeptide bindingKappa-type opioid receptorHomo sapiens (human)
transcription cis-regulatory region bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
delayed rectifier potassium channel activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
ubiquitin protein ligase bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
identical protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
protein homodimerization activityPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
C3HC4-type RING finger domain bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
scaffold protein bindingPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel activity involved in ventricular cardiac muscle cell action potential repolarizationPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
G protein-coupled opioid receptor activitySigma non-opioid intracellular receptor 1Homo sapiens (human)
protein bindingSigma non-opioid intracellular receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (41)

Processvia Protein(s)Taxonomy
plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
basal plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
membraneSolute carrier family 22 member 1 Homo sapiens (human)
basolateral plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
apical plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
lateral plasma membraneSolute carrier family 22 member 1 Homo sapiens (human)
presynapseSolute carrier family 22 member 1 Homo sapiens (human)
plasma membraneKappa-type opioid receptorMus musculus (house mouse)
endosomeMu-type opioid receptorHomo sapiens (human)
endoplasmic reticulumMu-type opioid receptorHomo sapiens (human)
Golgi apparatusMu-type opioid receptorHomo sapiens (human)
plasma membraneMu-type opioid receptorHomo sapiens (human)
axonMu-type opioid receptorHomo sapiens (human)
dendriteMu-type opioid receptorHomo sapiens (human)
perikaryonMu-type opioid receptorHomo sapiens (human)
synapseMu-type opioid receptorHomo sapiens (human)
plasma membraneMu-type opioid receptorHomo sapiens (human)
neuron projectionMu-type opioid receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneDelta-type opioid receptorHomo sapiens (human)
dendrite membraneDelta-type opioid receptorHomo sapiens (human)
presynaptic membraneDelta-type opioid receptorHomo sapiens (human)
axon terminusDelta-type opioid receptorHomo sapiens (human)
spine apparatusDelta-type opioid receptorHomo sapiens (human)
postsynaptic density membraneDelta-type opioid receptorHomo sapiens (human)
neuronal dense core vesicleDelta-type opioid receptorHomo sapiens (human)
plasma membraneDelta-type opioid receptorHomo sapiens (human)
neuron projectionDelta-type opioid receptorHomo sapiens (human)
nucleoplasmKappa-type opioid receptorHomo sapiens (human)
mitochondrionKappa-type opioid receptorHomo sapiens (human)
cytosolKappa-type opioid receptorHomo sapiens (human)
plasma membraneKappa-type opioid receptorHomo sapiens (human)
membraneKappa-type opioid receptorHomo sapiens (human)
sarcoplasmic reticulumKappa-type opioid receptorHomo sapiens (human)
T-tubuleKappa-type opioid receptorHomo sapiens (human)
dendriteKappa-type opioid receptorHomo sapiens (human)
synaptic vesicle membraneKappa-type opioid receptorHomo sapiens (human)
presynaptic membraneKappa-type opioid receptorHomo sapiens (human)
perikaryonKappa-type opioid receptorHomo sapiens (human)
axon terminusKappa-type opioid receptorHomo sapiens (human)
postsynaptic membraneKappa-type opioid receptorHomo sapiens (human)
plasma membraneKappa-type opioid receptorHomo sapiens (human)
neuron projectionKappa-type opioid receptorHomo sapiens (human)
plasma membraneMu-type opioid receptorMus musculus (house mouse)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
cell surfacePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
perinuclear region of cytoplasmPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
voltage-gated potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
inward rectifier potassium channel complexPotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
plasma membranePotassium voltage-gated channel subfamily H member 2Homo sapiens (human)
nuclear envelopeSigma non-opioid intracellular receptor 1Homo sapiens (human)
nuclear inner membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
nuclear outer membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulumSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulum membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
lipid dropletSigma non-opioid intracellular receptor 1Homo sapiens (human)
cytosolSigma non-opioid intracellular receptor 1Homo sapiens (human)
postsynaptic densitySigma non-opioid intracellular receptor 1Homo sapiens (human)
membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
growth coneSigma non-opioid intracellular receptor 1Homo sapiens (human)
cytoplasmic vesicleSigma non-opioid intracellular receptor 1Homo sapiens (human)
anchoring junctionSigma non-opioid intracellular receptor 1Homo sapiens (human)
postsynaptic density membraneSigma non-opioid intracellular receptor 1Homo sapiens (human)
endoplasmic reticulumSigma non-opioid intracellular receptor 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (141)

Assay IDTitleYearJournalArticle
AID1526832Ratio of unbound Cmax in human at 5 mg, po dosed as immediate release formulation to inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1681777Agonist activity at human MOR expressed in CHOK1 cells assessed as stimulation of cAMP accumulation incubated for 45 mins by HTRF assay2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID1681778Displacement of [3H]-DAMGO from human MOR expressed in CHOK1 cell membranes incubated for 60 mins by liquid scintillation counting method2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID1558982Antinociceptive activity in orally dosed mouse assessed as reduction in mechanical nociception measured after 30 mins post dose by paw pressure pain test2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
4-Aryl-1-oxa-4,9-diazaspiro[5.5]undecane Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID514209Inhibition of electric eel AChE at 500 uM by Ellman's method2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Morphinans and isoquinolines: acetylcholinesterase inhibition, pharmacophore modeling, and interaction with opioid receptors.
AID604021Unbound volume of distribution in Sprague-Dawley rat brain measured per gram of brain tissue administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr b2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID604024Unbound brain to plasma concentration ratio in Sprague-Dawley rat administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
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.
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.
AID1562939Agonist activity at MOR in Wistar rat brain membranes after 60 mins by [35S]-GTPgammaS binding assay relative to control2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1526826Unbound maximal portal vein concentration of in human at 10 mg, po dosed as controlled release formulation2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID604023Ratio of total drug level in brain to plasma in Sprague-Dawley rat administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
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).
AID1558955Displacement of [3H]-DAMGO from human MOR expressed in CHOK1 cell membranes incubated for 60 mins by liquid scintillation counting method2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
4-Aryl-1-oxa-4,9-diazaspiro[5.5]undecane Derivatives as Dual μ-Opioid Receptor Agonists and σ
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.
AID1562911Displacement of [3H]WIN-55,212-2 from CB1R/CB2R in Wistar rat brain membranes after 60 mins by liquid scintillation analysis2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID514204Displacement of [3H]DAMGO from mu opioid receptor in rat brain membrane2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Morphinans and isoquinolines: acetylcholinesterase inhibition, pharmacophore modeling, and interaction with opioid receptors.
AID1562923Effect on nociception of the contralateral paw in rat model of sodium iodoacetate-induced osteoarthritis paw withdrawal threshold in early phase at 20 ug administered as intrathecal injection measured up to 45 mins by Von Frey test (Rvb = 44 +/- 2.4 g)2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1526824Cmax in human at 10 mg, po dosed as controlled release formulation2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID178325Compound was tested for antinociceptive activity in heat stimulus rat tail flick assay after subcutaneous administration of the drug1981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Analgesic narcotic antagonists. 8. 7 alpha-Alkyl-4,5 alpha-epoxymorphinan-6-ones.
AID128214Narcotic agonistic activity in acetic acid mouse writhing assay after subcutaneous administration of the drug1981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Analgesic narcotic antagonists. 8. 7 alpha-Alkyl-4,5 alpha-epoxymorphinan-6-ones.
AID1526733Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.5 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
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).
AID765838Selectivity ratio of EC50 for human KOR to EC50 for human DOR2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID1811103Agonist activity at human MOR expressed in CHO-K1 cells assessed as reduction in forskolin-induced cAMP production incubated for 45 mins by by HTRF assay relative to DAMGO2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID1811139Antinociceptive activity in CD-1 mouse at 10 mg/kg, ip2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID1526830Unbound Cmax in human at 5 mg, po dosed as immediate release formulation2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1562903Displacement of [3H]JWH-018 from CB1R/CB2R in Wistar rat brain membranes after 60 mins by liquid scintillation analysis2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1211698Transactivation of human CAR1 transfected in human HepG2 cells assessed as CYP2B6 expression at 1 to 30 uM after 24 hrs by luciferase reporter gene assay2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Induction of xenobiotic receptors, transporters, and drug metabolizing enzymes by oxycodone.
AID1558961Displacement of [3H]-(+)-pentazocine from human sigma-1 receptor expressed in HEK293 membranes incubated for 120 mins by liquid scintillation counting method2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
4-Aryl-1-oxa-4,9-diazaspiro[5.5]undecane Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID239360Displacement of [3H[Ile5,6]-deltorphin II from delta opioid receptor of rat brain membranes2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
AID246957In vivo analgesic effect (sc) assessed as antinociceptive potency by hot plate test in mice2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
AID1216211Unbound brain to plasma concentration ratio in rat2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Morphine brain pharmacokinetics at very low concentrations studied with accelerator mass spectrometry and liquid chromatography-tandem mass spectrometry.
AID1562931Agonist activity at MOR/CB1R/CB2R receptor in Wistar rat brain membranes at 10 uM after 60 mins by [35S]-GTPgammaS binding assay relative to control2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1681774Inhibition of human ERG expressed in CHO cells at -80 mV holding potential by whole cell patch clamp assay2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID1211701Transactivation of human CAR1 Ala retention mutant transfected in human HepG2 cells assessed as CYP2B6 expression at 1 to 30 uM after 24 hrs by luciferase reporter gene assay2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Induction of xenobiotic receptors, transporters, and drug metabolizing enzymes by oxycodone.
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).
AID765833Activation of human MOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay relative to DAMGO2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
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.
AID765840Agonist activity at human KOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID1681776Agonist activity at human MOR expressed in CHOK1 cells assessed as stimulation of cAMP accumulation incubated for 45 mins by HTRF assay relative to DAMGO2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID765837Agonist activity at mouse KOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID1681746Antinociceptive activity in CD1 mouse PSNL model assessed as reduction in mechanical allodynia by measuring decrease in the pressure required to elicit withdrawal of the ipsilateral paw after von Frey filament stimulation at 1.25 mg/kg, ip BID for 11 days2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID765842Agonist activity at human DOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID514205Displacement of [3H][Ile5,6]deltorphin2 from delta opioid receptor in rat brain membrane2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Morphinans and isoquinolines: acetylcholinesterase inhibition, pharmacophore modeling, and interaction with opioid receptors.
AID1211703Transactivation of human CAR1 transfected in human primary hepatocytes assessed as nuclear translocation at 30 uM by confocal laser scanning microscopy2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Induction of xenobiotic receptors, transporters, and drug metabolizing enzymes by oxycodone.
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.
AID765828Activation of mouse KOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay relative to U695932013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID7783Unbound fraction (plasma)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID604025Unbound CSF to plasma concentration ratio in Sprague-Dawley rat administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID1209582Unbound volume of distribution in Sprague-Dawley rat brain slices at 100 nM after 5 hrs2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1526827Ratio of unbound Cmax in human at 10 mg, po dosed as controlled release formulation to inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1562937Agonist activity at MOR in Wistar rat brain membranes after 60 mins by [35S]-GTPgammaS binding assay2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
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).
AID1526829Cmax in human at 5 mg, po dosed as immediate release formulation2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1562927Antiallodynic activity in sodium iodoacetate-induced rat model of osteoarthritis assessed as increase in maximum effect in early phase at 20 ug administered as intrathecal injection measured up to 45 mins by Von Frey test2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID514203Inhibition of electric eel AChE by Ellman's method2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Morphinans and isoquinolines: acetylcholinesterase inhibition, pharmacophore modeling, and interaction with opioid receptors.
AID1558984Induction of constipation in mouse assessed as effect on intestinal transit at 10 mg/kg, po dosed 30 mins before charcoal suspension dosing and measured after 30 mins2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
4-Aryl-1-oxa-4,9-diazaspiro[5.5]undecane Derivatives as Dual μ-Opioid Receptor Agonists and σ
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).
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).
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).
AID8002Observed volume of distribution2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID1811134Antinociceptive activity in CD-1 mouse model of partial sciatic nerve ligation-induced neuropathic pain assessed as reduction in allodynia by measuring maximum efficacy at 1.25 mg/kg, ip administered for 10 days2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID1562929Antiallodynic activity in sodium iodoacetate-induced rat model of osteoarthritis assessed as reduction in maximum effect in late phase at 20 ug administered as intrathecal injection measured up to 60 to 90 mins by Von Frey test2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID247014In vivo analgesic effect (sc) assessed as antinociceptive potency by p-phenylquinone writhing test in mice2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
AID765830Activation of mouse MOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay relative to DAMGO2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
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.
AID1811100Displacement of [3H]-(+)-pentazocine from human sigma-1 receptor transfected in HEK293 membranes incubated for 120 mins measured by microBeta scintillation counter method2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID1526833Ratio of unbound maximal portal vein concentration in human at 5 mg, po dosed as immediate release formulation to inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1149090Analgesic activity in po dosed mouse by Nilsen assay1976Journal of medicinal chemistry, Mar, Volume: 19, Issue:3
Optical resolution of (+/-)-2,5-dimethyl-2'-hydroxy-9alpha- and -9beta-propyl-6,7-benzomorphans and their pharmacological properties.
AID1209581Fraction unbound in Sprague-Dawley rat brain homogenates at 5 uM by equilibrium dialysis analysis2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1211697Transactivation of human AhR at 0.1 to 30 uM after 24 to 48 hrs by cell-based luciferase reporter gene assay2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Induction of xenobiotic receptors, transporters, and drug metabolizing enzymes by oxycodone.
AID624608Specific activity of expressed human recombinant UGT1A42000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID239148Displacement of [3H]U-69593 from kappa opioid receptor of rat brain membranes2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
AID1526831Unbound maximal portal vein concentration of in human at 5 mg, po dosed as immediate release formulation2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
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.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
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.
AID1681775Displacement of 3H](+)-pentazocine from human sigma1 receptor expressed in HEK293 cell membranes incubated for 120 mins by liquid scintillation counting method2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
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.
AID1526828Ratio of unbound maximal portal vein concentration in human at 10 mg, po dosed as controlled release formulation to inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1558960Agonist activity at human MOR expressed in CHOK1 cells assessed as stimulation of cAMP accumulation incubated for 45 mins by HTRF assay relative to DAMGO2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
4-Aryl-1-oxa-4,9-diazaspiro[5.5]undecane Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID1562910Selectivity ratio of Ki for displacement of [3H]HS-665 from KOR in guinea pig brain membranes to Ki for displacement of [3H]DAMGO from MOR in Wistar rat brain membranes2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1562906Displacement of [3H]DAMGO from MOR in Wistar rat brain membranes after 60 mins by liquid scintillation analysis2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1562908Displacement of [3H]HS-665 from KOR in guinea pig brain membranes after 60 mins by liquid scintillation analysis2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1526731Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.05 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1562909Selectivity ratio, ratio of Ki for displacement of [3H]Ile5,6-deltorphin-2 from DOR in Wistar rat brain membranes to Ki for displacement of [3H]DAMGO from MOR in Wistar rat brain membranes2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1681742Toxicity in CD1 mouse assessed as inhibition of intestinal transit by measuring percentage of distance traveled by charcoal meal at 20 mg/kg, po2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID765839Selectivity ratio of EC50 for human KOR to EC50 for human MOR2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID1558957Agonist activity at human MOR expressed in CHOK1 cells assessed as stimulation of cAMP accumulation incubated for 45 mins by HTRF assay2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
4-Aryl-1-oxa-4,9-diazaspiro[5.5]undecane Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID246962In vivo analgesic effect (sc) assessed as antinociceptive potency by tail flick test in mice2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
AID1681767Displacement of 3H](+)-pentazocine from human sigma1 receptor expressed in HEK293 cell membranes at 10 uM incubated for 120 mins by liquid scintillation counting method2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID1209583Unbound drug partitioning coefficient, Kp of the compound assessed as ratio of unbound concentration in Sprague-Dawley rat brain to unbound concentration in plasma2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID781328pKa (acid-base dissociation constant) as determined by Luan ref: Pharm. Res. 20052014Pharmaceutical research, Apr, Volume: 31, Issue:4
Comparison of the accuracy of experimental and predicted pKa values of basic and acidic compounds.
AID1562907Displacement of [3H]Ile5,6-deltorphin-2 from DOR in Wistar rat brain membranes after 60 mins by liquid scintillation analysis2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID1558962Displacement of [3H]-(+)-pentazocine from human sigma-1 receptor expressed in HEK293 membranes at 10 uM incubated for 120 mins by liquid scintillation counting method relative to control2020Journal of medicinal chemistry, 03-12, Volume: 63, Issue:5
4-Aryl-1-oxa-4,9-diazaspiro[5.5]undecane Derivatives as Dual μ-Opioid Receptor Agonists and σ
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).
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.
AID1681772Inhibition of human ERG expressed in CHO cells at 10 uM at -80 mV holding potential by whole cell patch clamp assay2020Journal of medicinal chemistry, 12-24, Volume: 63, Issue:24
Discovery of EST73502, a Dual μ-Opioid Receptor Agonist and σ
AID1211696Transactivation of rat PXR at 0.1 to 30 uM after 24 to 48 hrs by cell-based luciferase reporter gene assay2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Induction of xenobiotic receptors, transporters, and drug metabolizing enzymes by oxycodone.
AID1562912Agonist activity at MOR/CB1R/CB2R receptor in Wistar rat brain membranes after 60 mins by [35S]-GTPgammaS binding assay2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID244397Selectivity ratio of binding affinities for kappa versus mu opioid receptors2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
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).
AID1562924Effect on nociception of the contralateral paw in rat model of sodium iodoacetate-induced osteoarthritis paw withdrawal threshold in late phase at 20 ug administered as intrathecal injection measured after 60 to 90 mins by Von Frey test (Rvb = 43 +/- 3.4 2019European journal of medicinal chemistry, Sep-15, Volume: 178Preparation of bivalent agonists for targeting the mu opioid and cannabinoid receptors.
AID514206Displacement of [3H]U69593 from kappa opioid receptor in guinea pig brain membrane2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Morphinans and isoquinolines: acetylcholinesterase inhibition, pharmacophore modeling, and interaction with opioid receptors.
AID765832Activation of human DOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay relative to DPDPE2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID624616Specific activity of expressed human recombinant UGT2B152000Annual review of pharmacology and toxicology, , Volume: 40Human UDP-glucuronosyltransferases: metabolism, expression, and disease.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID604020Unbound drug concentration in Sprague-Dawley rat plasma administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID765836Agonist activity at mouse MOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID1209593Dissociation constant, pKa of the acidic compound by capillary electrophoresis-mass spectrometry analysis2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID244396Selectivity ratio of binding affinities for delta versus mu opioid receptors2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
AID514207Selectivity ratio of Ki for delta opioid receptor in rat brain to mu opioid receptor in rat brain2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Morphinans and isoquinolines: acetylcholinesterase inhibition, pharmacophore modeling, and interaction with opioid receptors.
AID1811137Toxicity in CD-1 mouse assessed as intestinal transit reduction at 10 mg/kg, ip by measuring charcoal distance travel by charcoal meal test2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
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.
AID1811131Analgesic activity in ip dosed CD-1 mouse acute pain model by paw pressure test2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID1526732Substrate activity at human OCT1 expressed in HEK293 cells assessed as increase in compound uptake at 0.1 uM incubated for 2 mins by LC-MS/MS analysis relative to control empty vector transfected cells2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1811101Displacement of [3H]-DAMGO from human MOR expressed in CHO-K1 cell membranes incubated for 60 mins measured by MicroBeta scintillation counter method2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID1211695Transactivation of human PXR transfected in human HepG2 cells assessed as CYP2B6 expression at 1 to 30 uM by luciferase reporter gene assay2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Induction of xenobiotic receptors, transporters, and drug metabolizing enzymes by oxycodone.
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).
AID239089Displacement of [3H]DAMGO from mu opioid receptor of rat brain membranes2005Journal of medicinal chemistry, Jul-28, Volume: 48, Issue:15
Effect of a 6-cyano substituent in 14-oxygenated N-methylmorphinans on opioid receptor binding and antinociceptive potency.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID765831Activation of human KOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay relative to U695932013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID604022Fraction unbound in Sprague-Dawley rat plasma administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID1526751Inhibition of human OCT1 expressed in HEK293 cells assessed as reduction in ASP+ substrate uptake by microplate reader based analysis2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1526752Passive membrane permeability by LC-MS/MS analysis based PAMPA2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
AID1811102Agonist activity at human MOR expressed in CHO-K1 cells assessed as reduction in forskolin-induced cAMP production incubated for 45 mins by by HTRF assay2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
AID765841Agonist activity at human MOR assessed as inhibition of forskolin-stimulated cAMP accumulation after 30 mins by cell based TR-FRET assay2013Bioorganic & medicinal chemistry letters, Sep-01, Volume: 23, Issue:17
Access to 7β-analogs of codeine with mixed μ/δ agonist activity via 6,7-α-epoxide opening.
AID26362Ionization constant (pKa)2004Journal of medicinal chemistry, Feb-26, Volume: 47, Issue:5
Prediction of human volume of distribution values for neutral and basic drugs. 2. Extended data set and leave-class-out statistics.
AID514208Selectivity ratio of Ki for kappa opioid receptor in guinea pig brain to mu opioid receptor in rat brain2010Bioorganic & medicinal chemistry, Jul-15, Volume: 18, Issue:14
Morphinans and isoquinolines: acetylcholinesterase inhibition, pharmacophore modeling, and interaction with opioid receptors.
AID1811132Analgesic activity in CD-1 mouse acute pain model assessed as maximum efficacy at 2.5 to 20 mg/kg, ip by paw pressure test2021Journal of medicinal chemistry, 07-22, Volume: 64, Issue:14
Propionamide Derivatives as Dual μ-Opioid Receptor Agonists and σ
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).
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).
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1211699Transactivation of mouse CAR1 transfected in human HepG2 cells assessed as CYP2B6 expression at 1 to 30 uM after 24 hrs by luciferase reporter gene assay2013Drug metabolism and disposition: the biological fate of chemicals, May, Volume: 41, Issue:5
Induction of xenobiotic receptors, transporters, and drug metabolizing enzymes by oxycodone.
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).
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).
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1526825Unbound Cmax in human at 10 mg, po dosed as controlled release formulation2019Journal of medicinal chemistry, 11-14, Volume: 62, Issue:21
Opioids as Substrates and Inhibitors of the Genetically Highly Variable Organic Cation Transporter OCT1.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (2,667)

TimeframeStudies, This Drug (%)All Drugs %
pre-199098 (3.67)18.7374
1990's119 (4.46)18.2507
2000's542 (20.32)29.6817
2010's1331 (49.91)24.3611
2020's577 (21.63)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials744 (25.73%)5.53%
Reviews215 (7.43%)6.00%
Case Studies282 (9.75%)4.05%
Observational67 (2.32%)0.25%
Other1,584 (54.77%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (436)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Double-blind, Placebo-and Active-Controlled Crossover Study to Evaluate the Intranasal Abuse Potential of PF614 Compared With Immediate-Release Oxycodone and Placebo in Non-Dependent Recreational Opioid Users [NCT05567354]Phase 127 participants (Actual)Interventional2022-06-10Completed
Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery [NCT02238340]Phase 440 participants (Actual)Interventional2012-03-31Completed
Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin [NCT03253133]Phase 119 participants (Actual)Interventional2016-05-10Completed
A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers [NCT01127906]Phase 136 participants (Actual)Interventional2010-06-30Completed
Neurobehavioral Mechanisms of Choice in Opioid Use Disorder [NCT03958474]Early Phase 131 participants (Anticipated)Interventional2019-08-16Recruiting
Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain [NCT00312221]Phase 3418 participants (Actual)Interventional2004-04-30Terminated(stopped due to terminated early for administrative reasons unrelated to safety or efficacy)
Comparison of Analgesic Efficacy of Morphine Sulfate Immediate Release (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet) for Acute Pain in Emergency Department Patients [NCT03088826]Phase 280 participants (Actual)Interventional2017-08-18Completed
Opioid Analgesia for MAB: A Randomized Controlled Trial [NCT03139240]Phase 4172 participants (Actual)Interventional2017-05-01Completed
Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery [NCT03783702]Phase 4118 participants (Actual)Interventional2019-04-04Completed
A Clinical, Multicenter, Randomized, Parallel-group, Double-dummy, Comparative Study of Non-inferiority of the Fixed-dose Combination of Oxycodone 5 mg/Ibuprofen 400 mg From Eurofarma Versus Tylex® (Codeine 30 mg/Paracetamol 500 mg) in the Treatment of Mo [NCT05081102]Phase 3288 participants (Anticipated)Interventional2024-03-31Not yet recruiting
Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial [NCT05795478]264 participants (Anticipated)Interventional2023-04-15Not yet recruiting
Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis [NCT05054868]Phase 140 participants (Anticipated)Interventional2020-04-14Recruiting
Study of Ketorolac Versus Opioid for Pain After Endoscopy (SKOPE): A Double-blinded Randomized Control Trial Comparing Outpatient Analgesic Efficacy of NSAIDs and Opioids in Patients Undergoing Ureteroscopy for Kidney Stones [NCT03888144]Phase 481 participants (Actual)Interventional2017-10-13Completed
Adjunctive Oral Analgesia for Laceration Repair: Assessing Pain in a Pediatric Emergency Department [NCT01268670]150 participants (Anticipated)Interventional2012-07-31Suspended(stopped due to This study is currently suspended due to transition of the investigator.)
Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain [NCT01179828]Phase 3150 participants (Actual)Interventional2010-07-31Completed
Post-operative Pain Control After Photorefractive Keratectomy Comparing Acetaminophen/Codeine vs Acetaminophen/Oxycodone [NCT04399122]Phase 4200 participants (Actual)Interventional2017-03-21Completed
Population Pharmacokinetic-Pharmacodynamic Study of Intravenous Oxycodone in Malaysian Population [NCT02728648]Phase 433 participants (Actual)Interventional2016-04-30Completed
Post Operative Analgesia After Pediatric Hip Surgery - PCA, Epidural or Lumbar Plexus Catheter: A Prospective Randomized Control Trial [NCT03435692]42 participants (Actual)Interventional2011-07-15Terminated(stopped due to Funding was exhausted prior to enrolling intended number of patients.)
Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial [NCT05974501]Phase 484 participants (Anticipated)Interventional2023-09-29Recruiting
[NCT01109511]Phase 485 participants (Actual)Interventional2010-03-01Completed
An Open Study With OXN to Evaluate the Patient Preference for Pain Treatment With Respect to Quality of Life After WHO Stap I or Step II Analgesics for Patients With Moderate to Severe Non-malignant Pain [NCT01167699]Phase 3174 participants (Actual)Interventional2009-06-30Completed
An Exploratory, Randomised, Double-blind, Placebo-controlled, Parallel Group, Pilot Study to Assess the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets (OXN PR) Compared to Placebo in Opioid-naive Subjects Suffering From Severe Pain Due [NCT01197261]Phase 2120 participants (Actual)Interventional2010-09-30Completed
A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets [NCT01100086]Phase 184 participants (Actual)Interventional2007-01-31Completed
A Phase 1, Single-Center, Dose-Escalation Study to Determine the Safety and Pharmacokinetics of a Single Oral Dose of PF614 in Healthy Subjects Compared to OxyContin® [NCT02454712]Phase 164 participants (Actual)Interventional2016-11-16Completed
Magnesium Oral Supplementation to Reduce Pain in Patients With Severe Peripheral Arterial Occlusive Disease: The MAG-PAPER Randomized Clinical Trial [NCT02455726]150 participants (Anticipated)Interventional2015-09-30Not yet recruiting
A Study Examining the Pharmacodynamics Interaction Between Buprenorphine and Fentanyl [NCT03747341]Phase 122 participants (Actual)Interventional2018-03-22Completed
A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty [NCT03789318]Phase 254 participants (Actual)Interventional2018-12-03Completed
Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing: an Exploratory Study in Healthy Volunteers (The Polo Study) [NCT05598905]Phase 424 participants (Anticipated)Interventional2022-10-10Recruiting
Open-Label Parallel Group Flexible Dosing & Titration Study to Evaluate the Efficacy, Safety of Oxycodone/APAP Extended Release Formulation Xartemisxr® in the Management of Post-Operative Pain Following Outpatient Arthroscopic Knee Surgery [NCT02391844]Phase 450 participants (Actual)Interventional2014-05-31Completed
A One-Year, Randomized, Open-Label, Parallel-Group, Multiple-Dose Long-Term Safety Study With Controlled Adjustment of Dose of Tapentadol Extended-Release (ER) and Oxycodone Controlled-Release (CR) in Subjects With Chronic, Painful Diabetic Peripheral Neu [NCT01063868]Phase 347 participants (Actual)Interventional2010-01-31Terminated(stopped due to Business decision)
Avoiding Adverse Opioid Outcomes With Proactive Precision Care Following Cesarean Delivery [NCT05280743]341 participants (Actual)Observational2022-03-28Active, not recruiting
Utility of Pharmacogenomic Testing and Postoperative Dental Pain Outcomes [NCT02932579]Phase 459 participants (Actual)Interventional2017-07-01Terminated(stopped due to Study was halted permanently due to enrollment and logistic issues.)
A Phase 2, Randomized, Open Label, Multiple-Dose, Comparator, Parallel-Group, Safety and Tolerance Study of Buprenorphine Sublingual Spray (0.5 mg TID) Versus Standard of Care Post-Operative Narcotic Therapy for the Treatment of Post-Operative Pain [NCT03254459]Phase 2100 participants (Actual)Interventional2017-09-12Completed
Multimodal Anesthesia and Analgesia for Total Shoulder and Reverse Total Shoulder Arthroplasty: A Randomized Controlled Trial [NCT03586934]Phase 30 participants (Actual)Interventional2018-06-01Withdrawn(stopped due to Difficult to enroll patients for the study)
Abuse Liability of Controlled-Release Oxycodone Formulations [NCT02101840]Phase 411 participants (Actual)Interventional2014-02-28Completed
Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement [NCT03415555]Phase 419 participants (Actual)Interventional2018-02-07Completed
Analgesic Response to Opioid Analgesics in Buprenorphine-Maintained Individuals [NCT02136784]12 participants (Anticipated)Interventional2014-04-30Recruiting
Prospective Controlled Study of Surgical Management of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma [NCT02132416]92 participants (Actual)Interventional2014-05-31Completed
Inhaled PPP001 Versus Immediate-release Oral Opioids for the Management of Breakthrough Pain in Cancer Subjects: a Randomized, Open Label, Crossover, Comparison Study [NCT03564548]Phase 220 participants (Anticipated)Interventional2021-05-26Recruiting
A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery [NCT01374763]Phase 4165 participants (Actual)Interventional2011-07-31Completed
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Se [NCT01358526]Phase 31,095 participants (Actual)Interventional2011-05-31Completed
Influence of Medication on Functional Connectivity [NCT03612713]Early Phase 121 participants (Actual)Interventional2018-10-30Completed
An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water [NCT02165930]Phase 117 participants (Actual)Interventional2014-07-31Completed
A Prospective, Randomized, Blind, Multicentre, Parallel Group Study to Investigate the Efficacy and Safety of Oxycodone Hydrochloride Injection in the Postoperative Pain Relieving Treatment [NCT01304134]Phase 3240 participants (Actual)Interventional2010-03-31Completed
Factors Affecting the Speed of Recovery After Anterior Cruciate Ligament Reconstruction [NCT03770806]48 participants (Actual)Interventional2017-03-24Completed
A Single-site, Randomized, Double-blind, Double-dummy, Active-comparator, Placebo-controlled, 3-way Crossover Trial in Adult Non-dependent Recreational Opioid Users to Compare the Intranasal Abuse Potential of Immediate Release Abuse-deterrent and Standar [NCT03765346]Phase 1123 participants (Actual)Interventional2018-07-24Completed
A Randomized, Double-Blind, Double Dummy, 6-Period, Placebo-Controlled, Crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH), of Belbuca, Oxycodone Hydrochloride (HCl) and Placebo in Recreational Opioid Users [NCT03996694]Phase 119 participants (Actual)Interventional2019-07-23Completed
Ambulatory Gynecologic Surgery: Finding the Optimal Postoperative Opioid Prescription [NCT03588910]Phase 2120 participants (Actual)Interventional2018-08-08Completed
Clinical Research of the Prognostic Influence of NSAIDS's Anti-inflammatory Effect on Senior Patients With Hip Fracture [NCT01583660]800 participants (Anticipated)Observational2012-01-31Recruiting
Use of Oxycodone in Multimodel Perioperative Analgesia of Bariatric Surgery and Its Effect on Inflammatory Factors [NCT05515822]Phase 490 participants (Anticipated)Interventional2022-10-01Not yet recruiting
The Effect of Oxycodone Hydrochloride on Catheter-related Bladder Discomfort After TURBT Under General Anesthesia [NCT05510986]196 participants (Anticipated)Interventional2022-10-01Not yet recruiting
Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia [NCT03120962]140 participants (Anticipated)Interventional2017-05-31Not yet recruiting
A Comparison of Analgesic and Respiratory Effects From Tapentadol Versus Oxycodone After Laparoscopic Hysterectomy. [NCT03314792]Phase 486 participants (Actual)Interventional2017-12-04Completed
Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery [NCT05488847]Phase 480 participants (Anticipated)Interventional2022-06-25Recruiting
Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in Female Patients Before Anesthesia Induction [NCT04396587]Phase 480 participants (Actual)Interventional2020-05-20Completed
A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Effects of Q8003 to the Morphine-Equivalent Doses of Oxycodone and of Morphine on the Opioid-Related Adverse Events of Moderate to Severe Nausea, Emesis, and Dizziness in Subjects Wi [NCT01280331]Phase 3375 participants (Actual)Interventional2011-01-31Completed
An Open-Label Pilot Study of the Analgesic Efficacy and Safety Of Q8003 and of the Conversion From IV Morphine PCA Analgesia to Q8003 or to Percocet® in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty or Total Hip Arthroplasty [NCT00818493]Phase 244 participants (Actual)Interventional2009-02-28Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Arm, Multicenter Study in Subjects With End-Stage Joint Disease to Compare the Frequency of Constipation Symptoms in SubjectsTreated With Tapentadol IR and Oxycodone IR Using a Bowel Fun [NCT00784277]Phase 3597 participants (Actual)Interventional2008-10-31Completed
A Double-Blind, Randomized, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of the Opioid Combination Q8003 to Each of the Individual Milligram Components (Oxycodone and Morphine) in the Management of Acute Moderate to Severe Pa [NCT00831051]Phase 2197 participants (Actual)Interventional2008-12-31Completed
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of an Immediate Release Test Tablet Formulation of Oxycodone Hydrochloride (30 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Pr [NCT00853216]Phase 138 participants (Actual)Interventional2003-01-31Completed
"GREAT (Good Response With Appropriate Treatment) Factors Influencing the Analgesic Response Over Time of the Oxycodone-Naloxone Association in Painful Cancer Patients" [NCT02293785]200 participants (Actual)Observational2014-11-30Completed
Randomised, Double-blind, Double-dummy, Cross-over Multicenter Study to Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Taking Oxycodone Equivalents of 120 & 160 mg Per Day as Achieved With the Higher OXN PR Tablet Strengths (OXN60/30 mg PR [NCT02321397]Phase 2/Phase 3155 participants (Actual)Interventional2014-11-30Completed
Use of a Non-Opioid Pain Regimen for Post-Operative Analgesia Following Intracapsular Adenotonsillectomy [NCT04791761]Phase 1/Phase 2300 participants (Anticipated)Interventional2021-04-13Recruiting
An Open-label, Single Centre Prospective Cohort Study to Determine the Effectiveness and Safety of Targin® for Pain Management and Opioid-induced Constipation in Patients With Spinal Cord Injury: Can we Improve Pain and Ameliorate Secondary Complications [NCT03179475]Phase 41 participants (Actual)Interventional2019-09-05Completed
A Phase 1b, Randomized 2-Part Single-Center Study to Evaluate the PK and Safety of Multiple Ascending Oral Doses of PF614 and the Food Effect and BA/BE of Single Oral Doses of PF614 Relative to OxyContin in Healthy Adult Subjects [NCT05043766]Phase 184 participants (Actual)Interventional2021-09-08Completed
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
Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study [NCT04448457]72 participants (Actual)Interventional2017-09-01Completed
Neurotoxic Adverse Effects of Morphine and Oxycodone in Continuous Subcutaneous Infusion for Treatment of Pain in Terminal Patients With Diminished Renal Function: a Randomized Controlled Trial [NCT03616639]Phase 48 participants (Actual)Interventional2018-06-04Terminated(stopped due to Insufficient inclusion of subjects)
Are Narcotic Pain Medications Necessary Following Thyroidectomy and Parathyroidectomy [NCT03640247]Phase 1126 participants (Actual)Interventional2018-11-15Completed
A COMPARATIVE STUDY BETWEEN TWO PHARMACOLOGICAL ASSOCIATIONS OXYCODONE/NALOXONE AND CODEINE / PARACETAMOL IN TREATMENT OF MODERATE-SEVERE CHRONIC PAIN DUE TO OSTEOARTHRITIS OF KNEE AND/OR HIP [NCT02032927]Phase 40 participants (Actual)Interventional2013-06-30Withdrawn
Effects of Perioperative Intravenous Dexamethasone in Clinical Outcomes After Total Knee Arthroplasty in a Hispanic Population: A Randomized Controlled Trial [NCT06042426]Phase 4100 participants (Anticipated)Interventional2023-09-30Not yet recruiting
The Effects of Single Dose Oxycodone Versus Sufentanil on Pain and Inflammatory Response After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Randomized Controlled Study [NCT06041425]Phase 440 participants (Anticipated)Interventional2023-08-07Recruiting
Understanding Opioid Use Before and After Surgery in Norway: A Prospective Multicenter Study and Randomized Double-blind Controlled Study [NCT05639712]Phase 41,000 participants (Anticipated)Interventional2022-12-13Recruiting
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants [NCT03511118]1,600 participants (Anticipated)Observational2018-10-04Recruiting
A Randomized, Open Label,Prospective Study of the Analgesic Efficacy of Oral Xartemis Compared to Generic Oxycodone/APAP (Acetaminophen) in the Treatment of Moderate to Severe Post Operative Pain [NCT02101476]Phase 4114 participants (Actual)Interventional2014-05-31Completed
Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints [NCT05846451]Early Phase 116 participants (Anticipated)Interventional2023-06-01Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Double-Dummy, Single-Dose,4-Way Crossover Study With Exploratory Fifth Treatment to Determine the Relative Nasal Abuse Potential of PTI-821 (Oxycodone Extended-Release Capsules) [NCT03475862]Phase 138 participants (Actual)Interventional2017-05-15Completed
Comparison of Controlled-release Oxycodone to Control Chemoradiotherapy-induced Moderate or Severe Oral Mucositis Pain in Nasopharyngeal Carcinoma Patients [NCT03045484]70 participants (Anticipated)Interventional2016-05-31Recruiting
[NCT01366014]Phase 2157 participants (Actual)Interventional2011-06-30Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of JNJ-42160443 as Monotherapy in Subjects With Moderate to Severe, Chronic Knee Pain From Osteoarthritis [NCT01094262]Phase 2196 participants (Actual)Interventional2010-04-20Terminated(stopped due to Logistic reasons associated with the FDA-imposed clinical hold.)
A Randomized, Double-Blind, Multi-Center, Repeat-Dose, Comparison of the Analgesic Efficacy and Safety of Q8003 With Oxycodone and Morphine for the Management of Acute Moderate to Severe Postoperative Pain Following Bunionectomy Surgery [NCT01016808]Phase 3522 participants (Actual)Interventional2009-12-31Completed
Efficacy and Safety of Opioid Rotation Compared With Opioid Dose Escalation in Patients With Moderate to Severe Cancer Pain - Open Label, Randomized, Prospective Study [NCT02084355]Phase 3136 participants (Anticipated)Interventional2014-04-30Not yet recruiting
A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures. [NCT02094807]0 participants (Actual)Interventional2014-04-30Withdrawn(stopped due to Slow inclusion rate. Awaiting results from NCT02132416.)
Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study [NCT02110719]Phase 4138 participants (Actual)Interventional2014-03-31Completed
An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study To Estimate The Effects Of Food On Oxycodone Pharmacokinetics Following Oral Administration Of 40 Mg Doses Of Pf 00345439 Formulation K Taken Whole Or After Chewing In Healthy Volunteers [NCT02117583]Phase 134 participants (Actual)Interventional2014-04-30Completed
A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Structured Opioid Discontinuation Versus Continued Opioid Therapy in Suboptimal and Optimal Responders to High-dose Long-term Opioid Analgesic Therapy for Chronic Pain. [NCT02741076]Phase 444 participants (Actual)Interventional2016-09-14Terminated(stopped due to Inability to recruit sufficient no. of subjects over an acceptable time period)
Oxycodone Concentration in the Blood After Oral Premedication [NCT03386318]20 participants (Actual)Observational2019-01-01Completed
Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair [NCT05974423]Phase 460 participants (Anticipated)Interventional2022-12-16Enrolling by invitation
Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial [NCT03364088]402 participants (Actual)Interventional2016-10-03Completed
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate Improvement of Symptoms of RLS in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms Who Take OXN PR Compared to Subjects Taking Placebo (P [NCT01112644]Phase 3205 participants (Actual)Interventional2010-04-30Completed
Comparison of Oxycodone and Sufentanil for Analgesic Efficacy After Hip Surgery: a Prospective, Multicenter Randomized Controlled Trial [NCT03685188]Phase 4570 participants (Anticipated)Interventional2018-12-01Enrolling by invitation
Nausea in Patients Receiving Hydromorphone vs Oxycodone After Total Hip Replacement Surgery [NCT02295124]Phase 4200 participants (Actual)Interventional2012-08-31Completed
Oxycodone (10, 20 mg) in a Postoperative Dressing in Patients After Surgical Debridement of Burn Wounds. A Prospective, Double-blinded, Randomized, Controlled Trial. [NCT06142591]Phase 420 participants (Actual)Interventional2016-01-01Completed
A Randomized, Open-Label Study to Assess the Pain, Toxicity, and Quality of Life Effects of Adding Venlafaxine to the Pain Management Regimen for Patients Treated With Chemoradiation for Head and Neck Cancer [NCT03574792]62 participants (Actual)Interventional2018-05-03Completed
An Open Study to Observe OXN Treatment for Patients With Moderate to Severe Non-malignant Pain [NCT01167127]Phase 3113 participants (Actual)Interventional2009-06-30Completed
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion: a Randomized Controlled Trial [NCT03480009]Phase 3156 participants (Actual)Interventional2018-07-28Completed
Multi-Modal Pain Management After Outpatient Orthopaedic Surgery: A Prospective Randomized Trial [NCT05154682]Phase 3200 participants (Anticipated)Interventional2021-11-30Enrolling by invitation
A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty [NCT03845881]Early Phase 145 participants (Actual)Interventional2019-04-10Completed
An Exploratory, Single-Dose, Double-Blind, Randomized, Placebo-Controlled Crossover Study to Evaluate The Subjective and Objective Effects of Extended-Release Oxymorphone Compared to Controlled-Release Oxycodone in Healthy Non-Dependent Recreational Opioi [NCT00955110]Phase 478 participants (Actual)Interventional2009-06-30Completed
The Effect of Multimodal Pain Therapy After Hernia Repair [NCT03792295]Phase 20 participants (Actual)Interventional2021-07-01Withdrawn(stopped due to no enrollment, reallocation of resources)
A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers [NCT01568450]Phase 124 participants (Actual)Interventional2012-03-31Completed
Pain Management in Outpatient Urologic Procedures [NCT03393364]Early Phase 1150 participants (Actual)Interventional2018-04-01Completed
A Randomized, Placebo- and Active-Controlled, Double-Blind, Single and Multiple Ascending Dose Study in Healthy Adults to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of KP-1199 [NCT03880487]Phase 126 participants (Actual)Interventional2019-03-12Terminated(stopped due to The Study was terminated early by sponsor)
Randomized Clinical Trial of Non-Opioid Pain Medications After Adenotonsillectomy [NCT03618823]Phase 1/Phase 2268 participants (Actual)Interventional2018-10-25Terminated(stopped due to Early termination due to COVID-19 cases and cancelled surgeries.)
Comparing the Efficacy of Five Oral Analgesics for Treatment of Acute Musculoskeletal Extremity Pain in the Emergency Department [NCT03173456]Phase 2600 participants (Actual)Interventional2017-11-28Completed
A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy [NCT03599089]Phase 2147 participants (Actual)Interventional2018-07-09Completed
Phase II Study of Change the Dose Frequency of Controlled-Release Oxycodone to Refractory Pain [NCT03639415]Phase 40 participants (Actual)Interventional2018-10-30Withdrawn(stopped due to There is no fund to support)
The Effect of General Anesthesia on Pharmacokinetics and Pharmacogenomics of Liquid Oxycodone in Pediatric Surgical Patients [NCT03054831]Phase 440 participants (Anticipated)Interventional2019-07-08Recruiting
Optimal Dose of Intravenous Oxycodone for Attenuation of Hemodynamic [NCT02484352]Phase 495 participants (Actual)Interventional2015-07-31Completed
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of an Immediate Release Test Tablet Formulation of Oxycodone Hydrochloride (30 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Pr [NCT00853736]Phase 123 participants (Actual)Interventional2003-02-28Completed
Efficacy of Oxycodone-propofol Combination Compared With a Fentanyl-propofol Combination on Conscious Sedation Effect and Early Cognitive Function During Therapeutic Endoscopic Retrograde Cholangio-pancreatography:a Prospective,Randomized, Single- Blinded [NCT03755609]100 participants (Anticipated)Interventional2018-06-01Recruiting
Prescription After Cesarean Trial [NCT04296396]Phase 35,521 participants (Actual)Interventional2020-09-21Completed
Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain [NCT01344720]Phase 4250 participants (Anticipated)Interventional2011-05-31Not yet recruiting
A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets to OxyContin® 80-mg Tablets [NCT01101178]Phase 179 participants (Actual)Interventional2007-08-31Completed
A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 40-mg Tablets to OxyContin® 40-mg Tablets [NCT01100320]Phase 188 participants (Actual)Interventional2007-01-31Completed
Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain [NCT01264965]Phase 425 participants (Actual)Interventional2011-01-31Terminated(stopped due to recruitment problems)
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO AND OXYCODONE CONTROLLED MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP [NCT00985621]Phase 3614 participants (Actual)Interventional2009-10-30Terminated(stopped due to See termination reason in detailed description.)
[NCT02536209]Phase 120 participants (Actual)Interventional2015-08-31Completed
Evaluation of Fentalogs and Their Metabolites in Hair of Patients in a Monitored Clinical Context by Means of Hair Analysis [NCT05740657]225 participants (Anticipated)Observational [Patient Registry]2022-12-06Recruiting
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
A Single-Center, Randomized, Double-Blind, Active- and Placebo-Controlled Crossover Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse [NCT00734461]Phase 214 participants (Actual)Interventional2007-08-31Completed
Cognitive Function and Addiction in Patients With Chronic Pain Under Opioid Tapering in a Multidisciplinary Pain Treatment [NCT03365817]Phase 375 participants (Actual)Interventional2009-02-02Completed
A Comparative Study of Immediate-Release Oxycodone Capsules Versus Immediate-Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain. [NCT01675622]Phase 3242 participants (Actual)Interventional2011-01-31Completed
Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty. A Double Blinded Randomized Controlled Study. Tapentadol vs Oxycodone vs Placebo [NCT02604446]Phase 3134 participants (Actual)Interventional2015-09-30Completed
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures [NCT05076110]Phase 4188 participants (Anticipated)Interventional2022-04-07Recruiting
Efficacy of the Anterior Quadratus Lumborum Block Versus the Transversus Abdominis Plane Block for Elective Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial [NCT03023462]60 participants (Actual)Interventional2019-09-05Completed
An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study Of 40 Mg Doses Of Pf-00345439 To Evaluate The Bioequivalence Of Modified Formulation K Vs. Original Formulation X Under Intermediate-Fat Fed Conditions And To Estimate Relative Bioavailabil [NCT02059915]Phase 1134 participants (Actual)Interventional2014-04-30Completed
An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study [NCT01369615]Phase 323 participants (Actual)Interventional2011-10-31Completed
Influence of Oxycodone on Individuals Taking an SSRI [NCT05730062]Phase 155 participants (Anticipated)Interventional2023-03-15Not yet recruiting
Clinical Trial Simulation Using ODE/PDE Hemodialysis Model for Quantifying Oxycodone's Removal in End-Stage Kidney Disease [NCT02452437]Phase 420 participants (Anticipated)Interventional2015-05-31Recruiting
Comparison of the Effects of Oxycodone Versus Fentanyl on Airway Reflex to Tracheal Extubation and Postoperative Pain During Recovery of Anesthesia After Laparoscopic Cholecystectomy [NCT03204045]90 participants (Actual)Interventional2017-02-01Completed
An Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Dose Proportionality of 5 Mg, 20 Mg and 40 Mg of PF-00345439 Formulation K Under Intermediate-fat Fed Conditions in Healthy Volunteers [NCT02089295]Phase 118 participants (Actual)Interventional2014-04-30Completed
A Multicenter, Randomized, Phase IIa/IIb Clinical Trial of 3D1002 Combined With Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Patients With Moderate to Severe Cancer Pain [NCT05265052]Phase 2177 participants (Anticipated)Interventional2024-09-30Not yet recruiting
Individualising Drug Therapy in Neonates Using Pharmacogenomic Profiling, Population Based Modeling and Simulations [NCT02426463]Phase 480 participants (Anticipated)Interventional2015-04-20Completed
Randomized Comparison of Two Pre-induction Analgesia Regimens: Multimodal vs Acetaminophen in the Reduction of Post-operative Pain Following Ureteroscopy With Lithotripsy for Kidney Stones Evaluated With Text Messaging [NCT03549611]Phase 40 participants (Actual)Interventional2018-08-01Withdrawn(stopped due to elected not to proceed with the study)
Analysis of Analgesia Regimens During Concurrent Chemoradiation for Head and Neck Cancer: A Pilot Study [NCT02531906]Phase 160 participants (Actual)Interventional2015-04-24Completed
Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients [NCT02160301]Phase 40 participants (Actual)Interventional2017-11-30Withdrawn(stopped due to Insufficient infrastructure/funding for enrollment)
A Long Term, Open-Label, Multi-Center Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain [NCT03176121]Phase 473 participants (Actual)Interventional2016-10-31Completed
An Interventional, Open Label, and Randomized Controlled Study to Compare the Titration Efficacy and Safety of Control-released Oxycodone and Immediate-released Oxycodone in Opioid-naive Patients With Moderate to Severe Cancer Pain [NCT03176199]Phase 430 participants (Actual)Interventional2016-09-01Completed
Assessing the Impact of the Number of Opiates Prescribed on Post Cesarean Pain Control: A Randomized Controlled Trial [NCT03175653]0 participants (Actual)Interventional2017-06-16Withdrawn(stopped due to Feasibility - could not operationalize prior to PI leaving the institution.)
A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists in Physically Dependent Opioid Users With Moderate-to-Severe Opioid Use Disorder [NCT03389750]Phase 216 participants (Actual)Interventional2018-03-15Completed
"ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial" [NCT03987022]Phase 466 participants (Actual)Interventional2019-08-01Completed
A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Subjects With Moderate to Severe Chronic Low Back Pain [NCT00449176]Phase 3981 participants (Actual)Interventional2007-02-28Completed
Dexmedetomidine-esketamine Combined With Oxycodone for Ultrasound-guided Percutaneous Radiofrequency Ablation in Patients With Liver Cancer: a Randomized Controlled Study [NCT06003218]88 participants (Anticipated)Interventional2023-10-16Recruiting
The Effect of NSAIDs After a Rotator Cuff Repair Surgery. A Prospective Randomized Controlled Trial [NCT02153177]Phase 40 participants (Actual)Interventional2015-01-31Withdrawn(stopped due to The study was withdrawn prior to any participants being enrolled.)
Oxycodone Pharmacokinetics in Preterms, Infants and Children [NCT02564003]79 participants (Actual)Observational2012-06-30Completed
Norspan Versus Oxycontin as Postoperative Painkiller to Proximal Extracapsular Fractures of the Femur [NCT00964808]Phase 476 participants (Actual)Interventional2009-09-30Completed
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty [NCT04003350]216 participants (Actual)Interventional2017-12-21Completed
A Randomized, Double-Blind, Active-Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Compared With Immediate-release Oxycodone for the Management of Breakthrough Pain in Opioid-Tolerant Patient With Chronic Pain [NCT00463047]Phase 3323 participants (Actual)Interventional2007-07-31Completed
A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Trial, With Controlled Adjustment of Dose, of Multiple Doses of CG5503 PR and Oxycodone CR in Subjects With Chronic Pain [NCT00361504]Phase 31,123 participants (Actual)Interventional2006-11-30Completed
Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial [NCT05327777]Phase 4129 participants (Actual)Interventional2019-11-01Completed
Comparison of Tramacet Versus Percocet in Post Surgical Patients [NCT02361567]Phase 4160 participants (Actual)Interventional2015-04-30Completed
The Safety and Efficacy of Epidural Oxycodone [NCT02573909]Phase 4100 participants (Anticipated)Interventional2015-01-01Active, not recruiting
A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 10-mg [NCT01101308]Phase 155 participants (Actual)Interventional2008-07-31Completed
Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery [NCT02732262]Phase 3134 participants (Actual)Interventional2016-04-30Completed
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients [NCT02044497]Phase 468 participants (Anticipated)Interventional2014-05-31Recruiting
Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial [NCT02600247]100 participants (Anticipated)Interventional2015-11-30Not yet recruiting
Preoperative Controlled-Release Oxycodone or Intraoperative Morphine As Transition Opioid After Intravenous Anesthesia For Video-Assisted Thoracic Surgery: a Randomized, Double-blind, Controlled Trial. [NCT00681174]Phase 422 participants (Actual)Interventional2008-07-31Terminated(stopped due to Failure to enroll sufficient patients by expected deadline.)
Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery - AGE AWARE II [NCT04696445]34 participants (Actual)Observational2020-10-01Completed
A Single Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Solution is Co-Administered With Nafamostat, as an Immediate Release Solution and/or Extended Release (ER) Capsule Formulations in Healthy Subjects [NCT05090280]Phase 1111 participants (Actual)Interventional2021-12-01Active, not recruiting
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain [NCT02824276]Phase 135 participants (Actual)Interventional2017-01-06Active, not recruiting
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs [NCT04278404]5,000 participants (Anticipated)Observational2020-03-05Recruiting
Randomised, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee [NCT00902837]Phase 3181 participants (Actual)Interventional2009-05-31Completed
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS) [NCT00414453]Phase 419 participants (Actual)Interventional2007-01-31Terminated(stopped due to Did not reach enrollment goals)
Modulation of Opioid Effects by Garlic Supplements [NCT00499460]Phase 415 participants (Actual)Interventional2006-11-30Completed
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate Release Formulation in the Treatment of Acute Pain From Total Hip Replacement Surgery F [NCT00364533]Phase 3367 participants (Actual)Interventional2006-10-31Terminated(stopped due to Slow enrollment)
Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions: A Randomized, Double-blinded, Controlled Trial [NCT04112550]Phase 1150 participants (Anticipated)Interventional2020-02-11Not yet recruiting
A Double Blind, Active Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for the Management of Breakthrough Pain in Opioid Tolerant Patients With Chronic Pain [NCT00813488]Phase 3213 participants (Actual)Interventional2008-12-31Completed
NanaBis™ an Oro-buccal Administered Equimolar d9-THC & CBD Formulation as Monotherapy for Management of Opioid Requiring Bone Pain Due to Metastatic Cancer: Phase 3 Multi Centre Blinded Randomized Withdrawal Active & Placebo Controlled Trial [NCT04808531]Phase 3360 participants (Anticipated)Interventional2023-11-30Not yet recruiting
The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain [NCT01016821]15 participants (Anticipated)Interventional2009-11-30Completed
Study of Efficacy of OXN PR, Compared to Oxy PR, for Reduction of Intensity of Opioid-induced Constipation Symptoms in Pts Treated for Cancer or Non-cancer Pain: A Randomised, Double-blind, Controlled, Multicentre Study [NCT01014559]Phase 3225 participants (Actual)Interventional2010-02-28Terminated(stopped due to Lack of recruitment)
A Randomized Double-blind, Placebo- and Active-control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarth [NCT00486811]Phase 3990 participants (Actual)Interventional2007-06-30Completed
Chronic Administration of Opioids in Cancer Chronic Pain:an Open Prospective Study on Efficacy, Safety and Pharmacogenetic Factors Influence. [NCT00916890]Phase 4320 participants (Anticipated)Interventional2009-02-28Suspended(stopped due to difficulties in patients enrolment)
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacodynamics And Pharmacokinetics of TRV734 in Healthy Adult Male and Female Subjects [NCT02211625]Phase 175 participants (Actual)Interventional2014-07-31Completed
A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery [NCT04015908]Phase 4100 participants (Actual)Interventional2019-08-01Completed
A Randomized, Double-Blind, Placebo- and Oxycodone Immediate Release (IR)-Controlled Study of Tapentadol IR for the Treatment of Acute Pain Caused by Vertebral Compression Fractures Associated With Osteoporosis [NCT00771758]Phase 3108 participants (Actual)Interventional2008-09-30Completed
A Comparative Study With Pre-Emptive Parenteral Oxycodone, Morphine and Dexamethasone in the Treatment of Postoperative Pain in Paediatric Patients 4 to 12 Years of Age [NCT00733083]100 participants (Anticipated)Interventional2008-09-30Not yet recruiting
An Open-label Phase 3 Trial to Evaluate the Safety and Tolerability of Egalet ADER Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Noncancer Pain [NCT02603705]Phase 3281 participants (Actual)Interventional2016-03-07Completed
A Randomized, Double-Blind, Multi-Center, Parallel-Group Study of Tapentadol Immediate Release (IR) Versus Oxycodone IR for the Treatment of Subjects With Acute Post-Operative Pain Following Elective Arthroscopic Shoulder Surgery [NCT00814580]Phase 3382 participants (Actual)Interventional2008-12-31Completed
An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Op [NCT01192295]Phase 3155 participants (Actual)Interventional2010-11-30Completed
A Phase 2a, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of ADL5859 and ADL5747 in Subjects With Moderate to Severe Pain Due to Osteoarthritis of the Knee [NCT00979953]Phase 2408 participants (Actual)Interventional2009-10-31Completed
Multimodal Analgesia With NSAID vs. Narcotics Alone After Shoulder Instability Surgery [NCT04018768]80 participants (Actual)Observational2017-12-01Completed
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery [NCT02573922]Phase 4180 participants (Actual)Interventional2012-05-31Completed
Effectiveness of Quadratus Lumborum Block After Nephrectomy [NCT03529201]105 participants (Actual)Interventional2018-05-07Completed
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Fasting Conditions [NCT00864526]Phase 140 participants (Actual)Interventional2006-10-31Completed
Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments [NCT04155229]104 participants (Actual)Interventional2016-10-03Completed
A Randomized, Double-Blind, Active Controlled, Multi-center Study to Investigate the Safety and Efficacy of OROS Hydromorphone HCl Once-daily Compared With Oxycodone HCL Controlled-release Twice Daily in Subjects With Cancer Pain [NCT01205126]Phase 3260 participants (Actual)Interventional2009-12-31Completed
An Exploratory, Randomised, Double-blind, Single-dummy, Placebo Controlled, Parallel Group Study to Demonstrate the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Addition to Pregabalin Compared to Pregabalin Alone in Opioid-naïve S [NCT00944697]Phase 298 participants (Actual)Interventional2009-07-31Completed
Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation [NCT04310579]Phase 155 participants (Actual)Interventional2020-06-15Completed
A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets to OxyContin® 80-mg Tablets [NCT01101191]Phase 184 participants (Actual)Interventional2007-08-31Completed
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-Fasting Conditions [NCT00864357]Phase 140 participants (Actual)Interventional2006-10-31Completed
Towards Enhanced Recovery After Cesarean: Scheduled Post-operative Medication: a Randomized Controlled Trial [NCT04612920]Early Phase 133 participants (Actual)Interventional2020-12-12Completed
Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy: A Randomized Controlled Trial [NCT05597878]Phase 2/Phase 3100 participants (Anticipated)Interventional2023-04-18Recruiting
Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia for Postoperative Pain Control, Placebo-controlled RCT, 2021 [NCT05389813]Phase 2/Phase 3150 participants (Anticipated)Interventional2021-08-15Enrolling by invitation
A Prospective, Multi-center, Observational Registry of Patients Using Prescription Medications Containing Oxycodone Immediate Release for the Treatment of Pain [NCT00978328]827 participants (Actual)Observational2009-06-30Completed
A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction [NCT00941304]Phase 2153 participants (Actual)Interventional2009-08-31Completed
An Open, Multi-centre, Non-comparative Observational Study to Assess the Safety and Tolerability of Oxycodone Injection 50 mg/mL as a Subcutaneous Infusion in Patients With Severe Cancer Pain. [NCT00626600]Phase 333 participants (Actual)Interventional2008-05-31Terminated(stopped due to Lack of recruitment)
Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction [NCT03893175]Phase 186 participants (Actual)Interventional2019-05-10Completed
Visceral Pain Originating From the Upper Urinary Tract - a Randomized Controlled Trial on the Effect of Morphine and Oxycodone in Patients Undergoing Percutaneous Nephrolithotomy (PCNL) [NCT00784472]Phase 355 participants (Actual)Interventional2008-12-31Completed
A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain [NCT00315445]Phase 3134 participants (Actual)Interventional1997-12-31Completed
A Randomized Withdrawal, Double-blind, Placebo-controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Egalet® Abuse-deterrent, Extended-release (ADER) Oxycodone Tablet, Egalet-002, in Patients With Moderate-to-Severe Chronic Low Back Pain [NCT02716857]Phase 3549 participants (Actual)Interventional2016-03-31Completed
A Randomized, Double-blind, Triple-dummy, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Pf-00345439 (Oxycodone Extended Release Capsules) Compared To Immediate-release Oxycodone And Placebo When Admini [NCT01986283]Phase 167 participants (Actual)Interventional2013-11-30Completed
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of an Immediate Release Test Tablet Formulation of Oxycodone Hydrochloride (15 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Pr [NCT00853320]Phase 138 participants (Actual)Interventional2003-02-28Completed
A Phase IV Study to Evaluate the Pharmacokinetics and Safety of Oxycodone Oral Solution in Pediatric and Adolescent Subjects [NCT01959204]Phase 497 participants (Actual)Interventional2013-10-14Completed
The Utilization of Opioid Medication Following ACL Reconstruction [NCT04278703]192 participants (Anticipated)Interventional2019-02-15Enrolling by invitation
[NCT00801788]Phase 116 participants (Actual)Interventional2008-09-30Completed
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Tapentadol Immediate-Release Formulation in the Treatment of Acute Pain From Bunionectomy [NCT00613938]Phase 3901 participants (Actual)Interventional2008-02-29Completed
A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy [NCT02541396]Phase 272 participants (Actual)Interventional2015-10-31Completed
The Safety of Fentanyl TAIFUN Treatment After Titrated Dose Administration and the Current Breakthrough Pain Treatment for Breakthrough Pain in Cancer Patients [NCT00822614]Phase 3500 participants (Anticipated)Interventional2008-12-31Recruiting
A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial With Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Patients With Moderate to Severe Chronic Pain Due to Osteoarthr [NCT00421928]Phase 31,030 participants (Actual)Interventional2007-01-31Completed
Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuou [NCT00261495]Phase 3504 participants (Actual)Interventional2006-03-31Completed
A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain [NCT00313014]Phase 3660 participants (Actual)Interventional2004-02-29Terminated(stopped due to Terminated early due to administrative reasons unrelated to efficacy or safety.)
A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fed Bioequivalence of Oxycodone Tamper Resistant (OTR) 10-mg Tablets to OxyContin® 10-mg Tablets [NCT01099709]Phase 185 participants (Actual)Interventional2007-01-31Completed
A Randomized, Double-blind, Double-dummy, Parallel-group, Multicenter Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Non-malignant Pain Taking Oxycodone Equivalent of ≥10 mg/Day and ≤50 mg/Day as Oxycodone [NCT01918098]Phase 3230 participants (Actual)Interventional2013-09-01Completed
An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to P [NCT01924676]Phase 118 participants (Actual)Interventional2013-08-31Completed
Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine [NCT01939379]0 participants (Actual)Interventional2013-09-30Withdrawn(stopped due to PI left institution. Efforts made to contact PI unsuccessful. No study data available.)
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain [NCT01946555]150 participants (Actual)Observational2013-09-30Completed
A Randomsied, Double-blind, Double-dummy, Parallel-group Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of 60-80 mg/Day as Oxycodone/Naloxone Prolonged Release Compa [NCT00412100]Phase 30 participants Interventional2006-04-30Completed
[NCT01971632]Phase 3463 participants (Actual)Interventional2005-01-31Completed
The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study. [NCT01983137]1,338 participants (Actual)Observational2011-04-30Completed
A Randomized, Multicenter, Single-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Immediate Release Hydrocodone/Acetaminophen (NORCO®) to Placebo in Subjects With Acute Pain Following [NCT00404222]Phase 290 participants (Actual)Interventional2005-11-30Completed
Reducing the Abuse Liability of Prescription Opioids [NCT04587115]Early Phase 115 participants (Actual)Interventional2017-06-16Completed
Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures [NCT00254631]Phase 465 participants (Actual)Interventional2007-04-30Completed
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy [NCT04429022]Phase 368 participants (Actual)Interventional2020-11-24Completed
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty [NCT03859024]Phase 460 participants (Actual)Interventional2019-03-22Completed
Effects of Cannabis on Prescription Drug Abuse Liability and Analgesia [NCT03679949]Phase 126 participants (Actual)Interventional2019-04-01Active, not recruiting
A Comparison of the Analgesic Efficacy of Oral Opioid Medication vs. Injected Local Anesthetic in Emergency Department Patients With Toothache [NCT02862691]Phase 22 participants (Actual)Interventional2016-08-01Terminated(stopped due to Difficulty recruiting patients)
Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Thai Pediatric Surgical Patients : a Pilot Study [NCT03145272]Phase 420 participants (Actual)Interventional2018-10-08Active, not recruiting
A Phase 1 Double-Blind, Double-Dummy, Parallel-Group, Randomized, Positive Control Study Using fMRI to Evaluate the Effect of NKTR-181 on Brain Activity in Healthy, Non-physically Dependent Recreational Opioid Users [NCT03802227]Phase 18 participants (Actual)Interventional2018-10-22Terminated(stopped due to Sponsor Decision)
A Comparison of Nausea and Vomiting in Postoperative Paediatric Patients With Patient-controlled Analgesia (PCA): Morphine vs Oxycodone (POPCORN) [NCT06186141]Phase 4690 participants (Anticipated)Interventional2024-01-31Not yet recruiting
An Open-label Study to Characterize the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release (ORF) Tablets in Pediatric Patients Aged 6 to 16 Years Inclusive, Who Require Opioid Analgesia [NCT01160614]Phase 130 participants (Actual)Interventional2010-07-31Completed
Impact of Tramadol and Oxycodone on Sleep Apnea [NCT03454217]Phase 460 participants (Actual)Interventional2018-03-01Completed
Comparison of Epidural Oxycodone and Epidural Morphine for Post Caesarean Section Analgesia: a Randomised Controlled Trial [NCT02277678]Phase 3100 participants (Actual)Interventional2013-08-31Completed
A Randomised, Double-blind, Parallel Group Multicentre Study to Demonstrate Non-inferiority of the Analgesic Efficacy of Oxycodone/Naloxone 10/5 or 20/10 mg Prolonged Release Tablets (OXN PR) BID Compared to Oxycodone 10 or 20 mg Prolonged Release Tablets [NCT01083485]Phase 4137 participants (Actual)Interventional2010-03-31Completed
Randomized Trial of Two Analgesics in Elderly ED Patients [NCT02703610]Phase 40 participants (Actual)Interventional2024-07-01Withdrawn(stopped due to No participants were enrolled and the study will not be conducted.)
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients [NCT00600405]81 participants (Actual)Interventional2006-08-31Completed
A 4-week Multicentre, Randomized, Open Label, Parallel Group, Active Control Phase IV Study to Evaluate Efficacy and Safety of Oxycodone/Naloxone in Comparison With Oxycontin in Korean Patients With Cancer Pain(TOP) [NCT01313780]Phase 4128 participants (Actual)Interventional2011-05-31Completed
Evaluation of Multimodal Oral Strategies Using Sequential Analysis (Tramadol, Opioid) After Shoulder Ambulatory Surgery [NCT04110665]Phase 4200 participants (Anticipated)Interventional2017-09-01Recruiting
Impact of Reduced Initial Prescription Size on Opioid Consumption in Postoperative Pain Management for Scheduled Cesarean Deliveries [NCT05360433]Phase 4170 participants (Anticipated)Interventional2020-11-01Recruiting
Examining the Relationship Amongst Opioid Subjective Effects and Pharmacokinetics of Extended Release Opioids at Shortened Dosing Intervals in Patients With Chronic Pain: a Randomized, Blinded, N-of-1 Case Series Feasibility Study [NCT04132011]Phase 40 participants (Actual)Interventional2019-05-01Withdrawn(stopped due to No recruitment (Feasibility study).)
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery [NCT04246541]Phase 348 participants (Actual)Interventional2019-04-23Completed
Effect of Oxycodone Combined With Ultrasound Guided Thoracic Paravertebral Nerve Block on Postoperative Analgesia in Patients With Lung Cancer Undergoing Thoracoscopic Surgery [NCT05742256]Phase 1159 participants (Anticipated)Interventional2023-03-01Not yet recruiting
Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial [NCT02601586]Phase 2/Phase 367 participants (Actual)Interventional2016-09-30Completed
Open-Label Trial Comparing Oxycodone Medications for Effectiveness and Satisfaction (OUTCOMES) [NCT01162304]Phase 418 participants (Actual)Interventional2010-03-31Terminated(stopped due to unable to enroll subjects meeting Eligibility criteria)
Influence of Intraoperative Opioids (Oxycodone/Fentanyl) Usage on the Post-operative Pain Management of Peroral Endoscopic Myotomy (POEM) [NCT04177342]Phase 4196 participants (Anticipated)Interventional2020-01-01Not yet recruiting
A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 80-mg Tablets Manufactured at the Totowa, NJ Facility to Oxycodone Tamper Resistant (OTR) 80-mg [NCT01101321]Phase 158 participants (Actual)Interventional2008-06-30Completed
A Randomized, Open-Label, Single-Center, Single-Dose, Two-Way Crossover Study in Healthy Subjects to Determine the Fasting Bioequivalence of Oxycodone Tamper Resistant (OTR) 40-mg Tablets to OxyContin® 40-mg Tablets [NCT01101165]Phase 192 participants (Actual)Interventional2007-02-28Completed
A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain [NCT00820027]Phase 3776 participants (Actual)Interventional2008-12-15Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Moderate-to-Severe Acute Pain and the Prevention of Opioid [NCT03657810]Phase 3349 participants (Actual)Interventional2017-08-02Completed
Effect of Post-operative Ibuprofen After Surgery for Chronic Rhinosinusitis: A Prospective, Pilot, Cohort Study [NCT03055507]Phase 2/Phase 342 participants (Actual)Interventional2017-04-01Completed
Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain [NCT00637975]Phase 280 participants (Anticipated)Interventional2007-09-30Completed
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia [NCT05988710]Phase 472 participants (Anticipated)Interventional2023-10-19Recruiting
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-i [NCT01427270]Phase 3455 participants (Actual)Interventional2011-08-31Completed
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain [NCT00092326]Phase 3269 participants (Actual)Interventional2002-06-30Completed
A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opio [NCT01438567]Phase 3270 participants (Actual)Interventional2011-09-30Completed
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Pr [NCT00853268]Phase 134 participants (Actual)Interventional2005-04-30Completed
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Controlled-Release Test Tablet Formulation of Oxycodone Hydrochloride (40 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Pr [NCT00853892]Phase 134 participants (Actual)Interventional2005-04-30Completed
A Double-blind, Double-dummy, Parallel Group, Randomised Study to Compare the Efficacy & Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR) & Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoa [NCT00784810]Phase 4247 participants (Actual)Interventional2009-02-28Completed
A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion [NCT00337792]132 participants (Actual)Interventional2006-06-30Terminated(stopped due to DSMB review at 50% recruitment, further recruitment unlikely to change result)
A Randomized, Double-Blind, Placebo- and Active Controlled Study to Evaluate the Safety and Efficacy of GRT6005 in Patients With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee [NCT01709214]Phase 2619 participants (Actual)Interventional2012-12-04Completed
Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction [NCT04285853]Phase 498 participants (Actual)Interventional2020-09-16Completed
A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care [NCT03545893]Phase 470 participants (Actual)Interventional2018-06-19Completed
"A Randomized Comparison of Oral Methadone as a First-Switch Opioid Versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients With Pain Management Problems: The Simply Rotate Study" [NCT00726830]1 participants (Actual)Interventional2009-03-31Terminated(stopped due to Low Accrual.)
A Randomized, Double-Blind, Multiple-Dose, Parallel Group Study to Evaluate the Potential of Withdrawal Effects Following Administration of Oxycodone/Naltrexone Capsules and Oxycodone in Methadone-Maintained Opioid-Dependent Subjects [NCT02391571]Phase 326 participants (Actual)Interventional2015-02-28Completed
A Single Dose PK Study of Oxycodone Hydrochloride Injection 2.5, 5, and 10mg in Chinese Patients With Cancer Pain or Post-operation Patients [NCT01482936]Phase 144 participants (Actual)Interventional2010-05-31Completed
A Randomized, Double-Blind, Study of the Analgesic Efficacy and Safety of Flexible Dose Q8003 Versus Low Dose Q8003 in Patients Who Have Undergone Primary Unilateral Total Knee Arthroplasty [NCT01055015]Phase 3141 participants (Actual)Interventional2010-02-28Completed
Predictors of Postoperative Pain Following Oocyte Retrieval for Assisted Reproduction [NCT03105518]Phase 4100 participants (Actual)Interventional2011-03-01Active, not recruiting
A Randomized, Double-Blind, Parallel-Group Study of NUCYNTA (Tapentadol) Immediate Release vs. Oxycodone Immediate Release for the Treatment of Acute Low Back Pain [NCT00986180]Phase 3667 participants (Actual)Interventional2009-09-30Completed
Oxycodone in Treatment of Early Labour Pain Efficacy and Safety [NCT02575677]90 participants (Anticipated)Observational2012-10-31Recruiting
[NCT02936934]Phase 464 participants (Anticipated)Interventional2016-10-31Not yet recruiting
Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery [NCT03756961]220 participants (Anticipated)Interventional2019-05-01Recruiting
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care [NCT01431326]3,520 participants (Actual)Observational2011-11-30Completed
Multimodal Analgesia With NSAID vs. Narcotics Alone for Post-operative Meniscectomy: A Prospective Observational Study [NCT02915055]77 participants (Actual)Observational2016-09-01Completed
A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared With Oxycodone Immediate-Release Tablets and Placebo in Non-Dependent Recreational Opioid Users [NCT05571345]Phase 132 participants (Actual)Interventional2022-10-05Completed
The Pharmacogenetics of Oxycodone Analgesia in Postoperative Pain [NCT00260260]Phase 4300 participants (Anticipated)Interventional2005-06-30Completed
Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study [NCT04246697]Phase 430 participants (Actual)Interventional2019-11-01Completed
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Postoperative Dental Pain [NCT00092313]Phase 3271 participants (Actual)Interventional2002-06-30Completed
A Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) to Placebo in Subjects With Acute Pain Following Bunionectomy [NCT00402792]Phase 3150 participants (Actual)Interventional2006-12-31Completed
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy : Prospective Double Blind, Randomized, Placebo-Controlled Study [NCT00480142]Phase 4100 participants (Anticipated)Interventional2007-07-31Not yet recruiting
An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fasted State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 10 mg and OXYCONTIN® Tablet 10 mg in Chinese Subjects With Chronic Pain [NCT03403504]Phase 124 participants (Actual)Interventional2017-02-01Completed
A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery [NCT00404391]Phase 2210 participants (Actual)Interventional2003-10-31Completed
A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis [NCT00404183]Phase 2120 participants (Actual)Interventional2004-08-31Completed
A Phase 4 Randomized Double-blind Double-dummy Placebo & Active-controlled Single-dose Six-way Crossover Study Evaluating Abuse Potential of NEURONTIN® Taken Orally With Oxycodone HCL in Healthy Non-drug Dependent Recreational Opioid Users [NCT05319756]Phase 454 participants (Actual)Interventional2021-04-30Completed
A Randomized Controlled Trial to Study Reduced Opioid Prescription After Laparoscopic Hysterectomy [NCT05548582]120 participants (Anticipated)Interventional2023-01-12Recruiting
Non-intrusive Detection of Temporary Neurologic Impairment By Opioids [NCT04223609]Phase 1/Phase 214 participants (Actual)Interventional2020-02-28Completed
Cognitive, Behavioral and Aging Effects of Pain Medication in Alcohol Users [NCT02945293]128 participants (Actual)Observational2015-11-30Active, not recruiting
A Randomised, Double-blind, Parallel-group, Multicentre Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Non-malignant Pain Taking Oxycodone Equivalent of >20 mg/Day and <50 mg/Day as Oxycodone/Naloxone Prolonged Release Compa [NCT00412152]Phase 30 participants Interventional2006-01-31Completed
A Randomized, Double-Blind, Active Controlled, Optimal Dose Titration, Multicenter Study to Evaluate the Safety and Efficacy of Oral JNS024 Extended Release (ER) in Japanese and Korean Subjects With Moderate to Severe Chronic Malignant Tumor Related Cance [NCT01165281]Phase 3343 participants (Actual)Interventional2010-08-31Completed
New Neural Drug Targets: An Evaluation of the Effects of Aprepitant on the Response to Oxycodone [NCT00999544]9 participants (Actual)Interventional2009-10-31Completed
[NCT00478101]Phase 22,006 participants (Actual)Interventional2006-02-28Completed
Phase 4: A Comparison of Intravenous Administration of Morphine vs. Oxycodone for Postoperative Pain Management Following Laparoscopic Hysterectomy or Myomectomy [NCT00528177]Phase 490 participants (Anticipated)Interventional2007-09-30Completed
A Randomised, Double-blind, Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Cancer Pain [NCT00513656]Phase 2230 participants (Anticipated)Interventional2007-09-30Completed
The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures [NCT01328782]124 participants (Actual)Interventional2008-06-30Completed
Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers [NCT01530542]Phase 135 participants (Actual)Interventional2010-07-31Completed
Evaluation of Oxycodone Hydrochloride Versus Intravenous Morphine Hydrochloride for Postoperative Analgesia After Hip Prosthetic Surgery [NCT01536301]Phase 4246 participants (Actual)Interventional2012-06-30Completed
Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR Immediate-Release (IR) [NCT01545778]646,620 participants (Actual)Observational2010-02-28Completed
An Open-Label, Single-Dose, Randomized, Crossover Pharmacokinetics And Relative Bioavailability Study Of Three Modified 40 Mg Oxycodone Formulations Compared With 40 Mg Pf-00345439 Capsule Formulation In Healthy Volunteers [NCT01552850]Phase 118 participants (Actual)Interventional2012-04-30Completed
Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers [NCT01552863]Phase 121 participants (Actual)Interventional2012-03-31Completed
Department of Anesthesiology, Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital), Research Center for Neuro-Oncology Interaction , Institute of Basic Medicine and Cancer, Chinese Academy of Sciences [NCT05468671]Phase 434 participants (Actual)Interventional2021-01-04Completed
Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Major Inpatient Surgery in Children [NCT03495388]500 participants (Anticipated)Observational2018-04-01Active, not recruiting
Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery [NCT03959969]48 participants (Actual)Interventional2019-07-17Completed
The Effect of Oxycodone to the Placental Circulation at Early Labour [NCT02573831]Phase 422 participants (Actual)Interventional2015-02-01Active, not recruiting
Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section [NCT02571881]Phase 457 participants (Actual)Interventional2012-10-31Active, not recruiting
Herb-Opioid Interactions [NCT00027014]Phase 454 participants Interventional2001-09-30Completed
A Randomized, Repeated- Dose, Parallel-Group Comparison of Safety, Efficacy, and Quality of Life Measures With Dilaudid CR (Hydromorphone HCI) or Oxycontin (Oxycodone HCI) in Patients With Chronic Osteoarthritis [NCT00399048]Phase 3140 participants (Actual)InterventionalCompleted
Pilot Trial of Microsphere Oxycodone (Xtampza ER) for Pain Management in Patients Receiving Radiotherapy for Locally Advanced Head and Neck Cancer [NCT03317730]Early Phase 128 participants (Actual)Interventional2018-05-01Completed
PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY [NCT03597308]210 participants (Actual)Interventional2017-03-17Completed
Comparison of the Efficacy of Oral Oxycodone and Oral Codeine in the Treatment of Postcraniotomy Pain [NCT01672112]Phase 440 participants (Actual)Interventional2012-07-31Completed
Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial [NCT04939987]Phase 2/Phase 30 participants (Actual)Interventional2022-08-31Withdrawn(stopped due to PI left institution and study was not transferred to new PI)
Effects of Chronic Musculoskeletal Pain and Opioidergic Versus Placebo Interventions on Neuroendocrine Function in Men [NCT00737737]Phase 48 participants (Actual)Interventional2008-08-31Completed
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain in the ED [NCT00685295]Phase 1/Phase 260 participants (Actual)Interventional2008-08-31Completed
Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients [NCT02994173]Phase 4100 participants (Actual)Interventional2017-02-01Completed
Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway: A Single-Blinded, Randomized, Controlled Study [NCT02740114]Phase 3105 participants (Actual)Interventional2016-08-31Terminated(stopped due to Per PIs request)
Postoperative Pain Control in Septum and Sinus Surgery: A Novel Approach. [NCT04149964]Phase 465 participants (Actual)Interventional2019-11-27Completed
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery [NCT04522206]Phase 444 participants (Actual)Interventional2020-08-20Completed
A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users [NCT02218021]Phase 159 participants (Actual)Interventional2014-08-31Completed
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-i [NCT01427283]Phase 3450 participants (Actual)Interventional2011-08-31Completed
Clinical Evaluation of NMDA Modulator NYX-783 for OUD: Randomized, Double-blind, Placebo-Controlled Study to Assess Safety, Tolerability, and Pharmacokinetics of NYX-783 in Combination With Oxycodone (Study 1) [NCT05447286]Phase 19 participants (Anticipated)Interventional2023-05-15Recruiting
The Pharmacogenetics of Oxycodone Analgesia in Human Experimental Pain Models [NCT00271973]Phase 432 participants Interventional2006-02-28Completed
A Single-dose, Randomized, Double-blind, Placebo- and Active-controlled Crossover Trial to Evaluate the Abuse Potential of Two Doses of Cebranopadol in Adult Nondependent Recreational Opioid Users [NCT05256108]Phase 138 participants (Actual)Interventional2022-03-28Completed
An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Heal [NCT01677065]14 participants (Actual)Observational2012-09-30Completed
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes. [NCT02449369]Phase 4180 participants (Actual)Interventional2015-04-30Completed
The Evaluation of Targinact® in Daily Practice, With Regards to Pain Relief and Constipation, in Chronic Severe Pain Patients Compared to Previous Prolonged Release Oxycodone Treatment: a Non-interventional, Observational Study. [NCT01710904]68 participants (Actual)Observational2012-09-30Completed
Open Label, Single Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted Con [NCT01717027]Phase 119 participants (Actual)Interventional2012-11-30Completed
A Randomized, Open-label, Multiple-dose, Two-sequence, Two-period Crossover Study to Investigate The Pharmacokinetics Between a GL2907 and Oxycontin CR Tab. 10mg in Healthy Male Volunteers [NCT01779492]Phase 124 participants (Actual)Interventional2013-04-30Completed
Multimodal Analgesia Effect on Post Surgical Patient [NCT04240626]Phase 460 participants (Anticipated)Interventional2021-01-20Recruiting
Clinical Predictors and Epigenetic Markers for Liver Fibrosis in Alpha-1 Antitrypsin Deficiency [NCT01810458]109 participants (Actual)Observational2013-10-31Completed
A Placebo-controlled, Randomized, Double-blind Study of the Safety and Efficacy of Q8003 in the Management of Post-bunionectomy Pain [NCT00560183]Phase 3256 participants (Actual)Interventional2007-11-30Completed
A Blinded, Randomized Controlled Trial of Opioid Analgesics for the Management of Acute Fracture Pain in Adults Discharged From the Emergency Department [NCT03478423]5 participants (Actual)Interventional2018-02-05Terminated(stopped due to Study failed to recruit in sufficient numbers and was determined to not be feasible.)
A Randomized, Single-Dose, Placebo-Controlled, Double-Blind, 3-Way Crossover Study to Determine the Relative Abuse Potential of Intravenous Oxycodone Hydrochloride Alone or in Combination With Intravenous Naltrexone Hydrochloride in Opioid Experienced Non [NCT01825447]Phase 189 participants (Actual)Interventional2013-07-31Completed
Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study [NCT03837860]Early Phase 13 participants (Actual)Interventional2019-04-01Terminated(stopped due to PI leaving institution)
Prove the Feasibility of a Non-invasive Means to Identify Temporary Neurological Impairment Resulting From the Use of a Commonly Prescribed Opioid by Identifying an Oculomotor Biosignature Associated With Temporary Neurologic Impairment in Pain-free Opioi [NCT05489601]17 participants (Actual)Observational2020-02-28Completed
A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain [NCT01685684]Phase 3740 participants (Actual)Interventional2012-08-31Completed
Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial [NCT03978767]Phase 2286 participants (Anticipated)Interventional2019-06-10Recruiting
Doxazosin: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in Humans [NCT03415581]Phase 213 participants (Actual)Interventional2017-02-12Terminated(stopped due to Study terminated by sponsor due to bad risk/benefit ratio.)
A Laboratory Model for Heroin Abuse Medications [NCT00000273]Phase 28 participants (Actual)Interventional1995-08-31Completed
Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial. [NCT03584373]Phase 3119 participants (Actual)Interventional2018-07-27Completed
[NCT01439100]Phase 3172 participants (Anticipated)Interventional2011-10-31Completed
An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Relea [NCT01456507]Phase 124 participants (Actual)Interventional2011-10-31Completed
Responsiveness Index Versus the RASS Based Method for Adjusting Sedation in Critically Ill Patients [NCT03250481]32 participants (Actual)Interventional2013-03-31Completed
An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fasted State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain [NCT03398278]Phase 138 participants (Actual)Interventional2017-06-30Completed
Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block [NCT03011905]Phase 353 participants (Actual)Interventional2017-01-31Completed
Post-tonsillectomy Pain Control in Adults: a Randomized Prospective Study [NCT02358850]Phase 427 participants (Actual)Interventional2016-01-31Terminated(stopped due to low enrollment)
An Interventional Study to Compare the Efficacy and Tolerability of Current and Slow Titration With Targin® in the Treatment of Moderate to Severe Non-malignant Chronic Pain (GLORY) [NCT01811186]Phase 4261 participants (Actual)Interventional2012-12-31Completed
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge [NCT01402375]Phase 3720 participants (Actual)Interventional2012-01-31Completed
Fentanyl Administered Intraorally for Rapid Treatment of Orthopedic Pain: The FAIRTOP II Trial [NCT01270659]Phase 360 participants (Actual)Interventional2011-05-31Completed
Study of Parecoxib Versus Celecoxib Versus Oxycodone on Perioperative Pain Control of Transcatheter Chemoembolization Procedure for Patients With Hepatocelullar Carcinoma [NCT03059238]Phase 3213 participants (Actual)Interventional2016-09-30Completed
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure [NCT05463367]Phase 280 participants (Anticipated)Interventional2021-01-01Recruiting
Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion [NCT04872283]Phase 3140 participants (Anticipated)Interventional2019-05-23Enrolling by invitation
A Randomized, Multicenter, Single-blind, Placebo-controlled Study Comparing the Analgesic Efficacy and Safety of Hydrocodone/ Acetaminophen Extended-release Tablets and Hydrocodone/Acetaminophen (NORCO) to Placebo in Subjects With Acute Pain Following Thi [NCT00935311]Phase 2122 participants (Actual)Interventional2009-06-30Completed
An Open-label, Single-dose and Multiple-dose, Randomized, Crossover Study to Evaluate Pharmacokinetics, Safety and Tolerability After Administration of ALO-02 40 Mg Twice Daily Compared to ALO-02 80 Mg Once Daily and to Oxycontin 40 Mg Twice Daily in Heal [NCT01557257]Phase 113 participants (Actual)Interventional2012-03-31Completed
Narcotic Versus Non-narcotic Medication for Pain Management After Wrist/Hand Fractures: a Randomized Controlled Trial [NCT03375593]Phase 4250 participants (Anticipated)Interventional2019-08-01Recruiting
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic ACL Surgery [NCT04246554]Phase 349 participants (Actual)Interventional2019-05-21Completed
Levorphanol as a Second Line Opioid in Cancer Patients Undergoing Opioid Rotation: An Open Label Study [NCT03579446]Early Phase 143 participants (Actual)Interventional2018-11-29Completed
A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain [NCT00325949]Phase 3770 participants (Actual)Interventional2006-05-31Completed
Post-Op Pain Control for Prophylactic Intramedullary Nailing. [NCT03823534]Phase 360 participants (Anticipated)Interventional2019-02-20Recruiting
An Evaluation of the Tolerability of Switching Subjects on Chronic Around-the-Clock (ATC) Opioid Therapy to Buprenorphine HCl Buccal Film [NCT01871285]Phase 239 participants (Actual)Interventional2013-06-30Completed
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms (LUTS) Post Ureteroscopy for Stone Management [NCT01381120]Phase 484 participants (Actual)Interventional2010-10-31Completed
MEASURES OF GAIT AND SELF-REPORTED PAIN IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE: A RANDOMIZED, SINGLE-BLIND WASHOUT, DOUBLE-BLIND TREATMENT, DOUBLE DUMMY CROSS-OVER PILOT TRIAL USING PLACEBO, OXYCODONE AND CELECOXIB (A9011030) [NCT00484718]Phase 46 participants (Actual)Interventional2008-01-17Terminated(stopped due to See termination reason in detailed description.)
An Open, Randomized, Parallel Group Study in Patients With Cancer Pain, To Compare a Two-Step Analgesic Ladder (Non-Opioid to Oxycodone) With Conventional Management Using A Three-Step Approach [NCT00378937]Phase 430 participants (Anticipated)Interventional2004-01-31Completed
Relieving Acute Pain (RAP): A Pilot Study [NCT03426137]Phase 23 participants (Actual)Interventional2018-09-17Terminated(stopped due to The focus of the project has shifted to publishing a protocol for future trials because we were unable to recruit. Three participants signed the consent forms but withdrew before the randomization.)
The Potential of Oxytocin to Reduce Opioid Abuse Liability and Pain Among Older Adults [NCT05761860]Early Phase 145 participants (Anticipated)Interventional2023-09-12Recruiting
Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimal Invasive Nuss Repair of Pectus Excavatum: a Randomized Clinical Trial (ICE Trial) [NCT05731973]46 participants (Anticipated)Interventional2023-03-31Not yet recruiting
OxyNorm® Capsules (Immediate-Release) PK Study [NCT01643772]Phase 161 participants (Actual)Interventional2011-05-31Completed
Celecoxib for Pain Management After Tonsillectomy [NCT02934191]Phase 2172 participants (Actual)Interventional2016-06-30Completed
A Phase 4 Randomized Double-Blind Double-Dummy Placebo & Active-Controlled Single-Dose Six-Way Crossover Study Evaluating the Abuse Potential of Lyrica® Taken Orally With Oxycodone HCL in Healthy Non-Drug Dependent Recreational Opioid Users [NCT05053126]Phase 460 participants (Actual)Interventional2021-07-27Completed
Narcotic-Free Percutaneous Nephrolithotomy [NCT05924165]Phase 490 participants (Anticipated)Interventional2023-05-19Recruiting
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients [NCT04194528]2 participants (Actual)Interventional2020-01-22Terminated(stopped due to Study sponsor withdrew support.)
Transversus Abdominis Plane (TAP) Infiltration vs. Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Assisted Hysterectomy [NCT02519023]Phase 487 participants (Actual)Interventional2016-07-31Completed
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis [NCT02625181]27,034 participants (Actual)Interventional2016-07-31Completed
Clinical Study to Investigate the Effect of Administration of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation [NCT05470465]Phase 127 participants (Actual)Interventional2022-09-01Completed
Comparative Study of Oxycodone and Fentanyl Given Intravenously in the Treatment of Early Postoperative Pain After Laparoscopic Cholecystectomy [NCT00369811]Phase 480 participants (Anticipated)Interventional2006-08-31Completed
Oral Sedation During Cervical Dilator Placement: A Randomized Controlled Trial [NCT03202550]Phase 427 participants (Actual)Interventional2017-06-28Completed
Use of Xtampza ER to Overcome Difficulties in Swallowing Opioid Pills [NCT03588806]Phase 411 participants (Actual)Interventional2018-05-01Terminated(stopped due to Study halted permanently and will not resume; participants are no longer being examined or receiving intervention.)
An Open-label, Single Dose, Randomised, Cross-over Study to Determine the Fed State Pharmacokinetics of Oxycodone From Oxycodone Tamper Resistant (OTR) Tablet 40 mg and OXYCONTIN® Tablet 40 mg in Chinese Subjects With Chronic Pain [NCT03398330]Phase 142 participants (Actual)Interventional2017-03-16Completed
Comparison of the Effects of Tapentadol and Oxycodone on Gastrointestinal and Colonic Transit in Humans [NCT01500317]Phase 438 participants (Actual)Interventional2011-05-31Completed
A Randomized Trial Comparing Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Outpatient Soft Tissue Hand Surgery [NCT03111186]Phase 240 participants (Actual)Interventional2017-04-24Completed
A Double-Blind, Placebo-Controlled Crossover Study Comparing the Analgesic Efficacy of Cannabis Versus Oxycodone [NCT02892591]Phase 3100 participants (Anticipated)Interventional2017-06-01Recruiting
A Randomized Controlled Trial of Continuous Gastrocnemius Plane Block and Intravenous Analgesia After Foot and Ankle Surgery [NCT05463809]Phase 360 participants (Anticipated)Interventional2022-07-14Not yet recruiting
Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients [NCT02454881]Phase 4107 participants (Actual)Interventional2015-06-30Completed
A Phase III Study of Pre-operative Transversus Abdominis Plane Blocks Using the Nimbus Ambulatory Infusion System in Patients Undergoing Abdominal Free Flap-based Breast Reconstruction [NCT02601027]Phase 3120 participants (Actual)Interventional2015-11-30Completed
Randomized, Double-blind, Four Period, Six-treatment, Double-dummy, Placebo Controlled, Partial-crossover Study to Explore and Compare the Ventilatory Response to Hypercapnia (VRH) of Cebranopadol, Oxycodone, and Placebo in Healthy Subjects [NCT05491785]Phase 130 participants (Anticipated)Interventional2022-07-29Recruiting
An Open-label Study To Evaluate The Pharmacokinetics And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Children And Adolescents 7-17 Years Of Age Who Require Opioid Analgesia [NCT02680847]Phase 432 participants (Actual)Interventional2016-01-21Terminated(stopped due to The trial was terminated on 08FEB2018. Pfizer has decided to withdraw the New Drug Application and has notified FDA. There are no efficacy or safety concerns.)
To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine [NCT02440399]200 participants (Actual)Interventional2015-07-31Completed
NSAID Use After Robotic Partial Nephrectomy (No-PAIN): a Randomized, Controlled Trial [NCT05842044]Phase 2110 participants (Anticipated)Interventional2023-09-15Recruiting
A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of TARGIN(R) (Oxycodone/Naloxone) in Korean Patients With Spinal Disorders [NCT01811238]Phase 4240 participants (Actual)Interventional2012-09-30Completed
A Randomized Study of Ibuprofen + Oxycodone/Acetaminophen Versus Ibuprofen + Acetaminophen for ED Patients With Insufficient Relief of Acute Musculoskeletal Pain After Treatment With Prescription Strength Ibuprofen [NCT04122443]Phase 4154 participants (Actual)Interventional2019-12-01Completed
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acuroc Tablets Following Bunionectomy Surgery in Adult Patients [NCT00654069]Phase 3405 participants (Actual)Interventional2007-09-30Completed
A Multicenter, 12-month, Open-label, Single-arm, Safety Study Of Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules In Subjects With Moderate To Severe Chronic Noncancer Pain [NCT01428583]Phase 3395 participants (Actual)Interventional2010-12-31Completed
Prescription Opioid Effects in Drug and Non-drug Abusers - 1 [NCT00158184]Phase 227 participants (Actual)Interventional2004-06-30Completed
Phase 4 Study, Open, Observational, to Evaluate the Safety and Tolerability of Hydrochloride Controlled-release Oxycodone in Moderate and Severe Postoperative Pain in Oncologic Head and Neck Surgery. [NCT01834898]83 participants (Actual)Observational2010-10-31Completed
Oxycodone vs. Fentanyl in the Treatment of Early Postoperative Pain After Total Hip Replacement [NCT03019562]Phase 446 participants (Anticipated)Interventional2016-12-31Recruiting
Comparative Efficacy of 4 Oral Analgesics for the Initial Management of Acute Musculoskeletal Extremity Pain [NCT02455518]Phase 4416 participants (Actual)Interventional2015-07-31Completed
A Multi-center, Randomized, Multiple-dose, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Abuse-deterrent Capsules Oxycodone Hydrochloride Plus Naltrexone Hydrochloride (a) or Oxycodone Hydrochloride [NCT02401750]Phase 3163 participants (Actual)Interventional2015-06-30Completed
Comparison of Effects of Oxycodone and Sufentanil on Cardiovascular Stress Induced by Tracheal Intubation in the Patients With Coronary Heart Disease Undergoing Major Noncardiac Surgery [NCT04121416]50 participants (Actual)Interventional2019-04-01Completed
A Randomized Blinded Pilot Study to Compare Targinact vs. Oxycodone in Early Return of Gastrointestinal Function After Colorectal Surgery [NCT02109640]Phase 350 participants (Actual)Interventional2014-10-31Completed
Efficacy of Erector Spinae Plane Block and Pectoral Fascia Block in Patients Undergoing Mitral Valve Repair Through the Right Mini-thoracotomy [NCT03592485]Phase 433 participants (Actual)Interventional2018-06-28Completed
A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Acurox (Oxycodone HCl and Niacin) Tablets in Subjects With a History of Opioid Abuse [NCT00699010]Phase 230 participants (Actual)Interventional2008-03-31Completed
A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-dose, 6-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended-release Capsules) Compared To Oxycodone Imm [NCT01746901]Phase 181 participants (Actual)Interventional2013-02-28Completed
A 4-week, Open Label, Multi-center, Prospective, Single-arm, Non-interventional Phase IV Study to Evaluate the Efficacy of Targin for the Treatment of Korean Patients With Cancer Pain Under Conditions of Daily Practice [NCT01719757]Phase 4359 participants (Actual)Interventional2012-07-31Completed
Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery [NCT02240602]Phase 30 participants (Actual)Interventional2015-07-31Withdrawn(stopped due to Lack of internal resources)
Assessment of Postoperative Pain in Boys Undergoing Hypospadias Repair [NCT04423107]Phase 3150 participants (Anticipated)Interventional2020-07-01Recruiting
A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy Who Need Opioid Combination Treatment With Existing Pregabalin Treatment [NCT01675531]Phase 473 participants (Actual)Interventional2012-12-31Completed
Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury: A Pilot Study [NCT03906721]Phase 230 participants (Actual)Interventional2019-02-20Completed
Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination [NCT04218409]Early Phase 145 participants (Anticipated)Interventional2021-09-02Recruiting
A Phase III, Randomized, Double-blind, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxy/Nal Prolonged Release Tablets Compared to Oxy PR in Subjects With Moderate to Severe, Chronic Cancer Pain [NCT01885182]Phase 3232 participants (Actual)Interventional2013-06-01Completed
A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture [NCT03759028]Phase 490 participants (Anticipated)Interventional2019-02-26Recruiting
The Effect of Decreased Opioid Prescribing on Pain Control and Patient Satisfaction Following Cesarean Section [NCT03355248]60 participants (Actual)Interventional2017-08-18Completed
RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. [NCT01809106]Phase 4518 participants (Actual)Interventional2011-04-30Completed
Successful Implementation of an Opioid Reduction Toolkit in Pancreatectomy Patients Significantly Decreases Number of Opioids Prescribed and Consumed [NCT05363436]Phase 4159 participants (Actual)Interventional2018-01-01Suspended(stopped due to Recruitment Reorganzing)
A Randomized, Double-blind, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended Release Capsules) Compared To Oxycodone Immediate Release [NCT01775189]Phase 145 participants (Actual)Interventional2013-02-28Completed
A Randomized Double-blinded Study to Evaluate Preincisional Dextromethorphan in Patients Undergoing Total Knee Arthroplasty and Its Effect on Postoperative Opioid Use [NCT02987920]Phase 423 participants (Actual)Interventional2017-01-31Terminated(stopped due to The surgeon changed pain control protocol for all patients. Continued enrollment impossible under approved protocol.)
Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain [NCT01458015]Phase 45 participants (Actual)Interventional2011-10-31Terminated
Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus Oxycodone/Naloxone PR in Non-opioid Pre-treated Subjects With Uncontrolled Severe Chronic Low Back Pain With a Neuropathic Pain Component. [NCT01838616]Phase 4367 participants (Actual)Interventional2013-04-30Completed
Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent [NCT03427736]460 participants (Anticipated)Observational2018-12-13Recruiting
Investigational Plan for the Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain [NCT02293525]0 participants (Actual)InterventionalWithdrawn(stopped due to No subjects were enrolled and the sponsor suspended support at this time)
Influences on the Nutrition Statuses and Clinical Outcomes of Early Use of Opioid to Control Local Mucosa Pain Induced by Irradiation in Nasopharyngeal Carcinoma Patients [NCT02309437]Phase 2200 participants (Actual)Interventional2015-01-01Completed
A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis [NCT00483977]Phase 2113 participants (Actual)Interventional2007-06-30Terminated(stopped due to Met criteria for study futility at interim analysis)
A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation [NCT02480114]Phase 379 participants (Actual)Interventional2015-07-31Completed
A Study Comparing Recurrent Use of Morphine Sulfate Immediate Release, Oxycodone/Acetaminophen (Percocet), and Hydrocodone/Acetaminophen (Vicodin) at Discharge From the ED in Opioid-naïve Adult Patients With Moderate to Severe Pain. [NCT03529331]Phase 40 participants (Actual)Interventional2019-09-01Withdrawn(stopped due to The ED physicians no longer prescribe opioids at discharge; not feasible to conduct the study)
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? [NCT02307305]Phase 2168 participants (Anticipated)Interventional2014-08-31Recruiting
A 5-day, Multicentre, Randomized, Open-label, Parallel Group, Active Control Pilot Study to Evaluate the Efficacy and Safety of OxyNorm® (Oxycodone Hydrochloride Injection) in Comparison With Morphine Sulfate Through the IV Continuous Infusion Regimen in [NCT02660229]Phase 466 participants (Actual)Interventional2015-11-30Completed
Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial [NCT04523623]200 participants (Anticipated)Interventional2020-09-30Not yet recruiting
Pain Management in Head and Neck Surgery Patients [NCT03121963]Phase 40 participants (Actual)Interventional2017-11-10Withdrawn(stopped due to This protocol was difficult to enroll into, and changes to personnel have made it difficult to main this study. Data collection was not completed and therefore, no data analysis was performed. The PI has made the decision to close this study.)
Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer [NCT04726878]Phase 475 participants (Actual)Interventional2021-02-01Completed
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms [NCT01502644]Phase 481 participants (Actual)Interventional2009-02-28Completed
Hepatic Cytochrome Drug Interactions in Emergency Department Patients [NCT01859715]502 participants (Actual)Interventional2012-06-30Completed
Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies [NCT05965492]Phase 3100 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Does Postoperative Administration of Oral Oxycodone With/Without Naloxone, Reduce the Duration of Epidural Analgesia in Patients Undergoing Cystectomy Without Impairing Its Benefits? A Randomized, Double Blind Controlled Trial [NCT02516059]Phase 490 participants (Actual)Interventional2015-09-14Completed
Pain Management After Cardiac Surgery - Opioids or NSAID? A Randomized Prospective Study [NCT02479165]Phase 4182 participants (Actual)Interventional2009-05-31Completed
Effect of Pregabalin on Immediate Post-operative and Longterm Pain and Spinal Cord Monitoring in Children Undergoing Instrumented Spinal Surgery. [NCT02464813]Phase 464 participants (Actual)Interventional2015-08-01Completed
Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms [NCT05142267]120 participants (Anticipated)Interventional2022-03-02Recruiting
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
A Double-Blinded Randomized Controlled Trial Examining Multimodal Opioid-Free Orthopaedic Procedures [NCT04659317]Phase 380 participants (Anticipated)Interventional2020-12-11Recruiting
Achieving Peri-Operative Pain Control Without Opioids [NCT04813991]Phase 30 participants (Actual)Interventional2022-03-15Withdrawn(stopped due to Enrollment was never initiated and the PI is leaving the institution so the study is closing.)
A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chron [NCT01571362]Phase 3410 participants (Actual)Interventional2012-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00158184 (2) [back to overview]Drug Liking
NCT00158184 (2) [back to overview]Breakpoint
NCT00261495 (79) [back to overview]Number of Subjects Indicating That They Had Optimal Sleep at Week 24
NCT00261495 (79) [back to overview]Number of Subjects With Dose Escalation at Week 24 (ITT Population)
NCT00261495 (79) [back to overview]Number of Subjects With Dose Escalation at Week 4 (ITT Population)
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24
NCT00261495 (79) [back to overview]Amount of add-on Pain Medication
NCT00261495 (79) [back to overview]"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Vitality at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"
NCT00261495 (79) [back to overview]"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Physical Functioning at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Bodily Pain at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL General Health Perceptions at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL General Health Perceptions at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Health Transition at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Health Transition at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Mental Health at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Mental Health at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Vitality at Week 24"
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Snoring at Week 24
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Social Functioning at Week 4"
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Quantity at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24
NCT00261495 (79) [back to overview]Equi-analgesic Dose at Steady State (ITT Population)
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Social Functioning at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Physical at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Physical at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Physical Functioning at Week 24"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Emotional at Week 4"
NCT00261495 (79) [back to overview]"Change From Baseline in QoL Role Emotional at Week 24"
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality (MOS Index II) at Week 4
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality (MOS Index II) at Week 24
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality (MOS Index I) at Week 4
NCT00261495 (79) [back to overview]Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)
NCT00261495 (79) [back to overview]Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)
NCT00261495 (79) [back to overview]Number of Drop-outs
NCT00261495 (79) [back to overview]Equi-analgesic Dose at Steady-state (PP Population)
NCT00261495 (79) [back to overview]Number of Days With add-on Pain Medication
NCT00261495 (79) [back to overview]Resource Utilization of Pain Management
NCT00261495 (79) [back to overview]"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
NCT00261495 (79) [back to overview]Change From Baseline in QoL at Week 52
NCT00261495 (79) [back to overview]Change From Baseline in Sleep Quality at Week 52
NCT00261495 (79) [back to overview]Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
NCT00261495 (79) [back to overview]Change in Dose of Study Treatment
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24
NCT00261495 (79) [back to overview]Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)
NCT00261495 (79) [back to overview]Clinical Global Assessment of Efficacy
NCT00261495 (79) [back to overview]Mode and Convenience of Drug Intake.
NCT00261495 (79) [back to overview]Number of Subjects Indicating Optimal Sleep at Week 52
NCT00261495 (79) [back to overview]Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4
NCT00261495 (79) [back to overview]Number of Subjects With Dose Escalation
NCT00312221 (4) [back to overview]The Mean Daily Number of Supplemental Analgesic Medication Tablets
NCT00312221 (4) [back to overview]The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase
NCT00312221 (4) [back to overview]The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
NCT00312221 (4) [back to overview]"Average Pain Over the Last 24 Hours Scores at Weeks 4, 8, and 12 of the Double-blind Phase."
NCT00313014 (4) [back to overview]Mean Daily Number of Supplemental Analgesic Tablets
NCT00313014 (4) [back to overview]Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
NCT00313014 (4) [back to overview]Oswestry Disability Index (ODI) Score (V 2.0)
NCT00313014 (4) [back to overview]The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
NCT00315445 (22) [back to overview]Therapeutic Response - Investigator: Mean ± SEM (Day 84)(LOCF)
NCT00315445 (22) [back to overview]The Time to Discontinuation Due to Lack of Efficacy
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain on the Average Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]Subject Satisfaction: Mean ± SEM (Day 84)(LOCF)
NCT00315445 (22) [back to overview]Subject Comparison to Prestudy Analgesic: Mean ± SEM (Day 84)(LOCF)
NCT00315445 (22) [back to overview]Pain Right Now, Mean Change From Baseline, Days 21-84 (LOCF)
NCT00315445 (22) [back to overview]Pain on the Average, Mean Change From Baseline Days 21-84 (Last Observation Carried Forward [LOCF])
NCT00315445 (22) [back to overview]"Vitality (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Social Functioning (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain Right Now Change From Baseline to End of Treatment (Day 84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84), BOCF"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain Right Now Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]"Emotional Role (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"General Health (MOS SF-36): Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Mental Health (MOS SF-36):Mean Percent ± SEM at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Physical Functioning Scale of the Medical Outcomes Survey (MOS) 36 Item Short-Form Health Survey (SF-36): Mean Percent ± Standard Error of the Mean (SEM) at Day 84 (LOCF)"
NCT00315445 (22) [back to overview]"Physical Role Scale (MOS SF-36): Mean Percent ± SEM at Day 84(LOCF)"
NCT00315445 (22) [back to overview]"Sensitivity Analysis Pain on the Average Change From Baseline in the Maintenance Period (Days 21-84) (Hybrid BOCF/LOCF)"
NCT00315445 (22) [back to overview]"Sensitivity Analysis: Pain on the Average Change From Baseline in the Maintenance Period (Days 21 - 84) Baseline Observation Carried Forward (BOCF)"
NCT00315445 (22) [back to overview]Therapeutic Response - Subject: Mean ± SEM (Day 84) (LOCF)
NCT00315445 (22) [back to overview]Time to Stable Pain Management
NCT00315445 (22) [back to overview]"Bodily Pain (MOS SF-36): Mean Percent at Day 84 (LOCF)"
NCT00361504 (2) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAE)
NCT00361504 (2) [back to overview]Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)
NCT00364533 (1) [back to overview]Sum of Pain Intensity Difference Over 48 Hours (SPID48)
NCT00421928 (6) [back to overview]Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.
NCT00421928 (6) [back to overview]Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.
NCT00421928 (6) [back to overview]Change From Baseline in Responder Analysis 50% Improvement to Week 12
NCT00421928 (6) [back to overview]Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12
NCT00421928 (6) [back to overview]Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12
NCT00421928 (6) [back to overview]Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12
NCT00449176 (7) [back to overview]Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.
NCT00449176 (7) [back to overview]Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.
NCT00449176 (7) [back to overview]Number of Participants With Treatment Discontinuation Due to Lack of Efficacy
NCT00449176 (7) [back to overview]Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12
NCT00449176 (7) [back to overview]Responder Analysis 50% Improvement
NCT00449176 (7) [back to overview]Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12
NCT00449176 (7) [back to overview]Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.
NCT00463047 (41) [back to overview]Pain Intensity Difference (PID 60) at 60 Minutes
NCT00463047 (41) [back to overview]Pain Intensity Difference (PID15) At 15 Minutes
NCT00463047 (41) [back to overview]Pain Relief (PR) Score at 5 Minutes
NCT00463047 (41) [back to overview]Pain Relief Score (PR) at 10 Minutes
NCT00463047 (41) [back to overview]Pain Relief Score (PR) at 15 Minutes
NCT00463047 (41) [back to overview]Pain Relief Score (PR) at 30 Minutes
NCT00463047 (41) [back to overview]Pain Relief Score (PR) at 45 Minutes
NCT00463047 (41) [back to overview]Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)
NCT00463047 (41) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes
NCT00463047 (41) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment
NCT00463047 (41) [back to overview]Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes
NCT00463047 (41) [back to overview]Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes
NCT00463047 (41) [back to overview]Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes
NCT00463047 (41) [back to overview]Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes
NCT00463047 (41) [back to overview]Standard Rescue Medication Usage
NCT00463047 (41) [back to overview]Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)
NCT00463047 (41) [back to overview]Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)
NCT00463047 (41) [back to overview]Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes
NCT00463047 (41) [back to overview]Time to Any Pain Relief (APR) by Treatment, <=10 Minutes
NCT00463047 (41) [back to overview]Time to Any Pain Relief (APR) by Treatment, <=15 Minutes
NCT00463047 (41) [back to overview]Time to Any Pain Relief (APR) by Treatment, <=30 Minutes
NCT00463047 (41) [back to overview]Time to Any Pain Relief (APR) by Treatment, <=45 Minutes
NCT00463047 (41) [back to overview]Time to Any Pain Relief (APR) by Treatment, <=60 Minutes
NCT00463047 (41) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes
NCT00463047 (41) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes
NCT00463047 (41) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes
NCT00463047 (41) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes
NCT00463047 (41) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes
NCT00463047 (41) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes
NCT00463047 (41) [back to overview]Total Pain Relief (TOTPAR60) at 60 Minutes
NCT00463047 (41) [back to overview]Breakthrough Pain Preference Questionnaire
NCT00463047 (41) [back to overview]Medication Performance Assessment 30 Minutes After-treatment
NCT00463047 (41) [back to overview]Medication Performance Assessment 60 Minutes After-treatment
NCT00463047 (41) [back to overview]Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)
NCT00463047 (41) [back to overview]Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)
NCT00463047 (41) [back to overview]Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)
NCT00463047 (41) [back to overview]Pain Relief Score (PR) at 60 Minutes
NCT00463047 (41) [back to overview]Pain Intensity Difference (PID 10) at 10 Minutes
NCT00463047 (41) [back to overview]Pain Intensity Difference (PID 30) at 30 Minutes
NCT00463047 (41) [back to overview]Pain Intensity Difference (PID 45) at 45 Minutes
NCT00463047 (41) [back to overview]Pain Intensity Difference (PID 5) at 5 Minutes
NCT00486811 (11) [back to overview]Patient Global Impression of Change
NCT00486811 (11) [back to overview]Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time
NCT00486811 (11) [back to overview]Sleep Questionnaire: Number of Awakenings During Sleep
NCT00486811 (11) [back to overview]Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)
NCT00486811 (11) [back to overview]Change in the Health Survey Scores Form (SF-36)
NCT00486811 (11) [back to overview]Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS).
NCT00486811 (11) [back to overview]Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.
NCT00486811 (11) [back to overview]Sleep Questionnaire: Amount of Time Slept in Hours
NCT00486811 (11) [back to overview]EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
NCT00486811 (11) [back to overview]Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.
NCT00486811 (11) [back to overview]Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12
NCT00499460 (6) [back to overview]Somatic Side Effects Total Score
NCT00499460 (6) [back to overview]Cognitive-Affective Side Effects Total Score
NCT00499460 (6) [back to overview]Cold Pressor Tolerance AUC
NCT00499460 (6) [back to overview]Oral Digoxin Test
NCT00499460 (6) [back to overview]Oral Midazolam Test
NCT00499460 (6) [back to overview]Oxycodone Oral Clearance
NCT00613938 (5) [back to overview]Total Pain Relief (TOTPAR)at 48 Hours
NCT00613938 (5) [back to overview]The SPID at 12 Hours Relative to First Dose.
NCT00613938 (5) [back to overview]SPID at 24 Hours Relative to First Dose
NCT00613938 (5) [back to overview]Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3
NCT00613938 (5) [back to overview]Sum of Pain Intensity Difference Over 48 Hours (SPID48)
NCT00654069 (1) [back to overview]SPID48
NCT00685295 (3) [back to overview]Pain Reduction
NCT00685295 (3) [back to overview]Time to Analgesia
NCT00685295 (3) [back to overview]Occurrence of Untoward Opioid Side Effects
NCT00699010 (1) [back to overview]Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)
NCT00737737 (2) [back to overview]Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?
NCT00737737 (2) [back to overview]Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?
NCT00771758 (45) [back to overview]Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days
NCT00771758 (45) [back to overview]Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days
NCT00771758 (45) [back to overview]Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days
NCT00771758 (45) [back to overview]Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days
NCT00771758 (45) [back to overview]Sum of Pain Intensity Difference Over 3 Days (SPID72)
NCT00771758 (45) [back to overview]Sum of Pain Intensity Difference Over 2 Days (SPID48)
NCT00771758 (45) [back to overview]Sum of Pain Intensity Difference Over 10 Days
NCT00771758 (45) [back to overview]Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study
NCT00771758 (45) [back to overview]Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study
NCT00771758 (45) [back to overview]Sleep Quality - Shift From Baseline to End of Study (Placebo)
NCT00771758 (45) [back to overview]Summary of Subject Satisfaction With Treatment on Day 2
NCT00771758 (45) [back to overview]Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study
NCT00771758 (45) [back to overview]50% Responder Rate on Day 5.
NCT00771758 (45) [back to overview]50% Responder Rate on Day 3.
NCT00771758 (45) [back to overview]50% Responder Rate on Day 10.
NCT00771758 (45) [back to overview]30% Responder Rate on Day 3.
NCT00771758 (45) [back to overview]30% Responder Rate on Day 10.
NCT00771758 (45) [back to overview]Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study
NCT00771758 (45) [back to overview]Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10
NCT00771758 (45) [back to overview]Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2
NCT00771758 (45) [back to overview]Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5
NCT00771758 (45) [back to overview]Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5
NCT00771758 (45) [back to overview]Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10
NCT00771758 (45) [back to overview]Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2
NCT00771758 (45) [back to overview]Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3
NCT00771758 (45) [back to overview]Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5
NCT00771758 (45) [back to overview]Summary of Subject Satisfaction With Treatment on Day 10
NCT00771758 (45) [back to overview]Summary of Subject Satisfaction With Treatment on Day 3
NCT00771758 (45) [back to overview]Summary of Subject Satisfaction With Treatment on Day 5
NCT00771758 (45) [back to overview]Total Pain Relief (TOTPAR) Over 10 Days
NCT00771758 (45) [back to overview]Total Pain Relief (TOTPAR) Over 2 Days
NCT00771758 (45) [back to overview]Total Pain Relief (TOTPAR) Over 3 Days
NCT00771758 (45) [back to overview]Total Pain Relief (TOTPAR) Over 5 Days
NCT00771758 (45) [back to overview]Clinician Global Impression of Change (CGIC) at End of Study
NCT00771758 (45) [back to overview]Patient Global Impression of Change (PGIC) at End of Study
NCT00771758 (45) [back to overview]Sum of Pain Intensity Difference Over 5 Days (SPID120)
NCT00771758 (45) [back to overview]Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)
NCT00771758 (45) [back to overview]Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3
NCT00771758 (45) [back to overview]30% Responder Rate on Day 5.
NCT00771758 (45) [back to overview]Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)
NCT00771758 (45) [back to overview]Summary of Clinician Ease-of-Care at the End of Study: Bothersome
NCT00771758 (45) [back to overview]Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming
NCT00771758 (45) [back to overview]Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3
NCT00771758 (45) [back to overview]Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2
NCT00771758 (45) [back to overview]Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10
NCT00784277 (2) [back to overview]5-Day Sum of Pain Intensity Difference (SPID5)
NCT00784277 (2) [back to overview]Spontaneous Bowel Movements Per Week (SBMs/Week)
NCT00784810 (2) [back to overview]Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)
NCT00784810 (2) [back to overview]Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.
NCT00813488 (46) [back to overview]Total Pain Relief at 60 Minutes (TOTPAR60)
NCT00813488 (46) [back to overview]Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment
NCT00813488 (46) [back to overview]Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment
NCT00813488 (46) [back to overview]Clinician Global Impression of Change (CGIC)Endpoint
NCT00813488 (46) [back to overview]Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment
NCT00813488 (46) [back to overview]Pain Intensity Difference (PID) at 10 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)
NCT00813488 (46) [back to overview]Pain Intensity Difference (PID) at 30 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Intensity Difference (PID) at 45 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Intensity Difference (PID) at 5 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Intensity Difference (PID) at 60 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Relief (PR) Score at 5 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Relief Score at 10 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Relief Score at 15 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Relief Score at 30 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Relief Score at 45 Minutes Post-treatment
NCT00813488 (46) [back to overview]Pain Relief Score at 60 Minutes Post-treatment
NCT00813488 (46) [back to overview]Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment
NCT00813488 (46) [back to overview]Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment
NCT00813488 (46) [back to overview]Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment
NCT00813488 (46) [back to overview]Patient Global Impression of Change (PGIC) Endpoint
NCT00813488 (46) [back to overview]Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)
NCT00813488 (46) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment
NCT00813488 (46) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment
NCT00813488 (46) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment
NCT00813488 (46) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment
NCT00813488 (46) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment
NCT00813488 (46) [back to overview]Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment
NCT00813488 (46) [back to overview]Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)
NCT00813488 (46) [back to overview]Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)
NCT00813488 (46) [back to overview]Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes
NCT00813488 (46) [back to overview]Time to Any Pain Relief (APR) by Treatment <=10 Minutes
NCT00813488 (46) [back to overview]Time to Any Pain Relief (APR) by Treatment <=15 Minutes
NCT00813488 (46) [back to overview]Time to Any Pain Relief (APR) by Treatment <=30 Minutes
NCT00813488 (46) [back to overview]Time to Any Pain Relief (APR) by Treatment <=45 Minutes
NCT00813488 (46) [back to overview]Time to Any Pain Relief (APR) by Treatment <=60 Minutes
NCT00813488 (46) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes
NCT00813488 (46) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes
NCT00813488 (46) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes
NCT00813488 (46) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes
NCT00813488 (46) [back to overview]Use of Standard Rescue Medication
NCT00813488 (46) [back to overview]Breakthrough Pain Preference Questionnaire
NCT00813488 (46) [back to overview]Medication Performance Assessment 30 Minutes Post-treatment
NCT00813488 (46) [back to overview]Medication Performance Assessment 60 Minutes Post-treatment
NCT00813488 (46) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes
NCT00813488 (46) [back to overview]Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes
NCT00814580 (34) [back to overview]Clinician Global Impression of Change (CGIC) at End of Study
NCT00814580 (34) [back to overview]Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
NCT00814580 (34) [back to overview]Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
NCT00814580 (34) [back to overview]Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
NCT00814580 (34) [back to overview]Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
NCT00814580 (34) [back to overview]Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
NCT00814580 (34) [back to overview]Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
NCT00814580 (34) [back to overview]Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
NCT00814580 (34) [back to overview]Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
NCT00814580 (34) [back to overview]Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
NCT00814580 (34) [back to overview]Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
NCT00814580 (34) [back to overview]Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
NCT00814580 (34) [back to overview]Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
NCT00814580 (34) [back to overview]Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
NCT00814580 (34) [back to overview]Patient Global Impression of Change (PGIC) at End of Study
NCT00814580 (34) [back to overview]Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
NCT00814580 (34) [back to overview]Subject Satisfaction With Treatment
NCT00814580 (34) [back to overview]Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
NCT00814580 (34) [back to overview]Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
NCT00814580 (34) [back to overview]Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline
NCT00814580 (34) [back to overview]Summary of 50% Responder Rate (With Imputation) on Day 7
NCT00814580 (34) [back to overview]Summary of 50% Responder Rate (With Imputation) on Day 3
NCT00814580 (34) [back to overview]Summary of 30% Responder Rate (With Imputation) on Day 7
NCT00814580 (34) [back to overview]Summary of 30% Responder Rate (With Imputation) on Day 3
NCT00814580 (34) [back to overview]Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days
NCT00814580 (34) [back to overview]Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)
NCT00814580 (34) [back to overview]Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)
NCT00814580 (34) [back to overview]Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days
NCT00814580 (34) [back to overview]Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)
NCT00814580 (34) [back to overview]Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)
NCT00814580 (34) [back to overview]Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days
NCT00814580 (34) [back to overview]Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)
NCT00814580 (34) [back to overview]Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)
NCT00814580 (34) [back to overview]Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline
NCT00820027 (9) [back to overview]Percentage of Participants With at Least One Hypertension-Related AE
NCT00820027 (9) [back to overview]Percentage of Participants With at Least One Opioid-Related AE
NCT00820027 (9) [back to overview]Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
NCT00820027 (9) [back to overview]Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)
NCT00820027 (9) [back to overview]Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)
NCT00820027 (9) [back to overview]Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)
NCT00820027 (9) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an AE
NCT00820027 (9) [back to overview]Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure
NCT00820027 (9) [back to overview]Percentage of Participants With at Least One Edema-Related AE
NCT00935311 (4) [back to overview]Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)
NCT00935311 (4) [back to overview]Time to First Rescue Medication
NCT00935311 (4) [back to overview]TOTPAR (Total Pain Relief)
NCT00935311 (4) [back to overview]Participants With Adverse Events (AEs)
NCT00941304 (11) [back to overview]Change From Baseline in Cognitive Assessment Using CNS-VS
NCT00941304 (11) [back to overview]Duration of Analgesia
NCT00941304 (11) [back to overview]"Percentage of Participants With Excellent Investigator Global Rating of Study Drug"
NCT00941304 (11) [back to overview]Onset of Analgesia
NCT00941304 (11) [back to overview]Peak Pain Intensity Difference
NCT00941304 (11) [back to overview]Peak Pain Relief
NCT00941304 (11) [back to overview]Sum of Pain Intensity Difference From Baseline to 8 Hours
NCT00941304 (11) [back to overview]Sum of Pain Relief and Intensity Differences Over 2 Hours
NCT00941304 (11) [back to overview]Sum of Pain Relief and Intensity Differences Over 8 Hours
NCT00941304 (11) [back to overview]Total Pain Relief Over 8 Hours
NCT00941304 (11) [back to overview]"Percentage of Participants Reporting a Global Rating of Study Drug as Excellent"
NCT00944697 (1) [back to overview]Short Form McGill Pain Score.
NCT00955110 (1) [back to overview]High VAS - Emax (mm)
NCT00979953 (1) [back to overview]Change From Baseline in the Average Pain Score (NPRS) for Week 2
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population
NCT00985621 (47) [back to overview]Number of Days With Rescue Medication (RM) Usage
NCT00985621 (47) [back to overview]Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity
NCT00985621 (47) [back to overview]Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT00985621 (47) [back to overview]Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)
NCT00985621 (47) [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: mITT Population
NCT00985621 (47) [back to overview]Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population
NCT00985621 (47) [back to overview]Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population
NCT00985621 (47) [back to overview]Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
NCT00985621 (47) [back to overview]Number of Participants Who Discontinued From Study Due to Lack of Efficacy
NCT00985621 (47) [back to overview]Time to Discontinuation From Study Due to Lack of Efficacy
NCT00985621 (47) [back to overview]Amount of Rescue Medication Used
NCT00985621 (47) [back to overview]Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population
NCT00985621 (47) [back to overview]Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population
NCT00985621 (47) [back to overview]Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population
NCT00985621 (47) [back to overview]Number of Participants With Intravenous (IV) Doses of Study Medication
NCT00985621 (47) [back to overview]Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population
NCT00985621 (47) [back to overview]Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population
NCT00985621 (47) [back to overview]Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity
NCT00985621 (47) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population
NCT00985621 (47) [back to overview]Tanezumab Plasma Concentration
NCT00985621 (47) [back to overview]Total Nerve Growth Factor (NGF) Serum Concentration
NCT00985621 (47) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population
NCT00985621 (47) [back to overview]Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18
NCT00985621 (47) [back to overview]Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population
NCT00985621 (47) [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: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population
NCT00985621 (47) [back to overview]Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
NCT00985621 (47) [back to overview]Number of Participants With Rescue Medication (RM) Usage
NCT00986180 (36) [back to overview]Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5
NCT00986180 (36) [back to overview]Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event
NCT00986180 (36) [back to overview]Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)
NCT00986180 (36) [back to overview]Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)
NCT00986180 (36) [back to overview]SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)
NCT00986180 (36) [back to overview]SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)
NCT00986180 (36) [back to overview]SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)
NCT00986180 (36) [back to overview]SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)
NCT00986180 (36) [back to overview]SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation)
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit
NCT00986180 (36) [back to overview]Patient Global Impression of Change at End of Study
NCT00986180 (36) [back to overview]Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation
NCT00986180 (36) [back to overview]Satisfaction With Treatment at End of Study
NCT00986180 (36) [back to overview]Satisfaction With Treatment at Day 5
NCT00986180 (36) [back to overview]SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation)
NCT00986180 (36) [back to overview]Clinician Global Impression of Change at End of Study
NCT00986180 (36) [back to overview]Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days
NCT00986180 (36) [back to overview]Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event
NCT00986180 (36) [back to overview]Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event
NCT00986180 (36) [back to overview]Clinician Global Impression of Change at End of Study
NCT00986180 (36) [back to overview]Incidence of 30% Responders Without Nausea or Vomiting at Day 5
NCT00986180 (36) [back to overview]Incidence of 50% Responders Without Nausea or Vomiting at Day 5
NCT00986180 (36) [back to overview]Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain
NCT00986180 (36) [back to overview]Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain
NCT00986180 (36) [back to overview]Patient Global Impression of Change at End of Study
NCT00986180 (36) [back to overview]Satisfaction With Treatment at Day 5
NCT00986180 (36) [back to overview]Satisfaction With Treatment at End of Study
NCT00986180 (36) [back to overview]SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit
NCT00999544 (2) [back to overview]Abuse Liability Proxy
NCT00999544 (2) [back to overview]Respiration Depression
NCT01063868 (1) [back to overview]Number of Subjects With Treatment-emergent Adverse Events (TEAE)
NCT01083485 (2) [back to overview]Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets
NCT01083485 (2) [back to overview]Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value)
NCT01099709 (3) [back to overview]AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01099709 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01099709 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01100086 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01100086 (3) [back to overview]AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01100086 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01100320 (3) [back to overview]AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01100320 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01100320 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01101165 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01101165 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01101165 (3) [back to overview]AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01101178 (3) [back to overview]AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01101178 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01101178 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01101191 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01101191 (3) [back to overview]AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01101191 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01101308 (3) [back to overview]AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01101308 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01101308 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01101321 (3) [back to overview]Cmax - Maximum Observed Plasma Concentration
NCT01101321 (3) [back to overview]AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration
NCT01101321 (3) [back to overview]AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)
NCT01160614 (8) [back to overview]Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)
NCT01160614 (8) [back to overview]Single- and Multiple-dose PK Metric: Maximum Observed Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Cmax 0-12)
NCT01160614 (8) [back to overview]Multiple-dose PK Metric: Minimum Observed Plasma Concentration Just Prior to the Next Dose (Cmin)
NCT01160614 (8) [back to overview]Single- and Multiple-dose PK Metric: Mean Area Under the Plasma Concentration During Each Dosing Interval-time Curve From Hour 0 to 12 Hours of the First Dose of ORF (AUC 0-12)
NCT01160614 (8) [back to overview]Single- and Multiple-dose PK Metric: Time to Maximum Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Tmax 0-12)
NCT01160614 (8) [back to overview]Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]
NCT01160614 (8) [back to overview]The Number of Patients With Adverse Events as a Measure of Safety
NCT01160614 (8) [back to overview]Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)
NCT01165281 (7) [back to overview]Proportion of Patients With Various Levels of Pain Improvement (Responders)
NCT01165281 (7) [back to overview]Number of Patients Who Discontinued Due to Lack of Efficacy
NCT01165281 (7) [back to overview]Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories
NCT01165281 (7) [back to overview]Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period
NCT01165281 (7) [back to overview]Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale
NCT01165281 (7) [back to overview]Frequency of Rescue Medication Use for the Double-blind Treatment Period
NCT01165281 (7) [back to overview]Proportion of Patients Entering the Maintenance Period
NCT01192295 (11) [back to overview]Use of Supplemental Pain Medication
NCT01192295 (11) [back to overview]Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio
NCT01192295 (11) [back to overview]Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets
NCT01192295 (11) [back to overview]Parent/ Caregiver-Assessed Global Impression of Change (PGIC)
NCT01192295 (11) [back to overview]Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)
NCT01192295 (11) [back to overview]Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years
NCT01192295 (11) [back to overview]Pain Right Now Assessment by Patients Aged 6 to < 12 Years
NCT01192295 (11) [back to overview]Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years
NCT01192295 (11) [back to overview]The Number of Participants With Adverse Events as a Measure of Safety.
NCT01192295 (11) [back to overview]Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years
NCT01192295 (11) [back to overview]Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss
NCT01205126 (6) [back to overview]Breakthrough Pain Medication (Rescue Medication) Doses Taken
NCT01205126 (6) [back to overview]Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
NCT01205126 (6) [back to overview]Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29
NCT01205126 (6) [back to overview]Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29
NCT01205126 (6) [back to overview]Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29
NCT01205126 (6) [back to overview]Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29
NCT01270659 (3) [back to overview]Number of Participants Experiencing Any Adverse Events
NCT01270659 (3) [back to overview]Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)
NCT01270659 (3) [back to overview]Nausea Level
NCT01313780 (2) [back to overview]Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)
NCT01313780 (2) [back to overview]Change in Bowel Habits.
NCT01328782 (5) [back to overview]The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).
NCT01328782 (5) [back to overview]Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting
NCT01328782 (5) [back to overview]Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge
NCT01328782 (5) [back to overview]Time (in Minutes) to First Narcotic Administration
NCT01328782 (5) [back to overview]Need for IV Morphine of Fentanyl
NCT01358526 (5) [back to overview]Patient Global Impression of Change (PGIC)
NCT01358526 (5) [back to overview]Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
NCT01358526 (5) [back to overview]The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
NCT01358526 (5) [back to overview]Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
NCT01358526 (5) [back to overview]"The Average Pain Over the Last 24 Hours at Week 12 of the Double-blind Period"
NCT01369615 (1) [back to overview]The Number of Participants With Adverse Events as a Measure of Safety.
NCT01381120 (2) [back to overview]Change in Post-ureteroscopy Stent-induced Pain
NCT01381120 (2) [back to overview]Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.
NCT01402375 (4) [back to overview]50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score
NCT01402375 (4) [back to overview]Difference in Pain Intensity Score Before and After Last Dose.
NCT01402375 (4) [back to overview]Time to Follow up
NCT01402375 (4) [back to overview]Overall Satisfaction With the Pain Medicine
NCT01428583 (14) [back to overview]Number of Participants With Rescue Medication (Acetaminophen Tablets)
NCT01428583 (14) [back to overview]Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
NCT01428583 (14) [back to overview]Mean Daily Dose of Study Medication (Oxycodone Component)
NCT01428583 (14) [back to overview]Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity
NCT01428583 (14) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions
NCT01428583 (14) [back to overview]Subjective Opiate Withdrawal Scale (SOWS) Score
NCT01428583 (14) [back to overview]Percentage of Participants With Response to Urine Drug Test
NCT01428583 (14) [back to overview]Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above
NCT01428583 (14) [back to overview]Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score
NCT01428583 (14) [back to overview]Participants Global Assessment of Treatment Satisfaction
NCT01428583 (14) [back to overview]Duration of Exposure to Study Medication
NCT01428583 (14) [back to overview]Time to Stabilization of Study Medication
NCT01428583 (14) [back to overview]Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
NCT01428583 (14) [back to overview]Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination
NCT01500317 (5) [back to overview]Colonic Geometric Center at 8 and 48 Hours
NCT01500317 (5) [back to overview]Ascending Colon Emptying (AC t1/2)
NCT01500317 (5) [back to overview]Colonic Filling at 6 Hours
NCT01500317 (5) [back to overview]Colonic Transit, Geometric Center at 24 Hours
NCT01500317 (5) [back to overview]Gastric Emptying Half-time (t1/2) at 24 Hours
NCT01502644 (1) [back to overview]Percent Change in Average Daily Pain Score
NCT01571362 (101) [back to overview]Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
NCT01571362 (101) [back to overview]Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor
NCT01571362 (101) [back to overview]Satisfaction With Treatment at Randomization Baseline
NCT01571362 (101) [back to overview]Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants
NCT01571362 (101) [back to overview]SOWS Total Score During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]SOWS Total Score During the Post-Treatment Period
NCT01571362 (101) [back to overview]Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS
NCT01571362 (101) [back to overview]Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants
NCT01571362 (101) [back to overview]Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)
NCT01571362 (101) [back to overview]Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS
NCT01571362 (101) [back to overview]Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).
NCT01571362 (101) [back to overview]Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)
NCT01571362 (101) [back to overview]Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Mean Oxycodone Average Daily Dose During the Open-Label Titration Period
NCT01571362 (101) [back to overview]Mean Oxycodone Duration of Titration During the Open-Label Titration Period
NCT01571362 (101) [back to overview]Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Median Oxycodone Average Daily Dose During the Open-Label Titration Period
NCT01571362 (101) [back to overview]Median Oxycodone Duration of Titration During the Open-Label Titration Period
NCT01571362 (101) [back to overview]Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy
NCT01571362 (101) [back to overview]Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%
NCT01571362 (101) [back to overview]Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%
NCT01571362 (101) [back to overview]Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%
NCT01571362 (101) [back to overview]Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
NCT01571362 (101) [back to overview]Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
NCT01571362 (101) [back to overview]Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index
NCT01571362 (101) [back to overview]Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index
NCT01571362 (101) [back to overview]Change From Screening Period to Randomization Baseline in RMDQ Total Score
NCT01571362 (101) [back to overview]Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score
NCT01571362 (101) [back to overview]Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS
NCT01571362 (101) [back to overview]Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index
NCT01571362 (101) [back to overview]Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score
NCT01571362 (101) [back to overview]Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain
NCT01571362 (101) [back to overview]Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain
NCT01571362 (101) [back to overview]Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index
NCT01571362 (101) [back to overview]Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now
NCT01571362 (101) [back to overview]Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index
NCT01571362 (101) [back to overview]Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain
NCT01571362 (101) [back to overview]Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
NCT01571362 (101) [back to overview]Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital
NCT01571362 (101) [back to overview]Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
NCT01571362 (101) [back to overview]Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks
NCT01571362 (101) [back to overview]Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital
NCT01571362 (101) [back to overview]Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain
NCT01571362 (101) [back to overview]Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period
NCT01571362 (101) [back to overview]COWS Total Score During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]COWS Total Score During the Post-Treatment Period
NCT01571362 (101) [back to overview]Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
NCT01571362 (101) [back to overview]Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
NCT01571362 (101) [back to overview]Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period
NCT01571362 (101) [back to overview]Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period
NCT01571362 (101) [back to overview]Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period
NCT01571362 (101) [back to overview]Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).
NCT01571362 (101) [back to overview]Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment
NCT01571362 (101) [back to overview]Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline
NCT01571362 (101) [back to overview]Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period
NCT01571362 (101) [back to overview]Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category
NCT01571362 (101) [back to overview]Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category
NCT01587274 (1) [back to overview]Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire
NCT01643772 (22) [back to overview]ke for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]CL for Participants Who Received Multiple Dose
NCT01643772 (22) [back to overview]Tmax,t1/2 for Participants Who Received Multiple Dose
NCT01643772 (22) [back to overview]AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
NCT01643772 (22) [back to overview]Tmax,t1/2 for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Cmax,Clast for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)
NCT01643772 (22) [back to overview]Tmax,t1/2 for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
NCT01643772 (22) [back to overview]Fluctuation Index (DF) for Participants Who Received Multiple Dose
NCT01643772 (22) [back to overview]ke for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Vd for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Css_min,Css_max and Css_av for Participants Who Received Multiple Dose
NCT01643772 (22) [back to overview]Cmax,Clast for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Clearance Rate for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Clearance Rate for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)
NCT01643772 (22) [back to overview]The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)
NCT01643772 (22) [back to overview]AUCss for Participants Who Received Multiple Dose
NCT01643772 (22) [back to overview]AUC0-t and AUC0-∞ for Participants Who Received a Single Dose
NCT01643772 (22) [back to overview]Vd for Participants Who Received a Single Dose
NCT01675531 (4) [back to overview]Physician's Overall Satisfaction
NCT01675531 (4) [back to overview]Patient's Overall Satisfaction
NCT01675531 (4) [back to overview]NRS (Numeric Rating Scale)
NCT01675531 (4) [back to overview]Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).
NCT01675622 (9) [back to overview]Degree of Pain Relief Within 24hrs After Treatment
NCT01675622 (9) [back to overview]Numerical Rating Scale (NRS)
NCT01675622 (9) [back to overview]The Average Dose of Study Medicine Used During Double Blind Treatment Period
NCT01675622 (9) [back to overview]Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
NCT01675622 (9) [back to overview]Average Number of Titrations
NCT01675622 (9) [back to overview]Times of Breakthrough Pain Occurrence
NCT01675622 (9) [back to overview]Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
NCT01675622 (9) [back to overview]Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
NCT01675622 (9) [back to overview]the Total Dose of Rescue Medicine for Breakthrough Pain.
NCT01685684 (9) [back to overview]Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase
NCT01685684 (9) [back to overview]Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)
NCT01685684 (9) [back to overview]Time-to-exit From the Study for All Causes
NCT01685684 (9) [back to overview]Changes in Quality of Life
NCT01685684 (9) [back to overview]Percent Reduction in Pain Intensity for Responders
NCT01685684 (9) [back to overview]Rescue Medication Usage by Dose
NCT01685684 (9) [back to overview]Rescue Medication Use by Dosage
NCT01685684 (9) [back to overview]Weekly Changes in Pain Intensity
NCT01685684 (9) [back to overview]Patient Global Impression of Change (PGIC)
NCT01719757 (4) [back to overview]Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
NCT01719757 (4) [back to overview]Change of Constipation Assessment From Baseline to Visit 2(End Visit)
NCT01719757 (4) [back to overview]Change in Numeric Rating Scales (NRS) Score
NCT01719757 (4) [back to overview]Change of Eastern Cooperative Oncology Group(ECOG) Performance Status
NCT01746901 (52) [back to overview]Overall Drug Liking: Minimum Effect (Emin)
NCT01746901 (52) [back to overview]Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone
NCT01746901 (52) [back to overview]Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)
NCT01746901 (52) [back to overview]Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)
NCT01746901 (52) [back to overview]Nausea: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour
NCT01746901 (52) [back to overview]Bad Drug Effects: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone
NCT01746901 (52) [back to overview]Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Overall Drug Liking: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Overall Drug Liking: Mean Effect (Emean)
NCT01746901 (52) [back to overview]Plasma Terminal Half-Life (t1/2) of Oxycodone
NCT01746901 (52) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone
NCT01746901 (52) [back to overview]Number of Participants With Clinically Significant Change in Vital Sign Examinations
NCT01746901 (52) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol
NCT01746901 (52) [back to overview]Take Drug Again Effect at Hours 12, 24 and 36
NCT01746901 (52) [back to overview]Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Overall Drug Liking Effect at Hours 12, 24 and 36
NCT01746901 (52) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
NCT01746901 (52) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol
NCT01746901 (52) [back to overview]Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone
NCT01746901 (52) [back to overview]Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]Take Drug Again: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Take Drug Again: Minimum Effect (Emin)
NCT01746901 (52) [back to overview]Take Drug Again: Mean Effect (Emean)
NCT01746901 (52) [back to overview]Sleepy: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Sleepy: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Any Drug Effects: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)dn] of Oxycodone
NCT01746901 (52) [back to overview]Drug Liking: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Drug Liking: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Feel Sick: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Feel Sick: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Pupillometry: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Good Drug Effects: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]High: Area Under Effect Curve (AUE) From 0-2 Hour
NCT01746901 (52) [back to overview]Nausea: Peak Effect (Emax)
NCT01746901 (52) [back to overview]High: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
NCT01746901 (52) [back to overview]High: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Pupillometry: Peak Effect (Emax)
NCT01746901 (52) [back to overview]Dizzy: Time to Maximum (Peak) Effect (TEmax)
NCT01746901 (52) [back to overview]Dizzy: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Dizzy: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Subject Rating Scale for Nasal Effects: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Sleepy: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour
NCT01775189 (58) [back to overview]Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone
NCT01775189 (58) [back to overview]Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol
NCT01775189 (58) [back to overview]Overall Drug Liking Effect at Hours 12 and 24
NCT01775189 (58) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
NCT01775189 (58) [back to overview]Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone
NCT01775189 (58) [back to overview]Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol
NCT01775189 (58) [back to overview]High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours
NCT01775189 (58) [back to overview]Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone
NCT01775189 (58) [back to overview]Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol
NCT01775189 (58) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone
NCT01775189 (58) [back to overview]Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol
NCT01775189 (58) [back to overview]Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone
NCT01775189 (58) [back to overview]Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol
NCT01775189 (58) [back to overview]Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
NCT01775189 (58) [back to overview]Take Drug Again: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Take Drug Again: Mean Effect (Emean)
NCT01775189 (58) [back to overview]Sleepy: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Pupillometry: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Pupillometry: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Percentage of Dose (Drug Powder) Insufflated
NCT01775189 (58) [back to overview]Overall Drug Liking: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Overall Drug Liking: Mean Effect (Emean)
NCT01775189 (58) [back to overview]Number of Participants With Clinically Significant Change in Vital Sign Examinations
NCT01775189 (58) [back to overview]Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)
NCT01775189 (58) [back to overview]Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)
NCT01775189 (58) [back to overview]Nausea: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Nausea: Peak Effect (Emax)
NCT01775189 (58) [back to overview]High: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]High: Peak Effect (Emax)
NCT01775189 (58) [back to overview]High: Area Under Effect Curve (AUE) From 0-2 Hour
NCT01775189 (58) [back to overview]Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Good Drug Effects: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Feel Sick: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Feel Sick: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Drug Liking: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Drug Liking: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour
NCT01775189 (58) [back to overview]Dizzy: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Take Drug Again Effect at Hours 12 and 24
NCT01775189 (58) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol
NCT01775189 (58) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone
NCT01775189 (58) [back to overview]Bad Drug Effects: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
NCT01775189 (58) [back to overview]Any Drug Effects: Peak Effect (Emax)
NCT01775189 (58) [back to overview]Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)
NCT01809106 (3) [back to overview]The Opioid Escalation Index
NCT01809106 (3) [back to overview]Proportion of Full-responder
NCT01809106 (3) [back to overview]Proportion of Non-Responder (NR) Participants
NCT01811186 (6) [back to overview]Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
NCT01811186 (6) [back to overview]Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug
NCT01811186 (6) [back to overview]The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.
NCT01811186 (6) [back to overview]Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment
NCT01811186 (6) [back to overview]Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug
NCT01811186 (6) [back to overview]The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.
NCT01811238 (6) [back to overview]Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)
NCT01811238 (6) [back to overview]Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.
NCT01811238 (6) [back to overview]Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline
NCT01811238 (6) [back to overview]The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline
NCT01811238 (6) [back to overview]Clinical Global Impression of Change(CGIC)
NCT01811238 (6) [back to overview]Patient Global Impression of Change(PGIC)
NCT01838616 (31) [back to overview]Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment
NCT01838616 (31) [back to overview]Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment
NCT01838616 (31) [back to overview]Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids
NCT01838616 (31) [back to overview]Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids
NCT01838616 (31) [back to overview]Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep)
NCT01838616 (31) [back to overview]Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings
NCT01838616 (31) [back to overview]Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept
NCT01838616 (31) [back to overview]Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg
NCT01838616 (31) [back to overview]Changes in the Short Form Health Survey (SF-12) at the End of Treatment
NCT01838616 (31) [back to overview]Clinician Global Impression of Change at the End of Treatment
NCT01838616 (31) [back to overview]EuroQol-5 (EQ-5D) Health Status Index Outcome
NCT01838616 (31) [back to overview]Hospital Anxiety and Depression Scale: Anxiety
NCT01838616 (31) [back to overview]Hospital Anxiety and Depression Scale: Depression
NCT01838616 (31) [back to overview]Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment
NCT01838616 (31) [back to overview]painDETECT Final Assessment
NCT01838616 (31) [back to overview]Patient Global Impression of Change at the End of Treatment
NCT01838616 (31) [back to overview]Recalled Average Pain Intensity
NCT01838616 (31) [back to overview]Short Form Health Survey (SF-12)
NCT01838616 (31) [back to overview]Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep
NCT01838616 (31) [back to overview]Sleep Evaluation: Latency (Time Taken to Fall Asleep)
NCT01838616 (31) [back to overview]Sleep Evaluation: Number of Awakenings
NCT01838616 (31) [back to overview]Sleep Evaluation: Number of Hours Slept
NCT01838616 (31) [back to overview]Worst Pain Intensity Over the Past 24 Hours
NCT01838616 (31) [back to overview]Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment
NCT01838616 (31) [back to overview]Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression
NCT01838616 (31) [back to overview]Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety
NCT01838616 (31) [back to overview]Change in painDETECT Final Assessment at the End of Treatment
NCT01838616 (31) [back to overview]Change in Recalled Average Pain Intensity at the End of Treatment
NCT01838616 (31) [back to overview]Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)
NCT01838616 (31) [back to overview]Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score
NCT01838616 (31) [back to overview]Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment
NCT01859715 (2) [back to overview]Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users
NCT01859715 (2) [back to overview]Adverse Drug Events
NCT01871285 (5) [back to overview]Change From Baseline in Maximum COWS Total Score
NCT01871285 (5) [back to overview]Number of Responders
NCT01871285 (5) [back to overview]Change From Baseline in COWS Total Score Over Time
NCT01871285 (5) [back to overview]"Change From Baseline in Pain Now Over Time Using NRS"
NCT01871285 (5) [back to overview]Maximum COWS Total Score
NCT01885182 (9) [back to overview]The Change of BPI-SF at visit8
NCT01885182 (9) [back to overview]The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8
NCT01885182 (9) [back to overview]The Change of Bowel Movement by Visit
NCT01885182 (9) [back to overview]The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit
NCT01885182 (9) [back to overview]The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9
NCT01885182 (9) [back to overview]To Assess Quality of Life Based on EQ-5D
NCT01885182 (9) [back to overview]The Change of BFI-Bowel Function Index at visit8
NCT01885182 (9) [back to overview]The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8
NCT01885182 (9) [back to overview]The Change of Rescue Medication Use From visit5 to visit8
NCT01959204 (3) [back to overview]Cmax of Oxycodone Oral Solution.
NCT01959204 (3) [back to overview]Number of Participants With Adverse Events
NCT01959204 (3) [back to overview]Tmax of Oxycodone Oral Solution.
NCT02109640 (3) [back to overview]Pain Scores
NCT02109640 (3) [back to overview]Prevalence of Postoperative Gut Dysfunction
NCT02109640 (3) [back to overview]Total Opioid Analgesia Consumption
NCT02455518 (2) [back to overview]Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
NCT02455518 (2) [back to overview]Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores
NCT02480114 (3) [back to overview]Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))
NCT02480114 (3) [back to overview]Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)
NCT02480114 (3) [back to overview]Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)
NCT02519023 (14) [back to overview]Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
NCT02519023 (14) [back to overview]Total Opioid Use for Pain Control
NCT02519023 (14) [back to overview]Overall Benefit of Analgesia Score (OBAS)
NCT02519023 (14) [back to overview]Opioid Used From 24-48 Hours Post Surgery
NCT02519023 (14) [back to overview]Number of Patients Admitted Post Operatively
NCT02519023 (14) [back to overview]Number of Participants With Nausea and Vomiting
NCT02519023 (14) [back to overview]Quality of Recovery 15 (QoR15) Score
NCT02519023 (14) [back to overview]Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents
NCT02519023 (14) [back to overview]Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)
NCT02519023 (14) [back to overview]Maximal Pain Score Patient Felt From 48-72 Hours After Surgery
NCT02519023 (14) [back to overview]Maximal Pain Score of Patient From Time 0-24 Hours After Surgery
NCT02519023 (14) [back to overview]Maximal Pain Score for Patient From Time 24-48 Hours After Surgery
NCT02519023 (14) [back to overview]Length of Time in Phase 1 and Phase 2 of Recovery
NCT02519023 (14) [back to overview]Patient Satisfaction With Pain Management
NCT02601027 (6) [back to overview]Time to Ambulation
NCT02601027 (6) [back to overview]Quality of Life Measurement
NCT02601027 (6) [back to overview]Time to First Bowel Movement
NCT02601027 (6) [back to overview]Post-operative Anti-emetic Usage
NCT02601027 (6) [back to overview]Post-operative Narcotic Usage
NCT02601027 (6) [back to overview]Post-operative Pain Score
NCT02625181 (4) [back to overview]Adherence to PONV Guidelines
NCT02625181 (4) [back to overview]Time to Discharge From the Postanesthesia Care Unit (PACU)
NCT02625181 (4) [back to overview]The Number of Prophylactic Interventions for PONV
NCT02625181 (4) [back to overview]PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting
NCT02660229 (2) [back to overview]Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration
NCT02660229 (2) [back to overview]Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.
NCT02680847 (6) [back to overview]Number of Participants With Clinical Opiate Withdrawal Scale (COWS)
NCT02680847 (6) [back to overview]Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)
NCT02680847 (6) [back to overview]Number of Participants With All-causality and Treatment-related Adverse Events (AEs)
NCT02680847 (6) [back to overview]Number of All-causality and Treatment-related AEs, by Intensity
NCT02680847 (6) [back to overview]Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria
NCT02680847 (6) [back to overview]Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)
NCT02740114 (3) [back to overview]Participants Opioid-Free After Gynecologic Surgery
NCT02740114 (3) [back to overview]Symptom Scores
NCT02740114 (3) [back to overview]Participants Opioid-Free After Gynecologic Surgery for 48 Hours
NCT02741076 (14) [back to overview]Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
NCT02741076 (14) [back to overview]Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
NCT02741076 (14) [back to overview]Patient Global Impression of Change (PGIC)
NCT02741076 (14) [back to overview]Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)
NCT02741076 (14) [back to overview]Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument)
NCT02741076 (14) [back to overview]Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women
NCT02741076 (14) [back to overview]Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument
NCT02741076 (14) [back to overview]Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
NCT02741076 (14) [back to overview]Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)
NCT02741076 (14) [back to overview]Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)
NCT02741076 (14) [back to overview]Digit Symbol Substitution Test
NCT02741076 (14) [back to overview]Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)
NCT02741076 (14) [back to overview]Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)
NCT02741076 (14) [back to overview]Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8)
NCT02932579 (2) [back to overview]Number of Participants That Did Not Need Opioid Analgesic Prescriptions
NCT02932579 (2) [back to overview]Mean Pain Score
NCT02934191 (2) [back to overview]Difference in Amount of Rescue Pain Medication Consumed
NCT02934191 (2) [back to overview]Difference in Number of Days Requiring Rescue Pain Medication
NCT03055507 (6) [back to overview]Pain Visual Analogue Scale (VAS)
NCT03055507 (6) [back to overview]Pain Visual Analogue Scale
NCT03055507 (6) [back to overview]Pain Visual Analogue Scale
NCT03055507 (6) [back to overview]Number of Opioid Pills
NCT03055507 (6) [back to overview]Bleeding Visual Analogue Scale
NCT03055507 (6) [back to overview]0-4 Bleeding Scale
NCT03088826 (1) [back to overview]Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)
NCT03105518 (2) [back to overview]Amount of Discomfort Following Discharge Until Embryo Transfer
NCT03105518 (2) [back to overview]Amount of Discomfort
NCT03139240 (3) [back to overview]<7 Weeks of Gestation - Maximum Self-reported Pain Score
NCT03139240 (3) [back to overview]7-10 Weeks Gestation - Maximum Self-reported Pain Score
NCT03139240 (3) [back to overview]Overall Maximum Self-reported Pain Score
NCT03173456 (6) [back to overview]Percentage of Patients Who Received Rescue Medication
NCT03173456 (6) [back to overview]Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication
NCT03173456 (6) [back to overview]Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain
NCT03173456 (6) [back to overview]Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication
NCT03173456 (6) [back to overview]Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline
NCT03173456 (6) [back to overview]Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline
NCT03202550 (9) [back to overview]Baseline Pain Score Before Drugs Were Administered
NCT03202550 (9) [back to overview]Number of Participants With Desired Number of Dilators Inserted
NCT03202550 (9) [back to overview]Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device
NCT03202550 (9) [back to overview]Pain Score During Paracervical Block
NCT03202550 (9) [back to overview]Pain Score Before Speculum Placement
NCT03202550 (9) [back to overview]Pain Score at Tenaculum Placement
NCT03202550 (9) [back to overview]Pain Score After Speculum Placement
NCT03202550 (9) [back to overview]Pain Score After First Dilator Placement
NCT03202550 (9) [back to overview]Pain Score 15 Minutes After Last Dilator Placed
NCT03254459 (7) [back to overview]Percentage of Participants Provided Rescue Medication for Nausea
NCT03254459 (7) [back to overview]Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days
NCT03254459 (7) [back to overview]Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
NCT03254459 (7) [back to overview]Number of Participants With Abnormal Oral Cavity Examinations
NCT03254459 (7) [back to overview]Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
NCT03254459 (7) [back to overview]Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)
NCT03254459 (7) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs)
NCT03389750 (1) [back to overview]"Positive Subjective Drug Effects (i.e., Drug Liking)."
NCT03398278 (8) [back to overview]Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
NCT03398278 (8) [back to overview]AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
NCT03398278 (8) [back to overview]AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State
NCT03398278 (8) [back to overview]Number of AEs Related to Vital Sign
NCT03398278 (8) [back to overview]Number of AEs Related to ECGs
NCT03398278 (8) [back to overview]Number of AEs Related to Physical Examination
NCT03398278 (8) [back to overview]Number of Lab Tests With Clinical Significance
NCT03398278 (8) [back to overview]Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
NCT03398330 (8) [back to overview]Number of AEs Related to Vital Signs
NCT03398330 (8) [back to overview]Number of AEs Related to Physical Examination
NCT03398330 (8) [back to overview]Number of AEs Related to ECGs
NCT03398330 (8) [back to overview]AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
NCT03398330 (8) [back to overview]AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
NCT03398330 (8) [back to overview]Number of Lab Tests With Clinical Significance
NCT03398330 (8) [back to overview]Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State
NCT03398330 (8) [back to overview]Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State
NCT03403504 (8) [back to overview]AUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State
NCT03403504 (8) [back to overview]AUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State
NCT03403504 (8) [back to overview]Cmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State
NCT03403504 (8) [back to overview]Number of AEs Related to ECGs
NCT03403504 (8) [back to overview]Number of AEs Related to Physical Examination
NCT03403504 (8) [back to overview]Number of Lab Tests With Clinical Significance
NCT03403504 (8) [back to overview]Adverse Events of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State
NCT03403504 (8) [back to overview]Number of AEs Related to Vital Signs
NCT03415581 (2) [back to overview]Opioid Craving
NCT03415581 (2) [back to overview]Opioid Self-administration
NCT03435692 (6) [back to overview]Muscle Spasm
NCT03435692 (6) [back to overview]Maximum Pain Score
NCT03435692 (6) [back to overview]Itching
NCT03435692 (6) [back to overview]Hospital Length of Stay
NCT03435692 (6) [back to overview]Nausea
NCT03435692 (6) [back to overview]Total Perioperative Morphine Equivalents
NCT03480009 (4) [back to overview]Mean Pain Scores Via Numeric Rating Scale (NRS-11)
NCT03480009 (4) [back to overview]Worst Pain Measurement Via Numeric Rating Scale (NRS-11)
NCT03480009 (4) [back to overview]Analgesic Usage During Medication Abortion
NCT03480009 (4) [back to overview]Analgesic Usage During Medication Abortion
NCT03545893 (1) [back to overview]Maximum Pain Score
NCT03584373 (7) [back to overview]Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery
NCT03584373 (7) [back to overview]Rates of Constipation
NCT03584373 (7) [back to overview]Peak Pain Intensity Level
NCT03584373 (7) [back to overview]Average Pain Intensity Level
NCT03584373 (7) [back to overview]Perception of an Acceptable Pain Intensity Level
NCT03584373 (7) [back to overview]Satisfaction With Pain Relief
NCT03584373 (7) [back to overview]Current Pain Intensity Level
NCT03588806 (8) [back to overview]Patient Global Impression of Change (PGIC)
NCT03588806 (8) [back to overview]Opioid Medication Satisfaction
NCT03588806 (8) [back to overview]Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days
NCT03588806 (8) [back to overview]PROMIS Physical Function
NCT03588806 (8) [back to overview]Change in Pill Swallowing Difficulty Score
NCT03588806 (8) [back to overview]Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours
NCT03588806 (8) [back to overview]PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance
NCT03588806 (8) [back to overview]Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
NCT03588910 (5) [back to overview]Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)
NCT03588910 (5) [back to overview]Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)
NCT03588910 (5) [back to overview]Number of Oxycodone Tablets Used Day 1
NCT03588910 (5) [back to overview]Additional Contacts With Provider
NCT03588910 (5) [back to overview]Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery
NCT03599089 (3) [back to overview]Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)
NCT03599089 (3) [back to overview]Percentage of Subjects Opioid Free
NCT03599089 (3) [back to overview]Total Opioid Consumption (in Daily Morphine Equivalents)
NCT03618823 (9) [back to overview]Mean of Total Quantity of Pain Medications Taken
NCT03618823 (9) [back to overview]Non-opioid Group Switching to Opioid Group
NCT03618823 (9) [back to overview]Number of Participants With ED (Emergency Department) or Urgent Care Visits
NCT03618823 (9) [back to overview]Number of Participants With Readmissions
NCT03618823 (9) [back to overview]Overall Pain Relief Satisfaction
NCT03618823 (9) [back to overview]Post-operative Nursing Phone Calls
NCT03618823 (9) [back to overview]Average Dose of Each Analgesic Used
NCT03618823 (9) [back to overview]Average Pain Burden
NCT03618823 (9) [back to overview]Duration of Each Analgesic Used
NCT03657810 (9) [back to overview]Number of Doses of Study Medication Taken Over Days 3to7
NCT03657810 (9) [back to overview]Percentage of Patients With Complete Absence of OINV (no Nausea, no Vomiting, and no Use of Anti-emetic Medication) Over 48 Hours
NCT03657810 (9) [back to overview]Number of Doses of Study Medication Taken Per Day Over Days 3to7
NCT03657810 (9) [back to overview]The Sum of Pain Intensity Differences (on PI-NRS) Over 48 Hours (SPID48)
NCT03657810 (9) [back to overview]Percentage of Patients With Any Vomiting Over 48 Hours
NCT03657810 (9) [back to overview]Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)
NCT03657810 (9) [back to overview]Percentage of Patients With Any Nausea Over 48 Hours
NCT03657810 (9) [back to overview]Percentage of Patients With Any Nausea or Vomiting Over 48 Hours
NCT03657810 (9) [back to overview]Percentage of Participants With OINV Over 48 Hours
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Pain Severity
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Medication Log
NCT03783702 (25) [back to overview]Severity of Epistaxis
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Brief Pain Inventory (BPI) Score
NCT03783702 (25) [back to overview]Pain Severity
NCT03789318 (5) [back to overview]Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores
NCT03789318 (5) [back to overview]Percent of Opioid Free Subjects
NCT03789318 (5) [back to overview]Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)
NCT03789318 (5) [back to overview]Total Opioid Consumption
NCT03789318 (5) [back to overview]Time to Opioid Cessation or Freedom
NCT03802227 (5) [back to overview]Change in Pupil Diameter Via Pupillometry
NCT03802227 (5) [back to overview]Treatment-Emergent Adverse Events (TEAEs)
NCT03802227 (5) [back to overview]Brain Activity Measured Via fMRI
NCT03802227 (5) [back to overview]Time to Maximum Concentration (Tmax)
NCT03802227 (5) [back to overview]Plasma Drug Concentration
NCT03996694 (4) [back to overview]Change in Ratio of Minute Ventilation
NCT03996694 (4) [back to overview]Respiratory Drive
NCT03996694 (4) [back to overview]Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.
NCT03996694 (4) [back to overview]Pupil Diameter
NCT04149964 (8) [back to overview]Participant Use of Additional Pain Medication
NCT04149964 (8) [back to overview]Participant Use of Acetaminophen as Needed
NCT04149964 (8) [back to overview]Number of Doses of Opiate (Narcotic) Pain Medication
NCT04149964 (8) [back to overview]Lowest Subjective Pain Score
NCT04149964 (8) [back to overview]Highest Subjective Pain Score
NCT04149964 (8) [back to overview]Chronic Use of Pain Medication
NCT04149964 (8) [back to overview]Percentage of Time Participant Experienced Severe Pain
NCT04149964 (8) [back to overview]Participant Use of Scheduled Acetaminophen Around the Clock
NCT04194528 (1) [back to overview]Feasibility Determined by Accrual, Adherence and Patient Retention.
NCT04223609 (8) [back to overview]Saccadic Latency
NCT04223609 (8) [back to overview]Fixation Time - High Cognitive Workload
NCT04223609 (8) [back to overview]Vertical Saccadic Velocity
NCT04223609 (8) [back to overview]Fixation Time - Low Cognitive Workload
NCT04223609 (8) [back to overview]Fixation Time - Medium Cognitive Workload
NCT04223609 (8) [back to overview]Horizontal Saccadic Velocity
NCT04223609 (8) [back to overview]Oculo-Cognitive Addition Test (OCAT) Completion Time
NCT04223609 (8) [back to overview]Diagonal Saccadic Velocity
NCT04246541 (2) [back to overview]Narcotic Medication Consumed
NCT04246541 (2) [back to overview]Pain Levels Recorded With a Visual Analogue Scale
NCT04246554 (2) [back to overview]Narcotic Medication
NCT04246554 (2) [back to overview]Postoperative Visual Analogue Scale Scores
NCT04285853 (1) [back to overview]Pain Level: Numeric Rating Scale
NCT04296396 (9) [back to overview]Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge
NCT04296396 (9) [back to overview]Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge
NCT04296396 (9) [back to overview]Number of Participants Who Indicated an Improved Global Impression of Change
NCT04296396 (9) [back to overview]Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory
NCT04296396 (9) [back to overview]Pain Interference Score ≥ 4 at 2 Weeks Post Discharge
NCT04296396 (9) [back to overview]Worst Pain Severity Score at 2 Weeks Post Discharge
NCT04296396 (9) [back to overview]Number of Opioid Tablets Unused Since Discharge
NCT04296396 (9) [back to overview]Infant Hospital Readmissions
NCT04296396 (9) [back to overview]Maternal Depression Score ≥ 13
NCT04399122 (2) [back to overview]Post-operative Uncorrected Visual Acuity Right and Left Eye
NCT04399122 (2) [back to overview]Post-operative Average Pain Score
NCT04429022 (8) [back to overview]Operative Time
NCT04429022 (8) [back to overview]Length of Stay in Hours
NCT04429022 (8) [back to overview]Estimated Blood Loss
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required Through 3-24h Post op in MME
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
NCT04429022 (8) [back to overview]Pain Scores
NCT04429022 (8) [back to overview]Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
NCT04429022 (8) [back to overview]Pain Scores
NCT04522206 (3) [back to overview]Length of Stay in Hospital
NCT04522206 (3) [back to overview]Opioid Sparing and Rescue Time
NCT04522206 (3) [back to overview]Visual Analogue Scale (VAS) for Pain
NCT05053126 (5) [back to overview]"Bipolar VAS for Overall Drug Liking"
NCT05053126 (5) [back to overview]"Bipolar VAS for Take Drug Again"
NCT05053126 (5) [back to overview]"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."
NCT05053126 (5) [back to overview]"Unipolar VAS for Any Drug Effect"
NCT05053126 (5) [back to overview]"Unipolar VAS for High - Maximum Effect (Emax)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 8 Hours (AUEC8)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 4 Hours (AUEC4)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 3 Hours (AUEC3)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 2 Hours (AUEC2)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 1 Hour (AUEC1)"
NCT05319756 (26) [back to overview]"Unipolar VAS for Bad Drug Effect"
NCT05319756 (26) [back to overview]"Unipolar VAS for Any Drug Effect"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking - Time to Maximum Effect (TEmax)"
NCT05319756 (26) [back to overview]"Area Under the Effect Curve for High VAS (AUEClast)"
NCT05319756 (26) [back to overview]Tmax of Oxycodone
NCT05319756 (26) [back to overview]Tmax of Gabapentin
NCT05319756 (26) [back to overview]Half-life (t½) of Oxycodone
NCT05319756 (26) [back to overview]Half-life (t½) of Gabapentin
NCT05319756 (26) [back to overview]Cmax of Oxycodone
NCT05319756 (26) [back to overview]Cmax of Gabapentin
NCT05319756 (26) [back to overview]AUClast of Oxycodone
NCT05319756 (26) [back to overview]AUClast of Gabapentin
NCT05319756 (26) [back to overview]AUCinf of Oxycodone
NCT05319756 (26) [back to overview]AUCinf of Gabapentin
NCT05319756 (26) [back to overview]"Unipolar VAS for High: Time to Maximum Effect (TEmax)"
NCT05319756 (26) [back to overview]"Unipolar VAS for High - Maximum Effect (Emax)"
NCT05319756 (26) [back to overview]"Unipolar VAS for Good Drug Effect"
NCT05319756 (26) [back to overview]"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."
NCT05319756 (26) [back to overview]"Bipolar VAS for Take Drug Again"
NCT05319756 (26) [back to overview]"Bipolar VAS for Overall Drug Liking"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)"
NCT05327777 (2) [back to overview]Satisfaction Scores Ranging From 1 - 10
NCT05327777 (2) [back to overview]Morphine Milligram Equivalents Taken by Participants

Drug Liking

"Subjective rating of drug Liking on a scale of 0 to 100. Greater numbers indicate greater subjective report of Liking." (NCT00158184)
Timeframe: Highest rating obtained following adminstration of each of the 3 test doses.

,
Interventionunits on a scale (Mean)
Placebo: 0 mgOxycodone: 15 mgOxycodone: 30 mg
Rx Opioid Abusers236059
Rx Opioid Non-Abusers215340

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Breakpoint

"Maximum number of finger presses on a computer mouse completed. The Breakpoint is the amount of work (clicks on a mouse) participants were willing to do in order to received the dose of drug under investigation. This is a commonly used indicator of a drugs value and abuse liability." (NCT00158184)
Timeframe: Measured at 0, 60, 120, 180 and 240 minutes following administration of each oral oxycodone dose (0 , 15, 30 mg). Results presented as mean of the session

,
InterventionMouse Clicks (Mean)
Placebo: 0 mgOxycodone: 15mgOxycodone: 30mg
Rx Opioid Abusers2514001100
Rx Opioid Non-Abusers400850900

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Number of Subjects Indicating That They Had Optimal Sleep at Week 24

Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night. (NCT00261495)
Timeframe: baseline and week 24

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl83166
Oxycodone71171

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Number of Subjects With Dose Escalation at Week 24 (ITT Population)

The number of subjects with dose increase in study medication was assessed at week 24. (NCT00261495)
Timeframe: week 24

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl14657
Oxycodone14537

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Number of Subjects With Dose Escalation at Week 4 (ITT Population)

The number of subjects with dose increase in study medication was assessed at week 4. (NCT00261495)
Timeframe: week 4

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl17579
Oxycodone16684

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Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24

Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl8.6
Oxycodone11.5

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Amount of add-on Pain Medication

Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24. (NCT00261495)
Timeframe: 24 weeks

Interventionmg (Mean)
OROS Hydromorphone HCl80004.8
Oxycodone76191.9

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"Change From Baseline in Subject Diary Morning Mean Pain Score Pain Right Now at Week 24"

"Change from baseline to week 24 in subject diary morning mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.0
Oxycodone-2.0

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"Change From Baseline in Subject Diary Evening Mean Pain Score Pain Right Now at Week 24"

"Change from baseline to week 24 in subject diary evening mean pain score pain right now. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.2
Oxycodone-2.0

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"Change From Baseline in Quality of Life (QoL) Bodily Pain at Week 4"

Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl13.7
Oxycodone16.7

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"Change From Baseline in QoL Vitality at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl6.4
Oxycodone9.2

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"Change From Baseline in BPI Interference Score Interfered With General Activity (BPI Item 9a) at Week 4"

"Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.9

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"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 24"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.8
Oxycodone-1.7

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"Change From Baseline in BPI Pain Severity Average Pain (BPI Item 5) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically average pain (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in average pain." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.9
Oxycodone-2.1

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"Change From Baseline in BPI Pain Severity Pain at Its Least (BPI Item 4) at Week 24"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.3
Oxycodone-1.4

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"Change From Baseline in BPI Pain Severity Pain at Its Worst (BPI Item 3) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its worst (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.8
Oxycodone-2.1

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"Change From Baseline in BPI Pain Severity Score Pain at Its Least (BPI Item 4) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain at its least (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its least." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.3
Oxycodone-1.8

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"Change From Baseline in BPI Pain Severity Sub-score Pain at Its Worst (BPI Item 3) at Week 24 (ITT Population)"

"Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain at its worst." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.9
Oxycodone-1.9

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"Change From Baseline in BPI Questionnaire Item 6 Pain Right Now Score at Week 24 (Intent to Treat [ITT] Population)"

"Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.1
Oxycodone-2.1

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"Change From Baseline in BPI Severity Score Pain Right Now (BPI Item 6) at Week 4"

"Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain right now (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.2
Oxycodone-2.6

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"Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 Pain Right Now Score at Week 24 (Per Protocol [PP] Population)"

"Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 pain right now score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain right now." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.8
Oxycodone-3.2

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"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.2
Oxycodone-1.3

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"Change From Baseline in Pain Interference Pain Interfered With Enjoyment of Life (BPI Item 9g) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g pain interfered with enjoyment of life at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in pain interfered with enjoyment of life." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.9

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"Change From Baseline in QoL Physical Functioning at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl8.7
Oxycodone5.4

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"Change From Baseline in Pain Interference Pain Interfered With General Activity (BPI Item 9a) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a pain interfered with general activity at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with general activity." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.6

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"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.4
Oxycodone-1.3

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"Change From Baseline in Pain Interference Pain Interfered With Mood (BPI Item 9b) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b pain interfered with mood at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with mood." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.7
Oxycodone-1.9

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"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.3
Oxycodone-1.4

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"Change From Baseline in Pain Interference Pain Interfered With Normal Work (BPI Item 9d) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d pain interfered with normal work at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with normal work." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.4
Oxycodone-2.0

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"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-0.7
Oxycodone-0.9

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"Change From Baseline in Pain Interference Pain Interfered With Relations With Other People (BPI Item 9e) at Week 4"

"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e pain interfered with relations with other people at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with relations with other people." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.1
Oxycodone-1.4

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"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.4
Oxycodone-1.5

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"Change From Baseline in Pain Interference Pain Interfered With Sleep (BPI Item 9f) at Week 4"

"Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f pain interfered with sleep at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in pain interfered with sleep." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-2.1
Oxycodone-2.3

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"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 24"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.1
Oxycodone-1.2

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"Change From Baseline in Pain Interference Pain Interfered With Walking Ability (BPI Item 9c) at Week 4"

"Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c pain interfered with walking ability at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain interfered with walking ability." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.2
Oxycodone-1.5

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"Change From Baseline in QoL Bodily Pain at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl10.6
Oxycodone11.9

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"Change From Baseline in QoL General Health Perceptions at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl2.1
Oxycodone2.2

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"Change From Baseline in QoL General Health Perceptions at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl3.9
Oxycodone5.0

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"Change From Baseline in QoL Health Transition at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-0.2
Oxycodone-0.1

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"Change From Baseline in QoL Health Transition at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-0.4
Oxycodone-0.5

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"Change From Baseline in QoL Mental Health at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl2.6
Oxycodone2.6

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"Change From Baseline in QoL Mental Health at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl6.2
Oxycodone6.6

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"Change From Baseline in QoL Vitality at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl4.3
Oxycodone5.6

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Change From Baseline in Sleep Quality, Snoring at Week 24

Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.0
Oxycodone-4.1

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"Change From Baseline in QoL Social Functioning at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl10.5
Oxycodone12.9

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Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24

Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone3.0

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Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24

Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-5.3
Oxycodone-0.1

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Change From Baseline in Sleep Quality, Sleep Quantity at Week 24

Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl0.4
Oxycodone0.5

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Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24

Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-13.1
Oxycodone-11.7

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Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24

Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl9.1
Oxycodone7.3

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Equi-analgesic Dose at Steady State (ITT Population)

Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24. (NCT00261495)
Timeframe: week 4 to week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl19.50
Oxycodone48.41

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"Change From Baseline in QoL Social Functioning at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl6.6
Oxycodone5.0

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"Change From Baseline in QoL Role Physical at Week 4"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl13.2
Oxycodone16.9

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"Change From Baseline in QoL Role Physical at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl8.8
Oxycodone9.9

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"Change From Baseline in QoL Physical Functioning at Week 24"

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl7.7
Oxycodone4.4

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"Change From Baseline in QoL Role Emotional at Week 4"

"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional." (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl9.9
Oxycodone4.7

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"Change From Baseline in QoL Role Emotional at Week 24"

"Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role emotional score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in role emotional." (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl0.40
Oxycodone-1.5

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Change From Baseline in Sleep Quality at Week 24

Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-8.8
Oxycodone-6.2

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Change From Baseline in Sleep Quality (MOS Index II) at Week 4

Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-10.5
Oxycodone-9.0

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Change From Baseline in Sleep Quality (MOS Index II) at Week 24

Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-8.9
Oxycodone-6.5

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Change From Baseline in Sleep Quality (MOS Index I) at Week 4

Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-10.6
Oxycodone-8.7

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Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)

If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively. (NCT00261495)
Timeframe: week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl18.4
Oxycodone43.8

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Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)

If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively. (NCT00261495)
Timeframe: week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl18.9
Oxycodone48.3

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Number of Drop-outs

Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52. (NCT00261495)
Timeframe: baseline to week 24 (core); week 24 to week 52 (extension)

,
InterventionSubjects (Number)
Adverse events (core)Adverse events (extension)Consent withdrawn (core)Consent withdrawn (extension)Inadequate pain relief (core)Inadequate pain relief (extension)Investigator withdrew patient (core)Investigator withdrew patient (extension)Lost to follow up (core)Lost to follow up (extension)Non compliance (core)Non compliance (extension)Other (core)Other (extension)Protocol violation (core)Protocol violation (extension)Treatment completed no follow up visit (core)Treatment completed no follow up visit (extension)Inefficacy at maximal dosage (core)
OROS Hydromorphone HCl57412022040213164602017
Oxycodone561161181200010052600012

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Equi-analgesic Dose at Steady-state (PP Population)

Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24. (NCT00261495)
Timeframe: week 4 to week 24

Interventionmg per day (Mean)
OROS Hydromorphone HCl18.95
Oxycodone47.82

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Number of Days With add-on Pain Medication

Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24. (NCT00261495)
Timeframe: week 24

InterventionDays (Mean)
OROS Hydromorphone HCl68.2
Oxycodone66.1

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Resource Utilization of Pain Management

Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24. (NCT00261495)
Timeframe: week 24

InterventionAdditional visits (Mean)
OROS Hydromorphone HCl2.1
Oxycodone1.9

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"Change From Baseline in Subject Diary Mean Pain Score for Pain at Its Worst From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24"

"Change from baseline in subject diary mean pain score pain at its worst from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of pain right now on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score pain at its worst." (NCT00261495)
Timeframe: baseline and weeks 4, 8, 12, 16, 20, and 24

,
InterventionUnits on a scale (Mean)
BaselineWeek 4Week 8Week 12Week 16Week 20Week 24
OROS Hydromorphone HCl0.70.50.40.30.20.30.3
Oxycodone0.40.40.40.30.20.20.3

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Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)

Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief. (NCT00261495)
Timeframe: baseline and week 52

,
InterventionUnits on a scale (Mean)
Pain severity, BPI items 3 to 6Pain relief, BPI item 8Pain right now, BPI item 6Pain at its worst, BPI item 3Pain at its least, BPI item 4Average pain, BPI item 5Pain interfered general activity, BPI item 9aPain interfered mood, BPI item 9bPain interfered walking ability, BPI item 9cPain interfered normal work, BPI item 9dPain interfered relation other people, BPI item 9eBPI pain interfered sleep, BPI item 9fBPI pain interfered enjoyment of life, BPI item 9g
OROS Hydromorphone HCl-2.417.7-2.9-2.8-1.9-2.6-2.5-2.3-2.3-2.9-1.6-2.4-2.4
Oxycodone-2.423.6-2.8-2.4-2.3-2.6-2.6-2.7-2.5-3.2-1.9-3.0-2.6

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Change From Baseline in QoL at Week 52

Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL. (NCT00261495)
Timeframe: baseline and week 52

,
InterventionUnits on a scale (Mean)
SF-36 bodily pain indexSF-36 general health perceptionsSF-36 health transitionSF-36 mental healthSF-36 physical functioningSF-36 role emotionalSF-36 role physicalSF-36 social functioningSF-36 vitality
OROS Hydromorphone HCl23.19.6-0.311.711.422.117.015.411.5
Oxycodone19.65.5-0.16.99.27.315.012.811.9

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Change From Baseline in Sleep Quality at Week 52

Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures. (NCT00261495)
Timeframe: baseline and week 52

,
InterventionUnits on a scale (Mean)
MOS sleep disturbanceMOS snoringMOS sleep shortness of breath or headacheMOS sleep adequacyMOS sleep somnolenceMOS sleep quantity
OROS Hydromorphone HCl-17.6-2.5-8.412.3-6.50.5
Oxycodone-20.1-4.7-7.811.91.80.5

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Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24

Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores. (NCT00261495)
Timeframe: baseline and week 24

,
InterventionUnits on a scale (Mean)
Evening worst painEvening least painEvening average painMorning worst painMorning least painMorning average painAll day worst painAll day least painAll day average painAll day pain right now
OROS Hydromorphone HCl-2.2-1.6-2.0-1.9-1.5-1.7-2.1-1.5-1.8-2.1
Oxycodone-2.1-1.4-1.8-2.1-1.2-1.8-2.1-1.3-1.8-2.0

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Change in Dose of Study Treatment

Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52. (NCT00261495)
Timeframe: weeks 4, 24, and 52

,
InterventionSubjects (Number)
0 mg (week 4)+8 mg (week 4)+20 mg (week 4)+24 mg (week 4)+60 mg (week 4)-60 mg (week 24)-40 mg (week 24)-24 mg (week 24)-20 mg (week 24)-16 mg (week 24)-8 mg (week 24)0 mg (week 24)+8 mg (week 24)+16 mg (week 24)+20 mg (week 24)+40 mg (week 24)-16 mg (week 52)-8 mg (week 52)0 mg (week 52)+40 mg (week 52)
OROS Hydromorphone HCl7910207300010411172690031560
Oxycodone8401080582806001440081400502

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Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4

Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.7
Oxycodone-2.0

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Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24

Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity. (NCT00261495)
Timeframe: baseline and week 24

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl-1.6
Oxycodone-1.7

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Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)

Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24. (NCT00261495)
Timeframe: weeks 4 and 24

,
InterventionSubjects (Number)
Titration phase (on study at least 4 weeks) 0 mgTitration phase (on study at least 4 weeks) +8 mgTitration phase (on study at least 4 weeks) +20 mgTitration phase (on study at least 4 weeks) +24 mgTitration phase (on study at least 4 weeks) +60 mgTitration phase (on study <4 weeks) 0 mgTitration phase (on study <4 weeks) +8 mgTitration phase (on study <4 weeks) +20 mgTitration phase (on study <4 weeks) +24 mgTitration phase (on study <4 weeks) +60 mgWeek 24 (on study at least 4 weeks) 0 mgWeek 24 (on study at least 4 weeks ) +4 mgWeek 24 (on study at least 4 weeks ) +8 mgWeek 24 (on study at least 4 weeks) +20 mgWeek 24 (on study at least 4 weeks ) +24 mgWeek 24 (on study at least 4 weeks) +60 mgWeek 24 (on study <4 weeks) 0 mgWeek 24 (on study <4 weeks) +8 mgWeek 24 (on study <4 weeks) +20 mgWeek 24 (on study <4 weeks) +24 mgWeek 24 (on study <4 weeks) +60 mg
OROS Hydromorphone HCl5092065029100805807607302910080
Oxycodone4109405443014044010870614301404

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Clinical Global Assessment of Efficacy

Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52. (NCT00261495)
Timeframe: weeks 4, 24, and 52

,
InterventionSubjects (Number)
Visit 5, week 4: very goodVisit 5, week 4: goodVisit 5, week 4: moderateVisit 5, week 4: poorVisit 5, week 4: very poorVisit 8, week 24: very goodVisit 8, week 24: goodVisit 8, week 24: moderateVisit 8, week 24: poorVisit 8, week 24: very poorVisit 10, week 52: very goodVisit 10, week 52: goodVisit 10, week 52: moderateVisit 10, week 52: poorVisit 10, week 52: very poor
OROS Hydromorphone HCl49925112048915044161837500
Oxycodone27925093311034150101134610

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Mode and Convenience of Drug Intake.

Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient. (NCT00261495)
Timeframe: weeks 4, 24, and 52

,
InterventionSubjects (Number)
Very convenient, week 4Convenient, week 4Neither convenient or inconvenient, week 4Inconvenient, week 4Very inconvenient, week 4Very convenient, week 24Convenient, week 24Neither convenient or inconvenient, week 24Inconvenient, week 24Very inconvenient, week 24Very convenient, week 52Convenient, week 52Neither convenient or inconvenient, week 52Inconvenient, week 52Very inconvenient, week 52
OROS Hydromorphone HCl57973073639631872110200
Oxycodone369430615390331181115200

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Number of Subjects Indicating Optimal Sleep at Week 52

Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night. (NCT00261495)
Timeframe: week 52

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl2728
Oxycodone1930

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Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4

Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief. (NCT00261495)
Timeframe: baseline and week 4

InterventionUnits on a scale (Mean)
OROS Hydromorphone HCl13.8
Oxycodone15.2

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Number of Subjects With Dose Escalation

Number of subjects with dose increase in study medication. (NCT00261495)
Timeframe: week 4 and week 24

,
InterventionSubjects (Number)
YesNo
OROS Hydromorphone HCl27176
Oxycodone34148

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The Mean Daily Number of Supplemental Analgesic Medication Tablets

The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®. (NCT00312221)
Timeframe: Double-blind phase (84 days)

,,
InterventionTablets (Mean)
PrerandomizationDouble-blind
Double-blind BTDS 201.72.3
Double-blind BTDS 52.03.3
Double-blind Oxycodone Immediate-Release1.62.3

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The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase

"The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.~The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst)." (NCT00312221)
Timeframe: Weeks 4, 8 and 12 of the double-blind phase

,,
InterventionUnits on a scale (Mean)
ScreeningPrerandomizationWeek 4Week 8Week 12
Double-blind BTDS 2037.6924.1928.3428.3429.35
Double-blind BTDS 536.8825.9630.6028.7029.68
Double-blind Oxycodone Immediate-Release36.8124.4226.6526.5927.25

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The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase

The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. (NCT00312221)
Timeframe: Weeks 4, 8, and 12 of the Double-blind Phase

,,
InterventionUnits on a scale (Mean)
ScreeningPrerandomizationWeek 4Week 8Week 12
Double-blind BTDS 2055.2828.6532.4031.7132.95
Double-blind BTDS 551.9134.6439.2335.9539.13
Double-blind Oxycodone Immediate-Release55.7433.0335.7234.1336.32

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"Average Pain Over the Last 24 Hours Scores at Weeks 4, 8, and 12 of the Double-blind Phase."

"The average pain over the last 24 hours score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12)." (NCT00312221)
Timeframe: Weeks 4, 8, and 12 of the double-blind phase

,,
InterventionUnits on a scale (Mean)
ScreeningPrerandomizationWeek 4Week 8Week 12
Double-blind BTDS 206.583.023.573.373.56
Double-blind BTDS 56.603.254.213.783.67
Double-blind Oxycodone Immediate-Release6.443.033.453.593.37

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Mean Daily Number of Supplemental Analgesic Tablets

The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase (NCT00313014)
Timeframe: Double-blind phase (84 days)

Interventiontablets (Mean)
Double-blind BTDS 53.8
Double-blind BTDS 203.3
Double-blind Oxycodone Immediate-Release3.5

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Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.

"Subjects were evaluated during the double-blind phase for average pain over the last 24 hours prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)" (NCT00313014)
Timeframe: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase

,,
Interventionunits on a scale (Mean)
ScreeningPrerandomizationWeek 4Week 8Week 12
Double-blind BTDS 206.462.913.403.353.35
Double-blind BTDS 56.362.843.793.834.02
Double-blind Oxycodone Immediate-Release6.462.743.143.243.26

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Oswestry Disability Index (ODI) Score (V 2.0)

"The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.~The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)" (NCT00313014)
Timeframe: Weeks 4, 8, 12

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12
Double-blind BTDS 2033.0434.2733.06
Double-blind BTDS 534.8035.6936.30
Double-blind Oxycodone Immediate-Release30.7931.6432.96

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The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.

"The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).~Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance." (NCT00313014)
Timeframe: Weeks 4, 8, 12 of the double-blind phase

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12
Double-blind BTDS 2034.6535.6933.65
Double-blind BTDS 540.6742.2840.85
Double-blind Oxycodone Immediate-Release38.1039.1741.60

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

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

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

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The Time to Discontinuation Due to Lack of Efficacy

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

InterventionDays (Median)
PlaceboNA
OXY/APAPNA
BTDSNA

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Time to Stable Pain Management

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

InterventionDays (Median)
Placebo14
OXY/APAP7
BTDS7

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

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

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

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Number of Participants With Treatment-emergent Adverse Events (TEAE)

The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication. (NCT00361504)
Timeframe: 52 weeks

InterventionParticipants (Number)
Tapentadol (CG5503)766
Oxycodone202

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Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS)

"The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52." (NCT00361504)
Timeframe: Baseline, Week 52

InterventionScores on a Scale (Mean)
Tapentadol (CG5503)-3.22
Oxycodone-3.14

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Sum of Pain Intensity Difference Over 48 Hours (SPID48)

The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. (NCT00364533)
Timeframe: 48 hours

Interventionscore on a scale (Mean)
Tapentadol IR Fixed Dose 50 mg73.9
Tapentadol IR Fixed Dose 75 mg54.4
Tapentadol IR Fixed Dose 100 mg49.3
Oxycodone HCL IR Fixed Dose 10 mg57.6
Placebo Fixed Dose-18.6

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Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12.

"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT00421928)
Timeframe: Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period).

InterventionScores on a scale (Mean)
Tapentadol (CG5503)-3.0
Oxycodone-2.6
Placebo-2.2

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Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.

"A Sleep Questionniare addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement." (NCT00421928)
Timeframe: Baseline and 12 week endpoint

InterventionHours (Mean)
Tapentadol (CG5503)0.2
Oxycodone0.1
Placebo0.3

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Change From Baseline in Responder Analysis 50% Improvement to Week 12

"Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT00421928)
Timeframe: Baseline and Week 12

InterventionPercentage of participants (Number)
Tapentadol (CG5503)32.0
Oxycodone17.3
Placebo24.3

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Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12

"Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead" (NCT00421928)
Timeframe: Baseline and 12 week endpoint

Interventionscores on a scale (Mean)
Tapentadol (CG5503)0.6
Oxycodone0.5
Placebo0.5

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Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12

Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability (NCT00421928)
Timeframe: Baseline and 12 week endpoint

InterventionScores on a scale (Mean)
Tapentadol (CG5503)-1.2
Oxycodone-1.1
Placebo-0.9

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Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12

Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved) (NCT00421928)
Timeframe: Baseline and 12 week endpoint

Interventionpercentage of participants (Number)
Tapentadol (CG5503)51.1
Oxycodone37.7
Placebo32.4

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Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12.

"A Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night (hours)? 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement." (NCT00449176)
Timeframe: Baseline and 12 week endpoint

Interventionhours (Mean)
Tapentadol ER-0.2
Oxycodone CR-0.2
Placebo-0.1

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Change From Baseline of the Average Pain Intensity Based on a 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.

"For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT00449176)
Timeframe: Baseline and 12 weeks

Interventionscores on a scale (Mean)
Tapentadol ER-2.9
Oxycodone CR-2.9
Placebo-2.1

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Number of Participants With Treatment Discontinuation Due to Lack of Efficacy

The number of participants who discontinued due to lack of efficacy from baseline to endpoint (NCT00449176)
Timeframe: Baseline and 12 weeks

Interventionparticipants (Number)
Tapentadol ER18
Oxycodone CR9
Placebo64

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Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12

Ordinal measure indicating change from start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) (NCT00449176)
Timeframe: Baseline and 12 week endpoint

Interventionpercentage of participants (Number)
Tapentadol ER55.5
Oxycodone CR60
Placebo32.7

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Responder Analysis 50% Improvement

"Defined by the proportion of subjects achieving at least 50% improvement from baseline in the primary endpoint of change from baseline of the average pain intensity based on the 11-point Numerical Rating Scale (NRS) at week 12. The subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT00449176)
Timeframe: Baseline and Week 12

InterventionPercentage of participants (Number)
Tapentadol ER27.0
Oxycodone CR23.3
Placebo18.9

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Change From Baseline in EuroQol-5® (EQ-5D) Health Status Index to Week 12

"Change from baseline to end point in EuroQol-5 Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead." (NCT00449176)
Timeframe: Baseline and 12 week endpoint

Interventionscores on a scale (Mean)
Tapentadol ER0.2
Oxycodone CR0.2
Placebo0.1

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Change From Baseline in Brief Pain Inventory (BPI) Total Pain Score Over the Last Week of the Maintenance Period at Week 12.

"Total pain score where zero equals no pain to ten equals pain as bad as you can imagine from 12 week endpoint vs baseline." (NCT00449176)
Timeframe: Baseline and 12 week endpoint

Interventionscores on a scale (Mean)
Tapentadol ER-2.3
Oxycodone CR-2.1
Placebo-1.6

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Pain Intensity Difference (PID 60) at 60 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00463047)
Timeframe: Immediately before and 60 minutes after administration of study drug

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)3.35
Immediate-Release Oxycodone3.19

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Pain Intensity Difference (PID15) At 15 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00463047)
Timeframe: Immediately pre-dose and fifteen minutes after administration of study drug

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)0.82
Immediate-Release Oxycodone0.59

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Pain Relief (PR) Score at 5 Minutes

The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00463047)
Timeframe: Five minutes after administration of study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablets (FBT)0.10
Immediate-Release Oxycodone0.09

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Pain Relief Score (PR) at 10 Minutes

The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00463047)
Timeframe: 10 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablets (FBT)0.30
Immediate-Release Oxycodone0.25

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Pain Relief Score (PR) at 15 Minutes

The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00463047)
Timeframe: 15 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablets (FBT)0.69
Immediate-Release Oxycodone0.53

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Pain Relief Score (PR) at 30 Minutes

The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00463047)
Timeframe: 30 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablets (FBT)1.50
Immediate-Release Oxycodone1.23

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Pain Relief Score (PR) at 45 Minutes

The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00463047)
Timeframe: 45 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablets (FBT)2.08
Immediate-Release Oxycodone1.89

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Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)

The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) times 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase. (NCT00463047)
Timeframe: From 5 minutes through 60 minutes after study drug treatment

InterventionPercent change in units on a scale (Mean)
Fentanyl Buccal Tablets (FBT)39.48
Immediate-Release Oxycodone35.28

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Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 45 minutes divided by the baseline PI score times 100. (NCT00463047)
Timeframe: Immediately before and 45 minutes after study drug administration

InterventionPercent change in units on scale (Mean)
Fentanyl Buccal Tablets (FBT)40.94
Immediate-Release Oxycodone37.56

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Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 5 minutes divided by the baseline PI score times 100. (NCT00463047)
Timeframe: Immediately before and 5 minutes after administration of study drug

InterventionPercent change in units on a scale (Mean)
Fentanyl Buccal Tablets (FBT)1.11
Immediate-Release Oxycodone0.73

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Percentage Change in Pain Intensity Difference (%PID) at 10 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 10 minutes divided by the baseline PI score times 100. (NCT00463047)
Timeframe: Immediately before and 10 minutes after study drug administration

InterventionPercentage change in units on a scale (Mean)
Fentanyl Buccal Tablets (FBT)4.08
Immediate-Release Oxycodone3.16

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Percentage Change in Pain Intensity Difference (%PID) at 15 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 15 minutes divided by the baseline PI score times 100. (NCT00463047)
Timeframe: Immediately before and 15 minutes after administration of study drug

InterventionPercent change in units on a scale (Mean)
Fentanyl Buccal Tablets (FBT)11.40
Immediate-Release Oxycodone8.59

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Percentage Change in Pain Intensity Difference (%PID) at 30 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 30 minutes divided by the baseline PI score times 100. (NCT00463047)
Timeframe: Immediately before and 30 minutes after study drug administration

InterventionPercent change in units on a scale (Mean)
Fentanyl Buccal Tablets (FBT)27.83
Immediate-Release Oxycodone23.06

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Percentage Change in Pain Intensity Difference (%PID) at 60 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. The percentage is calculated as the PID at 60 minutes divided by the baseline PI score times 100. (NCT00463047)
Timeframe: Immediately before and 60 minutes after study drug administration

InterventionPercent change in units on a scale (Mean)
Fentanyl Buccal Tablets (FBT)48.08
Immediate-Release Oxycodone46.16

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Standard Rescue Medication Usage

Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded. (NCT00463047)
Timeframe: During the administration of study drug during the double blind treatment periods.

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)144
Immediate-Release Oxycodone131

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Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)

PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00463047)
Timeframe: From 5 minutes after dosing through 30 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)2.36
Immediate-Release Oxycodone1.87

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Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)

"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00463047)
Timeframe: From 5 minutes after dosing through 60 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)8.58
Immediate-Release Oxycodone7.65

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Time to Any Pain Relief (APR) by Treatment, <= 5 Minutes

Time to APR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment period. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 5 minutes was compared. (NCT00463047)
Timeframe: From time was administered to 5 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)48
Immediate-Release Oxycodone33

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Time to Any Pain Relief (APR) by Treatment, <=10 Minutes

The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 10 minutes was compared. (NCT00463047)
Timeframe: From study drug treatment until 10 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)286
Immediate-Release Oxycodone215

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Time to Any Pain Relief (APR) by Treatment, <=15 Minutes

The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APR fell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 15 minutes was compared. (NCT00463047)
Timeframe: From study drug administration to 15 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)687
Immediate-Release Oxycodone540

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Time to Any Pain Relief (APR) by Treatment, <=30 Minutes

The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 30 minutes was compared. (NCT00463047)
Timeframe: Time of study drug administration till 30 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)1259
Immediate-Release Oxycodone1157

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Time to Any Pain Relief (APR) by Treatment, <=45 Minutes

The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 45 minutes was compared. (NCT00463047)
Timeframe: Time of study drug treatment until 45 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)1499
Immediate-Release Oxycodone1480

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Time to Any Pain Relief (APR) by Treatment, <=60 Minutes

The time to APR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Any pain relief was defined as any subjective reduction in pain severity, even if not meaningful to patient. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes for which the time to APRfell into that category was compared. Here the number of episodes in which APR was achieved in less than or equal to 60 minutes was compared. (NCT00463047)
Timeframe: Time of study drug treatment until 60 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)1559
Immediate-Release Oxycodone1565

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Time to Meaningful Pain Relief (MPR) by Treatment, <= 5 Minutes

Time to MPR was measured by stopwatch and by scheduled questions at each time point up to 60 minutes after baseline during the double-blind treatment period. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to meaningful pain relief fell into that category was compared. (NCT00463047)
Timeframe: From time study drug was taken until 5 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)9
Immediate-Release Oxycodone18

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Time to Meaningful Pain Relief (MPR) by Treatment, <=10 Minutes

The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 10 minutes was compared. (NCT00463047)
Timeframe: Time of study drug treatment until 10 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)92
Immediate-Release Oxycodone83

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Time to Meaningful Pain Relief (MPR) by Treatment, <=15 Minutes

The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 15 minutes was compared. (NCT00463047)
Timeframe: Time of study drug administration until 15 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)286
Immediate-Release Oxycodone211

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Time to Meaningful Pain Relief (MPR) by Treatment, <=30 Minutes

The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 30 minutes was compared. (NCT00463047)
Timeframe: Time of study drug administration until 30 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)787
Immediate-Release Oxycodone636

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Time to Meaningful Pain Relief (MPR) by Treatment, <=45 Minutes

The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 45 minutes was compared. (NCT00463047)
Timeframe: From study drug administration until 45 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)1179
Immediate-Release Oxycodone1060

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Time to Meaningful Pain Relief (MPR) by Treatment, <=60 Minutes

The time to MPR was measured by stopwatch and scheduled questions at each time point up to 60 minutes after baseline during double-blind treatment periods. Meaningful pain relief was defined as a subject reduction of pain intensity that the subject found to be meaningful (substantive). For each category (<5, <10, <15, <30, <45, <60 min, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes for which the time to MPR fell into that category was compared. Here the number of episodes in which MPR was achieved in less than or equal to 60 minutes was compared. (NCT00463047)
Timeframe: Time of study drug administration until 60 minutes after treatment

InterventionNumber of episodes treated (Number)
Fentanyl Buccal Tablets (FBT)1359
Immediate-Release Oxycodone1313

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Total Pain Relief (TOTPAR60) at 60 Minutes

"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00463047)
Timeframe: From 5 minutes to 60 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)6.32
Immediate-Release Oxycodone5.63

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Breakthrough Pain Preference Questionnaire

The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference. (NCT00463047)
Timeframe: After completion of both double-blind treatment periods or early termination

InterventionParticipants (Number)
Preferred Fentanyl Buccal Tablet (FBT)Preferred Immediate-Release OxycodoneNo preferenceMissing
Total99631513

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Medication Performance Assessment 30 Minutes After-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00463047)
Timeframe: 30 minutes post-treatment

,
InterventionNumber of episodes treated (Number)
ExcellentVery goodGoodFairPoorNo response
Fentanyl Buccal Tablets (FBT)45153533450334249
Immediate-Release Oxycodone18104343566489238

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Medication Performance Assessment 60 Minutes After-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00463047)
Timeframe: 60 minutes post-treatment

,
InterventionNumber of episodes treated (Number)
ExcellentVery goodGoodFairPoorNo response
Fentanyl Buccal Tablets (FBT)15856267921012827
Immediate-Release Oxycodone10142472633514626

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Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at Endpoint (End of Second Double-blind Treatment Period or Last Observation After Start of Treatment Period)

The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the Endpoint (time of the last observation during the treatment period)who responded to each option is presented. (NCT00463047)
Timeframe: Endpoint (End of second double-blind treatment period or last observation after start of treatment period)

,
InterventionParticipants (Number)
Prior MedicationStudy MedicationNo Preference
Fentanyl Buccal Tablets (FBT)116612
Immediate-Release Oxycodone196312

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Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the First Double-blind Treatment Period (Visit 5)

The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the first double-blind treatment period (Visit 5) who responded to each option is presented. (NCT00463047)
Timeframe: The end of the first double-blind treatment period.

,
InterventionParticipants (Number)
Prior MedicationStudy MedicationNo Preference
Fentanyl Buccal Tablets (FBT)156112
Immediate-Release Oxycodone225018

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Pain Flare Treatment Satisfaction (PFTS) Questionnaire - Question 21 at the End of the Second Double-blind Treatment Period (Visit 6)

The PFTS is used to measure patient's satisfaction with study drug. Although the full scale has 25 questions, the question that is most useful (and least redundant with prior scales) for assessing the efficacy of the study drug is Question 21 which states: Which medication would you prefer to use when treating your pain flares? The subject can choose either: Prior medication, Study medication, or No preference. The number of subjects in each treatment group at the end of the second double-blind treatment period (Visit 6) who responded to each option is presented. (NCT00463047)
Timeframe: At the end of the second double-blind treatment period (Visit 6)

,
InterventionParticipants (Number)
Prior MedicationStudy MedicationNo Preference
Fentanyl Buccal Tablets (FBT)106310
Immediate-Release Oxycodone19599

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Pain Relief Score (PR) at 60 Minutes

The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00463047)
Timeframe: 60 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablets (FBT)2.38
Immediate-Release Oxycodone2.24

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Pain Intensity Difference (PID 10) at 10 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00463047)
Timeframe: Immediately before and 10 minutes after administration of study drug

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)0.30
Immediate-Release Oxycodone0.22

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Pain Intensity Difference (PID 30) at 30 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00463047)
Timeframe: Immediately before and 10 minutes after study drug administration

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)1.96
Immediate-Release Oxycodone1.58

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Pain Intensity Difference (PID 45) at 45 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00463047)
Timeframe: Immediately before and 45 minutes after study drug administration

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)2.87
Immediate-Release Oxycodone2.59

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Pain Intensity Difference (PID 5) at 5 Minutes

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00463047)
Timeframe: Immediately before and 5 minutes after study drug administration

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablets (FBT)0.08
Immediate-Release Oxycodone0.05

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Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT00486811)
Timeframe: Baseline; End of 12 week maintenance period

,,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
Oxycodone CR2565513019193
Placebo Matching3394765915143
Tapentadol ER409961229143

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Patient Assessment of Constipation Symptoms (PAC-SYM) Over Time

"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on Abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses are rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation." (NCT00486811)
Timeframe: Change from Baseline to Week 12 of the Maintenance Period

,,
InterventionUnits on a scale (Mean)
Overall abdominal subscale changeOverall rectal subscale changeOverall stool subscale changeOverall PAC-SYM score change
Oxycodone CR0.30.40.60.4
Placebo Matching-0.10.00.00.0
Tapentadol ER0.10.10.20.1

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Sleep Questionnaire: Number of Awakenings During Sleep

"The Sleep Questionnaire addressed the following question: How many times did you wake up during the night?. Sleep was assessed by the subject once a week during the entire double-blind treatment period. Reported are the baseline and end of maintenance period. Generally the less the number of awakenings the better the sleep." (NCT00486811)
Timeframe: Week 12 of the maintenance period compared with baseline

,,
Interventionparticipants (Number)
No awakening during night baselineNo awakening during night end point1 awakening per night baseline1 awakening per night end point2 awakening per night baseline2 awakening per night end point3 awakening per night baseline3 awakening per night end point4 awakening per night baseline4 awakening per night end point5 or more awakenings per night baseline5 or more awakenings per night end point
Oxycodone CR294657678589776138422823
Placebo Matching3255568910284826633212222
Tapentadol ER334453928894664639222621

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Number of Participants Reporting a Category From the Quality of Sleep (Sleep Questionnaire)

"The Sleep Questionnaire addressed the following question: Please rate the overall quality of your sleep last night? The quality of sleep at baseline and prior to completion of treatment are reported. The participant can choose one of the following options: Excellent, good, fair and poor." (NCT00486811)
Timeframe: Week 12 of the maintenance period compared to baseline

,,
Interventionparticipants (Number)
Excellent at baselineExcellent at end pointGood at baselineGood at end pointFair at baselineFair at end pointPoor at baselinePoor at end point
Oxycodone CR5191181581511254026
Placebo Matching11101341741461243629
Tapentadol ER8151221771381073720

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Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. (NCT00486811)
Timeframe: Change From Baseline to Week 12 of the Maintenance Period

,,
Interventionunits on a scale (Least Squares Mean)
Physical FunctioningRole-PhysicalBodily PainGeneral HealthVitalitySocial FunctioningRole-EmotionalMental Health
Oxycodone CR9.513.813.94.83.84.95.02.7
Placebo Matching11.118.715.46.86.87.57.96.3
Tapentadol ER11.7020.819.16.87.19.211.13.7

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Change From Baseline of the Average Pain Intensity Overall in the 12-week Maintenance Period of the Daily Pain Intensity on an 11-point Numeric Rating Scale (NRS).

"For this twice daily pain assessment, the participants were required to indicate the level of pain experienced over the previous 12 hours on an 11-point Numeric Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain in the treatment group. Negative values indicate a reduction in pain." (NCT00486811)
Timeframe: Change from baseline over the 12 week Maintenance Period

InterventionUnits on a scale (Mean)
Placebo Matching-2.2
Tapentadol ER-2.5
Oxycodone CR-2.1

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Sleep Questionnaire: Change From Baseline in Sleep Latency Time in Hours to the Last Week of the Maintenance Period.

"The Sleep Questionnaire addressed the following question: How long after bedtime/lights out did you fall asleep last night(hours)?. The mean change from baseline to 12 weeks was studied. Decrease in time, measured in hours, indicates an improvement." (NCT00486811)
Timeframe: Week 12 of the maintenance period compared to baseline

Interventionhours (Mean)
Placebo Matching0.4
Tapentadol ER0.2
Oxycodone CR0.2

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Sleep Questionnaire: Amount of Time Slept in Hours

"The Sleep Questionnaire addressed the following question: How long did you sleep last night?. The mean change for the number of hours slept during the night before from baseline to 12 weeks was studied." (NCT00486811)
Timeframe: Baseline to Week 12 of the maintenance period

Interventionhours (Mean)
Placebo Matching0.2
Tapentadol ER0.2
Oxycodone CR0.3

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EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time

"The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. The positive values indicate that during the study the health status improved." (NCT00486811)
Timeframe: Comparison of Baseline to Week 12 of the Maintenance Period

InterventionIndex value (Mean)
Placebo Matching0.2
Tapentadol ER0.2
Oxycodone CR0.1

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Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale (NRS) Over the Last Week of the Maintenance Period at Week 12.

"The twice daily pain assessments were averaged. The participants were to indicate their pain on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The lower the value the less pain intensity." (NCT00486811)
Timeframe: Change from Baseline to Week 12 of the Maintenance Period

InterventionUnits on a scale (Mean)
Placebo Matching-2.5
Tapentadol ER-2.7
Oxycodone CR-2.3

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Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12

Change from baseline to week 12 of Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) from 0 to 4. Higher scores indicate that a symptom is bothersome and physically disabling. (NCT00486811)
Timeframe: Change from baseline to week 12 of the maintenance period

Interventionunits on a scale (Mean)
Placebo Matching-1.0
Tapentadol ER-1.0
Oxycodone CR-1.1

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Somatic Side Effects Total Score

Subjects rated the bodily side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 35-item Somatic Side Effects (SSE) questionnaire. Total score (i.e., average of the scores for all 35 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak SSE scores at 150 min are reported herein. (NCT00499460)
Timeframe: SSE scores at 150 min after a single 15-mg oral dose of oxycodone

Interventionunits on a scale (Mean)
Garlic0.560
Placebo0.711

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Cognitive-Affective Side Effects Total Score

Subjects rated the mental side effects they experienced at 90, 150 and 300 min after oxycodone administration on a 36-item Cognitive-Affective Side Effects (CASE) questionnaire. Total score (i.e., average of the scores for all 36 items) ranges on a numerical scale from 0 (no somatic side effects) to a maximum of 4 (extreme somatic aide effects). Only the peak CASE scores at 150 min are reported herein. (NCT00499460)
Timeframe: CASE scores at 150 min after a single 15-mg oral dose of oxycodone

Interventionunits on a scale (Mean)
Garlic1.884
Placebo1.714

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Cold Pressor Tolerance AUC

Cold Pressor Test measures response to experimentally induced pain, in this case by immersion of a subject's hand in icy-cold water. Tolerance is the duration of time a subject is able to keep his/her hand immersed in the cold water. A prolongation in tolerance time indicates analgesic response to oxycodone treatment. Cold Pressor Tolerance AUC is the area under the tolerance versus time curve over a 300-min period after a test dose of oxycodone. Because of non-normality in sample distribution, log transformed AUC estimates were analyzed by Generalized Linear Model. (NCT00499460)
Timeframe: Repeated testing for tolerance to Cold Pressor Test just before and at 45, 90, 150 and 300 min after a single 15-mg oral dose of oxycodone

Interventionlog (sec*min) (Mean)
Garlic3.513
Placebo3.715

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Oral Digoxin Test

Digoxin when given orally is a probe substrate for the efflux activity of P-glycoprotein in the small intestine. The phenotype index in this case is the area under the plasma digoxin concentration from time zero to 240 min after a 0.5-mg oral test dose. A decrease in oral digoxin AUC indicates an enhanced activity of P-glycoprotein, possibly as a result of transporter upregulation. (NCT00499460)
Timeframe: Serial blood sampling over 4 hours after a 0.5-mg oral test dose of digoxin

Intervention(ng/mL)*min (Mean)
Garlic231
Placebo226

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Oral Midazolam Test

Midazolam when given orally is a probe substrate for the in vivo intestinal and hepatic activity of CYP3A (Cytochrome P450 3A) enzymes. The phenotype index in this case is the area under the plasma midazolam concentration from time zero to 360 min after a 5-mg oral test dose. A decrease in oral midazolam AUC indicates enhanced activity of CYP3A enzymes, possibly as a result of enzyme induction. (NCT00499460)
Timeframe: Serial blood sampling over 6 hours after a 5-mg oral test dose of midazolam

Intervention(ng/mL)*min (Mean)
Garlic2491
Placebo2495

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Oxycodone Oral Clearance

Oxycodone oral clearance is computed by Dose/AUC, where AUC is the area under the plasma oxycodone concentration-time curve from time zero to infinity. Oral clearance is a measure of the rate at which oxycodone is cleared from the body via metabolism. (NCT00499460)
Timeframe: Serial blood sampling over 24 hours after a 15-mg oral dose of oxycodone

InterventionL/min (Mean)
Garlic1.82
Placebo2.04

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Total Pain Relief (TOTPAR)at 48 Hours

Total Pain Relief (TOTPAR48) was defined as the weighted sum over all pain relief scores(PAR) from 0.5 hour to Hour 48, with the actual time elapsed from the previous PAR observation as the weight. A higher value in TOTPAR indicates greater pain relief. (NCT00613938)
Timeframe: 48 hours

Interventionscores on a scale (Mean)
Placebo68.2
Tapentadol 50mg Fixed Dose96.6
Tapentadol 75mg Fixed Dose107.5
Oxycodone 10mg Fixed Dose105.2

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The SPID at 12 Hours Relative to First Dose.

The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID12 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief. (NCT00613938)
Timeframe: 12 hours

InterventionScores on a scale (Mean)
Placebo7.5
Tapentadol 50mg Fixed Dose21.1
Tapentadol 75mg Fixed Dose26.0
Oxycodone 10mg Fixed Dose24.9

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SPID at 24 Hours Relative to First Dose

The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (12 to 72 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID24 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief. (NCT00613938)
Timeframe: 24 hours

InterventionScores on a scale (Mean)
Placebo12.1
Tapentadol 50mg Fixed Dose45.4
Tapentadol 75mg Fixed Dose58.1
Oxycodone 10mg Fixed Dose53.8

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Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change to Day 3

Ordinal measure indicating change from the start of treatment (On a scale of 7 = Very much Worse to 1 = very much improved) to endpoint at Day 3 (NCT00613938)
Timeframe: Baseline and 3 days

Interventionpercentage of participants (Number)
Placebo65.2
Tapentadol 50mg Fixed Dose83.2
Tapentadol 75mg Fixed Dose87.8
Oxycodone 10mg Fixed Dose86.0

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Sum of Pain Intensity Difference Over 48 Hours (SPID48)

The SPID score incorporates the cumulative analgesic effects of tapentadol IR on pain intensity over an extended period (48 hours) allowing for an evaluation of multiple doses of drug, even when dosing frequency may vary. Scoring is derived from the Numerical Rating Scale (NRS) from 0 = No pain to 11 = Pain as bad as you can imagine. A positive difference between the mean SPID48 for an active study drug and placebo would indicate a numerically larger analgesic effect for subjects dosed with active study drug than in the placebo group. A higher value in SPID indicates greater pain relief. (NCT00613938)
Timeframe: 48 hours

InterventionScores on a scale (Mean)
Placebo54.1
Tapentadol 50mg Fixed Dose122.2
Tapentadol 75mg Fixed Dose143.7
Oxycodone 10mg Fixed Dose140.3

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SPID48

"Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0).~SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5*.5 + PID1*.5 + PID2*1 + PID3*1 + PID4*1 + PID6*2 +PID12*6 + PID18*6 +PID24*6 + PID30*6 + PID36*6 + PID42*6 + PID48*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings)." (NCT00654069)
Timeframe: 48 hours

Interventionscore on a scale (Mean)
Placebo604.48
Acurox 5/30998.46
Acurox 7.5/301224.97

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Pain Reduction

Number of subjects who reached pain reduction. A subject was deemed to have reached pain reduction if there was a two-point drop in pain scale (0-10). (NCT00685295)
Timeframe: 60 minutes

InterventionParticipants (Count of Participants)
Arm 1 / Fentora30
Arm 2 / Percocet/Prevacid24

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Time to Analgesia

Time it took for subjects to achieve a pain score reduction of 2 units (on a 0 to 10 scale) (NCT00685295)
Timeframe: 60 minutes

Interventionminutes (Median)
Arm 1 / Fentora10
Arm 2 / Percocet/Prevacid35

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Occurrence of Untoward Opioid Side Effects

Subjects were monitored for any signs of untoward opioid side effects. (NCT00685295)
Timeframe: 120 minutes

InterventionParticipants (Count of Participants)
Arm 1 / Fentora0
Arm 2 / Percocet/Prevacid1

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Drug Like/Dislike Effect at 30 Minutes Post Dose (E 30 Min)

"Do you dislike or like the drug effect you are feeling now? This question was rated on a 1 to 29 point VAS scale that was anchored in the center with neither like nor dislike (14), on the left with dislike an awful lot (1), and on the right with like an awful lot (29)." (NCT00699010)
Timeframe: Effects assessed at 0.5 hours after dosing.

Interventionscore on a scale (Mean)
Acurox 5/30mg11.7
Oxycodone 5mg14.7

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Is Chronic Opioid Treatment Associated With Changes in Adrenocorticotropic Hormone (ACTH), Cortisol, Luteinizing Hormone (LH) and Testosterone Secretion?

(NCT00737737)
Timeframe: 4 weeks

Interventionng/ml (Number)
OpioidNA
PlaceboNA

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Is Placebo Analgesia Associated With a Similar Hormonal Response as Elicited by an Opioid Analgesic?

(NCT00737737)
Timeframe: 4 weeks

Interventionng/ml (Number)
OpioidNA
PlaceboNA

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Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief. (NCT00771758)
Timeframe: 5 Days

InterventionScores on a scale (Mean)
Tapentadol IR469.5
Oxycodone IR459.7
Placebo419.1

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Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief. (NCT00771758)
Timeframe: 3 Days

InterventionScores on a scale (Mean)
Tapentadol IR265.5
Oxycodone IR267.7
Placebo240.0

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Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief. (NCT00771758)
Timeframe: 2 Days

InterventionScores on a scale (Mean)
Tapentadol IR168.6
Oxycodone IR178.9
Placebo158.9

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Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief. (NCT00771758)
Timeframe: 10 Days

InterventionScores on a scale (Mean)
Tapentadol IR883.8
Oxycodone IR837.3
Placebo781.7

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Sum of Pain Intensity Difference Over 3 Days (SPID72)

"Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.~The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects." (NCT00771758)
Timeframe: 3 Days (72 hours)

InterventionScores on a scale (Mean)
Tapentadol IR139.0
Oxycodone IR129.4
Placebo114.2

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Sum of Pain Intensity Difference Over 2 Days (SPID48)

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief. (NCT00771758)
Timeframe: 2 Days (48 hours)

InterventionScores on a scale (Mean)
Tapentadol IR82.1
Oxycodone IR86.5
Placebo67.1

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Sum of Pain Intensity Difference Over 10 Days

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief. (NCT00771758)
Timeframe: 10 Days (216 Hours)

InterventionScores on a scale (Mean)
Tapentadol IR505.0
Oxycodone IR422.9
Placebo389.9

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Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study

The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved. (NCT00771758)
Timeframe: Day 10

Interventionseconds (Mean)
Tapentadol IR0.6
Oxycodone IR3.5
Placebo0.6

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Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study

The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance. (NCT00771758)
Timeframe: Day 10

Interventionmeters (Mean)
Tapentadol IR-0.1
Oxycodone IR0.4
Placebo0.0

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Sleep Quality - Shift From Baseline to End of Study (Placebo)

"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning." (NCT00771758)
Timeframe: 10 days

,,,,
Interventionparticipants (Number)
Excellent - BaselineGood - BaselineFair - BaselinePoor - BaselineMissing - BaselineEnd of Study Total
Baseline Total0597021
Excellent - End of Study021104
Fair - End of Study0362011
Good - End of Study002204
Poor - End of Study000202

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Summary of Subject Satisfaction With Treatment on Day 2

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied. (NCT00771758)
Timeframe: Day 2

InterventionScores on a scale (Mean)
Tapentadol IR3.5
Oxycodone IR3.0
Placebo3.6

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Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study

The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance. (NCT00771758)
Timeframe: Day 10

Interventionchair stands (Mean)
Tapentadol IR-0.1
Oxycodone IR-0.0
Placebo0.0

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50% Responder Rate on Day 5.

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM). (NCT00771758)
Timeframe: Day 5

Interventionpercentage of participants (Number)
Tapentadol IR25.0
Oxycodone IR26.8
Placebo25.0

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50% Responder Rate on Day 3.

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). (NCT00771758)
Timeframe: Day 3

Interventionpercentage of participants (Number)
Tapentadol IR25.0
Oxycodone IR24.4
Placebo25.0

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50% Responder Rate on Day 10.

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM). (NCT00771758)
Timeframe: Day 10

Interventionpercentage of participants (Number)
Tapentadol IR30.6
Oxycodone IR26.8
Placebo30.0

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30% Responder Rate on Day 3.

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). (NCT00771758)
Timeframe: Day 3

Interventionpercentage of participants (Number)
Tapentadol IR36.1
Oxycodone IR39.0
Placebo50.0

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30% Responder Rate on Day 10.

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM). (NCT00771758)
Timeframe: Day 10

Interventionpercentage of participants (Number)
Tapentadol IR52.8
Oxycodone IR39.0
Placebo55.0

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Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study

"The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.~Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved." (NCT00771758)
Timeframe: Day 10

Interventionsecond (Mean)
Tapentadol IR3.1
Oxycodone IR3.6
Placebo2.6

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Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 10

Interventionpercentage of participants (Number)
Tapentadol IR28.6
Oxycodone IR8.3
Placebo14.3

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Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 2

Interventionpercentage of participants (Number)
Tapentadol IR20.6
Oxycodone IR14.3
Placebo0

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Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 5

Interventionpercentage of participants (Number)
Tapentadol IR15.6
Oxycodone IR14.8
Placebo5.9

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Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 5

Interventionpercentage of participants (Number)
Tapentadol IR18.8
Oxycodone IR7.4
Placebo5.6

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Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 10

Interventionpercentage of participants (Number)
Tapentadol IR28.6
Oxycodone IR25.0
Placebo7.1

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Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 2

Interventionpercentage of participants (Number)
Tapentadol IR14.7
Oxycodone IR8.6
Placebo11.1

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Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 3

Interventionpercentage of participants (Number)
Tapentadol IR19.4
Oxycodone IR13.9
Placebo15.8

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Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 5

Interventionpercentage of participants (Number)
Tapentadol IR25.0
Oxycodone IR14.8
Placebo11.1

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Summary of Subject Satisfaction With Treatment on Day 10

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied. (NCT00771758)
Timeframe: Day 10

InterventionScores on a scale (Mean)
Tapentadol IR3.3
Oxycodone IR2.5
Placebo3.1

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Summary of Subject Satisfaction With Treatment on Day 3

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied. (NCT00771758)
Timeframe: Day 3

InterventionScores on a scale (Mean)
Tapentadol IR3.3
Oxycodone IR2.8
Placebo3.3

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Summary of Subject Satisfaction With Treatment on Day 5

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied. (NCT00771758)
Timeframe: Day 5

InterventionScores on a scale (Mean)
Tapentadol IR3.5
Oxycodone IR2.6
Placebo3.7

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Total Pain Relief (TOTPAR) Over 10 Days

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief. (NCT00771758)
Timeframe: 10 Days (216 Hours)

InterventionScores on a scale (Mean)
Tapentadol IR378.8
Oxycodone IR414.4
Placebo391.7

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Total Pain Relief (TOTPAR) Over 2 Days

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief. (NCT00771758)
Timeframe: 2 Days (48 Hours)

InterventionScores on a scale (Mean)
Tapentadol IR84.7
Oxycodone IR92.3
Placebo89.5

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Total Pain Relief (TOTPAR) Over 3 Days

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief. (NCT00771758)
Timeframe: 3 Days (72 Hours)

InterventionScores on a scale (Mean)
Tapentadol IR126.5
Oxycodone IR138.3
Placebo125.8

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Total Pain Relief (TOTPAR) Over 5 Days

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief. (NCT00771758)
Timeframe: 5 Days (120 Hours)

InterventionScores on a scale (Mean)
Tapentadol IR216.8
Oxycodone IR232.6
Placebo220.7

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Clinician Global Impression of Change (CGIC) at End of Study

Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse. (NCT00771758)
Timeframe: Day 10

,,
Interventionpercenatage of participants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Oxycodone IR7.039.534.99.34.72.30
Placebo14.323.833.319.04.804.8
Tapentadol IR19.529.319.526.8000

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Patient Global Impression of Change (PGIC) at End of Study

Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse. (NCT00771758)
Timeframe: Day 10

,,
Interventionpercenatage of participants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Oxycodone IR9.334.934.911.64.72.30
Placebo9.523.823.828.64.804.8
Tapentadol IR17.124.426.826.8000

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Sum of Pain Intensity Difference Over 5 Days (SPID120)

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief. (NCT00771758)
Timeframe: 5 Days (120 hours)

InterventionScores on a scale (Mean)
Tapentadol IR252.7
Oxycodone IR227.1
Placebo198.4

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Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)

"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via IVR system in the morning." (NCT00771758)
Timeframe: 10 days

,,,,,
Interventionparticipants (Number)
Excellent - BaselineGood - BaselineFair - BaselinePoor - BaselineMissing - BaselineEnd of Study Total
Baseline Total010248143
Excellent - End of Study018009
Fair - End of Study0273012
Good - End of Study0661013
Missing - End of Study010113
Poor - End of Study003306

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Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 3

Interventionpercentage of participants (Number)
Tapentadol IR16.7
Oxycodone IR8.3
Placebo10.5

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30% Responder Rate on Day 5.

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM). (NCT00771758)
Timeframe: Day 5

Interventionpercentage of participants (Number)
Tapentadol IR44.4
Oxycodone IR48.8
Placebo35.0

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Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)

"Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was Please rate the overall quality of your sleep last night., which was administered via Interactive Voice Response (IVR) system in the morning." (NCT00771758)
Timeframe: 10 days

,,,,,
Interventionparticipants (Number)
Excellent - BaselineGood - BaselineFair - BaselinePoor - BaselineMissing - BaselineEnd of Study Total
Baseline Total0121910041
Excellent - End of Study0525012
Fair - End of Study0283013
Good - End of Study0480012
Missing - End of Study010102
Poor - End of Study001102

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Summary of Clinician Ease-of-Care at the End of Study: Bothersome

"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal." (NCT00771758)
Timeframe: Day 10

,,
Interventionpercent of participants (Number)
Not at allA little bitSomewhatQuite a bitA great dealA very great deal
Oxycodone IR53.518.69.314.02.30
Placebo76.29.54.84.84.80
Tapentadol IR56.117.114.67.32.40

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Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming

"The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = not at all to 5=a very great deal." (NCT00771758)
Timeframe: Day 10

,,
Interventionpercent of participants (Number)
Not at allA little bitSomewhatQuite a bitA great dealA very great deal
Oxycodone IR51.216.316.39.34.70
Placebo47.623.819.04.84.80
Tapentadol IR51.219.512.212.22.40

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Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 3

Interventionpercentage of participants (Number)
Tapentadol IR16.7
Oxycodone IR19.4
Placebo10.5

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Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 2

Interventionpercentage of participants (Number)
Tapentadol IR11.8
Oxycodone IR14.3
Placebo11.1

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Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10

Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help. (NCT00771758)
Timeframe: Day 10

Interventionpercentage of participants (Number)
Tapentadol IR21.4
Oxycodone IR20.8
Placebo7.1

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5-Day Sum of Pain Intensity Difference (SPID5)

"SPID5 was calculated as the weighted (weights is taken as the number of hours elapsed since the previous measurement) sum of the PID collected up to 5 days. Pain intensity (PI) score is calculated as the average PI over the past 12 hours using an 11-point (0 to 10) numerical rating scale (NRS) where 0 is no pain and 10 is pain as bad as you can imagine. The difference between baseline PI at the qualifying period and current PI is pain intensity difference (PID)." (NCT00784277)
Timeframe: Day 1 to Day 5

InterventionUnits on a scale (Mean)
Placebo98.6
Tapentadol 50 mg153.1
Tapentadol 75 mg161.8
Oxycodone218.4

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Spontaneous Bowel Movements Per Week (SBMs/Week)

The number of SBM over the 14-day IR treatment phase was determined from the Bowel Function Patient Diary and factored to enable a per week value to be used. An SBM is defined as any BM that has occurred without the use of a laxative, enema, suppository, or manual manipulation within the previous 24 hours. (NCT00784277)
Timeframe: Week 1 to Week 2

Interventionnumber of stools/week (Mean)
Placebo9.9
Tapentadol 50 mg9.0
Tapentadol 75 mg8.6
Oxycodone6.7

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Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)

The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours) (NCT00784810)
Timeframe: Average daily pain over last 24 hours (at Week 12)

InterventionUnits on a BS-11 scale at Week 12 (Mean)
Oxycodone/Naloxone Tablets (OXN)4.2
Codeine/Paracetamol Tablets4.64

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Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.

"To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the number of intakes of rescue medication for this period (ie between Visit 8 and Visit 9)." (NCT00784810)
Timeframe: Between visit 8 and 9

InterventionNumber of rescue medication intakes (Mean)
Oxycodone/Naloxone Tablets (OXN)13.2
Codeine/Paracetamol Tablets9.4

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Total Pain Relief at 60 Minutes (TOTPAR60)

"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00813488)
Timeframe: From 5 minutes to 60 minutes after dosing

Interventionunits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)6.43
Immediate-release Oxycodone (OXY)5.70

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Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.~The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)." (NCT00813488)
Timeframe: Two months after start of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.4
Standard of Care (SOC)0.7

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Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period." (NCT00813488)
Timeframe: 3 months after start of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.6
Standard of Care (SOC)0.7

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Clinician Global Impression of Change (CGIC)Endpoint

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)." (NCT00813488)
Timeframe: End of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.4
Standard of Care (SOC)0.7

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Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period." (NCT00813488)
Timeframe: One month after start of open-label extension

InterventionUnit on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.4
Standard of Care (SOC)0.6

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Pain Intensity Difference (PID) at 10 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 10 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT).35
Immediate-release Oxycodone (OXY).29

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Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 15 minutes after dosing

InterventionUnits on scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)0.88
Immediate-release Oxycodone (OXY)0.76

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Pain Intensity Difference (PID) at 30 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 30 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)2.10
Immediate-release Oxycodone (OXY)1.79

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Pain Intensity Difference (PID) at 45 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 45 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)3.13
Immediate-release Oxycodone (OXY)2.85

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Pain Intensity Difference (PID) at 5 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 5 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT).08
Immediate-release Oxycodone (OXY).06

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Pain Intensity Difference (PID) at 60 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 60 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)3.65
Immediate-release Oxycodone (OXY)3.48

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Pain Relief (PR) Score at 5 Minutes Post-treatment

The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 5 minutes after treatment

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)0.11
Immediate-release Oxycodone (OXY)0.10

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Pain Relief Score at 10 Minutes Post-treatment

The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 10 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)0.32
Immediate-release Oxycodone (OXY)0.26

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Pain Relief Score at 15 Minutes Post-treatment

The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 15 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)0.68
Immediate-release Oxycodone (OXY)0.56

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Pain Relief Score at 30 Minutes Post-treatment

The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 30 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.48
Immediate-release Oxycodone (OXY)1.22

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Pain Relief Score at 45 Minutes Post-treatment

The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 45 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)2.14
Immediate-release Oxycodone (OXY)1.90

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Pain Relief Score at 60 Minutes Post-treatment

The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 60 minutes after treatment with study drug

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)2.44
Immediate-release Oxycodone (OXY)2.27

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Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period. (NCT00813488)
Timeframe: One month after start of open-label treatment

InterventionUnit on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.5
Standard of Care (SOC)0.6

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Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period. (NCT00813488)
Timeframe: 2 months after start of open-label extension period

InterventionUnits on scale (Mean)
Fentanyl Buccal Tablet (FBT)1.5
Standard of Care (SOC)0.8

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Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period. (NCT00813488)
Timeframe: 3 months after start of open-label extension period

InterventionUnits on scale (Mean)
Fentanyl Buccal Tablet (FBT)1.7
Standard of Care (SOC)0.8

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Patient Global Impression of Change (PGIC) Endpoint

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period. (NCT00813488)
Timeframe: At conclusion of open-label extension period

InterventionUnits on a scale (Mean)
Fentanyl Buccal Tablet (FBT)1.5
Standard of Care (SOC)0.9

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Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)

The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase. (NCT00813488)
Timeframe: From 5 minutes through 60 minutes after study drug treatment

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)40.11
Immediate-release Oxycodone (OXY)35.59

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Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period. (NCT00813488)
Timeframe: Immediately before treatment and 10 minutes after treatment.

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)4.83
Immediate-release Oxycodone (OXY)3.89

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Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment

Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Baseline (immediately pre-dose) and 15 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)12.38
Immediate-release Oxycodone (OXY)10.38

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Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Pre-dose and 30 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)29.72
Immediate-release Oxycodone (OXY)25.03

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Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 45 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)44.84
Immediate-release Oxycodone (OXY)40.49

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Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 5 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)1.01
Immediate-release Oxycodone (OXY)0.73

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Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 60 minutes after dosing

InterventionPercentage change (Mean)
Fentanyl Buccal Tablet (FBT)52.61
Immediate-release Oxycodone (OXY)49.47

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Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)

PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: From 5 minutes after dosing through 30 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)2.54
Immediate-release Oxycodone (OXY)2.16

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Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)

"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00813488)
Timeframe: From 5 minutes after dosing through 60 minutes after dosing

InterventionUnits on a scale (Least Squares Mean)
Fentanyl Buccal Tablet (FBT)9.32
Immediate-release Oxycodone (OXY)8.50

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Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared. (NCT00813488)
Timeframe: From time study drug was taken until 5 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)55
Immediate-release Oxycodone (OXY)50

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Time to Any Pain Relief (APR) by Treatment <=10 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared. (NCT00813488)
Timeframe: From study drug treatment until 10 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)226
Immediate-release Oxycodone (OXY)219

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Time to Any Pain Relief (APR) by Treatment <=15 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared. (NCT00813488)
Timeframe: From study drug administration to 15 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)515
Immediate-release Oxycodone (OXY)451

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Time to Any Pain Relief (APR) by Treatment <=30 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration till 30 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1004
Immediate-release Oxycodone (OXY)877

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Time to Any Pain Relief (APR) by Treatment <=45 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 45 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1217
Immediate-release Oxycodone (OXY)1150

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Time to Any Pain Relief (APR) by Treatment <=60 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 60 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1271
Immediate-release Oxycodone (OXY)1239

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Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes

Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. (NCT00813488)
Timeframe: From time study drug was taken until 5 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)21
Immediate-release Oxycodone (OXY)26

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Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 10 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)88
Immediate-release Oxycodone (OXY)91

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Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 15 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)230
Immediate-release Oxycodone (OXY)212

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Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared. (NCT00813488)
Timeframe: From study drug administration until 45 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)983
Immediate-release Oxycodone (OXY)864

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Use of Standard Rescue Medication

Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded. (NCT00813488)
Timeframe: Throughout the double-blind treatment period

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)39
Immediate-release Oxycodone (OXY)41

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Breakthrough Pain Preference Questionnaire

The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference. (NCT00813488)
Timeframe: At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.

InterventionParticipants (Number)
Preferred FBTPreferred OxycodoneNo PreferenceMissing
Total62462312

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Medication Performance Assessment 30 Minutes Post-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00813488)
Timeframe: 30 minutes post-treatment

,
InterventionEpisodes (Number)
ExcellentVery GoodGoodFairPoorNo Response
Fentanyl Buccal Tablet (FBT)4912537841634133
Immediate-release Oxycodone (OXY)1610430439148930

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Medication Performance Assessment 60 Minutes Post-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00813488)
Timeframe: 60 minutes post-treatment

,
InterventionEpisodes (Number)
ExcellentVery GoodGoodFairPoorNo Response
Fentanyl Buccal Tablet (FBT)1603715081819230
Immediate-release Oxycodone (OXY)11931356517913622

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Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 60 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)1139
Immediate-release Oxycodone (OXY)1047

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Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 30 minutes after treatment

InterventionEpisodes (Number)
Fentanyl Buccal Tablet (FBT)613
Immediate-release Oxycodone (OXY)503

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Clinician Global Impression of Change (CGIC) at End of Study

Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse. (NCT00814580)
Timeframe: 7 Days

,
Interventionpercentage of participants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worseMissing
Oxycodone IR29.339.812.77.22.21.15.02.8
Tapentadol IR33.347.411.53.61.01.01.01.0

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Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)

"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total2520341002
End of Study: 1-2 Days356170
End of Study: 3-5 Days4913250
End of Study: 6-7 Days12312422
End of Study: Missing the Measurement11020
End of Study: Not at All523140

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Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)

"Over the past 7 days patients reported Feeling alert during daytime hours by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total2324411031
End of Study: 1-2 Days6610190
End of Study: 3-5 Days3814380
End of Study: 6-7 Days11910381
End of Study: Missing the Measurement00030
End of Study: Not at All31750

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Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)

"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total273250702
End of Study: 1-2 Days61114130
End of Study: 3-5 Days41114151
End of Study: 6-7 Days6513291
End of Study: Missing the Measurement11020
End of Study: Not at All1049110

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Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)

"Over the past 7 days patients reported Feeling well rested by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total393455631
End of Study: 1-2 Days791360
End of Study: 3-5 Days9920210
End of Study: 6-7 Days11714261
End of Study: Missing the Measurement10110
End of Study: Not at All119790

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Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)

"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total573731542
End of Study: 1-2 Days15111682
End of Study: 3-5 Days15156140
End of Study: 6-7 Days965280
End of Study: Missing the Measurement21100
End of Study: Not at All164340

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Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)

"Over the past 7 days patients reported Pain interferes with sleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total564638511
End of Study: 1-2 Days171715100
End of Study: 3-5 Days13910140
End of Study: 6-7 Days257200
End of Study: Missing the Measurement12000
End of Study: Not at All2313671

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Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)

"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total1053424162
End of Study: 1-2 Days2312820
End of Study: 3-5 Days214350
End of Study: 6-7 Days147560
End of Study: Missing the Measurement30100
End of Study: Not at All4411732

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Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)

"Over the past 7 days patients reported trouble falling asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total1044026211
End of Study: 1-2 Days3412640
End of Study: 3-5 Days207440
End of Study: 6-7 Days165680
End of Study: Missing the Measurement01200
End of Study: Not at All3415851

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Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)

"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total774229303
End of Study: 1-2 Days1713631
End of Study: 3-5 Days128770
End of Study: 6-7 Days20139141
End of Study: Missing the Measurement20200
End of Study: Not at All268561

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Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)

"Over the past 7 days patients reported Trouble staying asleep by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total814131381
End of Study: 1-2 Days2413370
End of Study: 3-5 Days1771380
End of Study: 6-7 Days1389170
End of Study: Missing the Measurement01110
End of Study: Not at All2712551

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Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)

"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total824824252
End of Study: 1-2 Days2312830
End of Study: 3-5 Days2013650
End of Study: 6-7 Days896130
End of Study: Missing the Measurement30100
End of Study: Not at All2814342

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Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)

"Over the past 7 days patients reported Wake up feeling tired and worn out by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total714936351
End of Study: 1-2 Days19161060
End of Study: 3-5 Days8171480
End of Study: 6-7 Days968150
End of Study: Missing the Measurement02010
End of Study: Not at All358451

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Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)

"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total444636532
End of Study: 1-2 Days1471131
End of Study: 3-5 Days61110180
End of Study: 6-7 Days142312291
End of Study: Missing the Measurement20110
End of Study: Not at All85220

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Patient Global Impression of Change (PGIC) at End of Study

Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse. (NCT00814580)
Timeframe: 7 Days

,
Interventionpercentage of participants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worseMissing
Oxycodone IR26.042.513.37.72.20.65.52.2
Tapentadol IR27.646.915.63.12.11.61.02.1

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Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)

"Over the past 7 days patients reported Wake up several times during night by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7)." (NCT00814580)
Timeframe: Baseline and 7 Days

,,,,,
Interventionparticipants (Number)
Baseline: Not at allBaseline: 1-2 DaysBaseline: 3-5 DaysBaseline: 6-7 DaysBaseline: Miss the measurement
Baseline - Total423553611
End of Study: 1-2 Days12121770
End of Study: 3-5 Days8812140
End of Study: 6-7 Days121321330
End of Study: Missing the Measurement10020
End of Study: Not at All92351

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Subject Satisfaction With Treatment

Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied (NCT00814580)
Timeframe: 7 Days

,
Interventionpercentage of participants (Number)
Very satisfiedSomewhat satisfiedSlightly satisfiedNeither satisfied nor dissatisfiedSlightly dissatisfiedSomewhat dissatisfiedVery dissatisfiedMissing
Oxycodone IR48.120.45.55.03.31.714.41.7
Tapentadol IR58.315.62.67.33.62.19.90.5

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Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel

Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study. (NCT00814580)
Timeframe: 7 Days

,
InterventionNumber of calls (Number)
Total number of subjects who made callsNumber of adverse event related callsNumber of pain-related callsNumber of non-medical/administrative callsNumber of other medical conditions callsTotal number of calls
Oxycodone IR742870197122
Tapentadol IR6939461610105

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Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals

Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study. (NCT00814580)
Timeframe: 7 Days

,
InterventionNumber of participants (Number)
Patients visited a healthcare professionalNumber of patient with scheduled visitsNumber of patient with unscheduled visitsNumber of patient with InternistNumber of patient with Orthopedic surgeonNumber of patient with Physical therapistNumber of patient with Primary care physicianPatient with other healthcare professionalNumber of patient with emergency room visitNumber of patient with hospital admissions
Oxycodone IR8985618701162
Tapentadol IR8784728035260

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Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline

From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM. (NCT00814580)
Timeframe: 7 Days

InterventionHours (Median)
Tapentadol IR73.9
Oxycodone IR66.4

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Summary of 50% Responder Rate (With Imputation) on Day 7

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward. (NCT00814580)
Timeframe: Day 7

Interventionpercentage of participants (Number)
Tapentadol IR35.4
Oxycodone IR29.2

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Summary of 50% Responder Rate (With Imputation) on Day 3

The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward. (NCT00814580)
Timeframe: Day 3

Interventionpercentage of participants (Number)
Tapentadol IR19.0
Oxycodone IR22.7

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Summary of 30% Responder Rate (With Imputation) on Day 7

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward. (NCT00814580)
Timeframe: Day 7

Interventionpercentage of participants (Number)
Tapentadol IR48.1
Oxycodone IR42.2

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Summary of 30% Responder Rate (With Imputation) on Day 3

The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward. (NCT00814580)
Timeframe: Day 3

Interventionpercentage of participants (Number)
Tapentadol IR33.5
Oxycodone IR34.4

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Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief. (NCT00814580)
Timeframe: 7 Days

InterventionScores on a scale (Mean)
Tapentadol IR299.1
Oxycodone IR272.9

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Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief. (NCT00814580)
Timeframe: 3 Days (72hours)

InterventionScores on a scale (Mean)
Tapentadol IR151.3
Oxycodone IR140.9

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Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)

Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief. (NCT00814580)
Timeframe: 2 Days (48 hours)

InterventionScores on a scale (Mean)
Tapentadol IR97.7
Oxycodone IR92.0

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Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief. (NCT00814580)
Timeframe: 7 Days

InterventionScores on a scale (Mean)
Tapentadol IR435.2
Oxycodone IR395.0

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Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief. (NCT00814580)
Timeframe: 3 Days (72hours)

InterventionScores on a scale (Mean)
Tapentadol IR186.1
Oxycodone IR181.4

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Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)

The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief. (NCT00814580)
Timeframe: 2 Days (48 hours)

InterventionScores on a scale (Mean)
Tapentadol IR108.2
Oxycodone IR106.6

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Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief. (NCT00814580)
Timeframe: 7 Days

InterventionScores on a scale (Mean)
Tapentadol IR136.1
Oxycodone IR122.1

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Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief. (NCT00814580)
Timeframe: 3 Days (72 hours)

InterventionScores on a scale (Mean)
Tapentadol IR34.8
Oxycodone IR40.5

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Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief. (NCT00814580)
Timeframe: 2 Days (48 hours)

InterventionScores on a scale (Mean)
Tapentadol IR10.6
Oxycodone IR14.6

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Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline

From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM. (NCT00814580)
Timeframe: 7 Days

InterventionHours (Median)
Tapentadol IR125.3
Oxycodone IRNA

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Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)

The pain intensity difference was measured at rest over Days 1 through 3 in participants treated with etoricoxib (120 mg, 90 mg) compared to ibuprofen for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to ibuprofen was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints [Pain Intensity Difference (PID) and morphine] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment. (NCT00820027)
Timeframe: Baseline and Days 1-3

InterventionScore on a scale (Least Squares Mean)
Etoricoxib 90 mg-3.93
Etoricoxib 120 mg-3.87
Ibuprofen 1800 mg-3.83

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Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)

The pain intensity difference was measured at rest over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) compared to placebo for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to placebo was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints [Pain Intensity Difference (PID) and Morphine] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment. (NCT00820027)
Timeframe: Baseline and Days 1-3

InterventionScore on a scale (Least Squares Mean)
Etoricoxib 90 mg-3.93
Etoricoxib 120 mg-3.87
Placebo-3.39

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Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)

The difference in average total daily dose of morphine used over Days 1 through 3 between participants treated with etoricoxib (120 mg, 90 mg) or ibuprofen 1800 mg (administered as 600 mg three times daily, every 8 hours) in the treatment of pain following total knee replacement orthopedic surgery was assessed. Opioids taken were converted to mg morphine equivalents according to the following conventions:1 mg morphine sulphate = 1 mg morphine, 1 mg morphine hydrochloride = 1.17 mg morphine. A 5 mg oxycodone tablet = 2.5 mg morphine,12.5 mg meperidine = 1.67 mg morphine. (NCT00820027)
Timeframe: Days 1-3

Interventionmilligrams (mg) (Geometric Least Squares Mean)
Etoricoxib 90 mg8.87
Etoricoxib 120 mg9.25
Ibuprofen 1800 mg8.82

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Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)

The average total dose of morphine was assessed when participant received etoricoxib 120 milligram(mg)/90 mg compared to placebo. Opioids taken were converted to mg morphine equivalents according to the following conventions: 1 mg morphine sulphate=1 mg morphine,1 mg morphine hydrochloride=1.17 mg morphine. A 5 mg oxycodone tablet=2.5 mg morphine,12.5 mg meperidine =1.67 mg morphine. Least-squares mean back-transformed; estimate obtained from longitudinal analysis of variance (ANOVA) model on log-transformed morphine dose with terms for baseline pain intensity(moderate or severe),type of anesthesia (spinal, general), treatment, day, and the interaction of day by treatment. (NCT00820027)
Timeframe: Days 1-3

Interventionmilligrams (mg) (Geometric Least Squares Mean)
Etoricoxib 90 mg8.87
Etoricoxib 120 mg9.25
Placebo13.40

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Percentage of Participants Who Discontinued Study Drug Due to an AE

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. (NCT00820027)
Timeframe: Up to 7 days

InterventionPercentage of Participants (Number)
Etoricoxib 90 mg6.3
Etoricoxib 120 mg3.5
Ibuprofen 1800 mg4.5
Placebo5.1

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Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure

An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. (NCT00820027)
Timeframe: Up to 21 days

InterventionPercentage of Participants (Number)
Etoricoxib 90 mg0.5
Etoricoxib 120 mg0.0
Ibuprofen 1800 mg0.0
Placebo0.0

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Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)

"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule." (NCT00935311)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
ABT-712268.8
Hydrocodone/Acetaminophen230.9
Placebo54.8

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Time to First Rescue Medication

The median time (minutes) from first dose of study drug to first use of analgesic rescue medication. (NCT00935311)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionminutes (Median)
ABT-712442.0
Hydrocodone/Acetaminophen205.0
Placebo123.5

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TOTPAR (Total Pain Relief)

TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule. (NCT00935311)
Timeframe: From time of first study drug administration to 12 hours following first study drug administration

Interventionscores on a scale (Least Squares Mean)
ABT-71218.0
Hydrocodone/Acetaminophen15.9
Placebo10.5

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Participants With Adverse Events (AEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details. (NCT00935311)
Timeframe: AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 30 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).

,,
Interventionparticipants (Number)
Any AE"Any AE at least possibly drug related""Any AE at least probably not drug related""Any severe AE"Any SAEAny AE leading to discontinuation of study drugAny AE leading to deathDeath
ABT-712145910000
Hydrocodone/Acetaminophen128400000
Placebo1441020000

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Change From Baseline in Cognitive Assessment Using CNS-VS

"Cognition assessed using computer-based CNS Vital Signs® neurocognitive function test (CNS-VS), including symbol digit coding, Stroop test, and shifting attention test to measure cognitive flexibility, executive functioning, processing speed, and reaction time(*). Scores are computed from raw score calculations using the data values of individual subtests. An asterisk denotes that lower score is better, otherwise higher scores are better." (NCT00941304)
Timeframe: Baseline (screening), 2 hours 15 minutes postdose

,,,,
InterventionScore (Mean)
Cognitive flexibilityExecutive functioningProcessing speedReaction time
0.25-mg Buprenorphine HCl Buccal Film, M25.95.7-0.826.9
0.5-mg Buprenorphine HCl Buccal Film, M1-3.2-3.0-9.129.7
0.5-mg Buprenorphine HCl Buccal Film, M24.04.10.8-19.5
Oxycodone 5 mg2.12.21.5-8.9
Placebo7.37.22.8-3.5

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Duration of Analgesia

Duration of analgesia was the median time to use of rescue medication; earliest concomitant medication start time for medications identified as rescue medications from time of study drug administration. (NCT00941304)
Timeframe: 24 hours

Interventionhours (Median)
0.25-mg Buprenorphine HCl Buccal Film, M21.75
0.5-mg Buprenorphine HCl Buccal Film, M22.62
0.5-mg Buprenorphine HCl Buccal Film, M14.12
Placebo1.69
Oxycodone 5 mg2.17

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"Percentage of Participants With Excellent Investigator Global Rating of Study Drug"

"Investigators rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to Overall, how would you rate the study medication for this subject?" (NCT00941304)
Timeframe: 24 hours

Interventionpercentage of participants (Number)
0.25-mg Buprenorphine HCl Buccal Film, M26.5
0.5-mg Buprenorphine HCl Buccal Film, M213.3
0.5-mg Buprenorphine HCl Buccal Film, M112.9
Placebo3.3
Oxycodone 5 mg0

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Onset of Analgesia

Time to onset of analgesia defined as median time to perceptible pain relief if confirmed by experiencing meaningful pain relief from time of study drug administration. (NCT00941304)
Timeframe: 8 hours

Interventionhours (Median)
0.25-mg Buprenorphine HCl Buccal Film, M2NA
0.5-mg Buprenorphine HCl Buccal Film, M22.43
0.5-mg Buprenorphine HCl Buccal Film, M1NA
PlaceboNA
Oxycodone 5 mgNA

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Peak Pain Intensity Difference

"The maximum PID at any time following dosing determined from the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
0.25-mg Buprenorphine HCl Buccal Film, M22.2
0.5-mg Buprenorphine HCl Buccal Film, M22.9
0.5-mg Buprenorphine HCl Buccal Film, M12.8
Placebo1.5
Oxycodone 5 mg1.9

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Peak Pain Relief

"Maximum pain relief (PAR) at any time following dosing, recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain?" (NCT00941304)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
0.25-mg Buprenorphine HCl Buccal Film, M21.5
0.5-mg Buprenorphine HCl Buccal Film, M21.8
0.5-mg Buprenorphine HCl Buccal Film, M11.9
Placebo1.1
Oxycodone 5 mg1.3

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Sum of Pain Intensity Difference From Baseline to 8 Hours

"Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: Baseline, 8 hours

Interventionunits on a scale (Mean)
0.25-mg Buprenorphine HCl Buccal Film, M26.016
0.5-mg Buprenorphine HCl Buccal Film, M211.867
0.5-mg Buprenorphine HCl Buccal Film, M111.282
Placebo5.283
Oxycodone 5 mg4.290

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Sum of Pain Relief and Intensity Differences Over 2 Hours

"Time-weighted sum of PAR and PID over 2 hours (SPRID-2) where total score ranges from 0 (worst) to 8 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain? PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: 2 hours

Interventionunits on a scale (Mean)
0.25-mg Buprenorphine HCl Buccal Film, M20.339
0.5-mg Buprenorphine HCl Buccal Film, M21.533
0.5-mg Buprenorphine HCl Buccal Film, M11.056
Placebo0.850
Oxycodone 5 mg1.484

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Sum of Pain Relief and Intensity Differences Over 8 Hours

"Time-weighted sum of PAR and pain intensity difference (PID) over 8 hours (SPRID-8) where total score ranges from -80 (worst) to 112 (best) and higher values indicate greater pain relief. PAR was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain? PID determined as the change from baseline pain intensity assessment. Pain intensity was recorded using an 11-point NRS, where 0=none and 10=worst pain imaginable, in response to What is your pain level at this time?" (NCT00941304)
Timeframe: 8 hours

Interventionunits on a scale (Mean)
0.25-mg Buprenorphine HCl Buccal Film, M213.290
0.5-mg Buprenorphine HCl Buccal Film, M221.725
0.5-mg Buprenorphine HCl Buccal Film, M121.782
Placebo11.675
Oxycodone 5 mg10.532

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Total Pain Relief Over 8 Hours

"Time-weighted sum of total pain relief over 8 hours (TOPAR-8) where total score ranges from 0 (worst) to 32 (best) and higher values indicate greater pain relief. Pain relief (PAR) was recorded using a 5-point categorical rating scale, where 0=none, 1=a little, 2=some, 3=a lot, and 4=complete, in response to How much relief have you had from your starting pain?" (NCT00941304)
Timeframe: 8 hours

Interventionunits on a scale (Mean)
0.25-mg Buprenorphine HCl Buccal Film, M27.274
0.5-mg Buprenorphine HCl Buccal Film, M29.858
0.5-mg Buprenorphine HCl Buccal Film, M110.500
Placebo6.392
Oxycodone 5 mg6.242

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"Percentage of Participants Reporting a Global Rating of Study Drug as Excellent"

"Subjects rated the global effectiveness of study drug as poor, fair, good, or excellent, in response to Overall, how would you rate the study medication you received for pain?" (NCT00941304)
Timeframe: 8 hours and 24 hours

,,,,
Interventionpercentage of participants (Number)
Excellent at 8 hoursExcellent at 24 hours
0.25-mg Buprenorphine HCl Buccal Film, M23.29.7
0.5-mg Buprenorphine HCl Buccal Film, M19.712.9
0.5-mg Buprenorphine HCl Buccal Film, M26.713.3
Oxycodone 5 mg3.20
Placebo6.73.3

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Short Form McGill Pain Score.

The McGill Pain Score is the sum of the answers to three questions: A - describe your pain during the last week, 15 descriptors, (from 0 to 45 total), B - rate your pain during the last week (from 0 to 100), C: present pain intensity (0 to 5). Total pain score will be out of 150, with 0 being least pain and 150 being most pain. (NCT00944697)
Timeframe: Visit 2 (randomisation) and Visit 10 (end of study (12 weeks) or withdrawal)

Interventionunits on a scale (Mean)
Placebo Tablets49.56
OXN PR Tablet47.65

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High VAS - Emax (mm)

"The High Visual Analog Scale (VAS) consisted of a horizontal line with a statement presented above the bar (I am feeling high). The ends of the line were marked with the descriptive anchors (Definitely not and Definitely so). Using a laptop computer, participants were instructed to click and drag the mouse to the appropriate position along the line, according to how they felt at that moment. Each scale was scored as an integer from 0 (Definitely not) to 100 (Definitely so), representing the position on the line." (NCT00955110)
Timeframe: High VAS was administered at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-dose.

Interventionmm (Mean)
Placebo23.1
Oxymorphone ER 15 mg30.6
Oxymorphone ER 30 mg62.5
Oxycodone CR 30 mg81.4
Oxycodone CR 60 mg93.0

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Change From Baseline in the Average Pain Score (NPRS) for Week 2

The mean of the daily average scores were calculated from the NPRS pain assessment for the previous 24 hours obtained once a day for at least 4 days from Day -6 through Day 1 (Baseline assessment) and everyday from Day 2 through Day 15 (Treatment Phase assessment). The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain. (NCT00979953)
Timeframe: Baseline, Week 2

Interventionunits on a scale (Least Squares Mean)
Placebo-2.20
Oxycodone CR-2.24
ADL5747-1.57
ADL5859-1.77

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. (NCT00985621)
Timeframe: Baseline, Weeks 2, 4, 12, and 16

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 12Change at Week 16
Oxycodone CR-2.31-2.87-2.80-2.79
Placebo-2.12-2.55-2.85-2.95
Tanezumab 10 mg-2.29-3.45-3.64-3.65
Tanezumab 5 mg-2.47-3.56-3.82-3.80

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. (NCT00985621)
Timeframe: Baseline, Weeks 2, 4, 12, and 16

,,,
Interventionunits on a scale (Mean)
Change at Week 2Change at Week 4Change at Week 12Change at Week 16
Oxycodone CR-2.08-2.48-2.57-2.58
Placebo-1.98-2.37-2.69-2.85
Tanezumab 10 mg-2.05-2.85-3.06-3.16
Tanezumab 5 mg-2.34-3.27-3.58-3.63

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00985621)
Timeframe: Baseline, Week 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
Oxycodone CR7.25-1.71-2.10-2.14-2.17-2.18
Placebo7.19-1.51-1.89-2.01-2.17-2.26
Tanezumab 10 mg7.04-1.95-2.94-3.08-3.09-3.10
Tanezumab 5 mg7.30-2.16-3.04-3.18-3.34-3.27

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population

The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 17 individual questions scored on an NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00985621)
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
Oxycodone CR7.26-1.56-1.83-1.87-1.95-1.97
Placebo7.17-1.41-1.73-1.87-2.03-2.20
Tanezumab 10 mg7.05-1.73-2.47-2.62-2.65-2.77
Tanezumab 5 mg7.32-2.00-2.80-3.00-3.19-3.22

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population

The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip). (NCT00985621)
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
Oxycodone CR7.39-1.78-2.16-2.19-2.25-2.19
Placebo7.22-1.49-1.88-1.92-2.15-2.20
Tanezumab 10 mg7.15-2.19-3.08-3.28-3.31-3.25
Tanezumab 5 mg7.30-2.24-3.12-3.09-3.33-3.24

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population

The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 2 individual questions scored on NRS of 0 to 10; with higher scores indicating more stiffness. Total score range for WOMAC stiffness subscale score is 0 to 10, where higher scores indicate more stiffness. Stiffness is defined as a sensation of decreased ease in moving the index joint (knee/hip). (NCT00985621)
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
Oxycodone CR7.39-1.57-1.92-1.92-2.06-2.06
Placebo7.22-1.38-1.71-1.77-2.01-2.14
Tanezumab 10 mg7.16-1.90-2.61-2.72-2.77-2.83
Tanezumab 5 mg7.29-2.08-2.91-2.97-3.24-3.24

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Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population

"Participants answered: How much pain have you had when going up or down stairs? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain." (NCT00985621)
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
Oxycodone CR8.53-2.08-2.64-2.51-2.68-2.66
Placebo8.59-2.06-2.64-2.77-2.87-3.02
Tanezumab 10 mg8.45-2.39-3.48-3.74-3.76-3.75
Tanezumab 5 mg8.39-2.34-3.39-3.58-3.70-3.61

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Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population

"Participants answered: How much pain have you had when going up or down stairs? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain." (NCT00985621)
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
Oxycodone CR8.55-1.87-2.24-2.21-2.40-2.40
Placebo8.59-1.90-2.44-2.62-2.71-2.91
Tanezumab 10 mg8.44-2.06-2.81-3.04-3.11-3.24
Tanezumab 5 mg8.42-2.21-3.10-3.25-3.40-3.42

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Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population

"Participants answered: How much pain have you had when walking on a flat surface? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain." (NCT00985621)
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
Oxycodone CR7.70-2.27-2.91-2.72-2.80-2.72
Placebo7.58-2.01-2.46-2.70-2.85-2.91
Tanezumab 10 mg7.67-2.43-3.58-3.82-3.85-3.76
Tanezumab 5 mg7.80-2.61-3.54-3.75-3.84-3.79

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Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population

"Participants answered: How much pain have you had when walking on a flat surface? Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicated greater pain." (NCT00985621)
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
Oxycodone CR7.72-1.99-2.50-2.39-2.56-2.51
Placebo7.60-1.85-2.26-2.50-2.66-2.83
Tanezumab 10 mg7.68-2.19-2.98-3.19-3.23-3.32
Tanezumab 5 mg7.80-2.47-3.20-3.36-3.54-3.57

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Number of Days With Rescue Medication (RM) Usage

In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are shown in number of days of rescue medication usage per week. (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventiondays per week (Mean)
Week 2Week 4Week 8Week 12Week 16
Oxycodone CR2.352.271.751.741.67
Placebo2.722.402.111.821.73
Tanezumab 10 mg2.581.951.721.631.40
Tanezumab 5 mg2.031.601.331.201.02

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Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity

Adverse event of abnormal peripheral sensation: allodynia, burning sensation, decreased vibratory sense, dysaesthesia, hyperaesthesia, hyperpathia, hypoaesthesia, neuralgia, neuritis, neuropathy peripheral, pallanesthesia, paraesthesia, paraesthesia oral, peripheral sensory neuropathy, polyneuropathy, sensory disturbance, sensory loss and thermohypoaesthesia. Adverse event of abnormal peripheral sensation was assessed according to severity: mild (did not interfere with participant's usual function); moderate (interfered to some extent with participant's usual function); and severe (interfered significantly with participant's usual function). (NCT00985621)
Timeframe: Baseline up to 112 days after last intravenous dose

,,,
InterventionParticipants (Count of Participants)
Burning Sensation: MildDecreased Vibratory Sense: MildDysaesthesia: MildHyperaesthesia: MildHyperaesthesia: ModerateHypoaesthesia: MildHypoaesthesia: ModerateHypoaesthesia: SevereNeuropathy peripheral: ModerateParaesthesia: MildParaesthesia: Moderate
Oxycodone CR00100200010
Placebo00100000001
Tanezumab 10 mg12020300030
Tanezumab 5 mg01001121142

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

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 112 days after last dose 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. (NCT00985621)
Timeframe: Baseline up to 112 days after last intravenous dose

,,,
InterventionParticipants (Count of Participants)
AEsSAEs
Oxycodone CR1004
Placebo502
Tanezumab 10 mg613
Tanezumab 5 mg724

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Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)

Human serum samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. A participant may be represented in more than 1 category. (NCT00985621)
Timeframe: Baseline, Week 8 and 18

,
InterventionParticipants (Count of Participants)
BaselineWeek 8Week 18
Tanezumab 10 mg120
Tanezumab 5 mg010

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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: mITT Population

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response. (NCT00985621)
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
Oxycodone CR7.51-1.74-2.08-2.07-2.20-2.20
Placebo7.38-1.60-1.94-2.08-2.25-2.40
Tanezumab 10 mg7.28-1.90-2.64-2.79-2.83-2.92
Tanezumab 5 mg7.50-2.14-2.99-3.13-3.34-3.36

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Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
InterventionParticipants (Count of Participants)
Week 2: >=30% ReductionWeek 2: >=50% ReductionWeek 2: >=70% ReductionWeek 2: >=90% ReductionWeek 4: >=30% ReductionWeek 4: >=50% ReductionWeek 4: >=70% ReductionWeek 4: >=90% ReductionWeek 8: >=30% ReductionWeek 8: >=50% ReductionWeek 8: >=70% ReductionWeek 8: >=90% ReductionWeek 12: >=30% ReductionWeek 12: >=50% ReductionWeek 12: >=70% ReductionWeek 12: >=90% ReductionWeek 16: >=30% ReductionWeek 16: >=50% ReductionWeek 16: >=70% ReductionWeek 16: >=90% Reduction
Oxycodone CR71331358648257754727481512667851283
Placebo59301017244153784721580442667847298
Tanezumab 10 mg66421549768471499734716102774418103754319
Tanezumab 5 mg754623598724820109714420107754825107764724

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Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported. (NCT00985621)
Timeframe: Baseline, Week 12

,,,
InterventionParticipants (Count of Participants)
Mobility, Baseline: Level 1Mobility, Baseline: Level 2Mobility, Baseline: Level 3Mobility, Change at Wk 12: ImprovedMobility, Change at Wk 12: No ChangeMobility, Change at Wk 12: WorsenedSelf-care, Baseline: Level 1Self-care, Baseline: Level 2Self-care, Baseline: Level 3Self-care, Change at Week 12: ImprovedSelf-care, Change at Week 12: No ChangeSelf-care, Change at Week 12: WorsenedUsual Activities, Baseline: Level 1Usual Activities, Baseline: Level 2Usual Activities, Baseline: Level 3Usual Activities, Change at Week 12: ImprovedUsual Activities, Change at Week 12: No ChangeUsual Activities, Change at Week 12: WorsenedPain and Discomfort, Baseline: Level 1Pain and Discomfort, Baseline: Level 2Pain and Discomfort, Baseline: Level 3Pain and Discomfort, Change at Week 12: ImprovedPain and Discomfort, Change at Week 12: No ChangePain and Discomfort, Change at Week 12: WorsenedAnxiety and Depression, Baseline: Level 1Anxiety and Depression, Baseline: Level 2Anxiety and Depression, Baseline: Level 3Anxiety and Depression, Change at Week 12: ImprovedAnxiety and Depression, Change at Week 12: No ChangeAnxiety and Depression, Change at Week 12: Worsened
Oxycodone CR71481453210848010445151365213621837217393846849428
Placebo813201243193452153921512321536527760232937952916355
Tanezumab 10 mg1014001739199501173821912561541109455213519252512378
Tanezumab 5 mg15146029311122381124632113462732219268322818668716405

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Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 dimensions/domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no dysfunction (level 1), moderate/some dysfunction (level 2), and extreme dysfunction (level 3). Change from baseline at Week 12 is defined as: Improved (positive change), No change, and Worsened (negative change). Number of participants with response is reported. (NCT00985621)
Timeframe: Baseline, Week 12

,,,
InterventionParticipants (Count of Participants)
Mobility, Baseline: Level 1Mobility, Baseline: Level 2Mobility, Baseline: Level 3Mobility, Change at Week 12: ImprovedMobility, Change at Week 12: No ChangeMobility, Change at Week 12: WorsenedSC, Baseline: Level 1Self-care, Baseline: Level 2Self-care, Baseline: Level 3Self-care, Change at Week 12: ImprovedSelf-care, Change at Week 12: No ChangeSelf-care, Change at Week 12: WorsenedUsual Activities, Baseline: Level 1Usual Activities, Baseline: Level 2Usual Activities, Baseline: Level 3Usual Activities, Change at Week 12: ImprovedUsual Activities, Change at Week 12: No ChangeUsual Activities, Change at Week 12: WorsenedPain and Discomfort, Baseline: Level 1Pain and Discomfort, Baseline: Level 2Pain and Discomfort, Baseline: Level 3Pain and Discomfort, Change at Week 12: ImprovedPain and Discomfort, Change at Week 12: No ChangePain and Discomfort, Change at Week 12: WorsenedAnxiety and Depression, Baseline: Level 1Anxiety and Depression, Baseline: Level 2Anxiety and Depression, Baseline: Level 3Anxiety and Depression, Change at Week 12: ImprovedAnxiety and Depression, Change at Week 12: No ChangeAnxiety and Depression, Change at Week 12: Worsened
Oxycodone CR71461453210846010445151345213621827117393836749428
Placebo812801243191432153921511921536527756232937651916355
Tanezumab 10 mg1013901739199491173821912461541109355213519251512378
Tanezumab 5 mg14139029311118341124632012852732218765322818264716405

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Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 8 are reported. (NCT00985621)
Timeframe: Week 8

,,,
InterventionParticipants (Count of Participants)
Greater than (>) 0% Reduction>=10% Reduction>=20% Reduction>=30% Reduction>=40% Reduction>=50% Reduction>=60% Reduction>=70% Reduction>=80% Reduction>=90% Reduction100% Reduction
Oxycodone CR13912510175574738271042
Placebo1211099178544731211150
Tanezumab 10 mg134127110998673614728165
Tanezumab 5 mg14913812510993716244302012

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

(NCT00985621)
Timeframe: Baseline up to Week 24

InterventionParticipants (Count of Participants)
Placebo10
Tanezumab 5 mg6
Tanezumab 10 mg5
Oxycodone CR12

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Time to Discontinuation From Study Due to Lack of Efficacy

(NCT00985621)
Timeframe: Baseline up to Week 24

Interventiondays (Median)
Placebo29.0
Tanezumab 5 mg43.0
Tanezumab 10 mg56.0
Oxycodone CR30.0

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Amount of Rescue Medication Used

In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. Results are presented as total dose of acetaminophen (in mg) per week. (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
Interventionmg per week (Mean)
Week 2Week 4Week 8Week 12Week 16
Oxycodone CR3553.333373.332539.742360.932420.53
Placebo4109.383293.893000.002561.072412.88
Tanezumab 10 mg3510.562614.582336.812333.331965.28
Tanezumab 5 mg2684.032136.991659.861394.561159.86

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Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. (NCT00985621)
Timeframe: Week 8

,,,
InterventionParticipants (Count of Participants)
>0% Reduction>=10% Reduction>=20% Reduction>=30% Reduction>=40% Reduction>=50% Reduction>=60% Reduction>=70% Reduction>=80% Reduction>=90% Reduction100% Reduction
Oxycodone CR1191059269513831221141
Placebo108948373514329161451
Tanezumab 10 mg1151119281675747392283
Tanezumab 5 mg1271191069480635443261911

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Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population

"PGA: Participants answered the following question: Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today? Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition." (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
InterventionParticipants (Count of Participants)
Week 2Week 4Week 8Week 12Week 16
Oxycodone CR1615141916
Placebo1516141821
Tanezumab 10 mg1732313335
Tanezumab 5 mg2339383939

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Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population

"PGA: Participants answered the following question: Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today? Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition." (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
InterventionParticipants (Count of Participants)
Week 2Week 4Week 8Week 12Week 16
Oxycodone CR1719172318
Placebo1617131718
Tanezumab 10 mg1937424744
Tanezumab 5 mg2445364038

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Number of Participants With Intravenous (IV) Doses of Study Medication

Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received. (NCT00985621)
Timeframe: Day 1 up to Week 16

,,,
InterventionParticipants (Count of Participants)
Number of IV Doses: 1Number of IV Doses: 2
Oxycodone CR9761
Placebo7962
Tanezumab 10 mg8565
Tanezumab 5 mg8972

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Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population

OMERACT-OARSI response: greater than or equal to (>=) 50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty). (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
InterventionParticipants (Count of Participants)
Week 2Week 4Week 8Week 12Week 16
Oxycodone CR81979310095
Placebo7087818384
Tanezumab 10 mg82107105110112
Tanezumab 5 mg89117120120120

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. (NCT00985621)
Timeframe: Baseline, Week 8

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 8
Oxycodone CR7.86-2.41
Placebo7.75-2.58
Tanezumab 10 mg7.64-3.01
Tanezumab 5 mg7.87-3.42

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Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population

OMERACT-OARSI response: >=50 percent (%) improvement from baseline and absolute change from baseline of >=2 units at Week of interest in WOMAC pain or physical function subscales, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty). (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
InterventionParticipants (Count of Participants)
Week 2Week 4Week 8Week 12Week 16
Oxycodone CR7083808787
Placebo6476788084
Tanezumab 10 mg7487868993
Tanezumab 5 mg79105108110111

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Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: ITT Population

SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning). (NCT00985621)
Timeframe: Baseline, Week 12

,,,
Interventionunits on a scale (Mean)
General Health: BaselineGeneral Health: Change at Week 12Physical Function: BaselinePhysical Function: Change at Week 12Role Physical: BaselineRole Physical: Change at Week 12Bodily Pain: BaselineBodily Pain: Change at Week 12Vitality: BaselineVitality: Change at Week 12Social Function: BaselineSocial Function: Change at Week 12Role Emotional: BaselineRole Emotional: Change at Week 12Mental Health: BaselineMental Health: Change at Week 12
Oxycodone CR55.471.2128.554.0536.755.6227.236.3645.332.2557.914.1160.810.4267.590.70
Placebo55.281.8929.096.0337.817.1428.436.3846.373.1057.365.4160.223.7268.401.03
Tanezumab 10 mg60.012.8532.145.5739.466.1729.088.3247.253.0861.584.5063.892.0668.272.20
Tanezumab 5 mg58.352.2231.8010.8840.7210.8328.8012.3848.954.1962.345.2864.704.9269.131.37

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Tanezumab Plasma Concentration

Plasma concentration of tanezumab was measured using a validated, sensitive and specific enzyme-linked immunosorbent assay (ELISA). Only participants receiving tanezumab were to be analyzed for this measure. (NCT00985621)
Timeframe: Predose, 1 hour post-dose on Day 1, Week 8; Week 18

,
Interventionnanogram per milliliter (ng/mL) (Mean)
Predose, Day 11 hour post-dose, Day 1Predose, Week 81 hour post-dose, Week 8Week 18
Tanezumab 10 mg124.15690402.63583240.2
Tanezumab 5 mg36.964192207.0225987.05

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Total Nerve Growth Factor (NGF) Serum Concentration

Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive, and specific immune-affinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method. (NCT00985621)
Timeframe: Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18

,,,
Interventionpicogram per milliliter (pg/mL) (Mean)
Predose, Day 11 hour post-dose, Day 1Predose, Week 81 hour post-dose, Week 8Predose, Week 18
Oxycodone CR38.539.045.544.048.7
Placebo58.155.892.639.841.0
Tanezumab 10 mg138.2163.83160.63026.02365.4
Tanezumab 5 mg89.3133.92152.22181.21437.1

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Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population

SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100 = highest level of functioning). (NCT00985621)
Timeframe: Baseline, Week 12

,,,
Interventionunits on a scale (Mean)
General Health: BaselineGeneral Health: Change at Week 12Physical Function: BaselinePhysical Function: Change at Week 12Role Physical: BaselineRole Physical: Change at Week 12Bodily Pain: BaselineBodily Pain: Change at Week 12Vitality: BaselineVitality: Change at Week 12Social Function: BaselineSocial Function: Change at Week 12Role Emotional: BaselineRole Emotional: Change at Week 12Mental Health: BaselineMental Health: Change at Week 12
Oxycodone CR55.560.7428.502.8236.664.2127.185.1445.111.6457.933.2960.68-0.1167.530.48
Placebo55.611.8529.185.3637.736.0728.555.5446.302.9757.394.6560.043.8968.030.62
Tanezumab 10 mg60.212.6132.293.7639.435.4929.217.4147.323.0261.665.1263.932.0768.362.55
Tanezumab 5 mg59.081.3931.548.8441.309.6029.0610.5348.734.3362.585.0764.544.5269.221.70

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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 Week 12: ITT Population

SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement. (NCT00985621)
Timeframe: Baseline, Week 12

,,,
Interventionz-score (Mean)
Mental Component Aggregate: BaselineMental Component Aggregate: Change at Week 12Physical Component Aggregate: BaselinePhysical Component Aggregate: Change at Week 12
Oxycodone CR-0.280.01-2.030.23
Placebo-0.280.08-1.990.26
Tanezumab 10 mg-0.200.07-1.880.28
Tanezumab 5 mg-0.130.04-1.910.47

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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 Week 12: mITT Population

SF-36v2: standardized survey evaluating 8 health concepts (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each health concept was scaled 0-100 (100=highest level of functioning). For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population. Change from baseline >0 indicates an improvement. (NCT00985621)
Timeframe: Baseline, Week 12

,,,
Interventionz-score (Mean)
Mental Component Aggregate: BaselineMental Component Aggregate: Change at Week 12Physical Component Aggregate: BaselinePhysical Component Aggregate: Change at Week 12
Oxycodone CR-0.29-0.00-2.030.18
Placebo-0.300.08-1.980.23
Tanezumab 10 mg-0.190.11-1.880.22
Tanezumab 5 mg-0.130.07-1.900.38

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Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population

Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week. (NCT00985621)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12Change at Week 16
Oxycodone CR7.05-1.16-1.46-1.58-1.70-1.85-1.78-1.83-1.83-1.84
Placebo7.16-0.79-1.23-1.54-1.63-1.78-1.82-1.95-1.96-1.96
Tanezumab 10 mg6.98-1.50-1.51-1.73-2.21-2.37-2.36-2.40-2.36-2.40
Tanezumab 5 mg7.31-1.71-1.99-2.28-2.70-2.92-2.88-2.98-3.00-2.97

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Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. (NCT00985621)
Timeframe: Baseline, Week 12

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 12
Oxycodone CR0.380.14
Placebo0.390.25
Tanezumab 10 mg0.430.22
Tanezumab 5 mg0.410.33

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Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on an NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
InterventionParticipants (Count of Participants)
Week 2: >=30% ReductionWeek 2: >=50% ReductionWeek 2: >=70% ReductionWeek 2: >=90% ReductionWeek 4: >=30% ReductionWeek 4: >=50% ReductionWeek 4: >=70% ReductionWeek 4: >=90% ReductionWeek 8: >=30% ReductionWeek 8: >=50% ReductionWeek 8: >=70% ReductionWeek 8: >=90% ReductionWeek 12: >=30% ReductionWeek 12: >=50% ReductionWeek 12: >=70% ReductionWeek 12: >=90% ReductionWeek 16: >=30% ReductionWeek 16: >=50% ReductionWeek 16: >=70% ReductionWeek 16: >=90% Reduction
Oxycodone CR63311357440226693822476432177544215
Placebo5428916239133734316576412167844258
Tanezumab 10 mg583712278553798157398836138987634010
Tanezumab 5 mg674121488614017946343199768452497714723

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Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains/items: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item has 3 possible responses: no problems (level 1), some problems (level 2), and extreme problems (level 3). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. (NCT00985621)
Timeframe: Baseline, Week 12

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 12
Oxycodone CR0.380.14
Placebo0.400.25
Tanezumab 10 mg0.430.22
Tanezumab 5 mg0.410.33

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Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18

NIS: 74 items, assess muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness are 24 items and scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes and sensation are 13 items and scored 0 = normal, 1= decreased, or 2 = absent. Total NIS score is the sum of the left and right limb scores. Total possible NIS score range 0 to 244, higher score=greater impairment. (NCT00985621)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 18

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 2Change at Week 4Change at Week 8Change at Week 12Change at Week 16Change at Week 18
Oxycodone CR1.73-0.16-0.31-0.39-0.33-0.53-0.18
Placebo1.43-0.42-0.09-0.18-0.19-0.40-0.25
Tanezumab 10 mg1.32-0.13-0.28-0.22-0.33-0.28-0.25
Tanezumab 5 mg1.01-0.22-0.33-0.22-0.13-0.14-0.02

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Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: ITT Population

"PGA: Participants answered the following question: Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today? Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition." (NCT00985621)
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
Oxycodone CR3.59-0.54-0.64-0.58-0.59-0.59
Placebo3.60-0.49-0.57-0.56-0.64-0.63
Tanezumab 10 mg3.57-0.63-0.99-1.01-1.07-1.07
Tanezumab 5 mg3.58-0.71-0.99-0.93-0.99-0.96

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Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, and 16: mITT Population

"PGA: Participants answered the following question: Considering all the ways the OA in your index (knee/hip) affects you, how are you doing today? Participants rated their condition by using a 5-point Likert scale: 1) very good (asymptomatic and no 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 which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition." (NCT00985621)
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
Oxycodone CR3.59-0.49-0.54-0.52-0.56-0.55
Placebo3.59-0.47-0.50-0.55-0.63-0.67
Tanezumab 10 mg3.56-0.55-0.82-0.81-0.83-0.87
Tanezumab 5 mg3.59-0.71-0.94-0.93-0.98-0.97

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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: ITT Population

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with OA of the index knee or index hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response. (NCT00985621)
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
Oxycodone CR7.50-1.94-2.38-2.35-2.41-2.39
Placebo7.39-1.71-2.11-2.23-2.39-2.47
Tanezumab 10 mg7.27-2.15-3.16-3.33-3.35-3.34
Tanezumab 5 mg7.48-2.29-3.24-3.32-3.49-3.42

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Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population

Participants assessed daily average pain in the index joint (knee/hip) during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Higher score indicated greater pain. The baseline mean was calculated using the daily pain scores in the index joint (knee/hip) over the 3 days in the initial pain assessment period and the weekly mean was calculated using the daily pain scores in the index joint (knee/hip) within each assessment week. (NCT00985621)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 1Change at Week 2Change at Week 3Change at Week 4Change at Week 6Change at Week 8Change at Week 10Change at Week 12Change at Week 16
Oxycodone CR7.03-1.15-1.54-1.67-1.76-1.94-1.83-1.89-1.88-1.86
Placebo7.18-0.79-1.26-1.57-1.70-1.91-1.96-2.06-2.07-2.09
Tanezumab 10 mg6.98-1.47-1.43-1.71-2.28-2.43-2.38-2.39-2.38-2.39
Tanezumab 5 mg7.28-1.71-1.96-2.27-2.65-2.87-2.82-2.92-2.94-2.90

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Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population

The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis (OA) in the index joint (knee/hip) during past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. (NCT00985621)
Timeframe: Baseline, Week 8

,,,
Interventionunits on a scale (Mean)
BaselineChange at Week 8
Oxycodone CR7.85-2.71
Placebo7.75-2.74
Tanezumab 10 mg7.63-3.63
Tanezumab 5 mg7.85-3.71

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Number of Participants With Rescue Medication (RM) Usage

In the event of inadequate pain relief for OA during the double-blind treatment period, participants were allowed to take up to 3000 mg of acetaminophen (tablet/capsule/caplets) per day up to 3 days per week as a rescue medication. (NCT00985621)
Timeframe: Weeks 2, 4, 8, 12, and 16

,,,
InterventionParticipants (Count of Participants)
Week 2Week 4Week 8Week 12Week 16
Oxycodone CR9085777872
Placebo9076676868
Tanezumab 10 mg9979656159
Tanezumab 5 mg8565635250

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Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event

Number of subjects that reported nausea as a treatment-emergent adverse event during the study. (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionParticipants (Number)
NUCYNTA51
Oxycodone IR67

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel. (NCT00986180)
Timeframe: Day 0 and Day 5

Interventionscore of scale (Mean)
NUCYNTA-2.0
Oxycodone IR-1.9

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Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event

Number of subjects that reported constipation as a treatment emergent adverse event during the study. (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionParticipants (Number)
NUCYNTA7
Oxycodone IR23

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Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. (NCT00986180)
Timeframe: Day 0 and Day 2

InterventionUnits on a Scale (Least Squares Mean)
NUCYNTA80.1
Oxycodone IR81.8

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Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours. (NCT00986180)
Timeframe: 0 hour (prior to first dose) and 120 hours

InterventionUnits on a scale (Least Squares Mean)
NUCYNTA264.6
Oxycodone IR264.0

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SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. (NCT00986180)
Timeframe: Day 0 and Day 3

InterventionUnits on a scale (Least Squares Mean)
NUCYNTA137.2
Oxycodone IR138.1

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SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. (NCT00986180)
Timeframe: Day 0 and Day 10

InterventionUnits on a scale (Least Squares Mean)
NUCYNTA540.2
Oxycodone IR538.6

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SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. (NCT00986180)
Timeframe: Day 0 and Day 3

InterventionUnits on a Scale (Least Squares Mean)
NUCYNTA125.5
Oxycodone IR123.0

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SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. (NCT00986180)
Timeframe: Day 0 and Day 2

InterventionUnits on a Scale (Least Squares Mean)
NUCYNTA73.6
Oxycodone IR72.1

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SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. (NCT00986180)
Timeframe: Day 0 and Day 10

InterventionUnits on a Scale (Least Squares Mean)
NUCYNTA488.0
Oxycodone IR476.4

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10. (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionUnits on a Scale (Mean)
NUCYNTA-2.2
Oxycodone IR-2.1

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10. (NCT00986180)
Timeframe: Day 0 and Day 10

InterventionUnits on a Scale (Mean)
NUCYNTA-2.7
Oxycodone IR-2.5

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5

"Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles and numbness." (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionUnits on a Scale (Mean)
NUCYNTA-1.5
Oxycodone IR-1.4

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit

"Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or pins and needles and numbness." (NCT00986180)
Timeframe: Day 0 and Day 10

InterventionUnits on a Scale (Mean)
NUCYNTA-1.8
Oxycodone IR-1.6

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing. (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionUnits on a Scale (Mean)
NUCYNTA-2.6
Oxycodone IR-2.5

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing. (NCT00986180)
Timeframe: Day 0 and Day 10

InterventionUnits on a Scale (Mean)
NUCYNTA-3.3
Oxycodone IR-3.2

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender. (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionUnits on a Scale (Mean)
NUCYNTA-2.4
Oxycodone IR-2.4

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender. (NCT00986180)
Timeframe: Day 0 and Day 10

InterventionUnits on a Scale (Mean)
NUCYNTA-3.1
Oxycodone IR-2.9

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Patient Global Impression of Change at End of Study

Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

,
InterventionUnits on a Scale (Number)
1 = Very much improved2 = Much improved3 = Minimally improved4 = No change5 = Minimally worse6 = Much worse7 = Very much worseMissing
NUCYNTA89111592721112
Oxycodone IR90116672400113

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Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation

(NCT00986180)
Timeframe: Day 0 and Day 10/last visit

,
InterventionParticipants (Number)
Number of subjects with adverse eventsEye disordersVision blurredGastrointestinal disordersNauseaVomitingDiarrheaAbdominal discomfortConstipationGeneral disorders and admin. site conditionsFatigueInfections and infestationsUpper respiratory tract infectionInjury, poisoning and procedural complicationsContusionInvestigationsHepatic enzyme increasedLiver function test abnormalMusculoskeletal and connective tissue disordersBack painMuscle spasmsNeoplasms benign, malignant and unspecifiedLung cancer metastaticNervous system disordersDizzinessSomnolenceHeadacheConvulsionSyncopePsychiatric disordersDepressionSkin and subcutaneous tissue disordersRashPruritusRash generalized
NUCYNTA2111116511022000011021111632100001001
Oxycodone IR2600149610100111110111000932211113210

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Satisfaction With Treatment at End of Study

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

,
InterventionUnits on a Scale (Number)
1 = Very satisfied2 = Somewhat satisfied3 = Slightly satisfied4 = Neither satisfied nor dissatisfied5 = Slightly dissatisfied6 = Somewhat dissatisfied7 = Very dissatisfiedMissing
NUCYNTA14684287781012
Oxycodone IR148872914341313

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Satisfaction With Treatment at Day 5

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). (NCT00986180)
Timeframe: Day 0 and Day 5

,
InterventionUnits on a Scale (Number)
1 = Very satisfied2 = Somewhat satisfied3 = Slightly satisfied4 = Neither satisfied nor dissatisfied5 = Slightly dissatisfied6 = Somewhat dissatisfied7 = Very dissatisfiedMissing
NUCYNTA113102311682327
Oxycodone IR9213232575434

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SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation)

Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days. (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionUnits on a Scale (Least Squares Mean)
NUCYNTA239.2
Oxycodone IR234.1

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Clinician Global Impression of Change at End of Study

Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

,
InterventionUnits on a Scale (Number)
1 = Very much improved2 = Much improved3 = Minimally improved4 = No change5 = Minimally worse6 = Much worse7 = Very much worseMissing
NUCYNTA78127602121212
Oxycodone IR77130701810013

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Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days

Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days. (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionUnits on a Scale (Least Squares Mean)
NUCYNTA254.8
Oxycodone IR256.4

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Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event

Number of subjects that reported vomiting as a treatment emergent adverse event during the study. (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionParticipants (Number)
NUCYNTA51
Oxycodone IR80

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Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event

Number of subjects that reported pruritus as a treatment emergent adverse event during the study. (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionParticipants (Number)
NUCYNTA27
Oxycodone IR26

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Clinician Global Impression of Change at End of Study

Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionUnits on a Scale (Mean)
NUCYNTA2.1
Oxycodone IR2.1

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Incidence of 30% Responders Without Nausea or Vomiting at Day 5

Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported. (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionParticipants (Number)
NUCYNTA117
Oxycodone IR104

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Incidence of 50% Responders Without Nausea or Vomiting at Day 5

Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported. (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionParticipants (Number)
NUCYNTA72
Oxycodone IR60

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Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain

30% response means >= 30% reduction from baseline in low back pain intensity score. (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionHours (Median)
NUCYNTA42.93
Oxycodone IR44.27

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Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain

50% response means >= 50% reduction from baseline in low back pain intensity score. (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionHours (Median)
NUCYNTA92.05
Oxycodone IR107.45

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Patient Global Impression of Change at End of Study

Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). (NCT00986180)
Timeframe: Day 0 and Day 10/lst visit

InterventionUnits on a Scale (Mean)
NUCYNTA2.1
Oxycodone IR2.1

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Satisfaction With Treatment at Day 5

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). (NCT00986180)
Timeframe: Day 0 and Day 5

InterventionUnits on a Scale (Mean)
NUCYNTA2.0
Oxycodone IR2.0

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Satisfaction With Treatment at End of Study

The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). (NCT00986180)
Timeframe: Day 0 and Day 10/last visit

InterventionUnits on a Scale (Mean)
NUCYNTA2.0
Oxycodone IR2.0

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SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit

Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel. (NCT00986180)
Timeframe: Day 0 and Day 10

InterventionUnits on a Scale (Mean)
NUCYNTA-2.4
Oxycodone IR-2.2

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Abuse Liability Proxy

"Visual analog scale ratings (from 0-100) on the subject-rated measure of How much do you like the drug? with higher scores indicating greater abuse liability (and 100 anchored with extremely and zero indicating none anchored with none at all. Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure." (NCT00999544)
Timeframe: 42 days

Interventionunits on a scale (points 0-100) (Mean)
Placebo-Placebo (in and po)0.197
Aprepitant 40 mg - Placebo0.483
Aprepitant 200 mg- Placebo0.159
Placebo- 15 mg Oxycodone Intranasal7.678
Placebo- 30 mg Oxycodone Intranasal17.450
Placebo- 20 mg Oxycodone Oral9.850
Placebo - 40 mg Oxycodone Oral16.646
Aprepitant 40 mg- 15 mg Oxycodone Intranasal8.543
Aprepitant 40 mg - 30 mg Oxycodone Intranasal15.092
Aprepitant 40 mg- 20 mg Oxycodone Oral13.281
Aprepitant 40 mg - 40 mg Oxycodone Oral17.244
Aprepitant 200 mg - 15 mg Oxycodone Intranasal17.195
Aprepitant 200 mg - 30 mg Oxycodone Intranasal28.211
Aprepitant 200 mg- 20 Oxycodone Oral8.196
Aprepitant 200 mg- 40 Oxycodone Oral26.322

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Respiration Depression

Respiration rate measured over 60 seconds. Data were collected across multiple time points, but the peak minimum score was used for this outcome measure. (NCT00999544)
Timeframe: 42 days

Interventionnumber of breaths per minute (Mean)
Placebo Aprepitant/0 mg Oxycodone IN PO13.75
Placebo Aprepitant/ Oxycodone 15 IN 0 PO11.63
Placebo Aprepitant/ Oxycodone 30 IN 0 PO11.25
Placebo Aprepitant/ Oxycodone 0 IN 20 PO12.13
Placebo Aprepitant/ Oxycodone 0 IN 40 PO10.25
Aprepitant 40 mg/ Oxycodone 0 IN 0 PO12.25
Aprepitant 40 mg/ Oxycodone 0 IN 20 PO12.25
Aprepitant 40 mg/ Oxycodone 0 IN 40 PO11.00
Aprepitant 40 mg/ Oxycodone 15 IN 0 PO12.38
Aprepitant 40 mg/ Oxycodone 30 IN 0 PO11.63
Aprepitant 200 mg/ Oxycodone 0 IN 0 PO14.00
Aprepitant 200 mg/ Oxycodone 0 IN 20 PO14.00
Aprepitant 200 mg/ Oxycodone 0 IN 40 PO12.13
Aprepitant 200 mg/ Oxycodone 15 IN 0 PO12.00
Aprepitant 200 mg/ Oxycodone 30 IN 0 PO11.38

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Number of Subjects With Treatment-emergent Adverse Events (TEAE)

The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication. (NCT01063868)
Timeframe: Entire Study

Interventionparticipants (Number)
Tapentadol ER23
Oxycodone CR11

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Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets

To compare the use of rescue analgesia for the 2 groups (OXN 20/10mg tablets and OXY 20mg tablets) during the double blind treatment phase. Rescue medication was given (OXY Immediate Release, 5mg capsules) if the subjects pain score on the (Numeric Rating Scale (NRS), 0 (no pain) to 10 (worst possible pain)), was greater than or equal to 4. The value presented is the mean dose over the double blind phase. (NCT01083485)
Timeframe: Mean dose during the whole double blind treatment phase (2.5 days)

Interventionmg of rescue analgesia (Mean)
OXN Tablets24
OXY Tablets17

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Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value)

"The primary efficacy variable was the 24hr pain intensity score at rest, on a Numerical Rating Scale (NRS), with 0 = no pain and 10 = worst possible pain. This was assessed 1 hour after dosing on Day 1 (evening only), Day 2(morning and evening) and Day 3 (morning only). The primary efficacy end point (absolute change from baseline) was analysed on the per protocol (PP) data. The mean of these scores is shown as a value that is a mean change (a decrease in pain score) from the baseline value." (NCT01083485)
Timeframe: Mean of 24 hour pain intensity (absolute change from baseline)

InterventionUnits on a scale (Mean)
OXN Tablets-1.2
OXY Tablets-1.1

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AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT01099709)
Timeframe: Blood samples collected over a 72-hour time period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)143
Original OxyContin® (OXY) (Reference)150

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

Bioequivalence based on AUC0-t (NCT01099709)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)142
Original OxyContin® (OXY) (Reference)149

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Cmax - Maximum Observed Plasma Concentration

Bioeqivalence based on Cmax. (NCT01099709)
Timeframe: Blood samples collected over 72-hour period

Interventionng/mL (Mean)
Reformulated OXY (Test)14.2
Original OxyContin® (OXY) (Reference)13.6

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t. (NCT01100086)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)110
Original OxyContin® (OXY) (Reference)113

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AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf. (NCT01100086)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)110
Original OxyContin® (OXY) (Reference)114

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Cmax - Maximum Observed Plasma Concentration

Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax. (NCT01100086)
Timeframe: Blood samples collected over 72-hour period

Interventionng/mL (Mean)
Reformulated OXY (Test)9.60
Original OxyContin® (OXY) (Reference)9.38

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AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT01100320)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)537
Original OxyContin® (OXY) (Reference)579

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

Bioequivalence based on AUC0-t (NCT01100320)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)535
Original OxyContin® (OXY) (Reference)577

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Cmax - Maximum Observed Plasma Concentration

Bioequivalence based on Cmax (NCT01100320)
Timeframe: Blood samples collected over 72-hour period

Interventionng/mL (Mean)
Reformulated OXY (Test)62.0
Original OxyContin® (OXY) (Reference)61.5

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Cmax - Maximum Observed Plasma Concentration

Bioequivalence based on Cmax (NCT01101165)
Timeframe: Blood samples collected over 72-hour period

Interventionng/mL (Mean)
Reformulated OXY (Test)47.4
Original OxyContin® (OXY) (Reference)48.4

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

Bioequivalence based on AUC0-t (NCT01101165)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)453
Original OxyContin® (OXY) (Reference)477

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AUC0-inf - Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT01101165)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)454
Original OxyContin® (OXY) (Reference)480

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AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-inf is the Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)and bioequivalence is based on AUC0-inf values. (NCT01101178)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated Oxycodone (OXY) (Test)1033
Original OxyContin® (OXY) (Reference)1070

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

AUC0-t is the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration and bioequivalence based on AUC0-t (NCT01101178)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated Oxycodone (OXY) (Test)1030
Original OxyContin® (OXY) (Reference)1064

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Cmax - Maximum Observed Plasma Concentration

Cmax is the Maximum Observed Plasma Concentration and bioequivalence is based on Cmax. (NCT01101178)
Timeframe: Blood samples collected over 72-hour period

Interventionng/mL (Mean)
Reformulated Oxycodone (OXY) (Test)109
Original OxyContin® (OXY) (Reference)97.6

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Cmax - Maximum Observed Plasma Concentration

Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax. (NCT01101191)
Timeframe: Blood samples collected over a 72-hour period.

Interventionng/mL (Mean)
Reformulated OXY (Test)85.1
Original OxyContin® (OXY) (Reference)83.0

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AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf. (NCT01101191)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)966
Original OxyContin® (OXY) (Reference)989

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t. (NCT01101191)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Test)964
Original OxyContin® (OXY) (Reference)981

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AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

AUC0-inf is the area under the plasma concentration-time curve from time zero to infinity (extrapolated) and bioequivalence is based on AUC0-inf. (NCT01101308)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Totowa) (Test)112
Reformulated OXY (Wilson) (Reference)111

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

AUC0-t is the area under the plasma concentration-time curve from time zero to time of last non-zero plasma concentration and bioequivalence is based on AUC0-t. (NCT01101308)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Totowa) (Test)111
Reformulated OXY (Wilson) (Reference)110

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Cmax - Maximum Observed Plasma Concentration

Cmax is the maximum observed plasma concentration and bioequivalence is based on Cmax. (NCT01101308)
Timeframe: Blood samples collected over 72-hour period

Interventionng/mL (Mean)
Reformulated OXY (Totowa) (Test)9.81
Reformulated OXY (Wilson) (Reference)9.58

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Cmax - Maximum Observed Plasma Concentration

Bioequivalence based on Cmax (NCT01101321)
Timeframe: Blood samples collected over 72-hour period

Interventionng/mL (Mean)
Reformulated OXY (Totowa) (Test)78.4
Reformulated OXY (Wilson) (Reference)78.2

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AUC0-t - Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Non-zero Plasma Concentration

Bioequivalence based on AUC0-t (NCT01101321)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Totowa) (Test)843
Reformulated OXY (Wilson) (Reference)848

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AUC0-inf - Area Under Plasma Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf (NCT01101321)
Timeframe: Blood samples collected over 72-hour period

Interventionng*h/mL (Mean)
Reformulated OXY (Totowa) (Test)846
Reformulated OXY (Wilson) (Reference)850

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Single-dose PK Metric: Time to Maximum Plasma Concentration (Tmax)

(NCT01160614)
Timeframe: Up to 24 hours

Interventionhour (h) (Median)
6 to < 12 Years (10 mg ORF)6
6 to < 12 Years (15 mg ORF)3
6 to < 12 Years (20 mg ORF)12
≥ 12 to ≤ 16 Years (10 mg ORF)5.3
≥ 12 to ≤ 16 Years (15 mg ORF)3
≥ 12 to ≤ 16 Years (20 mg ORF)6

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Single- and Multiple-dose PK Metric: Maximum Observed Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Cmax 0-12)

(NCT01160614)
Timeframe: Up to 12 hours

Interventionng/mL (Mean)
6 to < 12 Years (10 mg ORF)9.4
6 to < 12 Years (15 mg ORF)23.5
6 to < 12 Years (20 mg ORF)21.9
≥ 12 to ≤ 16 Years (10 mg ORF)10.0
≥ 12 to ≤ 16 Years (15 mg ORF)21.8
≥ 12 to ≤ 16 Years (20 mg ORF)25.1

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Single- and Multiple-dose PK Metric: Mean Area Under the Plasma Concentration During Each Dosing Interval-time Curve From Hour 0 to 12 Hours of the First Dose of ORF (AUC 0-12)

(NCT01160614)
Timeframe: Up to 12 hours

Interventionng*h/mL (Mean)
6 to < 12 Years (10 mg ORF)67.5
6 to < 12 Years (15 mg ORF)114.5
6 to < 12 Years (20 mg ORF)112.8
≥ 12 to ≤ 16 Years (10 mg ORF)82.5
≥ 12 to ≤ 16 Years (15 mg ORF)139.0
≥ 12 to ≤ 16 Years (20 mg ORF)174.2

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Single- and Multiple-dose PK Metric: Time to Maximum Plasma Concentration From Hour 0 to 12 Hours of the First Dose of ORF (Tmax 0-12)

(NCT01160614)
Timeframe: Up to 12 hours

Interventionh (Median)
6 to < 12 Years (10 mg ORF)9
6 to < 12 Years (15 mg ORF)7.3
6 to < 12 Years (20 mg ORF)12
≥ 12 to ≤ 16 Years (10 mg ORF)4.6
≥ 12 to ≤ 16 Years (15 mg ORF)4.5
≥ 12 to ≤ 16 Years (20 mg ORF)6

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Single-dose PK Metric: Area Under the Plasma Concentration-time Curve From Hour 0 to the Last Measurable Plasma Concentration [AUCt]

(NCT01160614)
Timeframe: Up to 24 hours

Interventionng*h/mL (Mean)
6 to < 12 Years (10 mg ORF)129.2
6 to < 12 Years (15 mg ORF)121.1
6 to < 12 Years (20 mg ORF)272.2
≥ 12 to ≤ 16 Years (10 mg ORF)85.5
≥ 12 to ≤ 16 Years (15 mg ORF)193.0
≥ 12 to ≤ 16 Years (20 mg ORF)264.4

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The Number of Patients With Adverse Events as a Measure of Safety

(NCT01160614)
Timeframe: Adverse events (AEs) & serious adverse events (SAEs) were reported from start of study participation through the period beyond study completion (AEs) & through 30 days following last study drug dose, or until last study visit, whichever was later (SAEs).

,
Interventionparticipants (Number)
DeathSerious Adverse Event (SAE)Any TEAE reported in ≥ 5% of participants
≥ 12 to ≤ 16 Years0116
6 to < 12 Years005

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Single-dose PK Metric: Maximum Observed Plasma Concentration (Cmax)

(NCT01160614)
Timeframe: Up to 24 hours

Interventionng/mL (Mean)
6 to < 12 Years (10 mg ORF)12.3
6 to < 12 Years (15 mg ORF)16.6
6 to < 12 Years (20 mg ORF)21.9
≥ 12 to ≤ 16 Years (10 mg ORF)8.3
≥ 12 to ≤ 16 Years (15 mg ORF)26.6
≥ 12 to ≤ 16 Years (20 mg ORF)26.2

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Proportion of Patients With Various Levels of Pain Improvement (Responders)

The proportion of patients with at least a 30 percentage improvement based on the percent change from baseline in Numerical Rating Scale score during the last 3 days of the double-blind treatment period. (NCT01165281)
Timeframe: Baseline, Last 3 Days of Study Drug Administration (4 weeks)

,
InterventionPercentage of Participants (Number)
Proportion with at least a 30 percent improvementProportion with at least a 50 percent improvement
Oxycodone Controlled-release (CR) Oral Tablets59.042.4
Tapentadol (JNS024) Extended-release (ER) Oral Tablets63.550.0

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Number of Patients Who Discontinued Due to Lack of Efficacy

The duration from the date of first study drug intake to treatment discontinuation due to lack of efficacy. (NCT01165281)
Timeframe: 4 weeks

InterventionNumber of participants (Number)
Tapentadol (JNS024) Extended-release (ER) Oral Tablets1
Oxycodone Controlled-release (CR) Oral Tablets0

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Percentage of Patients in Patient Global Impression of Change (PGIC) Score Categories

"The PGIC was rated by the patient and was based on the single question Since the start of this treatment, my cancer-related pain overall is, where 1=very much improved, 2=much improved, 3=minimally improved, 4=not changed, 5=minimally worse, 6=much worse, 7=very much worse." (NCT01165281)
Timeframe: Baseline, Endpoint of the 4-week Treatment Period

,
InterventionPercentage of Participants (Number)
"Percentage much improved or very much improved""Percentage much worse or very much worse"
Oxycodone Controlled-release (CR) Oral Tablets50.41.4
Tapentadol (JNS024) Extended-release (ER) Oral Tablets58.74.0

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Total Daily Dose of Rescue Medication Use for the Double-blind Treatment Period

During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average total daily dose of Morphine IR taken (mg) was assessed. (NCT01165281)
Timeframe: 4 weeks

InterventionMilligrams (Mean)
Tapentadol (JNS024) Extended-release (ER) Oral Tablets6.95
Oxycodone Controlled-release (CR) Oral Tablets6.73

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Change From Baseline to the Last 3 Days of Study Drug Administration (Last Observation Carried Forward) in the Score for Average Pain Intensity on an 11-point Numerical Rating Scale

"The patients recorded their average pain intensity over the past 24 hours once daily in the evening and at the same time as much as possible (eg, 10:00 PM) throughout the study in response to the following question: What has your average pain level been for the past 24 hours, where 0=no pain and 10=pain as bad as you can imagine. The score at 3 days before the completion of study drug administration was defined as the average pain intensity score averaged over the last 3 days before completion of study drug administration." (NCT01165281)
Timeframe: Baseline, Last 3 Days of Study Drug Administration (4 weeks)

InterventionScores on scale (Mean)
Tapentadol (JNS024) Extended-release (ER) Oral Tablets-2.69
Oxycodone Controlled-release (CR) Oral Tablets-2.57

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Frequency of Rescue Medication Use for the Double-blind Treatment Period

During the study, if a patient experienced breakthrough pain (pain that occurs for short periods of time between doses of study drug), treatment with rescue medication (morphine immediate release [IR] 5 mg) was to be given. The average number of doses of Morphine IR taken per day was assessed. (NCT01165281)
Timeframe: 4 weeks

InterventionNumber of doses per day (Mean)
Tapentadol (JNS024) Extended-release (ER) Oral Tablets1.39
Oxycodone Controlled-release (CR) Oral Tablets1.35

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Proportion of Patients Entering the Maintenance Period

Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. (NCT01165281)
Timeframe: 4 weeks

InterventionPercentage of Participants (Number)
Tapentadol (JNS024) Extended-release (ER) Oral Tablets86
Oxycodone Controlled-release (CR) Oral Tablets80

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Use of Supplemental Pain Medication

Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight. (NCT01192295)
Timeframe: Baseline to week 4

,
Interventionparticipants (Number)
Any supplemental pain medicationAny opioid supplemental pain medicationAny nonopioid supplemental pain medication
≥ 12 to ≤ 16 Years1129375
6 to < 12 Years242117

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Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio

A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. The accumulation ratio is used to derive steady-state Cmin and Cmax and first-dose area under the concentration-time curve (AUCtau). (NCT01192295)
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]

InterventionRatio (Median)
Accumulation ratio - first doseAccumulation ratio - last dose
6 to 16 Years1.141.14

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Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets

"A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. Cmax was taken as the maximum simulated oxycodone concentration over the dosing interval and Cmin was the simulated oxycodone concentration when time was equal to 12 hours. Steady-state Cmin and Cmax were derived from the accumulation ratio.~The following PK parameters are presented: Cmin / Cmax (minimum / maximum concentration); Cmin,ss / Cmax,ss (Cmin / Cmax at steady state); CAVGss (average concentration at steady state)." (NCT01192295)
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]

Interventionng/mL (Median)
Cmin - first doseCmin - last doseCmin,ss - first doseCmin,ss - last doseCmax - first doseCmax - last doseCmax,ss - first doseCmax,ss - last doseCAVGss - first doseCAVGss - last dose
6 to 16 Years6.866.357.737.4616.315.820.917.916.115.7

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Parent/ Caregiver-Assessed Global Impression of Change (PGIC)

The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group. (NCT01192295)
Timeframe: Baseline to week 4 or early discontinuation

,
Interventionparticipants (Number)
1 = Very much improved2 = Much improved3 = Minimally improved4 = No change5 = Minimally worse6 = Much worse7 = Very much worse
≥ 12 to ≤ 16 Years4251155101
6 to < 12 Years10833001

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Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax)

A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. (NCT01192295)
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]

InterventionHours (Median)
Tmax - first doseTmax - last dose
6 to 16 Years3.753.75

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Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years

The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver. (NCT01192295)
Timeframe: Baseline to week 4

Interventionunits on a scale (Mean)
BaselineWeek 4
≥ 12 to ≤ 16 Years23.220.4

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Pain Right Now Assessment by Patients Aged 6 to < 12 Years

"Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with no hurt at the far left and hurts worst at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment." (NCT01192295)
Timeframe: Baseline to week 4

Interventionunits on a scale (Mean)
BaselineAverage during week 1: morningAverage during week 1: eveningAverage during week 2: morningAverage during week 2: eveningAverage during week 3: morningAverage during week 3: eveningAverage during week 4: morningAverage during week 4: evening
6 to < 12 Years4.444.114.073.663.703.643.763.133.42

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Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years

"Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked no pain and the opposite end marked as pain as bad as it could be. The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the no pain end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment." (NCT01192295)
Timeframe: Baseline to week 4

Interventionunits on a scale (Mean)
BaselineAverage during week 1: morningAverage during week 1: eveningAverage during week 2: morningAverage during week 2: eveningAverage during week 3: morningAverage during week 3: eveningAverage during week 4: morningAverage during week 4: evening
≥ 12 to ≤ 16 Years44.5840.3839.2434.4933.0432.5633.4635.5835.30

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The Number of Participants With Adverse Events as a Measure of Safety.

Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population. (NCT01192295)
Timeframe: Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment).

,
Interventionparticipants (Number)
Serious adverse eventsAll other adverse events in ≥ 5% of patients
≥ 12 to ≤ 16 Years2260
6 to < 12 Years513

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Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years

The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver. (NCT01192295)
Timeframe: Baseline to week 4

Interventionunits on a scale (Mean)
BaselineWeek 4
6 to < 12 Years27.123.0

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Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss

"A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. First-dose area under the concentration-time curve (AUC) was derived from the accumulation ratio. For all calculations, the dosing interval was assumed to be 12 hours.~The following PK parameters are presented: AUCtau (area under the concentration-time curve from time zero to time equal to dosing interval); AUCss (AUC at steady state)." (NCT01192295)
Timeframe: Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose]

Interventionng*hour/mL (Median)
AUCtau - first doseAUCtau - last doseAUCss - first doseAUCss - last dose
6 to 16 Years181158194188

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Breakthrough Pain Medication (Rescue Medication) Doses Taken

Any breakthrough pain medication taken during the overall study was reported. Morphine hydrochloride was used as a rescue medication in case of breakthrough pain. (NCT01205126)
Timeframe: Baseline up to Day 29

InterventionDoses (Mean)
Hydromorphone Hydrochloride (HCl)24.2
Oxycodone HCl Controlled Release (CR)29.3

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Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in average pain in the past 24 hours, in BPI score was reported. The score ranges from 0 to 10 wherein, 0 indicates no pain and 10 indicates pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)4.7-1.8
Oxycodone HCl Controlled Release (CR)4.7-1.4

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Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in pain at its least, in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)2.4-0.8
Oxycodone HCl Controlled Release (CR)2.3-0.5

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Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. BPI comprises of total 9 items in total, and the 8th item consisting of 7 sub-items is a question asking the degree of disturbance due to pain. The score ranges from 0% to 100%, wherein 0% indicates no relief and 100% indicates complete relief. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)48.815.8
Oxycodone HCl Controlled Release (CR)48.014.1

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Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in Pain Right now in BPI was reported. The score ranges from 0=no pain to 10=pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)4.1-1.4
Oxycodone HCl Controlled Release (CR)4.1-1.4

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Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29

The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine. (NCT01205126)
Timeframe: Baseline and Day 29

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 29
Hydromorphone Hydrochloride (HCl)6.7-1.8
Oxycodone HCl Controlled Release (CR)6.9-1.8

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Number of Participants Experiencing Any Adverse Events

Occurrence of any adverse event. (NCT01270659)
Timeframe: Full 2 hours of the study period

InterventionParticipants (Count of Participants)
Low-FBT1
High-FBT9
Low Control3
High Control10

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Median Time to Significant Analgesia (at Least 2 Units Decrease in Pain Level)

Median time (in minutes) to 2 units decrease in pain level after drug administration. Patients were asked to rate their pain at every 5 minutes intervals from 0 to 60 minutes post drug administration. The 10-point verbally administered numeric pain rating scale (NPRS) was used to have patients rate their level of pain on a scale of 0 (no pain) to 10 (worst pain ever). (NCT01270659)
Timeframe: 60 minutes

Interventionminutes (Median)
Low-FBT15.0
High-FBT20.0
Low Control15.0
High Control15.0

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Nausea Level

"Subjects' nausea level was recorded to determine how fentanyl buccal tablet compares to standard therapy in causing nausea. Treatment induced nausea and severity of nausea level was assessed.~Nausea was assessed by a 10-point verbally administered scale. Patients rated their degree of nausea on a scale of 0 (no nausea) to 10 (worst nausea).~At the beginning of the study, literature review found relatively little evidence guiding objective means to rate nausea, but there was some precedent for this approach (Warden C. Prehospital use of ondansetron reduces nausea and episodes of vomiting in adults and children over 12 years old [abstract]. Prehosp Emerg Care. 2007;11:132)." (NCT01270659)
Timeframe: every 5 minutes for the first 60 minutes

InterventionParticipants (Count of Participants)
Low-FBT0
High-FBT0
Low Control0
High Control0

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Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3)

Change of pain intensity from 0(No pain) to 10(worst pain imaginable) after 4 weeks treatment . (NCT01313780)
Timeframe: 4weeks

Interventionunits on a scale (Mean)
Oxycodone and Naloxone1.586
Oxycodone1.559

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Change in Bowel Habits.

The change of bowel habits from baseline (Visit 1) in bowel habits at Week 4 was investigated, and was categorized as 'improved', 'unchanged', and 'worsened'. (NCT01313780)
Timeframe: 4 weeks

,
Interventionparticipants (Number)
UnchangedworsenedImproved
Oxycodone20115
Oxycodone and Naloxone3175

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The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).

The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. (NCT01328782)
Timeframe: Will be obtained 30 - 60 minutes after arrival to the recovery room

InterventionScores on a scale (Mean)
Oral Narcotic Group4.14
Bupivacaine Group2.73
Ropivacaine Group3.66

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Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting

Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain. (NCT01328782)
Timeframe: Will be obtained from parent(s) 120 minutes after arrival to the recovery room

InterventionScores on a scale (Mean)
Oral Narcotic Group4.58
Bupivacaine Group2.73
Ropivacaine Group4.32

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Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge

(NCT01328782)
Timeframe: Analgesic data collected during first four hours following the end of surgery (surgery close)

InterventionMorphine (po) equivalents [mg*kg-1] (Mean)
Oral Narcotic Group0.09
Bupivacaine Group0.05
Ropivacaine Group0.08

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Time (in Minutes) to First Narcotic Administration

(NCT01328782)
Timeframe: first 72 hours after surgery close time

InterventionMinutes (Median)
Oral Narcotic Group30
Bupivacaine Group50.5
Ropivacaine Group34

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Need for IV Morphine of Fentanyl

Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl. (NCT01328782)
Timeframe: First 120 minutes after the end of surgery (surgery close time)

Interventionparticipants (Number)
Oral Narcotic Group19
Bupivacaine Group4
Ropivacaine Group15

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Patient Global Impression of Change (PGIC)

"The PGIC observational scale was completed by the subject. Subjects were asked to assess 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 proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test." (NCT01358526)
Timeframe: Week 12

Interventionparticipants (responders) (Number)
OXN Group153
Placebo Group109

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Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline

"A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the average pain over the last 24 hours score for week 12 of the double-blind period." (NCT01358526)
Timeframe: Week 12

Interventionparticipants (responders) (Number)
OXN Group164
Placebo Group124

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The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12

The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance. (NCT01358526)
Timeframe: Weeks 4, 8, and 12

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12
OXN Group32.530.831.1
Placebo Group38.036.836.4

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Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline

"A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the average pain over the last 24 hours score for week 12 of the double-blind period." (NCT01358526)
Timeframe: Week 12

Interventionparticipants (responders) (Number)
OXN Group109
Placebo Group75

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"The Average Pain Over the Last 24 Hours at Week 12 of the Double-blind Period"

"The average pain over the last 24 hours score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine." (NCT01358526)
Timeframe: 24 hours (Week 12)

Interventionunits on a scale (0 - 10) (Mean)
OXN Group3.86
Placebo Group4.32

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The Number of Participants With Adverse Events as a Measure of Safety.

Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population. (NCT01369615)
Timeframe: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).

,
Interventionparticipants (Number)
Serious adverse eventsAll other adverse events in ≥ 5% of patients
≥ 12 to ≤ 16 Years28
6 to < 12 Years38

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Change in Post-ureteroscopy Stent-induced Pain

Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and 3 months.

Interventionunits on a scale (Mean)
VESIcare + Narcotic Painkiller4.61
Narcotic Painkiller3.11

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Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.

Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure. (NCT01381120)
Timeframe: Baseline and three months.

Interventionunits on a scale (Mean)
VESIcare + Narcotic Painkiller1.90
Narcotic Painkiller1.13

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50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score

(NCT01402375)
Timeframe: 2 hours

InterventionParticipants (Count of Participants)
Hydrocodone (First Trial)50
Codeine (First Trial)45
Oxycodone (for Second Trial)73
Codeine (for Second Trial)64
Oxycodone (Third Trial)68
Hydrocodone (Third Trial)66

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Difference in Pain Intensity Score Before and After Last Dose.

"Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken." (NCT01402375)
Timeframe: 2 hrs

,,,,,
Interventionunits on a scale (Mean)
before most recent dose2 hours after most recent dosechange in NRS before to after most recent dose
Codeine (First Trial)7.64.13.5
Codeine (for Second Trial)7.93.64.2
Hydrocodone (First Trial)7.63.63.9
Hydrocodone (Third Trial)7.63.64.0
Oxycodone (for Second Trial)7.93.44.5
Oxycodone (Third Trial)7.83.34.4

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Time to Follow up

Median time to contact patients for data collection, measured from discharge to time contacted (NCT01402375)
Timeframe: up to 48 hours

Interventionhours (Median)
Hydrocodone (First Trial)27
Codeine (First Trial)25
Oxycodone (for Second Trial)26
Codeine (for Second Trial)28
Oxycodone (Third Trial)27
Hydrocodone (Third Trial)28

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Overall Satisfaction With the Pain Medicine

Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication. (NCT01402375)
Timeframe: 24 hrs

,,,,,
InterventionParticipants (Count of Participants)
Number of participants satisfied with analgesicparticipants would want the same analgesic again
Codeine (First Trial)6666
Codeine (for Second Trial)9185
Hydrocodone (First Trial)7259
Hydrocodone (Third Trial)9790
Oxycodone (for Second Trial)9991
Oxycodone (Third Trial)9386

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Number of Participants With Rescue Medication (Acetaminophen Tablets)

Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication. (NCT01428583)
Timeframe: Baseline- less than (<) Week 1, Week 1-<4, Week 4-

Interventionparticipants (Number)
Baseline-Week 1-<4 (n= 361)Week 4-Month 2-<3 (n= 252)Month 3-<4 (n= 222)Month 4-<5 (n= 209)Month 5-<6 (n= 199)Month 6-<7 (n= 191)Month 7-<8 (n= 185)Month8-<9 (n= 179)Month 9-<10 (n= 172)Month 10-<11 (n= 167)Month 11-<12 (n= 163)Month 12-
Oxycodone Hydrochloride (HCl) and Naltrexone HCl25620416712412011210496969379808530

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Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination

"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain at its worst in the last 24 hours was reported." (NCT01428583)
Timeframe: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination

Interventionunit on a scale (Mean)
Baseline (n= 382)Change at Week 1 (n= 354)Change at Week 4 (n= 301)Change at Month 2 (n= 248)Change at Month 3 (n= 219)Change at Month 4 (n= 208)Change at Month 5 (n= 197)Change at Month 6 (n= 189)Change at Month 7 (n= 184)Change at Month 8 (n= 180)Change at Month 9 (n= 173)Change at Month 10 (n= 166)Change at Month 11 (n= 161)Change at Month 12 (n= 153)Change at Month 12/ET (n= 368)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl7.4-0.7-1.3-1.6-1.8-1.9-1.9-2.0-2.0-2.0-2.2-2.1-2.2-2.2-1.6

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Mean Daily Dose of Study Medication (Oxycodone Component)

(NCT01428583)
Timeframe: Baseline- less than (<) Week 1, Week 1-<4, Week 4-

Interventionmilligram/day (Mean)
Baseline-less than (<) Week 1 (n= 378)Week 1-<4 (n= 344)Week 4-Month 2-< 3 (n= 238)Month 3-<4 (n= 217)Month 4-< 5 (n= 205)Month 5-<6 (n= 193)Month 6-<7 (n= 183)Month 7- <8 (n= 183)Month 8-<9 (n= 177)Month 9-<10 (n= 169)Month 10- <11 (n= 163)Month 11- <12 (n= 160)Month 12-
Oxycodone Hydrochloride (HCl) and Naltrexone HCl38.651.762.866.168.068.671.573.176.777.776.577.976.226.9

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Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state. (NCT01428583)
Timeframe: Baseline up to end of study (2 weeks post-end of month 12)

Interventionparticipants (Number)
MildModerateSevere
Oxycodone Hydrochloride (HCl) and Naltrexone HCl9420247

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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state. (NCT01428583)
Timeframe: Baseline up to end of study (2 weeks post-end of month 12)

Interventionparticipants (Number)
Adverse event (all causalities)Adverse reaction
Oxycodone Hydrochloride (HCl) and Naltrexone HCl343207

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Subjective Opiate Withdrawal Scale (SOWS) Score

The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal. (NCT01428583)
Timeframe: Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

Interventionunits on a scale (Mean)
Baseline (n= 395)Week 1 (n= 362)Week 4 (n= 307)Month 2 (n= 252)Month 3 (n= 221)Month 4 (n= 210)Month 5 (n= 198)Month 6 (n= 190)Month 7 (n= 185)Month 8 (n= 180)Month 9 (n= 174)Month 10 (n= 167)Month 11 (n= 162)Month 12 (n= 154)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl5.44.63.63.63.32.93.22.52.42.52.42.22.32.4

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Percentage of Participants With Response to Urine Drug Test

Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed. (NCT01428583)
Timeframe: Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination

Interventionpercentage of participants (Number)
Screening (n= 393)Week 4 (n= 302)Month 2 (n= 251)Month 3 (n= 222)Month 4 (n= 211)Month 5 (n= 198)Month 6 (n= 190)Month 7 (n= 184)Month 8 (n= 179)Month 9 (n= 174)Month 10 (n= 167)Month 11 (n= 161)Month 12 or early termination (n= 343)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl86.841.743.043.239.341.444.241.844.144.844.350.357.1

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Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above

The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior. (NCT01428583)
Timeframe: Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination

Interventionpercentage of participants (Number)
Baseline (n= 395)Week 4 (n= 302)Month 2 (n= 250)Month 3 (n= 217)Month 4 (n= 208)Month 5 (n= 197)Month 6 (n= 189)Month 7 (n= 185)Month 8 (n= 181)Month 9 (n= 174)Month 10 (n= 167)Month 11 (n= 162)Month 12 or early termination (n= 333)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl21.38.910.08.36.75.12.63.25.05.74.83.715.3

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Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score

The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported. (NCT01428583)
Timeframe: Baseline up to Month 12

Interventionpercentage of participants (Number)
Mild (score 5-12)Moderate (score 13-24)Moderately severe (score 25-36)Severe (score greater than 36)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl13.20.00.30.0

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Participants Global Assessment of Treatment Satisfaction

"Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question Please rate your overall satisfaction with the study drug you received? where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied." (NCT01428583)
Timeframe: Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment

Interventionunit on a scale (Mean)
Week 1 (n= 361)Week 4 (n= 304)Month 2 (n= 251)Month 3 (n= 220)Month 4 (n= 209)Month 5 (n= 197)Month 6 (n= 190)Month 7 (n= 185)Month 8 (n= 181)Month 9 (n= 174)Month 10 (n= 167)Month 11 (n= 162)Month 12 (n= 154)End of treatment (n= 372)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl3.33.83.94.14.14.24.24.24.24.24.34.34.23.6

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Duration of Exposure to Study Medication

Duration of exposure to study medication during the course of the study was assessed. (NCT01428583)
Timeframe: Baseline up to 2 weeks after last dose

Interventiondays (Median)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl171.0

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Time to Stabilization of Study Medication

Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1. (NCT01428583)
Timeframe: Baseline up to Month 12

Interventiondays (Median)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl11.0

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Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination

"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours was reported." (NCT01428583)
Timeframe: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination

Interventionunit on a scale (Mean)
Baseline (n= 384)Change at Week 1 (n= 357)Change at Week 4 (n= 303)Change at Month 2 (n= 250)Change at Month 3 (n= 219)Change at Month 4 (n= 206)Change at Month 5 (n= 196)Change at Month 6 (n= 189)Change at Month 7 (n= 184)Change at Month 8 (n= 180)Change at Month 9 (n= 173)Change at Month 10 (n= 166)Change at Month 11 (n= 161)Change at Month 12 (n= 153)Change at Month 12/ET (n= 372)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl5.9-0.6-1.2-1.5-1.7-1.7-1.7-1.7-1.7-1.9-1.8-1.7-1.8-1.9-1.3

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Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination

"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain right now was reported." (NCT01428583)
Timeframe: Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)

Interventionunits on a scale (Mean)
Baseline (n= 386)Change at Week 1 (n= 360)Change at Week 4 (n= 306)Change at Month 2 (n= 251)Change at Month 3 (n= 218)Change at Month 4 (n= 208)Change at Month 5 (n= 197)Change at Month 6 (n= 189)Change at Month 7 (n= 184)Change at Month 8 (n= 180)Change at Month 9 (n= 172)Change at Month 10 (n= 166)Change at Month 11 (n= 161)Change at Month 12 (n= 153)Change at Month 12/ET (n= 373)
Oxycodone Hydrochloride (HCl) and Naltrexone HCl5.6-0.6-1.3-1.6-1.7-1.8-1.8-1.8-1.7-1.8-1.8-1.7-1.9-1.9-1.4

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Colonic Geometric Center at 8 and 48 Hours

The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. (NCT01500317)
Timeframe: 8 hours, 48 hours

,,
Interventionunits on a scale (Mean)
Colonic geometric center at 8 hrColonic geometric center at 48 hr
Oxycodone0.753.51
Placebo0.793.742
Tapentadol0.783.59

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Ascending Colon Emptying (AC t1/2)

Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 24 hour data. (NCT01500317)
Timeframe: Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles

Interventionhours (Mean)
Tapentadol21.92
Oxycodone19.3
Placebo17.88

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Colonic Filling at 6 Hours

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time. (NCT01500317)
Timeframe: 6 hours

Interventionpercentage of radio-labeled meal (Mean)
Tapentadol35.55
Oxycodone38.6
Placebo65.54

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Colonic Transit, Geometric Center at 24 Hours

The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool. (NCT01500317)
Timeframe: 24 hours

Interventionunits on a scale (Mean)
Tapentadol2.06
Oxycodone2.07
Placebo2.17

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Gastric Emptying Half-time (t1/2) at 24 Hours

(NCT01500317)
Timeframe: 24 hours

Interventionminutes (Mean)
Tapentadol159.2
Oxycodone155.2
Placebo124.7

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Percent Change in Average Daily Pain Score

Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure. Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure. A positive change from baseline indicates an improvement. (NCT01502644)
Timeframe: Baseline and Week 20

Interventionpercent change (Mean)
Low NA38.6
Moderate NA30.0
High NA20.6

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Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. (NCT01571362)
Timeframe: Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)

InterventionPercentage of participants (Number)
Screening COWS less than(<)5 (n=387)Screening COWS=5-12 (n=387)Week 1 COWS <5 (n=353)Week 1 COWS=5-12 (n=353)Week 2 COWS <5 (n=327)Week 2 COWS 5-12 (n=327)Week 3 COWS <5 (n=316)Week 3 COWS 5-12 (n=316)Week 4 COWS <5 (n=210)Week 4 COWS 5-12 (n=210)Week 5 COWS <5 (n=138)Week 6 COWS <5 (n=375)Week 6 COWS 5-12 (n=375)Max. Titration Period Value COWS <5 (n=375)Max. Titration Period Value COWS 5-12 (n=375)
Open ALO-0298.41.699.20.898.81.299.10.999.50.510098.91.196.83.2

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Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor

Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. (NCT01571362)
Timeframe: Randomization Baseline, Week 4

,
InterventionPercentage of participants (Number)
Very Good / Very GoodVery Good / GoodVery Good / FairVery Good / PoorVery Good / Very PoorGood / Very GoodGood / GoodGood / FairGood / PoorGood / Very PoorFair / Very GoodFair / GoodFair / FairFair / PoorFair / Very PoorPoor / Very GoodPoor / GoodPoor / FairPoor / PoorPoor / Very PoorVery Poor / Very GoodVery Poor / GoodVery Poor / FairVery Poor / PoorVery Poor / Very Poor
ALO-02 To ALO-028.70.80.00.00.06.327.813.50.00.01.615.123.02.40.00.00.00.00.80.00.00.00.00.00.0
ALO-02 To Placebo7.33.70.90.00.05.524.87.30.00.00.915.624.81.80.00.92.82.80.00.00.00.00.00.90.0

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Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor

Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. (NCT01571362)
Timeframe: Randomization Baseline, Week 8

,
InterventionPercentage of participants (Number)
Very Good / Very GoodVery Good / GoodVery Good / FairVery Good / PoorVery Good / Very PoorGood / Very GoodGood / GoodGood / FairGood / PoorGood / Very PoorFair / Very GoodFair / GoodFair / FairFair / PoorFair / Very PoorPoor / Very GoodPoor / GoodPoor / FairPoor / PoorPoor / Very PoorVery Poor / Very GoodVery Poor / GoodVery Poor / FairVery Poor / PoorVery Poor / Very Poor
ALO-02 To ALO-028.93.61.80.00.08.023.211.60.90.00.915.221.41.80.00.00.00.90.90.00.00.90.00.00.0
ALO-02 To Placebo8.05.70.00.00.05.725.012.50.00.03.414.817.02.30.00.01.11.10.00.00.00.02.31.10.0

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Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? (NCT01571362)
Timeframe: Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)

,
InterventionPercentage of participants (Number)
Yes/Yes Week 4 (n=108, 123)Yes/No Week 4 (n=108, 123)No/Yes Week 4 (n=108, 123)No/No Week 4 (n=108, 123)Yes/Yes Week 8 (n=85, 110)Yes/No Week 8 (n=85, 110)No/Yes Week 8 (n=85, 110)No/No Week 8 (n=85, 110)Yes/Yes Week12/ET (n=129, 134)Yes/No Week12/ET (n=129, 134)No/Yes Week12/ET (n=129, 134)No/No Week 12/ET (n=129, 134)
ALO-02 To ALO-020.00.80.099.20.00.90.099.10.00.00.799.3
ALO-02 To Placebo0.03.71.994.40.01.22.496.50.03.11.695.3

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Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionPercentage of participants (Number)
Yes/YesYes/NoNo/YesNo/No
Open ALO-020.30.82.596.4

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Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionPercentage of participants (Number)
Yes/YesYes/NoNo/YesNo/No
Open ALO-020.41.12.995.6

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Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire

Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? (NCT01571362)
Timeframe: Screening, Weeks 4, 8, and 12

,
InterventionPercentage of participants (Number)
Yes/Yes Week 4 (n=109,124)Yes/No Week 4 (n=109,124)No/Yes Week 4 (n=109,124)No/No Week 4 (n=109,124)Yes/Yes Week 8 (n=86,111)Yes/No Week 8 (n=86, 111)No/Yes Week 8 (n=86, 111)No/No Week 8 (n=86, 111)Yes/Yes Week 12/ET (n=130,136)Yes/No Week 12/ET (n=130,136)No/Yes Week 12/ET (n=130,136)No/No Week 12/ET (n=130,136)
ALO-02 To ALO-020.00.81.697.60.00.91.897.30.00.02.297.8
ALO-02 To Placebo0.92.82.893.60.01.22.396.50.82.33.893.1

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Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor

Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionPercentage of participants (Number)
Very Good / Very GoodVery Good / GoodVery Good / FairVery Good / PoorVery Good / Very PoorGood / Very GoodGood / GoodGood / FairGood / PoorGood / Very PoorFair / Very GoodFair / GoodFair / FairFair / PoorFair / Very PoorPoor / Very GoodPoor / GoodPoor / FairPoor / PoorPoor / Very PoorVery Poor / Very GoodVery Poor / GoodVery Poor / FairVery Poor / PoorVery Poor / Very Poor
Open ALO-020.42.99.42.90.00.05.829.28.71.40.02.522.010.51.40.00.42.20.40.00.00.00.00.00.0

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Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor

Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. (NCT01571362)
Timeframe: Screening, Randomization Baseline, or Early Termination

InterventionPercentage of participants (Number)
Very Good / Very GoodVery Good / GoodVery Good / FairVery Good / PoorVery Good / Very PoorGood / Very GoodGood / GoodGood / FairGood / PoorGood / Very PoorFair / Very GoodFair / GoodFair / FairFair / PoorFair / Very PoorPoor / Very GoodPoor / GoodPoor / FairPoor / PoorPoor / Very PoorVery Poor / Very GoodVery Poor / GoodVery Poor / FairVery Poor / PoorVery Poor / Very Poor
Open ALO-020.32.77.62.20.00.05.425.07.61.10.02.727.210.61.40.00.33.02.20.30.00.00.00.30.3

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Satisfaction With Treatment at Randomization Baseline

Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied. (NCT01571362)
Timeframe: Randomization Baseline

InterventionPercentage of participants (Number)
Very Dissatisfied (n=278)Dissatisfied (n=278)Neither Satisfied or Dissatisfied (n=278)Satisfied (n=278)Very Satisfied (n=278)
Open ALO-025.42.24.746.041.7

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Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants

Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied. (NCT01571362)
Timeframe: End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)

InterventionPercentage of participants (Number)
Very Dissatisfied (n=369)Dissatisfied (n=369)Neither Satisfied or Dissatisfied (n=369)Satisfied (n=369)Very Satisfied (n=369)
Open ALO-026.87.011.740.733.9

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SOWS Total Score During the Double-Blind Treatment Period

The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. (NCT01571362)
Timeframe: Randomization Baseline, Weeks 1, 2, 4, 8, and 12

,
InterventionUnits on a scale (Mean)
Randomization Baseline (n=134,146)Week 1 (n=134,143)Change from Baseline at Week 1 (n=134,143)Week 2 (n=123,135)Change from Baseline at Week 2 (n=123,135)Max. SOWS, First 2 Weeks of Period (n=134,143)Week 4 (n=105,122)Change from Baseline at Week 4 (n=105,122)Week 8 (n=85,110)Change from Baseline at Week 8 (n=85,110)Week 12 (n=134,143)Change from Baseline at Week 12 (n=134,143)Max. SOWS (Double-Blind Period) (n=134,143)Change from Baseline at max. SOWs (n=134,143)
ALO-02 To ALO-021.52.30.81.90.34.42.10.52.10.62.40.95.23.7
ALO-02 To Placebo2.43.00.63.51.16.32.50.12.40.13.30.96.74.3

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SOWS Total Score During the Post-Treatment Period

The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. (NCT01571362)
Timeframe: Follow-Up Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
FU Week 1 (n=94,108)Change from Baseline at FU Week 1 (n=94,108)FU Week 2 (n=95,109)Change from Baseline at FU Week 2 (n=95,109)Max. SOWS (FU Period)(n=96,110)Change from Baseline at Max. SOWS, (n=96,110)
ALO-02 To ALO-022.30.82.51.04.53.0
ALO-02 To Placebo2.60.22.70.24.72.2

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Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionScore on a scale (Mean)
Screening (n=279)Randomization Baseline (n=276)Change from Screening (n=275)
Open ALO-0267.0276.859.84

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Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period

The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. (NCT01571362)
Timeframe: Screening, Weeks 1, 2, 3, 4, 5, and 6

InterventionUnits on a scale (Mean)
Screening (n=395)Week 1 (n=355)Change from Screening at Week 1 (n=346)Week 2 (n=329)Change from Screening at Week 2 (n=320)Week 3 (n=311)Change from Screening at Week 3 (n=304)Week 4 (n=206)Change from Screening at Week 4 (n=199)Week 5 (n=139)Change from Screening at Week 5 (n=133)Week 6/ET (n=369)Change from Screening at Week 6/ET (n=359)Max. SOWS (Titration Period) (n=369)Change from Screening at Max. SOWS (n=359)
Open ALO-024.13.5-0.73.0-1.22.7-1.42.2-2.12.2-2.43.0-1.24.90.7

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Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Randomization Baseline, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=30,42)Week 8 (n=21,37)Week 12/ET (n=35,46)
ALO-02 To ALO-02-1.54-1.364.39
ALO-02 To Placebo5.223.636.77

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Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability. (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionUnits on a scale (Mean)
Screening (n=405)End of Open-Label Titration Period (n=345)Change from Screening (n=343)
Open ALO-0212.79.0-3.9

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Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)

NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain. (NCT01571362)
Timeframe: Randomization Baseline, Weeks 11 and 12

InterventionChange in units on a scale*days (Least Squares Mean)
ALO-02 To Placebo39.00
ALO-02 To ALO-0211.25

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Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period

The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period. (NCT01571362)
Timeframe: Daily from Day 1 of the Double-Blind Period through Week 12

InterventionAverage mg/day (Least Squares Mean)
ALO-02 To Placebo207.84
ALO-02 To ALO-02203.97

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Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index

Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health (NCT01571362)
Timeframe: Randomization Baseline, Week 12

InterventionScore on a scale (Least Squares Mean)
ALO-02 To Placebo-0.061
ALO-02 To ALO-02-0.029

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Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. (NCT01571362)
Timeframe: Randomization Baseline, Week 12

InterventionScore on a scale (Least Squares Mean)
ALO-02 To Placebo-3.61
ALO-02 To ALO-02-2.89

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Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index

Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. (NCT01571362)
Timeframe: Screening, Week 12

InterventionScore on a scale (Least Squares Mean)
ALO-02 To Placebo0.085
ALO-02 To ALO-020.106

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Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. (NCT01571362)
Timeframe: Screening, Week 12

InterventionScore on a scale (Least Squares Mean)
ALO-02 To Placebo4.75
ALO-02 To ALO-027.01

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Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).

The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability. (NCT01571362)
Timeframe: Week 12

InterventionUnits on a Scale (Least Squares Mean)
ALO-02 To Placebo0.50
ALO-02 To ALO-020.67

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Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)

Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 11 and 12

InterventionUnits on a Scale (Least Squares Mean)
ALO-02 To Placebo1.23
ALO-02 To ALO-020.60

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Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period

(NCT01571362)
Timeframe: Double-Blind Period

Interventionmg (Mean)
ALO-02 To Placebo70.1
ALO-02 To ALO-0263.6

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Mean Oxycodone Average Daily Dose During the Open-Label Titration Period

(NCT01571362)
Timeframe: Open-Label Period

Interventionmg (Mean)
Open ALO-0245.8

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Mean Oxycodone Duration of Titration During the Open-Label Titration Period

(NCT01571362)
Timeframe: Open-Label Period

Interventiondays (Mean)
Open ALO-0231.0

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Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period

(NCT01571362)
Timeframe: Double-Blind Period

Interventiondays (Mean)
ALO-02 To Placebo62.7
ALO-02 To ALO-0270.9

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Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period

(NCT01571362)
Timeframe: Double-Blind Period

Interventionmg (Median)
ALO-02 To Placebo60.0
ALO-02 To ALO-0259.6

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Median Oxycodone Average Daily Dose During the Open-Label Titration Period

(NCT01571362)
Timeframe: Open-Label Period

Interventionmg (Median)
Open ALO-0242.3

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Median Oxycodone Duration of Titration During the Open-Label Titration Period

(NCT01571362)
Timeframe: Open-Label Period

Interventiondays (Median)
Open ALO-0235.0

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Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period

(NCT01571362)
Timeframe: Double-Blind Period

Interventiondays (Median)
ALO-02 To Placebo84.0
ALO-02 To ALO-0285.0

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Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period

If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1]. (NCT01571362)
Timeframe: Week 1 up to Week 12

Interventiondays (Median)
ALO-02 To PlaceboNA
ALO-02 To ALO-02NA

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Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy

If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. (NCT01571362)
Timeframe: Week 1 up to Week 12

InterventionPercentage of participants (Number)
ALO-02 To Placebo11.9
ALO-02 To ALO-022.7

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Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 11 and 12

Interventionpercentage of participants (Number)
ALO-02 To Placebo44.0
ALO-02 To ALO-0257.5

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Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 11 and 12

Interventionpercentage of participants (Number)
ALO-02 To Placebo35.1
ALO-02 To ALO-0250.7

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Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 11 and 12

Interventionpercentage of participants (Number)
ALO-02 To Placebo29.9
ALO-02 To ALO-0239.7

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Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%

Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 11 and 12

Interventionpercentage of participants (Number)
ALO-02 To Placebo48.5
ALO-02 To ALO-0262.3

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Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=125,135)Week 4 (n=111,124)Week 8 (n=88,112)Week 12/ET (n=131,138)
ALO-02 To ALO-020.360.300.350.39
ALO-02 To Placebo1.011.040.991.27

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Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,135)Week 4 (n=111,125)Week 8 (n=89,112)Week 12/ET(n=131,138)
ALO-02 To ALO-020.340.060.190.28
ALO-02 To Placebo0.740.940.831.13

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Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,135)Week 4 (n=111,127)Week 8 (n=89,113)Week 12/ET (n=131,138)
ALO-02 To ALO-020.360.430.470.49
ALO-02 To Placebo0.770.920.641.14

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Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,135)Week 4 (n=111,125)Week 8 (n=88,112)Week 12/ET (n=131,138)
ALO-02 To ALO-020.400.240.330.36
ALO-02 To Placebo1.041.031.041.43

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Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index

Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=125,135)Week 4 (n=111,124)Week 8 (n=88,112)Week 12/ET (n=131,138)
ALO-02 To ALO-020.370.280.340.38
ALO-02 To Placebo0.951.040.951.32

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Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,135)Week 4 (n=111,125)Week 8 (n=89,113)Week 12/Early Termination (ET)(n=131,138)
ALO-02 To ALO-020.380.510.490.47
ALO-02 To Placebo1.001.150.861.45

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Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain. (NCT01571362)
Timeframe: Randomization Baseline, Weeks 4, 8, and 12

,
InterventionDollars (Mean)
Randomization Baseline (n=124,136)Week 4 (n=104,119)Change from Baseline at Week 4 (n=99,117)Week 8 (n=81,106)Change from Baseline at Week 8 (n=76,105)Week 12/ET (n=125,133)Change from Baseline at Week 12/ET (n=119,128)
ALO-02 To ALO-0211.315.04.416.77.529.320.0
ALO-02 To Placebo96.419.9-24.7146.2-0.1113.0-47.8

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Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital

Question 3b: nights stayed in the hospital (NCT01571362)
Timeframe: Randomization Baseline, Weeks 4, 8, and 12

,
InterventionNumber of nights (Mean)
Randomization Baseline (n=1,2)Week 4 (n=4,0)Change from Baseline at Week 4 (n=0,0)Week 8 (n=1,1)Change from Baseline at Week 8 (n=0,0)Week 12/ET (n=4,1)Change from Baseline at Week 12/ET (n=0,0)
ALO-02 To ALO-020.0NANA0.0NA0.0NA
ALO-02 To Placebo0.00.3NA99.0NA24.8NA

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Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Randomization Baseline, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=108,125)Week 8 (n=85,112)Week 12/ET (n=128,135)
ALO-02 To ALO-021.983.056.41
ALO-02 To Placebo6.232.0510.56

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Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Randomization Baseline, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=30,42)Week 8 (n=21,37)Week 12/ET (n=35,46)
ALO-02 To ALO-02-2.03-0.665.71
ALO-02 To Placebo5.318.6910.85

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Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Randomization Baseline, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=36,44)Week 8 (n=25,41)Week 12/ET (n=40,50)
ALO-02 To ALO-02-0.771.413.72
ALO-02 To Placebo3.544.296.49

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Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. (NCT01571362)
Timeframe: Randomization Baseline, Week 12

,
InterventionScore on a scale (Least Squares Mean)
Physical Functioning (n=122,125)Role-Physical (n=124,126)Bodily Pain (n=124,127)General Health Perceptions (n=124,126)Vitality (n=123,127)Social Functioning (n=124,127)Role-Emotional (n=124,127)Mental Health (n=124,127)Physical Component Score (n=121,125)Mental Component Score (n=121,125)
ALO-02 To ALO-02-1.44-2.59-2.69-2.10-2.77-1.69-3.44-2.93-1.68-2.98
ALO-02 To Placebo-2.06-2.56-5.07-1.55-1.62-3.17-2.57-2.95-2.70-2.29

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Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. (NCT01571362)
Timeframe: Randomization Baseline, Weeks 2, 4, and 8

,
InterventionUnits on a scale (Least Squares Mean)
Week 2 (n=111,118)Week 4 (n=98,107)Week 8 (n=73,93)
ALO-02 To ALO-02-0.190.320.41
ALO-02 To Placebo0.541.02-0.01

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Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. (NCT01571362)
Timeframe: Screening, Week 12

,
InterventionScore on a scale (Least Squares Mean)
Physical Functioning (n=123,126)Role-Physical (n=125,127)Bodily Pain (n=125,127)General Health Perceptions (n=125,126)Vitality (n=125,127)Social Functioning (n=125,127)Role-Emotional (n=125,127)Mental Health (n=125,127)Physical Component Score (n=123,126)Mental Component Score (n=123,126)
ALO-02 To ALO-026.846.788.781.073.015.571.220.478.09-0.45
ALO-02 To Placebo5.325.686.391.283.463.580.990.096.42-0.44

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Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. (NCT01571362)
Timeframe: Screening, Weeks 2, 4, 8, and 12

,
InterventionUnits on a scale (Least Squares Mean)
Week 2 (n=114,124)Week 4 (n=101,111)Week 8 (n=77,95)Week 12/ET (n=123,128)
ALO-02 To ALO-02-4.93-4.60-3.92-4.26
ALO-02 To Placebo-3.88-3.90-4.50-4.33

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Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain

Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain (NCT01571362)
Timeframe: Screening, Weeks 4, 8, and 12

,
InterventionDollars (Mean)
Screening (n=126,138)Week 4 (n=104,119)Change from Screening at Week 4 (n=100,114)Week 8 (n=81,106)Change from Screening at Week 8 (n=78,103)Week 12/ET (n=125,133)Change from Screening at Week 12/ET (n=120,128)
ALO-02 To ALO-0285.615.0-80.316.7-84.529.3-58.1
ALO-02 To Placebo83.619.9-79.8146.256.9113.032.1

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Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain

Question 3b: nights stayed in the hospital (NCT01571362)
Timeframe: Screening, Weeks 4, 8, and 12

,
InterventionNumber of nights (Mean)
Screening (n=6,3)Week 4 (n=4,0)Change from Screening at Week 4 (n=1,0)Week 8 (n=1,1)Change from Screening at Week 8 (n=0,0)Week 12/ET (n=4,1)Change from Screening at Week 12/ET (n=1,0)
ALO-02 To ALO-020.3NANA0.0NA0.0NA
ALO-02 To Placebo0.00.30.099.0NA24.80.0

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Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Screening, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=109,125)Week 8 (n=87,112)Week 12/ET (n=130,136)
ALO-02 To ALO-02-31.24-29.87-26.81
ALO-02 To Placebo-23.75-25.25-18.62

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Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Screening, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=33,42)Week 8 (n=22,37)Week 12/ET (n=38,46)
ALO-02 To ALO-02-31.03-29.37-25.38
ALO-02 To Placebo-18.65-16.43-16.18

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Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Screening, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=32,41)Week 8 (n=21,37)Week 12/ET (n=37,46)
ALO-02 To ALO-02-32.40-29.37-25.51
ALO-02 To Placebo-19.84-15.21-15.16

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Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Screening, Weeks 4, 8, and 12

,
InterventionPercentage (Least Squares Mean)
Week 4 (n=36,43)Week 8 (n=24,40)Week 12/ET (n=40,49)
ALO-02 To ALO-02-4.82-3.01-2.09
ALO-02 To Placebo-0.09-1.42-1.00

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Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment.~work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionPercentage (Mean)
Percent Work Time Missed (n=119)Percent Impairment While Working (n=112)Percent Overall Work Impairment (n=110)Percent Activity Impairment (n=363)
Open ALO-02-1.3-22.4-21.6-27.2

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Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index

BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. (NCT01571362)
Timeframe: Screening, Week 4, 5, or 6

InterventionUnits on a Scale (Mean)
Worst Pain Score (n=400)Least Pain Score (n=400)Average Pain Score (n=400)Pain Right Now (n=400)Pain Severity Index (n=400)Pain Interference Index (n=401)
Open ALO-02-3.3-2.6-3.0-3.3-3.1-2.8

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Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. (NCT01571362)
Timeframe: Screening, Randomization Baseline

Interventionunits on scale (Mean)
Worst Pain Score (n=279)Least Pain Score (n=279)Average Pain Score (n=279)Pain Right Now (n=279)Pain Severity Index (n=279)Pain Interference Index (n=279)
Open ALO-02-4.2-3.4-3.8-4.2-3.9-3.4

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Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index

Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionScore on a scale (Mean)
Screening (n=272)Randomization Baseline (n=267)Change from Screening (n=260)
Open ALO-020.680.820.14

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Change From Screening Period to Randomization Baseline in RMDQ Total Score

RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionUnits on a scale (Mean)
Screening (n=277)Randomization Baseline (n=256)Change from Screening (n=255)
Open ALO-0212.87.9-4.8

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Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionScore on a scale (Mean)
Physical Functioning (n=276)Role-Physical (n=276)Bodily Pain (n=276)General Health (n=277)Vitality (n=276)Social Functioning (n=277)Role-Emotional (n=277)Mental Health (n=277)Physical Component Score (n=274)Mental Component Score (n=274)
Open ALO-028.09.111.63.15.87.04.73.59.62.9

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Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain

"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity." (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionPercentage (Mean)
Percent Work Time Missed (n=91)Percent Impairment While Working (n=86)Percent Overall Work Impairment (n=85)Percent Activity Impairment (n=273)
Open ALO-02-4.9-25.9-26.9-32.0

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Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS

The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionScore on a scale (Mean)
Screening (n=406)End of Open-Label (n=367)Change from Screening (n=364)
Open ALO-0266.2374.698.16

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Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index

The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionScore on a scale (Mean)
Screening (n=400)End of Open-Label (n=354)Change from Screening (n=346)
Open ALO-020.680.800.12

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Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score

SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state. (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionScore on a scale (Mean)
Physical Functioning (n=366)Role-Physical (n=366)Bodily Pain (n=366)General Health (n=367)Vitality (n=366)Social Functioning (n=367)Role-Emotional (n=367)Mental Health (n=367)Physical Component Score (n=364)Mental Component Score (n=364)
Open ALO-026.77.79.82.34.65.03.42.38.21.6

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Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=125,134)Week 4 (n=111,123)Week 8 (n=88,111)Week 12/ET (n=131,137)
ALO-02 To ALO-02-3.43-3.55-3.50-3.43
ALO-02 To Placebo-2.63-2.76-2.71-2.39

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Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,134)Week 4 (n=111,124)Week 8 (n=89,111)Week 12/ET (n=131,137)
ALO-02 To ALO-02-3.05-3.29-3.21-3.12
ALO-02 To Placebo-2.55-2.40-2.44-2.14

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Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index

Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,134)Week 4 (n=111,126)Week 8 (n=89,112)Week 12/ET (n=131,137)
ALO-02 To ALO-02-2.99-2.99-2.87-2.88
ALO-02 To Placebo-2.58-2.52-2.72-2.24

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Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,134)Week 4 (n=111,124)Week 8 (n=88,111)Week 12/ET (n=131,137)
ALO-02 To ALO-02-3.72-3.82-3.71-3.74
ALO-02 To Placebo-3.12-3.15-3.00-2.72

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Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index

Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity. (NCT01571362)
Timeframe: Weeks 2, 4, 8, and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=125,134)Week 4 (n=111,123)Week 8 (n=88,111)Week 12/ET (n=131,137)
ALO-02 To ALO-02-3.50-3.60-3.53-3.51
ALO-02 To Placebo-2.83-2.83-2.80-2.47

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Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain

BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01571362)
Timeframe: Weeks 2, 4, 8 and 12

,
InterventionUnits on a Scale (Least Squares Mean)
Week 2 (n=126,134)Week 4 (n=111,124)Week 8 (n=89,112)Week 12/ET (n=131,137)
ALO-02 To ALO-02-3.80-3.74-3.72-3.73
ALO-02 To Placebo-3.09-3.01-3.16-2.63

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Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionDollars (Mean)
Screening (n=388)Randomization Baseline (n=343)Change from Screening (n=329)
Open ALO-02104.188.0-28.3

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Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital

Question 3b: nights stayed in the hospital, if answer to Q3a was yes. (NCT01571362)
Timeframe: Screening, Week 6 (or Early Termination)

InterventionNumber of days (Mean)
Screening (n=9)Randomization Baseline (n=3)Change from Screening (n=1)
Open ALO-020.10.00.0

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Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks

Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionDollars (Mean)
Screening (n=264)Randomization Baseline (n=260)Change from Screening (n=248)
Open ALO-0284.751.8-41.8

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Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital

Question 3b: nights stayed in the hospital, if answer to Q3a was yes. (NCT01571362)
Timeframe: Screening, Randomization Baseline

InterventionNumber of days (Mean)
Screening (n=9)Randomization Baseline (n=3)Change from Screening (n=1)
Open ALO-020.10.00.0

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Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. (NCT01571362)
Timeframe: Screening, Weeks 1, 2, 3, 4, 5, and 6

InterventionUnits on a scale (Mean)
Screening (n=387)Week 1 (n=353)Change from Screening at Week 1 (n=333)Week 2 (n=327)Change from Screening at Week 2 (n=308)Week 3 (n=316)Change from Screening at Week 3 (n=295)Week 4 (n=210)Change from Screening at Week 4 (n=194)Week 5 (n=138)Change from Screening at Week 5 (n=131)Week 6/ET (n=375)Change from Screening at Week 6 (n=352)Maximum Titration Period (MTP) Value (n=375)Change from screening to MTP Value (n=352)
Open ALO-020.60.60.00.50.00.5-0.10.60.00.6-0.10.60.01.20.6

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COWS Total Score During the Double-Blind Treatment Period

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. (NCT01571362)
Timeframe: Randomization Baseline, Weeks 1, 2, 4, 8, and 12

,
InterventionUnits on a scale (Mean)
Randomization Baseline (n=134,146)Week 1 (n=111,133)Change from Baseline at Week 1 (n=111,133)Week 2 (n=115,128)Change from Baseline at Week 2 (n=115,128)Week 4 (n=106,123)Change from Baseline at Week 4 (n=106,123)Week 8 (n=87,107)Change from Baseline at Week 8 (n=87,107)Week 12/ET (n=126,140)Change from Baseline at Week 12/ET(n=126,140)Max. Double-Blind Period (DBP) Value (n=126,140)Change from Baseline to max. DBP Value (n=126,140)
ALO-02 To ALO-020.40.60.30.70.30.40.10.60.20.60.21.30.9
ALO-02 To Placebo0.60.80.30.80.20.60.10.60.10.70.21.40.9

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COWS Total Score During the Post-Treatment Period

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. (NCT01571362)
Timeframe: Follow-Up (FU) Weeks 1 and 2

,
InterventionUnits on a scale (Mean)
FU Week 1 (n=68,83)Change from Baseline at FU Week 1 (n=68,83)FU Week 2 (n=78,91)Change from Baseline at FU Week 2 (n=78,91)Max.FU Period Value (n=94,108)Change to max. FU Period Value (n=94,108)
ALO-02 To ALO-020.60.20.90.71.10.7
ALO-02 To Placebo0.60.10.5-0.10.70.1

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Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1]. (NCT01571362)
Timeframe: Screening, Week 4, 5, or 6

Interventiondays (Median)
Time to 20% Analgesic Response from ScreeningTime to 30% Analgesic Response from ScreeningTime to 40% Analgesic Response from ScreeningTime to 50% Analgesic Response from Screening
Open ALO-0215212835

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Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1]. (NCT01571362)
Timeframe: Screening, Randomization Baseline (up to 6 weeks)

Interventiondays (Median)
Time to 20% Analgesic ResponseTime to 30% Analgesic ResponseTime to 40% Analgesic ResponseTime to 50% Analgesic Response
Open ALO-0214202633

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Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period

The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1]. (NCT01571362)
Timeframe: Randomization Baseline, up to Week 12

,
Interventiondays (Median)
Time to 20% Loss of Analgesic ResponseTime to 30% Loss of Analgesic ResponseTime to 40% Loss of Analgesic ResponseTime to 50% Loss of Analgesic Response
ALO-02 To ALO-0231NANANA
ALO-02 To Placebo12214162

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Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period

Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol (NCT01571362)
Timeframe: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

,
Interventionpg/mL (Mean)
Naltrexone at Baseline (n=127,139)Naltrexone at Week 4 (n=3,115)Naltrexone at Week 8 (n=3,107)Naltrexone at Week 12/ET (n=4,137)6-β-naltrexol at Baseline (n=127,139)6-β-naltrexol at Week 4 (n=3,115)6-β-naltrexol at Week 8 (n=3,107)6-β-naltrexol at Week 12/ET (n=4,137)
ALO-02 To ALO-025.33.42.93.097.586.148.355.6
ALO-02 To Placebo24.90.00.00.0216.00.00.00.0

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Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period

Cobs of naltrexone and 6-β-naltrexol (NCT01571362)
Timeframe: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Interventionpg/mL (Mean)
Naltrexone at Week 6/ET (n=77)Naltrexone at Randomization Baseline (n=266)6-β-naltrexol at Week 6/ET (n=77)6-β-naltrexol at Randomization Baseline (n=266)
Open ALO-024.614.682.0154.1

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Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone (NCT01571362)
Timeframe: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12

,
Interventionng/mL (Mean)
Oxycodone at Baseline (n=127,140)Oxycodone at Week 4 (n=0,116)Oxycodone at Week 8 (n=0,107)Oxycodone at Week 12/ET (n=1,137)Noroxycodone at Baseline (n=127,140)Noroxycodone at Week 4 (n=0,116)Noroxycodone at Week 8 (n=0,107)Noroxycodone at Week 12/ET (n=1,137)
ALO-02 To ALO-0225.923.323.122.627.125.526.226.3
ALO-02 To Placebo27.0NANA0.033.1NANA0.0

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Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period

Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone. (NCT01571362)
Timeframe: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline

Interventionng/mL (Mean)
Oxycodone at Week 6/ET (n=77)Oxycodone at Randomization Baseline (n=267)Noroxycodone at Week 6/ET (n=77)Noroxycodone at Randomization Baseline (n=267)
Open ALO-0214.126.415.529.9

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Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).

Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes 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). (NCT01571362)
Timeframe: Randomization Baseline, Week 12

,
InterventionPercentage of participants (Number)
Very Good / Very GoodVery Good / GoodVery Good / FairVery Good / PoorVery Good / Very PoorGood / Very GoodGood / GoodGood / FairGood / PoorGood / Very PoorFair / Very GoodFair / GoodFair / FairFair / PoorFair / Very PoorPoor / Very GoodPoor / GoodPoor / FairPoor / PoorPoor / Very PoorVery Poor / Very GoodVery Poor / GoodVery Poor / FairVery Poor / PoorVery Poor / Very Poor
ALO-02 To ALO-0211.72.91.50.00.03.619.76.60.70.00.021.226.32.20.00.01.52.20.00.00.00.00.00.00.0
ALO-02 To Placebo5.46.21.50.80.06.218.54.60.00.03.117.723.10.80.00.82.34.61.50.00.01.51.50.00.0

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Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period

Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied). (NCT01571362)
Timeframe: Week 12 or Early Termination

,
InterventionPercentage of participants (Number)
Yes (n=125,128)No (n=125,128)
ALO-02 To ALO-0279.720.3
ALO-02 To Placebo59.240.8

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Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100. (NCT01571362)
Timeframe: Screening, Week 4, 5 or 6

InterventionPercentage of participants (Number)
Participants with 20% Analgesic ResponseParticipants with 30% Analgesic ResponseParticipants with 40% Analgesic ResponseParticipants with 50% Analgesic Response
Open ALO-0285.278.967.349.7

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Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline

The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. (NCT01571362)
Timeframe: Screening, Randomization Baseline (up to 6 weeks)

InterventionPercentage of participants (Number)
Participants with 20% Analgesic ResponseParticipants with 30% Analgesic ResponseParticipants with 40% Analgesic ResponseParticipants with 50% Analgesic Response
Open ALO-0299.395.386.064.0

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Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period

The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1]. (NCT01571362)
Timeframe: Randomization Baseline, up to Week 12

,
InterventionPercentage of participants (Number)
Participants with 20% Loss of Analgesic ResponseParticipants with 30% Loss of Analgesic ResponseParticipants with 40% Loss of Analgesic ResponseParticipants with 50% Loss of Analgesic Response
ALO-02 To ALO-0254.546.234.331.5
ALO-02 To Placebo72.064.457.650.8

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Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. (NCT01571362)
Timeframe: Follow-Up Weeks 1 and 2

,
InterventionPercentage of participants (Number)
FU Week 1 COWS <5 (n=68,83)FU Week 2 COWS <5 (n=78,91)FU Week 2 COWS=5-12 (n=78,91)Maximum FU Period COWS <5 (n=94,108)Maximum FU Period COWS=5-12 (n=94,108)
ALO-02 To ALO-02100.095.64.496.33.7
ALO-02 To Placebo100.01000100.00

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Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. (NCT01571362)
Timeframe: Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)

,
InterventionPercentage of participants (Number)
Randomization Baseline COWS <5 (n=134,146)Week 1 COWS <5 (n=111,133)Week 1 COWS 5-12 (n=111,133)Week 1 COWS 13-24 (n=111,133)Week 2 COWS <5 (n=115,128)Week 2 COWS 5-12 (n=115,128)Week 4 COWS <5 (n=106,123)Week 4 COWS 5-12 (n=106,123)Week 8 COWS <5 (n=87,107)Week 8 COWS 5-12 (n=87,107)Week 12/ET COWS <5 (n=126,140)Week 12/ET COWS 5-12 (n=126,140)Week 12/ET COWS 13-24 (n=126,140)Max. DBP Value COWS <5 (n=126,140)Max. DBP Value COWS 5-12 (n=126,140)Max. DBP Value COWS 13-24 (n=126,140)
ALO-02 To ALO-0210098.51.5098.41.6100098.11.997.92.1095.05.00
ALO-02 To Placebo10099.100.999.10.999.10.9100098.40.80.897.61.60.8

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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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ke for Participants Who Received a Single Dose

To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

,
Interventionh^-1 (Mean)
OxycodoneNoroxycodoneHydroxymorphineNormethoxymorphone
Oxycodone Hydrochloride Single Dose 10 mg0.160.110.060.08
Oxycodone Hydrochloride Single Dose 20 mg0.170.110.090.10

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CL for Participants Who Received Multiple Dose

To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg. (NCT01643772)
Timeframe: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

InterventionL*hour (Mean)
OxycodoneNoroxycodoneHydroxymorphineNormethoxymorphone
Oxycodone Hydrochloride Multiple Dose73.5490.662374.20773.01

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Tmax,t1/2 for Participants Who Received Multiple Dose

To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg. (NCT01643772)
Timeframe: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Interventionhour (Mean)
Oxycodone( Tmax)Noroxycodone( Tmax)Hydroxymorphine( Tmax)Normethoxymorphone( Tmax)Oxycodone(t1/2)Noroxycodone(t1/2)Hydroxymorphine(t1/2)Normethoxymorphone(t1/2)
Oxycodone Hydrochloride Multiple Dose1.351.511.491.865.077.238.099.07

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AUC0-t and AUC0-∞ for Participants Who Received a Single Dose

To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

,
Interventionng*hr*ml (Mean)
Oxycondone(AUC0-t)Oxycondone(AUC0-∞)Noroxycodone(AUC0-t)Noroxycodone(AUC0-∞)Hydroxymorphine(AUC0-t)Hydroxymorphine(AUC0-∞)Normethoxymorphone(AUC0-t)Normethoxymorphone(AUC0-∞)
Oxycodone Hydrochloride Single Dose 10 mg102.10104.5689.7699.153.123.9628.6933.31
Oxycodone Hydrochloride Single Dose 20 mg205.89210.61163.68178.613.794.3637.6443.85

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The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose. (NCT01643772)
Timeframe: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

,,
Interventionμg (Mean)
Oxycondone(Pre-dose)Oxycondone(post dose0-2h)Oxycondone(post dose2-4h)Oxycondone(post dose4-8h)Oxycondone(post dose8-12h)Oxycondone(post dose12-24h)Noroxycodone(Pre-dose)Noroxycodone(post dose0-2h)Noroxycodone(post dose2-4h)Noroxycodone(post dose4-8h)Noroxycodone(post dose8-12h)Noroxycodone(post dose12-24h)Hydroxymorphine(Pre-dose)Hydroxymorphine(post dose0-2h)Hydroxymorphine(post dose2-4h)Hydroxymorphine(post dose4-8h)Hydroxymorphine(post dose8-12h)Hydroxymorphine(post dose12-24h)Normethoxymorphone(Pre-dose)Normethoxymorphone(post dose0-2h)Normethoxymorphone(post dose2-4h)Normethoxymorphone(post dose4-8h)Normethoxymorphone(post dose8-12h)Normethoxymorphone(post dose12-24h)
Oxycodone Hydrochloride Single Dose 10 mg0.0054.55172.38169.2878.4836.12063.80346.22418.95212.68128.7500.942.525.802.971.6707.1623.5368.8730.1730.16
Oxycodone Hydrochloride Single Dose 20 mg0.00108.57316.07165.4571.0767.920157.75784.70712.81360.37265.3102.899.995.852.492.9008.5340.2939.6448.3833.76
Oxycodone Hydrochloride Single Dose 5 mg0.0025.6964.2464.9356.0740.30023.29105.53153.49139.4553.0900.511.031.722.072.3103.9715.4425.1528.5926.74

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Tmax,t1/2 for Participants Who Received a Single Dose

To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Interventionhour (Mean)
Oxycodone (Tmax)Oxycodone (t1/2)Noroxycodone (Tmax)Noroxycodone (t1/2)Hydroxymorphine(Tmax)Normethoxymorphone(Tmax)Normethoxymorphone(t1/2)
Oxycodone Hydrochloride Single Dose 5 mg0.984.421.326.220.901.627.78

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Cmax,Clast for Participants Who Received a Single Dose

To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

,
Interventionng*mL (Mean)
Oxycodone(Cmax)Noroxycodone(Cmax)Hydroxymorphine(Cmax)Normethoxymorphone(Cmax)Oxycodone(Clast)Noroxycodone(Clast)Hydroxymorphine(Clast)Normethoxymorphone(Clast)
Oxycodone Hydrochloride Single Dose 10 mg21.1411.620.421.770.370.890.050.36
Oxycodone Hydrochloride Single Dose 20 mg35.5619.190.763.520.741.560.050.49

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Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)

Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day . (NCT01643772)
Timeframe: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

Interventionμg (Mean)
Oxycondone(post dose0-2h)Oxycondone(post dose2-4h)Oxycondone(post dose4-8h)Oxycondone(post dose8-12h)Oxycondone(post dose12-24h)Noroxycodone(post dose0-2h)Noroxycodone(post dose2-4h)Noroxycodone(post dose4-8h)Noroxycodone(post dose8-12h)Noroxycodone(post dose12-24h)Hydroxymorphine(post dose0-2h)Hydroxymorphine(post dose2-4h)Hydroxymorphine(post dose4-8h)Hydroxymorphine(post dose8-12h)Hydroxymorphine(post dose12-24h)Normethoxymorphone(post dose0-2h)Normethoxymorphone(post dose2-4h)Normethoxymorphone(post dose4-8h)Normethoxymorphone(post dose8-12h)Normethoxymorphone(post dose12-24h)
Oxycodone Hydrochloride Single Dose 10 mg263.32605.961037.66913.591290.63372.51810.751326.141693.832618.446.1330.1654.6872.85108.81130.63338.90601.46575.47796.81

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Tmax,t1/2 for Participants Who Received a Single Dose

To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

,
Interventionhour (Mean)
Oxycodone (Tmax)Oxycodone (t1/2)Noroxycodone (Tmax)Noroxycodone (t1/2)Hydroxymorphine(Tmax)Hydroxymorphine (t1/2)Normethoxymorphone(Tmax)Normethoxymorphone(t1/2)
Oxycodone Hydrochloride Single Dose 10 mg0.804.381.086.630.8711.701.779.17
Oxycodone Hydrochloride Single Dose 20 mg0.734.240.986.591.077.902.048.22

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Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose. (NCT01643772)
Timeframe: post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h

,,
Interventionμg (Mean)
Oxycondone(post dose0-2h)Oxycondone(post dose2-4h)Oxycondone(post dose4-8h)Oxycondone(post dose8-12h)Oxycondone(post dose12-24h)Noroxycodone(post dose0-2h)Noroxycodone(post dose2-4h)Noroxycodone(post dose4-8h)Noroxycodone(post dose8-12h)Noroxycodone(post dose12-24h)Hydroxymorphine(post dose0-2h)Hydroxymorphine(post dose2-4h)Hydroxymorphine(post dose4-8h)Hydroxymorphine(post dose8-12h)Hydroxymorphine(post dose12-24h)Normethoxymorphone(post dose0-2h)Normethoxymorphone(post dose2-4h)Normethoxymorphone(post dose4-8h)Normethoxymorphone(post dose8-12h)Normethoxymorphone(post dose12-24h)
Oxycodone Hydrochloride Single Dose 10 mg54.55226.92396.20474.68510.8063.80410.02828.971041.661170.410.943.469.2712.2413.917.1630.6899.55129.72159.88
Oxycodone Hydrochloride Single Dose 20 mg108.57424.64590.08661.15729.07157.75942.441655.252015.622280.922.8912.8818.7321.2224.118.5348.8288.46136.84170.60
Oxycodone Hydrochloride Single Dose 5 mg25.6989.93154.86210.92251.2223.29128.82282.31421.75474.850.511.543.275.337.643.9719.4044.5573.1499.87

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Fluctuation Index (DF) for Participants Who Received Multiple Dose

To calculate Fluctuation index (DF) of Drug Valley and Peak Concentration of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg. (NCT01643772)
Timeframe: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Interventionng/ml (Mean)
OxycodoneNoroxycodoneHydroxymorphineNormethoxymorphone
Oxycodone Hydrochloride Multiple Dose94.1155.75123.9552.07

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ke for Participants Who Received a Single Dose

To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Interventionh^-1 (Mean)
OxycodoneNoroxycodoneNormethoxymorphone
Oxycodone Hydrochloride Single Dose 5 mg0.160.120.09

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Vd for Participants Who Received a Single Dose

To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

InterventionL (Mean)
OxycodoneNoroxycodoneNormethoxymorphone
Oxycodone Hydrochloride Single Dose 5 mg568.111119.225004.50

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Css_min,Css_max and Css_av for Participants Who Received Multiple Dose

To calculate Css_min,Css_max and Css_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg. (NCT01643772)
Timeframe: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Interventionng/ml (Mean)
Oxycodone(Css_min)Noroxycodone(Css_min)Hydroxymorphine(Css_min)Normethoxymorphone(Css_min)Oxycodone(Css_max )Noroxycodone(Css_max )Hydroxymorphine(Css_max )Normethoxymorphone(Css_max )Oxycodone(Css_av)Noroxycodone(Css_av)Hydroxymorphine(Css_av)Normethoxymorphone(Css_av)
Oxycodone Hydrochloride Multiple Dose16.9215.740.402.1840.1726.711.103.6526.0120.440.752.76

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Cmax,Clast for Participants Who Received a Single Dose

To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Interventionng*mL (Mean)
Oxycodone(Cmax)Noroxycodone(Cmax)Hydroxymorphine(Cmax)Normethoxymorphone(Cmax)Oxycodone(Clast)Noroxycodone(Clast)Normethoxymorphone(Clast)
Oxycodone Hydrochloride Single Dose 5 mg12.976.190.271.640.200.320.16

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Clearance Rate for Participants Who Received a Single Dose

To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

,
InterventionL*hour (Mean)
Oxycodone (CL)Noroxycodone (CL)Hydroxymorphine(CL)Normethoxymorphone(CL)
Oxycodone Hydrochloride Single Dose 10 mg101.53113.302525.30530.65
Oxycodone Hydrochloride Single Dose 20 mg101.33119.384587.50681.64

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Clearance Rate for Participants Who Received a Single Dose

To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

InterventionL*hour (Mean)
Oxycodone (CL)Noroxycodone (CL)Normethoxymorphone(CL)
Oxycodone Hydrochloride Single Dose 5 mg91.49125.78443.45

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Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)

Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose. (NCT01643772)
Timeframe: post dose 24h

,,
Intervention% of ug (Mean)
OxycondoneNoroxycodoneHydroxymorphineNormethoxymorphone
Oxycodone Hydrochloride Single Dose 10 mg5.1111.700.141.60
Oxycodone Hydrochloride Single Dose 20 mg3.6511.400.120.85
Oxycodone Hydrochloride Single Dose 5 mg5.029.500.152.00

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The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)

The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day. (NCT01643772)
Timeframe: Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day

Interventionμg (Mean)
Oxycondone(Pre-dose)Oxycondone(post dose0-2h)Oxycondone(post dose2-4h)Oxycondone(post dose4-8h)Oxycondone(post dose8-12h)Oxycondone(post dose12-24h)Noroxycodone(Pre-dose)Noroxycodone(post dose0-2h)Noroxycodone(post dose2-4h)Noroxycodone(post dose4-8h)Noroxycodone(post dose8-12h)Noroxycodone(post dose12-24h)Hydroxymorphine(Pre-dose)Hydroxymorphine(post dose0-2h)Hydroxymorphine(post dose2-4h)Hydroxymorphine(post dose4-8h)Hydroxymorphine(post dose8-12h)Hydroxymorphine(post dose12-24h)Normethoxymorphone(Pre-dose)Normethoxymorphone(post dose0-2h)Normethoxymorphone(post dose2-4h)Normethoxymorphone(post dose4-8h)Normethoxymorphone(post dose8-12h)Normethoxymorphone(post dose12-24h)
Oxycodone Hydrochloride Multiple Dose 10 mg745.99263.32342.64431.70137.13344.15897.44372.51438.24515.39500.42865.379.436.1324.0324.5215.1031.73337.01130.63208.27262.56102.36240.75

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AUCss for Participants Who Received Multiple Dose

To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg. (NCT01643772)
Timeframe: Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.

Interventionng*hours*mL (Mean)
OxycodoneNoroxycodoneHydroxymorphineNormethoxymorphone
Oxycodone Hydrochloride Multiple Dose156.03122.694.5116.56

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AUC0-t and AUC0-∞ for Participants Who Received a Single Dose

To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

Interventionng*hr*ml (Mean)
Oxycondone(AUC0-t)Oxycondone(AUC0-∞)Noroxycodone(AUC0-t)Noroxycodone(AUC0-∞)Hydroxymorphine(AUC0-∞)Normethoxymorphone(AUC0-t)Normethoxymorphone(AUC0-∞)
Oxycodone Hydrochloride Single Dose 5 mg57.0358.3838.8541.93013.2715.07

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Vd for Participants Who Received a Single Dose

To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg. (NCT01643772)
Timeframe: blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.

,
InterventionL (Mean)
OxycodoneNoroxycodoneHydroxymorphineNormethoxymorphone
Oxycodone Hydrochloride Single Dose 10 mg626.451026.6542608.807297.56
Oxycodone Hydrochloride Single Dose 20 mg611.171138.7252264.207460.04

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Physician's Overall Satisfaction

Physician's overall satisfaction was scored 7 scales from Very much worse to Very much improved. (Very much worse, much worse, minimally worse, No change, Minimally improved, much improved, very much improved). (NCT01675531)
Timeframe: 4 weeks

Interventionparticipants (Number)
Very much worsemuch worseminimally worseNo changeMinimally improvedMuch improvedVery much improved
Oxycontin/Naloxone0322519161

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Patient's Overall Satisfaction

Patient's overall satisfaction was assessed 7 scales from very much worse to very much improved. (Very much worse, much worse, minimally worse, no change, minimally improved, much improved, very much improved) (NCT01675531)
Timeframe: 4weeks

Interventionparticipants (Number)
Very much worseMuch worseMinimally worseNo changeMinimally improvedMuch improvedVery much improved
Oxycontin/Naloxone0322615182

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NRS (Numeric Rating Scale)

"Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0).~NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline." (NCT01675531)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Oxycodone/Naloxone-1.29

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Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).

"Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FAICT-GOG/NTX).~The mean changes in FACT/GOG-NTX total score and each FACT/GOG-NTX subscale score from Visit 1 (Week 0) to Visit 4 (Week 4 post-treatment) were analyzed. Missing data was handled as LOCF(Last Observation Carried Forward Method).~FACT/GOG-NTX total score range was from 0 to 152. The average change score from baseline to visit 4 indicates thay a lower score on the FACT/GOG-NTX means lower quality of life and a greater impact of neurotoxic symptom on the patient's life." (NCT01675531)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Oxycontin/Naloxone-2.78

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Degree of Pain Relief Within 24hrs After Treatment

Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%). (NCT01675622)
Timeframe: baseline up to 5-8 days (double blind period)

Interventionpercentage of pain relief (Mean)
Oxycodone Capsules for Cancer Pain35.23
Morphine Tablets for Cancer Pain34.19

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Numerical Rating Scale (NRS)

The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting. (NCT01675622)
Timeframe: baseline up to 5-8 days (double blind period)

Interventionscores on a scale (Mean)
Oxycodone Capsules for Cancer Pain3.91
Morphine Tablets for Cancer Pain3.87

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The Average Dose of Study Medicine Used During Double Blind Treatment Period

the average dose of study medicine used during double blind treatment period between the two treatment groups. (NCT01675622)
Timeframe: baseline up to 5-8 days (double blind period)

,
Interventionmg (Mean)
Average total dosage during double-blind titrationAve. total dosage during double-blind maintenance
Morphine Tablets for Cancer Pain141.61308.63
Oxycodone Capsules for Cancer Pain83.29167.41

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Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment

The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items. (NCT01675622)
Timeframe: baseline up to 19-22 days (open label treatment)

,
Interventionscores on a scale (Mean)
Highest pain intensity in 24 hrsLowest pain intensity in 24 hrsAverage pain intensity in 24 hrsCurrent Pain intensity
Morphine Tablets for Cancer Pain3.952.643.483.71
Oxycodone Capsules for Cancer Pain3.982.573.333.62

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Average Number of Titrations

the average times to change the dose in order to find the proper dose between two treatment groups (NCT01675622)
Timeframe: baseline up to 1-3 days(double blind period)

Interventiondose changes (Mean)
Oxycodone Capsules for Cancer Pain8.25
Morphine Tablets for Cancer Pain7.89

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Times of Breakthrough Pain Occurrence

the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups (NCT01675622)
Timeframe: Within 8 days after baseline

Interventionbreakthrough pain events (Number)
Oxycodone Capsules for Cancer Pain15
Morphine Tablets for Cancer Pain20

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Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment

For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%). (NCT01675622)
Timeframe: baseline up to 19-22 days (open label treatment)

Interventionpercentage of pain relief (Mean)
Oxycodone Capsules for Cancer Pain32.31
Morphine Tablets for Cancer Pain31.64

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Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period

The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items. (NCT01675622)
Timeframe: baseline up to 5-8 days (double blind period)

,
Interventionscores on a scale (Mean)
Highest pain intensity in 24 hrsLowest pain intensity in 24 hrsAverage pain intensity in 24 hrsCurrent Pain intensity
Morphine Tablets for Cancer Pain4.032.533.353.70
Oxycodone Capsules for Cancer Pain4.252.623.393.78

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the Total Dose of Rescue Medicine for Breakthrough Pain.

the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups (NCT01675622)
Timeframe: baseline up to 22 days (double blind period)

,
Interventionmg (Mean)
the total dose of rescue medicine -day1the total dose of rescue medicine -day2the total dose of rescue medicine-day3the total dose of rescue medicine-day4the total dose of rescue medicine-day5the total dose of rescue medicine -day6the total dose of rescue medicine after day6
Morphine Tablets for Cancer Pain7.006.006.827.866.675.005.00
Oxycodone Capsules for Cancer Pain10.6310.0010.6320.0011.0005.00

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Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase

The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain). (NCT01685684)
Timeframe: Randomized Baseline through Week 12

Interventionunits on a scale (Mean)
Oxycodone DETERx (Double-blind Maintenance Phase)0.29
Placebo (Double-blind Maintenance Phase)1.85

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Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)

The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain. (NCT01685684)
Timeframe: Randomization Baseline and Week 12

Interventionunits on a scale (Mean)
Oxycodone DETERx (Double-blind Maintenance Phase)0.4
Placebo (Double-blind Maintenance Phase)0.7

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Time-to-exit From the Study for All Causes

Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module. (NCT01685684)
Timeframe: Randomization Baseline through Week 12

InterventionDays (Number)
Oxycodone DETERx (Double-blind Maintenance Phase)58.0
Placebo (Double-blind Maintenance Phase)35.0

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Changes in Quality of Life

Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12. (NCT01685684)
Timeframe: Randomization Baseline through Week 12

,
Interventionunits on a scale (Mean)
Physical Component ScoreMental Component ScorePhysical FunctioningRole PhysicalBodily PainGeneral Health
Oxycodone DETERx (Double-blind Maintenance Phase)7.524-2.5540.61.20.70.28
Placebo (Double-blind Maintenance Phase)3.6220.6740.50.60.40.22

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Percent Reduction in Pain Intensity for Responders

Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity. (NCT01685684)
Timeframe: Screening Baseline through Week 12

,
Interventionparticipants (Number)
Subjects with 30% ImprovementSubjects with 50% Improvement
Oxycodone DETERx (Double-blind Maintenance Phase)9574
Placebo (Double-blind Maintenance Phase)6548

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Rescue Medication Usage by Dose

Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study) (NCT01685684)
Timeframe: Randomization Baseline through Week 12

,
Interventiondoses (Mean)
Doses per DayDoses per WeekTotal Number of Doses
Oxycodone DETERx (Double-blind Maintenance Phase)0.151.048.0
Placebo (Double-blind Maintenance Phase)0.231.6011.2

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Rescue Medication Use by Dosage

Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study) (NCT01685684)
Timeframe: Randomization Baseline through Week 12

,
Interventionmilligrams (Mean)
Dosage per DayDosage per WeekTotal Dosage
Oxycodone DETERx (Double-blind Maintenance Phase)144.631012.397873.1
Placebo (Double-blind Maintenance Phase)189.321325.279028.1

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Weekly Changes in Pain Intensity

Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain). (NCT01685684)
Timeframe: Randomization Baseline and weekly through Week 12

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 5Week 6Week 7Week 8Week 9Week 10Week 11Week 12
Oxycodone DETERx (Double-blind Maintenance Phase)0.10.00.10.10.20.20.10.00.10.20.20.3
Placebo (Double-blind Maintenance Phase)0.30.40.50.80.70.70.70.80.70.70.80.8

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Patient Global Impression of Change (PGIC)

"The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes very much improved, improved, a little improved, no change, a little worse, worse, and very much worse." (NCT01685684)
Timeframe: Screening Baseline through Week 12

,
Interventionparticipants (Number)
Very Much ImprovedImprovedA Little ImprovedNo ChangeA Little WorseWorseVery Much Worse
Oxycodone DETERx (Double-blind Maintenance Phase)3652239020
Placebo (Double-blind Maintenance Phase)17392612411

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Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject

The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad. (NCT01719757)
Timeframe: 4 weeks

,
Interventionparticipants (Number)
Very goodGoodSatisfactoryBadVery Bad
Investigator2480146531
Subject1278156553

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Change of Constipation Assessment From Baseline to Visit 2(End Visit)

Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms) (NCT01719757)
Timeframe: 4 weeks

Interventionscore (Mean)
Oxycodone/Naloxone-0.03

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Change in Numeric Rating Scales (NRS) Score

Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable). (NCT01719757)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Oxycodone/Naloxone-1.89

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Change of Eastern Cooperative Oncology Group(ECOG) Performance Status

"If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse.~ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death." (NCT01719757)
Timeframe: 4weeks

InterventionScore (Mean)
Oxycodone/Naloxone0.08

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Overall Drug Liking: Minimum Effect (Emin)

"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emin= Average observed score." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo49.6
ALO-02 40 Mg-C58.5
OXY 40 mg71.1
ALO-02 60 Mg-I43.6
ALO-02 60 mg- C65.6
OXY 60 mg74.3

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Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone were reported. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,
Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
AUC (0-1)AUC (0-2)AUC (0-8)AUC (0-12)AUC (0-24)
ALO-02 40 Mg-C45.21103.5276.8319.6356.2
ALO-02 60 mg- C72.25157.5405.5464.8513.9
ALO-02 60 Mg-I0.021020.783479.08181.6455.3
OXY 40 mg37.6088.12265.0314.1355.9
OXY 60 mg53.38120.0366.5451.5527.8

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Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)

Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurements was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator might had administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported. (NCT01746901)
Timeframe: pre-dose up to 5 hours in drug discrimination phase; pre-dose up to 12 hours in intervention period

Interventionparticipants (Number)
Placebo0
ALO-02 40 Mg-C0
OXY 40 mg0
ALO-02 60 Mg-I0
ALO-02 60 mg- C0
OXY 60 mg0
Oxycodone HCl 40 mg0
Placebo Oxycodone HCl0

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Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)

End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion. (NCT01746901)
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5 hours post-dose in drug discrimination phase; pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in intervention period

Interventionparticipants (Number)
Placebo0
ALO-02 40 Mg-C0
OXY 40 mg0
ALO-02 60 Mg-I0
ALO-02 60 mg- C0
OXY 60 mg0
Oxycodone HCl 40 mg0
Placebo Oxycodone HCl0

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Nausea: Time to Maximum (Peak) Effect (TEmax)

Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.250
ALO-02 40 Mg-C0.267
OXY 40 mg0.267
ALO-02 60 Mg-I0.267
ALO-02 60 mg- C0.267
OXY 60 mg0.267

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Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours." (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2 hours post-dose

Interventionhours*mm (Mean)
Placebo100.004
ALO-02 40 Mg-C118.480
OXY 40 mg141.305
ALO-02 60 Mg-I100.188
ALO-02 60 mg- C127.320
OXY 60 mg149.484

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Bad Drug Effects: Peak Effect (Emax)

Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo5.8
ALO-02 40 Mg-C16.4
OXY 40 mg26.5
ALO-02 60 Mg-I20.6
ALO-02 60 mg- C16.9
OXY 60 mg31.4

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone

Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone were reported. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionng*hr/mL (Mean)
ALO-02 40 Mg-C361.6
OXY 40 mg361.6
ALO-02 60 Mg-I575.8
ALO-02 60 mg- C521.0
OXY 60 mg538.6

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Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.258
ALO-02 40 Mg-C1.017
OXY 40 mg1.017
ALO-02 60 Mg-I0.758
ALO-02 60 mg- C1.258
OXY 60 mg1.017

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Overall Drug Liking: Peak Effect (Emax)

"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emax = Maximum observed score." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo50.8
ALO-02 40 Mg-C64.3
OXY 40 mg80.8
ALO-02 60 Mg-I52.9
ALO-02 60 mg- C74.0
OXY 60 mg81.6

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Overall Drug Liking: Mean Effect (Emean)

"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emean = Average observed score." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo50.19
ALO-02 40 Mg-C61.26
OXY 40 mg75.70
ALO-02 60 Mg-I47.72
ALO-02 60 mg- C69.94
OXY 60 mg77.90

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Plasma Terminal Half-Life (t1/2) of Oxycodone

Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
ALO-02 40 Mg-C4.470
OXY 40 mg4.240
ALO-02 60 Mg-I9.340
ALO-02 60 mg- C4.300
OXY 60 mg4.195

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone

Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,
Interventionhours (Median)
Oxycodone (n= 36, 37, 38, 37, 36)Oxymorphone (n= 36, 36, 37, 37, 35)Noroxycodone (n= 36, 37, 38, 37, 36)
ALO-02 40 Mg-C1.030.5591.03
ALO-02 60 mg- C0.5830.5670.600
ALO-02 60 Mg-I12.114.014.1
OXY 40 mg1.030.5671.07
OXY 60 mg1.040.5501.05

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Number of Participants With Clinically Significant Change in Vital Sign Examinations

Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, respiratory rate and oral temperature. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion. (NCT01746901)
Timeframe: Screening up to 7 days following last study drug administration (Day 8)

Interventionparticipants (Number)
Naloxone0
Oxycodone HCl 40 mg0
Placebo Oxycodone HCl0
Placebo0
ALO-02 40 Mg-C0
OXY 40 mg0
ALO-02 60 Mg-I0
ALO-02 60 mg- C0
OXY 60 mg0

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol

Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,
Interventionhour (Median)
Naltrexone (n= 36, 1, 37)6-beta-naltrexol (n= 36, 19, 37)
ALO-02 40 Mg-C0.5500.567
ALO-02 60 Mg-C0.5500.550
ALO-02 60 Mg-I1.581.55

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Take Drug Again Effect at Hours 12, 24 and 36

"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

,,,,,
Interventionmm (Mean)
Hour 12Hour 24Hour 36
ALO-02 40 Mg-C54.755.553.9
ALO-02 60 mg- C68.769.668.1
ALO-02 60 Mg-I45.841.041.1
OXY 40 mg79.776.976.8
OXY 60 mg78.978.376.8
Placebo44.041.842.9

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Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C9.16044.152196.691239.566295.941299.316
ALO-02 60 mg- C10.78949.125223.984270.109341.922362.922
ALO-02 60 Mg-I9.00427.512127.855195.418346.949382.012
OXY 40 mg17.55566.906295.727352.289407.820414.008
OXY 60 mg22.59079.848378.309440.809487.559493.559
Placebo3.66017.80957.03568.785107.254135.941

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Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C4.0227.56430.12947.586103.711162.961
ALO-02 60 mg- C3.9867.38429.29846.136102.183161.977
ALO-02 60 Mg-I5.0399.88933.60546.15583.530130.199
OXY 40 mg3.5996.22623.79538.71391.216149.454
OXY 60 mg3.4895.92721.91335.08883.832141.638
Placebo5.16010.16441.08862.550125.791188.828

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Overall Drug Liking Effect at Hours 12, 24 and 36

"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking)." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

,,,,,
Interventionmm (Mean)
Hour 12Hour 24Hour 36
ALO-02 40 Mg-C61.262.759.9
ALO-02 60 mg- C69.870.169.9
ALO-02 60 Mg-I51.844.846.6
OXY 40 mg78.575.573.2
OXY 60 mg78.178.177.6
Placebo50.650.349.7

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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 medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial 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 3 - 7 days following last study drug administration. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial. (NCT01746901)
Timeframe: Screening up to 28 days after last study drug administration (Day 29)

,,,,,,,,
Interventionparticipants (Number)
AEsSAEs
ALO-02 40 Mg-C290
ALO-02 60 mg- C340
ALO-02 60 Mg-I270
Naloxone50
OXY 40 mg370
OXY 60 mg360
Oxycodone HCl 40 mg701
Placebo120
Placebo Oxycodone HCl140

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Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol

Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,
Interventionnanogram per milliliter (ng/mL) (Mean)
Naltrexone6-beta-naltrexol
ALO-02 40 Mg-C1.3898.516
ALO-02 60 Mg-C2.33113.70
ALO-02 60 Mg-I0.018080.3012

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Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C1.3136.93817.65617.65617.65617.844
ALO-02 60 mg- C0.2813.81315.45318.82821.20321.391
ALO-02 60 Mg-I0.0430.52012.46516.34076.40294.777
OXY 40 mg3.86711.50034.10240.60252.50852.508
OXY 60 mg2.7979.39839.64841.52342.99243.742
Placebo1.5513.3095.8015.80113.61322.988

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High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x). (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C20.203119.055131.805131.930132.305
ALO-02 60 mg- C27.465153.941160.004171.129173.379
ALO-02 60 Mg-I4.47339.14578.582161.613168.176
OXY 40 mg40.801257.527277.715282.902282.902
OXY 60 mg45.836322.250355.250362.531362.531
Placebo0.7856.5126.51224.19934.137

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Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C20.72756.352130.758148.195148.883148.883
ALO-02 60 mg- C28.23471.305159.750168.688180.875180.875
ALO-02 60 Mg-I5.25410.54340.41877.855161.043171.355
OXY 40 mg40.992110.430261.813282.875297.656297.844
OXY 60 mg44.656114.953332.352372.414380.414380.602
Placebo0.8053.0559.0639.25017.46926.844

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Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C0.6293.0045.1765.1765.6456.582
ALO-02 60 mg- C0.0390.7585.2816.1567.4067.594
ALO-02 60 Mg-I0.0351.05112.32412.94964.69983.449
OXY 40 mg0.9574.16013.38713.38713.38713.387
OXY 60 mg0.9962.76215.44919.13719.60521.855
Placebo0.5390.7270.9840.9848.79718.359

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Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)." (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C57.770431.973640.2231267.4101893.848
ALO-02 60 mg- C61.125465.945677.3201285.2891907.414
ALO-02 60 Mg-I50.703404.578616.2031203.8281783.578
OXY 40 mg64.820492.578704.3281337.0161955.953
OXY 60 mg69.734531.586758.3361398.8362024.711
Placebo50.020399.957600.6451202.8631805.113

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Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone

Cmax[dn]=Dose normalized maximum observed plasma concentration of participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,
Interventionnanogram/milliliter/milligram (Mean)
Oxycodone (n= 36, 37, 38, 37, 36)Oxymorphone (n= 36, 36, 38, 37, 35)Noroxycodone (n= 36, 37, 38, 37, 36)
ALO-02 40 Mg-C1.9890.032711.295
ALO-02 60 mg- C1.9230.031821.343
ALO-02 60 Mg-I0.49780.00680.3672
OXY 40 mg1.6720.028471.123
OXY 60 mg1.5140.024191.026

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Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C7.11724.00847.29748.42249.92250.109
ALO-02 60 mg- C6.20718.40241.41042.16043.75444.129
ALO-02 60 Mg-I1.2382.73823.93447.684120.934135.559
OXY 40 mg10.11728.75875.82883.26685.48485.859
OXY 60 mg14.04335.691117.738122.551122.895123.457
Placebo0.1250.9221.8441.90610.09419.844

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Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C0.9778.16428.98429.98430.20330.578
ALO-02 60 mg- C0.9184.84038.19146.69150.34851.473
ALO-02 60 Mg-I0.4452.35922.19541.570138.039169.352
OXY 40 mg4.35916.02360.13371.19585.47785.852
OXY 60 mg3.62117.05981.77796.715102.434102.621
Placebo0.6521.2702.5272.52710.34019.715

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Take Drug Again: Peak Effect (Emax)

"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo45.7
ALO-02 40 Mg-C57.9
OXY 40 mg83.4
ALO-02 60 Mg-I48.1
ALO-02 60 mg- C72.0
OXY 60 mg81.3

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Take Drug Again: Minimum Effect (Emin)

"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo41.1
ALO-02 40 Mg-C50.9
OXY 40 mg73.2
ALO-02 60 Mg-I37.8
ALO-02 60 mg- C66.3
OXY 60 mg75.2

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Take Drug Again: Mean Effect (Emean)

"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score." (NCT01746901)
Timeframe: 12, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo42.90
ALO-02 40 Mg-C54.71
OXY 40 mg77.80
ALO-02 60 Mg-I42.63
ALO-02 60 mg- C68.78
OXY 60 mg78.02

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Sleepy: Time to Maximum (Peak) Effect (TEmax)

Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm)to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.758
ALO-02 40 Mg-C2.025
OXY 40 mg2.508
ALO-02 60 Mg-I2.000
ALO-02 60 mg- C2.017
OXY 60 mg2.033

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Sleepy: Peak Effect (Emax)

Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo24.7
ALO-02 40 Mg-C56.8
OXY 40 mg72.0
ALO-02 60 Mg-I38.3
ALO-02 60 mg- C59.2
OXY 60 mg76.1

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Any Drug Effects: Peak Effect (Emax)

Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo8.8
ALO-02 40 Mg-C47.2
OXY 40 mg82.4
ALO-02 60 Mg-I27.7
ALO-02 60 mg- C56.0
OXY 60 mg88.7

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Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)dn] of Oxycodone

[AUC (0 - ∞)dn]= Dose normalized area under the plasma concentration versus time curve [AUC(dn)] from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0- t) plus AUC (t - ∞). Participants who received oxycodone were reported. Participants who received oxycodone were reported. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionng*hr/mL/mg (Mean)
ALO-02 40 Mg-C9.079
OXY 40 mg9.085
ALO-02 60 Mg-I10.88
ALO-02 60 mg- C8.718
OXY 60 mg9.018

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Drug Liking: Peak Effect (Emax)

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score." (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase

Interventionmm (Mean)
Placebo51.6
ALO-02 40 Mg-C70.1
OXY 40 mg85.5
ALO-02 60 Mg-I59.3
ALO-02 60 mg- C74.4
OXY 60 mg89.7

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Drug Liking: Time to Maximum (Peak) Effect (TEmax)

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score." (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.267
ALO-02 40 Mg-C1.017
OXY 40 mg1.017
ALO-02 60 Mg-I0.758
ALO-02 60 mg- C1.017
OXY 60 mg1.008

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Feel Sick: Peak Effect (Emax)

Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo3.1
ALO-02 40 Mg-C5.4
OXY 40 mg8.8
ALO-02 60 Mg-I10.1
ALO-02 60 mg- C2.6
OXY 60 mg11.7

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Feel Sick: Time to Maximum (Peak) Effect (TEmax)

Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.250
ALO-02 40 Mg-C0.267
OXY 40 mg0.267
ALO-02 60 Mg-I0.267
ALO-02 60 mg- C0.267
OXY 60 mg0.267

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Pupillometry: Time to Maximum (Peak) Effect (TEmax)

Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo2.275
ALO-02 40 Mg-C1.517
OXY 40 mg1.517
ALO-02 60 Mg-I12.050
ALO-02 60 mg- C1.775
OXY 60 mg1.533

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Good Drug Effects: Peak Effect (Emax)

Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo11.6
ALO-02 40 Mg-C48.1
OXY 40 mg81.8
ALO-02 60 Mg-I24.2
ALO-02 60 mg- C54.7
OXY 60 mg84.3

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Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.258
ALO-02 40 Mg-C1.017
OXY 40 mg1.017
ALO-02 60 Mg-I0.517
ALO-02 60 mg- C1.017
OXY 60 mg1.017

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High: Area Under Effect Curve (AUE) From 0-2 Hour

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose

Interventionhours*mm (Mean)
Placebo2.496
ALO-02 40 Mg-C55.250
OXY 40 mg112.082
ALO-02 60 Mg-I9.902
ALO-02 60 mg- C71.254
OXY 60 mg117.578

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Nausea: Peak Effect (Emax)

Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo6.1
ALO-02 40 Mg-C11.5
OXY 40 mg17.8
ALO-02 60 Mg-I9.5
ALO-02 60 mg- C11.3
OXY 60 mg22.0

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High: Peak Effect (Emax)

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase

Interventionmm (Mean)
Placebo10.9
ALO-02 40 Mg-C47.3
OXY 40 mg77.9
ALO-02 60 Mg-I21.7
ALO-02 60 mg- C53.4
OXY 60 mg84.7

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Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.250
ALO-02 40 Mg-C0.267
OXY 40 mg1.517
ALO-02 60 Mg-I0.308
ALO-02 60 mg- C0.267
OXY 60 mg1.758

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Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour

Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01746901)
Timeframe: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

,,,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-12)AUE (0-24)AUE (0-36)
ALO-02 40 Mg-C20.12957.504140.152156.652157.059157.059
ALO-02 60 mg- C26.56669.059167.137176.199184.137186.387
ALO-02 60 Mg-I4.53910.73453.242107.180218.805235.117
OXY 40 mg40.199112.910283.770317.270345.301345.488
OXY 60 mg48.328124.617354.391392.828402.516402.703
Placebo1.1053.0905.9495.94913.76223.324

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High: Time to Maximum (Peak) Effect (TEmax)

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.250
ALO-02 40 Mg-C1.017
OXY 40 mg1.017
ALO-02 60 Mg-I0.767
ALO-02 60 mg- C1.017
OXY 60 mg1.017

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Pupillometry: Peak Effect (Emax)

Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo-0.8
ALO-02 40 Mg-C-2.0
OXY 40 mg-2.7
ALO-02 60 Mg-I-2.4
ALO-02 60 mg- C-2.1
OXY 60 mg-3.0

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Dizzy: Time to Maximum (Peak) Effect (TEmax)

Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionhours (Median)
Placebo0.250
ALO-02 40 Mg-C0.758
OXY 40 mg0.767
ALO-02 60 Mg-I0.258
ALO-02 60 mg- C0.292
OXY 60 mg0.758

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Dizzy: Peak Effect (Emax)

Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01746901)
Timeframe: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose

Interventionmm (Mean)
Placebo3.6
ALO-02 40 Mg-C23.4
OXY 40 mg30.6
ALO-02 60 Mg-I12.0
ALO-02 60 mg- C19.5
OXY 60 mg39.3

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Dizzy: Time to Maximum (Peak) Effect (TEmax)

Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.267
ALO-02 30 mg0.267
Placebo Lactose Tablet0.250
Oxycodone 30 mg0.267

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Subject Rating Scale for Nasal Effects: Peak Effect (Emax)

"Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). Emax = Maximum observed score." (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose

,,,
Interventionunits on a scale (Mean)
BurningNeed to Blow NoseRunny Nose/ Nasal DischargeFacial Pain/ PressureNasal Congestion
ALO-02 30 mg0.10.10.10.00.2
Oxycodone 30 mg0.50.40.40.30.4
Placebo Lactose Tablet0.00.10.30.10.4
Placebo Sugar Spheres0.00.10.00.00.1

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Sleepy: Time to Maximum (Peak) Effect (TEmax)

Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.267
ALO-02 30 mg1.517
Placebo Lactose Tablet0.267
Oxycodone 30 mg2.517

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Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour

"Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)." (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose

,,,
Interventionunits on a scale*hours (Mean)
Burning: AUE (0-1)Burning: AUE (0-2)Need to Blow Nose: AUE (0-1)Need to Blow Nose: AUE (0-2)Runny Nose/ Nasal Discharge: AUE (0-1)Runny Nose/ Nasal Discharge: AUE (0-2)Facial Pain/ Pressure: AUE (0-1)Facial Pain/ Pressure: AUE (0-2)Nasal Congestion: AUE (0-1)Nasal Congestion: AUE (0-2)
ALO-02 30 mg0.0250.0250.1170.1830.0830.1080.0330.0500.1750.250
Oxycodone 30 mg0.1840.2700.2930.5040.1840.3010.0660.1840.2500.484
Placebo Lactose Tablet0.0330.0330.0880.0880.0380.1460.0420.0500.2000.242
Placebo Sugar Spheres0.0000.0000.1290.1640.0690.0860.0090.0090.1720.259

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Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg8.84834.571125.196187.839
Oxycodone 30 mg20.46461.750304.652496.652
Placebo Lactose Tablet2.9208.08934.43864.795
Placebo Sugar Spheres0.8132.58019.51826.875

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Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg4.7469.11434.874110.574
Oxycodone 30 mg3.2295.86823.90494.012
Placebo Lactose Tablet5.13210.16241.658128.937
Placebo Sugar Spheres5.33310.53842.623130.666

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Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,
Interventionhours (Mean)
Oxycodone (n = 30, 32)Oxymorphone (n = 1, 1)Noroxycodone (n = 28, 27)
ALO-02 30 mg4.171NA7.116
Oxycodone 30 mg4.134NA7.101

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Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Mean)
Naltrexone (n = 30)6-beta-naltrexol (n = 11)
ALO-02 30 mg3.5779.230

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Overall Drug Liking Effect at Hours 12 and 24

"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking)." (NCT01775189)
Timeframe: Intervention period: 12, 24 hours post-dose

,,,
Interventionmm (Mean)
Hour 12Hour 24
ALO-02 30 mg56.057.6
Oxycodone 30 mg81.880.8
Placebo Lactose Tablet50.547.8
Placebo Sugar Spheres50.350.4

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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 medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial 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 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial. (NCT01775189)
Timeframe: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal

,,,,,,
Interventionparticipants (Number)
AEsSAEs
ALO-02 30 mg180
Naloxone10
Oxycodone 30 mg320
Oxycodone HCl 30 mg430
Placebo Lactose Tablet100
Placebo Oxycodone HCl80
Placebo Sugar Spheres60

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Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg2.4555.1799.06310.848
Oxycodone 30 mg2.3397.35746.40258.759
Placebo Lactose Tablet0.2900.7815.3535.638
Placebo Sugar Spheres0.0360.4731.0001.071

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Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone

Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,
Interventionnanogram per milliliter (ng/mL) (Mean)
OxycodoneOxymorphoneNoroxycodone
ALO-02 30 mg57.930.461329.02
Oxycodone 30 mg82.630.344118.88

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Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol

Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionnanogram per milliliter (ng/mL) (Mean)
Naltrexone6-beta-naltrexol
ALO-02 30 mg4.5744.085

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High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x). (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-8)AUE (0-24)
ALO-02 30 mg14.25060.14375.429
Oxycodone 30 mg68.223290.670330.813
Placebo Lactose Tablet2.31312.95516.598
Placebo Sugar Spheres0.7901.0491.121

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Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg14.26326.60358.74669.246
Oxycodone 30 mg69.464138.679307.589348.732
Placebo Lactose Tablet2.3935.16114.79514.795
Placebo Sugar Spheres0.8040.9022.7776.420

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Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg1.5493.4249.37110.513
Oxycodone 30 mg0.4423.04925.10342.460
Placebo Lactose Tablet0.2320.7144.8044.875
Placebo Sugar Spheres0.0360.5451.1701.313

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Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)." (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-8)AUE (0-24)
ALO-02 30 mg53.455414.0451223.902
Oxycodone 30 mg81.250540.5541397.911
Placebo Lactose Tablet49.884401.0361202.750
Placebo Sugar Spheres49.143395.4551198.955

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Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg1.1615.1348.48211.768
Oxycodone 30 mg9.19217.73748.82657.469
Placebo Lactose Tablet0.7951.2594.9385.152
Placebo Sugar Spheres0.0360.4823.2867.143

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Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg3.9116.92015.00019.214
Oxycodone 30 mg4.08010.10743.23271.375
Placebo Lactose Tablet0.2460.7015.7196.004
Placebo Sugar Spheres0.0450.1160.4826.696

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone

Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,
Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
OxycodoneOxymorphoneNoroxycodone
ALO-02 30 mg353.02.498280.6
Oxycodone 30 mg435.32.469248.5

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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol

Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
Naltrexone6-beta-naltrexol
ALO-02 30 mg11.0737.28

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,
Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
Oxycodone (n = 30, 32)Oxymorphone (n = 1, 1)Noroxycodone (n = 28, 27)
ALO-02 30 mg361.2NA309.9
Oxycodone 30 mg447.3NA288.8

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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol

AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
Naltrexone (n = 11)6-beta-naltrexol (n = 30)
ALO-02 30 mg10.7145.85

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Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose

,
Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
Oxycodone: AUC (0-1)Oxycodone: AUC (0-2)Oxycodone: AUC (0-8)Oxymorphone: AUC (0-1)Oxymorphone: AUC (0-2)Oxymorphone: AUC (0-8)Noroxycodone: AUC (0-1)Noroxycodone: AUC (0-2)Noroxycodone: AUC (0-8)
ALO-02 30 mg33.5981.26263.90.095440.40231.9795.72626.37147.7
Oxycodone 30 mg59.56116.3328.20.15890.42111.8566.41018.91119.9

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Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose

Interventionnanogram*hour/milliliter (ng*hr/mL) (Mean)
Naltrexone: AUC (0-1)Naltrexone: AUC (0-2)Naltrexone: AUC (0-8)6-beta-naltrexol: AUC (0-1)6-beta-naltrexol: AUC (0-2)6-beta-naltrexol: AUC (0-8)
ALO-02 30 mg3.1275.66910.251.0503.86218.78

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Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour

Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x). (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,,,
Interventionhours*mm (Mean)
AUE (0-1)AUE (0-2)AUE (0-8)AUE (0-24)
ALO-02 30 mg18.64738.29082.37196.013
Oxycodone 30 mg69.692138.888329.004399.719
Placebo Lactose Tablet1.6923.70112.51312.585
Placebo Sugar Spheres0.2950.4290.8301.045

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Take Drug Again: Peak Effect (Emax)

"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score." (NCT01775189)
Timeframe: Intervention period: 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres48.0
ALO-02 30 mg58.3
Placebo Lactose Tablet46.6
Oxycodone 30 mg87.8

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Take Drug Again: Mean Effect (Emean)

"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emean = Average observed score." (NCT01775189)
Timeframe: Intervention period: 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres44.71
ALO-02 30 mg52.16
Placebo Lactose Tablet43.95
Oxycodone 30 mg85.34

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Sleepy: Peak Effect (Emax)

Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres7.6
ALO-02 30 mg35.0
Placebo Lactose Tablet11.1
Oxycodone 30 mg62.9

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Pupillometry: Time to Maximum (Peak) Effect (TEmax)

Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres3.017
ALO-02 30 mg3.017
Placebo Lactose Tablet2.025
Oxycodone 30 mg0.800

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Pupillometry: Peak Effect (Emax)

Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres-0.9
ALO-02 30 mg-1.7
Placebo Lactose Tablet-0.7
Oxycodone 30 mg-2.9

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Percentage of Dose (Drug Powder) Insufflated

The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period. (NCT01775189)
Timeframe: Intervention period: 0 Hour post-dose

Interventionpercentage of dose (Mean)
Placebo Sugar Spheres100.00
ALO-02 30 mg99.85
Placebo Lactose Tablet100.00
Oxycodone 30 mg99.37

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Overall Drug Liking: Peak Effect (Emax)

"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emax = Maximum observed score." (NCT01775189)
Timeframe: Intervention period: 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres50.5
ALO-02 30 mg59.9
Placebo Lactose Tablet51.5
Oxycodone 30 mg85.1

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Overall Drug Liking: Mean Effect (Emean)

"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emean = Average observed score." (NCT01775189)
Timeframe: Intervention period: 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres50.32
ALO-02 30 mg56.77
Placebo Lactose Tablet49.16
Oxycodone 30 mg81.25

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Number of Participants With Clinically Significant Change in Vital Sign Examinations

Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion. (NCT01775189)
Timeframe: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal

Interventionparticipants (Number)
Naloxone0
Oxycodone HCl 30 mg0
Placebo Oxycodone HCl0
Placebo Sugar Spheres0
ALO-02 30 mg0
Placebo Lactose Tablet0
Oxycodone 30 mg0

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Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)

Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurement was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported. (NCT01775189)
Timeframe: Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours

Interventionparticipants (Number)
Oxycodone HCl 30 mg0
Placebo Oxycodone HCl0
Placebo Sugar Spheres0
ALO-02 30 mg0
Placebo Lactose Tablet0
Oxycodone 30 mg0

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Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)

End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionparticipants (Number)
Placebo Sugar Spheres0
ALO-02 30 mg0
Placebo Lactose Tablet0
Oxycodone 30 mg0

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Nausea: Time to Maximum (Peak) Effect (TEmax)

Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.267
ALO-02 30 mg0.267
Placebo Lactose Tablet0.250
Oxycodone 30 mg0.267

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Nausea: Peak Effect (Emax)

Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres1.9
ALO-02 30 mg9.3
Placebo Lactose Tablet5.3
Oxycodone 30 mg12.3

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High: Time to Maximum (Peak) Effect (TEmax)

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.258
ALO-02 30 mg0.275
Placebo Lactose Tablet0.250
Oxycodone 30 mg0.517

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High: Peak Effect (Emax)

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres2.2
ALO-02 30 mg26.6
Placebo Lactose Tablet6.0
Oxycodone 30 mg85.8

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High: Area Under Effect Curve (AUE) From 0-2 Hour

High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose

Interventionhours*mm (Mean)
Placebo Sugar Spheres0.871
ALO-02 30 mg27.750
Placebo Lactose Tablet4.768
Oxycodone 30 mg135.670

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Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.267
ALO-02 30 mg0.275
Placebo Lactose Tablet0.250
Oxycodone 30 mg0.400

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Good Drug Effects: Peak Effect (Emax)

Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres4.3
ALO-02 30 mg25.6
Placebo Lactose Tablet8.4
Oxycodone 30 mg87.9

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Feel Sick: Time to Maximum (Peak) Effect (TEmax)

Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.267
ALO-02 30 mg0.267
Placebo Lactose Tablet0.250
Oxycodone 30 mg0.267

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Feel Sick: Peak Effect (Emax)

Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres2.1
ALO-02 30 mg8.7
Placebo Lactose Tablet3.9
Oxycodone 30 mg4.6

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Drug Liking: Time to Maximum (Peak) Effect (TEmax)

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score." (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.383
ALO-02 30 mg0.758
Placebo Lactose Tablet0.500
Oxycodone 30 mg0.383

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Drug Liking: Peak Effect (Emax)

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score." (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres50.9
ALO-02 30 mg60.5
Placebo Lactose Tablet51.3
Oxycodone 30 mg92.8

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Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour

"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours." (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose

Interventionhours*mm (Mean)
Placebo Sugar Spheres98.518
ALO-02 30 mg105.286
Placebo Lactose Tablet100.241
Oxycodone 30 mg159.580

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Dizzy: Peak Effect (Emax)

Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres4.4
ALO-02 30 mg7.4
Placebo Lactose Tablet4.1
Oxycodone 30 mg23.5

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Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.267
ALO-02 30 mg0.267
Placebo Lactose Tablet0.250
Oxycodone 30 mg0.642

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Take Drug Again Effect at Hours 12 and 24

"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would)." (NCT01775189)
Timeframe: Intervention period: 12, 24 hours post-dose

,,,
Interventionmm (Mean)
Hour 12Hour 24
ALO-02 30 mg51.552.8
Oxycodone 30 mg87.483.3
Placebo Lactose Tablet43.244.7
Placebo Sugar Spheres43.446.1

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol

Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Naltrexone6-Beta-naltrexol
ALO-02 30 mg0.3172.05

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Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone

Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone. (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

,
Interventionhours (Median)
Oxycodone (n = 30, 32)Oxymorphone (n = 29, 32)Noroxycodone (n = 30, 32)
ALO-02 30 mg1.592.052.08
Oxycodone 30 mg0.4752.554.05

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Bad Drug Effects: Peak Effect (Emax)

Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres1.4
ALO-02 30 mg13.0
Placebo Lactose Tablet5.6
Oxycodone 30 mg18.5

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Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)

Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score. (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionhours (Median)
Placebo Sugar Spheres0.267
ALO-02 30 mg0.517
Placebo Lactose Tablet0.250
Oxycodone 30 mg0.267

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Any Drug Effects: Peak Effect (Emax)

Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score. (NCT01775189)
Timeframe: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose

Interventionmm (Mean)
Placebo Sugar Spheres0.6
ALO-02 30 mg35.5
Placebo Lactose Tablet6.2
Oxycodone 30 mg88.6

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Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)

"Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). TEmax = Time to maximum observed score." (NCT01775189)
Timeframe: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose

,,,
Interventionhours (Median)
BurningNeed to Blow NoseRunny Nose/ Nasal DischargeFacial Pain/ PressureNasal Congestion
ALO-02 30 mg0.5170.5170.5170.5170.517
Oxycodone 30 mg0.5170.5170.5170.5170.525
Placebo Lactose Tablet0.5170.5170.5170.5170.517
Placebo Sugar Spheres0.5170.5170.5170.5170.517

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The Opioid Escalation Index

The proportion of subjects with an increase of opioid daily dose > 5% compared with the basal dosage (OEI%). (NCT01809106)
Timeframe: 28 days

Interventionparticipants (Number)
Morphine13
Oxycodone24
Buprenorphine18
Fentanyl45

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Proportion of Full-responder

Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/> 30% from visit 6 and visit 1 (NRS 0 to 10). (NCT01809106)
Timeframe: 28 days

Interventionparticipants (Number)
Morphine89
Oxycodone90
Buprenorphine95
Fentanyl88

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Proportion of Non-Responder (NR) Participants

"Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity stable or worsened at day 28 compared with baseline values." (NCT01809106)
Timeframe: 28 days

Interventionparticipants (Number)
Morphine14
Oxycodone18
Buprenorphine14
Fentanyl11

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Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug

Investigator's overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test. (NCT01811186)
Timeframe: 6 weeks

,
Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worsevery much worse
Start Oxycodone/Naloxone 10/5mg b.i.d227485000
Start Oxycodone/Naloxone 5/2.5mg b.i.d2304314000

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Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug

At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC). (NCT01811186)
Timeframe: 6weeks

,
Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Start Oxycodone/Naloxone 10/5mg b.i.d.2244411010
Start Oxycodone/Naloxone 5/2.5mg b.i.d.2284216100

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The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.

The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test. (NCT01811186)
Timeframe: 1 week

Interventionpercentage of participants (Number)
Start Oxycodone/Naloxone 10/5mg b.i.d.28.79
Start Oxycodone/Naloxone 5/2.5mg b.i.d.19.84

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Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment

To assess the drop-out rate caused by adverse event* after 6 weeks treatment (NCT01811186)
Timeframe: 6 weeks

Interventionpercentage of participants (Number)
Start Oxycodone/Naloxone 10/5mg b.i.d.40.91
Start Oxycodone/Naloxone 5/2.5mg b.i.d.30.16

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Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug

"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life." (NCT01811186)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Start Oxycodone/Naloxone 10/5mg b.i.d.0.14
Start Oxycodone/Naloxone 5/2.5mg b.i.d.0.07

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The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.

Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable). (NCT01811186)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Start Oxycodone/Naloxone 10/5mg b.i.d.-1.62
Start Oxycodone/Naloxone 5/2.5mg b.i.d.-1.48

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Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.

"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 8/ET minus mean score at Baseline." (NCT01811238)
Timeframe: Baseline, 8 week

Interventionscores on a scale (Mean)
Oxycodone/Naloxone-1.69

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Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline

"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 4/ET minus mean score at Baseline." (NCT01811238)
Timeframe: Baseline, 4 week

Interventionunits on a scale (Mean)
Oxycodone/Naloxone-1.36

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The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline

"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life." (NCT01811238)
Timeframe: Baseline, 8 week

Interventionscores on a scale (Mean)
Oxycodone/Naloxone0.15

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Clinical Global Impression of Change(CGIC)

"The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF.~Very much improved much improved minimally improved no change minimally worse much worse very much worse" (NCT01811238)
Timeframe: Baseline, 8 week

Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worsemuch worseVery much worse
Oxycodone/Naloxone20497057652

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Patient Global Impression of Change(PGIC)

Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT01811238)
Timeframe: Baseline, 8week

Interventionparticipants (Number)
Very much improvedMuch improvedMinimally improvedNo changeMinimally worseMuch worseVery much worse
Oxycodone/Naloxone16496960663

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Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment

"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit.~A negative change indicates that the pain intensity decreased from the start of the trial." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release-3.7
Oxycodone/Naloxone Prolonged Release-2.8

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Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment

"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release-3.9
Oxycodone/Naloxone Prolonged Release-2.8

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Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids

"In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest.~The composition score from participant who reported:~Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated." (NCT01838616)
Timeframe: Baseline (Randomization Visit) to End of Titration Period (End of Week 3)

Interventionparticipants (Number)
Tapentadol Prolonged Release42
Oxycodone/Naloxone Prolonged Release59

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Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids

"In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest.~The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Week 3 (End of Titration Period)

Interventionnumber of events (Number)
Tapentadol Prolonged Release56
Oxycodone/Naloxone Prolonged Release81

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Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep)

The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Visit (Week 12)

Interventionhours (Least Squares Mean)
Tapentadol Prolonged Release-0.300
Oxycodone/Naloxone Prolonged Release-0.177

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Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings

The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionnumber of awakenings (Least Squares Mean)
Tapentadol Prolonged Release-0.8
Oxycodone/Naloxone Prolonged Release-0.5

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Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept

The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionhours (Least Squares Mean)
Tapentadol Prolonged Release0.460
Oxycodone/Naloxone Prolonged Release0.412

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Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg

"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release7.64.7
Tapentadol Prolonged Release7.53.7

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Changes in the Short Form Health Survey (SF-12) at the End of Treatment

"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement since starting the trial." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Least Squares Mean)
Physical FunctioningRole-PhysicalBodily PainGeneral HealthVitalitySocial FunctioningRole-EmotionalMental HealthPhysical Component SummaryMental Component Summary
Oxycodone/Naloxone Prolonged Release5.0734.6687.4584.3091.4682.2862.5872.9736.2021.146
Tapentadol Prolonged Release8.3587.26010.9908.4474.9435.2464.7645.1589.7353.077

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Clinician Global Impression of Change at the End of Treatment

"In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
Oxycodone/Naloxone Prolonged Release18253726791
Tapentadol Prolonged Release32442221630

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EuroQol-5 (EQ-5D) Health Status Index Outcome

"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release0.33920.5745
Tapentadol Prolonged Release0.31860.6686

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Hospital Anxiety and Depression Scale: Anxiety

"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release8.26.7
Tapentadol Prolonged Release7.35.3

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Hospital Anxiety and Depression Scale: Depression

The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release8.06.5
Tapentadol Prolonged Release7.45.1

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Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment

In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
Baseline Overall ScoreEnd Continuation Period Overall ScoreBaseline Sub-Score Burning PainEnd Continuation Period Sub-Score Burning PainBaseline Sub-score pressing painEnd Continuation Period Sub-Score Pressing PainBaseline Sub-Score Paroxysmal PainEnd Continuation Period Sub-Score Paroxysmal PainBaseline Sub-Score Evoked PainEnd Continuation Period Sub-Score Evoked PainBaseline Sub-Score Pare/DysesthesiaEnd Continuation Period Sub-Score Pare/Dysesthesia
Oxycodone/Naloxone Prolonged Release0.6120.3540.6340.3370.6080.3750.6700.3750.5480.3210.6420.372
Tapentadol Prolonged Release0.5980.2510.6120.2480.5950.2760.6380.2690.5550.2190.6210.260

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painDETECT Final Assessment

"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release22.514.6
Tapentadol Prolonged Release22.311.9

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Patient Global Impression of Change at the End of Treatment

"In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionparticipants (Number)
Very Much ImprovedMuch ImprovedMinimally ImprovedNo ChangeMinimally WorseMuch WorseVery Much Worse
Oxycodone/Naloxone Prolonged Release18194629643
Tapentadol Prolonged Release27433221321

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Recalled Average Pain Intensity

"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release7.64.8
Tapentadol Prolonged Release7.73.9

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Short Form Health Survey (SF-12)

The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
Baseline Physical FunctioningEnd Continuation Period Physical functioningBaseline Role-PhysicalEnd Continuation Period Role-PhysicalBaseline Bodily PainEnd Continuation Period Bodily PainBaseline General HealthEnd Continuation Period General HealthBaseline VitalityEnd Continuation Period VitalityBaseline Social FunctioningEnd Continuation Period Social FunctioningBaseline Role-EmotionalEnd Continuation Period Role-EmotionalBaseline Mental HealthEnd Continuation Period Mental healthBaseline Physical Component summaryEnd Continuation Period Physical component summaryBaseline Mental Component SummaryEnd Continuation Period Mental Component Summary
Oxycodone/Naloxone Prolonged Release33.81339.12033.69538.75731.11738.63734.65239.94145.51647.72441.73444.47537.04641.21942.39446.45131.68437.76545.21647.595
Tapentadol Prolonged Release33.25641.70133.78341.02530.43042.00336.11044.38246.51851.20242.29047.49441.01844.72744.96749.82830.31940.49348.73651.117

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Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep

"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionparticipants (Number)
ImprovementNo ChangeWorseningMissing
Oxycodone/Naloxone Prolonged Release43561512
Tapentadol Prolonged Release6246166

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Sleep Evaluation: Latency (Time Taken to Fall Asleep)

The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionhours (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release1.2030.865
Tapentadol Prolonged Release1.0470.803

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Sleep Evaluation: Number of Awakenings

"The participants were requested to answer the following question:~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionnumber of awakenings (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release2.62.2
Tapentadol Prolonged Release3.02.0

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Sleep Evaluation: Number of Hours Slept

"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionhours (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release5.6756.218
Tapentadol Prolonged Release5.7816.207

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Worst Pain Intensity Over the Past 24 Hours

"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit" (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Mean)
BaselineEnd of Continuation Period
Oxycodone/Naloxone Prolonged Release8.05.2
Tapentadol Prolonged Release8.14.3

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Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment

"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release0.3395
Oxycodone/Naloxone Prolonged Release0.2398

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Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression

The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release-2.4
Oxycodone/Naloxone Prolonged Release-1.1

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Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety

"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release-2.1
Oxycodone/Naloxone Prolonged Release-1.1

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Change in painDETECT Final Assessment at the End of Treatment

"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release-10.8
Oxycodone/Naloxone Prolonged Release-7.9

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Change in Recalled Average Pain Intensity at the End of Treatment

"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit)." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release-3.7
Oxycodone/Naloxone Prolonged Release-2.8

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Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)

"For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline Visit)." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release-3.7
Oxycodone/Naloxone Prolonged Release-2.7

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Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score

"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing)." (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

Interventionunits on a scale (Least Squares Mean)
Tapentadol Prolonged Release0.07
Oxycodone/Naloxone Prolonged Release0.14

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Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment

In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment. (NCT01838616)
Timeframe: Baseline (Randomization Visit); End of Continuation Period (Week 12)

,
Interventionunits on a scale (Least Squares Mean)
Overall ScoreSub-Score Burning PainSub-Score Pressing PainSub-Score Paroxysmal PainSub-score Evoked PainSub-Score Pare/Dysesthesia
Oxycodone/Naloxone Prolonged Release-0.248-0.278-0.226-0.283-0.225-0.252
Tapentadol Prolonged Release-0.353-0.375-0.331-0.385-0.334-0.363

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Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users

Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED. (NCT01859715)
Timeframe: Baseline and 90 minutes

Interventionmillimeters (Mean)
Oxycodone Group7.4
Hydrocodone/Acetaminophen Group10.9
Nausea-observational Group-14.0

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Adverse Drug Events

Determine all possible adverse drug events that occurred after the study drugs were administered. (NCT01859715)
Timeframe: Duration of ED stay, <24 hours. (up to 24 hours)

Interventionparticipants (Number)
Oxycodone Group0
Hydrocodone/Acetaminophen Group0
Nausea-observational Group0

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Change From Baseline in Maximum COWS Total Score

Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score. (NCT01871285)
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

Interventionscore (Mean)
MSE Dose Group 1 - Buprenorphine4.0
MSE Dose Group 1 - ATC Opioid3.9
MSE Dose Group 2 - Buprenorphine4.5
MSE Dose Group 2 - ATC Opioid4.3

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Number of Responders

A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. (NCT01871285)
Timeframe: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

Interventionparticipants (Number)
MSE Dose Group 1 - Buprenorphine1
MSE Dose Group 1 - ATC Opioid2
MSE Dose Group 2 - Buprenorphine0
MSE Dose Group 2 - ATC Opioid0

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Change From Baseline in COWS Total Score Over Time

Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. (NCT01871285)
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

,,,
Interventionscore (Mean)
Hour 0.5Hour 1Hour 1.5Hour 2Hour 2.5Hour 3Hour 3.5Hour 4Hour 6Hour 9Hour 12Hour 12.5Hour 13Hour 13.5Hour 14Hour 16Hour 24
MSE Dose Group 1 - ATC Opioid-0.30.00.20.20.30.20.30.40.61.41.50.50.50.40.2-0.10.7
MSE Dose Group 1 - Buprenorphine0.10.30.40.30.60.60.90.80.60.92.11.00.91.00.70.51.8
MSE Dose Group 2 - ATC Opioid-1.3-1.0-1.0-1.0-1.0-1.0-0.8-1.00.01.00.31.30.0-0.3-0.3-0.32.8
MSE Dose Group 2 - Buprenorphine0.00.80.51.81.30.31.51.01.01.33.33.03.31.83.31.82.0

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"Change From Baseline in Pain Now Over Time Using NRS"

Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine. (NCT01871285)
Timeframe: Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

,,,
Interventionunits on a scale (Mean)
Hour 0.5Hour 1Hour 2Hour 4Hour 9Hour 12Hour 12.5Hour 13Hour 14Hour 16Hour 24
MSE Dose Group 1 - ATC Opioid-0.6-1.1-1.2-1.0-0.10.3-0.4-0.7-1.2-1.4-0.2
MSE Dose Group 1 - Buprenorphine-0.3-0.5-0.7-0.9-0.50.50.0-0.4-0.7-0.9-0.2
MSE Dose Group 2 - ATC Opioid-1.3-1.5-1.3-1.8-0.8-0.3-0.3-0.8-1.0-1.30.0
MSE Dose Group 2 - Buprenorphine-0.50.30.80.51.01.51.00.81.00.30.8

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Maximum COWS Total Score

Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject. (NCT01871285)
Timeframe: Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence

Interventionscore (Mean)
MSE Dose Group 1 - Buprenorphine4.6
MSE Dose Group 1 - ATC Opioid5.3
MSE Dose Group 2 - Buprenorphine5.5
MSE Dose Group 2 - ATC Opioid6.3

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The Change of BPI-SF at visit8

Brief pain inventory short-form(BPI-SF) recorded at final visit assesses subject's average pain over the last 24 hours. score range is 0(no pain)-10(pain as bad as you can imagine).Do higher values represent a worse outcome. (NCT01885182)
Timeframe: Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study

InterventionScore on BPI-Brief Pain Index (Mean)
Oxycodone/Naloxone3.7
Oxycodone3.6

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The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8

At Visit5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)*) for OXN PR and OXY PR groups (NCT01885182)
Timeframe: visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicable

,
Interventionlaxatives/day (Mean)
Daily number of bisacodyl taken at Visit5Daily number of bisacodyl taken at Visit8
Oxycodone1.10.9
Oxycodone/Naloxone0.90.9

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The Change of Bowel Movement by Visit

Number pf bowel movements(BM) and number of days the subjects had a bowel movement in the last 7 days before the study visit will be summarized at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28).. (NCT01885182)
Timeframe: visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study)

,
InterventionBowel movement/day (Mean)
Number of BM baseline in last 7 days-visit2Number of BM baseline in last 7 days-visit5Number of BM baseline in last 7 days-visit6Number of BM baseline in last 7 days-visit7Number of BM baseline in last 7 days-visit8Number of days with BM in last 7 days-visit2Number of days with BM in last 7 days-visit5Number of days with BM in last 7 days-visit6Number of days with BM in last 7 days-visit7Number of days with BM in last 7 days-visit8
Oxycodone3.13.53.93.93.53.03.03.53.53.2
Oxycodone/Naloxone2.93.74.24.23.72.83.13.43.63.3

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The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit

To compare the change of Brief pain inventory short-form (BPI-SF) 11 indivial items (except for pain in average) at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28). each item range (except for how much relief from treatment /medication last 24hours is 0-100%,do higher values represent a better outcome.) is 0-10, do higher values represent a worse outcome. (NCT01885182)
Timeframe: visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study)

,
Interventionscore on BPI-SF (Mean)
Rate your pain at its worst last 24hrs-V2Rate your pain at its worst last 24hrs-V5Rate your pain at its worst last 24hrs-V6Rate your pain at its worst last 24hrs-V7Rate your pain at its worst last 24hrs-V8Rate your pain at its least last 24hrs-V2Rate your pain at its least last 24hrs-V5Rate your pain at its least last 24hrs-V6Rate your pain at its least last 24hrs-V7Rate your pain at its least last 24hrs-V8Rate how much pain you have right now-visit2Rate how much pain you have right now-visit5Rate how much pain you have right now-visit6Rate how much pain you have right now-visit7Rate how much pain you have right now-visit8How much relief from TRT/MED last 24hrs-visit2How much relief from TRT/MED last 24hrs-visit5How much relief from TRT/MED last 24hrs-visit6How much relief from TRT/MED last 24hrs-visit7How much relief from TRT/MED last 24hrs-visit8Pain affect general activity last 24hrs-visit2Pain affect general activity last 24hrs-visit5Pain affect general activity last 24hrs-visit6Pain affect general activity last 24hrs-visit7Pain affect general activity last 24hrs-visit8Pain affect mood last 24hrs-visit2Pain affect mood last 24hrs-visit5Pain affect mood last 24hrs-visit6Pain affect mood last 24hrs-visit7Pain affect mood last 24hrs-visit8Pain affect walking ability last 24hrs-visit2Pain affect walking ability last 24hrs-visit5Pain affect walking ability last 24hrs-visit6Pain affect walking ability last 24hrs-visit7Pain affect walking ability last 24hrs-visit8Pain affect normal work last 24hrs-visit2Pain affect normal work last 24hrs-visit5Pain affect normal work last 24hrs-visit6Pain affect normal work last 24hrs-visit7Pain affect normal work last 24hrs-visit8Pain affect relation with others last 24hrs-visit2Pain affect relation with others last 24hrs-visit5Pain affect relation with others last 24hrs-visit6Pain affect relation with others last 24hrs-visit7Pain affect relation with others last 24hrs-visit8Pain affect sleep last 24hrs-visit2Pain affect sleep last 24hrs-visit5Pain affect sleep last 24hrs-visit6Pain affect sleep last 24hrs-visit7Pain affect sleep last 24hrs-visit8Pain affect enjoyment of life last 24hrs-visit2Pain affect enjoyment of life last 24hrs-visit5Pain affect enjoyment of life last 24hrs-visit6Pain affect enjoyment of life last 24hrs-visit7Pain affect enjoyment of life last 24hrs-visit8Mean of seven interference items-visit2Mean of seven interference items-visit5Mean of seven interference items-visit6Mean of seven interference items-visit7Mean of seven interference items-visit8
Oxycodone6.35.35.25.05.22.13.51.92.12.23.53.33.03.13.366.967.166.665.864.75.74.94.94.85.05.64.94.54.54.54.74.14.34.44.66.55.45.65.45.54.13.53.63.64.05.14.13.93.94.15.74.64.74.84.95.44.44.54.54.7
Oxycodone/Naloxone5.95.45.35.05.42.03.41.92.12.03.43.33.13.23.267.367.767.664.164.75.64.64.44.44.65.14.64.13.84.34.34.03.63.84.16.35.65.14.75.03.83.53.23.23.45.04.33.83.83.85.34.64.44.04.65.04.44.14.04.3

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The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9

to compare the Modified SOWS's Change from Visit 1(day-10-0) to Visit 3(day1),Change from Visit 1 to Visit 9(day35).The SOWS was scored as the total of the 15 symptoms. each symptoms score is 0(not at all)-4(extremely).total score range is 0-60.Do higher values represent a better outcome. (NCT01885182)
Timeframe: Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5)

,
Interventionscore on SOWS (Mean)
Change from Visit 1 to Visit 3Change from Visit 1 to Visit 9
Oxycodone-1.6-1.7
Oxycodone/Naloxone-1.2-1.3

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To Assess Quality of Life Based on EQ-5D

To assess quality of life based on EQ-5D by subjects evaluation via patient dairy.the quality of life based on EQ-5D at Visit1 (day-10-0) and end of treatment Visit8(day28). The scarc range is 0(the best state you can imagine)-100(the worst state you can imagine).Do higher values represent a worse outcome. (NCT01885182)
Timeframe: Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study)

,
InterventionScore on EQ-5D (Mean)
V1V8
Oxycodone54.453.9
Oxycodone/Naloxone58.659.0

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The Change of BFI-Bowel Function Index at visit8

"BFI is the mean of NAS for the following items:~Ease of defecation~Feeling of incomplete bowel evacuation.~Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome." (NCT01885182)
Timeframe: Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study

Interventionscore on BFI (Mean)
Oxycodone/Naloxone48.3
Oxycodone51.2

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The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8

At Visit 5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)*) for OXN PR and OXY PR groups. (NCT01885182)
Timeframe: visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)

,
Interventionlaxatives/week (Mean)
Weekly number of bisacodyl taken at Visit5Weekly number of bisacodyl taken at Visit8
Oxycodone2.52.2
Oxycodone/Naloxone2.12.2

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The Change of Rescue Medication Use From visit5 to visit8

The average daily dose of rescue medication (Morphine Sulfate Tablet) for OXN PR group and OXY PR group at Visit 5(first week of double blind) and at Visit 8(last week of double blind). (NCT01885182)
Timeframe: visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)

,
InterventionMorphine Sulfate mg/day (Mean)
V5V8
Oxycodone13.915.5
Oxycodone/Naloxone18.515.4

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Cmax of Oxycodone Oral Solution.

Cmax of Oxycodone over a 24 hour period. (NCT01959204)
Timeframe: 5, 15, 30, and 60 minutes post dose; and 2, 4, 6, 8, 12, and 24 hours post-dose.

Interventionmg/kg (Mean)
Active5.92

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Number of Participants With Adverse Events

Patients will be monitored for adverse events such as change in blood pressure and lack of efficacy. (NCT01959204)
Timeframe: 48 hours

InterventionParticipants (Count of Participants)
Active20

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Tmax of Oxycodone Oral Solution.

Tmax of Oxycodone Oral Solution over 24 hours in a pediatric population (NCT01959204)
Timeframe: 5, 15, 30, and 60 minutes post-dose; and 2, 4, 6, 8, 12, and 24 hours post-dose.

InterventionHours (Mean)
Active2.71

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Pain Scores

"Overall Benefit of Analgesia Score (OBAS): Score range 0-28 with low score=high benefit. Summed from subscales of 0-4 for the following questions:~Please rate your current pain at rest on a scale between 0⁄4 minimal pain and 4⁄4 maximum imaginable pain~Please grade any distress and bother from vomiting in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from itching in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from sweating in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from freezing in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from dizziness in the past 24 h (0⁄4 not at all to 4⁄4 very much)~How satisfied are you with your pain treatment during the past 24 h (0⁄4 not at all to 4⁄4 very much) Lehmann N. British Journal of Anaesthesia 105 (4): 511-18 (2010)" (NCT02109640)
Timeframe: Postoperative day 3

Interventionunits on a scale (Median)
Targinact2
Oxycodone2

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Prevalence of Postoperative Gut Dysfunction

The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation. (NCT02109640)
Timeframe: Day 3 post-op

InterventionParticipants (Count of Participants)
Targinact13
Oxycodone15

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Total Opioid Analgesia Consumption

Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant (NCT02109640)
Timeframe: Total postoperative period of analgesic consumption, an average of 1 week

Interventionmilligram morphine equivalents (Mean)
Targinact78
Oxycodone94

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Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores

Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) (NCT02455518)
Timeframe: 2 hours

Interventionunits on a scale (Number)
Oxycodone/Acetaminophen4.4
Hydrocodone/Acetaminophen3.5
Codeine/Acetaminophen3.9
Ibuprofen/Acetaminophen4.3

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Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores

Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible) (NCT02455518)
Timeframe: 1 hour

Interventionunits on a scale (Number)
Oxycodone/Acetaminophen3.1
Hydrocodone/Acetaminophen2.4
Codeine/Acetaminophen2.7
Ibuprofen/Acetaminophen2.9

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Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))

The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain. (NCT02480114)
Timeframe: Up to 3 months post-treatment

Interventionscore on a scale (Median)
Arm I Standard of Care4.26
Arm II Standard of Care Plus Gabapentin3.68

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Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)

Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom. (NCT02480114)
Timeframe: Up to 3 months post-treatment

Interventionscore on a scale (Median)
Arm I Standard of Care1.91
Arm II Standard of Care Plus Gabapentin1.23

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Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)

Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome. (NCT02480114)
Timeframe: Up to 3 months post-treatment

InterventionParticipants (Count of Participants)
Arm I Standard of Care0
Arm II Standard of Care Plus Gabapentin0

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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

opioid use from time 48-72 hours in mg morphine equivalents (NCT02519023)
Timeframe: 48-72 hours after end of surgery

Interventionmg morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine0
Surgical Infiltration With Bupivacaine5

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Total Opioid Use for Pain Control

total opioid used from time 0 after surgery through 72 hours after surgery was complete. (NCT02519023)
Timeframe: 72 hours

Interventionmg Morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine20.8
Surgical Infiltration With Bupivacaine25.0

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Overall Benefit of Analgesia Score (OBAS)

The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome. (NCT02519023)
Timeframe: 72 hours post-procedure

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine2
Surgical Infiltration With Bupivacaine3

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Opioid Used From 24-48 Hours Post Surgery

opioids in mg of morphine equivalents used from 24-48 hours after surgery (NCT02519023)
Timeframe: 24-48 hours after the end of surgery

Interventionmg of morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine0
Surgical Infiltration With Bupivacaine.5

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Number of Patients Admitted Post Operatively

(NCT02519023)
Timeframe: 72 hours post-procedure

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine11
Surgical Infiltration With Bupivacaine16

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Number of Participants With Nausea and Vomiting

(NCT02519023)
Timeframe: 72 hours post-procedure

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine10
Surgical Infiltration With Bupivacaine16

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Quality of Recovery 15 (QoR15) Score

The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome. (NCT02519023)
Timeframe: 72 hours post-procedure

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine126
Surgical Infiltration With Bupivacaine115

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Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents

(NCT02519023)
Timeframe: 0-24 post-procedure

Interventionmg of morphine equivalents (Median)
TAP-Block With Liposomal Bupivacaine7.5
Surgical Infiltration With Bupivacaine22.5

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Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)

the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30. (NCT02519023)
Timeframe: 0-72 hours post-procedure

Interventionscores on a scale (Median)
TAP-Block With Liposomal Bupivacaine8
Surgical Infiltration With Bupivacaine13

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Maximal Pain Score Patient Felt From 48-72 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 48-72 hours after surgery

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine2
Surgical Infiltration With Bupivacaine3

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Maximal Pain Score of Patient From Time 0-24 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 0-24 hours after surgery

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine3
Surgical Infiltration With Bupivacaine5

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Maximal Pain Score for Patient From Time 24-48 Hours After Surgery

the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome. (NCT02519023)
Timeframe: 24-48 hours after surgery

Interventionunits on a scale (Median)
TAP-Block With Liposomal Bupivacaine3
Surgical Infiltration With Bupivacaine4

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Length of Time in Phase 1 and Phase 2 of Recovery

time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge. (NCT02519023)
Timeframe: an expected average of 120 mins

Interventionhours (Median)
TAP-Block With Liposomal Bupivacaine3.3
Surgical Infiltration With Bupivacaine3.1

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Patient Satisfaction With Pain Management

number of patients who answered yes to if they were satisfied with their pain management (NCT02519023)
Timeframe: at 72 hours after surgery

InterventionParticipants (Count of Participants)
TAP-Block With Liposomal Bupivacaine30
Surgical Infiltration With Bupivacaine24

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Time to Ambulation

Time to ambulation is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant to be able to stand up and walk a few steps post-operatively. The assessment of whether or not the participant was able to walk was subjective on the part of the shift nurse (ie, no defined number of steps nor quantitative assessment of gait or stability), and was not explicitly defined in the protocol or elsewhere. The outcome is reported as the time to ambulation in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.28
Placebo1.45

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Quality of Life Measurement

Quality of life for the study groups was assessed with the BREAST-Q questionnaire, a survey set of 6 pre-operative questionnaires comprised of 58 questions, and 15 post-operative questionnaires, collected 2 to 6 months after surgery, which is comprised of 109 questions. The results range for the pre-operative and post-operative questionnaire sets is 0 to 269 and 0 to 462, respectively. Because the baseline and post-operative domains are different, the BREAST-Q survey is not a measure of quality of life change over time. The Breast Q questionnaire was validated by Pusic, et al (citation provided). Higher scores for a domain represents better quality of life. The outcome is reported as the mean for each group and timepoint, with standard deviation. (NCT02601027)
Timeframe: Pre-operative Baseline and Post-operative (2-6 months)

,
Interventionscore on a scale (Mean)
Pre-operative baselinePost-operative (2 to 6 month)
0.125% Bupivacaine97.30342.11
Placebo99.08358.00

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Time to First Bowel Movement

Time to first bowel movement is defined as the amount of time, from midnight on post-operative Day 1 (ie, first midnight following the surgery), to when the participant was to be able to pass a stool post-operatively. The outcome is reported as the time in days, with standard deviation, for the group receiving transversus abdominis plane (TAP) nerve block and the group receiving the placebo control. (NCT02601027)
Timeframe: up to 1 week

Interventiondays (Mean)
0.125% Bupivacaine1.67
Placebo1.62

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Post-operative Anti-emetic Usage

Odansetron by intravenous administration was used to control nausea (ie, an anti-emetic drug). Anti-emetic usage was collected for first 48 hours post-operatively after breast reconstruction for the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the mean quantity of Odansetron in milligrams (mg) administered to each group, with standard deviation. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine5.14
Placebo9.93

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Post-operative Narcotic Usage

Narcotic usage was collected for first 48 hours post-operatively after breast reconstruction. The type and amount of each narcotic administered were each converted to the morphine equivalent amount that would be orally administered to achieve the same event. This term is known as the oral morphine equivalent (OME). Narcotic usage was assessed between the group receiving transversus abdominis plane (TAP) nerve block compared to the group receiving the placebo control. The outcome is reported as the observed OME for each group. (NCT02601027)
Timeframe: 48 hours

Interventionmilligrams (mg) (Mean)
0.125% Bupivacaine139.3
Placebo169.2

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Post-operative Pain Score

Post-operative Pain Score is defined using Visual Analog Scale (VAS), a patient-reported pain score based on viewing a graphic of a scale 0 to 10, and indicating pain level. Each participant was asked about 48 hours after breast reconstruction to indicate their their perceived pain according on the VAS scale. Higher scores represent greater pain. The outcome is reported as the mean VAS score at 48 hours, with standard deviation. (NCT02601027)
Timeframe: 2 days

Interventionunits on a scale (Mean)
0.125% Bupivacaine3.76
Placebo3.96

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Adherence to PONV Guidelines

PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case

InterventionParticipants (Count of Participants)
Baseline Measurement666
CDS Email Recommendations5260
CDS Email + Real TIme Recommenations5863

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Time to Discharge From the Postanesthesia Care Unit (PACU)

This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU

Interventionminutes (Mean)
Baseline Measurement266
CDS Email Recommendations264
CDS Email + Real TIme Recommenations266

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The Number of Prophylactic Interventions for PONV

the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU. (NCT02625181)
Timeframe: A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case

Interventionprophylactic antiemetics administered (Mean)
Baseline Measurement2.196
CDS Email Recommendations2.176
CDS Email + Real TIme Recommenations2.129

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PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting

The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU. (NCT02625181)
Timeframe: PACU recovery period

InterventionParticipants (Count of Participants)
Baseline Measurement139
CDS Email Recommendations1323
CDS Email + Real TIme Recommenations1343

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Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration

"The dose of the study drugs intravenously administered was checked and recorded every day. The information on the dose administered from baseline to each assessment time point was collected based on records on the chart, and in the event of dose change/end of treatment, pertinent date and time, and dose were recorded accurately on the chart.~‡ Total administered dose of the study drugs (mg)= IV infusion (mg/hr) * [(End date - start date) * 24 + (end time - start time)] + bolus injection (mg)" (NCT02660229)
Timeframe: 5 days

Interventionmg (Mean)
Oxycodone Hydrochloride226.80
Morphine Sulphate226.64

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Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.

"For the pain assessment value for efficacy assessment, Subjects perform pain grading through Numeric rating score(NRS) from 1 to 10 for the mean pain intensity over the past 7 days at Screening, and mean pain intensity over the past 24 hours at Baseline (Day 0), Day 1, Day 2, Day 3, Day 4, Day 5.~Verbal measurement can be conducted by subjects without using visual data. '0' indicates 'no pain', and as the number increases, the pain gets more severe, and '10' indicates the worst pain." (NCT02660229)
Timeframe: 5 days

Interventionunits on a scale (Mean)
Oxycodone Hydrochloride-3.52
Morphine Sulphate-3.13

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Number of Participants With Clinical Opiate Withdrawal Scale (COWS)

The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject's level of withdrawal. A subject assessed with a COWS score>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment. The total COWS score ranges from 0 to 48. Higher scores indicate worse outcome. Different score ranges represent different severities of withdrawal: no withdrawal (<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (>36) (NCT02680847)
Timeframe: Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.

,,
InterventionParticipants (Count of Participants)
COWS score<5 (screening)COWS score 5-12 (mild) (screening)COWS score<5 (end of maintenance phase)COWS score 5-12 (mild) (end of maintenance phase)
ALO-02 <= 20 mg151151
ALO-02 >20-40 mg9081
ALO-02 >40-80 mg7070

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Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria

Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate. In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) >= 30 mmHg and diastolic blood pressure (DBP) >=20 mmHg criteria. None of the vital sign changes were clinically significant. (NCT02680847)
Timeframe: Baseline up to Day 58

,,
InterventionParticipants (Count of Participants)
Maximum decrease from baseline in SBP>=30mmHgMaximum decrease from baseline in DBP>=20mmHg
ALO-02 <= 20 mg11
ALO-02 >20-40 mg02
ALO-02 >40-80 mg10

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Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)

Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %). Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase. None of the lab abnormalities were clinically significant. (NCT02680847)
Timeframe: Baseline up to Day 77

,,
InterventionParticipants (Count of Participants)
HematologyChemistry
ALO-02 <= 20 mg81
ALO-02 >20-40 mg53
ALO-02 >40-80 mg43

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Participants Opioid-Free After Gynecologic Surgery

Treatment arms compared with respect to the number of opioid-free days using the Cochran-Mantel-Haenszel test stratified by surgeon. (NCT02740114)
Timeframe: 8 weeks

InterventionParticipants (Count of Participants)
Active Comparator: Bupivacaine Group6
Experimental: Liposomal Bupivacaine + Bupivacaine Group8

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Symptom Scores

"Daily pain scores were ascertained by routine nursing care every 4 hours while awake, on a 0 to 10 scale. Descriptive statistics and graphical methods used to summarize MD Anderson Symptom Inventory (MDASI) scores at each assessment time by treatment arm. For each symptom component, individuals were asked to rank symptom severity during the previous 24 hours on a scale of 0 to 10, with 0 being not present and 10 being as bad as you can imagine. Symptom interference was also assessed on a 0 to 10 scale, with 0 being did not interfere and 10 being interfered completely. Higher values represent worst outcomes." (NCT02740114)
Timeframe: Days 0, 2 and 4 postoperatively, up to 8 weeks

,
Interventionscore on a scale (Median)
Median daily pain scores Postoperative day 0Median daily pain scores Postoperative day 2Median daily pain scores Postoperative day 4
Active Comparator: Bupivacaine Group2.52.20.8
Experimental: Liposomal Bupivacaine + Bupivacaine Group2.72.51.2

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Participants Opioid-Free After Gynecologic Surgery for 48 Hours

Treatment arms compared with respect to the proportion of patients opioid-free at 48 hours using the Cochran-Mantel-Haenszel test stratified by surgeon. (NCT02740114)
Timeframe: 48 hours

Interventionpercentage of participants (Number)
Active Comparator: Bupivacaine Group14.8
Experimental: Liposomal Bupivacaine + Bupivacaine Group16.70

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Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS)

"Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing.~PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10." (NCT02741076)
Timeframe: From baseline to the 1 week period prior to the Week 12 visit

InterventionScore on a scale (Mean)
Structured Discontinuation Opioid Therapy Suboptimal Responder-0.2198
Continuation of Opioid Therapy Suboptimal Responder-0.3328
Structured Discontinuation Opioid Therapy Optimal Responder0.3750
Continuation of Opioid Therapy Optimal Responder1.00

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Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women

For the International Index of Erectile Function (IIEF)(15-items) each question is scored on a scale of 0 or 1 to 5, with 0 as no sexual attempts, 1 as the highest frequency, and 5 as the lowest, except where 1=1-2, 2=3-4, 3=5-6, 4=7-10 attempts, and 5=11 or more attempts. Missing responses are scored as 0. For the Female Sexual Function Index (FSFI)(19 items) each question is scored on a scale of 0-5 or 1-5. The FSFI examines the following 6 domains with minimum and maximum scores as indicated: desire(1.2-6.0), arousal(0-6.0), lubrication(0-6.0), orgasm(0-6.0), satisfaction(0.8-6.0), and pain(0-6.0). A computational formula sums the scores within each domain and multiplies that sum by a prescribed weighting factor: desire 0.6, arousal 0.3, lubrication 0.3, orgasm 0.4, satisfaction 0.4, pain 0.4. Higher scores indicate greater functionality. The single final score range is 2.0 to 36, which is reported as an average for each group of female study participants as change from baseline. (NCT02741076)
Timeframe: Change from Baseline to 12 and 24 week visit

InterventionScore on a scale (Mean)
Male Erectile Function Week 12Male Erectile Function Week 24Male Orgasmic Function Week 12Male Orgasmic Function Week 24Male Sexual Desire Week 12Male Sexual Desire Week 24Male Intercourse Satisfaction Week 12Male Intercourse Satisfaction Week 24Male Overall Satisfaction Week 12Male Overall Satisfaction Week 24Female Desire Week 12Female Arousal Week 12Female Lubrication Week 12Female Orgasm Week 12Female Satisfaction Week 12Female Pain Week 12
Structured Discontinuation Opioid Therapy Optimal Responder4.07.00.51.50.0-1.50.52.01.50.00.00-6.00-3.60-4.40-0.40-3.20

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Patient Global Impression of Change (PGIC)

The Patient Global Impression of Change (PGIC) is a self-administered questionnaire that assesses the participant's level of improvement/worsening from the beginning to the end of treatment. Participants are asked to select the category of change that most closely describes any change experienced in the pain of their painful areas from the beginning of the Blinded Structured Opioid Discontinuation Period to Week 12 and to Week 24. The scale has levels describing change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. (NCT02741076)
Timeframe: Baseline to 12 and 24 week visit

,,,
InterventionParticipants (Count of Participants)
Very much improved Week 12Much improved Week 12Minimally improved Week 12No change Week 12Minimally Worse Week 12Much Worse Week 12Very Much Worse Week 12Very much improved Week 24Much improved Week 24Minimally improved Week 24No change Week 24Minimally Worse Week 24Much Worse Week 24Very Much Worse Week 24
Continuation of Opioid Therapy Optimal Responder01101100200010
Continuation of Opioid Therapy Suboptimal Responder01531200141200
Structured Discontinuation Opioid Therapy Optimal Responder00101010020000
Structured Discontinuation Opioid Therapy Suboptimal Responder03811000333100

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Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)

Optimal Sleep Index is based on the average number of hours of sleep each night during the past 4 weeks. Index=1 represents 7-8 hours and Index=0 represents < 7 hours or > 8 hours. (NCT02741076)
Timeframe: 4 weeks prior to baseline and prior to 12 and 24 week visits

,,,
InterventionParticipants (Count of Participants)
Index=0 BaselineIndex=1 BaselineIndex=0 Week 12Index=1 Week 12Index=0 Week 24Index=1 Week 24
Continuation of Opioid Therapy Optimal Responder311321
Continuation of Opioid Therapy Suboptimal Responder9310271
Structured Discontinuation Opioid Therapy Optimal Responder212111
Structured Discontinuation Opioid Therapy Suboptimal Responder10311291

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Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument)

The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments. The visual analog scale (VAS) rates the subject's health on a 0-100 scale from the worst imaginable health state to the best imaginable health state. (NCT02741076)
Timeframe: Baseline to 12 and 24 week visit

,,,
InterventionScore on a scale (Mean)
Week 12 visitWeek 24 visit
Continuation of Opioid Therapy Optimal Responder-6.30.3
Continuation of Opioid Therapy Suboptimal Responder3.28.4
Structured Discontinuation Opioid Therapy Optimal Responder-17.7-4.5
Structured Discontinuation Opioid Therapy Suboptimal Responder5.54.5

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Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women

For the International Index of Erectile Function (IIEF)(15-items) each question is scored on a scale of 0 or 1 to 5, with 0 as no sexual attempts, 1 as the highest frequency, and 5 as the lowest, except where 1=1-2, 2=3-4, 3=5-6, 4=7-10 attempts, and 5=11 or more attempts. Missing responses are scored as 0. For the Female Sexual Function Index (FSFI)(19 items) each question is scored on a scale of 0-5 or 1-5. The FSFI examines the following 6 domains with minimum and maximum scores as indicated: desire(1.2-6.0), arousal(0-6.0), lubrication(0-6.0), orgasm(0-6.0), satisfaction(0.8-6.0), and pain(0-6.0). A computational formula sums the scores within each domain and multiplies that sum by a prescribed weighting factor: desire 0.6, arousal 0.3, lubrication 0.3, orgasm 0.4, satisfaction 0.4, pain 0.4. Higher scores indicate greater functionality. The single final score range is 2.0 to 36, which is reported as an average for each group of female study participants as change from baseline. (NCT02741076)
Timeframe: Change from Baseline to 12 and 24 week visit

,,
InterventionScore on a scale (Mean)
Male Erectile Function Week 12Male Erectile Function Week 24Male Orgasmic Function Week 12Male Orgasmic Function Week 24Male Sexual Desire Week 12Male Sexual Desire Week 24Male Intercourse Satisfaction Week 12Male Intercourse Satisfaction Week 24Male Overall Satisfaction Week 12Male Overall Satisfaction Week 24Female Desire Week 12Female Desire Week 24Female Arousal Week 12Female Arousal Week 24Female Lubrication Week 12Female Lubrication Week 24Female Orgasm Week 12Female Orgasm Week 24Female Satisfaction Week 12Female Satisfaction Week 24Female Pain Week 12Female Pain Week 24
Continuation of Opioid Therapy Suboptimal Responder-4.6-0.4-1.00.41.00.8-1.40.41.42.2-0.86-1.40-0.47-0.900.940.300.910.27-0.40-0.672.690.80
Continuation of Opioid Therapy Optimal Responder2.004.51.52.00.00.00.01.50.50.00.300.001.350.900.3000.20-0.400.00.00-0.400.40
Structured Discontinuation Opioid Therapy Suboptimal Responder2.01.4-1.0-0.62.21.8-1.0-1.01.83.40.230.480.381.800.000.30-0.050.40-0.10-0.720.650.88

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Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument

The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments.The EQ-5D-5L measures quality of life in 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each is rated in 5 levels from no problems/pain/anxiety to being unable/extreme pain/extreme anxiety. The responses for each category are summarized by treatment and visit with frequencies and percentages reporting each level. (NCT02741076)
Timeframe: Baseline and weeks 12, 24

,,,
InterventionParticipants (Count of Participants)
No problem Walking BaselineSlight Problem Walking BaselineModerate Problem Walking BaselineSevere Problem Walking BaselineUnable to Walk BaselineNo problem washing or dressing BaselineSlight problem washing or dressing baselineModerate problem washing or dressing baselineSevere problem washing or dressing baselineUnable to wash or dress baselineNo problem doing usual activities BaselineSlight problem doing usual activities BaselineModerate problem doing usual activities baselineSevere problem doing usual activities baselineUnable to do usual activities baselineNo pain or discomfort baselineSlight pain or discomfort baselineModerate pain or discomfort baselineSevere pain or discomfort baselineExtreme pain or discomfort baselineNot anxious or depressed baselineSlightly anxious or depressed baselineModerately anxious or depressed baselineSeverely anxious or depressed baselineExtremely anxious or depressed baselineNo problem Walking Week 12Slight Problem Walking Week 12Moderate Problem Walking Week 12Severe Problem Walking Week 12Unable to Walk Week 12No problem washing or dressing Week 12Slight problem washing or dressing Week 12Moderate problem washing or dressing week 12Severe problem washing or dressing Week 12Unable to wash or dress Week 12No problem doing usual activities Week 12Slight problem doing usual activities Week 12Moderate problem doing usual activities Week 12Severe problem doing usual activities Week 12Unable to do usual activities Week 12No pain or discomfort Week 12Slight pain or discomfort Week 12Moderate pain or discomfort Week 12Severe pain or discomfort Week 12Extreme pain or discomfort Week 12Not anxious or depressed Week 12Slightly anxious or depressed Week 12Moderately anxious or depressed Week 12Severely anxious or depressed Week 12Extremely anxious or depressed Week 12No problem Walking Week 24Slight Problem Walking Week 24Moderate Problem Walking Week 24Severe Problem Walking Week 24Unable to Walk Week 24No problem washing or dressing Week 24Slight problem washing or dressing Week 24Moderate problem washing or dressing Week 24Severe problem washing or dressing Week 24Unable to washing or dressing Week 24No problem doing usual activities Week 24Slight problem doing usual activities Week 24Moderate problem doing usual activities Week 24Severe problem doing usual activities Week 24Unable to do usual activities Week 24No pain or discomfort Week 24Slight pain or discomfort Week 24Moderate pain or discomfort Week 24Severe pain or discomfort Week 24Extreme pain or discomfort Week 24Not anxious or depressed Week 24Slightly anxious or depressed Week 24Moderately anxious or depressed Week 24Severely anxious or depressed Week 24Extremely anxious or depressed Week 24
Continuation of Opioid Therapy Optimal Responder211003100012100022002200012100301001120001210301001200021000111001110021000
Continuation of Opioid Therapy Suboptimal Responder027213351001560006603450003720363000363001911741001411124020051200413050300
Structured Discontinuation Opioid Therapy Optimal Responder120003000002100012001200010200102000111000210102000110010100101000110011000
Structured Discontinuation Opioid Therapy Suboptimal Responder118301110100010300067045400128202452014440001120724002251033310124210154043300

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Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)

"Percent pain intensity difference (PID) relative to baseline is defined as 100* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.~This outcome measure applies only to Optimal Responders." (NCT02741076)
Timeframe: Weeks 12 and 24

,,,
InterventionParticipants (Count of Participants)
greater than or equal to 40% Week 12Greater than or equal to 30% Week 12greater than or equal to 20% Week 12Greater than or equal to 10% Week 12Equal to 0% (any worsening) Week 12Greater than or equal to 40% week 24greater than or equal to 30% Week 24greater than or equal to 20% Week 24Greater than or equal to 10% Week 24Greater than 0% (any worsening) Week 24
Continuation of Opioid Therapy Optimal Responder0022201111
Continuation of Opioid Therapy Suboptimal Responder0000000000
Structured Discontinuation Opioid Therapy Optimal Responders1111100011
Structured Discontinuation Opioid Therapy Suboptimal Responder0000000000

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Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)

"Percent pain intensity difference (PID) relative to baseline is defined as 100* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.~This outcome measure applies only to Suboptimal Responders." (NCT02741076)
Timeframe: Weeks 12 and 24

,,,
InterventionParticipants (Count of Participants)
greater than or equal to 30% Week 12greater than or equal to 20% Week 12greater than or equal to 10% Week 12>0% (any improvement) Week 12greater than or equal to 30% Week 24greater than or equal to 20% Week 24greater than or equal to 10% Week 24>0% (any improvement) Week 24
Continuation of Opioid Therapy Optimal Responder00000000
Continuation of Opioid Therapy Suboptimal Responder01350133
Structured Discontinuation Opioid Therapy Optimal Responder00000000
Structured Discontinuation Opioid Therapy Suboptimal Responder11370158

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Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)

"The PHQ-8 is an 8-item questionnaire that aims at assessing the level of depression of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the scores for each item, can be from 0 to 24. A score >= 10 is considered major depression and >= 20 is severe major depression." (NCT02741076)
Timeframe: Baseline, 12 and 24 week visit

,,,
InterventionParticipants (Count of Participants)
Major Depression BaselineSevere Major Depression BaselineMajor Depression Week 12Severe Major Depression Week 12Major Depression Week 24Severe Major Depression Week 24
Continuation of Opioid Therapy Optimal Responder001000
Continuation of Opioid Therapy Suboptimal Responder503000
Structured Discontinuation Opioid Therapy Optimal Responder001000
Structured Discontinuation Opioid Therapy Suboptimal Responder201020

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Digit Symbol Substitution Test

Overall neuropsychological function is assessed using the DSST, a test that is sensitive to brain damage, dementia, age, and depression, and is a widely used instrument for measuring the neuropsychological effects of opioid therapy. The digits (1-9) are paired with symbols, and the test consists of matching the symbol for a series of digits as fast as possible. Score is number of correct symbols in 90 seconds. A decrease from baseline detects deterioration in processing speed. An increase from baseline detects improvement in processing speed. (NCT02741076)
Timeframe: Change from Baseline to 12 and 24 week visit

,,,
InterventionScore on a test (Mean)
Week 12 from baselineWeek 24 from baseline
Continuation of Opioid Therapy Optimal Responder0.00-3.3
Continuation of Opioid Therapy Suboptimal Responder6.10.1
Structured Discontinuation Opioid Therapy Optimal Responder3.3-6.0
Structured Discontinuation Opioid Therapy Suboptimal Responder7.88.9

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Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)

"Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing.~PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10." (NCT02741076)
Timeframe: From baseline to weeks 4, 8, 16, 20, and 24

,,,
InterventionScore on a scale (Mean)
4 weeks8 weeks16 weeks20 weeks24 weeks
Continuation of Opioid Therapy Optimal Responder0.31430.14130.4508-0.30951.5
Continuation of Opioid Therapy Suboptimal Responder-0.14130.0984-0.5714-0.6873-0.1532
Structured Discontinuation Opioid Therapy Optimal Responder0.49400.3393-0.6964-0.48210.2857
Structured Discontinuation Opioid Therapy Suboptimal Responder-0.1123-0.3671-0.3462-0.4153-0.5000

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Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)

"The MOS Sleep Scale is a 12-item questionnaire which measures sleep quality in 7 scales over the past 4 weeks: sleep disturbance, snoring, sleep short of breath or headache, sleep adequacy, sleep somnolence, and 2 sleep problems indexes. In addition, the average hours of sleep over the past 4 weeks is recorded as a raw measure and also coded as an optimal sleep index.~The MOS is scored and the sleep scales calculated according to the MOS Sleep Scale User's Manual v1.0 (Spritzer and Hays, 2003). The scores on the dimensions and the sleep indices were converted to a 0-100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater sleep adequacy of sleep)." (NCT02741076)
Timeframe: Weeks 12 and 24

,,,
InterventionScore on a scale (Mean)
Sleep Disturbance Week 12Snoring Week 12Awaken Short of Breath or Headache Week 12Sleep Adequacy Week 12Sleep Somnolence Week 12Sleep Problems Index I Week 12Sleep Problems Index II Week 12Sleep Quantity Week 12Sleep Disturbance Week 24Snoring Week 24Awaken Short of Breath or Headache Week 24Sleep Adequacy Week 24Sleep Somnolence Week 24Sleep Problems Index I Week 24Sleep Problems Index II Week 24Sleep Quantity Week 24
Continuation of Opioid Therapy Optimal Responder2.81315.0010.005.008.33330.83331.80560.5-10.00013.340.000.00-11.1111-2.2222-2.22220.0
Continuation of Opioid Therapy Suboptimal Responder-5.0010.000.000.82.7778-0.2778-2.222-0.1-10.3130.010.013.8-4.1667-9.1667-6.8056-0.1
Structured Discontinuation Opioid Therapy Optimal Responder-0.4170.0013.33.36.66674.44442.0370-2.3-5.0040.0020.025.016.6667-6.6667-2.22220.5
Structured Discontinuation Opioid Therapy Suboptimal Responder-5.6730.003.110.00-4.6154-4.1026-5.42740.15.3750.010.00.06.00006.66674.8333-0.8

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Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8)

"The PHQ-8 is an 8-item questionnaire that aims at assessing the level of mood of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the score for each item, can be from 0 to 24. A score ≥10 is considered major depression and ≥20 is severe major depression." (NCT02741076)
Timeframe: Weeks 12 and 24

,,,
InterventionScore on a scale (Mean)
12 Weeks24 Weeks
Continuation of Opioid Therapy Optimal Responder3.3-1.3
Continuation of Opioid Therapy Suboptimal Responder-0.8-1.1
Structured Discontinuation Opioid Therapy Optimal Responder3.30.00
Structured Discontinuation Opioid Therapy Suboptimal Responder-1.20.7

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Number of Participants That Did Not Need Opioid Analgesic Prescriptions

To determine the number of patients who did not require prescribed opioid analgesic'rescue' after pharmacogenomic-guided acute postoperative dental pain management versus those taking the non-guided combined formulation of hydrocodone and acetaminophen. (NCT02932579)
Timeframe: 6 hours

InterventionParticipants (Count of Participants)
Standard of Care7
Pharmacogenomic Group4

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Mean Pain Score

To compare the pain control outcomes between a single-dose of pharmacogenomics- testing-driven-prescription of ibuprofen (400mg) or acetaminophen (650mg) with those of single-dose (standard of care) of combined formulation of hydrocodone and acetaminophen (5/650mg). A visual analog scale for dental pain will be used. Scale ranges from 0-100 with 100 worse pain. (NCT02932579)
Timeframe: 6 hours

Interventionunits on a scale (Mean)
Standard of Care41.9
Pharmacogenomic Group28.9

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Difference in Amount of Rescue Pain Medication Consumed

The total amount of rescue pain medication consumed in the 2-week postop period will be compared between the two treatment groups. (NCT02934191)
Timeframe: 2 weeks post-operative

Interventionmg/kg (Mean)
Acetaminophen/Oxycodone + Celecoxib1.03
Acetaminophen/Oxycodone + Placebo1.40

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Difference in Number of Days Requiring Rescue Pain Medication

The number of days on narcotic pain medication following surgery will be compared between the two treatment groups (NCT02934191)
Timeframe: 2 weeks post-operative

InterventionDays (Mean)
Acetaminophen/Oxycodone + Celecoxib5.00
Acetaminophen/Oxycodone + Placebo5.75

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Pain Visual Analogue Scale (VAS)

10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable. (NCT03055507)
Timeframe: Post-operative day 1

Interventionunits on a scale (Mean)
Control3.3
Ibuprofen2.3

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Pain Visual Analogue Scale

10-cm visual analogue scale used to indicate level of post-operative pain. Scale from 0-10 with 0 indicating no pain and 10 indicating worst pain imaginable. (NCT03055507)
Timeframe: Post-operative day 7

Interventionunits on the pain visual analogue scale (Mean)
Control3.3
Ibuprofen2.3

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Pain Visual Analogue Scale

10-cm visual analogue scale used to indicate level of post-operative pain. 10-cm visual analogue scale used to indicate level of post-operative pain. 0 indicates no pain and 10 indicates worst pain imaginable. (NCT03055507)
Timeframe: Post-operative day 3

Interventionunits on a scale (Mean)
Control3.0
Ibuprofen1.7

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Number of Opioid Pills

Number of opioid pills taken daily following surgery (NCT03055507)
Timeframe: Post-operative days 1-7

Interventionpills per day (Mean)
Control4
Ibuprofen4

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Bleeding Visual Analogue Scale

10-cm visual analogue scale used to indicate amount of nasal bleeding post-operatively. 0 = no bleeding, 10 = life-threatening bleeding (NCT03055507)
Timeframe: Post-operative days 1, 3, and 7

,
Interventionunits on a scale (Mean)
Post-operative day 1Post-operative day 3Post-operative day 7
Control3.23.21.2
Ibuprofen2.32.30.5

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0-4 Bleeding Scale

Previously used 0-4 scale to indicate amount of nasal bleeding. 0 indicating no bleeding and 4 indicating life threatening bleeding. (NCT03055507)
Timeframe: Post-operative days 1, 3, and 7

,
Interventionscore on a scale (Mean)
Post-operative day 1Post-operative day 3Post-operative day 7
Control1.51.50.7
Ibuprofen0.90.90.3

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Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)

The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain. (NCT03088826)
Timeframe: 60 minutes

Interventionunits on a scale (Mean)
MSIR and Acetaminophen Group3.95
Oxycodone and Acetaminophen Group3.95

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Amount of Discomfort Following Discharge Until Embryo Transfer

Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer. (NCT03105518)
Timeframe: After 1 hrs but less than 3 days

Interventionunits on a scale (Mean)
POD1; ≤10 FolliPOD1; >10 FolliclesPOD2; ≤10 FolliPOD2; >10 Folli
Analgesia Options2.153.211.282.50

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Amount of Discomfort

Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. (NCT03105518)
Timeframe: PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3

Interventionunits on a scale (Mean)
Time 0; ≤10 FolliclesTime 0; > 10 FolliclesTime 15; ≤10 FolliclesTime 15; >10 FolliclesTime 30; ≤10 FolliclesTime 30; >10 FolliclesTime 60; ≤10 FolliclesTime 60; >10 FolliclesTime POD 3; ≤ 10 FolliclesTime POD 3; > 10 Follicles
Analgesia Options1.533.252.683.611.662.930.972.191.441.64

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<7 Weeks of Gestation - Maximum Self-reported Pain Score

Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain). (NCT03139240)
Timeframe: 24 hours after misoprostol administration

Interventionunits on a scale (Median)
Oxycodone8
Placebo8

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7-10 Weeks Gestation - Maximum Self-reported Pain Score

Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain). (NCT03139240)
Timeframe: 24 hours after misoprostol administration

Interventionunits on a scale (Median)
Oxycodone9
Placebo8

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Overall Maximum Self-reported Pain Score

Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain). (NCT03139240)
Timeframe: 24 hours after misoprostol administration

Interventionunits on a scale (Median)
Oxycodone Arm8
Placebo Arm8

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Percentage of Patients Who Received Rescue Medication

Number of patients who received additional analgesics divided by total number of patients x 100 (NCT03173456)
Timeframe: Entire two-hour time period

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP29
800 Ibuprofen/APAP28
Codeine/APAP26
Hydrocodone/APAP27
Oxycodone/APAP28

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Percentage of Patients Who Experience Side Effects Within One Hour of Ingestion of Study Medication

Number of patients who experience side effects within one hour ofr ingestion of study medication divided by total number of patients x 100 (NCT03173456)
Timeframe: From time of ingestion of study medication to one hour later

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP26
800 Ibuprofen/APAP37
Codeine/APAP33
Hydrocodone/APAP34
Oxycodone/APAP37

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Percentage of Patients Who Would Choose to Take the Study Medication Again if They Returned to the ED With Similar Pain

Number of patients who would choose to take study medication again divided by number of patients x 100. Question asked at end of two-hour time period (NCT03173456)
Timeframe: End of two-hour time period

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP78
800 Ibuprofen/APAP83
Codeine/APAP75
Hydrocodone/APAP89
Oxycodone/APAP81

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Percentage of Patients Who Experience Side Effects in Two Hours After Ingestion of Study Medication

Number of patients who experience side effects in two hours after ingestion of study medication divided by total number of patients x 100 (NCT03173456)
Timeframe: From time of ingestion of study medication to two hours later

InterventionParticipants (Count of Participants)
400 Ibuprofen/APAP31
800 Ibuprofen/APAP44
Codeine/APAP40
Hydrocodone/APAP51
Oxycodone/APAP49

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Change in Pain From Before Medication Administered (Baseline) to Two Hour Post-baseline

Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10=worst possible pain. Change is calculated as Numerical Rating Scale before medication is administered (denoted as baseline) minus NRS 2- hours past baseline. Higher numbers indicate better outcomes. (NCT03173456)
Timeframe: Prior to ingestion of study medication to 2 hours after ingestion of the study medication

Interventionunits on a scale (Mean)
400 Ibuprofen/APAP4.3
800 Ibuprofen/APAP4.6
Codeine/APAP4.4
Hydrocodone/APAP4.5
Oxycodone/APAP4.7

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Change in Pain From Before Medication Administered (Baseline) to One-hour Post-baseline

Pain intensity measured by 11-point Numerical Rating Scale (NRS) of Pain 0 = no pain 10 = worse possible pain. Change calculated as NRS before medication administered (denoted as baseline) minus NRS 1-hour post-baseline. Higher scores mean more change which is the better outcome. (NCT03173456)
Timeframe: Prior to Ingestion of study medication to one hour after ingestion of the study medication

InterventionUnits on a scale (Mean)
400 Ibuprofen/APAP3.0
800 Ibuprofen/APAP3.0
Codeine/APAP3.4
Hydrocodone/APAP3.1
Oxycodone/APAP3.3

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Baseline Pain Score Before Drugs Were Administered

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given prior to administration of study drugs, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm3
Active Drug Arm: Lorazepam and Oxycodone2

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Number of Participants With Desired Number of Dilators Inserted

Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms. (NCT03202550)
Timeframe: After speculum removed, up to 30 minutes

InterventionParticipants (Count of Participants)
Placebo Arm13
Active Drug Arm: Lorazepam and Oxycodone10

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Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: Immediately after the last dilator is placed, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm55
Active Drug Arm: Lorazepam and Oxycodone44

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Pain Score During Paracervical Block

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given at time of paracervical block administration, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm57
Active Drug Arm: Lorazepam and Oxycodone51

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Pain Score Before Speculum Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given before specula placed, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm1
Active Drug Arm: Lorazepam and Oxycodone1

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Pain Score at Tenaculum Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: Immediately scored at time of tenacula placement, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm31
Active Drug Arm: Lorazepam and Oxycodone50

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Pain Score After Speculum Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given at time of speculum placement, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm20
Active Drug Arm: Lorazepam and Oxycodone11

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Pain Score After First Dilator Placement

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever) (NCT03202550)
Timeframe: pain score given immediately after first dilator placed, up to 1 minute

Interventionunits on a scale (Median)
Placebo Arm50
Active Drug Arm: Lorazepam and Oxycodone9

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Pain Score 15 Minutes After Last Dilator Placed

Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark). (NCT03202550)
Timeframe: Assessed up to 45 minutes after last dilator placed

Interventionunits on a scale (Median)
Placebo Arm29
Active Drug Arm: Lorazepam and Oxycodone13

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Percentage of Participants Provided Rescue Medication for Nausea

Zofran was used at the clinician's discretion as rescue medication for nausea. (NCT03254459)
Timeframe: Days 1 to7

Interventionpercentage of participants (Number)
Standard of Care Narcotic Therapy12
Buprenorphine Sublingual Spray 0.5 mg35

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Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days

Zofran was used at the clinician's discretion as rescue medication for nausea. The total use of rescue medication was calculated for the following 4 time-frames: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days. (NCT03254459)
Timeframe: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days

,
Interventioncumulative number of rescue doses (Number)
0 to 24 hours0 to 48 hours0 to 72 hours0 to 7 days
Buprenorphine Sublingual Spray 0.5 mg6892110152
Standard of Care Narcotic Therapy9182242

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Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours

Pulse oximetry is a non-invasive method to measure a person's oxygen saturation. (NCT03254459)
Timeframe: 90 Minutes,12, 24, 48 and 72 Hours

,
Interventionpercentage of oxygen saturation (Mean)
90 minutes12 hours24 hours48 hours72 hours
Buprenorphine Sublingual Spray 0.5 mg96.095.896.696.096.2
Standard of Care Narcotic Therapy96.396.096.996.597.3

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Number of Participants With Abnormal Oral Cavity Examinations

Study staff will perform a sublingual (under the tongue) assessment, noting the color of mucosa and whether inflammation is present. (NCT03254459)
Timeframe: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose on Days 1 to 4 and End of Study Day 8

,
InterventionParticipants (Count of Participants)
Pre-dose90 minutes12 hours24 hours48 hours72 hours
Buprenorphine Sublingual Spray 0.5 mg000010
Standard of Care Narcotic Therapy000000

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Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours

A standard 12-lead ECG will be performed after the participant is in the supine (lying face up) position for 5 minutes. (NCT03254459)
Timeframe: Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose

,
InterventionParticipants (Count of Participants)
Pre-dose90 minutes12 hours24 hours48 hours72 hours
Buprenorphine Sublingual Spray 0.5 mg323034292518
Standard of Care Narcotic Therapy263331231814

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Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)

"Zofran was used at the clinician's discretion as rescue medication for nausea. Time 0 is defined as the time of the administration of study drug." (NCT03254459)
Timeframe: Days 1 to 7

Interventionhours (Median)
Standard of Care Narcotic TherapyNA
Buprenorphine Sublingual Spray 0.5 mg11.25

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Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug. (NCT03254459)
Timeframe: Days 1 to 8

InterventionParticipants (Count of Participants)
Standard of Care Narcotic Therapy33
Buprenorphine Sublingual Spray 0.5 mg47

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"Positive Subjective Drug Effects (i.e., Drug Liking)."

"The positive subjective effects of the most efficacious dose of the intravenous challenge drugs. These are measured using self-reported assessment by the participant in terms of drug liking rated on a visual analog scale of 0-100. Higher values indicate a greater drug effect." (NCT03389750)
Timeframe: Throughout study enrollment period (8-9 weeks)

Interventionunits on a scale (Mean)
IV Placebo52.1
IV Oxymorphone 1.8 mg57.5
IV Oxymorphone 3.2 mg71.8
IV Oxymorphone 5.6 mg71.5
IV Oxymorphone 10 mg84
IV Hydromorphone 3.2 mg66.3
IV Hydromorphone 5.6 mg71.3
IV Hydromorphone 10 mg84.3
IV Hydromorphone 18 mg79.6
IV Oxycodone 10 mg59.5
IV Oxycodone 18 mg63.3
IV Oxycodone 32 mg70.3
IV Oxycodone 56 mg79.1

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Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State

The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments. (NCT03398278)
Timeframe: up to 32 hours

Interventionng/mL (Mean)
Cmax of OTR 40 mg60.98
Cmax of OXYCONTIN® 40 mg52.23

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AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State

The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments. (NCT03398278)
Timeframe: up to 32 hours

Interventionng*h/ml (Mean)
AUCt of OTR Tablet 40 mg604.5095
AUCt of OXYCONTIN Tablet 40 mg588.6874

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AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State

The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments. (NCT03398278)
Timeframe: up to 32 hours

Interventionng*h/ml (Mean)
AUCINF of OTR Tablet 40 mg610.9314
AUCINF of OXYCONTIN Tablet 40 mg612.8057

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Number of Lab Tests With Clinical Significance

Clinical laboratory data to be summarised includes haematology, blood chemistry, and urinalysis.Each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N) or higher than (H) the reference range for that parameter. Results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than). (NCT03398278)
Timeframe: up to 35 days

InterventionLab tests with clinical significance (Number)
Clinical Laboratory Data of OTR Tablet 40 mg3
Clinical Laboratory Data of OXYCONTIN Tablet 40 mg3

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Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State

An overall summary of adverse events will be provided by treatment groups. The number and percentage of subjects reporting adverse events will be summarised by the preferred term nested within the System Organ Classification. In addition the number of reported adverse events will be summarised. (NCT03398278)
Timeframe: up to 35 days

,
InterventionTEAEs (Number)
Number of AEs (#)Number of TEAEs (#)Number of relateda TEAEs
Oxycodone Tamper Resistant (OTR)232315
OXYCONTIN®222216

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AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments. (NCT03398330)
Timeframe: up to 32 hours

Interventionng*h/ml (Mean)
AUCINF of OTR Tablet 40 mg648.2546
AUCINF of OXYCONTIN Tablet 40 mg664.0493

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AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments. (NCT03398330)
Timeframe: up to 32 hours

Interventionng*h/ml (Mean)
AUCt of OTR Tablet 40 mg641.3017
AUCt of OXYCONTIN Tablet 40 mg646.2133

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Number of Lab Tests With Clinical Significance

Clinical laboratory data to be summarised includes haematology, blood chemistry, and urinalysis.Each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N) or higher than (H) the reference range for that parameter. Results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than). (NCT03398330)
Timeframe: up to 35 days

InterventionLab tests with clinical significance (Number)
Clinical Laboratory Data of OTR Tablet 40 mg5
Clinical Laboratory Data of OXYCONTIN Tablet 40 mg11

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Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State

The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments. (NCT03398330)
Timeframe: up to 32 hours

Interventionng/ml (Mean)
Cmax of OTR Tablet 40 mg86.15
Cmax of OXYCONTIN Tablet 40 mg63.54

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Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State

An overall summary of the number and percentage of Adverse Events will be provided for each treatment groups to assess the safety of OTR tablet 40 mg and OXYCONTIN® tablet 40 mg. (NCT03398330)
Timeframe: up to 35 days

,
InterventionTEAEs (Number)
Number of AEs (#)Number of TEAEs (#)Number of relateda TEAEs
Adverse Events of OTR Tablet 40 mg292920
Adverse Events of OXYCONTIN Tablet 40 mg373530

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AUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State

The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments. (NCT03403504)
Timeframe: up to 32 hours

Interventionng*h/ml (Mean)
AUCINF of OTR Tablet 10 mg125.7605
AUCINF of OXYCONTIN Tablet 10 mg127.4811

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AUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State

The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments. (NCT03403504)
Timeframe: up to 32 hours

Interventionng*h/ml (Mean)
AUCt of OTR Tablet 10 mg123.5608
AUCt of OXYCONTIN Tablet 10 mg124.0294

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Cmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State

The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments. (NCT03403504)
Timeframe: up to 32 hours

Interventionng/ml (Mean)
Cmax of OTR 10 mg11.617
Cmax of OXYCONTIN 10 mg10.564

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Number of Lab Tests With Clinical Significance

Clinical laboratory data (hematology, blood chemistry, and urinalysis) to be summarized on the rate of lower than, within, and higher than the reference range values from baseline to end of study. (NCT03403504)
Timeframe: up to 35 days

Interventionlab tests with clinical significance (Number)
Clinical Laboratory Data of OTR Tablet 10 mg6
Clinical Laboratory Data of OXYCONTIN Tablet 10 mg3

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Adverse Events of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State

An overall summary of the number and percentage of Adverse Events will be provided for each treatment groups to assess the safety of OTR tablet 10 mg and OXYCONTIN tablet 10 mg. (NCT03403504)
Timeframe: up to 35 days

,
InterventionAEs (Number)
Number of AEsNumber of TEAEsNumber of related TEAEs
Adverse Events of OTR Tablet 10 mg17178
Adverse Events of OXYCONTIN Tablet 10 mg13136

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Opioid Craving

"Self-reported craving for opioid drugs. Participants are asked to indicate the extent to which they agree with the phrase I want opioids on a scale of 0 (Not-at-All) to 100 (Completely)." (NCT03415581)
Timeframe: Averaged across the 8-week trial.

,
Interventionunits on a scale (0-100) (Mean)
Oxycodone 50 mgOxycodone 0 mgOxycodone 12.5 mgOxycodone 25 mgOxycodone 100 mg
Doxazosin27.345.350.634.926.1
Placebo22.533.643.330.524.5

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Opioid Self-administration

Clinical laboratory task where the participant is asked to choose between drug and money. Shown as the mean percent of drug choices. (NCT03415581)
Timeframe: Averaged across the 8-week trial.

,
InterventionMean percentage of Drug Choices (Mean)
Oxycodone 50 mgOxycodone 0 mgOxycodone 12.5 mgOxycodone 100 mgOxycodone 25 mg
Doxazosin4638474444
Placebo4533404643

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Muscle Spasm

% of patients w/ muscle spasm (NCT03435692)
Timeframe: Post-Operative days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)80
Lumbar Plexus Catheter (< 6 Years Old)55.6
Lumbar Epidural Catheter (6 Years and Older)100
Lumbar Plexus Catheter (6 Years and Older)44.4
Patient Controlled Analgesia (6 Years and Older)71.4

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Maximum Pain Score

"Mean of Maximum Pain Score POD 0-2~Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC) for children 1-3 years of age, Faces Pain Scale - Revised (FPS-R) for children over age 3 and the Numeric scale (0-10) for children over age 7.~minimum value = 0, maximum value 10 (higher score is worse)" (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionscore on a scale (Mean)
Lumbar Epidural Catheter (< 6 Years Old)5.5
Lumbar Plexus Catheter (< 6 Years Old)4.3
Lumbar Epidural Catheter (6 Years and Older)6.4
Lumbar Plexus Catheter (6 Years and Older)5.5
Patient Controlled Analgesia (6 Years and Older)6.5

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Itching

% of patients with itching (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)28.6
Lumbar Plexus Catheter (6 Years and Older)22.2
Patient Controlled Analgesia (6 Years and Older)42.9

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Hospital Length of Stay

Total hospital length of stay (NCT03435692)
Timeframe: Through hospital stay, an average of 2-3 days.

Interventiondays (Mean)
Lumbar Epidural Catheter (< 6 Years Old)1.9
Lumbar Plexus Catheter (< 6 Years Old)2
Lumbar Epidural Catheter (6 Years and Older)2.9
Lumbar Plexus Catheter (6 Years and Older)2.5
Patient Controlled Analgesia (6 Years and Older)3.2

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Nausea

% of patients with nausea (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionpercentage of participants (Number)
Lumbar Epidural Catheter (< 6 Years Old)40
Lumbar Plexus Catheter (< 6 Years Old)33.3
Lumbar Epidural Catheter (6 Years and Older)71.4
Lumbar Plexus Catheter (6 Years and Older)55.6
Patient Controlled Analgesia (6 Years and Older)71.4

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Total Perioperative Morphine Equivalents

All administered opioids measured as morphine equivalents (mg/kg) (NCT03435692)
Timeframe: Post-Operative Days 0-2

Interventionmg/kg (Mean)
Lumbar Epidural Catheter (< 6 Years Old)0.54
Lumbar Plexus Catheter (< 6 Years Old)0.7
Lumbar Epidural Catheter (6 Years and Older)0.85
Lumbar Plexus Catheter (6 Years and Older)0.83
Patient Controlled Analgesia (6 Years and Older)2.23

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Mean Pain Scores Via Numeric Rating Scale (NRS-11)

"Marginal mean pain scores via Numeric Rating Scale (NRS-11) over 24 hours. The scale is from 0 to 10, where 0 represents no pain and 10 represents the worst pain possible." (NCT03480009)
Timeframe: Marginal mean pain scores over 24 hours

Interventionscore on a scale (NRS-11) (Mean)
Dextromethorphan, Opted for Narcotic Prescription2.93
Placebo, Opted for Narcotic Prescription2.96
Dextromethorphan, Declined Narcotic Prescription2.70
Placebo, Declined Narcotic Prescription2.41

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Worst Pain Measurement Via Numeric Rating Scale (NRS-11)

"Self-reported pain measurement via text-messaging system during first 24 hours after misoprostol administration. The scale is from 0 to 10, where 0 represents no pain and 10 represents the worst pain possible." (NCT03480009)
Timeframe: Over 24 hours starting from misoprostol administration

Interventionscore on a scale (Median)
Dextromethorphan, Opted for Narcotic Prescription8.0
Placebo, Opted for Narcotic Prescription7.0
Dextromethorphan, Declined Narcotic Prescription7.5
Placebo, Declined Narcotic Prescription6.5

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Analgesic Usage During Medication Abortion

Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication. (NCT03480009)
Timeframe: Over 24 hours

Interventionmg (Median)
ibuprofen9acetaminophen
Dextromethorphan, Declined Narcotic Prescription800800

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Analgesic Usage During Medication Abortion

Analgesic usage by study arm for women who received dextromethorphan vs. placebo as adjunct to routine pain management during medication abortion; missing data are for participants who did not take the specified pain medication. (NCT03480009)
Timeframe: Over 24 hours

,,
Interventionmg (Median)
ibuprofen9acetaminophenoxycodone
Dextromethorphan, Opted for Narcotic Prescription800100010
Placebo, Declined Narcotic Prescription100097515
Placebo, Opted for Narcotic Prescription600130015

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Maximum Pain Score

"Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning no pain and 10 meaning the worst possible pain)" (NCT03545893)
Timeframe: 24 hours

Interventionscore on a scale (Mean)
Ibuprofen4.66
Ibuprofen + Oxycodone6.51

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Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery

Unused medications is defined as the proportion of prescribed pills that were unused at 1 week post surgery as reported by the patient. More unused medications may indicate the potential to decrease the dosage needed. (NCT03584373)
Timeframe: 1 week post surgery

Interventionproportion of unused pills (Mean)
Non-Opioid Analgesia0.63
Opioid Analgesia0.58

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Rates of Constipation

Percentage of patients who experienced constipation any time during the week after surgery. A lower percentage of constipation may indicate less incidence of adverse events. (NCT03584373)
Timeframe: 1 week post surgery

InterventionParticipants (Count of Participants)
Non-Opioid Analgesia11
Opioid Analgesia17

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Peak Pain Intensity Level

The patient will be administered a survey and asked to rate the worst/peak pain intensity level since undergoing the surgery. The patient will be asked to rate this worst pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scoring is indicative of worst/peak pain intensity level since the time of surgery (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia5.61
Opioid Analgesia7.52

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Average Pain Intensity Level

The patient will be administered a survey and asked to rate their average pain intensity level since undergoing surgery. The patient will be asked to rate this average pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of higher average pain intensity. (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia3.34
Opioid Analgesia4.50

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Perception of an Acceptable Pain Intensity Level

The patient will be administered a survey and asked to rate what their perception or belief of an acceptable pain intensity level would be since undergoing the surgery. The patient will be asked to rate this acceptable pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 equaling no pain, and 10 being the worst possible pain. Higher scores are indicative of the patient's belief of an acceptable pain intensity level. (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia2.73
Opioid Analgesia3.28

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Satisfaction With Pain Relief

The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia8.70
Opioid Analgesia8.85

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Current Pain Intensity Level

The patient will be administered a survey and asked to rate their current pain intensity level (1 week post surgery) on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of greater pain intensity. (NCT03584373)
Timeframe: 1 week post surgery

Interventionscore on a scale (Mean)
Non-Opioid Analgesia1.14
Opioid Analgesia1.37

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Patient Global Impression of Change (PGIC)

The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved). Responses will be summarized as individual mean scores at clinic visit 4 (week 6). (NCT03588806)
Timeframe: Recorded in week 6.

Interventionunits on a scale (Mean)
Xtampza ER (Oxycodone) Treatment1.2

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Opioid Medication Satisfaction

"Opioid medication satisfaction will be measured via a 0-10 scale with 0 being not satisfied at all and 10 being completely satisfied. Responses will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study. Recorded baseline for current opioid medication and in week 6 for Xtampza ER.

Interventionunits on a scale (Mean)
Xtampza ER (Oxycodone) Treatment2.8

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Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days

"Percent change in pain intensity (in the past 7 days) from baseline to the end of the study at clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

Interventionpercent change (Mean)
Xtampza ER (Oxycodone) Treatment9.3

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PROMIS Physical Function

"The Physical Function questions (#1-4) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 5 being Without any difficulty and 1 being Unable to do. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Physical Function T-Scores will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

InterventionT-Score (Mean)
Xtampza ER (Oxycodone) Treatment0.7

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Change in Pill Swallowing Difficulty Score

"Pill swallowing difficulty will be measured via a 0-10 scale with 0 being no trouble at all and 10 being the greatest difficulty possible. Responses will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER.

Interventionunits on a scale (Mean)
Xtampza ER (Oxycodone) Treatment-5.7

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Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours

"Percent change in pain intensity (in the last 24 hours) from baseline to the end of the study averaged over the last 7 days before clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

Interventionpercent change (Mean)
Xtampza ER (Oxycodone) Treatment12.5

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PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance

"The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), and Sleep Disturbance (#17-20) questions from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Never and 5 being Always. Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. These T-Scores will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

InterventionT-Score (Mean)
DepressionAnxietySatisfaction with Social RolesSleep Disturbance
Xtampza ER (Oxycodone) Treatment-0.4-1.71.1-3.7

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Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

"The Pain Interference questions (#25-28) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Not at all and 5 being Very much. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Pain Interference T-Scores will be summarized as the change from baseline scores to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

InterventionT-Score (Mean)
Xtampza ER (Oxycodone) Treatment-3.6

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Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)

Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) (NCT03588910)
Timeframe: 7 days post operative

InterventionScore on Numeric Pain Scale (Median)
Number of Oxycodone Tablets Typically Prescribed2.0
Half the Number of Oxycodone Tablets Typically Prescribed1.3

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Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)

Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain) (NCT03588910)
Timeframe: 1 day post operative

InterventionScore on Numeric Pain Scale (Median)
Number of Oxycodone Tablets Typically Prescribed5.0
Half the Number of Oxycodone Tablets Typically Prescribed5

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Number of Oxycodone Tablets Used Day 1

During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery. (NCT03588910)
Timeframe: 24 hours post-operative

InterventionOxycodone Tablets (Median)
Number of Oxycodone Tablets Typically Prescribed1.0
Half the Number of Oxycodone Tablets Typically Prescribed1.0

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Additional Contacts With Provider

By chart review, unscheduled interactions with the healthcare system related to pain will be counted.These will include phone calls related to pain, unscheduled visits to the office or emergency department (NCT03588910)
Timeframe: 1 week post operative

InterventionUnscheduled patient contacts (Number)
Number of Oxycodone Tablets Typically Prescribed1
Half the Number of Oxycodone Tablets Typically Prescribed4

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Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery

During the survey phone call on day 7, participants will be asked to report the total number of oxycodone tablets used since the surgery. (NCT03588910)
Timeframe: 7 days post-operative

InterventionOxycodone Tablets (Median)
Number of Oxycodone Tablets Typically Prescribed2.5
Half the Number of Oxycodone Tablets Typically Prescribed2.0

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Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)

Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose (NCT03599089)
Timeframe: [time frame: 96 hours]

Interventionscores on a scale*hour (Mean)
CA-008 0.7 mg (0.05 mg/mL Concentration)317.09
CA-008 2.1 mg (0.15 mg/mL Concentration)321.72
CA-008 4.2 mg (0.3 mg/mL Concentration)266.86
Placebo400.56

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Percentage of Subjects Opioid Free

Percentage of subjects who are opioid-free for CA-008 compared to placebo. (NCT03599089)
Timeframe: [time frame: 96 hours]

Interventionpercentage of subjects (Number)
CA-008 0.7 mg (0.05 mg/mL Concentration)19.4
CA-008 2.1 mg (0.15 mg/mL Concentration)16.7
CA-008 4.2 mg (0.3 mg/mL Concentration)26.3
Placebo5.4

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Total Opioid Consumption (in Daily Morphine Equivalents)

Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo (NCT03599089)
Timeframe: [time frame: 96 hours]

Interventionmg morphine equivalents/day (Mean)
CA-008 0.7 mg (0.05 mg/mL Concentration)42.50
CA-008 2.1 mg (0.15 mg/mL Concentration)37.71
CA-008 4.2 mg (0.3 mg/mL Concentration)28.22
Placebo56.11

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Mean of Total Quantity of Pain Medications Taken

Using the take-home pain diary, the total amount in mL of each analgesic used over 14 days by each patient in a group will be averaged and reported. (NCT03618823)
Timeframe: 14 days post-operatively

,
InterventionMilliliters (Mean)
AcetaminophenIbuprofenOxycodone
Non-opioid Pain Control326.98334.652.96
Opioid Pain Control292.48324.146.47

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Non-opioid Group Switching to Opioid Group

Number of non-opioid group members switching to receiving opioid medication - assessed via the take-home pain diary. (NCT03618823)
Timeframe: 14 days post-operatively

InterventionParticipants (Count of Participants)
Non-opioid Pain Control7

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Number of Participants With ED (Emergency Department) or Urgent Care Visits

Number of participants with emergency department or urgent care visits in 14 post-operative days - assessed via the electronic medical record and the take-home pain diary. (NCT03618823)
Timeframe: 14 days post-operatively

InterventionParticipants (Count of Participants)
Opioid Pain Control8
Non-opioid Pain Control11

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Number of Participants With Readmissions

Number of participants with hospitalizations after discharge in 14 days - assessed using the electronic medical record and the take-home pain diary. (NCT03618823)
Timeframe: 14 days post-operatively

InterventionParticipants (Count of Participants)
Opioid Pain Control3
Non-opioid Pain Control8

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Overall Pain Relief Satisfaction

"Score assigned by the patient at the end of 14 post-operative days in the take-home pain diary using a Likert scale. Patients will respond to the following statement I am happy with the pain relief I received in the last 14 days with responses ranging from strongly agree to strongly disagree. The responses will be assigned a numerical value, from 0 (strongly disagree) to 4 (strongly agree), and the average value for all subjects in the group will be reported as the overall pain relief satisfaction. Higher scores mean a better outcome." (NCT03618823)
Timeframe: 14 days post-operatively

Interventionscore on a scale (Mean)
Opioid Pain Control3.35
Non-opioid Pain Control3.09

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Post-operative Nursing Phone Calls

Number of post-operative phone calls to nursing staff, obtained using the electronic medical record. (NCT03618823)
Timeframe: 14 days post-operatively

Interventionpost-operative phone calls (Mean)
Opioid Pain Control0.35
Non-opioid Pain Control0.47

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Average Dose of Each Analgesic Used

In the take-home pain diary, patients will record the amount of medication taken for each dose. The mean value of these doses will be calculated and averaged within each group to determine the average dose of each analgesic used. (NCT03618823)
Timeframe: 14 days post-operatively

,
InterventionMilliliters (Mean)
AcetaminophenIbuprofenOxycodone
Non-opioid Pain Control7.527.530.04
Opioid Pain Control6.547.530.13

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Average Pain Burden

Average pain over 14 post-operative days before and after medications. This is quantified using the validated Wong-Baker FACES pain metric. Patients receive a take-home pain diary and for 14 days report their maximum pain both before and after taking pain medication. The mean of these pain ratings will be the primary outcome measure. The Wong-Baker FACES scale is from 0 (min) to 10 (max). A higher score indicates worse outcome/pain. (NCT03618823)
Timeframe: 14 days post-operatively

,
InterventionScore on a scale (Mean)
BeforeAfter
Non-opioid Pain Control Group5.662.24
Opioid Pain Control Group5.782.33

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Duration of Each Analgesic Used

Using the results of the take-home pain diary, we will calculate the average number of days of use of each analgesic for each group. The last day after which there is no subsequent use of analgesic will define the end-point of the duration of use. (NCT03618823)
Timeframe: 14 days post-operatively

,
Interventiondays (Mean)
AcetaminophenIbuprofenOxycodone
Non-opioid Pain Control8.648.750.45
Opioid Pain Control8.618.492.62

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Number of Doses of Study Medication Taken Over Days 3to7

Number of doses of study medication taken over Days 3 to 7 (NCT03657810)
Timeframe: Day3 to Day7

Interventiondoses (Mean)
CL-10810.0
Norco8.4
Placebo6.2

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Percentage of Patients With Complete Absence of OINV (no Nausea, no Vomiting, and no Use of Anti-emetic Medication) Over 48 Hours

Percentage of patients with complete absence of OINV (no nausea, no vomiting, and no use of anti-emetic medication) over 48 hours comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg) (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-10850
Norco34
Placebo27

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Number of Doses of Study Medication Taken Per Day Over Days 3to7

Number of doses of study medication taken per day over Days 3 to 7 (NCT03657810)
Timeframe: Day3 to Day7

,,
Interventiondoses per day (Mean)
Number of Doses of Study Medication Taken over Day 3Number of Doses of Study Medication Taken over Day 4Number of Doses of Study Medication Taken over Day 5Number of Doses of Study Medication Taken over Day 6Number of Doses of Study Medication Taken over Day 7
CL-1083.02.11.91.81.1
Norco2.41.91.71.50.9
Placebo2.11.41.11.00.6

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The Sum of Pain Intensity Differences (on PI-NRS) Over 48 Hours (SPID48)

"The SPID48 endpoint is calculated from the PI-NRS values at baseline, every 30 minutes until hour 12, then every hour (when awake) until hour 48 as follows:~Each subsequent PI-NRS value is subtracted from the baseline PI-NRS value.~Each difference is weighted by the elapsed time from the previous PI-NRS value to the current one.~The weighed differences are summed to yield the SPID48.~Summed pain intensity differences over 48 hours (SPID48) will be compared for patients treated with CL-108 5 mg and those treated with placebo. Pain intensity will be measured on a 0-10 Pain Intensity Numerical Rating Scale (PI-NRS), where 0 is no pain and 10 is severe pain." (NCT03657810)
Timeframe: Up to 48 hours

Interventionscore on a scale (Mean)
CL-108108.5
Norco94.8
Placebo78.7

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Percentage of Patients With Any Vomiting Over 48 Hours

Percentage of patients with any vomiting over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-1083
Norco19
Placebo2

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Percentage of Patients With Any Post-discharge Nausea and Vomiting (PDNV)

Percentage of patients with any Post-discharge Nausea and Vomiting (PDNV) over Days 3 to 7 (NCT03657810)
Timeframe: Day 3 to 7

InterventionParticipants (Count of Participants)
CL-1089
Norco12
Placebo6

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Percentage of Patients With Any Nausea Over 48 Hours

Percentage of patients with any nausea over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-10836
Norco55
Placebo15

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Percentage of Patients With Any Nausea or Vomiting Over 48 Hours

Percentage of patients with any nausea or vomiting over 48 hours, comparing CL-108 5 mg to hydrocodone 5 mg/APAP 325 mg (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-10837
Norco55
Placebo16

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Percentage of Participants With OINV Over 48 Hours

Number and Percentage of participants With opioid-induced nausea and vomiting (OINV) who experienced any Vomiting / use of Anti-Emetic Medication Over 48 Hours (NCT03657810)
Timeframe: Up to 48 hours

InterventionParticipants (Count of Participants)
CL-1088
Norco31
Placebo4

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 2

Interventionunits on a scale (Mean)
Experimental Group23.0
Control Group21.6

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 1

Interventionunits on a scale (Mean)
Experimental Group36.3
Control Group38.9

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 4

Interventionunits on a scale (Mean)
Experimental Group9.3
Control Group11.8

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected at the preoperative visit

Interventionunits on a scale (Mean)
Experimental Group0
Control Group0

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for preoperative visit (the day before surgery)

Interventionunits on a scale (Mean)
Experimental Group12.4
Control Group8.5

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 7

Interventionunits on a scale (Mean)
Experimental Group8.1
Control Group10.1

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 6

Interventionunits on a scale (Mean)
Experimental Group13.9
Control Group11.7

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 5

Interventionunits on a scale (Mean)
Experimental Group15.8
Control Group15.0

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 5

Interventionunits on a scale (Mean)
Experimental Group10.1
Control Group7.8

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 4

Interventionunits on a scale (Mean)
Experimental Group14.1
Control Group16.8

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score was collected for postoperative day 1

Interventionunits on a scale (Mean)
Experimental Group30.2
Control Group29.4

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 1

Interventionunits on a scale (Mean)
Experimental Group2.8
Control Group2.9

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 2

Interventionunits on a scale (Mean)
Experimental Group27.0
Control Group23.5

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 2

Interventionunits on a scale (Mean)
Experimental Group2.5
Control Group2.3

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 3

Interventionunits on a scale (Mean)
Experimental Group1.9
Control Group2.1

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 6

Interventionunits on a scale (Mean)
Experimental Group6.5
Control Group6.6

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 7

Interventionunits on a scale (Mean)
Experimental Group4.6
Control Group5.4

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Medication Log

Patients kept a daily medication log and reported the number of doses consumed per day (650mg acetaminophen, 600mg ibuprofen, 5mg oxycodone). The mean number of medication doses per day was calculated for each treatment group. (NCT03783702)
Timeframe: Postoperative day 1 to 7

,
InterventionAverage number of medication doses/day (Mean)
Oxycodone POD1Oxycodone POD2Oxycodone POD3Oxycodone POD4Oxycodone POD5Oxycodone POD6Oxycodone POD7Acetaminophen POD1Acetaminophen POD2Acetaminophen POD3Acetaminophen POD4Acetaminophen POD5Acetaminophen POD6Acetaminophen POD7Ibuprofen POD1Ibuprofen POD2Ibuprofen POD3Ibuprofen POD4Ibuprofen POD5Ibuprofen POD6Ibuprofen POD7
Control Group0.60.40.30.30.30.102.11.91.61.51.31.10.60000000
Experimental Group0.30.10.10.10.10.102.01.81.31.00.90.90.60.60.50.40.30.40.30.2

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Severity of Epistaxis

"A 10-cm visual analog scale (VAS) will be used to assess bleeding. The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no bleeding with a score of 0 to continuous bleeding, corresponding to a score of 100." (NCT03783702)
Timeframe: Epistaxis severity will be collected for postoperative day 3

Interventionunits on a scale (Mean)
Experimental Group15.9
Control Group12.9

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: BPI score will be collected at the preoperative visit

Interventionunits on a scale (Mean)
Experimental Group1.6
Control Group1.0

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 7

Interventionunits on a scale (Mean)
Experimental Group1.3
Control Group1.4

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 6

Interventionunits on a scale (Mean)
Experimental Group1.5
Control Group1.4

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 5

Interventionunits on a scale (Mean)
Experimental Group1.7
Control Group1.6

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Brief Pain Inventory (BPI) Score

"The Brief Pain Inventory (BPI) Severity short form is a validated, patient-reported outcome measure that assesses pain over a 24-hour period. The Pain Severity score is calculated as a composite mean score using the degree of pain a patient experiences per day at its least, worst, average, and now. The score ranges from 0 to 10 (higher indicates more pain).~Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004. 20(5): 309-318." (NCT03783702)
Timeframe: Average BPI score will be collected for postoperative day 4

Interventionunits on a scale (Mean)
Experimental Group1.5
Control Group1.9

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Pain Severity

"A 10-cm visual analog scale (VAS) will be used to assess pain severity.The VAS is a continuous, patient-reported outcome measure determined using a horizontal 100-mm scale ranging from no pain with a score of 0 to worst imaginable pain, corresponding to a score of 100." (NCT03783702)
Timeframe: Average pain score will be collected for postoperative day 3

Interventionunits on a scale (Mean)
Experimental Group19.2
Control Group22.5

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Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores

Pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) from 0 to T96 hours (NCT03789318)
Timeframe: 0 to 96 hours

Interventionscore on a scale*hours (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 1392.98
Placebo for Cohort 1392.67
CA-008 10 mg (0.1 mg/mL)384.94
CA-008 15 mg (0.15 mg/mL)406.88
Placebo for Cohorts 2 and 3356.23

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Percent of Opioid Free Subjects

Percent of subjects who were opioid free at 0-96 hours (NCT03789318)
Timeframe: 0 to 96 hours

InterventionParticipants (Count of Participants)
CA-008 5 mg (0.05 mg/mL) Cohort 10
Placebo for Cohort 10
CA-008 10 mg (0.1 mg/mL)1
CA-008 15 mg (0.15 mg/mL)1
Placebo for Cohorts 2 and 30

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Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)

Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours (NCT03789318)
Timeframe: 96 hours

Interventionscore on a scale (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 12.8
Placebo for Cohort 12.0
CA-008 10 mg (0.1 mg/mL)3.0
CA-008 15 mg (0.15 mg/mL)2.8
Placebo for Cohorts 2 and 31.8

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Total Opioid Consumption

The sum of daily opioid consumption (in morphine equivalents) (NCT03789318)
Timeframe: 0 to 96 hours

Interventionmg morphine equivalents (Mean)
CA-008 5 mg (0.05 mg/mL) Cohort 185.83
Placebo for Cohort 196.67
CA-008 10 mg (0.1 mg/mL)69.77
CA-008 15 mg (0.15 mg/mL)58.00
Placebo for Cohorts 2 and 377.85

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Time to Opioid Cessation or Freedom

Time to the last use of opioid (NCT03789318)
Timeframe: From Surgery to Day 17

Interventionhours (Median)
CA-008 5 mg (0.05 mg/mL) Cohort 156.37
Placebo for Cohort 155.42
CA-008 10 mg (0.1 mg/mL)83.89
CA-008 15 mg (0.15 mg/mL)59.55
Placebo for Cohorts 2 and 342.26

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Change in Pupil Diameter Via Pupillometry

Analysis of change in pupil diameter after administration of NKTR-181 or Oxycodone IR. (NCT03802227)
Timeframe: 24 hour period following dose administration Day 1 to 2

,
Interventionmillimeters (Mean)
Baseline Pupil DiameterPupil Diameter After 1 HourPupil Diameter After 2 HoursPupil Diameter After 4 HoursPupil Diameter After 6 HoursPupil Diameter After 8 HoursPupil Diameter After 12 HoursPupil Diameter After 24 Hours
NKTR-1814.455.034.824.343.994.284.914.61
Oxycodone IR 40 mg4.814.874.975.325.015.073.874.20

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Treatment-Emergent Adverse Events (TEAEs)

Number of patients who experienced any type of adverse event as a result of one of the treatments. (NCT03802227)
Timeframe: 19 days

InterventionParticipants (Count of Participants)
NKTR-1811
Oxycodone IR 40 mg0

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Brain Activity Measured Via fMRI

The primary objective of the study was to evaluate the effects of NKTR-181 on brain activity. Functional MRI assessments in subjects administered opioids such as morphine, buprenorphine, and nalbuphine have shown drug-induced signaling changes in reward structures such as the nucleus accumbens, orbitofrontal cortex, and hippocampus, as well as changes in the functional connectivity of reward circuitry (Becerra, 2006; Gear, 2013; Upadhyay, 2012). (NCT03802227)
Timeframe: 8 hour period following dose of NKTR-181

,
InterventionCorrelation Coefficient (Mean)
Effective Connectivity between ACC and R Hippocampus at BaselineEffective Connectivity between ACC and R Hippocampus after 1 hourEffective Connectivity between ACC and R Hippocampus after 2 hoursEffective Connectivity between ACC and R Hippocampus after 4 hoursEffective Connectivity between ACC and R Hippocampus after 8 hoursEffective Connectivity between R Amygdala and mPFC at BaselineEffective Connectivity between R Amygdala and mPFC after 1 hourEffective Connectivity between R Amygdala and mPFC after 2 hoursEffective Connectivity between R Amygdala and mPFC after 4 hoursEffective Connectivity between R Amygdala and mPFC after 8 hours
NKTR-1810.00.00.10.0-0.10.1-0.20.20.20.1
Oxycodone IR 40 mg0.20.0-0.10.00.20.00.10.40.10.1

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Time to Maximum Concentration (Tmax)

The amount of time needed for maximum drug concentration to be reached. (NCT03802227)
Timeframe: 24 hour period following dose administration Day 1 to 2

,
Interventionng/mL (Mean)
Plasma Drug Concentration at Hour 1Plasma Drug Concentration at Hour 2Plasma Drug Concentration at Hour 4Plasma Drug Concentration at Hour 8Plasma Drug Concentration at Hour 12Plasma Drug Concentration at Hour 24Time to Maximum Concentration (Tmax) measured in hours
NKTR-18119702360135038818563.51.54
Oxycodone IR 40 mg35.754.146.727.114.83.92.21

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Plasma Drug Concentration

Plasma drug concentration for NKTR-181 and Oxycodone IR over 24 hours. (NCT03802227)
Timeframe: 24 hour period following dose administration Day 1 to 2

,
Interventionng/mL (Mean)
Plasma Drug Concentration at Hour 1Plasma Drug Concentration at Hour 2Plasma Drug Concentration at Hour 4Plasma Drug Concentration at Hour 8Plasma Drug Concentration at Hour 12Plasma Drug Concentration at Hour 24
NKTR-18119702360135038818563.5
Oxycodone IR 40 mg35.754.146.727.114.83.9

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Change in Ratio of Minute Ventilation

Change in ratio of maximum decrease (Emax) in minute ventilation (mL/min) over maximum (Emax) end-tidal carbon dioxide (CO2, mmHg) after administration of Belbuca, oxycodone hydrochloride, and placebo. (NCT03996694)
Timeframe: pre-dose, 0.5, 1, 2, 2.5, 3 and 4 hours

Interventionratio (Mean)
Treatment A: Belbuca 300 µg and Oral Placebo591.74
Treatment B: Belbuca 600 µg and Oral Placebo536.28
Treatment C: Belbuca 900 µg and Oral Placebo576.76
Treatment D: Oxycodone 30 mg and Buccal Placebo518.81
Treatment E: Oxycodone 60 mg and Buccal Placebo411.88
Treatment F: Oral Placebo and Buccal Placebo546.09

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Respiratory Drive

Respiratory drive was evaluated by measuring the Ventilatory Response to Hypercapnia (VRH) through assessment of the maximum decrease (Emax) in minute ventilation (mL/min) after administration of Belbuca, Oxycodone hydrochloride, and placebo. (NCT03996694)
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours

InterventionmL/min (Mean)
Treatment A: Belbuca 300 µg and Oral Placebo23957.34
Treatment B: Belbuca 600 µg and Oral Placebo22460.95
Treatment C: Belbuca 900 µg and Oral Placebo23626.79
Treatment D: Oxycodone 30 mg and Buccal Placebo21577.15
Treatment E: Oxycodone 60 mg and Buccal Placebo17223.80
Treatment F: Oral Placebo and Buccal Placebo22645.74

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Adverse Event (AE) Reporting of Belbuca, Oxycodone Hydrochloride and Placebo for 6 Periods.

Number of Participants with indicated Adverse Event (AE) in subjects receiving Belbuca, oxycodone hydrochloride, and placebo for 6 periods. (NCT03996694)
Timeframe: 44 days

,,,,,
Interventionparticipants (Number)
MildModerateSevere
Treatment A: Belbuca 300 µg and Oral Placebo710
Treatment B: Belbuca 600 µg and Oral Placebo1110
Treatment C: Belbuca 900 µg and Oral Placebo1020
Treatment D: Oxycodone 30 mg and Buccal Placebo810
Treatment E: Oxycodone 60 mg and Buccal Placebo1220
Treatment F: Oral Placebo and Buccal Placebo200

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Pupil Diameter

Pupil diameter will be assessed by pupillometry predose and at multiple timepoints after completion of Belbuca, oxycodone hydrochloride, and placebo dosing. (NCT03996694)
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 2.5, 3 and 4 hours

,,,,,
Interventionmm (Mean)
Predose0.5 hours Post1 hour Post1.5 hours Post2 hours Post2.5 hours Post3 hours Post4 hours Post
Treatment A: Belbuca 300 µg and Oral Placebo4.934.654.494.423.893.873.673.57
Treatment B: Belbuca 600 µg and Oral Placebo5.115.004.834.453.803.563.313.25
Treatment C: Belbuca 900 µg and Oral Placebo4.914.914.323.853.273.152.992.92
Treatment D: Oxycodone 30 mg and Buccal Placebo5.114.173.093.163.173.313.283.51
Treatment E: Oxycodone 60 mg and Buccal Placebo4.823.482.772.812.72.872.822.90
Treatment F: Oral Placebo and Buccal Placebo4.874.904.714.754.654.894.804.89

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Participant Use of Additional Pain Medication

Number of participants who took other pain medication (over-the-counter or narcotic) in addition to study-prescribed pain medications during first postoperative week. (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm3
Study Arm1

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Participant Use of Acetaminophen as Needed

Number of participants who took acetaminophen as needed during the first postoperative week. (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm12
Study Arm2

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Number of Doses of Opiate (Narcotic) Pain Medication

Number of doses of opiates (narcotic) pain medication participants took for breakthrough pain in the first postoperative week. (NCT04149964)
Timeframe: 7 days

Interventionnumber of doses (Median)
Standard of Care Arm1.0
Study Arm1.5

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Lowest Subjective Pain Score

Lowest post-operative pain score during the first postoperative week as measured on an 11 point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. (NCT04149964)
Timeframe: 7 days

Interventionscore on a scale (Median)
Standard of Care Arm2.0
Study Arm2.0

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Highest Subjective Pain Score

Highest post-operative pain score during the first postoperative week as measured on an 11-point numeric pain scale from 0-10, with 0 = no pain and 10 = worst pain possible. (NCT04149964)
Timeframe: 7 days

Interventionscore on a scale (Median)
Standard of Care Arm6.0
Study Arm5.0

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Chronic Use of Pain Medication

"Number of participants who answered Yes to the survey question, Do you take pain medication, including narcotics, for any other medical condition?" (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm4
Study Arm2

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Percentage of Time Participant Experienced Severe Pain

Percentage of time participant experienced severe pain requiring breakthrough pain medication during the first postoperative week, as measured on an 11 point numeric scale, from 0% to 100%, where 0% means never in severe pain and 100% means always in severe pain. (NCT04149964)
Timeframe: 7 days

Interventionpercentage of time (Median)
Standard of Care Arm0
Study Arm0

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Participant Use of Scheduled Acetaminophen Around the Clock

Number of participants who took acetaminophen every 6 hours around the clock during first postoperative week. (NCT04149964)
Timeframe: 7 days

InterventionParticipants (Count of Participants)
Standard of Care Arm3
Study Arm11

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Feasibility Determined by Accrual, Adherence and Patient Retention.

Feasibility will be determined by accrual (as confirmed by registration to the trial), adherence and patient retention (as measured and relayed by the wearable patch/sensor). (NCT04194528)
Timeframe: adherence and retention - 6 weeks; accrual - 6 months

InterventionParticipants (Count of Participants)
Oxycodone/Acetaminophen (5/325 mg) DMP1

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Saccadic Latency

measured in seconds (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventionseconds (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone0.400.450.38
Placebo0.400.380.38

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Fixation Time - High Cognitive Workload

measure in milliseconds (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventionmilliseconds (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone1572.631644.751564.34
Placebo1572.631641.861528.17

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Vertical Saccadic Velocity

measured in deg/s (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventiondeg/s (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone298.52274.51309.83
Placebo298.52272.93276.21

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Fixation Time - Low Cognitive Workload

measure in milliseconds (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventionmilliseconds (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone1079.821145.601132.70
Placebo1079.821198.861073.96

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Fixation Time - Medium Cognitive Workload

measure in milliseconds (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventionmilliseconds (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone1316.451347.901249.38
Placebo1316.451381.201264.03

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Horizontal Saccadic Velocity

measured in deg/s (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventiondeg/s (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone302.93288.52289.74
Placebo302.93283.77286.66

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Oculo-Cognitive Addition Test (OCAT) Completion Time

Time it takes participants to complete the OCAT measured in seconds. (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventionseconds (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone57.2259.5656.12
Placebo57.2258.1854.47

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Diagonal Saccadic Velocity

measured in deg/s (NCT04223609)
Timeframe: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)

,
Interventiondeg/s (Mean)
BaselineApprox. 30 minutes after initial 5 mg doseApprox. 30 minutes after second 5 mg dose
Oxycodone284.81293.82281.42
Placebo284.81277.44285.74

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Narcotic Medication Consumed

Number of oxycodone- acetaminophen tablets consumed (NCT04246541)
Timeframe: up to 5 days postoperatively

Interventiontablets (Mean)
Control5.7
Ketorolac3.5

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Pain Levels Recorded With a Visual Analogue Scale

Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level. (NCT04246541)
Timeframe: 2 weeks postoperatively

Interventionscore on a scale (Mean)
Control25.6
Ketorolac28.8

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Narcotic Medication

Number of oxycodone-acetaminophen tablets (NCT04246554)
Timeframe: 5 days

Interventiontablets (Mean)
Control12.4
Ketorolac5.5

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Postoperative Visual Analogue Scale Scores

Patients will record their pain on a visual analogue scale with a minimum score of 0 and a maximum score of 100 where lower values indicate a lower pain level, and higher values indicate a higher pain level. (NCT04246554)
Timeframe: Up to 8 weeks postoperative

Interventionscore on a scale (Mean)
Control50.4
Ketorolac40.0

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Pain Level: Numeric Rating Scale

Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome). (NCT04285853)
Timeframe: Postoperative days 0-6

,
Interventionscore on a scale (Mean)
Study Day 0Study Day 1Study Day 2Study Day 3Study Day 4Study Day 5Study Day 6
Oxycodone Arm4.64.73.83.03.02.62.9
Placebo Arm4.55.13.83.33.02.92.8

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Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge

Total morphine milligram equivalents (MME) used from discharge to 2 weeks post-discharge. MME is the amount of milligrams of morphine an opioid dose is equal to when prescribed. Calculating MME accounts for differences in opioid drug type and strength. (NCT04296396)
Timeframe: 2 weeks post discharge

Interventionmorphine milligram equivalent (Median)
Individualized Opioid Prescription22.5
Fixed Opioid Prescription37.5

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Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge

Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum (NCT04296396)
Timeframe: After hospital discharge and up to 90 days postpartum

InterventionParticipants (Count of Participants)
Individualized Opioid Prescription200
Fixed Opioid Prescription166

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Number of Participants Who Indicated an Improved Global Impression of Change

Number of participants who indicated an improved global impression of change in overall pain at 2 weeks post-discharge. This represents a selection on a multiple choice survey question with the response options: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. (NCT04296396)
Timeframe: 2 weeks post discharge

InterventionParticipants (Count of Participants)
Individualized Opioid Prescription Protocol (IOPP)2436
Fixed Opioid Prescription2436

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Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory

"Number of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the Worst Pain question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain." (NCT04296396)
Timeframe: 1 week post hospital discharge

InterventionParticipants (Count of Participants)
Individualized Opioid Prescription1497
Fixed Opioid Prescription1535

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Pain Interference Score ≥ 4 at 2 Weeks Post Discharge

Pain interference scores ≥ 4 on the Brief Pain Inventory (numeric scale from 0 to 10) at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain. This outcome asks participants to indicate their pain scores for the week prior to completing the inventory. (NCT04296396)
Timeframe: 2 weeks post discharge

InterventionParticipants (Count of Participants)
Individualized Opioid Prescription Protocol (IOPP)415
Fixed Opioid Prescription427

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Worst Pain Severity Score at 2 Weeks Post Discharge

Pain severity scores assessed on the Brief Pain Inventory numeric scale from 0 to 10 at 2 weeks post-discharge. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain. (NCT04296396)
Timeframe: 2 weeks post discharge

Interventionscore on a scale (Median)
Individualized Opioid Prescription Protocol (IOPP)2.0
Fixed Opioid Prescription2.0

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Number of Opioid Tablets Unused Since Discharge

Number of opioid tablets unused from discharge to 90 days postpartum (NCT04296396)
Timeframe: 90 days postpartum

Interventiontablets (Median)
Individualized Opioid Prescription2
Fixed Opioid Prescription7

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Infant Hospital Readmissions

Proportion of infants readmitted to the hospital (NCT04296396)
Timeframe: 6 weeks postpartum

InterventionParticipants (Count of Participants)
Individualized Opioid Prescription (IOPP) -Neonates/Infants59
Fixed Opioid Prescription - Neonates/Infants63

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Maternal Depression Score ≥ 13

The proportion of participants with a score of 13 or higher on the Edinburgh Postnatal Depression Scale. The minimum score is 0 and the maximum score is 30. Higher scores indicate worse outcomes, where persons scoring about 13 are likely to be suffering from a depressive illness. The scale indicates how the respondent has felt during the previous week. (NCT04296396)
Timeframe: 6 weeks postpartum

InterventionParticipants (Count of Participants)
Individualized Opioid Prescription Protocol (IOPP)185
Fixed Opioid Prescription191

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Post-operative Uncorrected Visual Acuity Right and Left Eye

Right and left eye uncorrected visual acuity at post-operative month 6. (NCT04399122)
Timeframe: Post-operative month 6.

,
InterventionlogMAR (Mean)
Right Eye logMARLeft Eye logMAR
Acetaminophen With Codeine-0.07-0.06
Acetaminophen With Oxycodone-0.05-0.06

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Post-operative Average Pain Score

The PRK Post-Operative Pain Survey consisted of a scale of 0 - 10 with a score of 0 equal to no pain, a score of 1 - 3 equal to mild pain, a score of 4 - 6 equal to moderate pain and a score of 7 - 10 equal to severe pain (NCT04399122)
Timeframe: 2 days post surgery

Interventionunits on a scale (Mean)
Acetaminophen With Codeine2.82
Acetaminophen With Oxycodone3.58

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Operative Time

minutes (NCT04429022)
Timeframe: 0-300 minutes

Interventionminutes (Mean)
Prospective Cohort128.80
Historical Control139.69

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Length of Stay in Hours

Length of stay in hours (NCT04429022)
Timeframe: 0- 240 hours

Interventionhours (Mean)
Prospective Cohort12.05
Historical Control35.82

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Estimated Blood Loss

milliliters (mL) (NCT04429022)
Timeframe: 0-300 minutes

Interventionmilliliters (Mean)
Prospective Cohort63.50
Historical Control58.46

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Total Opioid Pain Medications Required Through 3-24h Post op in MME

Total opioid pain medications required through 3-24h post op in MME (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort.20
Historical Control12.27

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Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)

Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME) (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort2.00
Historical Control5.32

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort1.75
Historical Control5.43

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Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period

Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period (NCT04429022)
Timeframe: 0-14 days

InterventionParticipants (Count of Participants)
Prospective Cohort1
Historical Control3

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort3.82
Historical Control5.13

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Length of Stay in Hospital

(NCT04522206)
Timeframe: Up to 12 days

InterventionHours (Mean)
Patients Undergoing Elective Spine Surgery139

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Opioid Sparing and Rescue Time

Time interval from patient extubation to time when pain medication is first demanded in the PACU (NCT04522206)
Timeframe: 24 hours

InterventionHours (Mean)
Patients Undergoing Elective Spine Surgery1.5

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Visual Analogue Scale (VAS) for Pain

VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. (NCT04522206)
Timeframe: 24 hours

Interventionscore on a scale (Mean)
Patients Undergoing Elective Spine Surgery4.8

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"Bipolar VAS for Overall Drug Liking"

"100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question Overall, my liking for this drug is where 0 = definitely not, 50 = neutral, and 100 = definitely so. The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included" (NCT05053126)
Timeframe: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo53.74
Oxycodone 20 mg75.73
Lyrica 300 mg60.14
Lyrica 450 mg63.54
Lyrica 300mg With Oxycodone 20 mg74.86
Lyrica 450 mg With Oxycodone 20 mg75.01

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"Bipolar VAS for Take Drug Again"

"100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question I would take this drug again where 0 = definitely not, 50 = neutral, and 100 = definitely so. The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included" (NCT05053126)
Timeframe: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo53.58
Oxycodone 20 mg77.05
Lyrica 300 mg63.98
Lyrica 450 mg64.87
Lyrica 300mg With Oxycodone 20 mg77.91
Lyrica 450 mg With Oxycodone 20 mg75.92

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"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."

"Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05053126)
Timeframe: up to 48 hours after treatment

InterventionScore on a 100 mm scale (Mean)
Placebo54.30
Oxycodone 20 mg90.85
Lyrica 300 mg72.53
Lyrica 450 mg76.05
Lyrica 300mg With Oxycodone 20 mg96.11
Lyrica 450 mg With Oxycodone 20 mg95.06

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"Unipolar VAS for Any Drug Effect"

"100 mm visual analog scale for the question At this moment, I can feel any drug effects where 0 = not at all and 100 = extremely" (NCT05053126)
Timeframe: up to 48 hours after treatment

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo2.14
Oxycodone 20 mg29.97
Lyrica 300 mg16.68
Lyrica 450 mg20.00
Lyrica 300mg With Oxycodone 20 mg36.55
Lyrica 450 mg With Oxycodone 20 mg40.98

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"Unipolar VAS for High - Maximum Effect (Emax)"

"Maximum effect on the 100 mm visual analog scale for the question I am feeling high where 0 = not at all and 100 = extremely" (NCT05053126)
Timeframe: up to 48 hours after treatment

InterventionScore on a 100 mm scale (Mean)
Placebo10.83
Oxycodone 20 mg85.83
Lyrica 300 mg55.83
Lyrica 450 mg60.43
Lyrica 300mg With Oxycodone 20 mg91.36
Lyrica 450 mg With Oxycodone 20 mg92.23

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 8 Hours (AUEC8)"

"Area under the effect-time profile from time 0 to 8 hours post-dose for the Drug liking visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05319756)
Timeframe: Up to 8 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)

Interventionunits on a scale * hour (Mean)
Placebo411.58
Oxycodone HCl 20 mg Single Dose551.53
Gabapentin 600 mg Single Dose421.12
Gabapentin 1200 mg Single Dose438.30
Gabapentin 600 mg and Oxycodone HCl 20 mg599.96
Gabapentin 1200 mg and Oxycodone HCl 20 mg574.98

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 4 Hours (AUEC4)"

"Area under the effect-time profile from time 0 to 4 hours post-dose for the Drug liking visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05319756)
Timeframe: Up to 4 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours)

Interventionunits on a scale * hour (Mean)
Placebo208.32
Oxycodone HCl 20 mg Single Dose294.28
Gabapentin 600 mg Single Dose214.53
Gabapentin 1200 mg Single Dose220.08
Gabapentin 600 mg and Oxycodone HCl 20 mg305.08
Gabapentin 1200 mg and Oxycodone HCl 20 mg293.99

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 3 Hours (AUEC3)"

"Area under the effect-time profile from time 0 to 3 hours post-dose for the Drug liking visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05319756)
Timeframe: up to 3 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, and 3 hours)

Interventionunits on a scale * hour (Mean)
Placebo155.48
Oxycodone HCl 20 mg Single Dose219.31
Gabapentin 600 mg Single Dose161.07
Gabapentin 1200 mg Single Dose164.03
Gabapentin 600 mg and Oxycodone HCl 20 mg223.22
Gabapentin 1200 mg and Oxycodone HCl 20 mg214.99

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 2 Hours (AUEC2)"

"Area under the effect-time profile from time 0 to 2 hours post-dose for the Drug liking visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05319756)
Timeframe: Up to 2 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, and 2 hours)

Interventionunits on a scale * hour (Mean)
Placebo102.62
Oxycodone HCl 20 mg Single Dose140.44
Gabapentin 600 mg Single Dose105.20
Gabapentin 1200 mg Single Dose107.19
Gabapentin 600 mg and Oxycodone HCl 20 mg138.72
Gabapentin 1200 mg and Oxycodone HCl 20 mg133.84

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 1 Hour (AUEC1)"

"Area under the effect-time profile from time 0 to 1 hour post-dose for the Drug liking visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05319756)
Timeframe: Up to 1 hour post-dose (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, and 1 hour)

Interventionunits on a scale * hour (Mean)
Placebo50.17
Oxycodone HCl 20 mg Single Dose58.86
Gabapentin 600 mg Single Dose51.28
Gabapentin 1200 mg Single Dose50.61
Gabapentin 600 mg and Oxycodone HCl 20 mg57.02
Gabapentin 1200 mg and Oxycodone HCl 20 mg55.76

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"Unipolar VAS for Bad Drug Effect"

"100 mm visual analog scale for the question At this moment, I can feel bad drug effects where 0 = not at all and 100 = extremely" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo0.19
Oxycodone HCl 20 mg Single Dose4.41
Gabapentin 600 mg Single Dose0.82
Gabapentin 1200 mg Single Dose0.97
Gabapentin 600 mg and Oxycodone HCl 20 mg4.10
Gabapentin 1200 mg and Oxycodone HCl 20 mg3.41

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"Unipolar VAS for Any Drug Effect"

"100 mm visual analog scale for the question At this moment, I can feel any drug effects where 0 = not at all and 100 = extremely" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo3.77
Oxycodone HCl 20 mg Single Dose28.46
Gabapentin 600 mg Single Dose6.63
Gabapentin 1200 mg Single Dose7.88
Gabapentin 600 mg and Oxycodone HCl 20 mg34.34
Gabapentin 1200 mg and Oxycodone HCl 20 mg33.76

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"Bipolar VAS for Drug Liking - Time to Maximum Effect (TEmax)"

Time after dosing when the maximum effect for Drug Liking VAS is reached (NCT05319756)
Timeframe: up to 48 hours after treatments

Interventionhours (Median)
Placebo Single Dose0.25
Oxycodone HCl 20 mg Single Dose1.00
Gabapentin 600 mg Single Dose0.25
Gabapentin 1200 mg Single Dose0.28
Gabapentin 600 mg and Oxycodone HCl 20 mg1.00
Gabapentin 1200 mg and Oxycodone HCl 20 mg1.50

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"Area Under the Effect Curve for High VAS (AUEClast)"

"Area under the effect-time profile from time 0 to the time of the last available data for the High visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question I am feeling high where 0 = not at all and 100 =extremely" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionunits on a scale * hour (Mean)
Placebo Single Dose33.45
Oxycodone HCl 20 mg Single Dose321.75
Gabapentin 600 mg Single Dose86.41
Gabapentin 1200 mg Single Dose123.74
Gabapentin 600 mg and Oxycodone HCl 20 mg512.08
Gabapentin 1200 mg and Oxycodone HCl 20 mg425.01

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Tmax of Oxycodone

Time when the maximum concentration of Oxycodone is reached (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionhours (Median)
Oxycodone HCl 20 mg Single Dose1.15
Gabapentin 600 mg and Oxycodone HCl 20 mg1.15
Gabapentin 1200 mg and Oxycodone HCl 20 mg1.63

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Tmax of Gabapentin

Time when the maximum concentration of gabapentin is reached (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

InterventionHours (Median)
Gabapentin 600 mg Single Dose3.13
Gabapentin 1200 mg Single Dose3.13
Gabapentin 600 mg and Oxycodone HCl 20 mg3.13
Gabapentin 1200 mg and Oxycodone HCl 20 mg3.13

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Half-life (t½) of Oxycodone

Half-life (t½) of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionhours (Median)
Oxycodone HCl 20 mg Single Dose4.12
Gabapentin 600 mg and Oxycodone HCl 20 mg3.84
Gabapentin 1200 mg and Oxycodone HCl 20 mg3.90

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Half-life (t½) of Gabapentin

Half-life (t½) of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

InterventionHours (Mean)
Gabapentin 600 mg Single Dose9.14
Gabapentin 1200 mg Single Dose10.62
Gabapentin 600 mg and Oxycodone HCl 20 mg8.20
Gabapentin 1200 mg and Oxycodone HCl 20 mg9.19

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Cmax of Oxycodone

Maximum plasma concentration of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionnanograms/milliliter (Mean)
Oxycodone HCl 20 mg Single Dose44.92
Gabapentin 600 mg and Oxycodone HCl 20 mg43.82
Gabapentin 1200 mg and Oxycodone HCl 20 mg40.79

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Cmax of Gabapentin

Maximum plasma concentration of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionmicrograms/milliliter (Mean)
Gabapentin 600 mg Single Dose4.16
Gabapentin 1200 mg Single Dose6.07
Gabapentin 600 mg and Oxycodone HCl 20 mg4.17
Gabapentin 1200 mg and Oxycodone HCl 20 mg6.18

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AUClast of Oxycodone

Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionnanograms*hour/milliliter (Mean)
Oxycodone HCl 20 mg Single Dose229.31
Gabapentin 600 mg and Oxycodone HCl 20 mg224.79
Gabapentin 1200 mg and Oxycodone HCl 20 mg234.65

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AUClast of Gabapentin

Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatment (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionmicrograms*hour/milliliter (Mean)
Gabapentin 600 mg Single Dose39.76
Gabapentin 1200 mg Single Dose61.42
Gabapentin 600 mg and Oxycodone HCl 20 mg47.31
Gabapentin 1200 mg and Oxycodone HCl 20 mg72.73

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AUCinf of Oxycodone

Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionnanograms*hour/milliliter (Mean)
Oxycodone HCl 20 mg Single Dose233.29
Gabapentin 600 mg and Oxycodone HCl 20 mg228.40
Gabapentin 1200 mg and Oxycodone HCl 20 mg234.94

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AUCinf of Gabapentin

Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionmicrograms*hour/milliliter (Mean)
Gabapentin 600 mg Single Dose41.42
Gabapentin 1200 mg Single Dose65.38
Gabapentin 600 mg and Oxycodone HCl 20 mg48.58
Gabapentin 1200 mg and Oxycodone HCl 20 mg75.18

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"Unipolar VAS for High: Time to Maximum Effect (TEmax)"

"Time after dosing when the maximum effect for High VAS is reached" (NCT05319756)
Timeframe: up to 48 hours after treatments

Interventionhours (Median)
Placebo Single Dose0.25
Oxycodone HCl 20 mg Single Dose1.00
Gabapentin 600 mg Single Dose0.26
Gabapentin 1200 mg Single Dose0.27
Gabapentin 600 mg and Oxycodone HCl 20 mg1.00
Gabapentin 1200 mg and Oxycodone HCl 20 mg1.50

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"Unipolar VAS for High - Maximum Effect (Emax)"

"Maximum effect on the 100 mm visual analog scale for the question I am feeling high where 0 = not at all and 100 = extremely" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Mean)
Placebo Single Dose13.45
Oxycodone HCl 20 mg Single Dose77.36
Gabapentin 600 mg Single Dose28.61
Gabapentin 1200 mg Single Dose25.21
Gabapentin 600 mg and Oxycodone HCl 20 mg81.86
Gabapentin 1200 mg and Oxycodone HCl 20 mg88.74

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"Unipolar VAS for Good Drug Effect"

"100 mm visual analog scale for the question At this moment, I can feel good drug effects where 0 = not at all and 100 = extremely" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo2.54
Oxycodone HCl 20 mg Single Dose27.91
Gabapentin 600 mg Single Dose6.13
Gabapentin 1200 mg Single Dose8.73
Gabapentin 600 mg and Oxycodone HCl 20 mg34.72
Gabapentin 1200 mg and Oxycodone HCl 20 mg32.71

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"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."

"Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Mean)
Placebo54.89
Oxycodone HCl 20 mg Single Dose87.40
Gabapentin 600 mg Single Dose57.89
Gabapentin 1200 mg Single Dose63.62
Gabapentin 600 mg and Oxycodone HCl 20 mg88.43
Gabapentin 1200 mg and Oxycodone HCl 20 mg92.17

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"Bipolar VAS for Take Drug Again"

"100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question I would take this drug again where 0 = definitely not, 50 = neutral, and 100 = definitely so. The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo Single Dose53.43
Oxycodone HCl 20 mg Single Dose72.16
Gabapentin 600 mg Single Dose55.19
Gabapentin 1200 mg Single Dose58.05
Gabapentin 600 mg and Oxycodone HCl 20 mg79.16
Gabapentin 1200 mg and Oxycodone HCl 20 mg77.85

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"Bipolar VAS for Overall Drug Liking"

"100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question Overall, my liking for this drug is where 0 = definitely not, 50 = neutral, and 100 = definitely so. The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo Single Dose51.75
Oxycodone HCl 20 mg Single Dose72.06
Gabapentin 600 mg Single Dose54.40
Gabapentin 1200 mg Single Dose58.25
Gabapentin 600 mg and Oxycodone HCl 20 mg75.90
Gabapentin 1200 mg and Oxycodone HCl 20 mg79.94

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)"

"Area under the effect-time profile from time 0 to the time of the last available data for the Drug liking visual analog scale which assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionunits on a scale * hour (Mean)
Placebo Single Dose2394.21
Oxycodone HCl 20 mg Single Dose2661.43
Gabapentin 600 mg Single Dose2422.37
Gabapentin 1200 mg Single Dose2444.4
Gabapentin 600 mg and Oxycodone HCl 20 mg2744.86
Gabapentin 1200 mg and Oxycodone HCl 20 mg2759.57

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Satisfaction Scores Ranging From 1 - 10

Patient will be asked to rank their satisfaction scores on a scale from 1 - 10 (with 1 being extremely dissatisfied and 10 being extremely satisfied) since discharge from the hospital (NCT05327777)
Timeframe: 14 days

Interventionunits on a scale (Median)
Control10
Opioid Sparing10
Zero Opioid10

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Morphine Milligram Equivalents Taken by Participants

Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals (NCT05327777)
Timeframe: 14 days

Interventionmorphine milligram equivalents (Median)
Control46
Opioid Sparing15
Zero Opioid0

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