celecoxib and Edema studies

Edema: Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.

Research Excerpts

Excerpt	Relevance	Reference
" The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis."	9.19	Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. ( Baek, HJ; Cho, CS; Choi, IA; Chung, WT; Kang, SW; Kim, HA; Lee, J; Lee, SS; Lee, YA; Lee, YJ; Park, YB; Park, YE; Song, JS; Song, YW; Yoo, WH, 2014)
" This study evaluated the effects of celecoxib 200 mg/day and rofecoxib 25 mg/day on blood pressure (BP) and edema in a 6-week, randomized, parallel-group, double-blind study in patients > or =65 years of age with osteoarthritis who were treated with fixed antihypertensive regimens."	9.10	Effects of celecoxib and rofecoxib on blood pressure and edema in patients > or =65 years of age with systemic hypertension and osteoarthritis. ( Bello, AE; Fort, JG; Puma, JA; Whelton, A; White, WB, 2002)
" In the present study, we report the nanoconjugates of mercaptopropionic acid- (MPA-) capped CdTe quantum dots (QDs) and Celecoxib for bio-imaging in carrageenan-induced mouse paw edema model of inflammation."	7.88	Synthesis, Characterization, and Biodistribution of Quantum Dot-Celecoxib Conjugate in Mouse Paw Edema Model. ( Jain, S; Kalangi, SK; Narayana Rao, D; Reddanna, P; Sathyavathi, R; Swarnakar, NK, 2018)
"Lornoxicam exhibits strong analgesic but weak antipyretic effects in rats with paw inflammation."	7.75	The importance of brain PGE2 inhibition versus paw PGE2 inhibition as a mechanism for the separation of analgesic and antipyretic effects of lornoxicam in rats with paw inflammation. ( Arai, I; Futaki, N; Harada, M; Hashimoto, Y; Honma, Y; Hoshi, K; Nakaike, S; Sugimoto, M, 2009)
"NAF and plasma samples were collected before, 2 weeks after taking celecoxib 400 mg bid, and two weeks after washout from 26 women who were at increased breast cancer risk."	7.73	Celecoxib decreases prostaglandin E2 concentrations in nipple aspirate fluid from high risk postmenopausal women and women with breast cancer. ( Flynn, JT; Hewett, JE; Qin, W; Sauter, ER; Schlatter, L, 2006)
"Rofecoxib, but not celecoxib and NS NSAID, is associated with an increased risk of edema and blood pressure increase compared to nonusers of NSAID."	7.72	Blood pressure destabilization and edema among 8538 users of celecoxib, rofecoxib, and nonselective nonsteroidal antiinflammatory drugs (NSAID) and nonusers of NSAID receiving ordinary clinical care. ( Pettitt, D; Wolfe, F; Zhao, S, 2004)
"For a 100,000-member Medicare Choice population, an estimated 25,630 persons would have OA and hypertension (stages I-III), and an estimated 5126 of these patients would use celecoxib or rofecoxib."	7.72	A model analysis of costs of blood pressure destabilization and edema associated with rofecoxib and celecoxib among older patients with osteoarthritis and hypertension in a Medicare Choice population. ( Becker, RV; Burke, TA; McCoy, MA; Trotter, JP, 2003)
"This study evaluates the action of celecoxib and rofecoxib, two selective cyclooxygenase-2 (COX-2) inhibitors in two acute models of inflammation, carrageenan (Cg)-induced rat pleurisy, and paw oedema formation."	7.71	Effect of the selective COX-2 inhibitors, celecoxib and rofecoxib in rat acute models of inflammation. ( Calixto, JB; Pinheiro, RM, 2002)
" The aim of this study was to compare the efficacy and safety profiles of pelubiprofen with those of celecoxib in patients with rheumatoid arthritis."	5.19	Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. ( Baek, HJ; Cho, CS; Choi, IA; Chung, WT; Kang, SW; Kim, HA; Lee, J; Lee, SS; Lee, YA; Lee, YJ; Park, YB; Park, YE; Song, JS; Song, YW; Yoo, WH, 2014)
"The cardiorenal safety database from the Celecoxib Long-term Arthritis Safety Study (CLASS) was analyzed to examine whether supratherapeutic doses of celecoxib are associated with decreased renal function and blood pressure (BP) effects compared with standard doses of diclofenac and ibuprofen in osteoarthritis (OA) and rheumatoid arthritis (RA) patients."	5.12	Cardiorenal effects of celecoxib as compared with the nonsteroidal anti-inflammatory drugs diclofenac and ibuprofen. ( Lefkowith, JL; Verburg, KM; West, CR; Whelton, A, 2006)
" This study evaluated the effects of celecoxib 200 mg/day and rofecoxib 25 mg/day on blood pressure (BP) and edema in a 6-week, randomized, parallel-group, double-blind study in patients > or =65 years of age with osteoarthritis who were treated with fixed antihypertensive regimens."	5.10	Effects of celecoxib and rofecoxib on blood pressure and edema in patients > or =65 years of age with systemic hypertension and osteoarthritis. ( Bello, AE; Fort, JG; Puma, JA; Whelton, A; White, WB, 2002)
"The novel cyclooxygenase- (COX)-2 inhibitor celecoxib is an effective treatment for the signs and symptoms of osteoarthritis and rheumatoid arthritis."	4.80	Renal safety and tolerability of celecoxib, a novel cyclooxygenase-2 inhibitor. ( Geis, GS; Maurath, CJ; Verburg, KM; Whelton, A, 2000)
"These cases revealed that low-dose celecoxib may be an effective management for symptoms caused by perihematomal edema in patients with ICH, particularly those involving the thalamus."	4.12	Improvement After Celecoxib Treatment in Patients with Thalamic Hemorrhage - A Case Report. ( Jeng, JS; Lin, YW; Tang, SC; Tsai, LK; Yeh, SJ, 2022)
" The acetylcholinesterase inhibitor (ACHEI); neostigmine, is known clinically for its analgesic effect in the perioperative phases proving high efficacy; besides possessing anti-inflammatory properties controlling immune cells and cytokine level."	4.02	The effective interplay of (non-) selective NSAIDs with neostigmine in animal models of analgesia and inflammation. ( Abdel-Bary, A; El-Tahan, RA; Gowayed, MA, 2021)
" Compounds that showed promising COX-2 selectivity were further subjected to in vivo anti-inflammatory screening applying formalin induced paw edema (acute model) and cotton-pellet induced granuloma (chronic model) assays using celecoxib and diclofenac sodium as reference drugs."	3.88	Design, synthesis and evaluation of some pyrazolo[3,4-d]pyrimidine derivatives bearing thiazolidinone moiety as anti-inflammatory agents. ( Ashour, HM; Fahmy, SM; Khalil, MA; Labouta, IM; Nassra, RA; Tageldin, GN, 2018)
" In the present study, we report the nanoconjugates of mercaptopropionic acid- (MPA-) capped CdTe quantum dots (QDs) and Celecoxib for bio-imaging in carrageenan-induced mouse paw edema model of inflammation."	3.88	Synthesis, Characterization, and Biodistribution of Quantum Dot-Celecoxib Conjugate in Mouse Paw Edema Model. ( Jain, S; Kalangi, SK; Narayana Rao, D; Reddanna, P; Sathyavathi, R; Swarnakar, NK, 2018)
" All synthesized new compounds along with compound III as a parent compound and Celecoxib as a reference, were assessed for their antiinflammatory activity both in-vivo and in-vitro using the formalin-induced hind paw edema method and inhibition of albumin denaturation and Red Blood Cells (RBCs) membrane stabilization, respectively."	3.88	Synthesis, In-vivo and In-vitro Anti-inflammatory Evaluation of some Novel Coumarin Derivatives. ( Al-Wabli, R; El-Haggar, R; Fouad, M, 2018)
" Amongst all the synthesized derivatives, compound 56 showed the significant anti-inflammatory activity in both rat paw edema models with very less ulcerogenic liability in comparison to standard diclofenac, celecoxib, and zileuton."	3.85	Design, synthesis, and biological evaluation of some novel indolizine derivatives as dual cyclooxygenase and lipoxygenase inhibitor for anti-inflammatory activity. ( Bandresh, R; Shrivastava, SK; Srivastava, P; Tripathi, A; Tripathi, PN, 2017)
" The compounds 3a, 3b, 3c, 3e, and 3f presented anti-hyperalgesic action, while the compounds 3a, 3c, 3d, 3f, and 3g exhibited anti-edematogenic effects, without causing locomotive disorders in animals, thus making them comparable to Celecoxib in an arthritic pain model."	3.81	Regioselectively controlled synthesis of 3(5)-(trifluoromethyl)pyrazolylbenzenesulfonamides and their effects on a pathological pain model in mice. ( Bonacorso, HG; Brusco, I; Canova, B; da Silva, TV; de Souza, ON; Dos Santos, JM; Lobo, MM; Machado, P; Martins, MA; Oliveira, SM; Timmers, LF; Zanatta, N, 2015)
" While all the compounds (20mg/kg) showed significant anti-inflammatory activity after 3h of inflammation induction (69-89%) as compared to celecoxib (80%), 1-(4-methanesulfonylphenyl)-5-(4-methylaminomethylphenyl)-3-trifluoromethyl-1H-pyrazole (12 a) was found to be the most effective one (89%)."	3.80	Synthesis of new 1-(4-methane(amino)sulfonylphenyl)-5-(4-substituted-aminomethylphenyl)-3-trifluoromethyl-1H-pyrazoles: a search for novel nitric oxide donor anti-inflammatory agents. ( Abdellatif, KR; Knaus, EE; Moawad, A, 2014)
" In particular, the glycine derivative proved to be extremely active in suppressing hyperalgesia and edema."	3.80	Enhancing the pharmacodynamic profile of a class of selective COX-2 inhibiting nitric oxide donors. ( Alfonso, S; Anzini, M; Battilocchio, C; Biava, M; Calderone, V; Colovic, M; Consalvi, S; Di Capua, A; Di Cesare Mannelli, L; Dovizio, M; Ghelardini, C; Giordani, A; Martelli, A; Patrignani, P; Persiani, S; Poce, G; Rossi, A; Sautebin, L; Testai, L, 2014)
"86% inhibition of edema at 5h) in comparison to celecoxib (51."	3.80	Synthesis, biological evaluation and docking analysis of 3-methyl-1-phenylchromeno[4,3-c]pyrazol-4(1H)-ones as potential cyclooxygenase-2 (COX-2) inhibitors. ( Grover, J; Jachak, SM; Kumar, V; Sobhia, ME, 2014)
"We previously reported that 2-fluoroloxoprofen has lower gastric ulcerogenic activity than loxoprofen, a nonsteroidal anti-inflammatory drug (NSAID) without selectivity for COX-2."	3.78	Synthesis and biological evaluation of derivatives of 2-{2-fluoro-4-[(2-oxocyclopentyl)methyl]phenyl}propanoic acid: nonsteroidal anti-inflammatory drugs with low gastric ulcerogenic activity. ( Asano, T; Ishihara, T; Miyata, K; Mizushima, T; Okamoto, Y; Otsuka, M; Suemasu, S; Tanaka, K; Yamakawa, N, 2012)
" Two compounds 2c and 2e showed good anti-inflammatory activity which is comparable to the reference drug celecoxib in carrageenan-induced rat paw edema bioassay and found safe from the point of view of ulcer induction."	3.77	Synthesis and biological evaluation of some new 2-pyrazolines bearing benzene sulfonamide moiety as potential anti-inflammatory and anti-cancer agents. ( Ahmad, S; Alam, MS; Bano, S; Javed, K; Rathish, IG; Singh, S, 2011)
"When compared to celecoxib, WIN-34B exhibited similar or better anti-nociceptive and anti-inflammatory activities in osteoarthritic animal models, which may become a potential novel treatment for osteoarthritis."	3.76	The analgesic and anti-inflammatory effect of WIN-34B, a new herbal formula for osteoarthritis composed of Lonicera japonica Thunb and Anemarrhena asphodeloides BUNGE in vivo. ( Cho, YB; Hur, J; Jung, I; Jung, KC; Kang, JY; Kang, M; Kim, KS; Kim, SH; Lee, JD; Lee, JH; Park, DS; Yoo, MC, 2010)
"Lornoxicam exhibits strong analgesic but weak antipyretic effects in rats with paw inflammation."	3.75	The importance of brain PGE2 inhibition versus paw PGE2 inhibition as a mechanism for the separation of analgesic and antipyretic effects of lornoxicam in rats with paw inflammation. ( Arai, I; Futaki, N; Harada, M; Hashimoto, Y; Honma, Y; Hoshi, K; Nakaike, S; Sugimoto, M, 2009)
" Additionally, LASSBio-1135 (3a) presented activity similar to celecoxib (1) regarding the reduction of the carrageenan-induced rat paw edema (33% of inhibition at 100 micromol/kg, po)."	3.75	Discovery of novel analgesic and anti-inflammatory 3-arylamine-imidazo[1,2-a]pyridine symbiotic prototypes. ( Barreiro, EJ; da Silva, LL; de Lima, CK; Fraga, CA; Lacerda, RB; Miranda, AL; Romeiro, NC, 2009)
"32%), which is comparable to that of celecoxib in the carrageenan-induced rat paw edema method."	3.74	Synthesis and biological evaluation of 2-trifluoromethyl/sulfonamido-5,6-diaryl substituted imidazo[2,1-b]-1,3,4-thiadiazoles: a novel class of cyclooxygenase-2 inhibitors. ( Anand, K; Boreddy, TS; Gadad, AK; Noolvi, MN; Palkar, MB; Wagwade, J, 2008)
" All the target compounds showed anti-inflammatory activity and three of them 3b, 3c and 4c surpassed that of indomethacin both locally and systemically in the cotton pellet granuloma and rat paw edema bioassay."	3.74	Synthesis and biological evaluation of some thiazolyl and thiadiazolyl derivatives of 1H-pyrazole as anti-inflammatory antimicrobial agents. ( Abdel Ghany, YS; Ashour, HM; Baraka, A; Bekhit, AA; Bekhit, Ael-D, 2008)
"Substituted thiazoles with different structural features were synthesized and screened for their anti-inflammatory activity in acute carrageenin induced rat paw edema model and chronic formalin induced rat paw edema model."	3.74	2-Amino-5-thiazolyl motif: a novel scaffold for designing anti-inflammatory agents of diverse structures. ( Franklin, PX; Nivsarkar, M; Padh, H; Pillai, AD; Rathod, PD; Sudarsanam, V; Vasu, KK; Yerande, S, 2008)
"NAF and plasma samples were collected before, 2 weeks after taking celecoxib 400 mg bid, and two weeks after washout from 26 women who were at increased breast cancer risk."	3.73	Celecoxib decreases prostaglandin E2 concentrations in nipple aspirate fluid from high risk postmenopausal women and women with breast cancer. ( Flynn, JT; Hewett, JE; Qin, W; Sauter, ER; Schlatter, L, 2006)
"0032 muM) and COX-2 selectivity (SI > 120 000), 14s exhibited moderate antiinflammatory activity compared to celecoxib in a carrageenan-induced rat paw edema assay."	3.72	Design, synthesis, and biological evaluation of 6-substituted-3-(4-methanesulfonylphenyl)-4-phenylpyran-2-ones: a novel class of diarylheterocyclic selective cyclooxygenase-2 inhibitors. ( Amini, M; Habeeb, AG; Knaus, EE; Li, H; Praveen Rao, PN, 2003)
"For a 100,000-member Medicare Choice population, an estimated 25,630 persons would have OA and hypertension (stages I-III), and an estimated 5126 of these patients would use celecoxib or rofecoxib."	3.72	A model analysis of costs of blood pressure destabilization and edema associated with rofecoxib and celecoxib among older patients with osteoarthritis and hypertension in a Medicare Choice population. ( Becker, RV; Burke, TA; McCoy, MA; Trotter, JP, 2003)
"The effect of valeryl salicylate (VS), an inhibitor of cyclooxygenase-1 (COX-1), was evaluated in arachidonic acid or croton oil-induced ear oedema and carrageenan-induced paw oedema in mice."	3.72	Effects of valeryl salicylate, a COX-1 inhibitor, on models of acute inflammation in mice. ( Brum-Fernandes, AJ; Peters, RR; Ribeiro-do-Valle, RM; Siqueira-Junior, JM, 2003)
"The anti-inflammatory activity of fluoxetine, a selective serotonin reuptake inhibitor (SSRI), was studied on the carrageenan-induced paw inflammation in the rat."	3.72	Studies on the anti-inflammatory effect of fluoxetine in the rat. ( Abdel-Salam, OM; Arbid, MS; Baiuomy, AR, 2004)
"In conscious rats celecoxib, indomethacin and acetylsalicylic acid significantly reduced the paw oedema induced by carrageenan."	3.72	Gastric effects of the selective cyclooxygenase-2 inhibitor, celecoxib, in the rat. ( Coppelli, G; Coruzzi, G; Guaita, E; Spaggiari, S, 2004)
"Rofecoxib, but not celecoxib and NS NSAID, is associated with an increased risk of edema and blood pressure increase compared to nonusers of NSAID."	3.72	Blood pressure destabilization and edema among 8538 users of celecoxib, rofecoxib, and nonselective nonsteroidal antiinflammatory drugs (NSAID) and nonusers of NSAID receiving ordinary clinical care. ( Pettitt, D; Wolfe, F; Zhao, S, 2004)
"The aim of this study was to describe physician-reported management of clinically significant edema and/or destabilized blood pressure in patients with osteoarthritis (OA) and hypertension when initiating therapy with rofecoxib or celecoxib."	3.71	Physician-reported management of edema and destabilized blood pressure in cyclooxygenase-2-specific inhibitor users with osteoarthritis and treated hypertension. ( Bristol, S; Burke, TA; May, C; Osterhaus, JT; Wentworth, C; Whelton, A, 2002)
"This study evaluates the action of celecoxib and rofecoxib, two selective cyclooxygenase-2 (COX-2) inhibitors in two acute models of inflammation, carrageenan (Cg)-induced rat pleurisy, and paw oedema formation."	3.71	Effect of the selective COX-2 inhibitors, celecoxib and rofecoxib in rat acute models of inflammation. ( Calixto, JB; Pinheiro, RM, 2002)
" Adverse event frequency was higher with tanezumab than with NSAIDs and highest with combination therapy."	2.80	Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. ( Brown, MT; Ekman, EF; Greenberg, HS; Schnitzer, TJ; Smith, MD; Spierings, EL; Verburg, KM; West, CR, 2015)
"Mechanical hyperalgesia, joint edema, leukocyte recruitment to the joint and damage to cartilage in experimental arthritis and cytotoxicity, spread of disease, phagocytic activity and nitric oxide (NO) and hydrogen peroxide production by macrophages were evaluated."	1.91	1,4-Diaryl-1,2,3-triazole neolignan-celecoxib hybrids inhibit experimental arthritis induced by zymosan. ( B Carvalho, D; Baroni, ACM; Bonfá, IS; Candeloro, L; das Neves, AR; Felipe, JL; Ferreira, GIS; Lencina, JS; Lossavaro, PKMB; Silva-Filho, SE; Souza, MIL; Toffoli-Kadri, MC, 2023)
" However, their long-term administration is associated with various side effects including gastrointestinal ulceration."	1.72	Nonacidic thiophene-based derivatives as potential analgesic and design, synthesis, biological evaluation, and metabolic stability study. ( El-Nassan, HB; Fahim, SH; Mahmoud, ST; Mikhail, DS, 2022)
"Celecoxib (CXB) is a widely used anti-inflammatory drug that also acts as a chemopreventive agent against several types of cancer, including skin cancer."	1.48	Liquid Crystalline Systems Based on Glyceryl Monooleate and Penetration Enhancers for Skin Delivery of Celecoxib: Characterization, In Vitro Drug Release, and In Vivo Studies. ( Borgheti-Cardoso, LN; Dante, MCL; Fantini, MCA; Lara, MG; Medina, WSG; Pierre, MBR; Praça, FSG, 2018)
"Celecoxib (CXB) has been explored as an anti-inflammatory or chemopreventive drug for topical treatment of skin diseases and cancer."	1.46	In Vitro and In Vivo Evaluation of DMSO and Azone as Penetration Enhancers for Cutaneous Application of Celecoxib. ( de Padula, M; Kibwila, DM; Lara, MG; Leitao, AC; Mata Dos Santos, HA; Padua, TA; Riemma Pierre, MB; Rosas, EC; Santos Pyrrho, AD; Senna, TD, 2017)
"Outcome measures were postsurgical pain at rest and during walking, consumption of opioids for pain rescue, knee swelling and knee range of motion, and complications."	1.46	Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. ( Hansen, TB; Munk, S; Rytter, S; Stilling, M, 2017)
" The lead compound demonstrated very good oral bioavailability in mice, slow metabolic degradation, modest distribution into the brain and a remarkable anti-inflammatory efficacy in carrageenan-induced mouse paw edema model."	1.40	Potent, orally available, selective COX-2 inhibitors based on 2-imidazoline core. ( Gavalas, A; Geronikaki, A; Hammock, B; Hwang, SH; Iurchenko, V; Ivanenkov, Y; Krasavin, M; Morisseau, C; Mujumdar, P; Sarnpitak, P; Zozulya, S, 2014)
" Finally, these compounds have shown efficacy when dosed orally in multiple acute and chronic prostaglandin and leukotriene dependent in vivo models."	1.35	Indole cytosolic phospholipase A2 alpha inhibitors: discovery and in vitro and in vivo characterization of 4-{3-[5-chloro-2-(2-{[(3,4-dichlorobenzyl)sulfonyl]amino}ethyl)-1-(diphenylmethyl)-1H-indol-3-yl]propyl}benzoic acid, efipladib. ( Abraham, WM; Albert, L; Behnke, ML; Chen, L; Clark, JD; Donahue, F; Foley, MA; Goodwin, DG; Hegen, M; Hu, B; Hu, Y; Ipek, M; Keith, J; Kirincich, SJ; Ku, MS; Lee, KL; McKew, JC; Michalak, R; Murphy, EA; Nickerson-Nutter, CL; Ramarao, MK; Shen, MW; Sum, FW; Tam, S; Thakker, P; Thomason, J; Williams, C; Wooder, L; Wu, K; Xu, X, 2008)
" Recently, cardiotoxic effects associated with conventional modes of delivery of celecoxib have made it pertinent to develop alternate dosage forms capable of selectively delivering the drug topically to affected joints."	1.34	Niosomal gel for site-specific sustained delivery of anti-arthritic drug: in vitro-in vivo evaluation. ( Jain, S; Kaur, K; Sapra, B; Tiwary, AK, 2007)
"Paw edema and hyperalgesia were monitored from day zero to day 21 after induction as signs of arthritis development."	1.32	Role of endogenous glucocorticoids in hyperalgesia and edema in old arthritic rats. ( Alves, DL; Francischi, JN; Pereira, LS; Tatsuo, MA; Yokoro, CM, 2003)
"Acute inflammation was induced by subplantar injection of carrageenan (1%) in the rat hind paw."	1.32	The anti-inflammatory effects of the phosphodiesterase inhibitor pentoxifylline in the rat. ( Abdel-Salam, OM; Arbid, MS; Baiuomy, AR; El-Shenawy, SM, 2003)
"2."	1.31	Selective inhibitors of cyclo-oxygenase-2 (COX-2) induce hypoalgesia in a rat paw model of inflammation. ( Bakhle, YS; Chaves, CT; Ferreira-Alves, DL; Francischi, JN; Lima, AS; Moura, AC; Rocha, OA, 2002)
" Both exhibit good oral bioavailability and are potent in standard models of pain, fever, and inflammation yet have a much reduced effect on the GI integrity of rats compared to standard nonsteroidal antiflammatory drugs."	1.30	2,3-Diarylcyclopentenones as orally active, highly selective cyclooxygenase-2 inhibitors. ( Black, WC; Brideau, C; Chan, CC; Charleson, S; Chauret, N; Claveau, D; Ethier, D; Gordon, R; Greig, G; Guay, J; Hughes, G; Jolicoeur, P; Leblanc, Y; Nicoll-Griffith, D; Ouimet, N; Prasit, P; Riendeau, D; Visco, D; Wang, Z; Xu, L, 1999)

Research

Studies (178)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (1.12)	18.2507
2000's	64 (35.96)	29.6817
2010's	87 (48.88)	24.3611
2020's	25 (14.04)	2.80

Authors	Studies
Black, WC	2
Brideau, C	2
Chan, CC	2
Charleson, S	2
Chauret, N	1
Claveau, D	1
Ethier, D	1
Gordon, R	2
Greig, G	1
Guay, J	1
Hughes, G	2
Jolicoeur, P	1
Leblanc, Y	1
Nicoll-Griffith, D	1
Ouimet, N	1
Riendeau, D	2
Visco, D	1
Wang, Z	2
Xu, L	1
Prasit, P	2
Talley, JJ	2
Brown, DL	1
Carter, JS	1
Graneto, MJ	1
Koboldt, CM	2
Masferrer, JL	2
Perkins, WE	1
Rogers, RS	1
Shaffer, AF	1
Zhang, YY	1
Zweifel, BS	2
Seibert, K	2
Inagaki, M	1
Tsuri, T	1
Jyoyama, H	1
Ono, T	1
Yamada, K	1
Kobayashi, M	1
Hori, Y	1
Arimura, A	1
Yasui, K	1
Ohno, K	1
Kakudo, S	1
Koizumi, K	1
Suzuki, R	1
Kawai, S	1
Kato, M	1
Matsumoto, S	1
Shin, SS	2
Noh, MS	3
Byun, YJ	1
Choi, JK	2
Kim, JY	2
Lim, KM	2
Ha, JY	2
Kim, JK	2
Lee, CH	1
Chung, S	3
Almansa, C	1
de Arriba, AF	1
Cavalcanti, FL	1
Gómez, LA	1
Miralles, A	1
Merlos, M	1
García-Rafanell, J	1
Forn, J	1
Habeeb, AG	2
Praveen Rao, PN	2
Knaus, EE	8
Hyup, YH	1
Kwan, JK	1
Kang, SH	1
Kyu, JK	1
Min, KM	1
Hoon, CH	1
Cromlish, W	1
Grimm, EL	1
Leger, S	1
Li, CS	1
Thérien, M	1
Xu, LJ	1
Pal, M	1
Madan, M	1
Padakanti, S	1
Pattabiraman, VR	1
Kalleda, S	1
Vanguri, A	1
Mullangi, R	1
Mamidi, NV	1
Casturi, SR	1
Malde, A	1
Gopalakrishnan, B	1
Yeleswarapu, KR	1
Amini, M	2
Li, H	1
Byun, Y	1
Lee, KW	1
Moh, JH	1
Jeong, YS	1
Choi, YH	1
Koh, HJ	1
Park, YH	1
Oh, YI	1
Rao, PN	2
Uddin, MJ	1
Chen, QH	1
Kaila, N	1
Janz, K	1
DeBernardo, S	1
Bedard, PW	1
Camphausen, RT	1
Tam, S	2
Tsao, DH	1
Keith, JC	1
Nickerson-Nutter, C	1
Shilling, A	1
Young-Sciame, R	1
Wang, Q	1
Franklin, PX	1
Pillai, AD	1
Rathod, PD	1
Yerande, S	1
Nivsarkar, M	2
Padh, H	1
Vasu, KK	2
Sudarsanam, V	2
Bekhit, AA	3
Ashour, HM	3
Abdel Ghany, YS	1
Bekhit, Ael-D	1
Baraka, A	1
Biava, M	5
Porretta, GC	3
Poce, G	4
Supino, S	2
Forli, S	2
Rovini, M	3
Cappelli, A	2
Manetti, F	3
Botta, M	3
Sautebin, L	6
Rossi, A	6
Pergola, C	4
Ghelardini, C	5
Vivoli, E	1
Makovec, F	3
Anzellotti, P	4
Patrignani, P	5
Anzini, M	5
Gadad, AK	1
Palkar, MB	2
Anand, K	1
Noolvi, MN	1
Boreddy, TS	2
Wagwade, J	1
Szabó, G	1
Fischer, J	1
Kis-Varga, A	1
Gyires, K	1
Abouzid, K	1
Bekhit, SA	1
McKew, JC	1
Lee, KL	1
Shen, MW	1
Thakker, P	1
Foley, MA	1
Behnke, ML	1
Hu, B	1
Sum, FW	1
Hu, Y	1
Chen, L	1
Kirincich, SJ	1
Michalak, R	1
Thomason, J	1
Ipek, M	1
Wu, K	1
Wooder, L	1
Ramarao, MK	1
Murphy, EA	1
Goodwin, DG	1
Albert, L	1
Xu, X	1
Donahue, F	1
Ku, MS	1
Keith, J	1
Nickerson-Nutter, CL	1
Abraham, WM	1
Williams, C	1
Hegen, M	1
Clark, JD	1
Vomero, S	1
Norcini, M	2
Giordani, A	4
Cirilli, R	1
Ferretti, R	1
Gallinella, B	1
La Torre, F	1
Chowdhury, MA	3
Abdellatif, KR	8
Dong, Y	3
Das, D	2
Suresh, MR	2
Rathish, IG	2
Javed, K	4
Ahmad, S	3
Bano, S	4
Alam, MS	6
Pillai, KK	2
Singh, S	3
Bagchi, V	1
Lacerda, RB	1
de Lima, CK	1
da Silva, LL	1
Romeiro, NC	1
Miranda, AL	1
Barreiro, EJ	2
Fraga, CA	1
Feng, Z	1
Chu, F	1
Guo, Z	2
Sun, P	1
Yu, G	1
Velázquez, C	1
Eissa, AA	1
Farag, NA	1
Soliman, GA	1
Koeberle, A	1
Haberl, EM	1
Dehm, F	1
Northoff, H	1
Troschuetz, R	1
Werz, O	1
Youssef, AM	1
White, MS	1
Villanueva, EB	1
El-Ashmawy, IM	1
Klegeris, A	1
da Silva, YK	1
Augusto, CV	1
de Castro Barbosa, ML	1
de Albuquerque Melo, GM	1
de Queiroz, AC	1
de Lima Matos Freire Dias, T	1
Júnior, WB	1
Lima, LM	1
Alexandre-Moreira, MS	1
Fahmy, HT	1
Rostom, SA	1
El-Din A Bekhit, A	1
Liu, W	1
Zhou, J	1
Bensdorf, K	1
Zhang, H	2
Liu, H	1
Wang, Y	1
Qian, H	1
Zhang, Y	2
Wellner, A	1
Rubner, G	1
Huang, W	1
Guo, C	1
Gust, R	1
Akhter, M	1
Akhter, N	1
Alam, MM	2
Zaman, MS	1
Saha, R	1
Kumar, A	2
Abdel-Aziz, AA	5
ElTahir, KE	5
Asiri, YA	3
El-Sayed, MA	1
Abdel-Aziz, NI	3
El-Azab, AS	4
Manivannan, E	2
Chaturvedi, SC	2
Battilocchio, C	2
Alfonso, S	2
Valenti, S	1
Giorgi, G	1
Calderone, V	2
Martelli, A	2
Testai, L	2
Papa, G	1
Di Cesare Mannelli, L	2
Bruno, A	1
Eleftheriou, P	1
Geronikaki, A	2
Hadjipavlou-Litina, D	1
Vicini, P	1
Filz, O	1
Filimonov, D	1
Poroikov, V	1
Chaudhaery, SS	1
Roy, KK	1
Saxena, AK	1
Shafi, S	3
Mulakayala, N	1
Mulakayala, C	1
Vanaja, G	1
Kalle, AM	2
Pallu, R	1
Yamakawa, N	1
Suemasu, S	1
Okamoto, Y	1
Tanaka, K	1
Ishihara, T	1
Asano, T	1
Miyata, K	1
Otsuka, M	1
Mizushima, T	1
Abbas, SE	1
Awadallah, FM	1
Ibrahin, NA	1
Said, EG	1
Kamel, GM	1
Hanna, MM	1
Yewale, SB	1
Ganorkar, SB	1
Baheti, KG	1
Shelke, RU	1
Al-Suwaidan, IA	2
Alanazi, AM	2
Al-Obaid, AM	2
Maarouf, AR	1
Abu El-Enin, MA	1
Haider, S	3
Hamid, H	3
Nargotra, A	1
Mahajan, P	1
Nazreen, S	3
Kharbanda, C	3
Ali, Y	3
Alam, A	1
Panda, AK	1
Irannejad, H	1
Kebriaieezadeh, A	1
Zarghi, A	1
Montazer-Sadegh, F	1
Shafiee, A	1
Assadieskandar, A	1
Consalvi, S	1
Di Capua, A	1
Persiani, S	1
Colovic, M	1
Dovizio, M	1
Lokwani, DK	1
Mokale, SN	2
Shinde, DB	1
Khalil, NA	1
Ahmed, EM	2
Mohamed, KO	2
Nissan, YM	4
Zaitone, SA	1
Abdel-Aziz, M	1
Beshr, EA	1
Abdel-Rahman, IM	1
Ozadali, K	1
Tan, OU	1
Aly, OM	1
Dube, PN	1
Bule, SS	1
Kumbhare, MR	1
Dighe, PR	1
Ushir, YV	1
Pyee, Y	1
Chung, HJ	1
Choi, TJ	1
Park, HJ	1
Hong, JY	1
Kim, JS	1
Kang, SS	1
Lee, SK	1
Mohammed, KO	1
Singhai, AS	1
Ronad, PM	1
Vishwanathswamy, AH	1
Veerapur, VP	1
Shaikh, MS	1
Rane, RA	1
Karpoormath, R	1
Dhulap, A	2
Hussain, F	2
Alam, P	1
Umar, S	2
Pasha, MA	1
Sarnpitak, P	1
Mujumdar, P	1
Morisseau, C	1
Hwang, SH	1
Hammock, B	1
Iurchenko, V	1
Zozulya, S	1
Gavalas, A	1
Ivanenkov, Y	1
Krasavin, M	1
Grover, J	1
Kumar, V	1
Sobhia, ME	1
Jachak, SM	1
Moawad, A	1
Rajanarendar, E	1
Rama Krishna, S	1
Nagaraju, D	1
Govardhan Reddy, K	1
Kishore, B	1
Reddy, YN	1
Lobo, MM	1
Oliveira, SM	1
Brusco, I	1
Machado, P	1
Timmers, LF	1
de Souza, ON	1
Martins, MA	1
Bonacorso, HG	1
Dos Santos, JM	1
Canova, B	1
da Silva, TV	1
Zanatta, N	1
Firke, SD	1
Bari, SB	1
Abdelgawad, MA	2
Labib, MB	1
Zidan, TH	1
Elshemy, HA	1
Alsayed, SS	1
Undare, SS	1
Valekar, NJ	1
Patravale, AA	1
Jamale, DK	1
Vibhute, SS	1
Walekar, LS	1
Kolekar, GB	1
Deshmukh, MB	1
Anbhule, PV	1
Abou-Zeid, LA	1
Ayyad, RR	1
Sun, J	1
Wang, S	1
Sheng, GH	1
Lian, ZM	1
Liu, HY	1
Zhu, HL	1
Banerjee, AG	1
Das, N	1
Shengule, SA	1
Sharma, PA	1
Srivastava, RS	1
Shrivastava, SK	2
Bai, R	1
Shi, Q	1
Liang, Z	1
Yoon, Y	1
Han, Y	1
Feng, A	1
Liu, S	1
Oum, Y	1
Yun, CC	1
Shim, H	1
Rathore, A	1
Sudhakar, R	1
Ahsan, MJ	1
Ali, A	1
Subbarao, N	1
Jadav, SS	1
Yar, MS	1
Li, J	1
Li, D	1
Xu, Y	1
Liu, X	1
Yang, H	1
Wu, L	1
Wang, L	1
Singh, J	1
Saini, V	1
Bansal, R	1
Khatri, CK	1
Indalkar, KS	1
Patil, CR	1
Goyal, SN	1
Chaturbhuj, GU	1
El-Miligy, MMM	1
Hazzaa, AA	1
El-Messmary, H	1
Nassra, RA	3
El-Hawash, SAM	1
Guan, LP	2
Xia, YN	1
Jin, QH	1
Liu, BY	1
Wang, SH	2
Chen, LZ	1
Sun, WW	1
Bo, L	1
Wang, JQ	1
Xiu, C	1
Tang, WJ	1
Shi, JB	1
Zhou, HP	1
Liu, XH	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS[NCT00809354]	Phase 3	2,720 participants (Actual)	Interventional	2009-02-12	Terminated (stopped due to See termination reason in detailed description.)
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients[NCT01781702]	Phase 3	120 participants (Actual)	Interventional	2010-10-31	Completed
The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.[NCT04084912]	Phase 3	86 participants (Anticipated)	Interventional	2020-01-01	Not yet recruiting
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand[NCT05003596]	Phase 2/Phase 3	60 participants (Anticipated)	Interventional	2021-09-01	Not yet recruiting
Non-Inferiority Clinical Trial On The Efficacy And Safety Of Chondroitin Sulfate And Glucosamine Hydrochloride In Combination Versus Celecoxib In Patients With Knee Osteoarthritis[NCT01425853]	Phase 4	606 participants (Actual)	Interventional	2011-09-30	Completed
Cytokine Responses to Acute Inflammation in the Oral Surgery Model[NCT00006175]		160 participants	Observational	2000-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

Intervention	change in percent impairment (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-11.90
Tanezumab 10 mg (Naproxen Exposure)	-11.68
Tanezumab 5 mg + Naproxen 500 mg	-5.51
Tanezumab 10 mg + Naproxen 500 mg	-13.00
Naproxen 500 mg	-7.35
Tanezumab 5 mg (Celecoxib Exposure)	-17.81
Tanezumab 10 mg (Celecoxib Exposure)	-13.01
Tanezumab 5 mg + Celecoxib 100 mg	-9.33
Tanezumab 10 mg + Celecoxib 100 mg	-9.63
Celecoxib 100 mg	-5.81

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

Intervention	change in percent work time missed (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-0.88
Tanezumab 10 mg (Naproxen Exposure)	0.04
Tanezumab 5 mg + Naproxen 500 mg	0.63
Tanezumab 10 mg + Naproxen 500 mg	-0.77
Naproxen 500 mg	1.11
Tanezumab 5 mg (Celecoxib Exposure)	-2.85
Tanezumab 10 mg (Celecoxib Exposure)	-0.42
Tanezumab 5 mg + Celecoxib 100 mg	1.51
Tanezumab 10 mg + Celecoxib 100 mg	-1.64
Celecoxib 100 mg	-0.61

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF

Intervention	change in percent activity impairment (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-12.30
Tanezumab 10 mg (Naproxen Exposure)	-15.51
Tanezumab 5 mg + Naproxen 500 mg	-13.55
Tanezumab 10 mg + Naproxen 500 mg	-14.96
Naproxen 500 mg	-10.00
Tanezumab 5 mg (Celecoxib Exposure)	-17.24
Tanezumab 10 mg (Celecoxib Exposure)	-17.84
Tanezumab 5 mg + Celecoxib 100 mg	-18.04
Tanezumab 10 mg + Celecoxib 100 mg	-17.31
Celecoxib 100 mg	-11.90

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24

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

Number of Participants With Positive Urine or Serum Pregnancy Test

Intervention	change in percent work impairment (Mean)
Tanezumab 5 mg (Naproxen Exposure)	-5.40
Tanezumab 10 mg (Naproxen Exposure)	-1.46
Tanezumab 5 mg + Naproxen 500 mg	-0.75
Tanezumab 10 mg + Naproxen 500 mg	-1.35
Naproxen 500 mg	2.09
Tanezumab 5 mg (Celecoxib Exposure)	-10.17
Tanezumab 10 mg (Celecoxib Exposure)	-0.22
Tanezumab 5 mg + Celecoxib 100 mg	1.25
Tanezumab 10 mg + Celecoxib 100 mg	-4.30
Celecoxib 100 mg	-2.29

Intervention	Participants (Count of Participants)
Tanezumab 5 mg (Naproxen Exposure)	23
Tanezumab 10 mg (Naproxen Exposure)	23
Tanezumab 5 mg + Naproxen 500 mg	22
Tanezumab 10 mg + Naproxen 500 mg	15
Naproxen 500 mg	40
Tanezumab 5 mg (Celecoxib Exposure)	19
Tanezumab 10 mg (Celecoxib Exposure)	21
Tanezumab 5 mg + Celecoxib 100 mg	15
Tanezumab 10 mg + Celecoxib 100 mg	18
Celecoxib 100 mg	38

Female participants, who reported positive in urine or serum pregnancy test were reported. (NCT00809354)
Timeframe: Baseline up to Week 56

Time to Discontinuation Due to Lack of Efficacy

Intervention	Participants (Count of Participants)
Tanezumab 5 mg (Naproxen Exposure)	0
Tanezumab 10 mg (Naproxen Exposure)	1
Tanezumab 5 mg + Naproxen 500 mg	0
Tanezumab 10 mg + Naproxen 500 mg	0
Naproxen 500 mg	0
Tanezumab 5 mg (Celecoxib Exposure)	0
Tanezumab 10 mg (Celecoxib Exposure)	0
Tanezumab 5 mg + Celecoxib 100 mg	0
Tanezumab 10 mg + Celecoxib 100 mg	0
Celecoxib 100 mg	0

Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy. (NCT00809354)
Timeframe: Baseline up to Week 56

Amount of Rescue Medication Used

Intervention	days (Mean)
Tanezumab 5 mg (Naproxen Exposure)	319.87
Tanezumab 10 mg (Naproxen Exposure)	331.69
Tanezumab 5 mg + Naproxen 500 mg	394.80
Tanezumab 10 mg + Naproxen 500 mg	271.89
Naproxen 500 mg	306.11
Tanezumab 5 mg (Celecoxib Exposure)	329.79
Tanezumab 10 mg (Celecoxib Exposure)	314.16
Tanezumab 5 mg + Celecoxib 100 mg	334.84
Tanezumab 10 mg + Celecoxib 100 mg	324.25
Celecoxib 100 mg	303.08

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized. (NCT00809354)
Timeframe: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48, and 49-56

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	milligram (mg) (Mean)
	Weeks 1-2	Weeks 3-4	Weeks 5-8	Weeks 9-12	Weeks 13-16	Weeks 17-24	Weeks 25-32	Weeks 33-40	Weeks 41-48	Weeks 49-56
Celecoxib 100 mg	3455.85	3281.23	3182.45	3067.56	3269.78	2816.00	3126.26	3032.17	3101.63	3035.33
Naproxen 500 mg	3543.99	3415.52	2991.01	2919.20	2920.39	2759.90	2792.04	2755.66	2746.29	3106.46
Tanezumab 10 mg (Celecoxib Exposure)	3834.79	3769.17	2969.34	3008.85	2938.95	2725.86	2927.44	2976.37	3033.87	2770.28
Tanezumab 10 mg (Naproxen Exposure)	3365.46	3582.77	2875.55	2955.84	2912.14	2778.55	2824.83	2900.69	2906.70	2910.73
Tanezumab 10 mg + Celecoxib 100 mg	3250.69	3011.67	2223.15	2266.13	2486.23	2370.30	2723.26	2682.35	2618.83	2842.74
Tanezumab 10 mg + Naproxen 500 mg	3524.27	3066.65	2396.99	2415.93	2551.21	2261.93	2289.28	2361.40	2373.66	2545.36
Tanezumab 5 mg (Celecoxib Exposure)	3132.30	3255.16	2571.99	2380.78	2450.55	2261.84	2383.27	2449.87	2521.27	2840.21
Tanezumab 5 mg (Naproxen Exposure)	3144.66	3411.93	2846.58	2863.10	2993.63	2733.43	2823.39	2810.18	2927.31	2979.89
Tanezumab 5 mg + Celecoxib 100 mg	2910.68	2672.18	2140.44	2166.23	2244.74	2235.23	2432.81	2428.51	2408.58	2511.61
Tanezumab 5 mg + Naproxen 500 mg	2739.96	2660.11	2131.45	2291.41	2562.94	2525.71	2548.20	2608.91	2673.48	2938.47

The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status. (NCT00809354)
Timeframe: Baseline, Weeks 12 and 24

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	General health at baseline	Physical function at baseline	Role physical at baseline	Bodily pain at baseline	Vitality at baseline	Social function at baseline	Role emotional at baseline	Mental health at baseline	Change at Week 12: General health	Change at Week 12: Physical function	Change at Week 12: Role physical	Change at Week 12: Bodily pain	Change at Week 12: Vitality	Change at Week 12: Social function	Change at Week 12: Role emotional	Change at Week 12: Mental health	Change at Week 24: General health	Change at Week 24: Physical function	Change at Week 24: Role physical	Change at Week 24: Bodily pain	Change at Week 24: Vitality	Change at Week 24: Social function	Change at Week 24: Role emotional	Change at Week 24: Mental health
Celecoxib 100 mg	55.69	32.81	43.55	36.96	51.52	64.31	63.39	69.08	4.68	7.48	7.58	8.01	2.43	3.33	4.13	0.67	3.90	8.00	7.70	8.72	2.87	4.07	2.23	0.00
Naproxen 500 mg	57.61	35.46	46.09	35.72	50.78	62.23	68.45	70.34	3.88	5.76	6.70	7.83	3.97	7.41	0.92	1.57	2.90	5.75	7.28	8.87	1.90	6.16	2.92	1.52
Tanezumab 10 mg (Celecoxib Exposure)	56.93	34.79	42.86	35.57	51.52	63.68	64.07	71.08	3.37	9.05	10.04	12.50	4.35	5.36	3.64	0.36	4.25	9.33	10.46	10.22	4.00	6.25	4.95	0.42
Tanezumab 10 mg (Naproxen Exposure)	57.41	32.74	43.88	35.90	51.28	65.97	66.35	70.23	4.66	12.88	12.59	13.08	5.14	5.25	5.50	3.28	2.95	9.50	7.42	9.63	3.93	3.21	0.58	1.48
Tanezumab 10 mg + Celecoxib 100 mg	58.27	35.11	45.60	36.47	53.63	66.90	65.05	71.07	5.66	12.99	13.71	16.83	6.47	8.94	6.82	3.17	4.28	12.00	10.50	13.47	4.15	5.78	3.39	0.87
Tanezumab 10 mg + Naproxen 500 mg	57.92	33.88	44.69	37.67	52.57	64.47	67.92	70.40	5.14	14.38	15.39	16.53	6.12	7.76	4.47	3.04	4.54	12.30	11.54	13.04	4.52	6.14	2.16	2.26
Tanezumab 5 mg (Celecoxib Exposure)	56.20	33.43	42.59	34.14	50.52	63.19	63.02	70.95	5.46	12.70	13.36	16.74	7.41	10.19	8.23	3.00	4.07	10.40	10.24	10.69	5.71	7.63	5.81	1.33
Tanezumab 5 mg (Naproxen Exposure)	56.76	32.82	43.29	36.91	51.58	65.63	66.08	70.42	3.29	11.68	9.73	11.44	5.68	5.90	5.08	2.85	3.08	10.52	9.40	10.73	5.94	4.01	3.35	2.31
Tanezumab 5 mg + Celecoxib 100 mg	56.34	33.41	42.65	34.11	51.45	64.51	62.68	68.25	5.18	13.84	15.51	17.15	6.32	8.14	8.63	3.78	3.46	11.83	10.93	14.02	2.84	7.06	6.47	0.94
Tanezumab 5 mg + Naproxen 500 mg	60.66	34.79	44.58	37.80	53.73	68.13	67.74	72.20	3.66	14.23	13.13	14.41	6.47	5.36	4.91	0.96	3.77	9.83	9.58	10.41	3.77	3.21	2.38	0.95

Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56

Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Change at Week 12: General health	Change at Week 12: Physical function	Change at Week 12: Role physical	Change at Week 12: Bodily pain	Change at Week 12: Vitality	Change at Week 12: Social function	Change at Week 12: Role emotional	Change at Week 12: Mental health	Change at Week 24: General health	Change at Week 24: Physical function	Change at Week 24: Role physical	Change at Week 24: Bodily pain	Change at Week 24: Vitality	Change at Week 24: Social function	Change at Week 24: Role emotional	Change at Week 24: Mental health	Change at Week 40: General health	Change at Week 40: Physical function	Change at Week 40: Role physical	Change at Week 40: Bodily pain	Change at Week 40: Vitality	Social function at Week 40	Change at Week 40: Role emotional	Change at Week 40: Mental health	Change at Week 56: General health	Change at Week 56: Physical function	Change at Week 56: Role physical	Change at Week 56: Bodily pain	Change at Week 56: Vitality	Change at Week 56: Social function	Change at Week 56: Role emotional	Change at Week 56: Mental health
Celecoxib 100 mg	4.68	7.48	7.58	8.01	2.43	3.33	4.13	0.67	4.45	8.41	8.27	9.09	2.40	3.97	2.76	0.20	4.09	7.24	7.58	8.17	2.67	2.65	3.41	0.82	3.99	6.91	7.28	8.69	2.08	2.84	3.51	0.96
Naproxen 500 mg	3.88	35.46	46.09	7.83	3.97	7.41	0.92	1.57	3.77	6.43	7.97	9.19	2.57	7.32	2.59	1.38	3.47	6.23	7.01	7.11	2.32	7.23	1.61	0.49	3.33	5.95	7.19	7.47	2.68	7.23	1.67	0.41
Tanezumab 10 mg (Celecoxib Exposure)	3.37	9.05	10.04	12.50	4.35	5.36	3.64	0.36	4.59	10.00	11.84	12.00	4.87	7.09	5.09	0.30	3.31	8.74	10.53	10.87	4.40	6.20	2.99	0.26	3.41	8.25	10.46	10.32	4.47	6.10	3.25	0.18
Tanezumab 10 mg (Naproxen Exposure)	4.66	32.74	43.88	13.08	5.14	5.25	5.50	3.28	3.18	11.35	9.53	11.63	4.34	3.56	1.56	1.51	2.45	10.23	8.79	10.73	3.30	3.21	1.91	1.41	2.31	9.19	8.01	10.21	3.10	2.95	1.53	1.42
Tanezumab 10 mg + Celecoxib 100 mg	5.66	12.99	13.71	16.83	6.47	8.94	6.82	3.17	4.62	12.91	12.45	14.83	4.50	6.57	4.58	1.06	3.45	11.78	12.13	13.28	4.17	6.23	5.47	1.11	3.75	11.48	12.06	13.36	4.15	6.67	5.07	1.25
Tanezumab 10 mg + Naproxen 500 mg	5.14	33.88	44.69	16.53	6.12	7.76	4.47	3.04	4.66	13.73	13.03	14.73	5.48	7.11	3.10	2.65	3.87	11.96	10.00	12.42	4.45	4.56	0.76	1.76	3.69	11.15	9.01	11.92	3.82	3.99	0.47	1.53
Tanezumab 5 mg (Celecoxib Exposure)	5.46	12.70	13.36	16.74	7.41	10.19	8.23	3.00	4.42	11.23	11.74	12.24	5.95	8.51	6.73	1.37	3.74	9.91	11.32	11.45	5.29	7.43	6.69	1.22	3.75	10.12	11.20	11.52	4.82	7.73	6.10	1.10
Tanezumab 5 mg (Naproxen Exposure)	3.29	32.82	43.29	11.44	5.68	5.90	5.08	2.85	3.95	11.70	11.14	12.95	7.17	5.19	5.22	2.90	3.40	10.00	9.64	11.27	5.92	4.05	4.08	2.16	3.12	9.95	9.13	11.58	5.70	4.53	4.23	2.28
Tanezumab 5 mg + Celecoxib 100 mg	5.18	13.84	15.51	17.15	6.32	8.14	8.63	3.78	3.72	12.92	11.84	15.22	3.09	7.35	6.83	1.39	3.20	12.32	12.38	13.96	3.24	6.03	5.98	1.22	3.10	12.07	11.96	13.53	3.41	6.23	6.11	1.47
Tanezumab 5 mg + Naproxen 500 mg	3.66	34.79	44.58	14.41	6.47	5.36	4.91	0.96	3.93	10.85	10.71	11.75	4.42	2.81	3.63	0.45	2.83	10.49	10.98	10.79	4.42	2.19	2.80	0.25	2.59	10.19	10.49	10.38	4.17	1.65	1.99	-0.11

Intervention	millimeter (mm) (Mean)
	Baseline	Change at Week 56
NSAID	3.022	-0.041
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	2.850	-0.213
Tanezumab 10 mg + NSAID	2.982	-0.172
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	2.769	-0.189
Tanezumab 5 mg + NSAID	3.005	-0.162

Intervention	millimeter (Mean)
	Baseline	Change at Week 56
NSAID	2.724	-0.028
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	2.372	-0.137
Tanezumab 10 mg + NSAID	2.195	-0.136
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	2.447	-0.075
Tanezumab 5 mg + NSAID	2.346	-0.240

The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	2.18	-0.34	-0.13	-0.22	-0.28	-0.34	-0.36	-0.34	-0.39	-0.36	-0.41
Naproxen 500 mg	2.31	-0.11	-0.08	-0.12	-0.26	-0.18	-0.31	-0.32	-0.40	-0.43	-0.46
Tanezumab 10 mg (Celecoxib Exposure)	2.09	-0.29	-0.30	-0.35	-0.50	-0.56	-0.38	-0.56	-0.50	-0.52	-0.44
Tanezumab 10 mg (Naproxen Exposure)	2.56	-0.25	-0.46	-0.46	-0.43	-0.48	-0.57	-0.57	-0.55	-0.58	-0.53
Tanezumab 10 mg + Celecoxib 100 mg	2.08	-0.33	-0.40	-0.33	-0.26	-0.30	-0.22	-0.26	-0.33	-0.34	-0.43
Tanezumab 10 mg + Naproxen 500 mg	2.54	-0.16	-0.33	-0.38	-0.65	-0.58	-0.60	-0.53	-0.49	-0.65	-0.58
Tanezumab 5 mg (Celecoxib Exposure)	2.04	-0.11	-0.21	-0.32	-0.53	-0.43	-0.35	-0.44	-0.41	-0.44	-0.41
Tanezumab 5 mg (Naproxen Exposure)	2.64	-0.20	-0.37	-0.49	-0.52	-0.77	-0.73	-0.56	-0.50	-0.43	-0.48
Tanezumab 5 mg + Celecoxib 100 mg	2.24	-0.14	-0.40	-0.53	-0.69	-0.79	-0.90	-0.93	-0.50	-0.87	-0.89
Tanezumab 5 mg + Naproxen 500 mg	1.93	-0.30	-0.20	-0.25	-0.38	-0.35	-0.44	-0.52	-0.32	-0.38	-0.45

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	2.18	-0.34	-0.11	-0.35	-0.44	-0.50	-0.50	-0.63	-0.73	-0.69	-0.54
Naproxen 500 mg	2.31	-0.11	-0.11	-0.12	-0.29	-0.26	-0.43	-0.39	-0.42	-0.48	-0.36
Tanezumab 10 mg (Celecoxib Exposure)	2.09	-0.29	-0.30	-0.36	-0.56	-0.64	-0.46	-0.71	-0.58	-0.65	-0.42
Tanezumab 10 mg (Naproxen Exposure)	2.56	-0.25	-0.42	-0.42	-0.38	-0.41	-0.50	-0.53	-0.47	-0.81	-0.70
Tanezumab 10 mg + Celecoxib 100 mg	2.08	-0.33	-0.39	-0.22	-0.38	-0.48	-0.47	-0.49	-0.71	-0.50	-0.38
Tanezumab 10 mg + Naproxen 500 mg	2.54	-0.16	-0.29	-0.30	-0.62	-0.58	-0.57	-0.47	-0.38	-0.80	-0.10
Tanezumab 5 mg (Celecoxib Exposure)	2.04	-0.11	-0.20	-0.32	-0.52	-0.41	-0.37	-0.50	-0.42	-0.56	-0.53
Tanezumab 5 mg (Naproxen Exposure)	2.64	-0.20	-0.40	-0.47	-0.53	-0.81	-0.78	-0.56	-0.61	-0.55	-0.30
Tanezumab 5 mg + Celecoxib 100 mg	2.24	-0.14	-0.41	-0.55	-0.72	-0.83	-0.99	-1.05	-1.06	-1.07	-1.01
Tanezumab 5 mg + Naproxen 500 mg	1.93	-0.30	-0.18	-0.22	-0.34	-0.38	-0.57	-0.78	-0.63	-0.67	-0.83

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

Intervention	change in percent impairment (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-5.81	-5.93
Naproxen 500 mg	-7.35	-5.31
Tanezumab 10 mg (Celecoxib Exposure)	-13.01	-12.88
Tanezumab 10 mg (Naproxen Exposure)	-11.68	-11.88
Tanezumab 10 mg + Celecoxib 100 mg	-9.63	-4.25
Tanezumab 10 mg + Naproxen 500 mg	-13.00	-11.33
Tanezumab 5 mg (Celecoxib Exposure)	-17.81	-16.99
Tanezumab 5 mg (Naproxen Exposure)	-11.90	-10.30
Tanezumab 5 mg + Celecoxib 100 mg	-9.33	-8.09
Tanezumab 5 mg + Naproxen 500 mg	-5.51	-4.08

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Week 24 and 56

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16

Intervention	change in percent work time missed (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-0.61	-0.82
Naproxen 500 mg	1.11	2.26
Tanezumab 10 mg (Celecoxib Exposure)	-0.42	-0.46
Tanezumab 10 mg (Naproxen Exposure)	0.04	-0.39
Tanezumab 10 mg + Celecoxib 100 mg	-1.64	-1.64
Tanezumab 10 mg + Naproxen 500 mg	0.77	-0.41
Tanezumab 5 mg (Celecoxib Exposure)	-2.85	-3.06
Tanezumab 5 mg (Naproxen Exposure)	-0.88	-1.10
Tanezumab 5 mg + Celecoxib 100 mg	1.51	1.51
Tanezumab 5 mg + Naproxen 500 mg	0.63	1.08

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 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 scores indicating worse condition." (NCT00809354)
Timeframe: Baseline, Week 16

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 16
Celecoxib 100 mg	3.37	-0.51
Naproxen 500 mg	3.38	-0.53
Tanezumab 10 mg (Celecoxib Exposure)	3.48	-0.64
Tanezumab 10 mg (Naproxen Exposure)	3.41	-0.63
Tanezumab 10 mg + Celecoxib 100 mg	3.41	-0.75
Tanezumab 10 mg + Naproxen 500 mg	3.39	-0.72
Tanezumab 5 mg (Celecoxib Exposure)	3.44	-0.69
Tanezumab 5 mg (Naproxen Exposure)	3.39	-0.54
Tanezumab 5 mg + Celecoxib 100 mg	3.45	-0.76
Tanezumab 5 mg + Naproxen 500 mg	3.39	-0.61

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24
Celecoxib 100 mg	-0.37	-0.49	-0.51	-0.54	-0.55
Naproxen 500 mg	-0.39	-0.43	-0.45	-0.46	-0.49
Tanezumab 10 mg (Celecoxib Exposure)	-0.33	-0.75	-0.69	-0.75	-0.59
Tanezumab 10 mg (Naproxen Exposure)	-0.42	-0.69	-0.70	-0.68	-0.54
Tanezumab 10 mg + Celecoxib 100 mg	-0.26	-0.75	-0.79	-0.83	-0.74
Tanezumab 10 mg + Naproxen 500 mg	-0.40	-0.68	-0.82	-0.84	-0.60
Tanezumab 5 mg (Celecoxib Exposure)	-0.46	-0.68	-0.63	-0.71	-0.57
Tanezumab 5 mg (Naproxen Exposure)	-0.45	-0.60	-0.58	-0.60	-0.58
Tanezumab 5 mg + Celecoxib 100 mg	-0.45	-0.80	-0.81	-0.77	-0.67
Tanezumab 5 mg + Naproxen 500 mg	-0.50	-0.74	-0.69	-0.69	-0.50

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.37	-0.51	-0.54	-0.57	-0.54	-0.59	-0.57	-0.57	-0.54	-0.54
Naproxen 500 mg	-0.39	-0.44	-0.48	-0.49	-0.57	-0.57	-0.57	-0.50	-0.49	-0.47
Tanezumab 10 mg (Celecoxib Exposure)	-0.33	-0.76	-0.74	-0.84	-0.73	-0.69	-0.66	-0.67	-0.62	-0.56
Tanezumab 10 mg (Naproxen Exposure)	-0.42	-0.72	-0.77	-0.79	-0.74	-0.68	-0.66	-0.60	-0.60	-0.55
Tanezumab 10 mg + Celecoxib 100 mg	-0.26	-0.74	-0.81	-0.86	-0.77	-0.77	-0.66	-0.66	-0.59	-0.58
Tanezumab 10 mg + Naproxen 500 mg	-0.40	-0.72	-0.86	-0.91	-0.79	-0.69	-0.68	-0.56	-0.48	-0.46
Tanezumab 5 mg (Celecoxib Exposure)	-0.46	-0.70	-0.68	-0.77	-0.76	-0.66	-0.63	-0.61	-0.53	-0.51
Tanezumab 5 mg (Naproxen Exposure)	-0.45	-0.60	-0.63	-0.67	-0.63	-0.69	-0.60	-0.58	-0.53	-0.53
Tanezumab 5 mg + Celecoxib 100 mg	-0.45	-0.78	-0.81	-0.81	-0.80	-0.73	-0.73	-0.59	-0.63	-0.61
Tanezumab 5 mg + Naproxen 500 mg	-0.50	-0.76	-0.75	-0.78	-0.72	-0.64	-0.60	-0.53	-0.51	-0.49

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Weeks 24, and 56

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF

Intervention	change in percent activity impairment (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-11.90	-11.19
Naproxen 500 mg	-10.00	-9.32
Tanezumab 10 mg (Celecoxib Exposure)	-17.84	-15.76
Tanezumab 10 mg (Naproxen Exposure)	-15.51	-14.77
Tanezumab 10 mg + Celecoxib 100 mg	-17.31	-15.86
Tanezumab 10 mg + Naproxen 500 mg	-14.96	-13.20
Tanezumab 5 mg (Celecoxib Exposure)	-17.24	-15.39
Tanezumab 5 mg (Naproxen Exposure)	-12.30	-12.12
Tanezumab 5 mg + Celecoxib 100 mg	-18.04	-18.04
Tanezumab 5 mg + Naproxen 500 mg	-13.55	-12.19

The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity. (NCT00809354)
Timeframe: Baseline, Weeks 24 and 56

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16

Intervention	change in percent work impairment (Mean)
	Change at Week 24	Change at Week 56
Celecoxib 100 mg	-2.29	-3.02
Naproxen 500 mg	2.09	4.11
Tanezumab 10 mg (Celecoxib Exposure)	-0.22	-1.01
Tanezumab 10 mg (Naproxen Exposure)	-1.46	-1.88
Tanezumab 10 mg + Celecoxib 100 mg	-4.30	-4.30
Tanezumab 10 mg + Naproxen 500 mg	-1.35	-0.85
Tanezumab 5 mg (Celecoxib Exposure)	-10.17	-10.32
Tanezumab 5 mg (Naproxen Exposure)	-5.40	-6.08
Tanezumab 5 mg + Celecoxib 100 mg	1.25	1.25
Tanezumab 5 mg + Naproxen 500 mg	-0.75	0.77

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00809354)
Timeframe: Baseline, Week 16

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 16
Celecoxib 100 mg	6.29	-1.48
Naproxen 500 mg	6.32	-1.34
Tanezumab 10 mg (Celecoxib Exposure)	6.44	-2.12
Tanezumab 10 mg (Naproxen Exposure)	6.50	-1.97
Tanezumab 10 mg + Celecoxib 100 mg	6.27	-2.41
Tanezumab 10 mg + Naproxen 500 mg	6.33	-2.26
Tanezumab 5 mg (Celecoxib Exposure)	6.49	-2.11
Tanezumab 5 mg (Naproxen Exposure)	6.39	-1.80
Tanezumab 5 mg + Celecoxib 100 mg	6.41	-2.28
Tanezumab 5 mg + Naproxen 500 mg	6.52	-2.09

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24
Celecoxib 100 mg	-0.93	-1.09	-1.15	-1.40	-1.63
Naproxen 500 mg	-0.90	-1.14	-1.13	-1.23	-1.32
Tanezumab 10 mg (Celecoxib Exposure)	-0.74	-1.78	-2.01	-2.20	-2.04
Tanezumab 10 mg (Naproxen Exposure)	-1.00	-1.87	-2.08	-1.95	-1.82
Tanezumab 10 mg + Celecoxib 100 mg	-0.86	-2.03	-2.36	-2.47	-2.29
Tanezumab 10 mg + Naproxen 500 mg	-0.89	-1.98	-2.18	-2.34	-1.95
Tanezumab 5 mg (Celecoxib Exposure)	-1.01	-1.69	-1.83	-2.15	-1.81
Tanezumab 5 mg (Naproxen Exposure)	-0.96	-1.68	-1.68	-1.86	-1.65
Tanezumab 5 mg + Celecoxib 100 mg	-1.08	-2.07	-2.23	-2.28	-2.10
Tanezumab 5 mg + Naproxen 500 mg	-1.27	-2.09	-2.10	-2.26	-1.83

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.93	-1.10	-1.17	-1.40	-1.50	-1.69	-1.62	-1.54	-1.45	-1.48
Naproxen 500 mg	-0.90	-1.15	-1.17	-1.32	-1.44	-1.54	-1.62	-1.44	-1.40	-1.36
Tanezumab 10 mg (Celecoxib Exposure)	-0.74	-1.73	-2.07	-2.32	-2.23	-2.25	-2.14	-1.99	-1.93	-1.72
Tanezumab 10 mg (Naproxen Exposure)	-1.00	-1.92	-2.20	-2.14	-2.19	-2.12	-2.08	-1.94	-1.93	-1.86
Tanezumab 10 mg + Celecoxib 100 mg	-0.86	-2.00	-2.34	-2.51	-2.46	-2.39	-2.14	-2.18	-2.03	-2.02
Tanezumab 10 mg + Naproxen 500 mg	-0.89	-2.05	-2.36	-2.56	-2.56	-2.33	-2.33	-2.12	-2.08	-2.03
Tanezumab 5 mg (Celecoxib Exposure)	-1.01	-1.76	-1.92	-2.29	-2.27	-2.05	-2.02	-1.98	-1.86	-1.83
Tanezumab 5 mg (Naproxen Exposure)	-0.96	-1.66	-1.76	-2.04	-2.00	-2.04	-1.94	-1.90	-1.86	-1.84
Tanezumab 5 mg + Celecoxib 100 mg	-1.08	-2.04	-2.22	-2.32	-2.34	-2.21	-2.20	-1.98	-2.05	-1.92
Tanezumab 5 mg + Naproxen 500 mg	-1.27	-2.12	-2.26	-2.45	-2.36	-2.20	-2.10	-1.88	-1.86	-1.84

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00809354)
Timeframe: Baseline, Week 16

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 16
Celecoxib 100 mg	6.47	-1.42
Naproxen 500 mg	6.32	-1.28
Tanezumab 10 mg (Celecoxib Exposure)	6.58	-2.09
Tanezumab 10 mg (Naproxen Exposure)	6.47	-1.84
Tanezumab 10 mg + Celecoxib 100 mg	6.39	-2.41
Tanezumab 10 mg + Naproxen 500 mg	6.39	-2.18
Tanezumab 5 mg (Celecoxib Exposure)	6.67	-2.13
Tanezumab 5 mg (Naproxen Exposure)	6.46	-1.80
Tanezumab 5 mg + Celecoxib 100 mg	6.57	-2.27
Tanezumab 5 mg + Naproxen 500 mg	6.57	-2.12

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, and 24

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24
Celecoxib 100 mg	-0.90	-1.07	-1.13	-1.36	-1.57
Naproxen 500 mg	-0.90	-1.01	-1.07	-1.23	-1.30
Tanezumab 10 mg (Celecoxib Exposure)	-0.95	-1.78	-2.00	-2.13	-2.00
Tanezumab 10 mg (Naproxen Exposure)	-1.13	-1.79	-2.01	-1.87	-1.76
Tanezumab 10 mg + Celecoxib 100 mg	-1.02	-2.00	-2.30	-2.46	-2.33
Tanezumab 10 mg + Naproxen 500 mg	-1.06	-2.00	-2.15	-2.29	-1.96
Tanezumab 5 mg (Celecoxib Exposure)	-1.18	-1.73	-1.89	-2.23	-1.92
Tanezumab 5 mg (Naproxen Exposure)	-1.10	-1.71	-1.62	-1.85	-1.66
Tanezumab 5 mg + Celecoxib 100 mg	-1.21	-1.97	-2.15	-2.34	-2.08
Tanezumab 5 mg + Naproxen 500 mg	-1.44	-2.04	-2.05	-2.18	-1.76

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48, and 56

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	6.47	-0.90	-1.09	-1.14	-1.36	-1.62	-1.57	-1.52	-1.44	-1.45
Naproxen 500 mg	6.32	-0.90	-1.04	-1.11	-1.31	-1.49	-1.53	-1.44	-1.39	-1.34
Tanezumab 10 mg (Celecoxib Exposure)	6.58	-0.95	-1.75	-2.08	-2.31	-2.24	-2.16	-2.04	-1.97	-1.78
Tanezumab 10 mg (Naproxen Exposure)	6.47	-1.13	-1.84	-2.13	-2.08	-2.08	-2.01	-1.90	-1.93	-1.84
Tanezumab 10 mg + Celecoxib 100 mg	6.39	-1.02	-1.91	-2.29	-2.50	-2.44	-2.20	-2.18	-2.05	-2.05
Tanezumab 10 mg + Naproxen 500 mg	6.39	-1.06	-2.06	-2.33	-2.50	-2.29	-2.25	-2.04	-1.96	-1.87
Tanezumab 5 mg (Celecoxib Exposure)	6.67	-1.18	-1.81	-2.02	-2.35	-2.14	-2.08	-2.06	-1.94	-1.90
Tanezumab 5 mg (Naproxen Exposure)	6.46	-1.10	-1.70	-1.69	-2.02	-2.04	-1.87	-1.87	-1.82	-1.82
Tanezumab 5 mg + Celecoxib 100 mg	6.57	-1.21	-1.95	-2.13	-2.37	-2.20	-2.22	-2.00	-2.03	-1.92
Tanezumab 5 mg + Naproxen 500 mg	6.57	-1.44	-2.08	-2.23	-2.40	-2.22	-2.15	-1.95	-1.90	-1.88

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	6.38	-0.89	-1.06	-1.14	-1.33	-1.42	-1.53
Naproxen 500 mg	6.41	-0.93	-1.13	-1.15	-1.27	-1.34	-1.34
Tanezumab 10 mg (Celecoxib Exposure)	6.54	-0.98	-1.87	-2.08	-2.24	-2.17	-2.05
Tanezumab 10 mg (Naproxen Exposure)	6.54	-1.15	-1.92	-2.11	-1.98	-1.98	-1.84
Tanezumab 10 mg + Celecoxib 100 mg	6.33	-0.99	-2.10	-2.42	-2.55	-2.48	-2.33
Tanezumab 10 mg + Naproxen 500 mg	6.38	-1.04	-2.06	-2.22	-2.35	-2.28	-1.99
Tanezumab 5 mg (Celecoxib Exposure)	6.60	-1.17	-1.79	-1.93	-2.26	-2.13	-1.90
Tanezumab 5 mg (Naproxen Exposure)	6.45	-1.13	-1.74	-1.68	-1.90	-1.84	-1.70
Tanezumab 5 mg + Celecoxib 100 mg	6.48	-1.23	-2.08	-2.23	-2.35	-2.30	-2.09
Tanezumab 5 mg + Naproxen 500 mg	6.60	-1.46	-2.15	-2.14	-2.31	-2.17	-1.87

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.89	-1.07	-1.16	-1.33	-1.45	-1.58	-1.53	-1.49	-1.40	-1.42
Naproxen 500 mg	-0.93	-1.15	-1.20	-1.37	-1.45	-1.58	-1.64	-1.51	-1.48	-1.43
Tanezumab 10 mg (Celecoxib Exposure)	-0.98	-1.84	-2.15	-2.37	-2.29	-2.28	-2.20	-2.07	-2.00	-1.81
Tanezumab 10 mg (Naproxen Exposure)	-1.15	-1.98	-2.25	-2.20	-2.24	-2.18	-2.10	-1.99	-2.02	-1.93
Tanezumab 10 mg + Celecoxib 100 mg	-0.99	-2.07	-2.41	-2.59	-2.53	-2.46	-2.22	-2.20	-2.08	-2.07
Tanezumab 10 mg + Naproxen 500 mg	-1.04	-2.13	-2.41	-2.58	-2.57	-2.36	-2.35	-2.14	-2.08	-1.99
Tanezumab 5 mg (Celecoxib Exposure)	-1.17	-1.87	-2.03	-2.40	-2.31	-2.16	-2.10	-2.05	-1.94	-1.90
Tanezumab 5 mg (Naproxen Exposure)	-1.13	-1.74	-1.78	-2.08	-2.05	-2.10	-1.96	-1.94	-1.91	-1.89
Tanezumab 5 mg + Celecoxib 100 mg	-1.23	-2.06	-2.22	-2.40	-2.36	-2.22	-2.30	-2.05	-2.10	-1.98
Tanezumab 5 mg + Naproxen 500 mg	-1.46	-2.18	-2.31	-2.52	-2.48	-2.30	-2.20	-1.99	-1.96	-1.93

"WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: How much pain have you had when going up or down the stairs? Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	7.52	-1.05	-1.29	-1.33	-1.50	-1.66	-1.73
Naproxen 500 mg	7.40	-0.94	-1.22	-1.34	-1.37	-1.53	-1.51
Tanezumab 10 mg (Celecoxib Exposure)	7.59	-1.23	-2.07	-2.26	-2.52	-2.35	-2.28
Tanezumab 10 mg (Naproxen Exposure)	7.68	-1.34	-2.13	-2.32	-2.16	-2.20	-2.01
Tanezumab 10 mg + Celecoxib 100 mg	7.54	-1.37	-2.36	-2.65	-2.79	-2.76	-2.63
Tanezumab 10 mg + Naproxen 500 mg	7.50	-1.36	-2.32	-2.53	-2.67	-2.53	-2.22
Tanezumab 5 mg (Celecoxib Exposure)	7.80	-1.41	-2.05	-2.17	-2.45	-2.39	-2.02
Tanezumab 5 mg (Naproxen Exposure)	7.55	-1.29	-1.78	-1.79	-2.09	-1.99	-1.82
Tanezumab 5 mg + Celecoxib 100 mg	7.55	-1.45	-2.43	-2.48	-2.48	-2.52	-2.47
Tanezumab 5 mg + Naproxen 500 mg	7.72	-1.67	-2.46	-2.41	-2.49	-2.35	-2.02

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-1.05	-1.30	-1.35	-1.55	-1.75	-1.84	-1.78	-1.76	-1.64	-1.71
Naproxen 500 mg	-0.94	-1.26	-1.35	-1.47	-1.63	-1.74	-1.70	-1.51	-1.48	-1.43
Tanezumab 10 mg (Celecoxib Exposure)	-1.23	-2.05	-2.37	-2.69	-2.53	-2.57	-2.50	-2.28	-2.24	-1.98
Tanezumab 10 mg (Naproxen Exposure)	-1.34	-2.20	-2.48	-2.40	-2.47	-2.38	-2.28	-2.21	-2.17	-2.08
Tanezumab 10 mg + Celecoxib 100 mg	-1.37	-2.37	-2.71	-2.90	-2.89	-2.83	-2.55	-2.47	-2.31	-2.34
Tanezumab 10 mg + Naproxen 500 mg	-1.36	-2.41	-2.75	-2.94	-2.88	-2.66	-2.62	-2.41	-2.29	-2.24
Tanezumab 5 mg (Celecoxib Exposure)	-1.41	-2.14	-2.27	-2.64	-2.62	-2.35	-2.27	-2.31	-2.20	-2.16
Tanezumab 5 mg (Naproxen Exposure)	-1.29	-1.80	-1.90	-2.29	-2.23	-2.26	-2.12	-2.06	-1.99	-2.00
Tanezumab 5 mg + Celecoxib 100 mg	-1.45	-2.43	-2.50	-2.57	-2.59	-2.60	-2.52	-2.26	-2.30	-2.16
Tanezumab 5 mg + Naproxen 500 mg	-1.67	-2.51	-2.62	-2.76	-2.70	-2.48	-2.43	-2.09	-2.10	-2.10

"WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	6.10	-0.86	-0.95	-1.11	-1.35	-1.38	-1.55
Naproxen 500 mg	6.12	-0.80	-1.04	-1.05	-1.10	-1.23	-1.20
Tanezumab 10 mg (Celecoxib Exposure)	6.30	-0.68	-1.64	-1.84	-2.02	-1.91	-1.88
Tanezumab 10 mg (Naproxen Exposure)	6.37	-1.02	-1.88	-1.95	-1.78	-1.77	-1.65
Tanezumab 10 mg + Celecoxib 100 mg	6.14	-0.86	-1.93	-2.26	-2.25	-2.22	-2.06
Tanezumab 10 mg + Naproxen 500 mg	6.13	-0.87	-1.92	-2.09	-2.22	-2.19	-1.83
Tanezumab 5 mg (Celecoxib Exposure)	6.28	-1.04	-1.49	-1.67	-2.04	-1.94	-1.63
Tanezumab 5 mg (Naproxen Exposure)	6.22	-1.05	-1.67	-1.57	-1.74	-1.71	-1.56
Tanezumab 5 mg + Celecoxib 100 mg	6.21	-1.01	-1.88	-2.11	-2.20	-2.08	-1.96
Tanezumab 5 mg + Naproxen 500 mg	6.34	-1.31	-1.98	-1.93	-2.15	-1.95	-1.64

"WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: How much pain have you had when walking on a flat surface?. Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain." (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.86	-0.96	-1.13	-1.36	-1.42	-1.64	-1.56	-1.40	-1.33	-1.36
Naproxen 500 mg	-0.80	-1.04	-1.07	-1.20	-1.33	-1.36	-1.45	-1.23	-1.22	-1.15
Tanezumab 10 mg (Celecoxib Exposure)	-0.68	-1.59	-1.85	-2.08	-1.98	-1.97	-1.80	-1.75	-1.64	-1.42
Tanezumab 10 mg (Naproxen Exposure)	-1.02	-1.92	-2.09	-1.98	-2.00	-1.94	-1.80	-1.78	-1.72	-1.64
Tanezumab 10 mg + Celecoxib 100 mg	-0.86	-1.91	-2.22	-2.27	-2.25	-2.15	-1.89	-1.89	-1.74	-1.72
Tanezumab 10 mg + Naproxen 500 mg	-0.87	-1.99	-2.26	-2.41	-2.44	-2.15	-2.12	-1.77	-1.78	-1.73
Tanezumab 5 mg (Celecoxib Exposure)	-1.04	-1.54	-1.73	-2.11	-2.03	-1.79	-1.78	-1.72	-1.62	-1.61
Tanezumab 5 mg (Naproxen Exposure)	-1.05	-1.65	-1.65	-1.93	-1.93	-1.95	-1.78	-1.69	-1.63	-1.65
Tanezumab 5 mg + Celecoxib 100 mg	-1.01	-1.84	-2.06	-2.20	-2.11	-2.04	-1.96	-1.73	-1.79	-1.67
Tanezumab 5 mg + Naproxen 500 mg	-1.31	-2.01	-2.08	-2.32	-2.20	-1.98	-1.91	-1.69	-1.68	-1.68

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Intervention	units on a scale (Mean)
	Baseline	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24
Celecoxib 100 mg	6.39	-0.82	-1.00	-1.13	-1.23	-1.34	-1.38
Naproxen 500 mg	6.60	-1.02	-1.23	-1.29	-1.40	-1.42	-1.46
Tanezumab 10 mg (Celecoxib Exposure)	6.58	-1.21	-2.05	-2.22	-2.36	-2.28	-2.10
Tanezumab 10 mg (Naproxen Exposure)	6.66	-1.32	-2.10	-2.26	-2.14	-2.15	-1.96
Tanezumab 10 mg + Celecoxib 100 mg	6.33	-1.11	-2.25	-2.60	-2.72	-2.62	-2.39
Tanezumab 10 mg + Naproxen 500 mg	6.42	-1.19	-2.19	-2.31	-2.42	-2.40	-2.04
Tanezumab 5 mg (Celecoxib Exposure)	6.62	-1.35	-1.94	-2.02	-2.38	-2.14	-1.97
Tanezumab 5 mg (Naproxen Exposure)	6.50	-1.35	-1.85	-1.76	-1.98	-1.93	-1.80
Tanezumab 5 mg + Celecoxib 100 mg	6.47	-1.41	-2.15	-2.28	-2.42	-2.35	-2.08
Tanezumab 5 mg + Naproxen 500 mg	6.70	-1.65	-2.31	-2.26	-2.49	-2.31	-1.98

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Number of Participants With Anti-Drug Antibody (ADA) Response

Intervention	units on a scale (Mean)
	Change at Week 2	Change at Week 4	Change at Week 8	Change at Week 12	Change at Week 16	Change at Week 24	Change at Week 32	Change at Week 40	Change at Week 48	Change at Week 56
Celecoxib 100 mg	-0.82	-1.01	-1.15	-1.24	-1.38	-1.43	-1.41	-1.43	-1.34	-1.34
Naproxen 500 mg	-1.02	-1.26	-1.35	-1.52	-1.58	-1.75	-1.80	-1.69	-1.69	-1.63
Tanezumab 10 mg (Celecoxib Exposure)	-1.21	-2.03	-2.30	-2.49	-2.41	-2.37	-2.31	-2.20	-2.10	-1.94
Tanezumab 10 mg (Naproxen Exposure)	-1.32	-2.17	-2.43	-2.39	-2.44	-2.36	-2.23	-2.15	-2.23	-2.10
Tanezumab 10 mg + Celecoxib 100 mg	-1.11	-2.22	-2.58	-2.76	-2.68	-2.55	-2.31	-2.26	-2.17	-2.14
Tanezumab 10 mg + Naproxen 500 mg	-1.19	-2.27	-2.52	-2.68	-2.70	-2.46	-2.48	-2.24	-2.20	-2.08
Tanezumab 5 mg (Celecoxib Exposure)	-1.35	-2.04	-2.15	-2.55	-2.35	-2.28	-2.18	-2.10	-2.01	-1.97
Tanezumab 5 mg (Naproxen Exposure)	-1.35	-1.88	-1.88	-2.18	-2.16	-2.22	-2.07	-2.05	-2.03	-1.99
Tanezumab 5 mg + Celecoxib 100 mg	-1.41	-2.13	-2.30	-2.49	-2.43	-2.23	-2.46	-2.16	-2.22	-2.10
Tanezumab 5 mg + Naproxen 500 mg	-1.65	-2.34	-2.44	-2.71	-2.64	-2.48	-2.36	-2.13	-2.11	-2.07

Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive. (NCT00809354)
Timeframe: Baseline, Weeks 16, 40, 24, and 56

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

Intervention	Participants (Count of Participants)
	Baseline	Week 16	Week 24	Week 40	Week 56
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	2	3	2	2	2
Tanezumab 10 mg + NSAID	2	0	1	2	2
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	3	5	4	2	3
Tanezumab 5 mg + NSAID	4	4	1	5	1

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. (NCT00809354)
Timeframe: Baseline, Week 16

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

Intervention	Participants (Count of Participants)
	>0%	>=10%	>=20%	>=30%	>=40%	>=50%	>=60%	>=70%	>=80%	>=90%	100%
Celecoxib 100 mg	170	150	124	100	81	62	44	25	13	7	5
Naproxen 500 mg	172	153	130	102	81	56	39	22	14	7	3
Tanezumab 10 mg (Celecoxib Exposure)	182	167	150	124	114	89	68	46	34	15	8
Tanezumab 10 mg (Naproxen Exposure)	201	184	162	135	117	94	75	50	29	18	11
Tanezumab 10 mg + Celecoxib 100 mg	194	184	162	138	123	108	79	63	50	32	11
Tanezumab 10 mg + Naproxen 500 mg	203	194	174	154	132	104	82	71	45	24	10
Tanezumab 5 mg (Celecoxib Exposure)	177	162	142	122	108	89	70	51	31	19	5
Tanezumab 5 mg (Naproxen Exposure)	198	179	148	127	103	78	53	43	29	17	4
Tanezumab 5 mg + Celecoxib 100 mg	193	176	151	135	115	96	72	56	36	20	7
Tanezumab 5 mg + Naproxen 500 mg	199	183	158	139	118	96	61	42	31	19	12

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported. (NCT00809354)
Timeframe: Baseline, Week 16

Number of Participants With Intravenous (IV) Doses of Study Medication

Intervention	Participants (Count of Participants)
	>0%	>=10%	>=20%	>=30%	>=40%	>=50%	>=60%	>=70%	>=80%	>=90%	100%
Celecoxib 100 mg	188	162	134	106	84	65	45	25	13	7	5
Naproxen 500 mg	201	175	144	112	88	61	43	24	16	7	3
Tanezumab 10 mg (Celecoxib Exposure)	202	184	167	137	120	93	72	50	38	17	8
Tanezumab 10 mg (Naproxen Exposure)	234	210	183	150	129	103	79	52	30	19	12
Tanezumab 10 mg + Celecoxib 100 mg	208	197	173	145	127	111	80	63	50	32	11
Tanezumab 10 mg + Naproxen 500 mg	245	229	201	176	150	119	92	78	48	26	12
Tanezumab 5 mg (Celecoxib Exposure)	197	179	157	133	117	97	77	53	32	20	5
Tanezumab 5 mg (Naproxen Exposure)	228	203	167	140	114	86	58	46	31	17	4
Tanezumab 5 mg + Celecoxib 100 mg	208	188	163	145	120	100	75	58	37	20	7
Tanezumab 5 mg + Naproxen 500 mg	233	215	181	159	132	105	68	47	36	21	14

Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received. (NCT00809354)
Timeframe: Baseline up to Week 48

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

Intervention	Participants (Count of Participants)
	Number of IV Doses: 1	Number of IV Doses: 2	Number of IV Doses: 3	Number of IV Doses: 4	Number of IV Doses: 5	Number of IV Doses: 6	Number of IV Doses: 7
Celecoxib 100 mg	22	24	12	37	73	44	44
Naproxen 500 mg	35	30	21	44	74	33	46
Tanezumab 10 mg (Celecoxib Exposure)	30	19	16	35	78	34	42
Tanezumab 10 mg (Naproxen Exposure)	36	18	28	51	70	44	41
Tanezumab 10 mg + Celecoxib 100 mg	21	12	22	48	72	38	41
Tanezumab 10 mg + Naproxen 500 mg	44	16	21	55	74	31	47
Tanezumab 5 mg (Celecoxib Exposure)	25	15	13	39	82	41	41
Tanezumab 5 mg (Naproxen Exposure)	32	19	27	41	71	45	50
Tanezumab 5 mg + Celecoxib 100 mg	22	12	18	44	84	43	33
Tanezumab 5 mg + Naproxen 500 mg	36	19	17	51	66	45	46

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. (NCT00809354)
Timeframe: Baseline up to Week 64

Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)

Intervention	Participants (Count of Participants)
	AEs	SAEs
Celecoxib 100 mg	172	21
Naproxen 500 mg	192	22
Tanezumab 10 mg (Celecoxib Exposure)	188	23
Tanezumab 10 mg (Naproxen Exposure)	211	23
Tanezumab 10 mg + Celecoxib 100 mg	193	34
Tanezumab 10 mg + Naproxen 500 mg	207	30
Tanezumab 5 mg (Celecoxib Exposure)	202	22
Tanezumab 5 mg (Naproxen Exposure)	203	22
Tanezumab 5 mg + Celecoxib 100 mg	185	26
Tanezumab 5 mg + Naproxen 500 mg	205	28

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized. (NCT00809354)
Timeframe: Weeks 1-2, 3-4, 5-8, 9-12, 13-16, 17-24, 25-32, 33-40, 41-48 and 49-56

Percentage of Participants Who Used Rescue Medication: Observed Data

Intervention	percentage of participants (Number)
	Weeks 1-2	Weeks 3-4	Weeks 5-8	Weeks 9-12	Weeks 13-16	Weeks 17-24	Weeks 25-32	Weeks 33-40	Weeks 41-48	Weeks 49-56
Celecoxib 100 mg	63.1	66.0	67.6	68.4	70.7	69.1	74.2	71.5	72.3	71.5
Naproxen 500 mg	63.0	63.0	69.8	66.2	69.4	75.8	70.8	71.9	71.5	72.6
Tanezumab 10 mg (Celecoxib Exposure)	64.4	64.4	61.0	63.9	62.3	64.3	67.5	67.5	67.9	70.0
Tanezumab 10 mg (Naproxen Exposure)	59.4	61.7	63.8	64.2	62.5	64.6	64.9	66.3	66.0	69.1
Tanezumab 10 mg + Celecoxib 100 mg	62.7	61.1	64.3	59.3	59.7	65.6	66.4	65.2	65.0	68.1
Tanezumab 10 mg + Naproxen 500 mg	63.0	60.7	58.9	60.3	57.8	64.5	63.1	64.1	64.8	67.6
Tanezumab 5 mg (Celecoxib Exposure)	70.0	69.4	69.8	65.1	67.5	69.8	71.8	71.4	71.4	71.5
Tanezumab 5 mg (Naproxen Exposure)	60.4	63.0	66.5	65.8	65.3	68.1	66.7	68.1	69.5	71.2
Tanezumab 5 mg + Celecoxib 100 mg	60.5	59.2	62.4	60.5	62.5	60.9	63.7	62.9	63.7	66.8
Tanezumab 5 mg + Naproxen 500 mg	56.9	54.7	55.0	55.4	60.0	63.2	60.0	61.8	63.9	65.4

Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF

Intervention	percentage of participants (Number)
	Weeks 1-2	Weeks 3-4	Weeks 5-8	Weeks 9-12	Weeks 13-16	Weeks 17-24	Weeks 25-32	Weeks 33-40	Weeks 41-48	Weeks 49-56
Celecoxib 100 mg	63.2	66.0	66.7	65.9	68.8	66.3	71.2	61.6	65.1	77.5
Naproxen 500 mg	61.9	62.3	68.8	64.8	68.1	76.6	69.5	73.7	66.0	78.2
Tanezumab 10 mg (Celecoxib Exposure)	64.2	64.9	61.2	64.5	61.3	65.1	70.2	71.2	70.7	74.1
Tanezumab 10 mg (Naproxen Exposure)	59.3	61.8	64.7	65.3	63.7	67.0	67.3	69.5	62.5	71.1
Tanezumab 10 mg + Celecoxib 100 mg	62.5	60.3	63.9	57.1	57.8	66.2	66.2	61.8	52.5	79.3
Tanezumab 10 mg + Naproxen 500 mg	62.9	60.6	57.9	61.4	57.8	66.0	59.6	61.8	60.9	74.2
Tanezumab 5 mg (Celecoxib Exposure)	69.7	68.4	68.0	62.9	64.2	67.0	66.5	63.8	64.1	75.9
Tanezumab 5 mg (Naproxen Exposure)	60.5	63.3	67.7	67.8	66.7	68.9	66.0	64.4	66.7	69.2
Tanezumab 5 mg + Celecoxib 100 mg	60.2	59.3	62.5	60.3	62.3	59.4	63.5	64.8	63.3	72.4
Tanezumab 5 mg + Naproxen 500 mg	57.6	55.1	55.1	56.3	62.1	64.7	59.1	58.2	59.2	62.9

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported. (NCT00809354)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 16, and 24

Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

Intervention	percentage of participants (Number)
	Week 2: >=30% Reduction	Week 2: >=50% Reduction	Week 2: >=70% Reduction	Week 2: >=90% Reduction	Week 4: >=30% Reduction	Week 4: >=50% Reduction	Week 4: >=70% Reduction	Week 4: >=90% Reduction	Week 8: >=30% Reduction	Week 8: >=50% Reduction	Week 8: >=70% Reduction	Week 8: >=90% Reduction	Week 12: >=30% Reduction	Week 12: >=50% Reduction	Week 12: >=70% Reduction	Week 12: >=90% Reduction	Week 16: >=30% Reduction	Week 16: >=50% Reduction	Week 16: >=70% Reduction	Week 16: >=90% Reduction	Week 24: >=30% Reduction	Week 24: >=50% Reduction	Week 24: >=70% Reduction	Week 24: >=90% Reduction
Celecoxib 100 mg	24.7	11.0	5.5	1.6	31.0	18.4	7.1	1.0	30.2	18.8	9.0	2.7	36.5	21.6	9.0	2.4	39.2	24.3	9.8	2.7	41.6	25.9	11.4	3.9
Naproxen 500 mg	22.7	12.8	5.3	1.1	29.8	19.5	6.7	2.5	29.8	16.7	8.2	2.1	34.0	19.5	7.8	2.8	36.2	19.9	7.8	2.5	36.5	21.3	11.7	3.5
Tanezumab 10 mg (Celecoxib Exposure)	22.8	13.8	6.3	1.2	41.7	26.0	11.4	3.9	45.7	29.9	16.5	6.7	52.0	35.8	19.3	7.9	48.8	35.0	18.1	5.9	46.5	33.5	18.5	7.1
Tanezumab 10 mg (Naproxen Exposure)	26.8	17.1	8.7	1.4	45.6	30.0	12.5	3.1	49.8	33.8	16.4	3.8	46.3	32.8	16.0	6.3	47.0	32.8	17.4	6.3	44.9	31.7	17.4	7.3
Tanezumab 10 mg + Celecoxib 100 mg	26.0	18.5	8.3	3.1	50.4	32.7	19.3	5.5	55.9	36.2	23.2	7.1	58.3	41.7	23.6	10.6	54.3	42.5	24.8	12.6	53.5	41.3	23.6	11.8
Tanezumab 10 mg + Naproxen 500 mg	24.9	16.1	7.4	1.8	47.7	32.3	17.5	4.2	49.8	35.1	21.1	7.7	54.4	39.3	23.9	9.8	54.0	36.5	24.9	8.4	46.0	34.4	21.4	6.0
Tanezumab 5 mg (Celecoxib Exposure)	28.0	12.6	7.1	2.4	39.8	22.4	13.8	4.3	44.1	27.2	13.8	5.1	48.0	33.5	19.3	4.7	48.0	35.0	20.1	7.5	42.5	30.3	15.4	7.5
Tanezumab 5 mg (Naproxen Exposure)	28.4	17.5	5.6	1.1	40.7	24.6	11.9	2.1	43.9	27.7	13.7	4.2	45.6	30.2	14.4	6.3	44.6	27.4	15.1	6.0	40.4	27.7	14.0	6.7
Tanezumab 5 mg + Celecoxib 100 mg	30.6	17.3	7.8	1.2	49.0	30.2	16.5	6.3	51.0	33.7	18.8	6.3	53.7	37.6	20.8	7.1	52.9	37.6	22.0	7.8	47.1	35.3	21.6	7.5
Tanezumab 5 mg + Naproxen 500 mg	35.0	20.4	6.4	2.9	52.1	27.5	15.0	6.8	49.3	29.6	18.2	6.4	53.2	32.1	18.6	6.8	49.6	34.3	15.0	6.8	44.3	28.2	16.4	6.4

WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported. (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)

Intervention	percentage of participants (Number)
	Week 2: >=30% Reduction	Week 2: >=50% Reduction	Week 2: >=70% Reduction	Week 2: >=90% Reduction	Week 4: >=30% Reduction	Week 4: >=50% Reduction	Week 4: >=70% Reduction	Week 4: >=90% Reduction	Week 8: >=30% Reduction	Week 8: >=50% Reduction	Week 8: >=70% Reduction	Week 8: >=90% Reduction	Week 12: >=30% Reduction	Week 12: >=50% Reduction	Week 12: >=70% Reduction	Week 12: >=90% Reduction	Week 16: >=30% Reduction	Week 16: >=50% Reduction	Week 16: >=70% Reduction	Week 16: >=90% Reduction	Week 24: >=30% Reduction	Week 24: >=50% Reduction	Week 24: >=70% Reduction	Week 24: >=90% Reduction	Week 32: >=30% Reduction	Week 32: >=50% Reduction	Week 32: >=70% Reduction	Week 32: >=90% Reduction	Week 40: >=30% Reduction	Week 40: >=50% Reduction	Week 40: >=70% Reduction	Week 40: >=90% Reduction	Week 48: >=30% Reduction	Week 48: >=50% Reduction	Week 48: >=70% Reduction	Week 48: >=90% Reduction	Week 56: >=30% Reduction	Week 56: >=50% Reduction	Week 56: >=70% Reduction	Week 56: >=90% Reduction
Celecoxib 100 mg	24.7	11.0	5.5	1.6	31.0	18.4	7.1	1.0	31.0	18.8	9.0	2.7	37.6	22.0	9.0	2.4	41.6	25.5	9.8	2.7	45.5	27.8	11.4	3.9	43.1	28.2	12.5	2.4	41.6	29.0	11.4	2.4	42.0	27.1	11.8	2.7	41.6	27.5	12.5	2.4
Naproxen 500 mg	22.7	12.8	5.3	1.1	30.5	20.2	6.7	2.5	31.2	17.7	8.5	2.1	36.9	21.3	8.5	2.8	39.7	21.6	8.5	2.5	42.9	25.2	13.1	4.3	44.3	27.3	12.1	5.0	42.2	25.5	9.2	3.2	40.4	23.4	11.0	3.9	40.4	22.7	9.9	3.2
Tanezumab 10 mg (Celecoxib Exposure)	22.8	13.8	6.3	1.2	41.7	26.0	11.4	3.9	48.8	30.7	17.3	7.1	57.1	37.8	20.9	8.7	53.9	36.6	19.7	6.7	53.9	35.4	20.5	7.9	51.6	36.2	21.7	9.1	50.8	31.1	20.5	5.9	49.2	31.9	18.9	5.5	46.5	28.7	16.5	4.7
Tanezumab 10 mg (Naproxen Exposure)	26.8	17.1	8.7	1.4	46.3	30.7	12.5	3.1	51.9	35.2	16.7	4.2	50.9	35.5	16.4	6.6	52.3	35.9	18.1	6.6	53.0	36.2	18.5	7.7	52.3	33.8	17.8	7.0	50.9	31.7	17.4	5.6	51.6	30.7	16.0	5.9	50.2	28.9	15.3	5.2
Tanezumab 10 mg + Celecoxib 100 mg	26.0	18.5	8.3	3.1	50.4	32.7	19.3	5.5	56.7	37.0	23.6	7.5	60.2	42.9	24.0	11.0	57.1	43.7	24.8	12.6	57.9	43.3	24.0	11.8	53.5	39.4	22.0	12.6	53.9	39.0	21.7	9.4	51.2	37.0	20.5	9.4	52.0	37.8	20.5	8.7
Tanezumab 10 mg + Naproxen 500 mg	24.9	16.1	7.4	1.8	49.8	33.7	17.9	4.6	55.1	38.9	22.8	8.4	60.7	43.5	26.0	10.5	61.8	41.8	27.4	9.1	55.8	40.7	24.6	7.4	56.5	42.5	22.1	8.4	52.6	38.2	19.3	5.6	51.9	36.5	18.9	6.7	52.6	36.1	17.9	6.3
Tanezumab 5 mg (Celecoxib Exposure)	28.0	12.6	7.1	2.4	41.3	23.6	14.2	4.7	46.5	28.7	14.6	5.9	52.8	36.6	20.5	5.1	52.4	38.2	20.9	7.9	49.2	34.3	16.5	7.9	49.6	35.4	19.3	7.9	49.2	34.3	17.7	7.5	48.4	30.7	16.1	5.9	46.9	29.9	14.2	5.1
Tanezumab 5 mg (Naproxen Exposure)	28.4	17.5	5.6	1.1	41.1	24.6	11.9	2.1	46.3	29.1	14.4	4.2	49.8	32.6	15.4	6.3	49.1	30.2	16.1	6.0	49.5	34.0	16.8	7.4	49.5	30.2	18.2	5.6	49.5	31.9	16.1	5.3	48.8	30.9	17.2	5.6	47.7	30.2	16.5	6.0
Tanezumab 5 mg + Celecoxib 100 mg	30.6	17.3	7.8	1.2	49.8	30.6	16.9	6.3	52.9	34.5	19.2	6.3	57.3	39.2	21.6	7.1	56.9	39.2	22.7	7.8	52.5	37.6	22.7	7.8	52.5	39.2	21.6	10.6	49.8	33.3	19.6	8.6	50.2	33.7	20.4	7.5	47.8	31.8	18.4	7.5
Tanezumab 5 mg + Naproxen 500 mg	35.0	20.4	6.4	2.9	53.2	27.9	15.0	6.8	53.9	31.4	19.3	6.4	59.3	34.3	19.6	7.1	56.8	37.5	16.8	7.5	54.3	33.2	19.6	7.5	53.6	33.9	16.1	5.4	51.8	30.4	15.7	4.6	51.4	30.4	15.4	4.6	51.4	28.6	16.1	4.6

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported." (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, and 24

Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)

Intervention	percentage of participants (Number)
	Week 2	Week 4	Week 8	Week 12	Week 16	Week 24
Celecoxib 100 mg	6.3	10.6	11.8	12.2	13.4	13.0
Naproxen 500 mg	6.4	10.6	9.2	12.7	10.6	14.1
Tanezumab 10 mg (Celecoxib Exposure)	9.4	18.5	16.5	17.7	15.4	12.6
Tanezumab 10 mg (Naproxen Exposure)	10.1	13.5	18.4	17.4	19.1	18.1
Tanezumab 10 mg + Celecoxib 100 mg	5.9	14.6	17.4	22.1	18.2	20.9
Tanezumab 10 mg + Naproxen 500 mg	10.9	15.1	19.3	25.3	22.5	18.6
Tanezumab 5 mg (Celecoxib Exposure)	11.3	19.1	15.6	17.2	18.4	13.3
Tanezumab 5 mg (Naproxen Exposure)	9.9	10.2	14.1	15.5	14.8	17.6
Tanezumab 5 mg + Celecoxib 100 mg	12.5	18.8	19.6	20.8	20.0	18.8
Tanezumab 5 mg + Naproxen 500 mg	8.2	17.5	18.2	18.2	16.4	12.1

"Patient global assessment of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= 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 scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported." (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

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

Intervention	percentage of participants (Number)
	Week 2	Week 4	Week 8	Week 12	Week 16	Week 24	Week 32	Week 40	Week 48	Week 56
Celecoxib 100 mg	6.3	11.0	13.0	13.4	14.6	15.0	15.0	15.4	14.6	15.0
Naproxen 500 mg	6.4	10.6	9.9	13.8	12.0	16.3	15.5	14.1	14.5	13.4
Tanezumab 10 mg (Celecoxib Exposure)	9.4	18.9	18.5	20.9	18.1	15.4	16.5	15.0	14.6	11.8
Tanezumab 10 mg (Naproxen Exposure)	10.1	14.2	20.5	20.8	22.6	22.2	18.8	17.4	16.7	15.3
Tanezumab 10 mg + Celecoxib 100 mg	5.9	14.6	18.2	23.3	19.4	22.5	20.2	20.6	17.4	17.8
Tanezumab 10 mg + Naproxen 500 mg	10.9	16.1	20.7	27.0	24.2	21.4	23.2	18.9	16.1	15.8
Tanezumab 5 mg (Celecoxib Exposure)	11.3	20.3	17.2	19.1	21.1	16.8	19.1	18.4	17.2	14.8
Tanezumab 5 mg (Naproxen Exposure)	9.9	10.6	15.1	16.9	16.5	20.1	14.4	14.8	14.4	14.4
Tanezumab 5 mg + Celecoxib 100 mg	12.5	18.8	19.6	21.6	20.8	20.4	19.2	18.4	18.8	18.4
Tanezumab 5 mg + Naproxen 500 mg	8.2	17.9	19.3	20.4	18.9	15.4	16.4	13.9	12.9	13.6

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, and 24

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

Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). (NCT00809354)
Timeframe: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56

Plasma Trough (Pre-dose) Concentration of Tanezumab

Consumption of Rescue Medication

"Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary.~Total Number of pills per month" (NCT01425853)
Timeframe: 6 months

Number of Participants With at Least One Adverse Events

The safety evaluation was done in the set of randomized patients who took at least one dose of the medication (NCT01425853)
Timeframe: 6 months

Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)

"The OARSI Standing Committee for Clinical Trials Response Criteria Initiative and the OMERACT committee, in concert with the international rheumatology community, has led to the development of a uniform core set of outcome measures for OA. One of the objectives was to propose a set of criteria for measurement based on multiple domains to present the results of changes after treatment in symptomatic parameters as a single variable for clinical trials.~To be considered as responder patients should met one the following criteria:~High improvement in pain or in function ≥ 50% and absolute change ≥ 20 or~Improvement in at least 2 of the 3 following:~Pain ≥ 20% and absolute change ≥ 10~Function ≥ 20% and absolute change ≥ 10~Patient's global assessment ≥ 20% and absolute change ≥ 10" (NCT01425853)
Timeframe: 6 months

Percentage of Presence of Joint Effusion

Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion. (NCT01425853)
Timeframe: 6 months

Percentage of Presence of Joint Swelling

Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion. (NCT01425853)
Timeframe: 6 months

WOMAC Pain Subscale

Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing. (NCT01425853)
Timeframe: 6 months

Health Status According to EuroQoL

"EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits.~The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3.~The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.~Total scale range for VAS dimension reported is 0 to 100." (NCT01425853)
Timeframe: 6 months

Huskisson's VAS

"Visual Analogue Scale: 0 No Pain 100 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 100 mm VAS as follows: Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line. Left hand marker represents No pain and right hand marker represents The worst pain imaginable." (NCT01425853)
Timeframe: 6 months

Number of Adverse Events Defined by Relationship With Treatment

The safety evaluation was done in the set of randomized patients who took at least one dose of the medication (NCT01425853)
Timeframe: 6 months

Patient's and Investigator's Global Assessment of Response to Therapy

"The investigator were asked to evaluated the patient's response to therapy of the index knee by marking a (I) a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Left hand marker Excellent-Best possible anticipated response, considering the severity and stage of the disease, right hand marker None-no response, absence of drug effect." (NCT01425853)
Timeframe: 6 months

Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity

"Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing. Left hand marker Very Well, Right hand marked Very Poor." (NCT01425853)
Timeframe: 6 months

WOMAC Function Subscale

Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 1700 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. (NCT01425853)
Timeframe: 6 months

WOMAC Stiffness Subscale

Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 200 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day. (NCT01425853)
Timeframe: 6 months

Intervention	nanogram/milliliter (Mean)
	Day 1	Week 16	Week 24	Week 40	Week 56
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)	164.068	556.854	545.672	523.214	385.733
Tanezumab 10 mg + NSAID	96.4720	723.316	538.756	527.108	377.231
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)	48.4570	222.779	250.813	231.840	168.673
Tanezumab 5 mg + NSAID	102.398	255.246	271.632	263.049	138.159

Intervention	daily tablets consumed/month (Mean)
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	31.0
Celecoxib	29.0

Intervention	percentage of participants (Number)
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	79.7
Celecoxib	79.2

Intervention	units on a scale (Mean)
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	185.79
Celecoxib	184.67

Intervention	points (Mean)
	Mobility Baseline	Mobility 180 Days	Self-care Baseline	Self-care 180 days	Usual activities Baseline	Usual activities 180 days	Pain Discomfort Baseline	Pain Discomfort 180 days	Anxiety depression baseline	Anxiety depression 180 days	VAS Baseline	VAS 180 days
Celecoxib	1.84	1.46	1.44	1.21	1.79	1.42	2.27	1.86	1.60	1.34	52.488	70.219
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	1.84	1.52	1.39	1.19	1.78	1.42	2.25	1.84	1.70	1.43	54.545	69.080

Intervention	units on a scale (Mean)
	Baseline	180 days
Celecoxib	73.47	37.64
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	72.79	37.86

Intervention	number of events (Number)
	Treatment-related AEs: Definitive	Treatment-related AEs: Possibly	Treatment-related AEs: Probably	Treatment-related AEs: Non-appraisable	Treatment-related AEs: unlikely or unrelated
Celecoxib	10	38	12	1	90
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	3	43	25	0	84

Intervention	units on a scale (Mean)
	PGA Therapy Baseline	PGA Therapy 180 days	IGA Therapy Baseline	IGA Therapy 180 days
Celecoxib	45.9	36.04	42.25	33.83
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	54.59	36.85	51.4	34.72

Intervention	units on a scale (Mean)
	PGA Activity Baseline	PGA Activity 180 days	IGA Activity Baseline	IGA Activity 180 daus
Celecoxib	69.41	36.88	63.28	33.40
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)	69.11	38.35	63.2	35.33

Article	Year
[Are there any differences in the cardiovascular tolerance between classical NSAIDs and coxibs?]. Presse medicale (Paris, France : 1983), 2006, Volume: 35, Issue:9 Spec No Topics: Age Factors; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Diseas	2006
Renal safety and tolerability of celecoxib, a novel cyclooxygenase-2 inhibitor. American journal of therapeutics, 2000, Volume: 7, Issue:3 Topics: Age Factors; Aged; Angiotensin-Converting Enzyme Inhibitors; Anti-Inflammatory Agents, Non-Steroidal	2000

Article	Year
Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Annals of the rheumatic diseases, 2015, Volume: 74, Issue:6 Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Antibodies, Monoclonal, Hum	2015
Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC musculoskeletal disorders, 2014, Nov-18, Volume: 15 Topics: Adult; Aged; Arthritis, Rheumatoid; Celecoxib; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Ede	2014
Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib. Annals of the rheumatic diseases, 2016, Volume: 75, Issue:1 Topics: Aged; Celecoxib; Chondroitin Sulfates; Cyclooxygenase 2 Inhibitors; Double-Blind Method; Drug Combin	2016
Effects of celecoxib and rofecoxib on blood pressure and edema in patients > or =65 years of age with systemic hypertension and osteoarthritis. The American journal of cardiology, 2002, Nov-01, Volume: 90, Issue:9 Topics: Age Factors; Aged; Anti-Inflammatory Agents, Non-Steroidal; Antihypertensive Agents; Blood Pressure;	2002
Cardiorenal effects of celecoxib as compared with the nonsteroidal anti-inflammatory drugs diclofenac and ibuprofen. Kidney international, 2006, Volume: 70, Issue:8 Topics: Acid-Base Equilibrium; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Arthritis,	2006

celecoxib and Edema

Research Excerpts

Research

Studies (178)

Authors

Clinical Trials (6)

Trial Overview

Trial Outcomes

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF

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

Number of Participants With Positive Urine or Serum Pregnancy Test

Time to Discontinuation Due to Lack of Efficacy

Amount of Rescue Medication Used

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56

Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data

Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)

Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)

Number of Participants With Anti-Drug Antibody (ADA) Response

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

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

Number of Participants With Intravenous (IV) Doses of Study Medication

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

Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)

Percentage of Participants Who Used Rescue Medication: Observed Data

Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF

Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)

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

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

Plasma Trough (Pre-dose) Concentration of Tanezumab

Consumption of Rescue Medication

Number of Participants With at Least One Adverse Events

Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)

Percentage of Presence of Joint Effusion

Percentage of Presence of Joint Swelling

WOMAC Pain Subscale

Health Status According to EuroQoL

Huskisson's VAS

Number of Adverse Events Defined by Relationship With Treatment

Patient's and Investigator's Global Assessment of Response to Therapy

Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity

WOMAC Function Subscale

WOMAC Stiffness Subscale

Reviews

Trials

Other Studies