Conditions: Localized Primary Osteoarthritis of Hip Localized Primary Osteoarthritis of Knee
Keywords: COX-1 COX-2 carbonic anhydrase anti-inflammatory Cyclooxygenase Inhibitors Polmacoxib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 362
Healthy volunteers: no

Brief summary:
* 6-week Efficacy Study The objective of this study is to prove the safety and non-inferiority of analgesic efficacy of CG100649 2 mg vs. celecoxib 200 mg, and analgesic superiority of CG100649 2 mg vs. placebo, when administered once a day in patients with osteoarthritis of the hip or knee over the 6 week Treatment period. The primary efficacy parameter is the difference from Baseline to Week 6 in the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC)-Pain subscale.
* Extended Safety Study The objective of the Extended Safety Study is to collect a total of 24 weeks of safety data for CG100649 including the initial 6 weeks of safety data, and an additional 18 weeks of safety data for those subjects who agree on the consent form to continue into the Extended Safety Study. Subjects will be administered CG100649 2 mg only during 18 weeks of Extended Safety Study.

Detailed description:
1. Number of Subjects: 350 (2:2:1 ratio of experimental vs. active comparator vs. placebo comparator)
2. Adverse Events will be coded to preferred term and body system using the Medical Dictionary for Regulatory Activities (MedDRA)

Arms:
arm 1: Celecoxib 200 mg by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase) arm 2: Placebo capsule by mouth, once a day for 6 weeks (Treatment Phase), followed by CG100649 2 mg, oral, for 18 weeks (Safety Phase) arm 3: CG100649 2 mg capsule by mouth, once a day for 6 weeks (Treatment Phase); CG100649 2 mg capsule by mouth, once a day for 18 weeks (Safety Phase)

Interventions: intervention 1: CG100649 intervention 2: Celecoxib intervention 3: Placebo
Intervention descriptions: intervention 1: 2 mg capsule intervention 2: 200 mg capsule intervention 3: Mimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule

Protocol document: