Conditions: Osteoarthritis
Keywords: COX-1 COX-2 carbonic anhydrase anti-inflammatory Cyclooxygenase Inhibitors Polmacoxib
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 125
Healthy volunteers: no

Brief summary:
This is a double-blind, randomized, multicenter, phase 2b, noninferiority comparison of two active dose levels of CG100649 vs. a standard anti-arthritic dose of celecoxib (Celebrex).

Detailed description:
This is a double-blind, randomized, multicenter, noninferiority, phase 2 study. Subjects will discontinue current medications (NSAID or COX-2 inhibitor) 5-14 days prior to randomization. Paracetamol (acetaminophen; ≤2 gm/day) may be used for breakthrough pain. Other NSAIDs, COX-2 inhibitors, opioids, and corticosteroids may not be used at any time during this study. Only subjects recording average WOMAC pain score of 4 to 8 on a 0-10 numerical rating scale during the washout period and meeting all other inclusion criteria will be randomized into the study.

Male and female adults, ages 20 and older, with a history of osteoarthritis (OA) of the knee or hip diagnosed by radiograph obtained within the past 20 years and with pain at least 3 months from OA can participate in this study. OA must be confirmed by radiographs and diagnosed according to American College of Rheumatology (ACR) guidelines. Subjects must qualify as ACR global functional status I, II, or III (excluding IV) and Kellgren-Lawrence grade 1, 2 or 3 (excluding grade 4).

Subjects meeting screening criteria will be randomized to receive 28 days dosing of an active dose of CG100649 or comparator (celecoxib).

Antiarthritic efficacy will be evaluated by changes in the Western Ontario and McMaster Universities (WOMAC) OA index completed on Day 1 (Baseline) and on Days 14, 28 and 42. The WOMAC pain subscale will be evaluated at screening and on Days 1, 7, 14, 21, 28, 35 and 42.

All doses will be administered orally once daily in the morning. There are 3 planned treatment arms (2 with active compound + one comparator (celecoxib) group) with n=44 per treatment arm. Total number of subjects will be 132.

Treatment A: CG100649: 2 mg/day (Days 1-28); Treatment B: CG100649: 4 mg/day (Days 1-28); Treatment C: celecoxib: 200 mg/day (Days 1-28); Active and comparator medications will have identical appearance.

Arms:
arm 1: capsule, once daily for 28 days arm 2: capsule, once daily for 28 days arm 3: capsule, once daily for 28 days

Interventions: intervention 1: CG100649 intervention 2: Celecoxib
Intervention descriptions: intervention 1: once daily for 28 days intervention 2: capsule, celecoxib 200 mg, once daily for 28 days

Protocol document: