OBJECTIVE: This 6-week, randomized, double-blind, parallel-group study compared the analgesic efficacy, tolerability and safety of celecoxib, naproxen and placebo in African Americans with osteoarthritis (OA) of the knee. METHODS: A total of 322 patients aged ≥ 45 years with OA of the knee in a flare state received 200 mg celecoxib orally once daily, 500 mg naproxen orally twice daily or placebo for 6 weeks. The primary endpoint was change from baseline in the Patient's Assessment of Arthritis Pain. RESULTS:Celecoxib was as effective as naproxen in reducing OA pain. Similar efficacy was observed in many of the secondary outcome measures. Celecoxib was well tolerated and demonstrated favorable upper gastro-intestinal tolerability. Improvements in outcome measures were numerically greater in the active treatment groups compared with the placebo group, but did not reach statistical significance. CONCLUSIONS:Celecoxib was as effective as naproxen in relieving OA pain in African Americans and was well tolerated. Few significant differences were observed between active treatments and placebo, possibly because of a strong placebo effect.
RCT Entities:
OBJECTIVE: This 6-week, randomized, double-blind, parallel-group study compared the analgesic efficacy, tolerability and safety of celecoxib, naproxen and placebo in African Americans with osteoarthritis (OA) of the knee. METHODS: A total of 322 patients aged ≥ 45 years with OA of the knee in a flare state received 200 mg celecoxib orally once daily, 500 mg naproxen orally twice daily or placebo for 6 weeks. The primary endpoint was change from baseline in the Patient's Assessment of Arthritis Pain. RESULTS:Celecoxib was as effective as naproxen in reducing OA pain. Similar efficacy was observed in many of the secondary outcome measures. Celecoxib was well tolerated and demonstrated favorable upper gastro-intestinal tolerability. Improvements in outcome measures were numerically greater in the active treatment groups compared with the placebo group, but did not reach statistical significance. CONCLUSIONS:Celecoxib was as effective as naproxen in relieving OA pain in African Americans and was well tolerated. Few significant differences were observed between active treatments and placebo, possibly because of a strong placebo effect.
Authors: Ken O'Reilly; Gary Donohoe; Danny O'Sullivan; Ciaran Coyle; Ronan Mullaney; Paul O'Connell; Catherine Maddock; Andrea Nulty; Padraic O'Flynn; Carina O'Connell; Harry G Kennedy Journal: BMC Psychiatry Date: 2016-01-13 Impact factor: 3.630