Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial

OBJECTIVE: To compare the efficacy and tolerability of celecoxib and ibuprofen for the treatment of knee osteoarthritis symptoms. METHOD: In this 6-week, multicentre, double-blind, non-inferiority trial, patients were randomized to 200 mg celecoxib once daily, 800 mg ibuprofen three times daily or placebo. The primary outcome was non-inferiority of celecoxib to ibuprofen in Patient’s Assessment of Arthritis Pain (scored 0–100). Secondary outcomes included the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, Pain Satisfaction Scale, and upper gastrointestinal tolerability. RESULTS: A total of 388 patients were treated (celecoxib n = 153; ibuprofen n = 156; placebo n = 79). Mean difference (95% confidence interval) between celecoxib and ibuprofen in the Patient’s Assessment of Arthritis Pain was 2.76 (−3.38, 8.90). As the lower bound was greater than −10, celecoxib was non-inferior to ibuprofen. The WOMAC total score was significantly improved with celecoxib and ibuprofen, versus placebo. Patients receiving celecoxib were significantly more satisfied (versus placebo) in 10 of 11 measures on the Pain Satisfaction Scale versus three measures with ibuprofen. Upper gastrointestinal events were less frequent with celecoxib (1.3%) than ibuprofen (5.1%) or placebo (2.5%). CONCLUSION: Celecoxib was well tolerated and as effective as ibuprofen for symptoms associated with knee osteoarthritis. CLINICALTRIALS.GOV IDENTIFIER: NCT00630929