Objectives We performed a randomised, double-blind, clinical trial to evaluate the efficacy and safety of rofecoxib and celecoxib at highest indicated once daily doses in osteoarthritis.
Methods 1082 patients meeting entry criteria for OA, responsive to NSAIDs, were randomised 3:3:1 to treatment with rofecoxib 25 mg qd (n = 471), celecoxib 200 mg qd (n = 460) or placebo (n = 151). Efficacy was assessed over the first 6 days of therapy and at weeks 2, 4, and 6 by WOMAC questionnaire and patient global assessment of response to therapy (PGART).
Results Demographics were well balanced. Significantly more patients on placebo discontinued prematurely compared to both active groups (p < 0.001) mainly due to lack of efficacy. Rofecoxib provided statistically superior relief of night pain (p = 0.023), morning stiffness (p = 0.002), rest pain (p = 0.023), and walking pain (p = 0.005) compared to celecoxib. Rofecoxib was significantly superior to celecoxib on all WOMAC subsacles, including pain (p = 0.008), stiffness (p = 0.001) and physical function (p = 0.01). Rofecoxib was superior to celecoxib in % of patients with good or excellent PGART over 6 weeks (p = 0.014) and provided quicker onset of efficacy as assessed by time to first report of good or excellent response (p < 0.001). Both active groups were superior to placebo on efficacy endpoints. Incidence of clinical AEs, drug related AEs, serious AEs, and discontinuations due to AEs was similar between active groups.
Conclusion In this study, once daily doses of rofecoxib provided superior relief of pain and other related symptoms in OA compared to celecoxib and placebo. All treatments were generally well tolerated.
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