Treatment of osteoarthritis with a once-daily dosing regimen of celecoxib: a randomized, controlled trial.

A previous study has shown celecoxib 100 mg b.i.d. to be comparably effective to naproxen 500 mg b.i.d. in treating osteoarthritis (OA). The primary objective of this study was to compare the efficacy of a once-daily regimen of celecoxib (200 mg q.d.) to the 100 mg b.i.d. regimen in treating the signs and symptoms of OA. In this double-blind, placebo-controlled, parallel-group, multicenter study, 686 patients with OA of the knee in a flare state were enrolled. Patients were randomly assigned to receive celecoxib 100 mg b.i.d. (N = 231), celecoxib 200 mg q.d. (N = 223), or the placebo (N = 232) for 6 weeks. Arthritis assessments were performed at baseline and at weeks 2 and 6, or at early termination. In all measurements of efficacy, at all assessments, improvements from baseline in both celecoxib groups were statistically superior to those in the placebo group (p </= 0.001 for all post-baseline comparisons of celecoxib vs the placebo), whereas the results were quite similar and statistically indistinguishable between celecoxib 100 mg b.i.d. and 200 mg q.d.. As a representative measure, 43% of patients in each celecoxib group met the definition of "improved" in Physician's Global Assessment at week 6, versus 25% of the placebo patients. The incidence of withdrawal as a result of treatment failure was 8% for celecoxib 100 mg b.i.d., 9% for celecoxib 200 mg q.d., and 24% for the placebo. Both regimens of celecoxib were well tolerated. We conclude that celecoxib 200 mg q.d. is efficacious and safe in treating patients with OA. Furthermore, no difference in efficacy or safety can be discerned between celecoxib 100 mg b.i.d. and 200 mg q.d., providing flexibility to both patients and physicians in choosing a dosing regimen.

RCT Entities:   Population Interventions Outcomes