Study objective: To evaluate the functional status of patients with signs and symptoms of osteoarthritis of the knee after treatment with celecoxib compared with placebo and naproxen.
Design: Prospective, randomized, double-blind, parallel-group, 12-week trial.
Setting: Multicenter study conducted at 71 sites in the United States and Canada.
Patients: One thousand four patients with active osteoarthritis of the knee in a flare state.
Interventions: Patients were assigned randomly to one of five treatment groups: placebo; celecoxib 50 mg twice/day, 100 mg twice/day, and 200 mg twice/day; and naproxen 500 mg twice/day.
Measurements and main results: The Western Ontario and McMaster Universities Osteoarthritis Index was used to measure functional status. At the end of the treatment period, patients in the four active treatment groups had significantly better functional status than those receiving placebo. Patients treated with celecoxib 100 mg twice/day had significantly better improvements in pain scores than those treated with placebo and naproxen.
Conclusion: Celecoxib was better than placebo and comparable with naproxen in improving aspects of functional status in patients with osteoarthritis.