Active adults commonly experience ankle sprain, resulting in pain, inflammation, ecchymosis, and swelling. Physicians often prescribe conventional nonsteroidal anti-inflammatory drugs to treat ankle sprain and accelerate return to activity. In a recent clinical trial, celecoxib, a COX-2 specific inhibitor with platelet-sparing properties, was as effective as ibuprofen and better than placebo in reducing ankle sprain signs and symptoms. We hypothesized that celecoxib would be as effective as naproxen in ankle sprain. In an 8-day, multicenter, randomized, double-blind, parallel group trial, 396 adults with first or second degree inversion ankle sprain were treated with celecoxib 200 mg BID (n = 198) or naproxen 500 mg BID (n = 198). At baseline, patients had moderate-to-severe ankle pain on weight bearing [at least 45 mm on 100-mm visual analog scale (VAS)]. Patients were mostly male (67%) with a mean age of 30 years. Injuries were sports- (54%) or non-sports-related and occurred within 48 hours of the first dose of study medication (mean duration, 23.2 hours). Covariate-adjusted analyses of the primary end points (Patient's Global Assessment and VAS) at Day 4 demonstrated that celecoxib was as effective as naproxen in improving signs and symptoms of ankle sprain. Both groups had a median of 5 days to return to normal function/activity or function improvement by at least 2 grades (5-point categorical scale).Table1Responders improved by ≥ 1 grade on 5-pt scale from 1 (very good) to 5 (very poor); †p ≥ 0.51; ‡cel vs napr within 95% CI limits for noninferiority. Celecoxib is as effective as the maximum recommended dose of naproxen in treating pain of ankle sprains. Celecoxib, with its platelet-sparing properties and superior gastrointestinal tolerability, may offer an advantage over naproxen in managing ankle sprain injuries. Sponsored by Pharmacia Corp.