Objectives To evaluate and compare the efficacy of 14-day dosing with celecoxib 200 mg BID and naproxen 500 mg BID in patients with acute shoulder pain.

Methods Patients with pain onset within the previous 14 days and pain intensity of > = 40 mm on a 100-mm VAS were randomly assigned to enter one of two parallel groups of a double-blind controlled, multicenter study. The primary assessment was pain at rest.

Results The primary ITT analysis was conducted in 202 randomised and treated patients, 99 in the celecoxib group and 103 in the naproxen group. Baseline characteristics were similar (47 ± 12 years of age; mean duration of acute episode, 5.6 ± 5.1 days). At 14 days, the mean (± SE) decrease in pain at rest was not statistically significantly different between the two groups. According to the limits of 95% CI of the difference between groups, celecoxib seemed to be at least as effective as naproxen. Fewer patients experienced epigastric pain with celecoxib (7 patients vs 14 with naproxen). This adverse event led to treatment discontinuation in 2 patients receiving celecoxib and 5 receiving naproxen. One patient with a history of ulcer had duodenitis (Hp positive) in the celecoxib group.

Conclusion This study provides data in favour of the use of celecoxib, which is probably at least as effective as naproxen in acute shoulder pain. Observed upper GI events rates in this study of limited sample size do not permit drawing conclusions in terms of improved GI safety, which has previously been shown in larger randomised controlled trials.

Sponsored by Pharmacia Corporation and Pfizer, Inc.