Celebrex celecoxib COX-2 inhibitor: Phase III data; under FDA review

A 12-week Phase III trial in 1,149 patients with active RA showed that 100, 200 and 400 mg of Celebrex was comparable to 500 mg of naproxen, a non-steroidal anti-inflammatory drug, in relieving joint tenderness, pain and swelling. The upper gastrointestinal (GI) safety profile was not significantly different from placebo.

In a 1,004-patient osteoarthritis trial, 100 or 200 mg of Celebrex was as effective as 500 mg of naproxen in relieving OA symptoms. In a test of 600 mg Celebrex versus 500 mg naproxen, Celebrex had no effect on platelet aggregation, while naproxen recuced aggregation by 95 percent. ...