Fifty patients with acute gouty arthritis entered into an 8-day multicenter open study designed to evaluate the efficacy and safety of Oxaprozin, a new nonsteroidal antiinflammatory drug (NSAID). Patients received 1,800 mg of Oxaprozin daily in two divided doses (1,200 mg in the morning and 600 mg in the evening) for 2 days, followed by 1,200 mg daily until pain was relieved. Based on evaluation of pain intensity recorded on patient diary cards, 84% of the patients ( P < .001) showed improvement during the 24 hours after receiving at least 2 doses (1,800 mg) of Oxaprozin. At the final clinical visit, 93% reported improvement ( P < .001 ). Fourteen patients reported adverse effects, but only two discontinued treatment for that reason. Five patients discontinued because of an unsatisfactory response. A significant decrease ( P < .001) from baseline occurred in mean total leukocyte count by the eighth day, probably due to the antiinflammatory effect of Oxaprozin. No clinically significant changes in renal or hepatic function test results or vital signs were observed. Oxaprozin was found to be effective and safe in the treatment of patients with acute gout.