Objective. To evaluate the efficacy and safety of etoricoxib and indomethacin in the treatment of patients with acute gout.Methods. A randomized, double-blind, activecomparator study was conducted at 42 sites. A total of 189 men and women (>18 years of age) who were experiencing an acute attack (<48 hours) of clinically diagnosed gout were treated for 8 days with etoricoxib, 120 mg/day (n ؍ 103), or indomethacin, 50 mg 3 times a day (n ؍ 86). The primary efficacy end point was the patient's assessment of pain in the study joint (0-4-point Likert scale) over days 2-5. Safety was assessed by adverse experiences (AEs) occurring during the trial.Results. Etoricoxib demonstrated clinical efficacy comparable to that of indomethacin in terms of the patient's assessment of pain in the study joint. The difference in the mean change from baseline over days 2-5 was -0.08 (95% confidence interval -0.29, 0.13) (P ؍ 0.46), which fell within the prespecified comparability bounds of -0.5 to 0.5. Secondary end points over the 8-day study, including the onset of efficacy, reduction in signs of inflammation, and patient's and investigator's global assessments of response to therapy, confirmed the comparable efficacy of the two treatments. The etoricoxib-treated patients had a numerically lower incidence of AEs (43.7%) than did the indomethacintreated patients (57.0%) and a significantly lower incidence of drug-related AEs (16.5% versus 37.2%; P < 0.05).Conclusion. Etoricoxib at a dosage of 120 mg once daily was confirmed to be an effective treatment for acute gout. Etoricoxib was comparable in efficacy to indomethacin at a dosage of 50 mg 3 times daily, and it was generally safe and well tolerated.Acute gouty arthritis is the most common form of inflammatory joint disease in men over the age of 40 years (1,2). It is estimated to affect 0.5-2.8% of men, with a lower rate of occurrence among women, who experience gout primarily after menopause (3). The prevalence is much higher among individuals with a positive family history (3). Monosodium urate monohydrate crystals, which arise from abnormal metabolism of purines, cause an intense inflammatory reaction that