Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.

Inclusion Criteria:

• Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
• Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

• Serum creatinine >1.5 mg/dL
• Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
• Pregnancy or lactation;
• Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
• Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
• A history of xanthinuria, active liver disease, or hepatic dysfunction;
• A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.