Safety and Efficacy of Oral Febuxostat in Subjects With Gout

A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout

The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

Inclusion Criteria:

• Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;
• Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
• No gout flare 2 weeks beforehand during 2-week screening period.

Exclusion Criteria:

• 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 active liver disease, or hepatic dysfunction;
• A history of bronchial asthma;
• A history of renal calculi or thyroid disease;
• Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
• Intolerance to allopurinol and Ibuprofen;
• Alcohol intake of ≥ 14 drinks/week;
• Clinically significant medical condition.