Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Allopurinol; Febuxostat

Criteria

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.