Safety and Efficacy of Oral Febuxostat in Subjects With Gout

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Xijing Hospital
• Collaborator: Qingdao Shengbang Pharmaceutical Co., Ltd.
• Treatments: Allopurinol; Febuxostat

Criteria

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.