Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

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

Details

• Lead Sponsor: Takeda
• Treatments: Allopurinol; Febuxostat

Criteria

Inclusion Criteria:

• Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American 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 Cockroft and Gault formula.

Exclusion Criteria:

• History of xanthinuria

• Intolerance to allopurinol

• Presence of renal calculi,

• Alcohol intake of ≥ 14 drinks/week

• Clinically significant medical condition