Overview

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