Status:
COMPLETED
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.
Lead Sponsor:
Takeda
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
Detailed Description
A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered on...
Eligibility Criteria
Inclusion
- 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
- History of xanthinuria
- Intolerance to allopurinol
- Presence of renal calculi,
- Alcohol intake of ≥ 14 drinks/week
- Clinically significant medical condition
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
1072 Patients enrolled
Trial Details
Trial ID
NCT00174915
Start Date
February 1 2003
End Date
April 1 2004
Last Update
February 2 2012
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