Status:
COMPLETED
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Lead Sponsor:
Takeda
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
Detailed Description
This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
760 Patients enrolled
Trial Details
Trial ID
NCT00102440
Start Date
July 1 2002
End Date
February 1 2004
Last Update
February 2 2012
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