Status:
COMPLETED
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
Lead Sponsor:
Takeda
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
Detailed Description
Gout is a chronic urate crystal deposition disorder, which if left untreated may result in progressive disease characterized by joint and bone destruction from tophaceous deposits and renal impairment...
Eligibility Criteria
Inclusion
- Hyperuricemia (serum uric acid ≥8.0 mg/dL).
- Must meet American College of Rheumatology criteria for gout.
- Must have adequate renal function (serum creatinine \<1.5 mg/dL).
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Exclusion
- History of xanthinuria
- Alcohol consumption \>14/week
- Has a history of significant concomitant illness.
- Has active liver disease.
- Has a body mass index greater than 50 kilogram per meter² (kg/m²)
- Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00174967
Start Date
January 1 2001
End Date
July 1 2001
Last Update
July 29 2011
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