Status:
COMPLETED
Efficacy and Safety of Oral Febuxostat in Participants With Gout
Lead Sponsor:
Takeda
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
Detailed Description
Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patient...
Eligibility Criteria
Inclusion
- Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
- 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.
- Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).
Exclusion
- Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
- Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
- History of xanthinuria.
- Alcohol consumption greater than 14/week.
- History of significant concomitant illness.
- Active liver or peptic ulcer disease.
- Has rheumatoid arthritis requiring treatment.
- Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
- Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
2269 Patients enrolled
Trial Details
Trial ID
NCT00430248
Start Date
February 1 2007
End Date
March 1 2008
Last Update
February 2 2012
Active Locations (258)
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1
Birmingham, Alabama, United States
2
Hoover, Alabama, United States
3
Hueytown, Alabama, United States
4
Huntsville, Alabama, United States