Efficacy and Safety of Oral Febuxostat in Participants With Gout

Completed · Phase 3

Conditions studied: Gout

In brief

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.

Key facts

Study ID

NCT00430248

Run by

Takeda

People needed

2269

Starts

2007-02-01

Expected to finish

2008-03-01

Last updated by the study team

2012-02-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Hoover, Alabama, United States
• Study site — Hueytown, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Northport, Alabama, United States
• Study site — Ozark, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Chandler, Arizona, United States
• Study site — Gilbert, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fort Smith, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Carmichael, California, United States
• Study site — Clovis, California, United States
• Study site — Concord, California, United States
• Study site — El Centro, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.