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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00102440 |
This study evaluated the safety and efficacy of febuxostat versus allopurinol in subjects with gout.
Condition | Intervention | Phase |
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Gout |
Drug: Febuxostat Drug: Allopurinol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout (FACT) |
Enrollment: | 760 |
Study Start Date: | July 2002 |
Study Completion Date: | February 2004 |
Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Febuxostat
Febuxostat 80 mg daily, capsules administered orally for 1 year.
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2: Experimental |
Drug: Febuxostat
Febuxostat 120 mg daily, capsules administered orally for 1 year.
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3: Active Comparator |
Drug: Allopurinol
Allopurinol 300 mg capsules administered orally, daily, for 1 year.
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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 randomized to one of three treatment groups: febuxostat 80 mg, febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | C02-010 |
Study First Received: | January 29, 2005 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00102440 History of Changes |
Health Authority: | United States: Food and Drug Administration |
uric Acid gout xanthine oxidase febuxostat tophi |
Antimetabolites Allopurinol Antioxidants Metabolic Diseases Joint Diseases Febuxostat Rheumatic Diseases Gout |
Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Uric Acid Musculoskeletal Diseases Genetic Diseases, Inborn Arthritis Antirheumatic Agents Metabolic Disorder |
Antimetabolites Allopurinol Antioxidants Metabolic Diseases Molecular Mechanisms of Pharmacological Action Joint Diseases Physiological Effects of Drugs Enzyme Inhibitors Febuxostat Rheumatic Diseases Protective Agents |
Gout Suppressants Pharmacologic Actions Gout Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Musculoskeletal Diseases Genetic Diseases, Inborn Therapeutic Uses Arthritis Free Radical Scavengers Antirheumatic Agents |