Official Title: “A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout (FACT)”

This study evaluated the safety and efficacy of febuxostat versus allopurinol in subjects with gout.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2004

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.

Intervention(s) in this Clinical Trial

• Drug: Febuxostat
  • Febuxostat 80 mg daily, capsules administered orally for 1 year.
• Drug: Febuxostat
  • Febuxostat 120 mg daily, capsules administered orally for 1 year.
• Drug: Allopurinol
  • Allopurinol 300 mg capsules administered orally, daily, for 1 year.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3

Primary Measures

• Proportion of subjects with the last 3 serum urate levels <6.0 mg/dL
  • Time Frame: Each study visit
    Safety Issue?: No

Secondary Measures

• Proportion of subjects with serum urate <6.0 mg/dL
  • Time Frame: Weeks 28, 52 and final visit
    Safety Issue?: No
• Percent reduction in serum urate levels.
  • Time Frame: Weeks 28,52 and final visit
    Safety Issue?: No
• Percent reduction in tophus size, as determined by physical measurement, in subjects with a palpable primary tophus at screening.
  • Time Frame: Weeks 28,52, and final visit
    Safety Issue?: No
• Reduction in total number of tophi in subjects with palpable tophi at screening.
  • Time Frame: Weeks 28,52 and final visit.
    Safety Issue?: No
• Proportion of subjects requiring treatment for gout flares between weeks 8 and 52.
  • Time Frame: Weeks 8-52 occurring in 8 week intervals.
    Safety Issue?: No

Inclusion Criteria:

• Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
• Serum uric acid ≥ 8.0 mg/dL at Baseline

Exclusion Criteria:

• Serum creatinine >1.5 mg/dL
• Calculated creatinine clearance of <50 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 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Takeda Global Research & Development Center, Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair Takeda Global Research & Development Center, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00102440

Study ID Number: C02-010

ClinicalTrials.gov Identifier: NCT00102440

Health Authority: United States: Food and Drug Administration

American College of Rheumatology