Official Title: “A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.”

A Study comparing febuxostat, allopurinol and placebo 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: April 2004

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

Intervention(s) in this Clinical Trial

• Drug: Febuxostat
  • Febuxostat 80 mg orally daily, provided as 2 small placebo tablets, 1 large febuxostat 80 mg tablet and 1 placebo tablet to match and 1 placebo capsule to match.
• Drug: Febuxostat
  • Febuxostat 120 mg, orally once daily, provided as 1 small 40 mg tablet and placebo to match, 1 large 80 mg febuxostat tablet and placebo to match and 1 placebo capsule to match.
• Drug: Febuxostat
  • Febuxostat 240 mg,orally daily, provided as 2 small 40 mg tablets, 2 large 80 mg febuxostat tablets, and 1 placebo capsule to match.
• Drug: Allopurinol
  • Allopurinol, 100 mg or 300 mg orally, daily, depending on baseline renal function, provided as 2 small placebo tablets, 2 large placebo tablets, and either one 100 or 300 mg allopurinol capsule.
• Drug: Placebo
  • Placebo, orally, daily, provided as 2 small tablets, 2 large tablets and 1 placebo capsule to match.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Experimental: 3
• Active Comparator: 4
• Placebo Comparator: 5

Primary Measures

• The proportion of subjects whose last three serum urate levels are < 6.0 mg/dL.
  • Time Frame: Weeks 2,4,8,12,16,20,24,and 28
    Safety Issue?: No

Secondary Measures

• The proportion of subjects whose serum urate levels are <6.0 mg/dL;
  • Time Frame: Week 28 and Final Visit
    Safety Issue?: No
• The percent reduction in serum urate levels;
  • Time Frame: Week 28 and Final Visit
    Safety Issue?: No
• The percent reduction in primary tophus size, as determined by physical measurement in the subset of subjects with palpable tophi at the Screening Visit.;
  • Time Frame: Week 28 and Final Visit
    Safety Issue?: No
• The reduction in the total number of tophi in the subset of subjects with palpable tophi at the Screening Visit;
  • Time Frame: Week 28 and Final Visit
    Safety Issue?: No
• The proportion of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the Double-Blind Treatment Period.
  • Time Frame: Weeks 8-28 in 4 week intervals
    Safety Issue?: No

Inclusion Criteria:

• Hyperuricemia (sUA ≥8.0mg/dL) and gout by ARA Criteria
• Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 mL/min by Cockroft and Gault formula.

Exclusion Criteria:

• History of xanthinuria
• Intolerance to allopurinol
• Presence of renal calculi,
• Alcohol intake of ≥ 14 drinks/week
• Clinically significant medical condition

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 TAP Pharmaceutical Products Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00174915

Study ID Number: C02-009

ClinicalTrials.gov Identifier: NCT00174915

Health Authority: United States: Food and Drug Administration