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

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.

Primary:

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

Secondary:

• The proportion of subjects whose serum urate levels are <6.0 mg/dL; Week 28 and Final Visit No
• The percent reduction in serum urate levels; Week 28 and Final Visit 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.; Week 28 and Final Visit No
• The reduction in the total number of tophi in the subset of subjects with palpable tophi at the Screening Visit; Week 28 and Final Visit No
• The proportion of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the Double-Blind Treatment Period. Weeks 8-28 in 4 week intervals 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

Lead Sponsor: TAP Pharmaceutical Products Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair TAP Pharmaceutical Products Inc.  

Information obtained from ClinicalTrials.gov on July 23, 2008

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