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

Patients with gout will receive febuxostat or allopurinol for 6 months. Tests will be done every 2 months to evaluate safety and efficacy.

Study Type: Interventional

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

Study Primary Completion Date: March 2008

Subjects will undergo a 30-day Washout Period (Day -30 Screening Visit), if on prior urate-lowering therapy (ULTs); no Washout Period is required for subjects not on prior ULTs.

Subjects will be randomized to 1 of 3 arms in a 1:1:1 ratio: febuxostat 40 mg QD; or febuxostat 80 mg QD; or allopurinol. Subjects randomized to allopurinol will receive either 300 mg QD or 200 mg QD, depending on renal function.

Treatment duration will be 6 months.

Intervention(s) in this Clinical Trial

• Drug: Febuxostat
  • Febuxostat 40 mg once daily, to be administered orally for 6 months.
• Drug: Febuxostat
  • Febuxostat 80 mg in capsule form to be administered orally once daily for 6 months.
• Drug: Allopurinol
  • Allopurinol, 200 or 300 mg in capsule form orally once daily for 6 months. The dose is dependent on the subject's renal function.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• The proportion of subjects whose sUA level is <6.0 mg/dL at the Final Visit.
  • Time Frame: Month 6 or final visit
    Safety Issue?: No

Secondary Measures

• The proportion of subjects whose serum urate levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL, at each visit.
  • Time Frame: Final visit
    Safety Issue?: No
• The percent reduction from baseline in serum urate levels, at each visit.
  • Time Frame: Months 2, 4, and 6
    Safety Issue?: No
• The proportion of renal impairment subjects whose final visit serum urate level is <6.0 mg/dl
  • Time Frame: Final visit
    Safety Issue?: No

Inclusion Criteria:

• Subject is defined as having one or more of the ARA criteria for the diagnosis of gout.
• Females must be postmenopausal, surgically sterile or using contraceptives (not breast feeding) and have a negative pregnancy test.
• Subject must have a sUA level ≥ 8.0 mg/dL.

Exclusion Criteria:

• 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 > 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 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; IV colchicine; cyclosporine;
• cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.

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 November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00430248

Study ID Number: F-GT06-153

ClinicalTrials.gov Identifier: NCT00430248

Health Authority: United States: Food and Drug Administration