Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

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

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

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 milligram (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, orally, once daily for up to 52 weeks.
• Drug: Febuxostat
  • Febuxostat 120 mg, orally, once daily for up to 52 weeks.
• Drug: Allopurinol
  • Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Febuxostat 80 mg QD
• Experimental: Febuxostat 120 mg QD
• Active Comparator: Allopurinol 300 mg QD

Primary Measures

• Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
  • Time Frame: Last 3 Visits (up to 52 weeks)
    Safety Issue?: No

Secondary Measures

• Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
  • Time Frame: Week 28
    Safety Issue?: No
• Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
  • Time Frame: Week 52
    Safety Issue?: No
• Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit
  • Time Frame: Final Visit (up to 52 weeks)
    Safety Issue?: No
• Percent Change From Baseline in Serum Urate Levels at Week 28.
  • Time Frame: Baseline and Week 28
    Safety Issue?: No
• Percent Change From Baseline in Serum Urate Levels at Week 52.
  • Time Frame: Baseline and Week 52
    Safety Issue?: No
• Percent Change From Baseline in Serum Urate Levels at Final Visit
  • Time Frame: Baseline and Final Visit (up to 52 weeks)
    Safety Issue?: No
• Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
  • Time Frame: Baseline and Week 28
    Safety Issue?: No
• Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
  • Time Frame: Baseline and Week 52
    Safety Issue?: No
• Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
  • Time Frame: Baseline and Final Visit (up to 52 weeks)
    Safety Issue?: No
• Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
  • Time Frame: Baseline and Week 28
    Safety Issue?: No
• Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
  • Time Frame: Baseline and Week 52
    Safety Issue?: No
• Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
  • Time Frame: Baseline and Final Visit (up to 52 weeks)
    Safety Issue?: No
• Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
  • Time Frame: Weeks 8 through 52
    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 milligrams per deciliter (mg/dL) at Baseline

Exclusion Criteria:

• Serum creatinine >1.5 mg/dL
• Calculated creatinine clearance of <50 milliliters per minutes (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 kilogram per meter²(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 Investigator: Takeda Global Research & Development Center, Inc. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 09, 2012

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

Uloric Package Insert

FDA Safety Alerts and Recalls