Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.

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

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

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, once daily for up to 28 weeks.
• Drug: Febuxostat
  • Febuxostat 120 mg, orally, once daily for up to 28 weeks.
• Drug: Febuxostat
  • Febuxostat 240 mg, orally, once daily for up to 28 weeks.
• Drug: Allopurinol
  • Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
• Drug: Placebo
  • Placebo, orally, once daily for up to 28 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Febuxostat 80 mg QD
• Experimental: Febuxostat 120 mg QD
• Experimental: Febuxostat 240 mg QD
• Active Comparator: Allopurinol QD
• Placebo Comparator: Placebo QD

Primary Measures

• Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).
  • Time Frame: Last 3 visits (any last 3 visits up to week 28)
    Safety Issue?: No

Secondary Measures

• Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28
  • Time Frame: Week 28
    Safety Issue?: No
• Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit
  • Time Frame: Final Visit (up to 28 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 Final Visit
  • Time Frame: Baseline and Final Visit (up to 28 weeks)
    Safety Issue?: No
• Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.
  • Time Frame: Baseline and Week 28
    Safety Issue?: No
• Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.
  • Time Frame: Baseline and Final Visit (up to 28 weeks)
    Safety Issue?: No
• Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.
  • Time Frame: Baseline and Week 28
    Safety Issue?: No
• Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit
  • Time Frame: Final Visit (up to 28 weeks)
    Safety Issue?: No
• Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.
  • Time Frame: Weeks 8 through 28
    Safety Issue?: No

Inclusion Criteria:

• Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association
• Criteria
• Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (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 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 12, 2012

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

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