Official Title: “A Phase 3, Open-Label, Randomized, Allopurinol-Controlled Study to Assess the Long-Term Safety of Oral Febuxostat in Subjects With Gout”

To evaluate the long-term safety of febuxostat to reduce serum urate levels to in subjects with gout, as compared to allopurinol.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2007

To evaluate the long-term safety of febuxostat 80 mg QD and 120 mg QD doses required to reduce serum urate levels to <6.0 mg/dL in subjects with gout, as compared to allopurinol 100 or 300 mg depending on renal function.

Intervention(s) in this Clinical Trial

• Drug: Febuxostat
  • Febuxostat 80 mg in tablet form orally daily for up to 41 ;months.
• Drug: Febuxostat
  • Febuxostat 120 mg in tablet form orally, daily for up to 41 months.
• Drug: Allopurinol
  • Allopurinol, 100 or 300 mg in tablet form administered orally,dose titrated according to renal function for up to 41 months.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • The C02-021 Study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet, to be administered orally. Subjects could be titrated to 120 mg, provided as one 40 and 80 mg tablet, between Months 2 and 6, if their serum uric acid rose > 6.0 mg/dL; the dose could be down-titrated to 80 mg if the serum uric acid decreased to < 3.0 mg/dL. The protocol was amended to add a comparator arm, and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol (100 or 300 mg, dependent on renal function). The information below reflects the treatments following the implementation of the revised protocol.
• Experimental: 2
• Active Comparator: 3
  • The C02-021 Study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet, to be administered orally. Subjects could be titrated to 120 mg, provided as one 40 and 80 mg tablet, between Months 2 and 6, if their serum uric acid rose > 6.0 mg/dL; the dose could be down-titrated to 80 mg if the serum uric acid decreased to < 3.0 mg/dL. The protocol was amended to add a comparator arm, and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol (100 or 300 mg, dependent on renal function). The information below reflects the treatments following the implementation of the revised protocol.

Primary Measures

• The proportion of subjects whose serum urate level decreases to <6.0 mg/dL.
  • Time Frame: At each visit
    Safety Issue?: No

Secondary Measures

• Percent reduction in serum urate from baseline.
  • Time Frame: At each vist
    Safety Issue?: No
• Percent reduction in primary tophus size for subjects with palpable tophi.
  • Time Frame: At each visit
    Safety Issue?: No
• Reduction in the total number of tophi for subjects with palpable tophi.
  • Time Frame: At each visit
    Safety Issue?: No
• Proportion of subjects requiring treatment for gout flare.
  • Time Frame: At each visit
    Safety Issue?: No

Inclusion Criteria:

• Subjects completing Phase 3 Studies C02-009 or C02-010.

Exclusion Criteria:

• Subject is breastfeeding or pregnant.
• Subject has any other significant medical condition as defined by the investigator that would interfere with the treatment.
• Subject is intolerant of allopurinol.

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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00175019

Study ID Number: C02-021

ClinicalTrials.gov Identifier: NCT00175019

Health Authority: United States: Food and Drug Administration