NCT00174915

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,072 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Gout

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-02-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2005-09-15
• Last updated: 2012-02-02
• Results posted: 2009-07-16