NCT00102440

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Gout

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-07-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2005-01-31
• Last updated: 2012-02-02
• Results posted: 2009-07-16