NCT00430248

Efficacy and Safety of Oral Febuxostat in Participants With Gout

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,269 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.

Detailed description

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects. Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout. Treatment duration will be 6 months.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Febuxostat	Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
DRUG	Febuxostat	Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
DRUG	Allopurinol	Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months. Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2007-02-01
• Last updated: 2012-02-02
• Results posted: 2009-07-16

Locations

258 sites across 1 country: United States