Conditions: Gout
Keywords: uric Acid xanthine oxidase tophi Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 760
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Allopurinol
Intervention descriptions: intervention 1: Febuxostat 80 mg, orally, once daily for up to 52 weeks. intervention 2: Febuxostat 120 mg, orally, once daily for up to 52 weeks. intervention 3: Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.

Protocol document: