Conditions: Gout
Keywords: Uric Acid, gout, xanthine oxidase, febuxostat, tophi
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1072
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Febuxostat intervention 2: Febuxostat intervention 3: Febuxostat intervention 4: Allopurinol intervention 5: Placebo
Intervention descriptions: intervention 1: Febuxostat 80 mg, orally, once daily for up to 28 weeks. intervention 2: Febuxostat 120 mg, orally, once daily for up to 28 weeks. intervention 3: Febuxostat 240 mg, orally, once daily for up to 28 weeks. intervention 4: 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. intervention 5: Placebo, orally, once daily for up to 28 weeks.

Protocol document: