NCT00174915 - Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects. | Biotech Hunter

Enrollment

1,072

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

April 30, 2004

Study Completion Date

April 30, 2004

Conditions

Gout

Interventions

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.