At a glance
ClinicalIndex Comparison Record- ✓Hyperuricemia with serum urate ≥8.0 mg/dL
- ✓Gout diagnosis by American Rheumatism Association Criteria
- ✓Renal function: serum creatinine <2.0 mg/dL
- ✓Renal function: creatinine clearance >20 mL/min by Cockroft and Gault formula
- ✕History of xanthinuria
- ✕Intolerance to allopurinol
- ✕Presence of renal calculi
- ✕Alcohol intake of ≥14 drinks/week
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Multicenter, Allopurinol and Placebo-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout.
In Brief
A Phase 3 clinical trial evaluating Febuxostat, Allopurinol, and 1 other intervention for Gout. Completed, enrolled 1,072 participants.
Detailed Summary
The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.
Study Details
Timeline
Interventions
Febuxostat 80 mg, orally, once daily for up to 28 weeks.
Febuxostat 120 mg, orally, once daily for up to 28 weeks.
Febuxostat 240 mg, orally, once daily for up to 28 weeks.
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.
Placebo, orally, once daily for up to 28 weeks.