At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 760 enrolled
Drug / intervention
Febuxostat +2 moredrug
Likely dose
Febuxostat 80 mg or 120 mg orally once daily for up to 52 weeks; or Allopurinol 300 mg orally once daily for up to 52 weeksAI-extracted
Key inclusion· 2
- ✓Meet American Rheumatism Association preliminary classification criteria for acute arthritis of primary gout
- ✓Serum uric acid ≥8.0 mg/dL at baseline
Key exclusion· 7
- ✕Serum creatinine >1.5 mg/dL
- ✕Calculated creatinine clearance <50 mL/min
- ✕Pregnancy or lactation
- ✕Concurrent therapy with urate-lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout
In Brief
A Phase 3 clinical trial evaluating Febuxostat and Allopurinol for Gout. Completed, enrolled 760 participants.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2002
Primary CompletionFeb 2004
First PostedJan 2005
TodayJul 2026
First PostedJan 31, 2005
Enrollment StartJul 1, 2002
Primary CompletionFeb 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 21.4 years ago
Interventions
Febuxostatdrug
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Febuxostatdrug
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Allopurinoldrug
Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.