At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 99 enrolled
Drug / intervention
Febuxostat +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo and Allopurinol Controlled, Phase 2 Study to Evaluate Febuxostat in the Medical Management of Subjects With Hyperuricosuria and Calcium Oxalate Stones
In Brief
A Phase 2 clinical trial evaluating Febuxostat, Allopurinol, and 1 other intervention for Hyperuricosuria and Kidney Stones. Completed, enrolled 99 participants across 28 sites.
Detailed Summary
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), compared to allopurinol or placebo in patients with excessive amounts of uric acid in their urine and who have recently had kidney stones.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperuricosuria, Kidney Stones
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedMar 2010
Primary CompletionNov 2011
TodayJul 2026
First PostedMar 1, 2010
Enrollment StartFeb 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago
Interventions
Febuxostatdrug
Febuxostat capsules
Allopurinoldrug
Allopurinol capsules
Placebodrug
Placebo-matching capsules