At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 189 enrolled
Drug / intervention
Febuxostat IR +5 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 Phase 2, Randomized, Double Blind, Multicenter, Placebo Controlled Study to Evaluate the Efficacy and Safety of Febuxostat 40 mg XR, 80 mg XR, 40 mg IR and 80 mg IR in Subjects With Gout and Moderate Renal Impairment
In Brief
A Phase 2 clinical trial evaluating Febuxostat IR, Febuxostat XR, and 4 other interventions for Gout and Moderate Renal Impairment. Completed, enrolled 189 participants across 89 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants with moderate renal impairment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout, Moderate Renal Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartMay 2014
Primary CompletionSep 2015
Study CompletionOct 2015
TodayJul 2026
First PostedMay 1, 2014
Enrollment StartMay 1, 2014
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.2 years ago
Interventions
Febuxostat IRdrug
Febuxostat IR over-encapsulated tablets
Febuxostat XRdrug
Febuxostat over-encapsulated capsules
Febuxostat placebodrug
Febuxostat IR and XR placebo-matching capsules
Colchicinedrug
Colchicine tablets
Naproxendrug
Naproxen tablets
Lansoprazoledrug
Lansoprazole capsules