At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 330 enrolled
Drug / intervention
Lesinurad +3 moredrug
Likely dose
Lesinurad 400 mgfrom 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 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout
In Brief
A Phase 3 clinical trial evaluating Lesinurad, Placebo, and 1 other intervention for Tophaceous Gout. Completed, enrolled 330 participants across 124 sites in 6 countries.
Detailed Summary
This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTophaceous Gout
CountriesAustralia, Canada, New Zealand, Poland, Switzerland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
First PostedJan 2012
Primary CompletionJun 2014
TodayJul 2026
First PostedJan 16, 2012
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.5 years ago
Interventions
Lesinuraddrug
Tablets, 400 mg once daily (QD)
Lesinuraddrug
Tablets, 200 mg QD
Placebodrug
Tablets, Placebo QD
Febuxostatdrug
80 mg