At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
AC-201 100 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 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF AC-201 IN SUBJECTS WITH GOUT
In Brief
A Phase 2 clinical trial evaluating Placebo, AC-201, and 1 other intervention for Gout. Completed, enrolled 127 participants across 1 site.
Detailed Summary
The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesTaiwan
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartDec 2014
Primary CompletionOct 2016
TodayJul 2026
First PostedNov 11, 2014
Enrollment StartDec 1, 2014
Primary CompletionOct 27, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.6 years ago
Interventions
Placebodrug
Placebo twice daily from Day 1 to Week 12
AC-201drug
AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
Febuxostatdrug
Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration \<6 mg/dL