At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 82 enrolled
Drug / intervention
Colchicine (Colcrys®) +2 moredrug
Likely dose
Colchicine (Colcrys®) 0.6 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.
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
In Brief
A Phase 4 clinical trial evaluating Colchicine (Colcrys®), placebo, and 1 other intervention for Intercritical Gout. Completed, enrolled 82 participants across 37 sites.
Detailed Summary
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntercritical Gout
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedOct 2011
Primary CompletionAug 2012
Study CompletionSep 2012
TodayJul 2026
First PostedOct 14, 2011
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.7 years ago
Interventions
Colchicine (Colcrys®)drug
daily 0.6 mg colchicine dosing for 16 weeks
placebodrug
daily placebo dosing for 16 weeks
allopurinoldrug
background therapy