CompletedPhase 4

Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol

United States82 participantsStarted 2011-10

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Men and postmenopausal women between the ages of 18 and 70
✓. Meets the ARA criteria for classification of acute gout
✓. Tophi present and/or a history of gout attacks in 2 or 3 joints
✓. Self-reported history of at least 2 gout flares in the prior 12 months
✓. Serum uric acid greater than or equal to 7.5 mg/dL at the first visit

Exclusion criteria

✕. Patients with an acute gout flare within 2 weeks prior to the first visit
✕. Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks
✕. Patients with more than three joints affected by gout
✕. History of intolerance or allergy to colchicine or allopurinol
✕. Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study
✕. Use of colchicine less than 14 days prior to entering the study

What they're measuring

Number of Gout Flares Per Participant From Day 1 to Week 16

Timeframe: Day 1 to Week 16

Trial details

NCT IDNCT01451645

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

Results submitted2013-09-24

View on ClinicalTrials.gov More Intercritical Gout trials