Status:
COMPLETED
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Intercritical Gout
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- Inclusion criteria include, but are not limited to the following:
- 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
- Exclusion criteria include, but are not limited to the following:
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01451645
Start Date
October 1 2011
End Date
September 1 2012
Last Update
May 12 2014
Active Locations (37)
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1
Alabaster, Alabama, United States
2
Mesa, Arizona, United States
3
Upland, California, United States
4
Trumbull, Connecticut, United States