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

Completed · Phase 4 · Has a placebo group

Conditions studied: Intercritical Gout

In brief

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.

Key facts

Study ID

NCT01451645

Run by

Regeneron Pharmaceuticals

People needed

82

Starts

2011-10-01

Expected to finish

2012-09-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Alabaster, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Upland, California, United States
• Study site — Trumbull, Connecticut, United States
• Study site — DeBary, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Canton, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Lexington, Kentucky, United States
• Study site — Bethesda, Maryland, United States
• Study site — Reisterstown, Maryland, United States
• Study site — Bingham Farms, Michigan, United States
• Study site — Brooklyn Center, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Billings, Montana, United States
• Study site — Elizabeth, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Hickory, North Carolina, United States
• Study site — Morganton, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Reading, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.