DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Regeneron Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intercritical Gout

Intervention: Colchicine (Colcrys®) (Drug); placebo (Drug); allopurinol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Regeneron Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Trial Management, Study Director, Affiliation: Regeneron Pharmaceuticals

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16

Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16

Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Inclusion criteria include, but are not limited to the following: 1. Men and postmenopausal women between the ages of 18 and 70 2. Meets the ARA criteria for classification of acute gout 3. Tophi present and/or a history of gout attacks in 2 or 3 joints 4. Self-reported history of at least 2 gout flares in the prior 12 months 5. Serum uric acid greater than or equal to 7. 5 mg/dL at the first visit Exclusion Criteria: Exclusion criteria include, but are not limited to the following: 1. Patients with an acute gout flare within 2 weeks prior to the first visit 2. Patients with chronic, active gout with at least 1 continuously inflamed joint for at least 4 weeks 3. Patients with more than three joints affected by gout 4. History of intolerance or allergy to colchicine or allopurinol 5. Use of allopurinol, benzbromarone, febuxostat, probenecid, or sulfinpyrazone less than 3 months prior to entering the study 6. Use of colchicine less than 14 days prior to entering the study

Locations and Contacts

Alabaster, Alabama, United States

Mesa, Arizona, United States

Upland, California, United States

Trumbull, Connecticut, United States

Debary, Florida, United States

Jacksonville, Florida, United States

Kissimmee, Florida, United States

Canton, Georgia, United States

Boise, Idaho, United States

Lexington, Kentucky, United States

Bethesda, Maryland, United States

Reisterstown, Maryland, United States

Bingham Farms, Michigan, United States

Brooklyn Center, Minnesota, United States

Kansas City, Missouri, United States

Billings, Montana, United States

Elizabeth, New Jersey, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Morganton, North Carolina, United States

Winston-Salem, North Carolina, United States

Duncansville, Pennsylvania, United States

Reading, Pennsylvania, United States

West Reading, Pennsylvania, United States

Greer, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Johnson City, Tennessee, United States

Dallas, Texas, United States

Katy, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

West Jordan, Utah, United States

Norfolk, Virginia, United States

Seattle, Washington, United States

Wauwatosa, Wisconsin, United States

Additional Information

Starting date: October 2011
Last updated: April 7, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017