Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
1 other identifier
interventional
82
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2011
Shorter than P25 for phase_4
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
October 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
May 12, 2014
CompletedMay 12, 2014
April 1, 2014
10 months
October 10, 2011
September 24, 2013
April 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Gout Flares Per Participant From Day 1 to Week 16
Day 1 to Week 16
Secondary Outcomes (3)
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
Day 1 to Week 16
Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
Day 1 to Week 16
Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
Day 1 to Week 16
Study Arms (2)
placebo
OTHERdaily placebo dosing for 16 weeks with background allopurinol therapy
Colchicine (Colcrys®)
ACTIVE COMPARATORdaily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Alabaster, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Upland, California, United States
Unknown Facility
Trumbull, Connecticut, United States
Unknown Facility
DeBary, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Kissimmee, Florida, United States
Unknown Facility
Canton, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Lexington, Kentucky, United States
Unknown Facility
Bethesda, Maryland, United States
Unknown Facility
Reisterstown, Maryland, United States
Unknown Facility
Bingham Farms, Michigan, United States
Unknown Facility
Brooklyn Center, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Billings, Montana, United States
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Elizabeth, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
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New York, New York, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Hickory, North Carolina, United States
Unknown Facility
Morganton, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Reading, Pennsylvania, United States
Unknown Facility
West Reading, Pennsylvania, United States
Unknown Facility
Greer, South Carolina, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Johnson City, Tennessee, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Katy, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Norfolk, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Wauwatosa, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This clinical trial was not directly related to the development of an investigational/medicinal product.
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2011
First Posted
October 14, 2011
Study Start
October 1, 2011
Primary Completion
August 1, 2012
Study Completion
September 1, 2012
Last Updated
May 12, 2014
Results First Posted
May 12, 2014
Record last verified: 2014-04