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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01451645
Recruitment Status : Completed
First Posted : October 14, 2011
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Intercritical Gout Drug: Colchicine (Colcrys®) Drug: placebo Drug: allopurinol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
placebo
daily placebo dosing for 16 weeks with background allopurinol therapy
Drug: placebo
daily placebo dosing for 16 weeks

Drug: allopurinol
background therapy

Active Comparator: Colchicine (Colcrys®)
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
Drug: Colchicine (Colcrys®)
daily 0.6 mg colchicine dosing for 16 weeks

Drug: allopurinol
background therapy




Primary Outcome Measures :
  1. Number of Gout Flares Per Participant From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ]

Secondary Outcome Measures :
  1. Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ]
  2. Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ]
  3. Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01451645


Locations
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United States, Alabama
Alabaster, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
United States, California
Upland, California, United States
United States, Connecticut
Trumbull, Connecticut, United States
United States, Florida
Debary, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
United States, Georgia
Canton, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Maryland
Bethesda, Maryland, United States
Reisterstown, Maryland, United States
United States, Michigan
Bingham Farms, Michigan, United States
United States, Minnesota
Brooklyn Center, Minnesota, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, New Jersey
Elizabeth, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
New York, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Morganton, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Reading, Pennsylvania, United States
West Reading, Pennsylvania, United States
United States, South Carolina
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
United States, Tennessee
Johnson City, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Katy, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Wauwatosa, Wisconsin, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01451645    
Other Study ID Numbers: IL1T-GA-1103
First Posted: October 14, 2011    Key Record Dates
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014
Last Verified: April 2014
Keywords provided by Regeneron Pharmaceuticals:
Gout
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Colchicine
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents