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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01451645
First received: October 10, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Intercritical Gout
Drug: Colchicine (Colcrys®)
Drug: placebo
Drug: allopurinol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Number of Gout Flares Per Participant From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ] [ Designated as safety issue: No ]
  • Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 [ Time Frame: Day 1 to Week 16 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451645

  Show 37 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01451645     History of Changes
Other Study ID Numbers: IL1T-GA-1103
Study First Received: October 10, 2011
Results First Received: September 24, 2013
Last Updated: April 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Regeneron Pharmaceuticals:
Gout

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Colchicine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 28, 2014