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

April 7, 2014 updated by: Regeneron Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alabaster, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
    • California
      • Upland, California, United States
    • Connecticut
      • Trumbull, Connecticut, United States
    • Florida
      • Debary, Florida, United States
      • Jacksonville, Florida, United States
      • Kissimmee, Florida, United States
    • Georgia
      • Canton, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Bethesda, Maryland, United States
      • Reisterstown, Maryland, United States
    • Michigan
      • Bingham Farms, Michigan, United States
    • Minnesota
      • Brooklyn Center, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Montana
      • Billings, Montana, United States
    • New Jersey
      • Elizabeth, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, 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
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
      • Reading, Pennsylvania, United States
      • West Reading, Pennsylvania, United States
    • South Carolina
      • Greer, South Carolina, United States
      • Mt. Pleasant, South Carolina, United States
    • Tennessee
      • Johnson City, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Katy, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Wauwatosa, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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: allopurinol
background therapy
Drug: Colchicine (Colcrys®)
daily 0.6 mg colchicine dosing for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Gout Flares Per Participant From Day 1 to Week 16
Time Frame: Day 1 to Week 16
Day 1 to Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
Time Frame: 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
Time Frame: 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
Time Frame: Day 1 to Week 16
Day 1 to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

May 12, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL1T-GA-1103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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