search
Back to results

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

Primary Purpose

Intercritical Gout

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Colchicine (Colcrys®)
placebo
allopurinol
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intercritical Gout focused on measuring Gout

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

placebo

Colchicine (Colcrys®)

Arm Description

daily placebo dosing for 16 weeks with background allopurinol therapy

daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 10, 2011
Last Updated
April 7, 2014
Sponsor
Regeneron Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01451645
Brief Title
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intercritical Gout
Keywords
Gout

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Other
Arm Description
daily placebo dosing for 16 weeks with background allopurinol therapy
Arm Title
Colchicine (Colcrys®)
Arm Type
Active Comparator
Arm Description
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
Intervention Type
Drug
Intervention Name(s)
Colchicine (Colcrys®)
Intervention Description
daily 0.6 mg colchicine dosing for 16 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
daily placebo dosing for 16 weeks
Intervention Type
Drug
Intervention Name(s)
allopurinol
Intervention Description
background therapy
Primary Outcome Measure Information:
Title
Number of Gout Flares Per Participant From Day 1 to Week 16
Time Frame
Day 1 to Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
Time Frame
Day 1 to Week 16
Title
Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
Time Frame
Day 1 to Week 16
Title
Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
Time Frame
Day 1 to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion criteria include, but are not limited to the following: 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 Exclusion Criteria: Exclusion criteria include, but are not limited to the following: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Alabaster
State/Province
Alabama
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Upland
State/Province
California
Country
United States
City
Trumbull
State/Province
Connecticut
Country
United States
City
Debary
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Kissimmee
State/Province
Florida
Country
United States
City
Canton
State/Province
Georgia
Country
United States
City
Boise
State/Province
Idaho
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Bethesda
State/Province
Maryland
Country
United States
City
Reisterstown
State/Province
Maryland
Country
United States
City
Bingham Farms
State/Province
Michigan
Country
United States
City
Brooklyn Center
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Billings
State/Province
Montana
Country
United States
City
Elizabeth
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Hickory
State/Province
North Carolina
Country
United States
City
Morganton
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Reading
State/Province
Pennsylvania
Country
United States
City
West Reading
State/Province
Pennsylvania
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
City
Johnson City
State/Province
Tennessee
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
West Jordan
State/Province
Utah
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Wauwatosa
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs