Clinical trial NCT01451645: Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intercritical Gout
Keywords: Gout
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-10-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of Gout Flares Per Participant From Day 1 to Week 16
timeFrame: Day 1 to Week 16
Secondary outcomes:
measure: Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16
timeFrame: Day 1 to Week 16
measure: Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16
timeFrame: Day 1 to Week 16
measure: Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16
timeFrame: Day 1 to Week 16
Other outcomes:
Locations:
city: Alabaster
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Upland
country: United States
state: California
city: Trumbull
country: United States
state: Connecticut
city: Debary
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Canton
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Lexington
country: United States
state: Kentucky
city: Bethesda
country: United States
state: Maryland
city: Reisterstown
country: United States
state: Maryland
city: Bingham Farms
country: United States
state: Michigan
city: Brooklyn Center
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Elizabeth
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Morganton
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Duncansville
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Johnson City
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Wauwatosa
country: United States
state: Wisconsin
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: