NCT01451645CompletedPhase 4
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 82
- Primary Endpoint
- Number of Gout Flares Per Participant From Day 1 to Week 16
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Colchicine (Colcrys®)
Active Comparator
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
Intervention: Colchicine (Colcrys®) (Drug)
placebo
Other
daily placebo dosing for 16 weeks with background allopurinol therapy
Intervention: placebo (Drug)
placebo
Other
daily placebo dosing for 16 weeks with background allopurinol therapy
Intervention: allopurinol (Drug)
Colchicine (Colcrys®)
Active Comparator
daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
Intervention: allopurinol (Drug)
Outcomes
Primary Outcomes
Number of Gout Flares Per Participant From Day 1 to Week 16
Time Frame: Day 1 to Week 16
Secondary Outcomes
- Percentage of Participants With at Least 1 Gout Flare From 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(Day 1 to Week 16)
- Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16(Day 1 to Week 16)
Investigators
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