Phase 4
N=82
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Intercritical Gout
Bottom Line
View on ClinicalTrials.gov: NCT01451645 ↗Enrolled (actual)
82
Serious AEs
1.2%
Results posted
May 2014
Primary outcome: Primary: Number of Gout Flares Per Participant From Day 1 to Week 16 — 1.1; 0.3 gout flares
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Colchicine (Colcrys®) (Drug); placebo (Drug); allopurinol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Gout Flares Per Participant From Day 1 to Week 16 |
1.1; 0.3 | — |
| SECONDARY Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16 |
43.9; 24.4 | — |
| SECONDARY Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16 |
24.4; 4.9 | — |
| SECONDARY Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16 |
6.6; 1.6 | — |
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:
- 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
Data sourced from ClinicalTrials.gov (NCT01451645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.