Phase 4
Completed N=82
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
Intercritical Gout
Source: ClinicalTrials.gov NCT01451645 ↗
Enrolled (actual)
82
Serious AEs
1.2%
Results posted
May 2014
Primary outcomePrimary: Number of Gout Flares Per Participant From Day 1 to Week 16 — 1.1; 0.3 gout flares
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.
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 | — |
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. Informational only — not medical advice.