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

Intercritical Gout Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451645
• Other study ID #: IL1T-GA-1103
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2011
• Last updated: April 7, 2014
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2014
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intercritical Gout

Intervention

Drug:
• Colchicine (Colcrys®)
daily 0.6 mg colchicine dosing for 16 weeks
• placebo
daily placebo dosing for 16 weeks
• allopurinol
background therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Gout Flares Per Participant From Day 1 to Week 16		Day 1 to Week 16	No
Secondary	Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16		Day 1 to Week 16	No
Secondary	Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16		Day 1 to Week 16	No
Secondary	Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16		Day 1 to Week 16	No