NCT00128414

Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)

Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP Trial: COlchicine for Recurrent Pericarditis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Azienda Sanitaria Locale 3, Torino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).

Detailed description

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the first attack of recurrent pericarditis and the prevention of further recurrences. Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of the first attack of recurrent pericarditis and the secondary prevention of recurrences. Colchicine will be used in addition to conventional treatment.

Conditions

• Pericarditis
• Recurrence

Interventions

Type	Name	Description
DRUG	Colchicine (for 6 months)	colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 1 month in patients ≥70 kg, and halved doses for patients \<70 kg or intolerant to the highest dose.
DRUG	Placebo	Tablets identical in colour, shape, and taste were provided in blister packs.

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-04-01
• Completion: 2010-10-01
• First posted: 2005-08-10
• Last updated: 2011-02-16

Locations

5 sites across 1 country: Italy