Clinical Trial: Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Per
Brief Summary: The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.
Detailed Summary: Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.
Sponsor: Azienda Sanitaria Locale 3, Torino
Current Primary Outcome: Recurrence rate at 18 months [ Time Frame: 18 m onths ]
Original Primary Outcome: Recurrence rate at 18 months
Current Secondary Outcome: Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. [ Time Frame: 1 week ]
Original Secondary Outcome: Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study.
Information By: Azienda Sanitaria Locale 3, Torino
Dates:
Date Received: October 6, 2005
Date Started: November 2005
Date Completion:
Last Updated: August 6, 2013
Last Verified: August 2013