Status:
COMPLETED
Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)
Lead Sponsor:
Azienda Sanitaria Locale 3, Torino
Conditions:
Pericarditis
Recurrence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 firs...
Eligibility Criteria
Inclusion
- Patients with the first attack of recurrent pericarditis
- Age≥ 18 years
- Informed consent
Exclusion
- Suspected neoplastic, tuberculous, or purulent etiology
- Known severe liver disease and/or elevated transaminases \>1.5 times the upper limit of normality
- Serum creatinine \>2.5 mg/dl
- Serum creatine kinase (CK) over the upper limit of normality or known myopathy
- Known gastrointestinal or blood disease
- Pregnant or lactating women or women not protected by a contraception method
- Known hypersensibility to colchicine
- Treatment with colchicine at enrolment
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00128414
Start Date
August 1 2005
End Date
October 1 2010
Last Update
February 16 2011
Active Locations (5)
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1
Internal Medicine Dpt. Ospedali Riuniti
Bergamo, Bergamo, Italy
2
Department of Cardiology, San Maurizio Regional Hospital
Bolzano, Bolzano, Italy
3
Cardiology Dpt. Ospedale SS Annunziata
Savigliano, CN, Italy
4
Cardiology Department. Maria Vittoria Hospital. ASL3 Torino
Torino, Torino, Italy, 10141