Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment. (CORP 2)

City of Turin Local Health Authority

Status and phase

Completed

Phase 4

Conditions

Pericarditis

Recurrence

Treatments

Drug: Placebo

Drug: Colchicine

Study type

Interventional

Funder types

Other

Identifiers

NCT00235079

EUDRACT number 2005-001570-28

DCASL30501-4

Details and patient eligibility

About

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.

Full description

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.

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with the second and subsequent attack of recurrent pericarditis,
Age≥ 18 years,
Informed consent.

Exclusion criteria

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 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 the enrolment.