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

City of Turin Local Health Authority

Status and phase: Completed; Phase 3

Conditions: Pericarditis; Recurrence

Treatments: Drug: Colchicine (for 6 months); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00128414

DCASL30501-2

EUDRACT number 2005-001570-28

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with the first 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Placebo

Colchicine

Experimental group

Description:

Colchicine 1.0 mg twice daily for the first day followed by a maintenance dose of 0.5 mg twice daily for 6 month in patients ≥70 kg, and halved doses for patients \<70 kg or intolerant to the highest dose.

Treatment:

Drug: Colchicine (for 6 months)