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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00235079
Other study ID # DCASL30501-4
Secondary ID EUDRACT number 2
Status Completed
Phase Phase 4
First received October 6, 2005
Last updated August 6, 2013
Start date November 2005
Est. completion date December 2011

Study information

Verified date August 2013
Source Azienda Sanitaria Locale 3, Torino
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Colchicine
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Placebo
Placebo comparator

Locations

Country Name City State
Italy Azienda Ospedaliera Papa Giovanni XXIII Bergamo
Italy Ospedale Regionale Bolzano
Italy Ospedale di Rivoli Rivoli
Italy Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center) Torino

Sponsors (1)

Lead Sponsor Collaborator
Azienda Sanitaria Locale 3, Torino

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Imazio M, Cecchi E, Ierna S, Trinchero R; CORP Investigators. CORP (COlchicine for Recurrent Pericarditis) and CORP-2 trials--two randomized placebo-controlled trials evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of recurrent pericarditis: study design and rationale. J Cardiovasc Med (Hagerstown). 2007 Oct;8(10):830-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence rate at 18 months 18 m onths No
Secondary Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. 1 week No
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