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Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

NCT ID: NCT00235079

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2011-12-31

Brief Summary

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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 Description

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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.

Conditions

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Pericarditis Recurrence

Keywords

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Pericarditis Recurrence Therapeutics Prevention Colchicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Colchicine

Colchicine 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

Colchicine 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Placebo

Placebo 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Interventions

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Colchicine

Colchicine 0.5mg BID (\>70Kg) or 0.5 once daily for 6 months

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with the second and subsequent attack of recurrent pericarditis,
* Ageā‰„ 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria Locale 3, Torino

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Massimo Imazio, MD

Role: STUDY_CHAIR

Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)

Rita Trinchero, MD

Role: STUDY_CHAIR

Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).

Locations

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Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)

Torino, Torino, Italy

Site Status

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , Italy

Site Status

Ospedale Regionale

Bolzano, , Italy

Site Status

Ospedale di Rivoli

Rivoli, , Italy

Site Status

Countries

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Italy

References

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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. doi: 10.2459/JCM.0b013e3280110616.

Reference Type BACKGROUND
PMID: 17885522 (View on PubMed)

Imazio M, Belli R, Brucato A, Cemin R, Ferrua S, Beqaraj F, Demarie D, Ferro S, Forno D, Maestroni S, Cumetti D, Varbella F, Trinchero R, Spodick DH, Adler Y. Efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis (CORP-2): a multicentre, double-blind, placebo-controlled, randomised trial. Lancet. 2014 Jun 28;383(9936):2232-7. doi: 10.1016/S0140-6736(13)62709-9. Epub 2014 Mar 30.

Reference Type DERIVED
PMID: 24694983 (View on PubMed)

Other Identifiers

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EUDRACT number 2005-001570-28

Identifier Type: -

Identifier Source: secondary_id

DCASL30501-4

Identifier Type: -

Identifier Source: org_study_id