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

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ClinicalTrials.gov Identifier: NCT00235079
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Azienda Sanitaria Locale 3, Torino

Brief 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.

Condition or disease Intervention/treatment Phase
Pericarditis Recurrence Drug: Colchicine Drug: Placebo Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
Study Start Date : November 2005
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Colchicine
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Drug: Colchicine
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Placebo Comparator: Placebo
Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
Drug: Placebo
Placebo comparator



Primary Outcome Measures :
  1. Recurrence rate at 18 months [ Time Frame: 18 m onths ]

Secondary Outcome Measures :
  1. Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00235079


Locations
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, Italy, 10141
Sponsors and Collaborators
Azienda Sanitaria Locale 3, Torino
Investigators
Study Chair: Massimo Imazio, MD Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)
Study Chair: Rita Trinchero, MD Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier: NCT00235079     History of Changes
Other Study ID Numbers: DCASL30501-4
EUDRACT number 2005-001570-28
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Azienda Sanitaria Locale 3, Torino:
Pericarditis
Recurrence
Therapeutics
Prevention
Colchicine

Additional relevant MeSH terms:
Recurrence
Pericarditis
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents