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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier:
NCT00235079
First received: October 6, 2005
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Pericarditis
Recurrence
Drug: Colchicine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Azienda Sanitaria Locale 3, Torino:

Primary Outcome Measures:
  • Recurrence rate at 18 months [ Time Frame: 18 m onths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: November 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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).
  More Information

Publications:
Additional 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
Study First Received: October 6, 2005
Last Updated: August 6, 2013
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 28, 2014