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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Azienda Sanitaria Locale 3, Torino.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier:
NCT00235079
First received: October 6, 2005
Last updated: NA
Last verified: October 2005
History: No changes posted
  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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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

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

Primary Outcome Measures:
  • Recurrence rate at 18 months

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.

Estimated Enrollment: 240
Study Start Date: November 2005
Estimated Study Completion Date: December 2009
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235079

Contacts
Contact: Massimo Imazio, MD + 39 011 4393391 massimo_imazio@yahoo.it
Contact: Rita Trinchero, MD +39 011 4393315 trinchero@asl3.to.it

Locations
Italy
Ospedale di Rivoli Not yet recruiting
Rivoli, Italy
Contact: Paolo Giay Pron, MD     + 39 011 95511        
Contact: Maria Rosa Conte, MD     + 39 011 95511        
Principal Investigator: Maria Rosa Conte, MD            
Sub-Investigator: Paolo Giay Pron, MD            
Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center) Not yet recruiting
Torino, Italy, 10141
Contact: Massimo Imazio, MD     + 39 011 4393391     massimo_imazio@yahoo.it    
Contact: Rita Trinchero, MD     + 39 011 4393315     trinchero@asl3.to.it    
Principal Investigator: Massimo Imazio, MD            
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

No publications provided

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: October 6, 2005
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 May 23, 2013