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Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences
This study has been completed.
Sponsor:
Azienda Sanitaria Locale 3, Torino
Information provided by (Responsible Party):
Azienda Sanitaria Locale 3, Torino
ClinicalTrials.gov Identifier:
NCT00128453
First received: August 8, 2005
Last updated: June 6, 2012
Last verified: June 2012
| Tracking Information | ||||||||||
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| First Received Date ICMJE | August 8, 2005 | |||||||||
| Last Updated Date | June 6, 2012 | |||||||||
| Start Date ICMJE | August 2005 | |||||||||
| Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
Recurrence rate at 18 months [ Time Frame: 18 months ] | |||||||||
| Original Primary Outcome Measures ICMJE |
Recurrence rate at 18 months | |||||||||
| Change History | Complete list of historical versions of study NCT00128453 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Symptom persistence at 72 hours, remission rate at 1 week. Number of recurrences. Time to first recurrence. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. Cost-efficacy analyses. | |||||||||
| Current Other Outcome Measures ICMJE | Not Provided | |||||||||
| Original Other Outcome Measures ICMJE | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Study of Colchicine to Treat Acute Pericarditis and Prevent Recurrences | |||||||||
| Official Title ICMJE | Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis | |||||||||
| Brief Summary | The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences. | |||||||||
| Detailed Description | Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the index attack of pericarditis and the prevention of further recurrences. Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment. |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase | Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Pericarditis | |||||||||
| Intervention ICMJE |
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| Study Arms |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Enrollment ICMJE | 240 | |||||||||
| Completion Date | June 2012 | |||||||||
| Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Italy | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00128453 | |||||||||
| Other Study ID Numbers ICMJE | DCASL30501-1 EUDRACT number 2005-001570-28 |
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| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Azienda Sanitaria Locale 3, Torino | |||||||||
| Study Sponsor ICMJE | Azienda Sanitaria Locale 3, Torino | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Azienda Sanitaria Locale 3, Torino | |||||||||
| Verification Date | June 2012 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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