PericarditisPhase 4CORP 2NCT00235079
Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.
A Phase 4 study testing Colchicine in people with Pericarditis and Recurrence, run by Azienda Sanitaria Locale 3, Torino at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pericarditis, Recurrence
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 4 sitesItaly
- Study dates
- Nov 2005to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the second and subsequent attack of recurrent pericarditis,
- Age≥ 18 years,
- Informed consent.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
Ospedale Regionale
Bolzano
Ospedale di Rivoli
Rivoli
Cardiology Department. Maria Vittoria Hospital ASL3 Torino (Coordinating Center)
Torino, Torino, 10141
About this study
Official title: Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
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.
Read the 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.
- Conditions
- Pericarditis, Recurrence
- Being tested
- Colchicine, Placebo
- Keywords
- Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
- Medical subject headings
- Pericarditis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at 18 months
Measured: 18 m onths
Secondary outcomes (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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PericarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale 3, Torino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Imazio, MD, Study chair, Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)Rita Trinchero, MD, Study chair, Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235079
- Sponsor's protocol ID
- DCASL30501-4
- Other IDs
- EUDRACT number 2005-001570-28
- Acronym
- CORP 2
- Status last verified
- Aug 2013
- First submitted
- 6 Oct 2005
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17885522Imazio 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.
PubMed 24694983
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
- ClinicalTrials.gov ID
- NCT00235079
- Acronym / sponsor ID
- CORP 2 / DCASL30501-4
- Conditions
- Pericarditis, Recurrence
- Keywords
- Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale 3, TorinoUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineColchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with the second and subsequent attack of recurrent pericarditis,
- Age≥ 18 years,
- Informed consent.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months | Drug | Colchicine |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Recurrence rate at 18 months
Time frame: 18 m onths
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Background: PubMed 17885522Imazio 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.
- Derived from this study: PubMed 24694983Imazio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Imazio, MD study chair
Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center)
Rita Trinchero, MD study chair
Cardiology Department. Maria Vittoria Hospital. ASL 3 Torino (Coordinating Center).
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine in people with Pericarditis and Recurrence, run by Azienda Sanitaria Locale 3, Torino at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate at 18 months (time frame: 18 m onths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00235079, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.