Heart Transplant PatientsPhase 3NCT00468936
Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms
A Phase 3 study testing Myfortic in people with Heart Transplant Patients, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Patients
- What is being tested?
- Myfortic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Dec 2009
- Phase
- Phase 3
- 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
- Stable dose MMF for at least 4 weeks
- Over 18 years of age
- Heart transplant at least three months prior to study
Who cannot join
- GI symptoms known not to be caused by MPA therapy
- Acute rejection episode in past 4 weeks
- History of malignancy since transplant
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3A 1A1
Charlene Barber, 514 934 1934 ext. 36764, charlene.barber@muhc.mcgill.ca
Nadia Giannetti
About this study
Official title: Open-Label, Randomized Study Comparing the Patient Reported Severity of GI Side Effects of MMF Versus EC-MPS in Maintenance Heart Transplant Patients.
Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Once they sign a study consent they are randomized to one of two arms. It is thought that the severity of GI side effects will be reduced over time in patients who are in the Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1 month, 3 months, 6 months, 12 months).
- Conditions
- Heart Transplant Patients
- Being tested
- Myfortic
- Keywords
- anti-rejection, GI side effects, heart transplant patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyforticDrug
enteric coated Cellcept pills in applicable dose for patient
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual medications (Cellcept) |
| 2 | Active comparator | Patients taking Myfortic Receives: Drug: Myfortic |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in GSRS score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant PatientsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Dr Nadia S Giannetti, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468936
- Sponsor's protocol ID
- BMB 06-006
- Other IDs
- OCC 2006-104
- Status last verified
- Oct 2008
- First submitted
- 1 May 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized Study Comparing the Patient Reported Severity of GI Side Effects of MMF Versus EC-MPS in Maintenance Heart Transplant Patients.
- ClinicalTrials.gov ID
- NCT00468936
- Acronym / sponsor ID
- BMB 06-006
- Conditions
- Heart Transplant Patients
- Keywords
- anti-rejection, GI side effects, heart transplant patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 3 May 2007 (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.
Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Once they sign a study consent they are randomized to one of two arms. It is thought that the severity of GI side effects will be reduced over time in patients who are in the Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1 month, 3 months, 6 months, 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual medications (Cellcept) |
| 2 | Active comparator | Drug: MyforticPatients taking Myfortic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable dose MMF for at least 4 weeks
- Over 18 years of age
- Heart transplant at least three months prior to study
Key exclusion criteria (4 listed)
- GI symptoms known not to be caused by MPA therapy
- Acute rejection episode in past 4 weeks
- History of malignancy since transplant
- Pregnancy
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 |
|---|---|---|
| Myforticenteric coated Cellcept pills in applicable dose for patient | Drug | 2 |
Primary outcome
reduction in GSRS score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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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.
Dr Nadia S Giannetti principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Myfortic in people with Heart Transplant Patients, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Nadia S Giannetti ((514) 934 1934 ext. 36511, nadia.giannetti@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in GSRS score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2008.