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Sponsors and Collaborators: |
McGill University Health Center Novartis |
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Information provided by: | McGill University Health Center |
ClinicalTrials.gov Identifier: | NCT00468936 |
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).
Condition | Intervention | Phase |
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Heart Transplant Patients |
Drug: Myfortic |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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. |
Estimated Enrollment: | 100 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Usual medications (Cellcept)
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2: Active Comparator
Patients taking Myfortic
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Drug: Myfortic
enteric coated Cellcept pills in applicable dose for patient
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr Nadia S Giannetti | (514) 934 1934 ext 36511 | nadia.giannetti@muhc.mcgill.ca |
Canada, Quebec | |
McGill University Health Centre | Recruiting |
Montreal, Quebec, Canada, H3A 1A1 | |
Contact: Charlene Barber 514 934 1934 ext 36764 charlene.barber@muhc.mcgill.ca | |
Principal Investigator: Nadia Giannetti |
Principal Investigator: | Dr Nadia S Giannetti | McGill University Health Center |
Responsible Party: | McGill University Health Center ( Dr Nadia Giannetti ) |
Study ID Numbers: | BMB 06-006, OCC 2006-104 |
Study First Received: | May 1, 2007 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00468936 History of Changes |
Health Authority: | Canada: Health Canada |
anti-rejection GI side effects heart transplant patients |
Mycophenolate mofetil Mycophenolic Acid |