Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms
Status:
Unknown status
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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. 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).
Phase:
Phase 3
Details
Lead Sponsor:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre