drugset
drugset / Trial / NCT00468936

Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

NCT00468936 ↗

Phase 3 Unknown 100 enrolled McGill University Health Centre/Research Institute of the McGill University Health Centre Novartis · collab
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2007-05
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator mycophenolic acid Small molecule — —

Indications

No indication recorded.