NCT00468936

Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

Open-Label, Randomized Study Comparing the Patient Reported Severity of GI Side Effects of MMF Versus EC-MPS in Maintenance Heart Transplant Patients.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Transplant Patients

Interventions

Type	Name	Description
DRUG	Myfortic	enteric coated Cellcept pills in applicable dose for patient

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2007-05-03
• Last updated: 2008-10-17

Locations

1 site across 1 country: Canada