This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by McGill University Health Center.
Recruitment status was:  Recruiting
Information provided by:
McGill University Health Center Identifier:
First received: May 1, 2007
Last updated: October 16, 2008
Last verified: October 2008
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
Heart Transplant Patients Drug: Myfortic Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • reduction in GSRS score [ Time Frame: 6 months ]

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
No Intervention: 1
Usual medications (Cellcept)
Active Comparator: 2
Patients taking Myfortic
Drug: Myfortic
enteric coated Cellcept pills in applicable dose for patient


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stable dose MMF for at least 4 weeks
  • Over 18 years of age
  • Heart transplant at least three months prior to study

Exclusion Criteria:

  • GI symptoms known not to be caused by MPA therapy
  • Acute rejection episode in past 4 weeks
  • History of malignancy since transplant
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00468936

Contact: Dr Nadia S Giannetti (514) 934 1934 ext 36511

Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Charlene Barber    514 934 1934 ext 36764   
Principal Investigator: Nadia Giannetti         
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Dr Nadia S Giannetti McGill University Health Center
  More Information

Responsible Party: Dr Nadia Giannetti, McGill University Health Center Identifier: NCT00468936     History of Changes
Other Study ID Numbers: BMB 06-006
OCC 2006-104
Study First Received: May 1, 2007
Last Updated: October 16, 2008

Keywords provided by McGill University Health Center:
GI side effects
heart transplant patients

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on September 20, 2017