Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00468936
First received: May 1, 2007
Last updated: October 16, 2008
Last verified: October 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468936

Contacts
Contact: Dr Nadia S Giannetti (514) 934 1934 ext 36511 nadia.giannetti@muhc.mcgill.ca

Locations
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         
Sponsors and Collaborators
McGill University Health Center
Novartis
Investigators
Principal Investigator: Dr Nadia S Giannetti McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr Nadia Giannetti, McGill University Health Center
ClinicalTrials.gov 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
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014