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Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

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ClinicalTrials.gov Identifier: NCT00468936
Recruitment Status : Unknown
Verified October 2008 by McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : May 3, 2007
Last Update Posted : October 17, 2008
Sponsor:
Collaborator:
Novartis
Information provided by:
McGill University Health Center

Brief 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).

Condition or disease Intervention/treatment Phase
Heart Transplant Patients Drug: Myfortic Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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.
Study Start Date : May 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009


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



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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: October 2008

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

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action