Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

This study is currently recruiting participants.

Verified by McGill University Health Center, October 2008

First Received: May 1, 2007 Last Updated: October 16, 2008 History of Changes

Sponsors and Collaborators:	McGill University Health Center Novartis
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00468936

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 III

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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
1: No Intervention Usual medications (Cellcept)
2: Active Comparator 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:	McGill University Health Center ( Dr Nadia Giannetti )
Study ID Numbers:	BMB 06-006, OCC 2006-104
Study First Received:	May 1, 2007
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00468936 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by McGill University Health Center:

anti-rejection
GI side effects
heart transplant patients

Study placed in the following topic categories:

Mycophenolate mofetil
Mycophenolic Acid

ClinicalTrials.gov processed this record on May 06, 2009