Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Unknown status

CT.gov ID

NCT00468936

Collaborator

Novartis (Industry)

100

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

reduction in GSRS score [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	McGill University Health Centre	Montreal	Quebec	Canada	H3A 1A1

Sponsors and Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre
Novartis

Investigators

Principal Investigator: Dr Nadia S Giannetti, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00468936

Other Study ID Numbers:

BMB 06-006
OCC 2006-104

First Posted:

May 3, 2007

Last Update Posted:

Oct 17, 2008

Last Verified:

Oct 1, 2008

Keywords provided by , ,

anti-rejection

GI side effects

heart transplant patients

Additional relevant MeSH terms:

Mycophenolic Acid

Study Results

No Results Posted as of Oct 17, 2008