Recruiting
Phase 3

Myfortic

Sponsor:

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

Code:

NCT00468936

Conditions

Heart Transplant Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Myfortic

Study Details

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).

Conditions

Heart Transplant Patients

Study ID

NCT00468936

Start date

May, 2007

Status verified date

Oct, 2008

Completion date

Dec, 2009

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: 1

Usual medications (Cellcept)

active comparator: 2

Patients taking Myfortic

Interventions

Myfortic

enteric coated Cellcept pills in applicable dose for patient

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Dr Nadia S Giannetti

(514) 934 1934nadia.giannetti@muhc.mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

Charlene Barber

514 934 1934charlene.barber@muhc.mcgill.ca

Principal Investigator:

Nadia Giannetti

More Information

Sponsor

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

Last update posted

Oct 17, 2008

Last verified

Oct, 2008

Keywords

  • anti-rejection
  • GI side effects
  • heart transplant patients

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2008-10-17.