Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

Heart Transplant Patients Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00468936
• Other study ID #: BMB 06-006
• Secondary ID: OCC 2006-104
• Status: Recruiting
• Phase: Phase 3
• First received: May 1, 2007
• Last updated: October 16, 2008
• Start date: May 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2008
• Source: McGill University Health Center
• Contact: Dr Nadia S Giannetti
• Phone: (514) 934 1934
• Email: nadia.giannetti[@]muhc.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Transplant Patients

Intervention

Drug:
• Myfortic
enteric coated Cellcept pills in applicable dose for patient

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Novartis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in GSRS score		6 months	Yes