NCT00468936

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

Enrollment Period

2.6 years

First QC Date

May 1, 2007

Last Update Submit

October 16, 2008

Conditions

Heart Transplant Patients

Keywords

anti-rejectionGI side effectsheart transplant patients

Outcome Measures

Primary Outcomes (1)

  • reduction in GSRS score

    6 months

Study Arms (2)

1

NO INTERVENTION

Usual medications (Cellcept)

2

ACTIVE COMPARATOR

Patients taking Myfortic

Drug: Myfortic

Interventions

MyforticDRUG

enteric coated Cellcept pills in applicable dose for patient

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable dose MMF for at least 4 weeks
  • Over 18 years of age
  • Heart transplant at least three months prior to study

You may not qualify if:

  • GI symptoms known not to be caused by MPA therapy
  • Acute rejection episode in past 4 weeks
  • History of malignancy since transplant
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Dr Nadia S Giannetti

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Nadia S Giannetti

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 1, 2007

First Posted

May 3, 2007

Study Start

May 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 17, 2008

Record last verified: 2008-10

Locations

CA(1)