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Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

NCT ID: NCT00468936

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2009-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Heart Transplant Patients

Keywords

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anti-rejection GI side effects heart transplant patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Usual medications (Cellcept)

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Patients taking Myfortic

Group Type ACTIVE_COMPARATOR

Myfortic

Intervention Type DRUG

enteric coated Cellcept pills in applicable dose for patient

Interventions

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Myfortic

enteric coated Cellcept pills in applicable dose for patient

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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McGill University Health Center

Principal Investigators

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Dr Nadia S Giannetti

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Dr Nadia S Giannetti

Role: CONTACT

Phone: (514) 934 1934

Email: [email protected]

Facility Contacts

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Charlene Barber

Role: primary

Other Identifiers

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OCC 2006-104

Identifier Type: -

Identifier Source: secondary_id

BMB 06-006

Identifier Type: -

Identifier Source: org_study_id