Myfortic in Heart Transplant Patients With Gastrointestin... | NCT00468936

Studies
Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

NCT00468936

Sponsor

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

Status

Unknown status

Last Update Posted

Oct 17, 2008Estimated

Enrollment

100Estimated

Phase

Phase 3

Conditions

Heart Transplant Patients

Interventions

Myfortic

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
OCC 2006-104

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

May 1, 2007

First Submission Date that Met QC Criteria

May 1, 2007

First Posted Date

May 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

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

Collaborators

Name	Class
Novartis	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Usual medications (Cellcept)
2	Active Comparator	Patients taking Myfortic	Drug: Myfortic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myfortic	Drug	enteric coated Cellcept pills in applicable dose for patient	2

Measure	Description	Time Frame
reduction in GSRS score		6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dr Nadia S Giannetti	Contact	(514) 934 1934	36511	nadia.giannetti@muhc.mcgill.ca

Overall Officials

Name	Affiliation	Role
Dr Nadia S Giannetti	McGill University Health Centre/Research Institute of the McGill University Health Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McGill University Health Centre	Recruiting	Montreal	Quebec	H3A 1A1	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D009173	Mycophenolic Acid

Ancestor Terms

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

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