Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-29 @ 10:36 AM
Study NCT ID:
NCT01044667
Status:
TERMINATED
Last Update Posted:
2018-02-20
First Post:
2010-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Gastrointestinal Quality of Life Study in Lung Transplant Recipients Converted From Mycophenolate Mofetil to Myfortic
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
Reduced Gastrointestinal Complaints and Improved Quality of Life in Lung Transplant Recipients Converted From Mycophenolate Mofetil (MMF) to Myfortic (Enteric-coated Mycophenolate Sodium, Ec-mps)
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor enrollment and lack of study staff
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health related quality of life in lung transplant recipients converted from Mycophenolate Mofetil (MMF) to Myfortic as part of standard immunosuppressive therapy.
Detailed Description:
Subjects administered MMF as part of their immunosuppression regimen after lung transplantation have a high incidence of GI symptoms related to the known side-effects of this drug. Previous studies have shown that GI symptoms are an important predictor of health related quality of life in other solid organ transplants (1). GI complications are common after lung transplant (2). We hypothesize that lung transplant patients converted from MMF to Myfortic will have significant reduction in severity of GI complaints. We also hypothesize that improvement in the severity of GI complaints will lead to an improved quality of life in these subjects. The study also includes data to evaluate the effect of GI complaints on health related quality of life.
Patients will complete questionnaires at each visit. Calls from the patients to the lung transplant center with GI complaints will be queried and documented on the case report form by the research nurse at each study visit. Similarly, hospital admissions for GI related complaints in the cohort will be documented. Symptom severity and health related quality of life will be assessed through the following questionnaires that have previously been validated in populations other than lung transplant (1). These questionnaires are selected specifically to capture the impact of GI complaints as related to the health related quality of life. The questionnaires that will be completed by the patient:
i.Gastrointestinal Quality of Life Index (GIQLI)
• The GIQLI is a 36-item questionnaire that assess the impact of GI distress on daily life
ii.SF-36 Health Survey • "The SF-36 Health Survey is a questionnaire that capture practical, reliable, and valid information about functional health and well-being from the patients' point of view" (4)
iii.EQ-5D Health Questionnaire
• "The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D provides a simple descriptive profile and a single value for health status" (5)
Patients will complete the three questionnaires at 4 outpatient visits occurring:
* when the patient comes in to an outpatient clinic visit after initial hospital discharge after lung transplantation with complaints of GI distress (Day 1-Convert to Myfortic);
* 60 Days;
* 90 days;
* 180 days
Patients will complete questionnaires at each visit. Calls from the patients to the lung transplant center with GI complaints will be queried and documented on the case report form by the research nurse at each study visit. Similarly, hospital admissions for GI related complaints in the cohort will be documented. Symptom severity and health related quality of life will be assessed through the following questionnaires that have previously been validated in populations other than lung transplant (1). These questionnaires are selected specifically to capture the impact of GI complaints as related to the health related quality of life. The questionnaires that will be completed by the patient:
i.Gastrointestinal Quality of Life Index (GIQLI)
• The GIQLI is a 36-item questionnaire that assess the impact of GI distress on daily life
ii.SF-36 Health Survey • "The SF-36 Health Survey is a questionnaire that capture practical, reliable, and valid information about functional health and well-being from the patients' point of view" (4)
iii.EQ-5D Health Questionnaire
• "The EQ-5D is a standardized instrument for use as a measure of health outcome. The EQ-5D provides a simple descriptive profile and a single value for health status" (5)
Patients will complete the three questionnaires at 4 outpatient visits occurring:
* when the patient comes in to an outpatient clinic visit after initial hospital discharge after lung transplantation with complaints of GI distress (Day 1-Convert to Myfortic);
* 60 Days;
* 90 days;
* 180 days
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: