Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00405652|
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : March 3, 2011
Last Update Posted : March 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation||Drug: Enteric-coated Mycophenolate sodium (EC-MPS)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients (MyLiver)|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
Experimental: Enteric-coated Mycophenolate sodium
Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Other Name: myfortic
- Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life [ Time Frame: Baseline, End of Study (6-8 weeks) ]Change in Gastrointestinal symptom rating scale (GSRS) total score from baseline visit to follow-up visit 6-8 weeks after treatment. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The GSRS total score was computed by the mean of the subscale scores.
- The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes [ Time Frame: 12-20 weeks ]The number of participants with subclinical rejection episodes as defined by a steroid-sensitive, clinically relevant increase of AST, ALT, gamma-GT, AP or bilirubin (i.e., elevation of one or more of these enzymes that was considered clinically relevant and showed resolution upon treatment with a slight increase of steroid dosage).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405652
|Novartis Investigative Site|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|