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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
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Transplantation
Intervention Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 34
Completed 30
Not Completed 4
Reason Not Completed
Adverse Event             4
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
55.8  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
14
  41.2%
Male
20
  58.8%
1.Primary Outcome
Title Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life
Hide Description 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.
Time Frame Baseline, End of Study (6-8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population (No last Observation Carried Forward). The number of participants completing the GSRS at Baseline = 31 and at the End of Study= 29.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline (Visit 1) n=31 2.88  (0.66)
End of Study (Visit 2) n=29 2.10  (0.78)
2.Secondary Outcome
Title The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes
Hide Description 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).
Time Frame 12-20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description 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.
All-Cause Mortality
Enteric-coated Mycophenolate Sodium
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enteric-coated Mycophenolate Sodium
Affected / at Risk (%)
Total   4/34 (11.76%) 
Gastrointestinal disorders   
Faecaloma  1  1/34 (2.94%) 
Infections and infestations   
Hepatitis c  1  1/34 (2.94%) 
Herpes zoster  1  1/34 (2.94%) 
Injury, poisoning and procedural complications   
Transplant failure  1  1/34 (2.94%) 
Investigations   
Alanine aminotransferase increased  1  1/34 (2.94%) 
Aspartate aminotransferase increased  1  1/34 (2.94%) 
Blood alkaline phosphatase increased  1  1/34 (2.94%) 
Gamma-glutamyltransferase increased  1  1/34 (2.94%) 
Glutamate dehydrogenase increased  1  1/34 (2.94%) 
Psychiatric disorders   
Alcoholism  1  1/34 (2.94%) 
Renal and urinary disorders   
Renal failure  1  1/34 (2.94%) 
Skin and subcutaneous tissue disorders   
Pruritus generalised  1  1/34 (2.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enteric-coated Mycophenolate Sodium
Affected / at Risk (%)
Total   23/34 (67.65%) 
Gastrointestinal disorders   
Abdominal distension  1  11/34 (32.35%) 
Abdominal pain  1  7/34 (20.59%) 
Constipation  1  3/34 (8.82%) 
Diarrhoea  1  10/34 (29.41%) 
Dyspepsia  1  3/34 (8.82%) 
Nausea  1  5/34 (14.71%) 
General disorders   
Fatigue  1  2/34 (5.88%) 
Feeling cold  1  2/34 (5.88%) 
Infections and infestations   
Nasopharyngitis  1  4/34 (11.76%) 
Investigations   
Alanine aminotransferase increased  1  2/34 (5.88%) 
Blood alkaline phosphatase increased  1  2/34 (5.88%) 
Blood bilirubin increased  1  3/34 (8.82%) 
Gamma-glutamyltransferase increased  1  3/34 (8.82%) 
Nervous system disorders   
Headache  1  3/34 (8.82%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/34 (5.88%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  2/34 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00405652     History of Changes
Other Study ID Numbers: CERL080ADE09
First Submitted: November 27, 2006
First Posted: November 30, 2006
Results First Submitted: December 1, 2010
Results First Posted: March 3, 2011
Last Update Posted: March 3, 2011