Trial Outcomes & Findings for Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients (NCT NCT00405652)

Last Updated: 2011-03-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

Baseline, End of Study (6-8 weeks)

Results posted on

2011-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	34
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	4

Baseline Characteristics

Measurement of Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Liver Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enteric-coated Mycophenolate Sodium n=34 Participants 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.
Age Continuous	55.8 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, End of Study (6-8 weeks)

Population: 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.

Outcome measures

Outcome measures
Measure	Enteric-coated Mycophenolate Sodium n=31 Participants 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.
Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life Baseline (Visit 1) n=31	2.88 Scores on a Scale Standard Deviation 0.66
Changes in Gastrointestinal Symptom Severity and Health Related Quality of Life End of Study (Visit 2) n=29	2.10 Scores on a Scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: 12-20 weeks

Population: Intent to Treat

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).

Outcome measures

Outcome measures
Measure	Enteric-coated Mycophenolate Sodium n=34 Participants 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.
The Number of Participants With Subclinical Rejection as Evaluated by a Change in Liver Enzymes	6 Participants

Adverse Events

Enteric-coated Mycophenolate Sodium

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Enteric-coated Mycophenolate Sodium n=34 participants at risk 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.
Gastrointestinal disorders Faecaloma	2.9% 1/34
Infections and infestations Hepatitis c	2.9% 1/34
Infections and infestations Herpes zoster	2.9% 1/34
Injury, poisoning and procedural complications Transplant failure	2.9% 1/34
Investigations Alanine aminotransferase increased	2.9% 1/34
Investigations Aspartate aminotransferase increased	2.9% 1/34
Investigations Blood alkaline phosphatase increased	2.9% 1/34
Investigations Gamma-glutamyltransferase increased	2.9% 1/34
Investigations Glutamate dehydrogenase increased	2.9% 1/34
Psychiatric disorders Alcoholism	2.9% 1/34
Renal and urinary disorders Renal failure	2.9% 1/34
Skin and subcutaneous tissue disorders Pruritus generalised	2.9% 1/34

Other adverse events

Other adverse events
Measure	Enteric-coated Mycophenolate Sodium n=34 participants at risk 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.
Gastrointestinal disorders Abdominal distension	32.4% 11/34
Gastrointestinal disorders Abdominal pain	20.6% 7/34
Gastrointestinal disorders Constipation	8.8% 3/34
Gastrointestinal disorders Diarrhoea	29.4% 10/34
Gastrointestinal disorders Dyspepsia	8.8% 3/34
Gastrointestinal disorders Nausea	14.7% 5/34
General disorders Fatigue	5.9% 2/34
General disorders Feeling cold	5.9% 2/34
Infections and infestations Nasopharyngitis	11.8% 4/34
Investigations Alanine aminotransferase increased	5.9% 2/34
Investigations Blood alkaline phosphatase increased	5.9% 2/34
Investigations Blood bilirubin increased	8.8% 3/34
Investigations Gamma-glutamyltransferase increased	8.8% 3/34
Nervous system disorders Headache	8.8% 3/34
Respiratory, thoracic and mediastinal disorders Cough	5.9% 2/34
Skin and subcutaneous tissue disorders Pruritus	5.9% 2/34

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER