Trial Outcomes & Findings for Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants (NCT NCT00267150)

Results Overview

The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. 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 primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

31 participants

Primary outcome timeframe

weeks 6-8

Results posted on

2011-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Enteric Coated Mycophenolate-sodium Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Enteric Coated Mycophenolate-sodium Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
Overall Study Adverse Event	1

Baseline Characteristics

Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enteric Coated Mycophenolate-sodium n=31 Participants Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
Age Continuous	48.9 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: weeks 6-8

The Gastrointestinal symptom rating scale (GSRS) is a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. 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 primary analysis examined changes from Visit 1 (baseline) to Visit 2 (6-8 weeks) by computing the difference of GSRS total score.

Outcome measures

Outcome measures
Measure	Enteric Coated Mycophenolate-sodium n=30 Participants Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
Changes in Gastrointestinal Symptom Severity and/or Health-related Quality of Life After Conversion From MMF to Enteric Coated Mycophenolate Sodium	-0.46 Change in Score of GSRS Standard Deviation 0.71

SECONDARY outcome

Timeframe: week 0

Population: Baseline population

Assessed by GI complications at baseline.

Outcome measures

Outcome measures
Measure	Enteric Coated Mycophenolate-sodium n=31 Participants Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy Any complication	19 Participants
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy Diarrhea	12 Participants
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy Dyspepsia	4 Participants
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy Nausea	3 Participants
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy Abdominal pain/bloating/fullness	11 Participants
Gastrointestinal Symptoms Under MMF-based Immunosuppressive Therapy Other	1 Participants

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Patients n=31 participants at risk All patients
Gastrointestinal disorders Constipation	6.5% 2/31

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