Trial Outcomes & Findings for Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance (NCT NCT00400400)
NCT ID: NCT00400400
Last Updated: 2011-08-15
Results Overview
Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) 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 total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
400 participants
Primary outcome timeframe
Baseline, Day 30
Results posted on
2011-08-15
Participant Flow
Participant milestones
| Measure |
Enteric-coated Mycophenolate Sodium
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
Intent-to-Treat Population
|
199
|
197
|
|
Overall Study
COMPLETED
|
186
|
185
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
Reasons for withdrawal
| Measure |
Enteric-coated Mycophenolate Sodium
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
8
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Administrative Problem
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Did not receive study drug
|
1
|
3
|
Baseline Characteristics
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Baseline characteristics by cohort
| Measure |
Enteric-coated Mycophenolate Sodium
n=199 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.4 Years
STANDARD_DEVIATION 13.4 • n=93 Participants
|
48.4 Years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
48.4 Years
STANDARD_DEVIATION 13.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
196 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 30Population: Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.
Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) 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 total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.
Outcome measures
| Measure |
Enteric-coated Mycophenolate Sodium
n=197 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy
No Response
|
74 Participants
|
88 Participants
|
|
The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy
Response
|
123 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.
TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy. BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria.
Outcome measures
| Measure |
Enteric-coated Mycophenolate Sodium
n=199 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)
BPAR
|
0 Participants
|
1 Participants
|
|
Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)
TAR
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. "n" in each of the categories is the number of participants with data.
The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms.
Outcome measures
| Measure |
Enteric-coated Mycophenolate Sodium
n=199 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score
Baseline (n= 198,195)
|
0.7 Score on a scale
Standard Deviation 0.4
|
0.6 Score on a scale
Standard Deviation 0.4
|
|
Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score
Day 30 (n=193, 191)
|
0.4 Score on a scale
Standard Deviation 0.4
|
0.4 Score on a scale
Standard Deviation 0.4
|
|
Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score
Change from Baseline to Day 30 (n=193,189)
|
-0.3 Score on a scale
Standard Deviation 0.4
|
-0.2 Score on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug.
The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia).
Outcome measures
| Measure |
Enteric-coated Mycophenolate Sodium
n=199 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment
Study drug change or interruption: YES
|
11 Participants
|
12 Participants
|
|
Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment
Study drug change or interruption: NO
|
188 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.
This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group.
Outcome measures
| Measure |
Enteric-coated Mycophenolate Sodium
n=197 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score
|
-0.6 change in score on a scale
Standard Deviation 0.9
|
-0.5 change in score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline to Day 30Population: Intention-to-treat (ITT) population consisted of all randomized participants who received at least one dose of study drug. 2 participants in the enteric-coated mycophenolate sodium group were excluded from the analysis because they had no baseline data.
The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales.
Outcome measures
| Measure |
Enteric-coated Mycophenolate Sodium
n=197 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Diarrhea: Baseline (BL)
|
3.3 Score on a scale
Standard Deviation 1.7
|
3.3 Score on a scale
Standard Deviation 1.7
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Indigestion: Change from BL to Day 30
|
-0.7 Score on a scale
Standard Deviation 1.2
|
-0.5 Score on a scale
Standard Deviation 1.4
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Reflux : Day 30
|
1.7 Score on a scale
Standard Deviation 1.1
|
1.7 Score on a scale
Standard Deviation 1.1
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Diarrhea: Day 30
|
2.4 Score on a scale
Standard Deviation 1.6
|
2.5 Score on a scale
Standard Deviation 1.6
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Diarrhea: Change from BL to Day 30
|
-0.9 Score on a scale
Standard Deviation 1.7
|
-0.8 Score on a scale
Standard Deviation 1.6
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Indigestion : Baseline
|
2.8 Score on a scale
Standard Deviation 1.3
|
2.8 Score on a scale
Standard Deviation 1.3
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Indigestion: Day 30
|
2.1 Score on a scale
Standard Deviation 1.0
|
2.4 Score on a scale
Standard Deviation 1.2
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Constipation: Baseline
|
2.2 Score on a scale
Standard Deviation 1.2
|
2.1 Score on a scale
Standard Deviation 1.1
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Constipation: Day 30
|
1.7 Score on a scale
Standard Deviation 0.9
|
1.8 Score on a scale
Standard Deviation 0.9
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Constipation: Change from BL to Day 30
|
-0.4 Score on a scale
Standard Deviation 1.1
|
-0.3 Score on a scale
Standard Deviation 1.0
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Abdominal pain: Baseline
|
2.3 Score on a scale
Standard Deviation 1.1
|
2.5 Score on a scale
Standard Deviation 1.1
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Abdominal pain: Day 30
|
1.8 Score on a scale
Standard Deviation 0.9
|
2.0 Score on a scale
Standard Deviation 1.1
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Abdominal pain: Change from BL to Day 30
|
-0.5 Score on a scale
Standard Deviation 1.1
|
-0.5 Score on a scale
Standard Deviation 1.2
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Reflux : Baseline
|
2.2 Score on a scale
Standard Deviation 1.3
|
2.2 Score on a scale
Standard Deviation 1.4
|
|
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Reflux : Change from BL o Day 30
|
-0.5 Score on a scale
Standard Deviation 1.3
|
-0.5 Score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: Participants from the Intention-to-treat (ITT) population consisting of all randomized participants who received at least one dose of study drug for whom data was available for analysis. "n" in each of the categories is the number of participants with data available.
The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction.
Outcome measures
| Measure |
Enteric-coated Mycophenolate Sodium
n=197 Participants
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 Participants
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Overall Total Score : Day 30 (n= 195,192)
|
105.0 Score on a scale
Standard Deviation 18.4
|
103.5 Score on a scale
Standard Deviation 18.1
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
GI Symptom: Day 30 (n= 195, 192)
|
52.6 Score on a scale
Standard Deviation 10.8
|
51.9 Score on a scale
Standard Deviation 10.7
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Overall Total Score: BL ( n= 197,197)
|
94.3 Score on a scale
Standard Deviation 17.9
|
93.4 Score on a scale
Standard Deviation 18.0
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Overall Total Score : Change from BL (n=193,192)
|
10.7 Score on a scale
Standard Deviation 16.4
|
10.2 Score on a scale
Standard Deviation 17.5
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
GI Symptom: BL (n= 197, 197)
|
46.7 Score on a scale
Standard Deviation 10.6
|
46.6 Score on a scale
Standard Deviation 10.3
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
GI Symptom: Change from BL (n= 193, 192)
|
5.9 Score on a scale
Standard Deviation 9.8
|
5.4 Score on a scale
Standard Deviation 10.2
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Emotional Status: BL (n= 196, 197)
|
11.9 Score on a scale
Standard Deviation 2.7
|
11.6 Score on a scale
Standard Deviation 2.9
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Emotional Status: Day 30 (n= 195, 192)
|
13.2 Score on a scale
Standard Deviation 2.8
|
13.1 Score on a scale
Standard Deviation 2.6
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Emotional Status: Change from BL (n= 192, 192)
|
1.3 Score on a scale
Standard Deviation 2.9
|
1.5 Score on a scale
Standard Deviation 3.0
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Physical Function: BL (n= 196, 197)
|
21.7 Score on a scale
Standard Deviation 3.8
|
21.5 Score on a scale
Standard Deviation 3.9
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Physical Function: Day 30 (n= 195, 192)
|
23.7 Score on a scale
Standard Deviation 3.4
|
23.3 Score on a scale
Standard Deviation 3.8
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Physical Function: Change from BL (n= 192, 192)
|
2.1 Score on a scale
Standard Deviation 3.2
|
1.9 Score on a scale
Standard Deviation 4.0
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Social Function: BL (n= 197, 197)
|
10.7 Score on a scale
Standard Deviation 2.8
|
10.4 Score on a scale
Standard Deviation 2.8
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Social Function: Day 30 (n= 195, 192)
|
11.9 Score on a scale
Standard Deviation 3.0
|
11.6 Score on a scale
Standard Deviation 2.8
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Social Function: Change from BL (n= 193, 192)
|
1.2 Score on a scale
Standard Deviation 2.6
|
1.2 Score on a scale
Standard Deviation 2.7
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Medical treatment: BL (n= 197, 197)
|
3.3 Score on a scale
Standard Deviation 1.0
|
3.4 Score on a scale
Standard Deviation 1.0
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Medical treatment: Day 30 (n= 194, 192)
|
3.6 Score on a scale
Standard Deviation 0.8
|
3.6 Score on a scale
Standard Deviation 0.7
|
|
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Medical treatment: Change from BL (n= 192, 192)
|
0.2 Score on a scale
Standard Deviation 1.0
|
0.3 Score on a scale
Standard Deviation 0.9
|
Adverse Events
Enteric-coated Mycophenolate Sodium
Serious events: 7 serious events
Other events: 75 other events
Deaths: 0 deaths
Mycophenolate Mofetil
Serious events: 11 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enteric-coated Mycophenolate Sodium
n=199 participants at risk
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 participants at risk
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/199
|
0.51%
1/197
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/199
|
0.51%
1/197
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.50%
1/199
|
1.0%
2/197
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/199
|
1.0%
2/197
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
1/199
|
1.0%
2/197
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.50%
1/199
|
0.00%
0/197
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/199
|
1.0%
2/197
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/199
|
1.0%
2/197
|
|
General disorders
Asthenia
|
0.00%
0/199
|
0.51%
1/197
|
|
General disorders
Chest pain
|
0.00%
0/199
|
0.51%
1/197
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/199
|
0.51%
1/197
|
|
Infections and infestations
Clostridium difficile colitis
|
0.50%
1/199
|
0.00%
0/197
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/199
|
0.51%
1/197
|
|
Infections and infestations
Pneumonia
|
0.50%
1/199
|
0.51%
1/197
|
|
Infections and infestations
Upper respiratory tract infection
|
0.50%
1/199
|
0.00%
0/197
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/199
|
0.00%
0/197
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/199
|
0.51%
1/197
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/199
|
0.51%
1/197
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/199
|
0.51%
1/197
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.50%
1/199
|
0.51%
1/197
|
|
Investigations
Weight decreased
|
0.00%
0/199
|
0.51%
1/197
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
1/199
|
0.51%
1/197
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
1/199
|
0.00%
0/197
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/199
|
0.51%
1/197
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/199
|
0.00%
0/197
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/199
|
0.51%
1/197
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/199
|
0.51%
1/197
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/199
|
1.0%
2/197
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
1/199
|
0.00%
0/197
|
|
Vascular disorders
Lymphocele
|
0.50%
1/199
|
0.00%
0/197
|
Other adverse events
| Measure |
Enteric-coated Mycophenolate Sodium
n=199 participants at risk
Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
Mycophenolate Mofetil
n=197 participants at risk
Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
13.6%
27/199
|
15.7%
31/197
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.0%
10/199
|
6.1%
12/197
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
9/199
|
8.1%
16/197
|
|
Gastrointestinal disorders
Constipation
|
3.5%
7/199
|
7.6%
15/197
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
21/199
|
8.6%
17/197
|
|
Gastrointestinal disorders
Dyspepsia
|
9.5%
19/199
|
8.6%
17/197
|
|
Gastrointestinal disorders
Eructation
|
4.5%
9/199
|
10.2%
20/197
|
|
Gastrointestinal disorders
Flatulence
|
5.5%
11/199
|
9.6%
19/197
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.5%
13/199
|
4.6%
9/197
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
5.0%
10/199
|
7.1%
14/197
|
|
Gastrointestinal disorders
Nausea
|
5.5%
11/199
|
10.7%
21/197
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
10/199
|
7.1%
14/197
|
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