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Trial record 10 of 1164 for:    MYCOPHENOLIC ACID

Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00351377
Recruitment Status : Completed
First Posted : July 12, 2006
Results First Posted : January 12, 2011
Last Update Posted : April 21, 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 Autoimmune Disease
Intervention Drug: Enteric-coated Mycophenolate Sodium
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Period Title: Overall Study
Started 111
Completed 104
Not Completed 7
Reason Not Completed
Adverse Event             5
Death             1
Unsatisfactory therapeutic effect             1
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Baseline Participants 111
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants
49.5  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
82
  73.9%
Male
29
  26.1%
1.Primary Outcome
Title Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
Hide Description Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.
Time Frame Baseline and 6 - 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline (N= 111) 2.28  (1.13)
6-8 Weeks (N= 102) 2.02  (0.93)
Change From Baseline (N = 102) -0.28  (0.92)
2.Secondary Outcome
Title Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium
Hide Description Changes in GI symptom severity was measured by changes in the total scores of 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit to the visit at 6-8 weeks. The GSRS is a 15-item instrument with a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
Time Frame Baseline and 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Reflux [n =102] -0.24  (1.36)
Diarrhea [n =104] -0.27  (1.43)
Constipation [n = 104] 0.02  (1.18)
Abdominal pain [n =102] -0.51  (1.20)
Indigestion [n = 104] -0.42  (1.33)
3.Secondary Outcome
Title Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium
Hide Description Assessed by changes in the Gastrointestinal Quality of Life Index (GIQLI) from Baseline visit to the 6-8 week visit. The GIQLI is a 36-item questionnaire and consists of 5 different subscales. The total score was calculated as the sum of the 36 single items which each ranged from 0-4, leading to a hypothetical range from 0-144 score points (lower scores indicate more unfavorable conditions). The mean change was calculated as (6-8 week visit value) minus (Baseline value).
Time Frame Baseline and 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline (N= 111) 100.2  (23.8)
6-8 Weeks (N= 104) 105.6  (22.9)
Change from Baseline (N= 104) 5.8  (18.6)
4.Secondary Outcome
Title Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium
Hide Description The 5 different subscales of the GI-related Quality of Life (GIQLI) were analyzed separately by calculating the average value of the items that were included in the respective subscore. Thus, the theoretical range for each of the subscores was the same as for the single items, i.e. 0-4 score points. An increase in the subscale score indicates an improvement in symptoms.
Time Frame Baseline and 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
GI symptoms [n=103] 0.18  (0.53)
Emotional status [n=103] 0.15  (0.68)
Physical function [n=102] 0.22  (0.68)
Social function [n=102] 0.10  (0.66)
Stress of medical treatment [n=102] 0.19  (1.22)
5.Secondary Outcome
Title Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium
Hide Description The PGWB consists of 22 single items (each ranging from 0-5) with 7 dimensions (including the total score) to be calculated. Lower scores indicate more unfavorable conditions. The total raw score is calculated by summing up all of the single items and thus has a hypothetical range from 0-110 score points. This raw score is further transformed using the formula: (raw score / 110) x 100 to fit a range from 0-100.
Time Frame Baseline and 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 110
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline (N= 110) 65.3  (16.1)
6-8 Weeks (N= 103) 66.8  (15.6)
Change From Baseline (N= 103) 2.0  (11.1)
6.Secondary Outcome
Title Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium
Hide Description The change from baseline to the 6-8 week visit for each of the six subscores (each ranging from 0-5) of the PGWB were analyzed individually. Each of the subscores was transformed to fit a range from 0-100. Lower scores indicate more unfavorable conditions, so an increase in score indicates an improvement in symptoms.
Time Frame Baseline and 6-8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Anxiety [n=103] 1.3  (14.1)
Depressed mood [n=104] 1.5  (14.1)
Positive well-being [n=104] 0.7  (14.4)
Self control [n=104] 1.5  (15.0)
General health [n=104] 3.4  (15.1)
Vitality [n=104] 2.7  (16.0)
7.Secondary Outcome
Title Overall Treatment Effects for GI Symptoms Assessed by the Physician
Hide Description Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: "Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms." The possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the physician.
Time Frame 6-8 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: Participants
Improved 49
About the same 43
Worsened 13
Missing data 6
8.Secondary Outcome
Title Overall Treatment Effects for GI Symptoms Assessed by the Patient
Hide Description Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: "Has there been any change in the participant’s GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms." The possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the patient.
Time Frame 6-8 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: Participants
Improved 38
About the same 53
Worsened 9
Missing data 11
9.Secondary Outcome
Title Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient
Hide Description Assessed using the Overall Treatment Effects for health-related quality of life questionnaire. Possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the patient.
Time Frame 6-8 week
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population consisting of all enrolled participants who received study medication.
Arm/Group Title Enteric-coated Mycophenolate Sodium
Hide Arm/Group Description:
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: Participants
Improved 31
About the same 61
Worsened 10
Missing data 9
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) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
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   6/111 (5.41%) 
Blood and lymphatic system disorders   
Nephrogenic anaemia  1  1/111 (0.90%) 
Thrombocytopenia  1  1/111 (0.90%) 
Gastrointestinal disorders   
Diverticulum  1  1/111 (0.90%) 
Infections and infestations   
Bronchitis  1  1/111 (0.90%) 
Endocarditis  1  1/111 (0.90%) 
Pneumonia  1  1/111 (0.90%) 
Septic shock  1  1/111 (0.90%) 
Nervous system disorders   
Dementia  1  1/111 (0.90%) 
Disturbance in attention  1  1/111 (0.90%) 
Dizziness  1  1/111 (0.90%) 
Syncope  1  1/111 (0.90%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/111 (0.90%) 
Pulmonary fibrosis  1  1/111 (0.90%) 
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   38/111 (34.23%) 
Gastrointestinal disorders   
Abdominal distension  1  8/111 (7.21%) 
Diarrhoea  1  16/111 (14.41%) 
Dyspepsia  1  8/111 (7.21%) 
Nausea  1  13/111 (11.71%) 
Vomiting  1  10/111 (9.01%) 
Infections and infestations   
Nasopharyngitis  1  10/111 (9.01%) 
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: NCT00351377     History of Changes
Other Study ID Numbers: CERL080ADE08
First Submitted: July 10, 2006
First Posted: July 12, 2006
Results First Submitted: December 14, 2010
Results First Posted: January 12, 2011
Last Update Posted: April 21, 2011