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Trial record 27 of 1164 for:    MYCOPHENOLIC ACID

Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT00239005
Recruitment Status : Completed
First Posted : October 14, 2005
Results First Posted : March 24, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Transplant
Interventions Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Drug: Mycophenolate Mofetil (MMF)
Enrollment 134
Recruitment Details In total, 135 patients were screened. One patient was not randomized due to an SAE prior to the randomization visit. Out of 134 randomized patients, 5 withdrew before taking study drug. Analysis population: 68 in EC-MPS, 61 in MMF.
Pre-assignment Details  
Arm/Group Title Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening. 250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Period Title: Overall Study
Started 69 65
Intention-to-treat Population (ITT) 68 61
Completed 57 53
Not Completed 12 12
Reason Not Completed
Adverse Event             6             6
Withdrawal by Subject             3             4
Unsatisfactory Therapeutic effect             2             0
Protocol Violation             1             0
Subj. cond. no longer needs study drug             0             1
Lost to Follow-up             0             1
Arm/Group Title Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF) Total
Hide Arm/Group Description Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening. 250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening. Total of all reporting groups
Overall Number of Baseline Participants 68 61 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 68 participants 61 participants 129 participants
<65 years 65 51 116
>=65 years 3 10 13
[1]
Measure Description: Baseline Measures are based on Intention to treat (ITT) population.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 61 participants 129 participants
Female
31
  45.6%
25
  41.0%
56
  43.4%
Male
37
  54.4%
36
  59.0%
73
  56.6%
1.Primary Outcome
Title Mycophenolic Acid (MPA) Maintenance Treatment
Hide Description The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.
Time Frame at week 13 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable.
Arm/Group Title Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Overall Number of Participants Analyzed 68 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Patients
47.06
(34.83 to 59.55)
16.39
(8.15 to 28.09)
2.Secondary Outcome
Title Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).
Hide Description The GSRS is a 15-item instrument designed to assess the impact of upper and lower GI symptoms. There are five subscales: reflux, diarrhea, constipation, abdominal pain, and indigestion—each of which produces a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). A higher score represents greater impairment of quality of life due to GI symptoms (range from 1 to 7).
Time Frame At week 3 and week 13 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GSRS questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.
Arm/Group Title Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Overall Number of Participants Analyzed 61 59
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 3: change in GSRS Total Score (N= 61, 59) -0.63  (0.139) -0.32  (0.142)
Week 13: change in GSRS Total Score (N= 60, 56) -0.44  (0.165) -0.25  (0.169)
3.Secondary Outcome
Title Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).
Hide Description Health-related quality of life (HRQoL)was assessed by the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI also has five different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) producing a total score of the 36 items. Lower scores represent more dysfunction. A higher score represents a better quality of life (range from 0 to 144).
Time Frame At week 3 and week 13 (last visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable. In this analysis patients who completed GIQLI questionnaire in visit 2 (week 1), visit 3 (week 3) and visit 4 (week 13) were included.
Arm/Group Title Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description:
Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Overall Number of Participants Analyzed 61 58
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 3: change in GIQLI Total Score (N= 61, 58) 11.65  (3.470) 6.08  (3.549)
Week 13: change in GIQLI Total Score (N= 60, 56) 4.84  (4.331) 1.77  (4.458)
Time Frame 13 weeks
Adverse Event Reporting Description The Safety population consisted of all randomized patients who had at least one post-baseline safety assessment.
 
Arm/Group Title Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF)
Hide Arm/Group Description Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening. 250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
All-Cause Mortality
Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enteric-Coated Mycophenolate Sodium (EC-MPS) Mycophenolate Mofetil (MMF)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/68 (13.24%)   7/61 (11.48%) 
Blood and lymphatic system disorders     
Anaemia  1  0/68 (0.00%)  1/61 (1.64%) 
Cardiac disorders     
Cardiac failure congestive  1  1/68 (1.47%)  0/61 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/68 (0.00%)  1/61 (1.64%) 
Diarrhoea  1  1/68 (1.47%)  1/61 (1.64%) 
Gastritis  1  0/68 (0.00%)  1/61 (1.64%) 
Nausea  1  1/68 (1.47%)  1/61 (1.64%) 
Vomiting  1  1/68 (1.47%)  0/61 (0.00%) 
General disorders     
Chest pain  1  0/68 (0.00%)  1/61 (1.64%) 
Chills  1  0/68 (0.00%)  1/61 (1.64%) 
Pyrexia  1  3/68 (4.41%)  0/61 (0.00%) 
Infections and infestations     
Cytomegalovirus infection  1  1/68 (1.47%)  0/61 (0.00%) 
Lower respiratory tract infection  1  0/68 (0.00%)  1/61 (1.64%) 
Pneumonia  1  1/68 (1.47%)  0/61 (0.00%) 
Sepsis  1  0/68 (0.00%)  2/61 (3.28%) 
Urinary tract infection  1  2/68 (2.94%)  1/61 (1.64%) 
Injury, poisoning and procedural complications     
Complications of transplanted kidney  1  1/68 (1.47%)  0/61 (0.00%) 
Investigations     
Blood creatinine increased  1  1/68 (1.47%)  0/61 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/68 (0.00%)  1/61 (1.64%) 
Hyperkalaemia  1  1/68 (1.47%)  1/61 (1.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/68 (1.47%)  0/61 (0.00%) 
Nervous system disorders     
Headache  1  0/68 (0.00%)  1/61 (1.64%) 
Renal and urinary disorders     
Renal failure acute  1  1/68 (1.47%)  0/61 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/68 (0.00%)  1/61 (1.64%) 
Vascular disorders     
Aortic dissection  1  0/68 (0.00%)  1/61 (1.64%) 
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 (EC-MPS) Mycophenolate Mofetil (MMF)
Affected / at Risk (%) Affected / at Risk (%)
Total   25/68 (36.76%)   26/61 (42.62%) 
Gastrointestinal disorders     
Abdominal pain  1  4/68 (5.88%)  1/61 (1.64%) 
Diarrhoea  1  12/68 (17.65%)  12/61 (19.67%) 
Dyspepsia  1  3/68 (4.41%)  5/61 (8.20%) 
Nausea  1  3/68 (4.41%)  4/61 (6.56%) 
Vomiting  1  5/68 (7.35%)  4/61 (6.56%) 
Infections and infestations     
Lower respiratory tract infection  1  2/68 (2.94%)  4/61 (6.56%) 
Nasopharyngitis  1  4/68 (5.88%)  4/61 (6.56%) 
Urinary tract infection  1  2/68 (2.94%)  4/61 (6.56%) 
Nervous system disorders     
Headache  1  4/68 (5.88%)  1/61 (1.64%) 
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: NCT00239005     History of Changes
Other Study ID Numbers: CERL080AGB03
2004-005071-42
First Submitted: October 12, 2005
First Posted: October 14, 2005
Results First Submitted: December 8, 2010
Results First Posted: March 24, 2011
Last Update Posted: March 30, 2017