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Trial record 74 of 1164 for:    MYCOPHENOLIC ACID

Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

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ClinicalTrials.gov Identifier: NCT00400400
Recruitment Status : Completed
First Posted : November 16, 2006
Results First Posted : August 15, 2011
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Renal Transplantation
Interventions Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Drug: Mycophenolate mofetil
Drug: Placebo to mycophenolate sodium
Drug: Placebo to mycophenolate mofetil
Enrollment 400
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 200 200
Intent-to-Treat Population 199 [1] 197
Completed 186 185
Not Completed 14 15
Reason Not Completed
Adverse Event             9             8
Protocol Violation             2             0
Withdrawal by Subject             1             3
Administrative Problem             1             0
Lost to Follow-up             0             1
Did not receive study drug             1             3
[1]
Participants who received study drug.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 199 197 396
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 199 participants 197 participants 396 participants
48.4  (13.4) 48.4  (12.6) 48.4  (13.0)
[1]
Measure Description: Baseline Measures are based on the Intent-to-Treat (ITT) population that consisted of all randomized participants who received study drug.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 199 participants 197 participants 396 participants
Female
105
  52.8%
95
  48.2%
200
  50.5%
Male
94
  47.2%
102
  51.8%
196
  49.5%
1.Primary Outcome
Title The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy
Hide Description 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.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 197 197
Measure Type: Number
Unit of Measure: Participants
Response 123 109
No Response 74 88
2.Secondary Outcome
Title Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)
Hide Description

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.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 199 197
Measure Type: Number
Unit of Measure: Participants
BPAR 0 1
TAR 0 1
3.Secondary Outcome
Title Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score
Hide Description 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.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 199 197
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline (n= 198,195) 0.7  (0.4) 0.6  (0.4)
Day 30 (n=193, 191) 0.4  (0.4) 0.4  (0.4)
Change from Baseline to Day 30 (n=193,189) -0.3  (0.4) -0.2  (0.4)
4.Secondary Outcome
Title Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment
Hide Description 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).
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population consisted of all randomized participants who received at least one dose of study drug.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 199 197
Measure Type: Number
Unit of Measure: Participants
Study drug change or interruption: YES 11 12
Study drug change or interruption: NO 188 185
5.Secondary Outcome
Title Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score
Hide Description 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.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 197 197
Mean (Standard Deviation)
Unit of Measure: change in score on a scale
-0.6  (0.9) -0.5  (1.0)
6.Secondary Outcome
Title Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Hide Description 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.
Time Frame Baseline to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 197 197
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Diarrhea: Baseline (BL) 3.3  (1.7) 3.3  (1.7)
Diarrhea: Day 30 2.4  (1.6) 2.5  (1.6)
Diarrhea: Change from BL to Day 30 -0.9  (1.7) -0.8  (1.6)
Indigestion : Baseline 2.8  (1.3) 2.8  (1.3)
Indigestion: Day 30 2.1  (1.0) 2.4  (1.2)
Indigestion: Change from BL to Day 30 -0.7  (1.2) -0.5  (1.4)
Constipation: Baseline 2.2  (1.2) 2.1  (1.1)
Constipation: Day 30 1.7  (0.9) 1.8  (0.9)
Constipation: Change from BL to Day 30 -0.4  (1.1) -0.3  (1.0)
Abdominal pain: Baseline 2.3  (1.1) 2.5  (1.1)
Abdominal pain: Day 30 1.8  (0.9) 2.0  (1.1)
Abdominal pain: Change from BL to Day 30 -0.5  (1.1) -0.5  (1.2)
Reflux : Baseline 2.2  (1.3) 2.2  (1.4)
Reflux : Day 30 1.7  (1.1) 1.7  (1.1)
Reflux : Change from BL o Day 30 -0.5  (1.3) -0.5  (1.5)
7.Secondary Outcome
Title Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Hide Description 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.
Time Frame Baseline, Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 197 197
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Overall Total Score: BL ( n= 197,197) 94.3  (17.9) 93.4  (18.0)
Overall Total Score : Day 30 (n= 195,192) 105.0  (18.4) 103.5  (18.1)
Overall Total Score : Change from BL (n=193,192) 10.7  (16.4) 10.2  (17.5)
GI Symptom: BL (n= 197, 197) 46.7  (10.6) 46.6  (10.3)
GI Symptom: Day 30 (n= 195, 192) 52.6  (10.8) 51.9  (10.7)
GI Symptom: Change from BL (n= 193, 192) 5.9  (9.8) 5.4  (10.2)
Emotional Status: BL (n= 196, 197) 11.9  (2.7) 11.6  (2.9)
Emotional Status: Day 30 (n= 195, 192) 13.2  (2.8) 13.1  (2.6)
Emotional Status: Change from BL (n= 192, 192) 1.3  (2.9) 1.5  (3.0)
Physical Function: BL (n= 196, 197) 21.7  (3.8) 21.5  (3.9)
Physical Function: Day 30 (n= 195, 192) 23.7  (3.4) 23.3  (3.8)
Physical Function: Change from BL (n= 192, 192) 2.1  (3.2) 1.9  (4.0)
Social Function: BL (n= 197, 197) 10.7  (2.8) 10.4  (2.8)
Social Function: Day 30 (n= 195, 192) 11.9  (3.0) 11.6  (2.8)
Social Function: Change from BL (n= 193, 192) 1.2  (2.6) 1.2  (2.7)
Medical treatment: BL (n= 197, 197) 3.3  (1.0) 3.4  (1.0)
Medical treatment: Day 30 (n= 194, 192) 3.6  (0.8) 3.6  (0.7)
Medical treatment: Change from BL (n= 192, 192) 0.2  (1.0) 0.3  (0.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Hide Arm/Group Description 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 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.
All-Cause Mortality
Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Enteric-coated Mycophenolate Sodium Mycophenolate Mofetil
Affected / at Risk (%) Affected / at Risk (%)
Total   7/199 (3.52%)   11/197 (5.58%) 
Blood and lymphatic system disorders     
Anaemia  1  0/199 (0.00%)  1/197 (0.51%) 
Cardiac disorders     
Angina unstable  1  0/199 (0.00%)  1/197 (0.51%) 
Gastrointestinal disorders     
Abdominal pain lower  1  1/199 (0.50%)  2/197 (1.02%) 
Abdominal pain upper  1  0/199 (0.00%)  2/197 (1.02%) 
Diarrhoea  1  1/199 (0.50%)  2/197 (1.02%) 
Impaired gastric emptying  1  1/199 (0.50%)  0/197 (0.00%) 
Nausea  1  0/199 (0.00%)  2/197 (1.02%) 
Vomiting  1  1/199 (0.50%)  2/197 (1.02%) 
General disorders     
Asthenia  1  0/199 (0.00%)  1/197 (0.51%) 
Chest pain  1  0/199 (0.00%)  1/197 (0.51%) 
Hepatobiliary disorders     
Cholecystitis  1  0/199 (0.00%)  1/197 (0.51%) 
Infections and infestations     
Clostridium difficile colitis  1  1/199 (0.50%)  0/197 (0.00%) 
Cytomegalovirus infection  1  0/199 (0.00%)  1/197 (0.51%) 
Pneumonia  1  1/199 (0.50%)  1/197 (0.51%) 
Upper respiratory tract infection  1  1/199 (0.50%)  0/197 (0.00%) 
Urinary tract infection  1  1/199 (0.50%)  0/197 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  0/199 (0.00%)  1/197 (0.51%) 
Skull fracture  1  0/199 (0.00%)  1/197 (0.51%) 
Subdural haematoma  1  0/199 (0.00%)  1/197 (0.51%) 
Therapeutic agent toxicity  1  1/199 (0.50%)  1/197 (0.51%) 
Investigations     
Weight decreased  1  0/199 (0.00%)  1/197 (0.51%) 
Metabolism and nutrition disorders     
Dehydration  1  1/199 (0.50%)  1/197 (0.51%) 
Hyperkalaemia  1  1/199 (0.50%)  0/197 (0.00%) 
Hypomagnesaemia  1  0/199 (0.00%)  1/197 (0.51%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/199 (0.50%)  0/197 (0.00%) 
Psychiatric disorders     
Mental status changes  1  0/199 (0.00%)  1/197 (0.51%) 
Renal and urinary disorders     
Renal failure acute  1  0/199 (0.00%)  1/197 (0.51%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea exertional  1  0/199 (0.00%)  2/197 (1.02%) 
Pulmonary embolism  1  1/199 (0.50%)  0/197 (0.00%) 
Vascular disorders     
Lymphocele  1  1/199 (0.50%)  0/197 (0.00%) 
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 Mycophenolate Mofetil
Affected / at Risk (%) Affected / at Risk (%)
Total   75/199 (37.69%)   89/197 (45.18%) 
Gastrointestinal disorders     
Abdominal distension  1  27/199 (13.57%)  31/197 (15.74%) 
Abdominal pain lower  1  10/199 (5.03%)  12/197 (6.09%) 
Abdominal pain upper  1  9/199 (4.52%)  16/197 (8.12%) 
Constipation  1  7/199 (3.52%)  15/197 (7.61%) 
Diarrhoea  1  21/199 (10.55%)  17/197 (8.63%) 
Dyspepsia  1  19/199 (9.55%)  17/197 (8.63%) 
Eructation  1  9/199 (4.52%)  20/197 (10.15%) 
Flatulence  1  11/199 (5.53%)  19/197 (9.64%) 
Gastrooesophageal reflux disease  1  13/199 (6.53%)  9/197 (4.57%) 
Intestinal functional disorder  1  10/199 (5.03%)  14/197 (7.11%) 
Nausea  1  11/199 (5.53%)  21/197 (10.66%) 
Metabolism and nutrition disorders     
Decreased appetite  1  10/199 (5.03%)  14/197 (7.11%) 
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: NCT00400400     History of Changes
Other Study ID Numbers: CERL080AUS51
First Submitted: November 15, 2006
First Posted: November 16, 2006
Results First Submitted: December 3, 2010
Results First Posted: August 15, 2011
Last Update Posted: August 15, 2011