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
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant||Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) Drug: Mycophenolate Mofetil (MMF)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of the Effect of Conversion to Enteric-Coated Mycophenolate Sodium (EC-MPS) on Quality of Life in Patients With Gastrointestinal (GI) Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation (MYQOL)|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||March 2008|
Active Comparator: Mycophenolate Mofetil (MMF)
250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Drug: Mycophenolate Mofetil (MMF)
Other Name: Cellcept®
Experimental: Enteric-Coated Mycophenolate Sodium (EC-MPS )
Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Other Name: Myfortic®
- Mycophenolic Acid (MPA) Maintenance Treatment [ Time Frame: at week 13 (last visit) ]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.
- Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS). [ Time Frame: At week 3 and week 13 (last visit) ]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).
- Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI). [ Time Frame: At week 3 and week 13 (last visit) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239005
|Novartis Investigative Site|
|Nottingham, United Kingdom|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Principal Investigator:||Magdi Shehata, MBBCh, MD, FRCS||Director of Transplantation, Nottingham City Hospital, Nottingham|