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This study will evaluate the impact that GI complaints have on patient-reported outcomes and to determine if there is improvement in patient-reported outcomes when converted from mycophenolate mofetil (MMF) to Enteric-coated mycophenolate sodium (EC-MPS)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom severity is assessed by the GSRS (GI Symptom Rating Scale); Health-related Quality of Life (HRQL) is assessed by the GIQLI (GI Quality of Life) Index. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of immunosuppressive-induced GI symptoms on patient's perception of symptom severity and HRQL. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion /exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Busan | South Korea | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21165291 | Background | Hwang HS, Hyoung BJ, Kim S, Oh HY, Kim YS, Kim JK, Kim YH, Kim YL, Kim CD, Shin GT, Yang CW. Improved gastrointestinal symptoms and quality of life after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients receiving tacrolimus. J Korean Med Sci. 2010 Dec;25(12):1759-65. doi: 10.3346/jkms.2010.25.12.1759. Epub 2010 Nov 24. |
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| Seoul |
| South Korea |