Measurement of Patient Reported Outcomes in Korean Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: September 11, 2007
Last updated: November 1, 2011
Last verified: November 2011
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)
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
||Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal Symptoms
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- Impact of immunosuppressive-induced GI symptoms on patient's perception of symptom severity and HRQL.
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||June 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Received kidney transplant at least 1 month prior to study enrollment
- Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment
- Eligible to convert to enteric-coated mycophenolate sodium (EC-MPS) because of GI complaints OR not currently experiencing GI complaints and stable on current immunosuppressive regimen
- At least 18 years of age
- Willing to provide written informed consent
- Able to meet all study requirements including completing electronically-administered questionnaires and completing two study visits.
- GI symptoms assumed or known not to be caused by MPA (Mycophenolic acid) therapy (e.g. oral biphosphonates induced, infectious diarrhea)
- Acute rejection < 1 week prior to study enrollment
- Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception
- Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
- Undergoing acute medical intervention or hospitalization
- Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including but not limited to, visual problems or cognitive impairment
- Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Other protocol-defined inclusion /exclusion criteria may apply.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00529269
|Novartis Investigative Site
|Busan, Korea, Republic of |
|Novartis Investigative Site
|Seoul, Korea, Republic of |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 11, 2007
||November 1, 2011
||South Korea: Food and Drug Administration
Keywords provided by Novartis:
Renal Transplant Patients, GI symptom, Enteric-coated mycophenolate sodium
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 16, 2014
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs