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


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Nafcillin Sodium Injection

Nallpen; Unipen Injection


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

This study is not yet open for patient recruitment.
Verified by Novartis November 2005

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00239005

Purpose

This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with MMF-induced GI adverse events after converting to EC-MPS
Condition Intervention Phase
Renal Transplant
 Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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)

Further study details as provided by Novartis:

Study start: November 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion criteria

  1. Received kidney transplant;
  2. Receiving immunosuppressive regimen that includes MMF;
  3. Patients with GI side effects on standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects.
  4. At least 18 years of age;
  5. Willing to provide written informed consent; and
  6. Able to meet all study requirements including completing questionnaires and completing four study visits.

Exclusion criteria

  1. Patients with GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral bisphosphonate induced, infectious diarrhea);
  2. Acute rejection < 1 week prior to study enrollment;
  3. 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;
  4. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
  5. Undergoing acute medical intervention or hospitalization;
  6. 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.
  7. Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

Additional protocol-defined inclusion/exclusion criteria may apply.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00239005

novartis      41 61 324 1111 

Study chairs or principal investigators

Novartis,  Study Director,  Novartis   

More Information

Study ID Numbers:  CERL080AGB03
Last Updated:  December 8, 2005
Record first received:  October 12, 2005
ClinicalTrials.gov Identifier:  NCT00239005
Health Authority: United Kingdom: National Health Service
ClinicalTrials.gov processed this record on 2006-01-10


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Page Updated: June 1, 2005
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