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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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00239005
First received: October 12, 2005
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated mycophenolate sodium (EC-MPS).


Condition Intervention Phase
Renal Transplant
 Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Drug: Mycophenolate Mofetil (MMF)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mycophenolic Acid (MPA) Maintenance Treatment [ Time Frame: at week 13 (last visit) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS). [ Time Frame: At week 3 and week 13 (last visit) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 134
Study Start Date: September 2005
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 medroxyprogesterone acetate (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 and 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239005

Locations
United Kingdom
Novartis Investigative Site
Nottingham, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Principal Investigator: Magdi Shehata, MBBCh, MD, FRCS Director of Transplantation, Nottingham City Hospital, Nottingham
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00239005     History of Changes
Other Study ID Numbers: CERL080AGB03, 2004-005071-42
Study First Received: October 12, 2005
Results First Received: December 8, 2010
Last Updated: February 23, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Novartis:
QoL
GI Side Effects
MPA

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013