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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00351377 |
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will 1) determine the proportion of patients with autoimmune diseases who are experiencing any GI complaints under MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes.
Condition | Intervention | Phase |
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Autoimmune Disease |
Drug: Enteric-coated Mycophenolate sodium (EC-MPS) |
Phase III |
Study Type: | Observational |
Official Title: | Measurement and Analysis of Patient Reported Gastrointestinal (GI) and Health-Related Quality of Life (HRQL) Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate (MPA) |
Estimated Enrollment: | 200 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | December 2008 |
Groups/Cohorts | Assigned Interventions |
---|---|
1 |
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Experimental
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion criteria Patients
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novarts Pharmaceuticals | 41613241111 |
Germany | |
Novartis Investigational Site | Recruiting |
Various cities, Germany | |
Contact: novartis |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CERL080ADE08 |
Study First Received: | July 10, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00351377 |
Health Authority: | Belgium: Institutional Review Board |
Autoimmune disease, mycophenolate, GI problems |
Autoimmune Diseases Mycophenolate mofetil Mycophenolic Acid Quality of Life |
Immunologic Factors Immune System Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |