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| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00351377 |
Purpose
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 |
|---|---|---|
|
Autoimmune Disease |
Drug: Enteric-coated Mycophenolate sodium (EC-MPS) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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) |
| Enrollment: | 111 |
| Study Start Date: | June 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Experimental
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria Patients
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
More Information
| Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
| Study ID Numbers: | CERL080ADE08 |
| Study First Received: | July 10, 2006 |
| Last Updated: | June 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00351377 History of Changes |
| Health Authority: | Belgium: Institutional Review Board |
|
Autoimmune disease, mycophenolate, GI problems |
|
Autoimmune Diseases Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Mycophenolic Acid |
Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Mycophenolate mofetil |