CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 111 enrolled
Drug / intervention
Enteric-coated Mycophenolate Sodiumdrug
Likely dose
Enteric-coated Mycophenolate Sodium 180 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00351377
NCT00351377Phase 3Completed
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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)

Novartis Pharmaceuticals·interventional·Posted Jul 12, 2006·Updated Apr 21, 2011

In Brief

A Phase 3 clinical trial evaluating Enteric-coated Mycophenolate Sodium for Autoimmune Disease. Completed, enrolled 111 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutoimmune Disease
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2006
Enrollment StartJun 1, 2006
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.0 years ago

Interventions

Enteric-coated Mycophenolate Sodiumdrug

Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.