MedTrace Logo

Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate

NCT00351377 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2011-04-21

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Enteric-coated Mycophenolate Sodium

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Germany

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00351377 on ClinicalTrials.gov