Status:
COMPLETED
Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointest...
Eligibility Criteria
Inclusion
- Kidney or liver transplanted patients
- Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events
Exclusion
- Recent graft rejection before the study
- Other pre-existing conditions that may cause gastro-intestinal complaints
- Use of other drugs known to cause gastro-intestinal complaints
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00149942
Start Date
October 1 2004
End Date
August 1 2006
Last Update
November 18 2016
Active Locations (1)
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1
Novartis
Basel, Switzerland