Not Signed In -
Imipenem and Cilastatin Sodium Injection |
Primaxin |
Clinical Trial: 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.
This study is currently recruiting patients.
Verified by Novartis September 2005
|
Purpose
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 gastrointestinal adverse events while on MMF therapy.
| Condition | Intervention | Phase |
|---|---|---|
| Kidney and liver transplantation | Drug: Enteric-coated Mycophenolate sodium (EC-MPS) | Phase IV |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Conversion Trial from Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering from GI Adverse Events While on Mycophenolate Mofetil Therapy.
Further Study Details:
Study start: October 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Kidney or liver transplanted patients
- Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events
Exclusion Criteria:
- 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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00149942
Novartis 41 61 324 1111
Switzerland
Novartis, Basel, Switzerland; Recruiting
Novartis 41 61 324 1111
Study chairs or principal investigators
Novartis, Study Director, Novartis
More Information
Study ID Numbers: CERL080ABE01
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149942
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149942
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Imipenem and Cilastatin Sodium Injection (Drug Digest)
- Primaxin (Drug Digest)
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