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Sponsors and Collaborators: |
University of California, Los Angeles Novartis |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00652834 |
The purpose of this study is to learn more about symptoms and gastrointestinal lesions associated with taking myfortic® by switching patients to a delayed release formulation that is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using a self-assessed questionnaire called Gastrointestinal Symptom Rating Scale (GSRS). To prove the incidence and improvement of GI lesions in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using Small Bowel Capsule Endoscopy (SBCE).
Condition | Intervention |
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Gastrointestinal Symptoms |
Procedure: Small bowel capsule endoscopy (SBCE) |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE) |
Estimated Enrollment: | 20 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
If there are positive findings in SBCE, that will be switched from MMF to Myfortic® and the second SBCE procedure will be repeated on Day 30.
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Procedure: Small bowel capsule endoscopy (SBCE)
SBCE will be performed at Day 2 and Day 30.
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1: Experimental
If there are negative findings on SBCE, that will be continued on MMF. No need to have second SBCE.
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Procedure: Small bowel capsule endoscopy (SBCE)
SBCE will be performed at Day 2.
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Myfortic® recently introduced to the market has shown to be similar to MMF in how effectively it works and how well it is tolerated. Both drugs have the same active ingredient, but they are different in the way that they deliver them to the body. Myfortic® is an advanced, enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the release of the active ingredient, MPA. MPA has more potent effects on the lymphocytes than other cells. This makes for improved GI tolerability of the MPA therapy.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Suphamai Bunnapradist, M.D. | 310-794-8516 | bunnapradist@mednet.ucla.edu |
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90095 |
Responsible Party: | University of California, Los Angeles ( Suphamai Bunnapradist ) |
Study ID Numbers: | 07-08-014-01 |
Study First Received: | April 1, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00652834 |
Health Authority: | United States: Institutional Review Board |
Renal transplant recipients Gastrointestinal findings in small bowel capsule endoscopy Mycophenolic acid Mycophenolate Mofetil Mycophenolate Sodium |
Signs and Symptoms Mycophenolate mofetil Mycophenolic Acid |
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