Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00652834|
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Lesions Signs and Symptoms, Digestive||Procedure: Small bowel capsule endoscopy (SBCE) Drug: myfortic||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE)|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||May 2011|
kidney recipients with GI symptoms
This was a four-week study designed to investigate GI mucosal lesions by SBCE in kidney transplant recipients who were using MMF, and to examine the changes in clinical symptoms and intestinal mucosa lesions 30 days after switching over from MMF to EC-MPS. The patient was switched from MMF to EC-MPS (Myfortic) on the equimola basis.
Procedure: Small bowel capsule endoscopy (SBCE)
SBCE will be performed at Day 2 and Day 30.
Other Name: PillCamEsoDrug: myfortic
switching from mycophenolate mofetil to mycophenolic acid on equimolar basis
Other Name: EC-MPS
- GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score [ Time Frame: one month ]
The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652834
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||suphamai bunnapradist, MD||University of California, Los Angeles|