NCT00652834

Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Gastrointestinal Lesions
• Signs and Symptoms, Digestive

Interventions

Type	Name	Description
PROCEDURE	Small bowel capsule endoscopy (SBCE)	SBCE will be performed at Day 2 and Day 30.
DRUG	myfortic	switching from mycophenolate mofetil to mycophenolic acid on equimolar basis

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-03-01
• Completion: 2011-05-01
• First posted: 2008-04-04
• Last updated: 2016-03-04
• Results posted: 2016-03-04

Locations

1 site across 1 country: United States