CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
myfortic +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00652834
NCT00652834Phase 4Completed
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Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE)

University of California, Los Angeles·interventional·Posted Apr 4, 2008·Updated Mar 4, 2016

In Brief

A Phase 4 clinical trial evaluating Small bowel capsule endoscopy (SBCE) and myfortic for Gastrointestinal Lesions and Signs and Symptoms, Digestive. Completed, enrolled 23 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Lesions, Signs and Symptoms, Digestive
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 4, 2008
Enrollment StartApr 1, 2009
Primary CompletionMar 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.2 years ago

Interventions

Small bowel capsule endoscopy (SBCE)procedure

SBCE will be performed at Day 2 and Day 30.

myforticdrug

switching from mycophenolate mofetil to mycophenolic acid on equimolar basis