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Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

NCT00652834 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2016-03-04

Study results available
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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).

Conditions

  • Gastrointestinal Lesions
  • Signs and Symptoms, Digestive

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • suphamai bunnapradist, MD · University of California, Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-03-31
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652834 on ClinicalTrials.gov