MedTrace Logo

The Effect of Nexium on Transmucosal Esophageal Leak

NCT00216788 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2010-03-16

No results posted yet for this study

Summary

In a related study, the investigators have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave their upper gastrointestinal tract, enter the blood, and be filtered into urine. The amount of sucrose appearing in an overnight urine sample can be used to indicate the presence of Barrett's esophagus and/or esophagitis in a patient reporting with reflux (GERD) symptoms. The leak is presumably in the Barrett's epithelium itself. This phenomenon will be used to test if a standard 8 week therapy of Nexium in a first-time-presenting GERD patient can reduce the leak as a means of assessing the efficacy of the drug in that patient. The investigators predict that Nexium will reduce leak in esophagitis but not Barrett's patients.

Conditions

  • Reflux
  • Esophagitis
  • Barrett's Esophagus

Interventions

DRUG

Esomeprazole (Nexium) 40 mg/day

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Sharpe-Strumia Research Foundation

    collaborator OTHER

  • Cancer Research Foundation of America

    collaborator OTHER

  • Main Line Health

    lead OTHER

Principal Investigators

  • James M Mullin, Ph.D. · Main Line Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Completion
2006-01-31

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 NCT00216788 on ClinicalTrials.gov