The Effect of Nexium on Transmucosal Esophageal Leak

March 15, 2010 updated by: Main Line Health

The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In a related study, we have found evidence that patients with Barrett's esophagus have a leak for oral sucrose to leave the lumen of their upper gastrointestinal tract, enter the blood, and be filtered into urine. Normally the disaccharide sucrose cannot leave the lumen of the gastrointestinal tract without being first hydrolyzed to glucose and fructose. Appearance of the disaccharide in the bloodstream suggests a paracellular leak of some type in the upper gastrointestinal tract. Once in the blood, sucrose is likewise not taken up or metabolized by the kidney but simply filtered into the 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. We predict that Nexium will reduce leak in esophagitis but not Barrett's patients.

In this study, patients over 18 years of age presenting with GERD symptoms to a primary care physician, will be recruited after providing informed consent. Patients will perform a sucrose leak test the evening after their recruitment by drinking a solution of 100 gms of sucrose in 200 cc of water at bedtime, then collecting an overnight urine sample (8 hrs). Within 5 days the patient will undergo an upper endoscopy exam. The patient will then begin Nexium therapy (40 mg/day of Esomeprazole) for 8 weeks, taking the dose each morning before breakfast. After 8 weeks the patient will undergo a second sucrose leak test as described above. Urine sucrose will be determined by HPLC.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniel Lazowick, D.O.
  • Phone Number: 610-645-6555

Study Contact Backup

  • Name: Gambril Murray, M.D.
  • Phone Number: 610-642-6990

Study Locations

  • United States
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Hospital
        • Contact:
          • Daniel Lazowick, D.O.
          • Phone Number: 610-645-6555
        • Sub-Investigator:
          • Daniel Lazowick, D.O.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients presenting to a general practitioner / internist with symptoms of GERD defined as:

  • Heartburn - uncomfortable, rising, burning sensation behind the breastbone
  • Regurgitation of gastric acid or sour contents into the mouth
  • Chest pain atypical for cardiac ischemia and more suggestive of GERD
  • Symptoms for more than three weeks with no concurrent use of PPI's or H-2 blockers during that time period
  • A score greater than or equal to 5 on the AstraZeneca RDQ

Exclusion Criteria:

  • Any patients presenting with alarm symptoms (GI bleeding, dysphagia, weight loss, abdominal mass, lymphadenopathy, or recurrent vomiting)
  • Diabetes (type I or II)
  • Renal insufficiency defined as creatinine >1.6
  • Under 18 years of age
  • Prior surgery on esophagus, stomach or duodenum
  • History of gastric/duodenal ulcers
  • History of H. pylori
  • Known history of Barrett's esophagus (recruited to parallel study)
  • On Coumadin or Heparin therapy
  • Chronic upper abdominal pain more consistent with dyspepsia or other diagnoses
  • Noncompliant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Urine sucrose level falls below 90 mg after 8 weeks of therapy

Secondary Outcome Measures

Outcome Measure
Reduction of patient symptoms consistent with GERD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Main Line Health

Collaborators

AstraZeneca
Sharpe-Strumia Research Foundation
Cancer Research Foundation of America

Investigators

  • Principal Investigator: James M Mullin, Ph.D., Main Line Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (ANTICIPATED)

January 1, 2006

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 15, 2010

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRUSESOM0388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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