The Effect of Nexium on Transmucosal Esophageal Leak

• Status: Unknown status
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Main Line Health
• Collaborators: AstraZeneca; Cancer Research Foundation of America; Sharpe-Strumia Research Foundation
• Treatments: Esomeprazole

Criteria

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