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The Effect of Nexium on Transmucosal Esophageal Leak
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Main Line Health.   Recruitment status was  Not yet recruiting

First Received on September 19, 2005.   Last Updated on March 15, 2010   History of Changes
Sponsor: Main Line Health
Collaborators: AstraZeneca
Sharpe Strumia Foundation
Cancer Research Foundation of America
Information provided by: Main Line Health
ClinicalTrials.gov Identifier: NCT00216788
  Purpose

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.


Condition Intervention Phase
Reflux
Esophagitis
Barrett's Esophagus
Drug: Esomeprazole (Nexium) 40 mg/day
Phase I

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak

Resource links provided by NLM:


Further study details as provided by Main Line Health:

Primary Outcome Measures:
  • Urine sucrose level falls below 90 mg after 8 weeks of therapy

Secondary Outcome Measures:
  • Reduction of patient symptoms consistent with GERD

Estimated Enrollment: 35
Study Start Date: January 2006
Estimated Study Completion Date: January 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216788

Contacts
Contact: Daniel Lazowick, D.O. 610-645-6555
Contact: Gambril Murray, M.D. 610-642-6990

Locations
United States, Pennsylvania
Lankenau Hospital Not yet recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Daniel Lazowick, D.O.     610-645-6555        
Sub-Investigator: Daniel Lazowick, D.O.            
Sponsors and Collaborators
Main Line Health
AstraZeneca
Sharpe Strumia Foundation
Cancer Research Foundation of America
Investigators
Principal Investigator: James M Mullin, Ph.D. Main Line Health
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00216788     History of Changes
Other Study ID Numbers: IRUSESOM0388
Study First Received: September 19, 2005
Last Updated: March 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Main Line Health:
Sucrose
Barrett's esophagus
Esophagitis
GERD
Reflux
Esophagus
Esomeprazole

Additional relevant MeSH terms:
Barrett Esophagus
Esophagitis
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastroenteritis
Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012