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The Effect of Nexium on Transmucosal Esophageal Leak
This study is not yet open for participant recruitment.
Verified by Lankenau Institute for Medical Research, November 2005
Sponsors and Collaborators: Lankenau Institute for Medical Research
AstraZeneca
Sharpe Strumia Foundation
Cancer Research Foundation of America
Information provided by: Lankenau Institute for Medical Research
ClinicalTrials.gov Identifier: NCT00216788
  Purpose

In a related study, we 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. We 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

MedlinePlus related topics: Esophagus Disorders Urine and Urination
Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Sucrose
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak

Further study details as provided by Lankenau Institute for Medical Research:

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
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Lankenau Institute for Medical Research
AstraZeneca
Sharpe Strumia Foundation
Cancer Research Foundation of America
Investigators
Principal Investigator: James M Mullin, Ph.D. Lankenau Institute for Medical Research
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: IRUSESOM0388
Study First Received: September 19, 2005
Last Updated: November 14, 2005
ClinicalTrials.gov Identifier: NCT00216788  
Health Authority: United States: Food and Drug Administration

Keywords provided by Lankenau Institute for Medical Research:
Sucrose
Barrett's esophagus
Esophagitis
GERD
Reflux
Esophagus
Esomeprazole

Study placed in the following topic categories:
Esophagitis
Digestive System Diseases
Digestive System Abnormalities
Esophageal disorder
Gastrointestinal Diseases
Omeprazole
Barrett Esophagus
Esophageal Diseases
Gastroenteritis
Congenital Abnormalities

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009