The Effect of Nexium on Transmucosal Esophageal Leak

Barrett's Esophagus Clinical Trial

Official title:

The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00216788
• Other study ID #: IRUSESOM0388
• Status: Unknown status
• Phase: Phase 1
• First received: September 19, 2005
• Last updated: March 15, 2010
• Start date: January 2006
• Est. completion date: January 2006

Study information

• Verified date: November 2005
• Source: Main Line Health
• Contact: Daniel Lazowick, D.O.
• Phone: 610-645-6555
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 35
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Esophagitis
• Reflux

Intervention

Drug:
• Esomeprazole (Nexium) 40 mg/day

Locations

Country	Name	City	State
United States	Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Main Line Health	AstraZeneca, Cancer Research Foundation of America, Sharpe-Strumia Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine sucrose level falls below 90 mg after 8 weeks of therapy
Secondary	Reduction of patient symptoms consistent with GERD

External Links

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