The Effect of Nexium on Transmucosal Esophageal Leak
The Effect of Proton Pump Inhibitors on Transmucosal Esophageal Leak
1 other identifier
interventional
35
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Start
First participant enrolled
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedMarch 16, 2010
November 1, 2005
September 19, 2005
March 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urine sucrose level falls below 90 mg after 8 weeks of therapy
Secondary Outcomes (1)
Reduction of patient symptoms consistent with GERD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Main Line Healthlead
- AstraZenecacollaborator
- Sharpe-Strumia Research Foundationcollaborator
- Cancer Research Foundation of Americacollaborator
Study Sites (1)
Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James M Mullin, Ph.D.
Main Line Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 19, 2005
First Posted
September 22, 2005
Study Start
January 1, 2006
Study Completion
January 1, 2006
Last Updated
March 16, 2010
Record last verified: 2005-11