Status:
UNKNOWN
The Effect of Nexium on Transmucosal Esophageal Leak
Lead Sponsor:
Main Line Health
Collaborating Sponsors:
AstraZeneca
Sharpe-Strumia Research Foundation
Conditions:
Reflux
Esophagitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 filte...
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 filtere...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00216788
Start Date
January 1 2006
End Date
January 1 2006
Last Update
March 16 2010
Active Locations (1)
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1
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096