Status:
TERMINATED
Esophageal Metaplasia Using a Novel Antibody: Reversibility by Proton Pump Inhibitor
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Esophageal Metaplasia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
In this project, we are trying to identify patients with the earliest signs of abnormality in the lining of the lower part of the food pipe (or esophagus) known as intestinal metaplasia (IM); also com...
Detailed Description
We propose to study prospectively 68 patients who have been identified as positive with mAb DAS-1 immunostaining without histological evidence of specialized columnar epithelium ("True Barrett's" epit...
Eligibility Criteria
Inclusion
- Dyspeptic symptoms, upper abdominal pain, heartburn, regurgitation;
- Endoscopically - normal appearing GE junction, irregular z-line, or erosive esophagitis up to Grade 2.
Exclusion
- Barrett's esophagus (Endoscopically greater than 2 cm of columnar epithelium on endoscopy and the presence of specialized columnar epithelium on histology);
- Patients who have been taking a PPI longer than the 3 months proceeding study entry. Patients currently taking a PPI but for less than 3 months who are not willing to discontinue PPI treatment for 4 weeks prior to enrollment into this study.
- Severe esophagitis Grade 3 or 4
- Documented active duodenal or gastric ulcer (at least 0.5cm diameter). Patients with erosions can be included.
- Presence of esophageal varices
- History of gastric surgery altering normal anatomy (eg, Billroth procedure, gastric bypass)
- Pregnant or nursing patients
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00161200
Start Date
December 1 2002
End Date
October 1 2006
Last Update
December 11 2009
Active Locations (1)
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1
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901