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NCT00161200 · ClinicalTrials.gov registry record · Phase 3
Esophageal Metaplasia Using a Novel Antibody: Reversibility by Proton Pump Inhibitor
A Phase 3 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Terminated
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT00161200 is a Phase 3 study that was terminated before completion, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 60 participants.
The verdict
NCT00161200, a Phase 3 study, was terminated before completion, sponsored by University of Medicine and Dentistry of New Jersey.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study 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 commonly called Barrett's esophagus or Barrett's Epithelium (BE). IM is sometimes difficult to diagnose by routine microscopic examination (called histology). We have developed a specific antibody, a protein called immunoglobulin that specifically reacts with another partner protein, if it exists. Using this marker antibody (called mAb Das-1) that has been patented (US patent #5,888,743), we have shown that this marker can detect the abnormal changes in the distal esophagus before it is evident by histology. IM usually develops in the face of long-term acid reflux from the stomach to the esophagus and causes the lining to change from the normal squamous type (like that of skin) to a type of lining normally seen in the small intestine and colon. A subgroup of patients with IM may, subsequently, develop histologically evident Barrett's Epithelium and a small percent of these patients may develop cancer of the esophagus. Thus, BE is considered as a pre-cancerous condition. We already have an ongoing IRB for the portion of the project involving taking biopsies and performing the antibody staining to identify patients that react with the antibody but histologically negative for BE.
Interventions
- DRUG Ranitidine & Pantoprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2002-12 |
| Est. Completion | 2006-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00161200
The ClinicalTrials.gov registry entry for NCT00161200 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Medicine and Dentistry of New Jersey, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ranitidine & Pantoprazole is the first listed.
NCT00161200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00161200 about?
NCT00161200 is a clinical study titled "Esophageal Metaplasia Using a Novel Antibody: Reversibility by Proton Pump Inhibitor". 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 commonly called Barrett's esophagus or Barrett's Epithelium (BE). IM is sometimes difficult to diagnose...
What is the current status of trial NCT00161200?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2002-12. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00161200?
The interventions under investigation include: Ranitidine & Pantoprazole (DRUG).
Who is sponsoring clinical trial NCT00161200?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
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