Esophageal Metaplasia Using a Novel Antibody: Reversibility by Proton Pump Inhibitor
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|ClinicalTrials.gov Identifier: NCT00161200|
Recruitment Status : Terminated (slow accrual)
First Posted : September 12, 2005
Last Update Posted : December 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Metaplasia||Drug: Ranitidine & Pantoprazole||Phase 3|
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" epithelium) during routine endoscopy for dyspepsia or GERD symptoms. These patients have been studied for initial screening for antibody staining under IRB protocol #1698. This number is based on the statistical analysis by Fisher's exact test and has 90% power to detect a 30% negativity (mAb Das-1 positive to negative) at a p<0.05 level. During participation in IRB Protocol #1698, initial biopsy specimens were taken at:
- the squamo-columnar junction (at least 2 sites - 12 o'clock and 6 o'clock positions and any other area with mucosal "tongues" of columnar epithelium),
- one from squamous epithelium at the distal esophagus to seek for the presence of esophagitis,
- one from antrum for the presence or absence of intestinal metaplasia of the stomach,
- and one from the gastric cardia.
Following endoscopy and participation in IRB Protocol #1698, for the symptomatic patients who are not taking any proton pump inhibitor, an H2 blocker, Ranitidine (ZantacÒ) 150 mg twice daily, will be started while the biopsy is being analyzed for histology and immunocytochemical stainings. This is usually completed within 2 weeks. Patients who showed positive reactivity in at least one biopsy sample taken during participation in Protocol #1698 with mAb Das-1 will be included in this study. Patients who have been taking a proton pump inhibitor (PPI) for longer than 3 months preceeding study entry are not eligible to participate in this study. Patients who have been taking proton pump inhibitors for 3 months or less at the time of the endoscopy and biopsy screening for mAb Das-1, may participate in this study 4 weeks after discontinuing the PPI (i.e., a 4 week washout period).
Patients will be randomized in a double-blinded fashion to receive either Pantoprazole, 40 mg twice daily (34 patients), or continued on Ranitidine, 150 mg twice daily (34 patients) for a total period of 6 months. Pantoprazole and Ranitidine will be provided by Wyeth and the code will be kept by the pharmacy department at The Cancer Institute of New Jersey. The drugs will be provided free of cost to the patients for the entire period. Patients will be followed as out-patients at three-month intervals up to 6 months. Patients will be advised to return any unused capsules during the follow-up visits. The number of unused capsules as well as review of the patient's medication diary will allow assessment of non-compliance. Patients must be at least 75% compliant to remain on the study. If any patient complains of persistent symptoms, an effort will be made to provide relief with antacids, as much as needed. However, if the patient is still symptomatic, they will be taken off the study and unblinded. If the patient is on Ranitidine they will be switched to open label Pantoprazole and will be followed and further treated in a routine manner. If the patient is taking Pantoprazole, pH monitoring to document acid reflux and planning of further management will be determined.
All patients will have a follow-up endoscopy at 6 months, with no cost to the patient. This cost will be born by the grant received by Dr. Das. Additional endoscopy will be performed at 12 months and 24 months, which is the current "standard care" procedure for surveillance in such patients. Follow-up biopsy specimens will be taken the same way as the initial specimens and processed to see any changes in histology and mAb Das-1 reactivity.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Studies of Esophageal Metaplasia Using a Novel Antibody: Reversibility of Columnar Metaplasia by Proton Pump Inhibitor|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||October 2006|
|Actual Study Completion Date :||October 2006|
- The monoclonal antibody mAb Das-1 has been shown to react with a colonic epitope that is expressed in Barrett's Esophagus. Recent work has shown that it may be able to detect the changes of Barrett's Esophagus before it is histologically evident. In
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161200
|United States, New Jersey|
|Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|Principal Investigator:||Kiron Das, MD, PhD||Rutgers, The State University of New Jersey|