Inadequate recruitment
Sponsor study identifier
interventional
102
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed "PPI failures." Esophageal pH monitoring studies have shown that PPI failure rarely is due to persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis underlies PPI failure for patients with GERD symptoms. Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD. Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to participate in the study. Patients who provide informed consent will have a medical history taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for one week. The patient will return to the clinic one week later. Patients who feel that their heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation. During the endoscopic examination, biopsy specimens will be taken as follows: A. Two specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made if there is at least one high-power field with \>25 eosinophils, or two or more high-power fields with \>15 eosinophils. Potential Benefits: This study will provide an estimate on the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD. This has substantial potential importance for patient management.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
May 2010
Actual (reported)May 2010
Actual (reported)July 27, 2011
Actual (reported)July 28, 2011
Actual (reported)February 27, 2013
Actual (reported)Number of Participants With Eosinophilic Esophagitis
8 weeks
Number of Patients Who Had Resolution of Heartburn With Lansoprazole
After 8 weeks of treatment
Treat with lansoprazole 30 mg BID for 2 weeks, perform endoscopic examination with esophageal biopsy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Stuart J Spechler, MD
Dallas VA Medical Center
102 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2011
First Posted
July 28, 2011
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
February 27, 2013
Results First Posted
February 27, 2013
Record last verified: 2013-02
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Source: ClinicalTrials.gov.
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