The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
Primary Purpose
Gastroesophageal Reflux Disease, Eosinophilic Esophagitis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux, Proton pump inhibitor, Eosinophilic esophagitis
Eligibility Criteria
Inclusion Criteria:Male and female patients ages 18 years and older who are referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy
Exclusion Criteria:
- Patients unwilling or unable to provide informed consent.
- Allergy to lansoprazole.
- Patients taking warfarin.
- Coagulopathy that precludes safe biopsy of the esophagus.
- Comorbidity that precludes safe participation in the study.
- Pregnancy.
Sites / Locations
- Dallas VA Medical Center
Outcomes
Primary Outcome Measures
Number of Participants With Eosinophilic Esophagitis
Secondary Outcome Measures
Number of Patients Who Had Resolution of Heartburn With Lansoprazole
Resolution of heartburn defined as >50% improvement in symptoms
Full Information
NCT ID
NCT01404832
First Posted
July 27, 2011
Last Updated
February 26, 2013
Sponsor
Dallas VA Medical Center
Collaborators
TAP Pharmaceutical Products Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01404832
Brief Title
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
Official Title
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Inadequate recruitment
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dallas VA Medical Center
Collaborators
TAP Pharmaceutical Products Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Eosinophilic Esophagitis
Keywords
Gastroesophageal reflux, Proton pump inhibitor, Eosinophilic esophagitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms
Intervention Description
Treat with lansoprazole 30 mg BID for 2 weeks, perform endoscopic examination with esophageal biopsy
Primary Outcome Measure Information:
Title
Number of Participants With Eosinophilic Esophagitis
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Who Had Resolution of Heartburn With Lansoprazole
Description
Resolution of heartburn defined as >50% improvement in symptoms
Time Frame
After 8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Male and female patients ages 18 years and older who are referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy
Exclusion Criteria:
Patients unwilling or unable to provide informed consent.
Allergy to lansoprazole.
Patients taking warfarin.
Coagulopathy that precludes safe biopsy of the esophagus.
Comorbidity that precludes safe participation in the study.
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart J Spechler, MD
Organizational Affiliation
Dallas VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
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