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NCT01404832 · ClinicalTrials.gov registry record · Phase 4
The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
A Phase 4 study, sponsored by Dallas VA Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 102
- Enrollment target
NCT01404832 is a Phase 4 study that was terminated before completion, run by Dallas VA Medical Center. The registered enrollment target is 102 participants.
The verdict
NCT01404832, a Phase 4 study, was terminated before completion, sponsored by Dallas VA Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 102 participants
- Enrollment target
Study 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 eso
Interventions
- DRUG Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01404832
The ClinicalTrials.gov registry entry for NCT01404832 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dallas VA Medical Center, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms is the first listed.
NCT01404832 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01404832 about?
NCT01404832 is a clinical study titled "The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors". 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 ref...
What is the current status of trial NCT01404832?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 102 participants. The study started on 2007-10. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01404832?
The interventions under investigation include: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms (DRUG).
Who is sponsoring clinical trial NCT01404832?
This trial is sponsored by Dallas VA Medical Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
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