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NCT00895817 · ClinicalTrials.gov registry record · NA
Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
A NA study, sponsored by Walter Reed Army Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
NCT00895817 is a NA study that has completed, run by Walter Reed Army Medical Center. The registered enrollment target is 42 participants.
The verdict
NCT00895817, a NA study, has completed, sponsored by Walter Reed Army Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presence of anatomical abnormalities in the esophagus such as longitudinal furrows, corrugated rings and a narrow caliber esophagus with friable mucosa are classic endoscopic findings. Diagnosis is established with the histologic finding of large numbers (\> 15) of eosinophils per high power field. The underlying pathologic mechanism remains poorly understood but food allergies and aeroallergens have been implicated. It is well known that gastroesophageal reflux disease (GERD) may cause esophageal eosinophilia, but it is unclear whether a complex relationship exists between GERD and EE, as recent data suggests. Furthermore, a large number of patients with clinical presentations and endoscopic findings highly suggestive of EE which is confirmed on histology are responding favorably to proton pump inhibitors. The aims of the study are to (1) compare the clinical efficacy of aerosolized swallowed Fluticasone to Esomeprazole for the treatment of eosinophilic esophagitis, (2) determine whether proton pump inhibitors are effective in the treatment of eosinophilic esophagitis, (3) determine the number of patients with eosinophilic esophagitis that have coexisting gastroesophageal reflux disease, and (4) correlate change in eosinophil count to improvement in symptoms before and after therapy.
Interventions
- DRUG Esomeprazole
- DRUG Swallowed fluticasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00895817
The ClinicalTrials.gov registry entry for NCT00895817 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed Army Medical Center, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Esomeprazole is the first listed.
NCT00895817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00895817 about?
NCT00895817 is a clinical study titled "Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis". The purpose of this study is to assess the clinical efficacy of proton pump inhibitors in comparison to aerosolized swallowed steroids for the treatment of eosinophilic esophagitis (EE). EE is an increasingly recognized disorder that has been associated with dysphagia and food impaction. The presenc...
What is the current status of trial NCT00895817?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2008-04. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00895817?
The interventions under investigation include: Esomeprazole (DRUG), Swallowed fluticasone (DRUG).
Who is sponsoring clinical trial NCT00895817?
This trial is sponsored by Walter Reed Army Medical Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
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