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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: Completed NA study, sponsored by Walter Reed Army Medical Center.
NCT00895817 is a NA study that has completed, run by Walter Reed Army Medical Center. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Histologic resolution of esophageal eosinophilia. Response is defined as achieving \< 7 eosinophils/high power field in both the proximal and distal esophagus.
Interventions
- DRUG Esomeprazole
- DRUG Swallowed fluticasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-10 |
| Phase | NA |
What the finished NCT00895817 record still lists
NCT00895817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Esomeprazole is the first listed.
NCT00895817 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00895817's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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