Status:
COMPLETED
Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
Lead Sponsor:
Walter Reed Army Medical Center
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 incr...
Eligibility Criteria
Inclusion
- Patients with an established diagnosis of EE defined as \> 20 eosinophils/HPF in the setting of dysphagia or food impaction.
- Males and females age \> 18 years of age.
- Ability to undergo ambulatory pH monitoring.
- DEERS (Defense Enrollment Eligibility Reporting System) eligible.
- Willingness to take a one month holiday from a PPI or steroids if they have been prescribed this prior to enrollment.
- Willingness to participate and have additional biopsies taken during endoscopy and answer a questionnaire.
Exclusion
- Patients \< 18 years of age.
- Inability to give consent.
- Inability to undergo endoscopy or contraindications to endoscopy. Any medical condition or disorder (including drug allergies), which would preclude the use of conscious sedation or the ability to tolerate upper endoscopy.
- Contraindications to proton pump inhibitors or steroids.
- Inability to accurately fill out a short questionnaire.
- Pregnant females. A urine beta human chorionic gonadotropin (BHCG) prior to endoscopy will be offered to all female patients of child bearing potential (exceptions include post-menopausal, hysterectomy or bilateral tubal ligation). Positive BHCG results will prevent enrollment.
- Known coagulation abnormalities, thrombocytopenia and patients on coumadin.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00895817
Start Date
April 1 2008
End Date
October 1 2010
Last Update
March 12 2013
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307