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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00895817 |
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Date of registration:
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06/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
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Scientific title:
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Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00895817 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Fouad J Moawad, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Walter Reed Army Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Eosinophilic Esophagitis
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Intervention(s)
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Drug: Esomeprazole
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Drug: Swallowed fluticasone
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Primary Outcome(s)
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Number of Participants Who Responded
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Endoscopic Change
[Time Frame: 8 weeks]
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Symptom Score
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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