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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: |
NCT00275561 |
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Date of registration:
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10/01/2006 |
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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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Topical Steroid Treatment for Eosinophilic Esophagitis
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Scientific title:
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A Randomized Placebo-controlled Trial of Swallowed Fluticasone in Treatment of Eosinophilic Esophagitis |
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Date of first enrolment:
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November 2005 |
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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/NCT00275561 |
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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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Phase 2
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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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Jeffrey A. Alexander, 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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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- > 20 eosinophils / hpf on biopsies from mid esophagus (hpf = high-powered field)
- Abnormal dysphagia questionnaire (question 1a "yes", question 1c > "moderate" and
question 2 > "less than once a week") on Mayo Dysphagia Questionnaire.
Exclusion Criteria:
- Clinical evidence of infectious process potentially contributing to dysphagia (e.g.,
candidiasis, cytomegalovirus, herpes)
- Systemic or topical steroid therapy for any reason over the past 3 months
- Previous steroid treatment for Eosinophilic Esophagitis
- Intolerance to steroid therapy in the past
- Other cause of dysphagia identified at endoscopy (e.g., reflux esophagitis, stricture,
web, ring, achalasia, esophageal neoplasm)
- Dilatation of esophagus at time of index endoscopy
Age minimum:
18 Years
Age maximum:
60 Years
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: Placebo
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Drug: Fluticasone
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Primary Outcome(s)
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Number of Participants With Complete Response to Dysphagia
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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Number of Participants With Partial or Complete Response to Dysphagia
[Time Frame: 2 weeks]
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Number of Participants With Complete Histologic Response
[Time Frame: 2 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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