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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: |
NCT00961233 |
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Date of registration:
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14/08/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)
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Scientific title:
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Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis. |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00961233 |
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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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Evan S Dellon, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- New diagnosis of eosinophilic esophagitis (per 2007 consensus guidelines)
Exclusion Criteria:
- Age < 18
- Inability to read or understand English
- Pregnant or nursing women
- Previous allergic reactions to steroid medications
- Current use of systemic steroids
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: inhaled/swallowed budesonide
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Drug: viscous/swallowed budesonide
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Primary Outcome(s)
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Tissue Eosinophil Counts
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Adrenal Insufficiency
[Time Frame: 8 weeks]
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Secondary ID(s)
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IRUSESOM0609
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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