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NCT00123630 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00123630 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 30 participants.
The verdict
NCT00123630, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults. The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising incidence of EE may be related to the worldwide allergy and asthma epidemic. Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have all been shown to be effective. However, none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects. The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE. Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related symptoms in patients with allergic asthma. The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis
Interventions
- DRUG Placebo
- DRUG omalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2005-11 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00123630
The ClinicalTrials.gov registry entry for NCT00123630 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00123630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00123630 about?
NCT00123630 is a clinical study titled "A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab". Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults. The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergi...
What is the current status of trial NCT00123630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2005-11. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00123630?
The interventions under investigation include: Placebo (DRUG), omalizumab (DRUG).
Who is sponsoring clinical trial NCT00123630?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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