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NCT01016223 · ClinicalTrials.gov registry record · Phase 1
A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis
A Phase 1 study, sponsored by Penn State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01016223 is a Phase 1 study that has completed, run by Penn State University. The registered enrollment target is 20 participants.
The verdict
NCT01016223, a Phase 1 study, has completed, sponsored by Penn State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The investigators hypothesize that swallowed beclomethasone leads not only to improvement of symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13, GM-CSF and TGF-beta as well as serum ultra-sensitive C-Reactive Protein (CRP). The investigators aim to characterize the response of esophageal inflammation to swallowed topical glucocorticoids, and identify biomarkers to assess response to treatment. This research will elucidate the effect of treatment with beclomethasone on various inflammatory markers in EoE, which is currently not well-understood. This work will explore the pathophysiology of EoE, and has the potential to find a non-invasive biomarker such as high-sensitivity CRP that can be used to monitor the response to treatment.
Interventions
- DRUG placebo
- DRUG Beclomethasone dipropionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01016223
The ClinicalTrials.gov registry entry for NCT01016223 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01016223 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01016223 about?
NCT01016223 is a clinical study titled "A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis". The investigators hypothesize that swallowed beclomethasone leads not only to improvement of symptoms and decreased number of eosinophils in esophageal mucosa, but also to a decrease in other markers of tissue inflammation like mast cells, CD4+ T lymphocytes, IL4, IL-5, IL13, GM-CSF and TGF-beta as ...
What is the current status of trial NCT01016223?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2010-03. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01016223?
The interventions under investigation include: placebo (DRUG), Beclomethasone dipropionate (DRUG).
Who is sponsoring clinical trial NCT01016223?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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