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NCT02019758 · ClinicalTrials.gov registry record · Phase 4
Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 129
- Enrollment target
NCT02019758 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 129 participants.
The verdict
NCT02019758, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 129 participants
- Enrollment target
Study Summary
Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response. Participants: A total of up to 200 16-80 year old patients with a new diagnosis of eosinophilic esophagitis (EoE) who are referred for upper endoscopy will be consented with a target of 122 randomized. Procedures: This will be a prospective, randomized, double-blind, double-dummy, clinical trial comparing OVB to fluticasone MDI for treatment of EoE. This overall study design will generate data for all three Aims
Interventions
- DRUG Oral Viscous Budesonide
- DRUG Fluticasone MDI
- DRUG Placebo slurry
- DRUG Placebo inhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2015-01-01 |
| Est. Completion | 2019-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02019758
The ClinicalTrials.gov registry entry for NCT02019758 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Oral Viscous Budesonide is the first listed.
NCT02019758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02019758 about?
NCT02019758 is a clinical study titled "Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis". Purpose: To determine whether oral viscous budesonide (OVB) or fluticasone metered dose inhaler (MDI) most effectively treats EoE by improving histologic findings and symptoms, which medication provides a more durable treatment response, and whether biomarkers can predict treatment response. Partic...
What is the current status of trial NCT02019758?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 129 participants. The study started on 2015-01-01. Estimated completion is 2019-04.
What interventions are being tested in trial NCT02019758?
The interventions under investigation include: Oral Viscous Budesonide (DRUG), Fluticasone MDI (DRUG), Placebo slurry (DRUG), Placebo inhaler (DRUG).
Who is sponsoring clinical trial NCT02019758?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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