Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 129 participants
Start Date 2015-01-01
Est. Completion 2019-04
Phase Phase 4

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.