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NCT04149470 · ClinicalTrials.gov registry record · Phase 4

Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)

A Phase 4 study of Eosinophilic Esophagitis, sponsored by University of Colorado, Denver.

Active
Registry status
Phase 4
Development phase
90
Enrollment target
1
Study location

NCT04149470 is a Phase 4 study of Eosinophilic Esophagitis that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 90 participants, below the 862-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04149470, a Phase 4 study of Eosinophilic Esophagitis, is active but no longer recruiting, sponsored by University of Colorado, Denver.

ACTIVE NOT RECRUITING
Registry status
Phase 4
Development phase
90 participants
Enrollment target
1
Study location

Study Summary

This study will enroll participants who have been diagnosed with Eosinophilic Esophagitis (EoE). Upon study enrollment, the participant will begin a proton pump inhibitor (PPI), Omeprazole 20mg twice daily. After taking Omeprazole for four weeks, the participant will have a Transnasal Endoscopy, and biopsies will be taken to determine the histological change. If the biopsies are abnormal, the participant continues Omeprazole and will undergo another endoscopy at eight weeks. The study aims to determine the percentage of children with Eosinophilic Esophagitis who improve with PPI use and to determine the length of time and effectiveness of PPI therapy in the management of EoE. The investigators hypothesize that following the initiation of PPI for treatment of Eosinophilic Esophagitis, biopsies obtained will show decreasing eosinophil counts at four weeks, which is sooner than the previously reported eight-week period.

Conditions Studied

Eosinophilic Esophagitis

Interventions

  • DRUG Omeprazole 20mg BID

Study Locations (1)

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2020-10-07
Est. Completion 2024-08
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

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What the Registry Record Tells You About NCT04149470

The ClinicalTrials.gov registry entry for NCT04149470 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 862-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (90% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Eosinophilic Esophagitis appearing as the primary indexed condition, and to 1 intervention - of which Omeprazole 20mg BID is the first listed.

NCT04149470 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT04149470 about?

NCT04149470 is a clinical study titled "Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)". This study will enroll participants who have been diagnosed with Eosinophilic Esophagitis (EoE). Upon study enrollment, the participant will begin a proton pump inhibitor (PPI), Omeprazole 20mg twice daily. After taking Omeprazole for four weeks, the participant will have a Transnasal Endoscopy, and...

What is the current status of trial NCT04149470?

This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 90 participants. The study started on 2020-10-07. Estimated completion is 2024-08.

What conditions does trial NCT04149470 study?

This clinical trial studies the following conditions: Eosinophilic Esophagitis.

What interventions are being tested in trial NCT04149470?

The interventions under investigation include: Omeprazole 20mg BID (DRUG).

Who is sponsoring clinical trial NCT04149470?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04149470 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.