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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: Active Phase 4 study of Eosinophilic Esophagitis, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- DRUG Omeprazole 20mg BID
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2024-08 |
| Phase | Phase 4 |
What the registry record for NCT04149470 still lists
NCT04149470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 862-participant average among 44 other Eosinophilic Esophagitis trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04149470's enrollment target sits among peer trials
90 21st of 44 higher than 24 of 44 other Eosinophilic Esophagitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Eosinophilic Esophagitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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