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NCT05267613 · ClinicalTrials.gov registry record · Phase 3
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
A Phase 3 study of Erosive Esophagitis, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT05267613: Recruiting Phase 3 study of Erosive Esophagitis, sponsored by AstraZeneca.
NCT05267613 is a Phase 3 study of Erosive Esophagitis that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 50 participants, below the 202-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05267613, a Phase 3 study of Erosive Esophagitis, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.
Primary Outcome
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
Conditions Studied
Interventions
- DRUG Nexium 20mg
- DRUG Nexium 10mg
Study Locations (20)
Other
- Research Site - Córdoba
- Research Site - Córdoba
- Research Site - Paraná
- Research Site - Rosario
California
- Research Site - Fontana
- Research Site - Orange
- Research Site - Sacramento
Florida
- Research Site - Miami
- Research Site - Orlando
Ohio
- Research Site - Akron
- Research Site - Cleveland
Alabama
- Research Site - Mobile
Illinois
- Research Site - Downers Grove
Indiana
- Research Site - Carmel
Massachusetts
- Research Site - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2027-09-06 |
| Phase | Phase 3 |
What NCT05267613 shows while recruiting
NCT05267613 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 202-participant average among 6 other Erosive Esophagitis trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Erosive Esophagitis appearing as the primary indexed condition, and to 2 interventions - of which Nexium 20mg is the first listed.
NCT05267613 names 20 study sites across 13 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05267613 about?
NCT05267613 is a clinical study titled "Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.". The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.
What is the current status of trial NCT05267613?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2022-07-01. Estimated completion is 2027-09-06.
What conditions does trial NCT05267613 study?
This clinical trial studies the following conditions: Erosive Esophagitis.
What interventions are being tested in trial NCT05267613?
The interventions under investigation include: Nexium 20mg (DRUG), Nexium 10mg (DRUG).
Who is sponsoring clinical trial NCT05267613?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05267613 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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