Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis. (EE)
A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age
Sponsor: AstraZeneca
This observational or N/A phase trial investigates Erosive Esophagitis and is currently ongoing. AstraZeneca leads this study, which shows 31 recorded versions since 2022 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age
Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.
Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age
Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.
Status Flow
Change History
31 versions recorded-
Apr 23, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting · Phase: PHASE3 → None
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Dec 2025 — Apr 2026 [monthly]
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▶ Show 26 earlier versions
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First recorded
Eligibility 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.
Contact Information
- AstraZeneca
- CISCRP
- Calyx
- IQVIA RDS Inc.
- Laboratory Corporation of America
- Little Journey Ltd.
- Medidata Solutions
- Quipment Inc.
- Thermo Fisher Scientific, Inc
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Akron, United States , Athens, Greece , Badalona, Spain , Braga, Portugal , Carmel, United States , Clayton, Australia , Cleveland, United States , Coimbra, Portugal , Córdoba, Argentina , Córdoba, Argentina and 32 more locations