Endoscopic evidence of maintenance of healing with oral NEXIUM in patients 1 to 11 years old with erosive esophagitis. - EE

Study identifier:D9612C09998

ClinicalTrials.gov identifier:NCT05267613

EudraCT identifier:2020-002515-21

CTIS identifier:N/A

Recruiting

Official Title

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

Medical condition

Erosive Esophagitis

Phase

Phase 3

Healthy volunteers

No

Study drug

Nexium 20mg, Nexium 10mg

Sex

All

Estimated Enrollment

100

Study type

Interventional

Age

1 Years - 11 Years

Date

Study Start Date: 01 Jul 2022
Estimated Primary Completion Date: 14 Aug 2026
Estimated Study Completion Date: 06 Nov 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

IQVIA RDS Inc., Calyx, Labcorp Central Laboratory Services, Medidata Solutions, Thermo Fisher Scientific, CISCRP (Center for Information and Study on Clinical Research Participation), Quipment Inc., Little Journey Ltd.

Inclusion and exclusion criteria