A Study of esomeplazole (D961H) in Japanese Paediatric Patients with Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer

Study identifier:D961WC00001

ClinicalTrials.gov identifier:NCT03553563

EudraCT identifier:2018-000213-20

CTIS identifier:N/A

Study Complete

Official Title

An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients with Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated with Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin

Medical condition

reflux esophagitis

Phase

Phase 3

Healthy volunteers

No

Study drug

D961H capsule 10mg, D961H sachet 10mg

Sex

All

Actual Enrollment

51

Study type

Interventional

Age

1 Years - 14 Years

Date

Study Start Date: 24 Jul 2018
Primary Completion Date: 27 Dec 2022
Study Completion Date: 27 Dec 2022

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention

Verification:

Verified 01 Dec 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria