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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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jun 2023

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At a glance

  • Drugs Esomeprazole (Primary)
  • Indications Duodenal ulcer; Gastric ulcer; Reflux oesophagitis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors AstraZeneca; AstraZeneca KK

Most Recent Events

  • 11 Apr 2023 Status changed from active, no longer recruiting to completed.
  • 03 Jan 2023 Planned End Date changed from 27 Dec 2022 to 26 Dec 2022.
  • 03 Jan 2023 Planned primary completion date changed from 27 Dec 2022 to 26 Dec 2022.

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