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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2019

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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

    • 01 Nov 2019 Last checked against the ClinicalTrials.gov record.
    • 31 Jul 2018 Planned End Date changed from 2 Jan 2023 to 4 Jan 2023.
    • 31 Jul 2018 Planned primary completion date changed from 2 Jan 2023 to 4 Jan 2023.
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