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An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases

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Trial Profile

An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2019

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At a glance

  • Drugs Esomeprazole (Primary) ; Esomeprazole (Primary)
  • Indications Duodenal ulcer; Gastric ulcer; Gastro-oesophageal reflux; Gastrointestinal ulcer; Reflux oesophagitis; Zollinger-Ellison syndrome
  • Focus Adverse reactions; Registrational
  • Sponsors AstraZeneca

Most Recent Events

  • 19 Jan 2018 According to an AstraZeneca media release, the approval was based on D961TC00002 and D961TC00004 trials.
  • 19 Jan 2018 According to an AstraZeneca media release, the MHLW has approved a partial registration change in terms of additional dosage and administration for children aged 1 year and older for Nexium 10 mg and 20 mg Capsules as a PPI indicated for gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux esophagitis (initial treatment), nonerosive reflux disease, and Zollinger-Ellison syndrome as well as marketing approval for Nexium 10 mg and 20 mg Granules for Suspension, Sachet with the same indication.
  • 27 Apr 2016 Status changed from active, no longer recruiting to completed.

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