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Clinical Trial Summary

The objective of this study is 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 aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02153398
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 3
Start date June 2014
Completion date April 2016

See also
  Status Clinical Trial Phase
Completed NCT00079833 - Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome Phase 3
Completed NCT00204373 - Treatment of Zollinger-Ellison Syndrome With Prevacid Phase 4
Terminated NCT02454075 - YF476 and Type II Gastric Carcinoids Phase 2