胃腸酸関連疾患を有する日本人小児患者を対象としたD961H 10mgおよび20mgの第I/III相臨床試験

基本情報

NCT ID: NCT02153398
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 55
治験依頼者名: AstraZeneca

概要

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.

対象疾患

Gastric Ulcer (GU)Duodenal Ulcer (DU)Anastomotic Ulcer (AU)Non-erosive Reflux Esophagitis Disease (NERD)Reflux Esophagitis (RE)Zollinger-Ellison Syndrome

介入

D961H sachet 10 mg(DRUG)

D961H capsule 10mg(DRUG)

D961H capsule 20 mg(DRUG)

依頼者（Sponsor）

アストラゼネカ株式会社(INDUSTRY)