Conditions: Gastric Ulcer (GU) Duodenal Ulcer (DU) Anastomotic Ulcer (AU) Non-erosive Reflux Esophagitis Disease (NERD) Reflux Esophagitis (RE) Zollinger-Ellison Syndrome
Keywords: Gastric ulcer (GU) Duodenal ulcer (DU) Anastomotic ulcer (AU) Non-erosive reflux esophagitis disease (NERD) Reflux esophagitis (RE) Zollinger-Ellison syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Age: ≥1 year Weight: \<20 kg arm 2: Age: ≥1 year to 11years Weight: ≥20 kg arm 3: Age: ≥1 year to 11years Weight: ≥20 kg arm 4: Age: 12 to 14 years Weight: ≥20 kg arm 5: Age: 12 to 14 years Weight: ≥20 kg

Interventions: intervention 1: D961H sachet 10 mg intervention 2: D961H capsule 10mg intervention 3: D961H capsule 20 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: