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An Open-label, Parallel-group, Multi-centre, Phase 1/3 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10mg and D961H 20mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases

An Open-label, Parallel-group, Multi-centre, Phase 1/3 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10mg and D961H 20mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222552
Enrollment
Unknown
Registered
2014-07-03
Start date
2014-07-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

investigational material(s) Generic name etc : Drug: D961H sachet 10mg, Drug: D961H capsule 10mg, Drug: D961H capsule 20mg INN of investigational material : Therapeutic category code : 232 Agents for

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Provision of signed written informed consent from the patient's guardian. -Patients aged 1 year or more to 14 years old. -Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.

Exclusion criteria

Exclusion criteria: -Patients less than 10 kg in weight. -Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the randomisation/registration. -Significant clinical illness within 4 weeks prior to the registration. -Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators. -Positive for pregnancy test by urinary or lactation for post-menarchal females. -Previous total gastrectomy.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026