Clinical trial · Interventional
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Ulcer (AU) | — | UNRESOLVED | — |
| Duodenal Ulcer (DU) | — | UNRESOLVED | — |
| Gastric Ulcer (GU) | — | UNRESOLVED | — |
| Non-erosive Reflux Esophagitis Disease (NERD) | — | UNRESOLVED | — |
| Reflux Esophagitis (RE) | — | UNRESOLVED | — |
| Zollinger-Ellison Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D961H capsule 10mg | Drug | — | UNRESOLVED |
| D961H capsule 20 mg | Drug | — | UNRESOLVED |
| D961H sachet 10 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Group 1: D961H sachet 10 mg
- description
- Age: ≥1 year Weight: \<20 kg
- interventionNames
- Drug: D961H sachet 10 mg
- type
- EXPERIMENTAL
- label
- Group 2: D961H capsule 10mg
- description
- Age: ≥1 year to 11years Weight: ≥20 kg
- interventionNames
- Drug: D961H capsule 10mg
- type
- EXPERIMENTAL
- label
- Group 3: D961H capsule 20 mg
- description
- Age: ≥1 year to 11years Weight: ≥20 kg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 14 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed written informed consent from the patient's guardian * Patients aged ≥ 1 year 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: * 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
References
Publications (0)
Data not yet available