An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223965

Enrollment

Registered

2018-07-03

Start date

2018-08-08

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

Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer

Interventions

investigational material(s) Generic name etc : D961H capsule 10mg, D961H sachet 10mg INN of investigational material : - Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administrati

Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily Group2: Initial healing phase (8 weeks), D961H 20 mg once-daily

Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion Group3: D961H 10 mg once-daily (32 or 52 weeks) Gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For healed reflux esophagitis study -Endoscopically verified reflux esophagitis, Grade A or higher according to the Los Angels classification as judged by central evaluation committee For prevention of gastric ulcer or duodenal ulcer recurrence study -Patients with documented medical history of gastric ulser or duodenal ulser diagnosis based on upper gastrointestinal symptoms, fecal occult blood, esophagogastroduodenoscopy findings, etc

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 enrolment - Significant clinical illness within 4 weeks prior to the informed consent - Previous total gastrectomy - Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by investigators. etc

Design outcomes

Primary

Measure	Time frame
safety efficacy	—

Secondary

Measure	Time frame
safety efficacy pharmacodynamics	—

Countries

none

Contacts

Public ContactHirotaka Tsugumi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3600

Outcome results

None listed

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