Phase 3
N=50
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
Reflux Esophagitis · Gastric Ulcer · Duodenal Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT03553563 ↗Enrolled (actual)
50
Serious AEs
12.0%
Results posted
Mar 2026
Primary outcome: Primary: Presence/Absence of Reflux Esophagitis Relapse — 0; 1; 7; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- D961H capsule 10mg (Drug); D961H sachet 10mg (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence/Absence of Reflux Esophagitis Relapse |
1; 4; 5; 12 | — |
| PRIMARY Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence |
1; 0; 5; 7 | — |
| PRIMARY Adverse Events During Reflux Esophagitis Maintenance Therapy |
6; 15 | — |
| PRIMARY Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy |
6; 6 | — |
| SECONDARY Presence/Absence of Reflux Esophagitis Relapse |
1; 4; 5; 12 | — |
| SECONDARY Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence |
1; 0; 5; 7 | — |
| SECONDARY Adverse Events During Reflux Esophagitis Maintenance Therapy |
6; 15 | — |
| SECONDARY Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy |
6; 6 | — |
Summary
This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis.
Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want
Eligibility 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
- 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.
Data sourced from ClinicalTrials.gov (NCT03553563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.