A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
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
2 other identifiers
interventional
50
1 country
15
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2018
Typical duration for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Start
First participant enrolled
July 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2022
CompletedResults Posted
Study results publicly available
March 4, 2026
CompletedMarch 4, 2026
February 1, 2026
4.4 years
April 5, 2018
December 20, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Presence/Absence of Reflux Esophagitis Relapse
Maintenance therapy for healed reflux esophagitis study part: Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all participants by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
8 to 32 weeks
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all participants by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
0 to 32 weeks
Adverse Events During Reflux Esophagitis Maintenance Therapy
Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all participants. Number of participants with any adverse event during the period.
8 to 32 weeks
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part: Safety from 0 to 32 weeks for all participants. Number of participants with any adverse event during the period.
0 to 32 weeks
Secondary Outcomes (4)
Presence/Absence of Reflux Esophagitis Relapse
8 to 52 weeks
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
0 to 52 weeks
Adverse Events During Reflux Esophagitis Maintenance Therapy
8 to 52 weeks
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
0 to 52 weeks
Study Arms (4)
Group1
EXPERIMENTALInitial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily
Group2
EXPERIMENTALInitial 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
EXPERIMENTALD961H 10 mg once-daily (32 or 52 weeks)
Group4
EXPERIMENTALD961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks)
Interventions
All Groups can select either capsule or sachet during the study.
All Groups can select either capsule or sachet during the study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Bunkyō City, 113-8431, Japan
Research Site
Bunkyō City, 113-8519, Japan
Research Site
Fuji-shi, 417-8567, Japan
Research Site
Izumi-shi, 594-1101, Japan
Research Site
Kagoshima, 890-8520, Japan
Research Site
Kanazawa, 920-8641, Japan
Research Site
Maebashi, 371-8511, Japan
Research Site
Matsumoto-shi, 390-8621, Japan
Research Site
Okayama, 701-1192, Japan
Research Site
Sakaishi, 593-8304, Japan
Research Site
Setagaya-ku, 157-8535, Japan
Research Site
Shinjuku-ku, 160-0023, Japan
Research Site
Takatsuki-shi, 569-8686, Japan
Research Site
Yokohama, 230-8765, Japan
Research Site
Yokohama, 232 8555, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Masahiro Nii/Japan project statistician
- Organization
- Biometrics & Real World Analytics Department, AstraZeneca Japan
Study Officials
- STUDY CHAIR
Toshiaki Shimizu, M.D., Ph.D.
Juntendo University Graduate School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2018
First Posted
June 12, 2018
Study Start
July 24, 2018
Primary Completion
December 27, 2022
Study Completion
December 27, 2022
Last Updated
March 4, 2026
Results First Posted
March 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.