Reflux EsophagitisPhase 3NCT03553563
A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
A Phase 3 study testing D961H capsule 10mg and D961H sachet 10mg in people with Reflux Esophagitis and Gastric Ulcer, run by AstraZeneca at 15 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- What is being tested?
- D961H capsule 10mg and D961H sachet 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 15 sitesJapan
- Study dates
- 24 Jul 2018to 27 Dec 2022
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Japan15 sites
Research Site
Bunkyō City, 113-8431
Research Site
Bunkyō City, 113-8519
Research Site
Fuji-shi, 417-8567
Research Site
Izumi-shi, 594-1101
Research Site
Kagoshima, 890-8520
Research Site
Kanazawa, 920-8641
Research Site
Maebashi, 371-8511
Research Site
Matsumoto-shi, 390-8621
Research Site
Okayama, 701-1192
Research Site
Sakaishi, 593-8304
Research Site
Setagaya-ku, 157-8535
Research Site
Shinjuku-ku, 160-0023
Research Site
Takatsuki-shi, 569-8686
Research Site
Yokohama, 230-8765
Research Site
Yokohama, 232 8555
About this study
Official title: 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
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
Read the detailed description
Subjects are allocated to four groups based on their disease and weight.
Number of Subjects
Maintenance therapy for healed reflux esophagitis study part:
- Group1:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg ), Maintenance phase, n=5 to 10
- Group2:aged 1 to 14 years (weight more than equal 20 kg), Maintenance phase, n=10 to 20
Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:
- Group3:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg), n=5 to 10 at Week 0
- Group4:aged 1 to 14 years (weight more than equal 20 kg), n=10 to 20 at Week 0
All subjects have a D961H administration for 32 or 52 weeks. all esophagogastroduodenoscopy findings are reviewed by central evaluation committee and study is conducted based on the judgement of central evaluation committee.
Data are entered in electric data capture system at study site by site staffs and all data are verified with source data by site monitors during the study.
Analyses will be performed by AstraZeneca or its representatives. A comprehensive statistical analysis plan will be developed and finalised before database lock and will describe the subject populations to be included in the analyses, and procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints. Any deviations from this plan will be reported in the clinical study report.
Efficacy analyses are intended for Efficacy Analysis Set. ・Efficacy Analysis Set:All subjects who take at least 1 dose of the investigational product and have at least 1 efficacy datum assessment during the maintenance/prevention therapy period, and who have no important protocol deviation.
All safety analyses are performed on the Safety Analysis Set.
・Safety Analysis Set:All subjects who take at least 1 dose of the investigational product and have any post-treatment assessment.
Frequency and incidence rate of adverse events (AEs), serious adverse events (SAEs), discontinuation of investigational product due to adverse events (DAEs) and other significant adverse events (OAEs) will be presented by MedDRA System Organ Class (SOC) and Preferred Term (PT) for each group. In addition, summaries of AEs will be further broken down by maximum intensity and relationship to the investigational product as assigned by investigators
- Conditions
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- Being tested
- D961H capsule 10mg, D961H sachet 10mg
- Keywords
- D961H, paediatric, reflux esophagitis, gastric ulcer
- Medical subject headings
- Esophagitis, Peptic, Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D961H capsule 10mgDrug
Also called esomeprazole
All Groups can select either capsule or sachet during the study.
D961H sachet 10mgDrug
Also called esomeprazole
All Groups can select either capsule or sachet during the study.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg |
| Group2 | Experimental | 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 Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg |
| Group3 | Experimental | D961H 10 mg once-daily (32 or 52 weeks) Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg |
| Group4 | Experimental | D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks) Receives: Drug: D961H capsule 10mg; Drug: D961H sachet 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 to 32 weeks
Secondary outcomes (4)
Presence/Absence of Reflux Esophagitis Relapse
Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (reflux esophagitis-related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.
Measured: 8 to 52 weeks
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for participants who continued the study treatment after Week 32 by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.
Measured: 0 to 52 weeks
Adverse Events During Reflux Esophagitis Maintenance Therapy
Maintenance therapy for healed reflux esophagitis study part:
Safety from 8 to 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event during the period
Measured: 8 to 52 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 52 weeks for participants who continued the study treatment after Week 32. Number of participants with any adverse event
Measured: 0 to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start24 Jul 2018
- Primary completion27 Dec 2022
- Study completion27 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- An open label, parallel four group, multi-centre, phase III study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshiaki Shimizu, M.D., Ph.D., Study chair, Juntendo University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553563
- Sponsor's protocol ID
- D961WC00001
- Other IDs
- 2018-000213-20, 2018
- Status last verified
- Feb 2026
- First submitted
- 5 Apr 2018
- Last updated
- 4 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.