A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer

Gastric Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553563
• Other study ID #: D961WC00001
• Secondary ID: 2018-000213-20
• Status: Completed
• Phase: Phase 3
• Start date: July 24, 2018
• Est. completion date: December 27, 2022

Study information

• Verified date: April 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duodenal Ulcer
• Esophagitis
• Esophagitis, Peptic
• Gastric Ulcer
• Gastroesophageal Reflux
• Reflux Esophagitis
• Stomach Ulcer
• Ulcer

Intervention

Drug:
• D961H capsule 10mg
All Groups can select either capsule or sachet during the study.
• D961H sachet 10mg
All Groups can select either capsule or sachet during the study.

Locations

Country	Name	City	State
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Fuji-shi
Japan	Research Site	Izumi-shi
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kanazawa-shi
Japan	Research Site	Kyoto-shi
Japan	Research Site	Maebashi-shi
Japan	Research Site	Matsumoto-shi
Japan	Research Site	Okayama-shi
Japan	Research Site	Saitama-shi
Japan	Research Site	Sakai-shi
Japan	Research Site	Setagaya-ku
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Takatsuki-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 subjects by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.	8 to 32 weeks
Primary	Adverse events during reflux esophagitis maintenance therapy	Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 32 weeks for all subjects.	8 to 32 weeks
Primary	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 subjects 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
Primary	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 subjects.	0 to 32 weeks
Secondary	Presence/absence of reflux esophagitis relapse	Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for subjects 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.	8 to 52 weeks
Secondary	Adverse events during reflux esophagitis maintenance therapy	Maintenance therapy for healed reflux esophagitis study part: Safety from 8 to 52 weeks for subjects who continued the study treatment after Week 32.	8 to 52 weeks
Secondary	Presence/absence of gastric ulcer or duodenal ulcer recurrence	Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for subjects 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.	0 to 52 weeks
Secondary	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 subjects who continued the study treatment after Week 32.	0 to 52 weeks