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

NCT ID: NCT03553563

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2022-12-27

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group1

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

Group Type: EXPERIMENTAL

D961H capsule 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

D961H sachet 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

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

Group Type: EXPERIMENTAL

D961H capsule 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

D961H sachet 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

Group3

D961H 10 mg once-daily (32 or 52 weeks)

Group Type: EXPERIMENTAL

D961H capsule 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

D961H sachet 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

Group4

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)

Group Type: EXPERIMENTAL

D961H capsule 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

D961H sachet 10mg

Intervention Type: DRUG

All Groups can select either capsule or sachet during the study.

Interventions

D961H capsule 10mg

All Groups can select either capsule or sachet during the study.

Intervention Type: DRUG

D961H sachet 10mg

All Groups can select either capsule or sachet during the study.

Intervention Type: DRUG

Other Intervention Names

esomeprazole; esomeprazole

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Toshiaki Shimizu, M.D., Ph.D.

Role: STUDY_CHAIR

Juntendo University Graduate School of Medicine

Locations

Research Site

Bunkyō City, , Japan

Research Site

Bunkyō City, , Japan

Research Site

Fuji-shi, , Japan

Research Site

Izumi-shi, , Japan

Research Site

Kagoshima, , Japan

Research Site

Kanazawa, , Japan

Research Site

Kyoto, , Japan

Research Site

Maebashi, , Japan

Research Site

Matsumoto-shi, , Japan

Research Site

Okayama, , Japan

Research Site

Saitama-shi, , Japan

Research Site

Sakaishi, , Japan

Research Site

Setagaya-ku, , Japan

Research Site

Shinjuku-ku, , Japan

Research Site

Takatsuki-shi, , Japan

Research Site

Yokohama, , Japan

Research Site

Yokohama, , Japan

Countries

Japan

Other Identifiers

2018-000213-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D961WC00001

Identifier Type: -

Identifier Source: org_study_id