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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Reflux Esophagitis

Gastric Ulcer

Duodenal Ulcer

Treatments

Drug: D961H sachet 10mg

Drug: D961H capsule 10mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03553563

2018-000213-20 (EudraCT Number)

D961WC00001

Details and patient eligibility

About

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

Full 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

Enrollment

51 patients

Sex

All

Ages

1 to 14 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 4 patient groups

Group1

Experimental group

Description:

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

Treatment:

Drug: D961H capsule 10mg

Drug: D961H sachet 10mg

Group2

Experimental group

Description:

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

Treatment:

Drug: D961H capsule 10mg

Drug: D961H sachet 10mg

Group3

Experimental group

Description:

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

Treatment:

Drug: D961H capsule 10mg

Drug: D961H sachet 10mg

Group4

Experimental group