A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer
Condition: Reflux Esophagitis; Gastric Ulcer; Duodenal Ulcer
MeSH terms: Gastroesophageal Reflux; Esophagitis; Stomach Ulcer; Duodenal Ulcer; Esophagitis, Peptic; Ulcer
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): D961H capsule 10mg; D961H sachet 10mg
Intervention type(s): Drug; Drug
Intervention description(s): All Groups can select either capsule or sachet during the study.; All Groups can select either capsule or sachet during the study.
Other intervention name(s): esomeprazole; esomeprazole
Intervention MeSH terms: Esomeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: An open label, parallel four group, multi-centre, phase III study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: D961H; paediatric; reflux esophagitis; gastric ulcer