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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 50
- 试验地点
- 15
- 主要终点
- Presence/Absence of Reflux Esophagitis Relapse
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group1
Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily
干预措施: D961H capsule 10mg (Drug)
Group1
Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily
干预措施: D961H sachet 10mg (Drug)
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
干预措施: D961H capsule 10mg (Drug)
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
干预措施: D961H sachet 10mg (Drug)
Group3
D961H 10 mg once-daily (32 or 52 weeks)
干预措施: D961H capsule 10mg (Drug)
Group3
D961H 10 mg once-daily (32 or 52 weeks)
干预措施: D961H sachet 10mg (Drug)
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)
干预措施: D961H capsule 10mg (Drug)
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)
干预措施: D961H sachet 10mg (Drug)
结局指标
主要结局
Presence/Absence of Reflux Esophagitis Relapse
时间窗: 8 to 32 weeks
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.
Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence
时间窗: 0 to 32 weeks
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.
Adverse Events During Reflux Esophagitis Maintenance Therapy
时间窗: 8 to 32 weeks
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.
Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy
时间窗: 0 to 32 weeks
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.
次要结局
- Presence/Absence of Reflux Esophagitis Relapse(8 to 52 weeks)
- Presence/Absence of Gastric Ulcer or Duodenal Ulcer Recurrence(0 to 52 weeks)
- Adverse Events During Reflux Esophagitis Maintenance Therapy(8 to 52 weeks)
- Adverse Events During Gastric Ulcer or Duodenal Ulcer Recurrence Prevention Therapy(0 to 52 weeks)