An Open-label, Parallel-group, Multi-centre, Phase I/III Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10 mg and D961H 20 mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Disappearance of Heartburn at Week 8 by Investigators
研究概览
简要总结
The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Provision of signed written informed consent from the patient's guardian
- •Patients aged ≥ 1 year to 14 years old
- •Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.
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 randomisation/registration.
- •Significant clinical illness within 4 weeks prior to the registration
- •Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
- •Positive for pregnancy test by urinary or lactation for post-menarchal females.
- •Previous total gastrectomy
研究组 & 干预措施
Group 1: D961H sachet 10 mg
Age: ≥1 year Weight: <20 kg
干预措施: D961H sachet 10 mg (Drug)
Group 2: D961H capsule 10mg
Age: ≥1 year to 11years Weight: ≥20 kg
干预措施: D961H capsule 10mg (Drug)
Group 3: D961H capsule 20 mg
Age: ≥1 year to 11years Weight: ≥20 kg
干预措施: D961H capsule 20 mg (Drug)
Group 4: D961H capsule 10 mg
Age: 12 to 14 years Weight: ≥20 kg
干预措施: D961H capsule 10mg (Drug)
Group 5: D961H capsule 20 mg
Age: 12 to 14 years Weight: ≥20 kg
干预措施: D961H capsule 20 mg (Drug)
结局指标
主要结局
Disappearance of Heartburn at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Regurgitation at Week 8 by Patient Diaries
时间窗: 8 weeks
The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Disappearance of Epigastric Pain at Week 8 by Patient Diaries
时间窗: 8 weeks
The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Disappearance of Regurgitation at Week 8 by Patient Diaries
时间窗: 8 weeks
The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Aggravation of Regurgitation at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Disappearance of Heartburn at Week 8 by Patient Diaries
时间窗: 8 weeks
The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Aggravation of Heartburn at Week 8 by Patient Diaries
时间窗: 8 weeks
The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Aggravation of Epigastric Pain at Week 8 by Patient Diaries
时间窗: 8 weeks
The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
时间窗: 8 weeks
The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
时间窗: 8 weeks
The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Disappearance of Epigastric Pain at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Disappearance of Regurgitation at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Heartburn at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Epigastric Pain at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
时间窗: 8 weeks
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
次要结局
- AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose(0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose)
- Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose(0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose)
- Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose(0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose)
- Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose(0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose)
- Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose(0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose)
- Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose(0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose)
- Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose(0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose)