EUCTR2016-003775-22-Outside-EU/EEA进行中（未招募）1 期
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 961H 10 mg and D961H 20 mg in Japanese paediatric patients 1 to 14 years old with gastrointestinal acid related diseases
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Provision of signed written informed consent from the patient’s guardian (including informed consent to a genetic test) prior to conducting of any study-related procedure and assent from the patient if possible.
- •·Patients aged = 1 year to 14 years old inclusive at the time of informed consent.
- •·Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.
- •·Patient’s BMI must be between the 10th and 90th percentile for his/her age.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 randomisation/registration, e.g., unintentional weight loss, gastrointestinal bleeding requiring abstinence from food, jaundice, or any other signs indicating serious or malignant diseases.
- •·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
- •·Need for H. pylori eradication therapy during the study period.
- •·Use of any PPIs within 14 days prior to the randomisation/registration.
研究者
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