JPRN-jRCT2080222552未知3 期
An Open-label, Parallel-group, Multi-centre, Phase 1/3 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10mg and D961H 20mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases
适应症
试验速览
- 阶段
- 3 期
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 1age old 至 <= 14age old（—）
- 性别
- All
入选标准
- •Provision of signed written informed consent from the patient's guardian.
- •-Patients aged 1 year or more 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.
研究者
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