JPRN-jRCT2080223965已完成3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
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
- •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
研究者
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