NCT00402259已完成3 期
A Randomised, Double-Blind, Double-Dummy, Active-Controlled, Multicenter Study to Assess the Efficacy and Safety of Esomeprazole or Omeprazole for 5 Days in Subjects With Acute Non-Variceal Upper Gastrointestinal Bleeding
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 440
- 试验地点
- 7
- 主要终点
- Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Esomeprazole and Omeprazole intravenous every 12 hours for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-65 years.
- •GI bleeding or with such signs within 48 hours as judged by the investigator as to have non-variceal upper GI bleeding.
- •One endoscopically confirmed bleeding peptic ulcer or erosive gastritis
排除标准
- •GI bleeding caused by Esophageal varices
- •Mallory Weiss syndrome
- •Zollinger-Ellison syndrome
- •Suspicion of gastric malignancy at baseline endoscopy
- •Post-Billroth-resection
- •Unknown source of GI bleeding · 2.Unstable vital signs
结局指标
主要结局
Evaluate the efficacy by assessment of proportion of subjects who present with no clinically significant bleeding after 5 days treatment
次要结局
- Proportion of subjects who present with no clinically significant upper GI bleeding after 72-hour treatment
- Time to absence of clinically significant upper GI bleeding
研究者
研究点 (7)
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