Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 58
研究概览
简要总结
Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
详细描述
This trial will be a triple-blind, double-dummy, prospective, multicenter, randomized clinical trial comparing the effectiveness of OSB-IR to the effectiveness of intravenous cimetidine in preventing upper GI bleeding at risk for SRMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omeprazole sodium bicarbonate immediate release PWD/FS
干预措施: Omeprazole sodium bicarbonate immediate release PWD/FS (Drug)
Cimetidine IV
干预措施: Cimetidine IV (Drug)