NCT00251979已完成3 期
A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.
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
- 1,312
- 试验地点
- 78
- 主要终点
- Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
研究概览
简要总结
This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signs of a bleeding in the stomach
- •One endoscopically confirmed bleeding ulcer in the stomach or duodenum
排除标准
- •Malignancy or other advanced disease.
- •Major cardiovascular event.
- •Severe hepatic disease
结局指标
主要结局
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo
时间窗: Within 72 hours
次要结局
- Clinically Significant Rebleeding Within 7 Days(Within 7 days)
- Clinically Significant Rebleeding Within 30 Days(Within 30 days)
- Death Within 72 Hours(Within 72 hours)
- Death Within 30 Days(Within 30 days)
- Death Related to Rebleeding Within 30 Days as Judged by the EpC(Within 30 days)
- Requirement for Surgery Within 72 Hours(Within 72 hours)
- Requirement for Surgery Within 30 Days(Within 30 days)
- Requirement for Endoscopic Re-treatment Within 72 Hours(Within 72 hours)
- Requirement for Endoscopic Re-treatment Within 30 Days(Within 30 days)
- Number of Blood Units Transfused Within 72 Hours(Within 72 hours)
- Number of Blood Units Transfused Within 30 Days(within 30 days)
- Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period(Within 30 days)
研究者
研究点 (78)
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