NCT00152399已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo Controlled Trial To Study The Efficacy And The Safety Of The Early Administration Of Somatostatin (Ucb) 12 Mg/24 H IV Infusion And Two IV Boluses Of 250 Mcg During 72 Hours In The Treatment Of Subjects With Acute Severe Upper Gastrointestinal Bleeding (UGIB) With Suspicion Of Peptic Ulcer Bleeding [The PUB Study]
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 370
- 试验地点
- 22
- 主要终点
- To assess the efficacy and safety of the early IV administration of somatostatin during 72 hours compared to placebo in the control of acute severe UGIB with suspicion of PUB by measuring the failure rate
研究概览
简要总结
To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU.
- •Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...).
- •Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia
排除标准
- •Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy.
- •Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation.
- •Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days.
- •Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab))
- •Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins)
- •Terminal stage illness in which endoscopy is contraindicated
结局指标
主要结局
To assess the efficacy and safety of the early IV administration of somatostatin during 72 hours compared to placebo in the control of acute severe UGIB with suspicion of PUB by measuring the failure rate
次要结局
- To evaluate the difference between somatostatin and placebo on the following variables; Type of failure; Time to failure(h) up to 72 hours; Mortality
研究者
研究点 (22)
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