A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Rate of Clinically Significant Rebleeding Within 72 Hours
研究概览
简要总结
To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in
详细描述
A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures.
- •Female or male aged =18 years and =70 years.
- •Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.
- •One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.
- •Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.
排除标准
- •Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
- •Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.
- •Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.
- •Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
- •Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.
研究组 & 干预措施
Esomeprazole
干预措施: Esomeprazole Na (Drug)
Esomeprazole
干预措施: Esomeprazole Mg (Drug)
Cimetidine
干预措施: Cimetidine (Drug)
结局指标
主要结局
Rate of Clinically Significant Rebleeding Within 72 Hours
时间窗: 72 hours
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
次要结局
- Rate of Clinically Significant Rebleeding During 7 Days(7 days)
- Number of Patients With Surgery Due to Rebleeding Within 72 Hours(within 72 hours)
- Number of Patients With Surgery Due to Rebleeding 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 Patients With Endoscopic Re-treatment Within 72 Hours(72 hours)
- Rate of Clinically Significant Rebleeding During 30 Days(30 days)
- Number of Patients With Endoscopic Re-treatment Within 30 Days(30 days)