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临床试验/NCT00573924
NCT00573924已完成不适用

Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers

University of Southern California1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Intragastric pH > 6

研究概览

简要总结

Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor [PPI]) either by mouth every 3 hours for 24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach will be used to determine intragastric pH (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. The purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting to hospital with overt upper GI bleeding and found to have an ulcer as the cause on endoscopy

排除标准

  • Previous gastric surgery
  • Active bleeding at end of endoscopy (despite hemostatic therapy)
  • Recent PPI or H2RA use

研究组 & 干预措施

1

Active Comparator

Oral PPI

干预措施: Proton pump inhibitor (lansoprazole) (Drug)

2

Active Comparator

Intravenous PPI

干预措施: Proton pump inhibitor (lansoprazole) (Drug)

结局指标

主要结局

Intragastric pH > 6

时间窗: 24 hours

次要结局

  • Mean intragastric pH(24 hrs)

研究者

申办方类型
Other

研究点 (1)

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