跳至主要内容
临床试验/NCT01926600
NCT01926600Unknown不适用

Sublingual Administration is More Fast Than Oral or IV Administration in PPI Dosing With Respect to Intragastric pH and Therapeutic Effectiveness: a Prospective, Randomized, Controlled Trial

The Catholic University of Korea1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Measure 24-hour intragastric pH

研究概览

简要总结

Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI) among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).

详细描述

Intragastric pH and therapeutic effectiveness of PPI was compared among patients given PPI with different administration methods. 24 hour intragastric pH catheter was inserted in stomach of patients with peptic ulcer an hour prior to PPI administration in order to observe the initial change in pH. Three groups of patients were given PPI through per oral, intravenous, and sublingual administration methods. The hypothesis of this study is that sublingual administration will be faster than oral or IV administration in PPI dosing with respect to intragastric pH change and re-bleeding rate.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with peptic ulcer disease
  • Age: 20-75 years old
  • Patients who submitted informed consent

排除标准

  • Peptic ulcer disease with spurting and oozing
  • Shock, hypotension, pregnancy
  • Gastrointestinal malignancy

结局指标

主要结局

Measure 24-hour intragastric pH

时间窗: 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin Il Kim

MD, PhD

The Catholic University of Korea

研究点 (1)

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