跳至主要内容
临床试验/NCT04394663
NCT04394663招募中不适用

High Dose Oral Omeprazole Versus Standard Continuous Intravenous Pantoprazole in Patient With Peptic Ulcer Bleeding and Undergo Successful Therapeutic Endoscopy; Non-inferiority Randomized Controlled Trial

King Chulalongkorn Memorial Hospital2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
128
试验地点
2
主要终点
Rate of 3-day peptic ulcer rebleeding

研究概览

简要总结

Peptic ulcer bleeding is the most common etiology in upper gastrointestinal bleeding all over the world. After endoscopic treatment, proton pump inhibitor (PPI) is recommended to prevent re-bleeding. Intravenous PPI is recommended as a standard treatment. In the past, there were many trials showing the efficacy of high-dose oral PPI after endoscopic hemostasis but most were industrial sponsor which assessing an expensive PPI. Moreover, the number of patients in those studies were insufficient to confirm a non-inferiority outcome in term of rebleeding by using oral PPI. This study will evaluate a high-dose, local-made PPI (omeprazole) in peptic ulcer treatment after successful endoscopic hemostasis compared to standard IV PPI continuous drip in term of rebleeding, as well as 24-hour gastric pH monitoring.

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
Single (Outcomes Assessor)

盲法说明

The outcomes assessor will not know the assigned treatment.

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 with peptic ulcer bleeding and endoscopic finding show ulcer with Forrest classification Ia (spurting haemorrhage), IIa (oozing haemorrhage), Ib (non-bleeding visible vessel)
  • Age > 18 years old

排除标准

  • Deny to participate
  • Pregnancy or lactation
  • Low risk peptic ulcer bleeding including clean base ulcer, flat pigmented spot
  • Non-peptic ulcer bleeding eg. erosive gastritis/duodenitis, Mallory Weiss tear, esophageal/gastric/duodenal varices, vascular lesions (eg. Dieulafoy) , malignant ulcer
  • Bleeding tendency
  • Terminal stage of cancer
  • ESRD on hemodialysis
  • Decompensated liver cirrhosis

研究组 & 干预措施

High-dose oral PPI

Experimental

Omeprazole 80 mg/day (40 mg twice a day) per oral route for 72 hours

干预措施: High-dose oral omeprazole (Drug)

Standard IV PPI

Active Comparator

Pantoprazole 8 mg/hour IV continuous drip for 72 hours

干预措施: Standard IV PPI (Drug)

结局指标

主要结局

Rate of 3-day peptic ulcer rebleeding

时间窗: 3 days

次要结局

  • Percentage of 24-hour gastric pH above 6(3 days)
  • Rate of 30-day peptic ulcer rebleeding(30 days)

研究者

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

Rapat Pittayanon

Principle investigator, Gastrointestinal Unit

King Chulalongkorn Memorial Hospital

研究点 (2)

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