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临床试验/NCT01737840
NCT01737840已完成4 期

Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.

Akdeniz University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
66
试验地点
1
主要终点
Visual Analogue Scale Score

研究概览

简要总结

The H0 hypothesis of the study is there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.

详细描述

Dyspepsia is one of the common complaints in emergency department. Proton pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Epigastric pain
  • Older than 18 years old

排除标准

  • Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
  • Pregnancy
  • Patients with unstable vital signs
  • Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
  • Allergy to H2 receptor blockers and proton pomp inhibitors.
  • Patients denied to give inform consent and who are illiterate

研究组 & 干预措施

pantoprazole

Experimental

Intravenous pantoprazole 40 mg flacon

干预措施: Pantoprazole (Drug)

ranitidine

Active Comparator

Intravenous ranitidine 50 mg

干预措施: Ranitidine (Drug)

结局指标

主要结局

Visual Analogue Scale Score

时间窗: 30th and 60th minutes

The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain.

次要结局

  • Need for Additional Drug(60 th minute)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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