跳至主要内容
临床试验/EUCTR2016-003739-40-NL
EUCTR2016-003739-40-NL进行中(未招募)1 期

The effect of Iberogast on heartburn in patients with dyspepsia - Iberogast and heartburn

AMC Amsterdam0 个研究点目标入组 18 人开始时间: 2017年3月6日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
18

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age above 18
  • A history of dyspepsia (according to the Rome III criteria) with heartburn
  • Upper gastro-intestinal causes of the complaints excluded via gastroscopy with in addition an abdominal echography if found to be necessary by the physician
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 18
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Surgery of the GI tract other than appendectomy or cholecystectomy
  • Use of any medication with a potential effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study (e.g. proton pump inhibitors, H2-blockers, tricyclic antidepressants …)
  • Proton pump inhibitors cannot be stopped for 7 days before start of the study
  • Known Barrett’s oesophagus
  • History of GI cancer
  • Known allergy to one of the ingredients of Iberogast
  • Known diabetes
  • Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
  • Pregnancy (women will be asked if they are pregnant)

研究者

发起方
AMC Amsterdam

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