跳至主要内容
临床试验/EUCTR2017-000141-52-DK
EUCTR2017-000141-52-DK进行中(未招募)1 期

The effect of tapentadol on the human pain system: A study based on advanced neurophysiology and imaging techniques to illustrate the mechanism of tapentadol and oxycodone in the central, autonomic and enteric nervous systems

Asbjørn Mohr Drewes0 个研究点目标入组 22 人开始时间: 2017年2月10日最近更新:
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
22

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
Male

入选标准

  • Signed informed consent before any study specific procedures
  • Able to read and understand Danish.
  • The researcher believes that the participant understands what the study entails, are capable of following instructions, are able to attend when needed, are expected to complete the study
  • Between 20 and 45 years of age
  • Scandinavian descent
  • Opioid naïve subjects (who have not taken opioid doses for 1 week or longer)
  • 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 21
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Known allergy towards pharmaceutical compounds similar to those used in the study
  • Participation in other studies within 14 days of first visit
  • Expected need of medical/surgical treatment during the course of the study
  • History of psychiatric illness
  • History of persistent or recurring pain conditions
  • Nicotine consumption
  • Daily alcohol consumption
  • History of substance abuse
  • Family history of substance abuse
  • Use of any analgesic medication within 48 hours before start as well as for the duration of the study period
  • Use of any medication (herbal as well as any over-the-counter drugs) within 48 hours before start of the study period
  • Intake of alcohol within 24 hours before start of the study period
  • Use of prescription medicine and/or herbal medicine
  • Need to drive motor vehicle within the treatment periods
  • Severe respiratory depression
  • Increased intracranial pressure
  • Paralytic ileus
  • Severe decreased renal or hepatic function
  • Treatment with MAO-inhibitors
  • Cor pulmonale
  • Severe COPD or acute severe asthma

研究者

发起方
Asbjørn Mohr Drewes

相似试验