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临床试验/EUCTR2012-001420-35-AT
EUCTR2012-001420-35-AT进行中(未招募)1 期

The effect of a single skin treatment with Capsaicine 8% in low back pain - LBP_Caps

Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien0 个研究点开始时间: 2012年4月17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

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

  • Subjects are eligible for the study if all the following apply:
  • 1.Men or women > 18 years.
  • 2.Low back pain of all types with or without irradiation for 3 months or more.
  • 3.Pain intensity: Mean Numerical Rating Scale (NRS) during the 24 h before inclusion > 3/10.
  • 4.Pain Detect Score > 13.
  • 5.No pain treatment at inclusion or stable pain treatment for 1 week prior to inclusion and study day.
  • 6.Intact skin surface at the potential patch application site.
  • 7.Females of child-bearing potential must agree to use effective methods of birth control during the study and for 30 days following study termination.
  • 8.The participant has given written informed consent
  • 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 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • Subjects are eligible for the study if all the following apply:
  • 1.Men or women > 18 years.
  • 2.Low back pain of all types with or without irradiation for 3 months or more.
  • 3.Pain intensity: Mean Numerical Rating Scale (NRS) during the 24 h before inclusion > 3/10.
  • 4.Pain Detect Score > 13.
  • 5.No pain treatment at inclusion or stable pain treatment for 1 week prior to inclusion and study day.
  • 6.Intact skin surface at the potential patch application site.
  • 7.Females of child-bearing potential must agree to use effective methods of birth control during the study and for 30 days following study termination.
  • 8.The participant has given written informed consent.

研究者

发起方
Abteilung für Anästhesie, Intensiv- und Schmerzmedizin, Wilhelminenspital der Stadt Wien

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