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临床试验/NCT00750048
NCT00750048已完成1 期

Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年9月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm.

研究概览

简要总结

The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials.

详细描述

Double Blind, cross-over study in healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy men
  • between 18 and 40 years old
  • written consent given

排除标准

  • Naloxone or paracetamol hypersensibility
  • Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
  • Concomitant medication

结局指标

主要结局

Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm.

时间窗: before and after administration of Naloxone

次要结局

  • Follow up of pain's evaluation using analogical visual scale. Follow up of pain's evaluation using analogical visual scale(following the pain's evaluation)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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