Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures
研究概览
简要总结
Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.
详细描述
Visit 1 / Visit 2 Inclusion of the subject, Clinical examination Trainings tests
Study period 1 Clinical examination Measurement of the basal pain thresholds Administration of product (T0) T0+100min : Thermal stimulation according to the established paradigm and fMRI data acquisition T0+180min : Thermal stimulation according to the established paradigm and fMRI data acquisition
Study period 2: same of period 1.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- Healthy volunteers
- •Aged at last 18 years and over 60 years
- •Non-smoking subject
- •Fasting coffe, tea, coca-cola or other stimulant products since the last evening
- •Subject free of any treatment within 7 days prior to inclusion including no use of analgesics or anti-inflammatory treatments
排除标准
- •Contraindications to the administration of paracetamol
- •Contraindications to the completion of MRI
- •Medical history and/or surgical judged by the investigator as being incompatible with the test
- •Progressive disease at the inclusion
研究组 & 干预措施
paracetamol
干预措施: Paracetamol (drug) (Drug)
结局指标
主要结局
Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures
时间窗: 100 min after administration of paracetamol or placebo
次要结局
- Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures(180 min after administration of paracetamol or placebo)