Double Blinded Randomized Placebo Controlled Study on Mental Effects of Analgesic Drugs
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Effect of paracetamol and ibuprofen on social pain and empathy
研究概览
简要总结
The objective of the present study is to study paracetamol effects on social pain and empathy under standardized international conditions (ICH-GCP) for planning, conduction and reporting of clinical pharmaceutical studies in humans. The study included MRI imaging of brain activity, analysis of genomic biomarkers potentially explaining interindividual variation. It is controversial whether the effects are of immediate nature or develop during a period of about 10 days. Therefore, the study is separated into two study phases. Single dosing (SD) is applied in study phase 1 and multiple-dosing (MD) in study phase 2. The study compares paracetamol with placebo and in the study phase 1 also with ibuprofen as analgetically active control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent obtained prior to study.
- •Willingness to meet the study instructions and to co-operate with the study personal.
- •No clinically relevant pathological findings in any of the investigations at the screening visit; minor deviations of laboratory values from the normal range may be accepted if judged by the investigator to have no clinical relevance.
- •Body weight not less than 48 kg and body mass index (BMI) not less than 17 kg/m² and not greater than 32 kg/m².
排除标准
- •Pacemaker devices, implantable or external ones.
- •Involvement in the planning and conduct of the study (applies to staff directly employed at the study site / department).
- •Known pregnancy or lactation period.
- •History of alcohol and / or drug abuse and / or any abusive use of medicaments.
- •Any disease affecting liver or kidney or impairment of the liver or kidney-function.
- •History of severe hypersensitivity reactions, anaphylaxis, psychiatric or neurologic disorder.
研究组 & 干预措施
Paracetamol
Study phase 1 (single dosing): 1000 mg once. Study phase 2 (multiple dosing): 1000 mg twice daily for a minimum of 12 and a maximum of 14 days.
干预措施: Paracetamol (Drug)
Ibuprofen
Study phase 1 (single dosing): 800 mg once.
干预措施: Ibuprofen (Drug)
Placebo
Study phase 1 (single dosing): Once. Study phase 2 (multiple dosing): Twice daily for a minimum of 12 and a maximum of 14 days.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Effect of paracetamol and ibuprofen on social pain and empathy
时间窗: 8 hours
Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.
Effect of paracetamol on social pain and empathy
时间窗: 14 days
Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.
次要结局
- Pharmacokinetics effects of paracetamol and ibuprofen(8 hours)
- Psychological effects of paracetamol(14 days)
- Pharmacokinetics effects of paracetamol(14 days)
- Pharmacogenes roles in paracetamol metabolism(14 days)
- Psychological effects of paracetamol and ibuprofen(8 hours)
- Pharmacogenes roles in paracetamol and ibuprofen metabolism(8 hours)
研究者
Prof. Jürgen Brockmöller
Director, Institute of Clinical Pharmacology at Universitätsmedizin Göttingen
University of Göttingen