Status:
UNKNOWN
Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen
Lead Sponsor:
Prof. Jürgen Brockmöller
Collaborating Sponsors:
University Hospital Ulm
Conditions:
Empathy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04424420
Start Date
November 7 2019
End Date
December 1 2021
Last Update
June 11 2020
Active Locations (1)
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1
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, Germany, 37075