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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04424420
Other study ID # 2018-004187-60
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date November 7, 2019
Est. completion date December 2021

Study information

Verified date June 2020
Source University of Göttingen
Contact Jürgen Brockmöller, Prof.
Phone +49 (0) 551 39-53 11
Email jbrockm@gwdg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2021
Est. primary completion date March 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. Written informed consent obtained prior to study.

2. Willingness to meet the study instructions and to co-operate with the study personal.

3. 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.

4. 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 Criteria:

1. Pacemaker devices, implantable or external ones.

2. Involvement in the planning and conduct of the study (applies to staff directly employed at the study site / department).

3. Known pregnancy or lactation period.

4. History of alcohol and / or drug abuse and / or any abusive use of medicaments.

5. Any disease affecting liver or kidney or impairment of the liver or kidney-function.

6. History of severe hypersensitivity reactions, anaphylaxis, psychiatric or neurologic disorder.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Paracetamol
Paracetamol oral tablet
Ibuprofen
Ibuprofen oral tablet
Placebo oral tablet
Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.

Locations

Country Name City State
Germany Universitätsmedizin Göttingen Göttingen Niedersachsen

Sponsors (2)

Lead Sponsor Collaborator
Prof. Jürgen Brockmöller University Hospital Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of paracetamol and ibuprofen on social pain and empathy Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale. 8 hours
Primary Effect of paracetamol on social pain and empathy Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale. 14 days
Secondary Psychological effects of paracetamol and ibuprofen Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test. 8 hours
Secondary Pharmacokinetics effects of paracetamol and ibuprofen Blood samples for determination of study drug concentrations in plasma will be taken at different time-point. This will be used to calculate Maximum Plasma Concentration (Cmax). 8 hours
Secondary Pharmacogenes roles in paracetamol and ibuprofen metabolism Genetic analysis of relevant genes responsible for paracetamol and ibuprofen Absorption, Distribution, Metabolism and Excretion (ADME).Healthy volunteers will provide a blood sample for molecular genetic analyses of the various candidate genes, e.g. drug transporters and metabolizing enzymes. This will shed light on the interindividual variation of analgesic effects. 8 hours
Secondary Psychological effects of paracetamol Interindividual variation of analgesic effects measured using fMRI. MRI will be performed to reflect differences in brain activation by Psychometric test. 14 days
Secondary Pharmacokinetics effects of paracetamol Blood samples for determination of study drug concentrations in plasma will be taken at different time-point. This will be used to calculate Maximum Plasma Concentration (Cmax). 14 days
Secondary Pharmacogenes roles in paracetamol metabolism Genetic analysis of relevant genes responsible for paracetamol Absorption, Distribution, Metabolism and Excretion (ADME). Healthy volunteers will provide a blood sample for molecular genetic analyses of the various candidate genes, e.g. drug transporters and metabolizing enzymes. This will shed light on the interindividual variation of analgesic effects. 14 days
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