NCT04424420

Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen

Double Blinded Randomized Placebo Controlled Study on Mental Effects of Analgesic Drugs

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Prof. Jürgen Brockmöller · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Empathy

Interventions

Type	Name	Description
DRUG	Paracetamol	Paracetamol oral tablet
DRUG	Ibuprofen	Ibuprofen oral tablet
DRUG	Placebo oral tablet	Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.

Timeline

• Start date: 2019-11-07
• Primary completion: 2021-03-01
• Completion: 2021-12-01
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

1 site across 1 country: Germany