MedTrace Logo

Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen

NCT04424420 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-06-11

No results posted yet for this study

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

DRUG

Paracetamol

Paracetamol oral tablet

DRUG

Ibuprofen

Ibuprofen oral tablet

DRUG

Placebo oral tablet

Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.

Sponsors & Collaborators

  • University Hospital Ulm

    collaborator OTHER

  • Prof. Jürgen Brockmöller

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2021-03-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424420 on ClinicalTrials.gov