NCT04424420

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

February 18, 2020

Last Update Submit

June 5, 2020

Conditions

Empathy

Keywords

Mental effectsSocial Pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Psychological effects of paracetamol and ibuprofen

    8 hours

  • Pharmacokinetics effects of paracetamol and ibuprofen

    8 hours

  • Pharmacogenes roles in paracetamol and ibuprofen metabolism

    8 hours

  • Psychological effects of paracetamol

    14 days

  • Pharmacokinetics effects of paracetamol

    14 days

  • +1 more secondary outcomes

Study Arms (3)

Paracetamol

EXPERIMENTAL

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.

Drug: Paracetamol

Ibuprofen

ACTIVE COMPARATOR

Study phase 1 (single dosing): 800 mg once.

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Study phase 1 (single dosing): Once. Study phase 2 (multiple dosing): Twice daily for a minimum of 12 and a maximum of 14 days.

Drug: Placebo oral tablet

Interventions

ParacetamolDRUG

Paracetamol oral tablet

Also known as: Acetaminophen
Paracetamol
IbuprofenDRUG

Ibuprofen oral tablet

Ibuprofen
Placebo oral tabletDRUG

Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

MeSH Terms

Interventions

AcetaminophenIbuprofen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Central Study Contacts

Jürgen Brockmöller, Prof.

CONTACT

+49 (0) 551 39-53 11jbrockm@gwdg.de

Johannes Matthaei, Dr.med.

CONTACT

matthaei.j@googlemail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Prospective with placebo-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Institute of Clinical Pharmacology at Universitätsmedizin Göttingen

Study Record Dates

First Submitted

February 18, 2020

First Posted

June 11, 2020

Study Start

November 7, 2019

Primary Completion

March 1, 2021

Study Completion

December 1, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

DE(1)