Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-07

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Empathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective with placebo-controlled

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Paracetamol

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.

Group Type EXPERIMENTAL

Paracetamol

Intervention Type DRUG

Paracetamol oral tablet

Ibuprofen

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

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen oral tablet

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.

Interventions

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Paracetamol

Paracetamol oral tablet

Intervention Type DRUG

Ibuprofen

Ibuprofen oral tablet

Intervention Type DRUG

Placebo oral tablet

Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.

Intervention Type DRUG

Other Intervention Names

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Acetaminophen

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes