EmpathyPhase 1MEADNCT04424420
Mental Effects of Analgesic Drugs: Paracetamol and Ibuprofen
A Phase 1 study testing Paracetamol and Ibuprofen in people with Empathy, run by Prof. Jürgen Brockmöller at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Empathy
- What is being tested?
- Paracetamol and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 7 Nov 2019to Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Johannes Matthaei, Dr.med. contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075
Jürgen Brockmöller, Prof., +49(0)551 39 5311, jbrockm@gwdg.de
Alexandra Sachkova, +4917627786662, alexandra.sachkova@med.uni-goettingen.de
About this study
Official title: Double Blinded Randomized Placebo Controlled Study on Mental Effects of Analgesic Drugs
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
- Being tested
- Paracetamol, Ibuprofen, Placebo oral tablet
- Keywords
- Mental effects, Social Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
Paracetamol oral tablet
IbuprofenDrug
Ibuprofen oral tablet
Placebo oral tabletDrug
Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paracetamol |
| Ibuprofen | Active comparator | Study phase 1 (single dosing): 800 mg once. Receives: 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. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Secondary outcomes (6)
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.
Measured: 8 hours
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).
Measured: 8 hours
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.
Measured: 8 hours
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.
Measured: 14 days
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).
Measured: 14 days
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start7 Nov 2019
- Primary completionMar 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective with placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Jürgen Brockmöller
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Ulm
- Responsible party
- Sponsor-investigator, Prof. Jürgen Brockmöller, University of Göttingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424420
- Sponsor's protocol ID
- 2018-004187-60
- Other IDs
- 2018
- Acronym
- MEAD
- Status last verified
- Jun 2020
- First submitted
- 18 Feb 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Placebo Controlled Study on Mental Effects of Analgesic Drugs
- ClinicalTrials.gov ID
- NCT04424420
- Acronym / sponsor ID
- MEAD / 2018-004187-60
- Conditions
- Empathy
- Keywords
- Mental effects, Social Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Prof. Jürgen BrockmöllerUniversity, hospital or other
- Collaborators
- University Hospital Ulm
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective with placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: ParacetamolStudy 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. |
| Ibuprofen | Active comparator | Drug: IbuprofenStudy phase 1 (single dosing): 800 mg once. |
| Placebo | Placebo comparator | Drug: Placebo oral tabletStudy phase 1 (single dosing): Once. Study phase 2 (multiple dosing): Twice daily for a minimum of 12 and a maximum of 14 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: AcetaminophenParacetamol oral tablet | Drug | Paracetamol |
| IbuprofenIbuprofen oral tablet | Drug | Ibuprofen |
| Placebo oral tabletSugar pill manufactured to mimic the Paracetamol and Ibuprofen. | Drug | Placebo |
Primary outcome
Effect of paracetamol and ibuprofen on social pain and empathy
Time frame: 8 hours
Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.
Effect of paracetamol on social pain and empathy
Time frame: 14 days
Primary outcome is defined as the composite score of standardized emotional scenarios and the hurt feeling scale.
6 secondary outcomes
Psychological effects of paracetamol and ibuprofen
Time frame: 8 hours
Pharmacokinetics effects of paracetamol and ibuprofen
Time frame: 8 hours
Pharmacogenes roles in paracetamol and ibuprofen metabolism
Time frame: 8 hours
Psychological effects of paracetamol
Time frame: 14 days
Pharmacokinetics effects of paracetamol
Time frame: 14 days
Pharmacogenes roles in paracetamol metabolism
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Matthaei, Dr.med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paracetamol and Ibuprofen in people with Empathy, run by Prof. Jürgen Brockmöller at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jürgen Brockmöller, Prof. (+49 (0) 551 39-53 11, jbrockm@gwdg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of paracetamol and ibuprofen on social pain and empathy (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.