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| Name | Class |
|---|---|
| University Hospital Ulm | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Ibuprofen | Active Comparator | Study phase 1 (single dosing): 800 mg once. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Paracetamol oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours |
| Pharmacokinetics effects of paracetamol and ibuprofen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jürgen Brockmöller, Prof. | Contact | +49 (0) 551 39-53 11 | jbrockm@gwdg.de | |
| Johannes Matthaei, Dr.med. | Contact | matthaei.j@googlemail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Göttingen | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Prospective with placebo-controlled
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| Ibuprofen | Drug | Ibuprofen oral tablet |
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| Placebo oral tablet | Drug | Sugar pill manufactured to mimic the Paracetamol and Ibuprofen. |
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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). |
| 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. | 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. | 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). | 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. | 14 days |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |