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| Name | Class |
|---|---|
| Dr. Gisèle PICKERING (MCU, PH) | UNKNOWN |
| Dr. Betty JEAN (PH) | UNKNOWN |
Paracetamol is one of the most widely used analgesic in the world, indicated for the symptomatic treatment of fever and pain. The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation.
Visit 1 / Visit 2 Inclusion of the subject, Clinical examination Trainings tests
Study period 1 Clinical examination Measurement of the basal pain thresholds Administration of product (T0) T0+100min : Thermal stimulation according to the established paradigm and fMRI data acquisition T0+180min : Thermal stimulation according to the established paradigm and fMRI data acquisition
Study period 2: same of period 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paracetamol | Experimental |
| |
| placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol (drug) | Drug | The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures | 100 min after administration of paracetamol or placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures | 180 min after administration of paracetamol or placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gisèle PICKERING | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26229445 | Derived | Pickering G, Kastler A, Macian N, Pereira B, Valabregue R, Lehericy S, Boyer L, Dubray C, Jean B. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial. Drug Des Devel Ther. 2015 Jul 23;9:3853-62. doi: 10.2147/DDDT.S81004. eCollection 2015. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Aniline Compounds |
| D000588 | Amines |