Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Conditions
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Pain

Intervention / Treatment
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* Drug: Paracetamol (drug)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy volunteers Aged at last 18 years and over 60 years Male Non-smoking subject Fasting coffe, tea, coca-cola or other stimulant products since the last evening Subject free of any treatment within 7 days prior to inclusion including no use of analgesics or anti-inflammatory treatments Exclusion Criteria: Contraindications to the administration of paracetamol Contraindications to the completion of MRI Medical history and/or surgical judged by the investigator as being incompatible with the test Progressive disease at the inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paracetamol<br> | Drug: Paracetamol (drug)<br>* 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<br>|
| Placebo Comparator: placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanism of action of paracetamol in the brain structures