Placebo Effect of Paracetamol in Healthy Volunteers

Study Overview
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Brief Summary
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Paracetamol is one of the most commonly used drugs in the world, indicated for the symptomatic treatment of fever and pain of mild to moderate. More precisely, it is a drug used to relieve pain and reduce fever. The objective of this study is to analyze whether a placebo effect occurs when you take paracetamol for pain, ie if the analgesic effect of paracetamol is partly due to the simple fact of taking a drug. Moreover, during the study you propose to do a saliva sample, optional, for biological research, pharmacogenetics, to assess how paracetamol is processed and eliminated in your body..

Detailed Description
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Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.

Official Title
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Placebo Effect of Paracetamol in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Healthy volunteers, Aged over 18 years and more than 50 years Males, Values of vital signs before administration of the test products: Systolic between 100-140 mm Hg diastolic between 50-90 mm Hg cardiac pulse between 45-90 beats per minute Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatory) Exclusion Criteria: Contraindications to the administration of paracetamol : Hypersensitivity to paracetamol, History of hepatitis B or C, Severe renal impairment Hepatic insufficiency Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain, Pathology evolutionary time of the review of inclusion Excessive consumption of alcohol, tobacco (over 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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

| Intervention/Treatment |
| --- |
|Drug: Paracetamol|Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main objective of this protocol is to assess the placebo effect in healthy volunteers by comparing pain thresholds and tolerance between two passages, when taking paracetamol. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives of this study are 1 - explore, through testing Cantab ®, if the administration of paracetamol alter performance on cognitive tests. 2 - to analyze the determination of paracetamol and its metabolites in urine and blood samples, |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers, Open / hidden, Placebo effect