Placebo Effect of Paracetamol in Healthy Volunteers

University Hospital, Clermont-Ferrand40 enrolled

Overview

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..

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

ParacetamolDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,

Locations (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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 Outcomes

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,

Data from ClinicalTrials.gov

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