Healthy Volunteers
Conditions
Keywords
Healthy volunteers, Open / hidden, Placebo effect
Brief summary
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
Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.
Interventions
DRUGParacetamol
Clinical trial conducted in healthy volunteers, prospective, single center, randomized, open / hidden.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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,
Design outcomes
Primary
| Measure | 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
| Measure | 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, | — |
Countries
France
Outcome results
None listed