Placebo Effect of Paracetamol in Healthy Volunteers (HOP)

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Paracetamol

Study type

Interventional

Funder types

Other

Identifiers

NCT01053650

CHU-0065

2009-015610-22 (EudraCT Number)

Details and patient eligibility

About

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..

Full description

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

Enrollment

40 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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,