Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI (IRMf)

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 1

Conditions

Pain

Treatments

Drug: Paracetamol (drug)

Study type

Interventional

Funder types

Other

Identifiers

NCT01562704

CHU-0110

Details and patient eligibility

About

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.

Full description

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.

Enrollment

21 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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