Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Paracetamol (drug) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University Hospital, Clermont-Ferrand Official(s) and/or principal investigator(s): Gisèle PICKERING, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand
Summary
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.
Clinical Details
Official title: Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures
Secondary outcome: Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
CHU Clermont-Ferrand, Clermont-Ferrand 63003, France
Additional Information
Starting date: January 2012
Last updated: January 11, 2013
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