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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

Page last updated: August 23, 2015

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