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

January 11, 2013 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Experimental: paracetamol
Drug: Paracetamol (drug)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures
Time Frame: 100 min after administration of paracetamol or placebo
100 min after administration of paracetamol or placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures
Time Frame: 180 min after administration of paracetamol or placebo
180 min after administration of paracetamol or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Dr. Gisèle PICKERING (MCU, PH)
Dr. Betty JEAN (PH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 27, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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