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

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ClinicalTrials.gov Identifier: NCT01562704
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : January 14, 2013
Sponsor:
Collaborators:
Dr. Gisèle PICKERING (MCU, PH)
Dr. Betty JEAN (PH)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Paracetamol (drug) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Study Start Date : January 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012
Arms and Interventions
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Arm Intervention/treatment
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
Placebo Comparator: placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562704


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Dr. Gisèle PICKERING (MCU, PH)
Dr. Betty JEAN (PH)
Investigators
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Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01562704    
Other Study ID Numbers: CHU-0110
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: January 14, 2013
Last Verified: January 2013
Keywords provided by University Hospital, Clermont-Ferrand:
mechanism of action of paracetamol in the brain structures
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics