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

This study has been completed.
Sponsor:
Collaborators:
Dr. Gisèle PICKERING (MCU, PH)
Dr. Betty JEAN (PH)
Musculo-skeletal and Neurological thoracic imaging service of Clermont-Ferrand Hospital (France)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01562704
First received: January 27, 2012
Last updated: January 11, 2013
Last verified: January 2013

January 27, 2012
January 11, 2013
January 2012
April 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01562704 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI
Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
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
  • Experimental: paracetamol
    Intervention: Drug: Paracetamol (drug)
  • Placebo Comparator: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01562704
CHU-0110
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • Dr. Gisèle PICKERING (MCU, PH)
  • Dr. Betty JEAN (PH)
  • Musculo-skeletal and Neurological thoracic imaging service of Clermont-Ferrand Hospital (France)
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP