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
  Purpose

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 Intervention Phase
Pain
Drug: Paracetamol (drug)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562704

Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
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)
Investigators
Principal Investigator: Gisèle PICKERING University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01562704     History of Changes
Other Study ID Numbers: CHU-0110
Study First Received: January 27, 2012
Last Updated: January 11, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
mechanism of action of paracetamol in the brain structures

Additional relevant MeSH terms:
Acetaminophen
Analgesics
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014