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Completed

NCT Number: NCT01562704

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol (drug)

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

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

Registry information

Acronym: IRMf

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2012
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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