Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI (IRMf)
This study has been completed.
Sponsor:
University Hospital, Clermont-Ferrand
Collaborators:
Dr. Gisèle PICKERING (MCU, PH)
Clinical Investigation center of Clermont-Ferrand Hospital (France)
Dr. Betty JEAN (PH)
Musculo-skeletal and Neurological thoracic imaging service of Clermont-Ferrand Hospital (France)
Pr Claude DUBRAY (PU PH)
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
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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
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)
Clinical Investigation center of Clermont-Ferrand Hospital (France)
Dr. Betty JEAN (PH)
Musculo-skeletal and Neurological thoracic imaging service of Clermont-Ferrand Hospital (France)
Pr Claude DUBRAY (PU PH)
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 May 19, 2013