Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Pain Clinical Trial

— IRMf  

Official title:

Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562704
• Other study ID #: CHU-0110
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2012
• Last updated: January 11, 2013
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: January 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Dr. Betty JEAN (PH), Dr. Gisèle PICKERING (MCU, PH), Musculo-skeletal and Neurological thoracic imaging service of Clermont-Ferrand Hospital (France)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 100 min after administration of paracetamol or placebo in brain structures		100 min after administration of paracetamol or placebo	Yes
Secondary	Difference between the matrice plans obtained in both treatments (paracetamol or placebo) and 180 min after administration of paracetamol or placebo in brain structures		180 min after administration of paracetamol or placebo	Yes