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

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2012

Last Updated Date

January 11, 2013

Start Date ^ICMJE

January 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01562704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Official Title ^ICMJE

Visualisation of the Central Analgesic Effect of Paracetamol in Functional MRI

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Pain

Intervention ^ICMJE

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

Study Arm (s)

Experimental: paracetamol
Intervention: Drug: Paracetamol (drug)
Placebo Comparator: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01562704

Other Study ID Numbers ^ICMJE

CHU-0110

Has Data Monitoring Committee

Not Provided

Responsible Party

University Hospital, Clermont-Ferrand

Study Sponsor ^ICMJE

University Hospital, Clermont-Ferrand

Collaborators ^ICMJE

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 ^ICMJE

Principal Investigator:

Gisèle PICKERING

University Hospital, Clermont-Ferrand

Information Provided By

University Hospital, Clermont-Ferrand

Verification Date

January 2013

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

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