NCT01562704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

January 27, 2012

Last Update Submit

January 11, 2013

Conditions

Pain

Keywords

mechanism of action of paracetamol in the brain structures

Outcome Measures

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

    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

    180 min after administration of paracetamol or placebo

Study Arms (2)

paracetamol

EXPERIMENTAL
Drug: Paracetamol (drug)

placebo

PLACEBO COMPARATOR

Interventions

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

paracetamol

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Pickering G, Kastler A, Macian N, Pereira B, Valabregue R, Lehericy S, Boyer L, Dubray C, Jean B. The brain signature of paracetamol in healthy volunteers: a double-blind randomized trial. Drug Des Devel Ther. 2015 Jul 23;9:3853-62. doi: 10.2147/DDDT.S81004. eCollection 2015.

    PMID: 26229445DERIVED

MeSH Terms

Conditions

Pain

Interventions

AcetaminophenPharmaceutical Preparations

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Gisèle PICKERING

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2012

First Posted

March 26, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

FR(1)