NCT00750048

Brief Summary

The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1 pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

January 30, 2012

Status Verified

January 1, 2012

Enrollment Period

2 months

First QC Date

September 9, 2008

Last Update Submit

January 26, 2012

Conditions

Pain

Keywords

pain,sensitization,analgesia

Outcome Measures

Primary Outcomes (1)

  • Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm.

    before and after administration of Naloxone

Secondary Outcomes (1)

  • Follow up of pain's evaluation using analogical visual scale. Follow up of pain's evaluation using analogical visual scale

    following the pain's evaluation

Interventions

Naloxone and paracetamolDRUG

to check if naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • between 18 and 40 years old
  • written consent given

You may not qualify if:

  • Naloxone or paracetamol hypersensibility
  • Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
  • Concomitant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPC-CIC

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

PainAgnosia

Interventions

NaloxoneAcetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pickering Gisele, Dr

    CIC-CPC

    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

September 9, 2008

First Posted

September 10, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

January 30, 2012

Record last verified: 2012-01

Locations

FR(1)