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Clinical Trials/NCT00750048
NCT00750048CompletedPhase 1

Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

University Hospital, Clermont-Ferrand2 sites in 1 country12 target enrollmentStarted: September 1, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
12
Locations
2
Primary Endpoint
Variation of amplitude of the N2P2 cerebral wave (before and after administration of Naloxone) induced by thermal stimulus applied on the arm.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Detailed Description

Double Blind, cross-over study in healthy volunteers.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: before and after administration of Naloxone

Secondary Outcomes

  • 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)

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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