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Completed

NCT Number: NCT00750048

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

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CPC-CIC

Clermont-Ferrand, 63000, France

About this study

Double Blind, cross-over study in healthy volunteers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naloxone and paracetamol

Drug

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

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.

    Time frame: 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

    Time frame: following the pain's evaluation

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2008
Registry last updated
Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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