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

Phase 1

Completed

• Conditions: Pain

• Registration Number: NCT00750048
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-09
• Study First Submitted QC: 2008-09-09
• Study First Posted: 2008-09-10
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CPC-CIC; 🇫🇷 Clermont-Ferrand, France