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

January 26, 2012 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Double Blind, cross-over study in healthy volunteers.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • CPC-CIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
before and after administration of Naloxone

Secondary Outcome Measures

Outcome Measure
Time Frame
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
following the pain's evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Pickering Gisele, Dr, CIC-CPC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 9, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (Estimate)

September 10, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2012

Last Update Submitted That Met QC Criteria

January 26, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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