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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750048
First Posted: September 10, 2008
Last Update Posted: January 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
  Purpose
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.

Condition Intervention Phase
Pain Drug: Naloxone and paracetamol Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Naloxone and paracetamol
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750048


Locations
France
CPC-CIC
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Pickering Gisele, Dr CIC-CPC
  More Information

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00750048     History of Changes
Other Study ID Numbers: CHU-0036
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: January 30, 2012
Last Verified: January 2012

Keywords provided by University Hospital, Clermont-Ferrand:
pain,
sensitization,
analgesia

Additional relevant MeSH terms:
Analgesics
Acetaminophen
Naloxone
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Antipyretics
Narcotic Antagonists