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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00750048
First received: September 9, 2008
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00750048     History of Changes
Other Study ID Numbers: CHU-0036
Study First Received: September 9, 2008
Last Updated: January 26, 2012
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on June 17, 2013