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

This study is not yet open for participant recruitment.

Verified by University Hospital, Clermont-Ferrand, September 2008

Sponsored by:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00750048

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 I

Drug Information available for: Naloxone Naloxone hydrochloride Acetaminophen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers

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 ]

Estimated Enrollment:	12
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts

Contact: pickering Gisèle, Dr

04.73.17.84.10

Gisele.pickering@u-clermont1.fr

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:	CHU Clermont-Ferrand ( Dr Pickering Gisèle )
Study ID Numbers:	CHU-0036
Study First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750048
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

pain,
sensitization,
analgesia

Study placed in the following topic categories:

Pain
Healthy
Acetaminophen
Naloxone

Additional relevant MeSH terms:

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009