Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers - Full Text View

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

ChemIDplus related topics:

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	Not yet recruiting
	Clermont-Ferrand, France, 63000
	Contact: Pickering Gisele, Dr 04.73.17.84.10 Gisele.pickering@u-clermont1.fr

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
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 October 06, 2008