Antagonistic Interaction CB1-paracetamol

This study is currently recruiting participants.

Verified by University Hospital, Clermont-Ferrand, October 2009

First Received: September 9, 2008 Last Updated: October 1, 2009 History of Changes

Sponsor:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00750347

Purpose

Evaluation of an possible inhibiting effect of Rimonabant on the analgesic effect of Paracetamol in healthy volunteers

Condition	Intervention	Phase
Pain	Drug: Rimonabant and Paracetamol and placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Evaluation of the Interaction of Rimonabant (Antagonist of CB1 Receptor) on the Analgesic Effect of Paracetamol in Intravenous Administration

Resource links provided by NLM:

Drug Information available for: Acetaminophen SR 141716A CT 2584 Rimonabant

U.S. FDA Resources

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

Primary Outcome Measures:

Pain's threshold with electrical stimulation (Pain Matcher). Pain's threshold with mechanical stimulation (electronical Von Frey). [ Time Frame: during electrical stimulation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Plasmatic concentration of paracetamol or his metabolite with or without Rimonabant [ Time Frame: with or without rimonabant ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

evaluation of an possible inhibiting effect of rimonabant on the analgesic effect of paracetamol in healthy volunteers

Detailed Description:

Double Blind, cross-over, randomized and controlled versus placebo, study in healthy volunteers.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteers
between 18 and 40 years old
written consent given

Exclusion Criteria:

Rimonabant or paracetamol hypersensibility
Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
Concomitant medication
Chronical diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750347

Contacts

Contact: DUBRAY Claude, Pr

04.73.17.84.10

cdubray@chu-clermontferrand.fr

Locations

France
CIC-CPC	Not yet recruiting
Clermont-Ferrand, France, 63000
Contact: Dubray Claude, Pr 04.73.17.84.10 cdubray@chu-clermontferrand.fr
CHU Clermont-Ferrand	Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick Lacarin placarin@chu-clermontferrand.fr

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator:

Dubray Claude, Pr

University Hospital, Clermont-Ferrand

More Information

No publications provided

Responsible Party:	CIC-CPC ( Pr Claude DUBRAY )
Study ID Numbers:	CHU-0037
Study First Received:	September 9, 2008
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00750347 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

pain,
analgesia
Healthy volunteers

Additional relevant MeSH terms:

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

Analgesics
Central Nervous System Agents
Pharmacologic Actions
Acetaminophen

ClinicalTrials.gov processed this record on February 04, 2010