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Antagonistic Interaction CB1-paracetamol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750347
First Posted: September 10, 2008
Last Update Posted: January 19, 2011
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:
University Hospital, Clermont-Ferrand
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Interaction of Rimonabant (Antagonist of CB1 Receptor) on the Analgesic Effect of Paracetamol in Intravenous Administration

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 ]

Secondary Outcome Measures:
  • Plasmatic concentration of paracetamol or his metabolite with or without Rimonabant [ Time Frame: with or without rimonabant ]

Estimated Enrollment: 24
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rimonabant and Paracetamol and placebo
    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

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:   All
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
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): NCT00750347


Locations
France
CIC-CPC
Clermont-Ferrand, France, 63000
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Dubray Claude, Pr University Hospital, Clermont-Ferrand
  More Information

Responsible Party: Pr Claude DUBRAY, CIC-CPC
ClinicalTrials.gov Identifier: NCT00750347     History of Changes
Other Study ID Numbers: CHU-0037
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: January 19, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
Acetaminophen
Rimonabant
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists