Antagonistic Interaction CB1-paracetamol

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00750347
First received: September 9, 2008
Last updated: January 18, 2011
Last verified: January 2011
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Pr Claude DUBRAY, CIC-CPC
ClinicalTrials.gov Identifier: NCT00750347     History of Changes
Other Study ID Numbers: CHU-0037
Study First Received: September 9, 2008
Last Updated: January 18, 2011
Health Authority: France: Ministry of Health

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014