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

ClinicalTrials.gov processed this record on April 17, 2014