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Antagonistic Interaction CB1-Paracetamol
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: 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

Drug Information available for: Acetaminophen Rimonabant SR 141716A
U.S. FDA Resources
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

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:
    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

Contacts
Contact: DUBRAY Claude, Pr 04.73.17.84.10 cdubray@chu-clermontferrand.fr

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

Responsible Party: CIC-CPC ( Pr Claude DUBRAY )
Study ID Numbers: CHU-0037
Study First Received: September 9, 2008
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00750347  
Health Authority: France: Ministry of Health

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

Study placed in the following topic categories:
Pain
Healthy
Acetaminophen

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

ClinicalTrials.gov processed this record on January 16, 2009



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