Antagonistic Interaction CB1-paracetamol

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00750347
• Date of registration: 09/09/2008
• Prospective Registration: No
• Primary sponsor: University Hospital, Clermont-Ferrand
• Public title: Antagonistic Interaction CB1-paracetamol
• Scientific title: Evaluation of the Interaction of Rimonabant (Antagonist of CB1 Receptor) on the Analgesic Effect of Paracetamol in Intravenous Administration
• Date of first enrolment: September 2008
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00750347
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Dubray Claude, Pr
• Affiliation: University Hospital, Clermont-Ferrand

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Rimonabant and Paracetamol and placebo

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

CHU-0037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors