Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered...
Date First Received: June 14, 2007
Last Updated: March 16, 2009
Verified by: University Hospital, Clermont-Ferrand, March 2009
Clinical Trial Phase: Phase 1 | Start Date: September 2007
Overall Status: Completed
Estimated Enrollment: 12
Brief Summary
Official Title: “Tramadol and Pain Sensitization”
Condition Keyword(s):
Intervention(s):
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
Study Primary Completion Date: December 2007
Detailed Clinical Trial Description
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment
Intervention(s) in this Clinical Trial
- Drug: Tramadol
- to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
Outcome Measures for this Clinical Trial
Primary Measures
- Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
- Time Frame: with an induced hyperalgic area
Safety Issue?: Yes
- Time Frame: with an induced hyperalgic area
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Healthy men
- Between 18 and 40 years old
- Written consent given
Exclusion Criteria:
- Concomitant medication
- Tramadol hypersensibility
- Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 40 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Clermont-Ferrand
Overall Clinical Trial Officials and Contacts
PICKERING Gisèle, MCU-PH, pharmacology Principal Investigator unaffiliated
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00487175
Study ID Number: CHU63-0020
ClinicalTrials.gov Identifier: NCT00487175
Health Authority: France: Ministry of Health
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
