Tramadol and Pain Sensitization (TRAMADOL)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00487175
First received: June 14, 2007
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Tramadol
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: Tramadol and Pain Sensitization

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: September 2007
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tramadol
    to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00487175

Locations
France
CIC
Clermont-Ferrand, France, 63000
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: PICKERING Gisèle, MCU-PH, pharmacology
  More Information

No publications provided

Responsible Party: Gisèle PICKERING, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00487175     History of Changes
Other Study ID Numbers: CHU63-0020
Study First Received: June 14, 2007
Last Updated: March 16, 2009
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Tramadol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 15, 2014