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Tramadol and Pain Sensitization (TRAMADOL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487175
First Posted: June 15, 2007
Last Update Posted: March 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Clermont-Ferrand
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gisèle PICKERING, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00487175     History of Changes
Other Study ID Numbers: CHU63-0020
First Submitted: June 14, 2007
First Posted: June 15, 2007
Last Update Posted: March 17, 2009
Last Verified: March 2009

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

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