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

June 14, 2007
March 16, 2009
September 2007
December 2007   (final data collection date for primary outcome measure)
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 ]
Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
Complete list of historical versions of study NCT00487175 on ClinicalTrials.gov Archive Site
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Tramadol and Pain Sensitization
Tramadol and Pain Sensitization

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pain
Drug: Tramadol
to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2008
December 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00487175
CHU63-0020
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Gisèle PICKERING, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
Not Provided
Principal Investigator: PICKERING Gisèle, MCU-PH, pharmacology
University Hospital, Clermont-Ferrand
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP