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Trial record 12 of 458 for:    TRAMADOL

Tramadol and Pain Sensitization (TRAMADOL)

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.
 
ClinicalTrials.gov Identifier: NCT00487175
Recruitment Status : Completed
First Posted : June 15, 2007
Last Update Posted : March 17, 2009
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE June 14, 2007
First Posted Date  ICMJE June 15, 2007
Last Update Posted Date March 17, 2009
Study Start Date  ICMJE September 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2007)
Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
Change History Complete list of historical versions of study NCT00487175 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tramadol and Pain Sensitization
Official Title  ICMJE Tramadol and Pain Sensitization
Brief Summary 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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE Drug: Tramadol
to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 15, 2008)
12
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00487175
Other Study ID Numbers  ICMJE CHU63-0020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gisèle PICKERING, CHU Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: PICKERING Gisèle, MCU-PH, pharmacology
PRS Account University Hospital, Clermont-Ferrand
Verification Date March 2009

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