Tramadol and Pain Sensitization (TRAMADOL)

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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: Male
Ages	18 Years to 40 Years (Adult)
Accepts Healthy Volunteers	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	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