Tramadol and Pain Sensitization (TRAMADOL)

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

Tracking Information

• First Submitted Date: June 14, 2007
• First Posted Date: June 15, 2007
• Last Update Posted Date: March 17, 2009
• Study Start Date: September 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Tramadol and Pain Sensitization
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Pain

Intervention

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

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: September 15, 2008): 12
• Original Enrollment: Not Provided
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00487175
• Other Study ID Numbers: 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: University Hospital, Clermont-Ferrand
• Collaborators: Not Provided

Investigators

• Principal Investigator: PICKERING Gisèle, MCU-PH, pharmacology

• PRS Account: University Hospital, Clermont-Ferrand
• Verification Date: March 2009