Tramadol and Pain Sensitization (TRAMADOL)
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ClinicalTrials.gov Identifier: NCT00487175 |
Recruitment Status
:
Completed
First Posted
: June 15, 2007
Last Update Posted
: March 17, 2009
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Sponsor:
University Hospital, Clermont-Ferrand
Information provided by:
University Hospital, Clermont-Ferrand
Tracking Information | ||||
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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 |
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 |
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 |
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Condition ICMJE | Pain | |||
Intervention ICMJE | Drug: Tramadol
to compare of the analgesic of tramadol versus placebo in a pain model using evoked potentials |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |