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| Tracking Information | |||||
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| First Received Date ICMJE | June 14, 2007 | ||||
| Last Updated Date | March 16, 2009 | ||||
| Start Date ICMJE | September 2007 | ||||
| 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 ] [ Designated as safety issue: Yes ] | ||||
| 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 | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| 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. |
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| 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 |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study | ||||
| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Drug: Tramadol | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 12 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00487175 | ||||
| Responsible Party | Gisèle PICKERING, CHU Clermont-Ferrand | ||||
| Study ID Numbers ICMJE | CHU63-0020 | ||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Clermont-Ferrand | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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