Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain (PhyDoNe)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Clermont-Ferrand
Collaborator:
Grünenthal GmbH
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01053845
First received: January 19, 2010
Last updated: January 18, 2011
Last verified: January 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 19, 2010 | ||||
| Last Updated Date | January 18, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Comparison of the amplitude of N2P2 waves between healthy volunteers and patients suffering of peripheral neuropathic pain. [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01053845 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 | Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain | ||||
| Official Title ICMJE | Study of Integrity of Down Inhibitor Bundle at Patients Suffering of Neuropathic Pain | ||||
| Brief Summary | Several studies showed that activity of down inhibitor bundle is weakened in different painful pathologies as the fibromyalgy or the trigeminal nevralgy. The purpose of the protocol is to study the working of down inhibitor bundle at patients suffering of neuropathic pain. |
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| Detailed Description | Prospective study with comparison groups |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Neuropathic pain
to study the working of down inhibitor bundle at patients suffering of neuropathic pain |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | February 2012 | ||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01053845 | ||||
| Other Study ID Numbers ICMJE | CHU-0066, 2009-A00155-52 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Patrick Lacarin, CHU Clermont-Ferrand | ||||
| Study Sponsor ICMJE | University Hospital, Clermont-Ferrand | ||||
| Collaborators ICMJE | Grünenthal GmbH | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Clermont-Ferrand | ||||
| Verification Date | January 2011 | ||||
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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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