Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy (APTODON)
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| First Received Date ICMJE | March 28, 2011 | ||||
| Last Updated Date | March 28, 2011 | ||||
| Start Date ICMJE | May 2011 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
decrease in average pain intensity as measured by the Brief Pain Inventory (BPI) [ Time Frame: one month ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Administration of Botox® in Neuropathic Pain Due to Thoracoscopy or Thoracotomy | ||||
| Official Title ICMJE | Early Administration of Botulinum Toxin Type A (Botox®) in Neuropathic Pain Due to Thoracoscopy or Thoracotomy: a Randomized, Double Blind, Placebo Controlled Study | ||||
| Brief Summary | Botulinum toxin type A has been reported to inhibit the release of various pain neurotransmitters (SP, CGRP, glutamate) responsible for neurogenic inflammation, a process that results from the sensitization of C-fiber nociceptors (peripheral sensitization). This action is probably responsible for the analgesic effect of botulinum toxin type A recently demonstrated in patients with neuropathic pain of peripheral origin.In those studies, patients had been suffering for years. The investigators can hypothesizes that earlier administration of Botox in the course of neuropathic pain might prevent central sensitization, that is secondary to peripheral sensitization. The investigators can hope to increase efficacy of Botulinum toxin type A injections and to prevent chronification of pain. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) |
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| Intervention ICMJE |
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| 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 | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 44 | ||||
| Estimated Completion Date | November 2014 | ||||
| Estimated Primary Completion Date | November 2013 (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 | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01325090 | ||||
| Other Study ID Numbers ICMJE | I09006 / APTODON, 2010-021506-38 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Marie SENGELEN / Directrice de la Recherche et de l'Innovation, CHU de Limoges | ||||
| Study Sponsor ICMJE | University Hospital, Limoges | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Limoges | ||||
| Verification Date | March 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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