Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
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| First Received Date ICMJE | December 19, 2006 | ||||
| Last Updated Date | August 16, 2011 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Mean daily diary pain ratings during final week of each treatment period [ Time Frame: Daily ] [ Designated as safety issue: No ] subject identifies daily pain rating using a numeric rating scale |
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| Original Primary Outcome Measures ICMJE |
Mean daily diary pain ratings during final week of each treatment period | ||||
| Change History | Complete list of historical versions of study NCT00414453 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis | ||||
| Official Title ICMJE | Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS) | ||||
| Brief Summary | This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology. |
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| Detailed Description | This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arm (s) |
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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 | Terminated | ||||
| Enrollment ICMJE | 19 | ||||
| Completion Date | August 2011 | ||||
| Primary Completion Date | August 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 | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00414453 | ||||
| Other Study ID Numbers ICMJE | TALENT-MS | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Robert H. Dworkin, PhD, University of Rochester | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE | Endo Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | University of Rochester | ||||
| Verification Date | August 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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