Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
NCT00414453 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2015-07-17
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.
Conditions
- Neuropathic Pain
- Chronic Pain
- Multiple Sclerosis
Interventions
- DRUG
-
Lidocaine patch 5%
lidocaine 5% patch; 12 hours on, 12 hours off
- DRUG
-
Extended-release oxycodone
extended-release oxycodone titrating schedule
- DRUG
-
Placebo extended-release oxycodone pills
placebo pills with titrating schedule
- DRUG
-
Placebo lidocaine patches
used with extended release oxycodone group; used with placebo pills/placebo patches
Sponsors & Collaborators
-
Endo Pharmaceuticals
collaborator INDUSTRY -
University of Rochester
lead OTHER
Principal Investigators
-
Robert H. Dworkin, PhD · University of Rochester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-01-31
- Primary Completion
- 2011-08-31
- Completion
- 2011-08-31
Countries
- United States
Study Locations
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