Status:
TERMINATED
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Endo Pharmaceuticals
Conditions:
Neuropathic Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 sclero...
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) plac...
Eligibility Criteria
Inclusion
- "Definite MS" as defined by revised McDonald criteria.
- Bilateral distal symmetric burning pain involving both feet for at least three months.
- Baseline weekly average pain rating equal to four or greater on 0-10 numerical scale.
- Stable MS medication and pain-related medications for 8 weeks prior to screening.
- Must come to Research Center for appointments
Exclusion
- Topical treatment with lidocaine, capsaicin, or other topical analgesics within 3 months prior to screening.
- Any treatment with opioid analgesics or tramadol within 3 months prior to screening.
- Hypersensitivity to Lidoderm, lidocaine, or other local anesthetics.
- Hypersensitivity or inability to tolerate opioid analgesics.
- Current treatment with a total of 3 or more antidepressant or anticonvulsant drugs for pain.
- Current treatment with Class I anti-arrhythmic agents at baseline.
- Beck Depression Inventory score \> 16 or clinically significant depression or dementia.
- History of suicide attempt or current intent or plan.
- History of excessive alcohol use or any illicit drug use within the past 2 years.
- Lack of adequate birth control in pre-menopausal women of childbearing age.
- Other pain more severe than lower extremity burning pain.
- Open skin lesions in the area where the lidocaine patch is to be applied.
- Cancer within the previous 5 years other than skin cancer.
- MS exacerbation or any treatment with corticosteroids within 3 months prior to screening.
- History of peripheral neuropathy, lower limb amputation, or another neuromuscular syndrome or systemic disorder known to be associated with sensory neuropathy.
- Does not meet criteria of baseline lab values at screening visit.
- Nerve conduction studies consistent with peripheral neuropathy.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00414453
Start Date
January 1 2007
End Date
August 1 2011
Last Update
July 17 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester Medical Center
Rochester, New York, United States, 14642