Back to resultsTrial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
Primary Purpose
Neuropathic Pain, Chronic Pain, Multiple Sclerosis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine patch 5%
Extended-release oxycodone
Placebo extended-release oxycodone pills
Placebo lidocaine patches
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic pain, Chronic pain, Multiple sclerosis, Central neuropathic pain, Peripheral neuropathic pain, Opioid analgesic, Lidocaine
Eligibility Criteria
Inclusion Criteria:
- "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 Criteria:
- 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.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Lidocaine 5% + placebo patch, ER and placebo pills
Arm Description
5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period
Outcomes
Primary Outcome Measures
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Secondary Outcome Measures
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries
Safety (i.e., Number of Serious Adverse Events)
Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales
Brief Pain Inventory Interference Items
subject completes the brief pain questionaire
Daily Diary Sleep Interference Ratings
Subject identifies degree of sleep interference on a daily basis
Beck Depression Inventory
Subject completes Beck questionaire
Short-form Health Survey 36 (SF-36)
Subject completes short form health survey 36 questionaire
Short-Form McGill Pain Questionnaire
Subject completes short form McGill Pain questionaire
Patient Global Impression of Change Scale
Subject completes patient global impression questionaire of change scale
Kurtzke Expanded Disability Status Scale
Subject completes questionaire on functional status
Full Information
NCT ID
NCT00414453
First Posted
December 19, 2006
Last Updated
June 23, 2015
Sponsor
University of Rochester
Collaborators
Endo Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00414453
Brief Title
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
Official Title
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Did not reach enrollment goals
Study Start Date
January 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Chronic Pain, Multiple Sclerosis
Keywords
Neuropathic pain, Chronic pain, Multiple sclerosis, Central neuropathic pain, Peripheral neuropathic pain, Opioid analgesic, Lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine 5% + placebo patch, ER and placebo pills
Arm Type
Active Comparator
Arm Description
5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period
Intervention Type
Drug
Intervention Name(s)
Lidocaine patch 5%
Other Intervention Name(s)
Lidoderm
Intervention Description
lidocaine 5% patch; 12 hours on, 12 hours off
Intervention Type
Drug
Intervention Name(s)
Extended-release oxycodone
Other Intervention Name(s)
Oxycontin
Intervention Description
extended-release oxycodone titrating schedule
Intervention Type
Drug
Intervention Name(s)
Placebo extended-release oxycodone pills
Other Intervention Name(s)
Placebo pill
Intervention Description
placebo pills with titrating schedule
Intervention Type
Drug
Intervention Name(s)
Placebo lidocaine patches
Other Intervention Name(s)
Placebo patch
Intervention Description
used with extended release oxycodone group; used with placebo pills/placebo patches
Primary Outcome Measure Information:
Title
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period
Description
subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Time Frame
Daily
Secondary Outcome Measure Information:
Title
Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs)
Description
subject is questioned regarding any adverse events that have occured since the last contact; also subject can document any issues on daily pain rating diaries
Time Frame
rating of adverse events occur at each visit
Title
Safety (i.e., Number of Serious Adverse Events)
Description
Subject is asked about any adverse events that may have occurred since last contact; also subject can document any adverse events on daily pain diary scales
Time Frame
rating and review of any adverse events occurs at each visit
Title
Brief Pain Inventory Interference Items
Description
subject completes the brief pain questionaire
Time Frame
occurs Visit 1, 3,4,5
Title
Daily Diary Sleep Interference Ratings
Description
Subject identifies degree of sleep interference on a daily basis
Time Frame
daily
Title
Beck Depression Inventory
Description
Subject completes Beck questionaire
Time Frame
occurs at Visit 1, 3, 4 and 5
Title
Short-form Health Survey 36 (SF-36)
Description
Subject completes short form health survey 36 questionaire
Time Frame
Occurs at Visit 1, 3, 4 and 5
Title
Short-Form McGill Pain Questionnaire
Description
Subject completes short form McGill Pain questionaire
Time Frame
Occurs Visit 1, 3, 4 and 5
Title
Patient Global Impression of Change Scale
Description
Subject completes patient global impression questionaire of change scale
Time Frame
Occurs Visit 3, 4, 5
Title
Kurtzke Expanded Disability Status Scale
Description
Subject completes questionaire on functional status
Time Frame
Occurs at Visit 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
"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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H. Dworkin, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis
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