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Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00414453
Recruitment Status : Terminated (Did not reach enrollment goals)
First Posted : December 21, 2006
Results First Posted : July 17, 2015
Last Update Posted : July 17, 2015
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Robert Dworkin, University of Rochester

Tracking Information
First Submitted Date  ICMJE December 19, 2006
First Posted Date  ICMJE December 21, 2006
Results First Submitted Date  ICMJE March 11, 2015
Results First Posted Date  ICMJE July 17, 2015
Last Update Posted Date July 17, 2015
Study Start Date  ICMJE January 2007
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
Mean Daily Diary Pain Ratings During Final Week of Each Treatment Period [ Time Frame: Daily ]
subject identifies daily pain rating during final week of each treatment period using a numeric rating scale
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
Mean daily diary pain ratings during final week of each treatment period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
  • Tolerability (e.g., Number of Adverse Effects, Number of Drop-outs) [ Time Frame: rating of adverse events occur at each visit ]
    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) [ Time Frame: rating and review of any adverse events occurs at each visit ]
    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 [ Time Frame: occurs Visit 1, 3,4,5 ]
    subject completes the brief pain questionaire
  • Daily Diary Sleep Interference Ratings [ Time Frame: daily ]
    Subject identifies degree of sleep interference on a daily basis
  • Beck Depression Inventory [ Time Frame: occurs at Visit 1, 3, 4 and 5 ]
    Subject completes Beck questionaire
  • Short-form Health Survey 36 (SF-36) [ Time Frame: Occurs at Visit 1, 3, 4 and 5 ]
    Subject completes short form health survey 36 questionaire
  • Short-Form McGill Pain Questionnaire [ Time Frame: Occurs Visit 1, 3, 4 and 5 ]
    Subject completes short form McGill Pain questionaire
  • Patient Global Impression of Change Scale [ Time Frame: Occurs Visit 3, 4, 5 ]
    Subject completes patient global impression questionaire of change scale
  • Kurtzke Expanded Disability Status Scale [ Time Frame: Occurs at Visit 1 ]
    Subject completes questionaire on functional status
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2006)
  • Tolerability (e.g., number of adverse effects, number of drop-outs)
  • Safety (i.e., number of serious adverse events)
  • Brief Pain Inventory interference items
  • Daily diary sleep interference ratings
  • Beck Depression Inventory
  • Short-form Health Survey 36 (SF-36)
  • Short-Form McGill Pain Questionnaire
  • Patient Global Impression of Change scale
  • Kurtzke Expanded Disability Status Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuropathic Pain
  • Chronic Pain
  • Multiple Sclerosis
Intervention  ICMJE
  • Drug: Lidocaine patch 5%
    lidocaine 5% patch; 12 hours on, 12 hours off
    Other Name: Lidoderm
  • Drug: Extended-release oxycodone
    extended-release oxycodone titrating schedule
    Other Name: Oxycontin
  • Drug: Placebo extended-release oxycodone pills
    placebo pills with titrating schedule
    Other Name: Placebo pill
  • Drug: Placebo lidocaine patches
    used with extended release oxycodone group; used with placebo pills/placebo patches
    Other Name: Placebo patch
Study Arms  ICMJE Active Comparator: Lidocaine 5% + placebo patch, ER and placebo pills
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
Interventions:
  • Drug: Lidocaine patch 5%
  • Drug: Extended-release oxycodone
  • Drug: Placebo extended-release oxycodone pills
  • Drug: Placebo lidocaine patches
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 16, 2011)
19
Original Enrollment  ICMJE
 (submitted: December 20, 2006)
60
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00414453
Other Study ID Numbers  ICMJE TALENT-MS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Robert Dworkin, University of Rochester
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Rochester
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Endo Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Robert H. Dworkin, PhD University of Rochester
PRS Account University of Rochester
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP