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

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00414453 on ClinicalTrials.gov