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Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury

NCT01112748 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-08-29

No results posted yet for this study

Summary

The primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. The primary outcome measure is the predictive role for these three measures for obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point pain reduction to lidocaine (change in median pain intensity (measured on a 10 point numeric rating scale) of pain from the baseline week to the last week of lidocaine treatment). Secondary effect variable will be efficacy of lidocaine on pain reduction (baseline week versus last week of each treatment) and pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain, and effect on ongoing pain, brush evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia evaluated on each visit.

Conditions

  • Neuropathic Pain

Interventions

DRUG

Topical lidocaine patch

Topical lidocaine patch 5%; up to 3 patches to cover the area of maximum pain for 12 h a day.

Sponsors & Collaborators

  • Grünenthal Denmark ApS

    collaborator UNKNOWN

  • Danish Pain Research Center

    lead OTHER

Principal Investigators

  • Nanna B. Finnerup, MD, DMSc. · Danish Pain Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-05-31
Completion
2011-06-30

Countries

  • Denmark

Study Locations

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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 NCT01112748 on ClinicalTrials.gov