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Completed

NCT Number: NCT01112748

Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Danish Pain Research Center

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged 18 or more with neuropathic pain after a peripheral nerve injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale.

Exclusion criteria

  • pregnancy or lactation,
  • allergy to lidocaine,
  • alcohol abuse,
  • psychiatric disorders,
  • skin diseases in the area where the patches are to be applied,
  • treatment with class I antiarrhythmic agents,
  • any treatment within the past one month or concomitantly with Na2+-channel blockers (e.g., mexiletine, phenytoine, propafenone),
  • any topical treatment with capsaicin within the last three months before entering the study, or any other topical treatment in the area of neuropathic pain,
  • concomitant therapy with TENS or acupuncture.

Treatment and study plan

Topical lidocaine patch

Drug

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

Other names: Versatis 5% Medicated Plaster, PL21727/0016.

Primary outcomes

  1. Change in pain intensity (measured daily on a 10 point NRS)of spontaneous pain from baseline week to last week of treatment

    Time frame: 4 or 12 weeks

    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 NRS) of pain from the baseline week to the last week.

Secondary outcomes

  1. Pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain

    Time frame: 4 or 12 weeks

  2. Effect on ongoing pain, brush-evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia

    Time frame: 4 or 12 weeks

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Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • Grünenthal Denmark ApS

Registry information

Official study title

Evaluation of Predictors of Response for the Efficacy of Topical Lidocaine Patch (Versatis) on Chronic Neuropathic Pain After Peripheral Nerve Injury

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 28, 2010
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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