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Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury

This study has been completed.
Sponsor:
Collaborator:
Grünenthal Denmark ApS
Information provided by (Responsible Party):
Danish Pain Research Center
ClinicalTrials.gov Identifier:
NCT01112748
First received: April 27, 2010
Last updated: August 26, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
 Drug: Topical lidocaine patch
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Predictors of Response for the Efficacy of Topical Lidocaine Patch (Versatis) on Chronic Neuropathic Pain After Peripheral Nerve Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Danish Pain Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain [ Time Frame: 4 or 12 weeks ] [ Designated as safety issue: No ]
  • Effect on ongoing pain, brush-evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia [ Time Frame: 4 or 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topical lidocaine patch
    Topical lidocaine patch 5%; up to 3 patches to cover the area of maximum pain for 12 h a day.
    Other Name: Versatis 5% Medicated Plaster, PL21727/0016.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112748

Locations
Denmark
Danish Pain Research Center
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
Grünenthal Denmark ApS
Investigators
Principal Investigator: Nanna B. Finnerup, MD, DMSc. Danish Pain Research Center
  More Information

No publications provided

Responsible Party: Danish Pain Research Center
ClinicalTrials.gov Identifier: NCT01112748     History of Changes
Other Study ID Numbers: LIDO-2009
Study First Received: April 27, 2010
Last Updated: August 26, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Danish Pain Research Center:
Focal neuropathic pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013