Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury

NCT01112748 | Completed Phase 4 DMC

• 1 other identifier: LIDO-2009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Focal neuropathic pain

Outcome Measures

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

  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.

  4 or 12 weeks

Secondary Outcomes (2)

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

  4 or 12 weeks

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

  4 or 12 weeks

Interventions

Topical lidocaine patch DRUG

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

Also known as: Versatis 5% Medicated Plaster, PL21727/0016.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Pain Research Center: lead
• Grünenthal Denmark ApS: collaborator

Study Sites (1)

Danish Pain Research Center

Aarhus C, 8000, Denmark

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Nanna B. Finnerup, MD, DMSc.

  Danish Pain Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 29, 2011

Record last verified: 2011-08

Locations

DK (1)