Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112748
• Other study ID #: LIDO-2009
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2010
• Last updated: August 26, 2011
• Start date: April 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Peripheral Nerve Injuries

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
Danish Pain Research Center	Grünenthal Denmark ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain		4 or 12 weeks	No
Secondary	Effect on ongoing pain, brush-evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia		4 or 12 weeks	No