Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury
CompletedPhase 4NCT01112748
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Evaluation of Predictors of Response for the Efficacy of Topical Lidocaine Patch (Versatis) on Chronic Neuropathic Pain After Peripheral Nerve Injury
- Conditions
- Interventions
- Drug: Topical lidocaine patch
- Sponsor
- Danish Pain Research Center
- Collaborators
- Grünenthal Denmark ApS
- Start date
- 2010-04
- Primary completion
- 2011-05
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01112748