CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 51 enrolled
Drug / intervention
Lidocaine 5% patches +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01086150
NCT01086150Phase 3Completed
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Use of Topical Lidocaine (Lidoderm 5% Patch) to Reduce Pain in Patients With Diabetic Neuropathy: Does the Density and Subtype of Sodium Channels Affect Response?

Albany Medical College·interventional·Posted Mar 12, 2010·Updated Jun 11, 2020

In Brief

A Phase 3 clinical trial evaluating Skin biopsy and Lidocaine 5% patches for Diabetic Peripheral Neuropathy. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy
CountriesUnited States
CollaboratorsEndo Pharmaceuticals

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2010
Enrollment StartOct 1, 2009
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 16.3 years ago

Interventions

Skin biopsyprocedure

Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.

Lidocaine 5% patchesdrug

Subject will apply patches to affected area QD for 12 hours then remove.