Phase 3
N=51
Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy
Diabetic Peripheral Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT01086150 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Pain Scores From Composite Visual Analog Scale — 6.5; 1.2; 4.5; 0.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Skin biopsy (Procedure); Lidocaine 5% patches (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albany Medical College
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores From Composite Visual Analog Scale |
6.5; 1.2; 4.5; 0.5 | — |
| SECONDARY Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP |
81.2; 101.4; 87.9; 91; 90.7; 90.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Group 1: 18-70 years of age, non-diabetic with no nervous system disease (healthy control group)
- Group 2: 18-70 years of age with Type I or Type II diabetes with significantly painful diabetic neuropathy (VAS > 40mm at Baseline)
- Group 3: 18-70 years of age with Type I or Type II diabetes with non- painful or insignificantly painful diabetic neuropathy (VAS 11%
- Active cancer within the previous two years except treated basal cell carcinoma of the skin
- Co-morbidities that can produce neuropathy
- Subjects taking sodium channel blockers within one week of study treatment and throughout the study
- Subjects taking any other experimental drugs within 30 days prior to Screening Visit (Visit 1)
- Application of lidocaine patch to either foot within two weeks of Screening Visit (Visit 1)
Data sourced from ClinicalTrials.gov (NCT01086150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.