Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086150
• Other study ID #: ENDO
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 2009
• Est. completion date: October 2015

Study information

• Verified date: May 2020
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 < 40mm at Baseline)

Exclusion Criteria:

• History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator

• Allergy to lidocaine

• Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study

• Women who are pregnant, breastfeeding or trying to become pregnant

• History of slow-healing diabetic foot ulcers

• Current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies

• Subjects taking Class I antiarrhythmics

• HgA1c > 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)

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

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

Drug:
• Lidocaine 5% patches
Subject will apply patches to affected area QD for 12 hours then remove.

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albany Medical College	Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores From Composite Visual Analog Scale	Scores range from 0 to 10 with higher scores indicating higher levels of pain.	baseline, 4 weeks
Secondary	Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP	Pixel intensity (0-256) of immunofluorescence for each individual biomarker.	Baseline, 4 weeks