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

NCT ID: NCT01086150

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-10-31

Brief 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.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy control patients

Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.

Group Type: OTHER

Skin biopsy

Intervention Type: PROCEDURE

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% patches

Intervention Type: DRUG

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

Type I or Type II diabetes with painful diabetic neuropathy

18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.

Group Type: OTHER

Skin biopsy

Intervention Type: PROCEDURE

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% patches

Intervention Type: DRUG

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

patients with non-painful diabetic peripheral neuropathy

18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.

Group Type: OTHER

Skin biopsy

Intervention Type: PROCEDURE

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% patches

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

Lidocaine 5% patches

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

Intervention Type: DRUG

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 < 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Charles Argoff

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Albany Medical College

Albany, New York, United States

Countries

United States

Other Identifiers

ENDO

Identifier Type: -

Identifier Source: org_study_id