Completed

A Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy.

What is being tested

Lidoderm

Drug

Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 90 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: April 2002

See protocol details

Summary

Principal SponsorEndo Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2002

Actual date on which the first participant was enrolled.

Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain distal symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower extremities, or patients with idiopathic distal predominantly sensory neuropathy participated in a Phase IV clinical trial to assess the efficacy of lidocaine patches in treating painful diabetic neuropathy or idiopathic distal sensory neuropathy.

Official TitleA Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy.

NCT00903851

Principal SponsorEndo Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

76 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

5 inclusion criteria required to participate

At Sites 1, 2, and 3 - Had painful diabetic polyneuropathy of 3 or more months duration

At Site 1 only - Had clinical signs and symptoms of distal predominantly sensory polyneuropathy of 3 or more months duration. Diagnosis of predominantly sensory polyneuropathy were to be confirmed by either nerve conduction studies (large fiber sensory or sensorimotor axonal neuropathy) or by abnormal epidermal innervations on punch skin biopsy (distal leg/proximal thigh) (Herrmann et al., 1999; Holland et al., 1997)

Had an average daily pain rating for the baseline week of pain ratings equal to 4 or greater on the 0 to 10 numerical pain rating scale

Had at least 2 hours of moderate or severe pain intensity due to polyneuropathy daily in the immediately prior 3-month period

Show More Criteria

4 exclusion criteria prevent from participating

Had prior treatment with topical lidocaine, except for use with the punch skin biopsy procedure

Were currently under treatment with Class I antiarrhythmic agents (such as tocainide and mexiletine)

Had any other pain more severe than the painful diabetic or idiopathic neuropathy

Had open skin lesions in the area where the lidocaine patches were to be applied

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

(1)Commercially available Lidoderm® (lidocaine patch 5%), up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers