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

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ClinicalTrials.gov Identifier: NCT01086150
Recruitment Status : Unknown
Verified December 2010 by Albany Medical College.
Recruitment status was:  Recruiting
First Posted : March 12, 2010
Last Update Posted : June 23, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetic Peripheral Neuropathy Other: Skin biopsy Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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?
Study Start Date : October 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Healthy control patients
Subjects 18 to 70 years of age, non-diabetic with no nervous system disease
Other: 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.
Type I or Type II diabetes with painful diabetic neuropathy
18 to 70 years old with significantly painful diabetic neuropathy
Other: Skin biopsy
Skin biopsy specimens will be processed and analyzed for nerve fiber count, nerve and skin morphology and sodium channel specific epitope expression in keratinocytes.
Subjects with Type I or Type II diabetes
18 to 70 years of age with Type I or Type II diabetes with significantly painful diabetic neuropathy.
Other: 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.


Outcome Measures

Primary Outcome Measures :
  1. To determine if the lidocaine patch provides therapeutic benefit to patients with painful diabetic neuropathy. [ Time Frame: 4 weeks to one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086150


Contacts
Contact: Charles Argoff, MD 518 262-6538 argoffc@mail.amc.edu
Contact: Margaret Czerwinski, RN 518 262-0034 czerwim@mail.amc.edu

Locations
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Contact: Margaret Czerwinski, RN    518-262-0034    czerwim@mail.amc.edu   
Contact: Katy Regan, BA    518 262-5938    regank@mail.amc.eddu   
Sponsors and Collaborators
Albany Medical College
Endo Pharmaceuticals
More Information

Responsible Party: Charles Argoff, MD, The Neurosciences Institute, Albany Medical College
ClinicalTrials.gov Identifier: NCT01086150     History of Changes
Other Study ID Numbers: ENDO
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action