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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Albany Medical College.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT01086150
First received: March 11, 2010
Last updated: June 21, 2011
Last verified: December 2010

March 11, 2010
June 21, 2011
October 2009
October 2012   (final data collection date for primary outcome measure)
To determine if the lidocaine patch provides therapeutic benefit to patients with painful diabetic neuropathy. [ Time Frame: 4 weeks to one year ] [ Designated as safety issue: No ]
To determine if the lidocaine patch provides therapuetic benefit to patients with painful diabetic neuropathy. [ Time Frame: 4 weeks to one year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01086150 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy
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?

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Peripheral 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.
  • 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.
  • Healthy control patients
    Subjects 18 to 70 years of age, non-diabetic with no nervous system disease
    Intervention: Other: Skin biopsy
  • Type I or Type II diabetes with painful diabetic neuropathy
    18 to 70 years old with significantly painful diabetic neuropathy
    Intervention: Other: Skin biopsy
  • 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.
    Intervention: Other: Skin biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
October 2013
October 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
Yes
Contact: Charles Argoff, MD 518 262-6538 argoffc@mail.amc.edu
Contact: Margaret Czerwinski, RN 518 262-0034 czerwim@mail.amc.edu
United States
 
NCT01086150
ENDO
No
Charles Argoff, MD, The Neurosciences Institute, Albany Medical College
Albany Medical College
Endo Pharmaceuticals
Not Provided
Albany Medical College
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP