Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00903851
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: Lidoderm
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy.

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Mean change from baseline to Week 3 in average pain intensity as measured from patient diaries using Brief Pain Inventory Question 5. [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • McGill Pain Questionnaire [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: No ]
  • Other Pain Questions in BPI [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: No ]
  • Weekly pain intensity/relief measures [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: No ]
  • Pain duration using questions that assess duration and frequency of pain [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: No ]
  • Assessment of allodynia [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: Yes ]
  • Neuropathy Pain Scale [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: No ]
  • Assessment of safety was based on AEs, skin assessment, physical examination, vital signs, clinical laboratory data, and plasma lidocaine levels [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: April 2002
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (1) Lidoderm
(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
Drug: Lidoderm
Patients participated in an 8-week treatment period; patients at one site were to continue treatment for the entire 8 weeks while patients at two sites were to terminate treatment after 3 weeks. Commercially available Lidoderm® (lidocaine patch 5%) was provided to each patient with up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain.
Other Name: Lidocaine Patch 5%

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Were using stable analgesic drug therapy for at least 1 week (regimen and dosages) prior to screening visit, with the exception of acetaminophen and lidocaine for patients undergoing a punch skin biopsy

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903851

Locations
United States, Alabama
Birmingham, Alabama, United States
Hueytown, Alabama, United States
United States, Florida
Jacksonville, Florida, United States
United States, New York
Rochester, New York, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00903851     History of Changes
Other Study ID Numbers: EN3220-005
Study First Received: May 15, 2009
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014