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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903851
First Posted: May 19, 2009
Last Update Posted: February 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Endo Pharmaceuticals
May 15, 2009
May 19, 2009
February 15, 2010
April 2002
June 2003   (Final data collection date for primary outcome measure)
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) ]
Same as current
Complete list of historical versions of study NCT00903851 on ClinicalTrials.gov Archive Site
  • McGill Pain Questionnaire [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ]
  • Other Pain Questions in BPI [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ]
  • Weekly pain intensity/relief measures [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ]
  • 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) ]
  • Assessment of allodynia [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ]
  • Neuropathy Pain Scale [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) ]
  • 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) ]
Same as current
Not Provided
Not Provided
 
Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy
A Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy.
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes
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%
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
Intervention: Drug: Lidoderm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
Not Provided
June 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00903851
EN3220-005
Not Provided
Not Provided
Not Provided
Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
Endo Pharmaceuticals
Not Provided
Study Director: Study Director Endo Pharmaceuticals
Endo Pharmaceuticals
February 2010

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