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

Completed · Phase 4

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID: NCT00903851
Run by: Endo USA Inc., a Keenova Therapeutics Company
People needed: 76
Starts: 2002-04-01
Last updated by the study team: 2010-02-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Study site — Birmingham, Alabama, United States
Study site — Hueytown, Alabama, United States
Study site — Jacksonville, Florida, United States
Study site — Rochester, New York, United States

Full record on ClinicalTrials.gov

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