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

Endo Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: Lidoderm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00903851

EN3220-005

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

(1) Lidoderm

Experimental group

Description:

(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

Treatment:

Drug: Lidoderm