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

Diabetes Clinical Trial

Official title:

A Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903851
• Other study ID #: EN3220-005
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2009
• Last updated: February 12, 2010
• Start date: April 2002

Study information

• Verified date: February 2010
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline to Week 3 in average pain intensity as measured from patient diaries using Brief Pain Inventory Question 5.		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	No
Secondary	McGill Pain Questionnaire		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	No
Secondary	Other Pain Questions in BPI		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	No
Secondary	Weekly pain intensity/relief measures		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	No
Secondary	Pain duration using questions that assess duration and frequency of pain		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	No
Secondary	Assessment of allodynia		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	Yes
Secondary	Neuropathy Pain Scale		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	No
Secondary	Assessment of safety was based on AEs, skin assessment, physical examination, vital signs, clinical laboratory data, and plasma lidocaine levels		Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)	Yes