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

NCT00903851 | Completed Phase 4

• 1 other identifier: EN3220-005
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• McGill Pain Questionnaire

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)

• Other Pain Questions in BPI

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)

• Weekly pain intensity/relief measures

  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

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)

• Assessment of allodynia

  Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)

Study Arms (1)

(1) Lidoderm

EXPERIMENTAL

(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

Interventions

Lidoderm DRUG

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.

Also known as: Lidocaine Patch 5%

(1) Lidoderm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (4)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Hueytown, Alabama, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Rochester, New York, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Lidoderm

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Study Director

  Endo Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 19, 2009
• Study Start: April 1, 2002
• Primary Completion: June 1, 2003
• Last Updated: February 15, 2010

Record last verified: 2010-02

Locations

US (4)