A Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

A Prospective, Open-Label, Multicenter Study of the Effectiveness And Safety Of Lidoderm® As Add-On Treatment in Patients With Postherpetic Neuralgia, Diabetic Neuropathy, or Low Back Pain

Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Diabetic Neuropathy; Postherpetic Neuralgia
• Intervention / Treatment: Drug: Lidoderm

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
  • Florida
    • Plantation, Florida, United States
  • Georgia
    • Marietta, Georgia, United States
  • Illinois
    • Burr Ridge, Illinois, United States
  • Kansas
    • Overland Park, Kansas, United States
  • New Jersey
    • Hackensack, New Jersey, United States
  • Pennsylvania
    • Altoona, Pennsylvania, United States
  • Wisconsin
    • Cudahy, Wisconsin, United States
    • Greenfield, Wisconsin, United States
    • West Bend, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Were currently receiving an analgesic regimen that contained gabapentin
• Had been on a stable dose of gabapentin for at least 14 days (same dose ±10% for 14 days)
• Had a partial response to a gabapentin-containing analgesic regimen defined as an average daily pain intensity score of >4 on a ) to 10 scale, with 0 being no pain and 10 being pain as bas as the patients have ever imagined (Question 5 of the Brief Pain Inventory [BPI] within 24 hours prior to the screening visit
• For diabetic patients, had a hemoglobin A1c level <0.13 (normal range, 0.047-0.064)

Exclusion Criteria:

• Had a neurological condition other than that associated with their pain diagnosis that, in the opinion of the investigator, would have interfered with their ability to participate in the study
• Had received an epidural steroid/local anesthetic injection within 14 days prior to study entry
• Had received trigger point injections within 14 days prior to study entry
• Had received Botox injections within 3 months prior to study entry
• Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
• Were taking Class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (1) Lidoderm; (1) Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.	Drug: Lidoderm; Patients participated in a 2-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.; Other Names: Lidocaine patach 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain quality using the Neuropathic Pain Scale (NPS)	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Investigator and Patient Global Impression of Change	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Extent of numbness at the site of pain using the Numbness Questionnaire	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Patient Global Assessment of Pain Relief	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Pain interference (BPI Question 9)	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Patient Global Assessment of Patch Satisfaction	Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals
• Investigators: Study Director: Study Director, Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): November 1, 2002

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimated): May 19, 2009

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Neuralgia; Diabetic Neuropathies; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: EN3220-008