A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions

Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy participated in a Phase IV clinical trial to assess the comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in treating a diverse group of peripheral neuropathic pain patients.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Complex Regional Pain Syndrome; Peripheral Neuropathy; Diabetic Neuropathy; Postherpetic Neuralgia; HIV Neuropathy; Idiopathic Sensory Neuropathy
• Intervention / Treatment: Drug: Placebo Capsules + Placebo Patch; Drug: Placebo capsules + Lidoderm®; Drug: Gabapentin + Placebo; Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch; Drug: Gabapentin + Lidoderm®; Drug: Gabapentin 1800 mg/day + Lidoderm patch

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Hueytown, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
  • Florida
    • Pembroke Pines, Florida, United States
  • New York
    • New York, New York, United States
    • Rochester, New York, United States
  • Pennsylvania
    • Altoona, Pennsylvania, United States

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the sponsor and investigator)
2. Patients with PHN must have had pain >3 months after rash healing
3. Patients with DN must have had Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities
4. Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic testing, and daily painful symptoms of at least 3 months' duration
6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration
7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration
8. Reached an average daily pain rating during the baseline week of pain ratings greater than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)
9. Had never received an analgesic regimen that contained lidocaine or gabapentin

Exclusion Criteria:

1. Had a neurological condition other than that associated with their pain diagnosis which, in the opinion of the investigator, would interfere with their ability to participate in the study
2. Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine
3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo capsules + placebo patch; Placebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing	Drug: Placebo Capsules + Placebo Patch; Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).; Other Names: Lidocaine patch 5%
Experimental: placebo capsules + Lidoderm patch (Lidocaine Group); Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing	Drug: Placebo capsules + Lidoderm®; Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).; Other Names: Lidocaine patch 5%
Active Comparator: Gabapentin capsules 1800 mg/day + placebo patch; Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain	Drug: Gabapentin + Placebo; Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).; Other Names: Lidocaine patch 5%; Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch; Gabapentin 300 mg capsules 1800 mg/day + placebo patch
Other: Gabapentin capsules 1800 mg/day + Lidoderm patch; Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain	Drug: Gabapentin + Lidoderm®; Patients participated in a 5-week treatment period. Eligible patients were randomized into one of four treatment groups: placebo capsules + placebo patch (Placebo Group), placebo capsules + Lidoderm patch (Lidocaine Group), Gabapentin capsules 1800 mg/day + placebo patch (Gabapentin Group), or Gabapentin capsules 1800 mg/day + Lidoderm patch (Combination Group).; Other Names: Lidocaine patch 5%; Drug: Gabapentin 1800 mg/day + Lidoderm patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average daily pain intensity (BPI Questions 3,4,5, and 6)	Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 21), V6 (Day 28), V7/EOS (Day 35)

Secondary Outcome Measures

Outcome Measure
Pain Quality Assessment Scale (PQAS)
Investigator and Patient Global Impression of Change
Allodynia Testing
QoL; Symptom Checklist, pain interference with QoL
Patient Global Impression of Treatment Satisfaction, disability assessment, and Percent Pain Relief (BPI Question 8)
Safety assessments include adverse events; dermal assessments/sensory testing, clinical laboratory tests, vital sign measurements and physical/neurological examination

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): June 1, 2003

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: Pathologic Processes; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Endocrine System Diseases; Disease; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Mononeuropathies; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Autonomic Nervous System Diseases; Syndrome; Carpal Tunnel Syndrome; Neuralgia; Peripheral Nervous System Diseases; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Diabetic Neuropathies; Neuralgia, Postherpetic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antimanic Agents; Lidocaine; Gabapentin
• Other Study ID Numbers: EN3220-009