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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00904202

Enrollment

Registered

2009-05-19

Start date

2003-01-31

Completion date

Unknown

Last updated

2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Complex Regional Pain Syndrome, Diabetic Neuropathy, HIV Neuropathy, Idiopathic Sensory Neuropathy, Peripheral Neuropathy, Postherpetic Neuralgia

Brief summary

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.

Interventions

DRUGPlacebo 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).

DRUGPlacebo capsules + Lidoderm®

DRUGGabapentin + Placebo

DRUGGabapentin + Lidoderm®

DRUGGabapentin 300 mg capsules 1800 mg/day + placebo patch

Gabapentin 300 mg capsules 1800 mg/day + placebo patch

DRUGGabapentin 1800 mg/day + Lidoderm patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Measure	Time frame
Investigator and Patient Global Impression of Change	—
Allodynia Testing	—
Pain Quality Assessment Scale (PQAS)	—
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	—
QoL; Symptom Checklist, pain interference with QoL	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026