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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Placebo Capsules + Placebo Patch
* Drug: Placebo capsules + Lidoderm®
* Drug: Gabapentin + Placebo
* Drug: Gabapentin + Lidoderm®
* Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch
* Drug: Gabapentin 1800 mg/day + Lidoderm patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Patients with PHN must have had pain >3 months after rash healing 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 Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria 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 Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration 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) Had never received an analgesic regimen that contained lidocaine or gabapentin Exclusion Criteria: 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 Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo capsules + placebo patch<br>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<br>* 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).<br>* Other names: Lidocaine patch 5%;|
| Experimental: placebo capsules + Lidoderm patch (Lidocaine Group)<br>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®<br>* 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).<br>* Other names: Lidocaine patch 5%;|
| Active Comparator: Gabapentin capsules 1800 mg/day + placebo patch<br>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<br>* 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).<br>* Other names: Lidocaine patch 5%;Drug: Gabapentin 300 mg capsules 1800 mg/day + placebo patch<br>* Gabapentin 300 mg capsules 1800 mg/day + placebo patch<br>|
| Other: Gabapentin capsules 1800 mg/day + Lidoderm patch<br>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®<br>* 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).<br>* Other names: Lidocaine patch 5%;Drug: Gabapentin 1800 mg/day + Lidoderm patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |