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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postherpetic Neuralgia, Diabetic Neuropathy, Low Back Pain

Intervention / Treatment
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* Drug: Lidoderm


Participation Criteria
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Eligibility Criteria
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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)

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (1) Lidoderm<br>(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<br>* 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.<br>* Other names: Lidocaine patach 5%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |