A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

Study Overview
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Brief Summary
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Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.

Official Title
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A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Lidoderm®
* Drug: Placebo Topical Patch


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Had axial LBP with or without radiation present for at least 3 months as defined as: Chronic axial LBP without radiation: pain isolated to the axial low back without radiation into the buttock or below Chronic axial LBP with radiation: pain that radiates to the buttock or below. This patient group could include patients with radicular/neuropathic and non-radicular components with leg pain component <50% Had daily moderate to severe LBP as the primary source of pain Had a normal neurological examination, including: Motor strength Sensory exam in lower extremities Deep tendon reflexes Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain). Had a daily average pain intensity rating of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 was defined as no pain and 10 was defined as pain as bad as ever imagined as measured by Question 5 of the Brief Pain Inventory (BPI) and recorded in a diary Key Exclusion Criteria: Had spinal stenosis with > 50% leg pain component Had elective surgery scheduled to occur during the 14-week study Had a history of one or more back surgeries within 1 year of study entry Had severe renal insufficiency (creatinine clearance of <30mL/min) Had moderate or greater hepatic impairment Were taking analgesic medications that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications. Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period Had received an epidural steroid/local anesthesia injection within 4 weeks prior to study entry Had received trigger point injections within 2 weeks prior to study entry Had received Botulinum Toxin (Botox) Injections for LBP within 6 months prior to study entry Were using a lidocaine-containing product that could not be discontinued during the study Were using any topical medication applied to the low back region Had previously failed treatment with Lidoderm analgesic patch for LBP Were taking class 1 anti-arrhythmic drugs (e.g. mexiletine, tocainide) Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief

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 |
| --- | --- |
| Experimental: Lidocaine 5% Patch<br>Lidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h) | Drug: Lidoderm®<br>* Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.<br>* Other names: Lidocaine 5% Patch;|
| Placebo Comparator: Placebo Topical Patch<br>Matching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h) | Drug: Placebo Topical Patch<br>* Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity (Question 5 of the BPI) |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration |  | Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84) |