Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee

Study Overview
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Brief Summary
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Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the treatment of pain from OA of the knee.

Official Title
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A Randomized, Double-Blind, Pilot Study Comparing the Efficacy and Safety of Lidocaine 5% Patch With Placebo in Patients With Pain From Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Lidoderm
* Drug: Placebo patch


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Had unilateral or bilateral OA of the knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (presence of osteophytes on x-ray and written evaluation) of OA Had functional capacity class rating of I, II, or III according to ACR classification Had 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 non study pain At baseline visit, patients were randomized to double-blind treatment if they had an average pain intensity rating for the index joint 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 is defined as no pain and 10 is defined as pain as bad as ever imagined as measured by Question 5 of the BPI and recorded in a diary At baseline visit, patients were randomized to double-blind treatment if they had, at the baseline visit, an OA severity score for the index joint of 7 or greater on a composite scale of 0 to 24 as measured by the Index of Severity for Osteoarthrosis of the Knee Key Exclusion Criteria: Had been diagnosed with inflammatory arthritis, gout, pseudo-gout or Paget's disease that in the investigator's opinion would have interfered with the assessment of pain and other symptoms of OA Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that could have confounded study results Had any other clinically significant joint disease or prior joint replacement surgery at the index joint Had severe renal insufficiency (creatinine clearance of <30 mL/min) Had moderate or greater hepatic impairment Were taking analgesic medications, glucosamine, or chondroitin 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. Were using lidocaine-containing product that could not be discontinued during the study Had previously failed treatment with Lidoderm analgesic patch for OA Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry Were unable to discontinue use of topical drugs applied to the knee Were taking class I 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 |
| --- | --- |
| Experimental: Lidocaine 5% patch<br>Lidocaine 5% patch (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied on each affected knee once every 24 hours | 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 patch<br>Matching placebo patch, 1⅓ patches applied on each affected knee once every 24 hours | Drug: Placebo 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 |
| --- | --- | --- |
| Western Ontario and McMaster Universities (WOMAC) OA Index |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 
| Pain intensity and pain relief (BPI Questions 3, 4, 5, 6, and 8) |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 
| Pain Quality Assessment Scale (PQAS) |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 
| Patient-rated and Investigator-rated Global Impression of Change in OA pain (categorical scale) |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 
| Patient-rated and Investigator-rated Global Assessment of Treatment Satisfaction (categorical scale) |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL: Pain interference on activities of daily living using Question 9 of the BPI |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 
| QoL: Beck Depression Inventory (BDI) |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 
| Quality of Sleep (QOS) |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) | 
| Safety assessments included AEs, dermal assessments, clinical laboratory tests (including urinalysis), vital sign measurements, physical examination results, and plasma lidocaine concentrations |  | Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84) |