Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee

Efficacy and Safety of the Lidocaine 5% Patch When Used as Adjunct Treatment in Patients With Osteoarthritis of the Knee Receiving Sub-Optimal Pain Relief From Their Current Analgesic Regimen

Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.

Key Inclusion criteria:

• Male or female patients ≥37 years with moderate-to-severe OA related pain in one knee
• Body mass index (BMI) ≤40 kg/m2
• Symptomatic OA of the index knee diagnosed with a functional capacity of II or III according to ACR criteria classification Note: Patients with symptomatic contralateral knee OA with persistent pain ≤2 cm on a 0-10 cm PI-NRS for ≥2 months will be allowed to participate.
• Unchanged dose of analgesic medication for OA for at least 4 weeks prior to screening and for the duration of the study
• Able and willing to complete all paper and e-diary assessments required by protocol

Key Exclusion criteria:

• Pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint
• Compromised integrity of the intact, superficial skin layer
• A grade 1 or 4 Kellgren and Lawrence score on radiographic examination
• Recent injury to either knee causing pain and interference with daily activities (eg. walking)
• Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL
• Known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product