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

Endo Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Osteoarthritis of the Knee

Treatments

Drug: Placebo Patch

Drug: Lidoderm (Lidocaine 5% Patch)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00589979

EN3260-003

Details and patient eligibility

About

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.

Enrollment

169 patients

Sex

All

Ages

37+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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