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



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:37 - Any
Updated:10/7/2017
Start Date:March 2007
End Date:October 2008

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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
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Delray Beach, Florida 33484
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
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4460 Red Bank Expressway
Cincinnati, Ohio 45227
513-721-3868
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
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1701 E. Thomas Road
Phoenix, Arizona 85016
480-924-8382
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Beachwood, OH
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Clearwater, Florida 33761
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Duncansville, Pennsylvania 16635
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Frederick, MD
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Lincoln, Nebraska 68516
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Oklahoma City, Oklahoma 73103
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4550 East Bell Road
Paradise Valley, Arizona 85253
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Phoenix, Arizona 85050
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Rapid City, South Dakota 57702
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Saint Peters, Missouri 63376
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11201 Corporate Cir N
Saint Petersburg, Florida 33702
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San Antonio, Texas
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San Antonio, TX
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5115 North Armenia Avenue
Tampa, Florida 33603
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Trumbull, Connecticut 06611
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1788 Republic Road
Virginia Beach, Virginia 23454
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Virginia Beach, VA
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