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 |
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.
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
We found this trial at
20
sites
Beachwood, Ohio 44122
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1788 Republic Road
Virginia Beach, Virginia 23454
Virginia Beach, Virginia 23454
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