Clinical trial NCT00589979: Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Knee
Lidoderm
Lidocaine
Topical patch
Adjunct therapy
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-10
Enrollment: 169
Sex: ALL
Minimum age (years): 37
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Time-to-Exit From Current Study Treatment
timeFrame: Baseline, Period 1 (up to 4 weeks ±2 days), Period 2 (up to 4 weeks ±2 days), Period 3 (up to 4 weeks ±2 days), or Premature Discontinuation
Secondary outcomes:
measure: Time-to-Exit Due to Lack of Efficacy
timeFrame: Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
measure: Exit Status From Current Study Treatment - Yes
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
measure: Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)
timeFrame: Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)
measure: Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores
timeFrame: Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks)
measure: Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
measure: Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
measure: Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
measure: Patient Global Assessment of Treatment Satisfaction
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
measure: Investigator Global Assessment of Treatment Satisfaction
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Other outcomes:
measure: Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score
timeFrame: Baseline and end of treatment period (up to 4 weeks)
measure: Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score
timeFrame: Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
measure: Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
measure: Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
measure: Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
measure: Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale
timeFrame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Locations:
city: Paradise Valley
country: United States
facility: Arizona Arthritis Research, PLC
state: Arizona
city: Phoenix
country: United States
facility: NextCare Institute for Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute, LLC
state: Arizona
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Delray Beach
country: United States
facility: Delray Research Associates
state: Florida
city: Saint Petersburg
country: United States
facility: CNS Clinical Trials
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Frederick
country: United States
facility: Arthritis & Osteoporosis Center of Maryland
state: Maryland
city: Saint Peters
country: United States
facility: Midwest Pharmaceutical Research
state: Missouri
city: Lincoln
country: United States
facility: Arthritis Center of Nebraska
state: Nebraska
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Beachwood
country: United States
facility: University Hospitals of Case Medical Center - Arthritis Translational Research Program
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Virginia Beach
country: United States
facility: Advanced Pain Management & Rehabilitation, Hilltop Medical
state: Virginia
Study officials:
affiliation: Endo Pharmaceuticals
name: Ernest A. Kopecky, PhD, MBA
role: STUDY_DIRECTOR
References: