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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00589979
First received: December 26, 2007
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: Lidoderm (Lidocaine 5% Patch)
Drug: Placebo Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Time-to-Exit From Current Study Treatment [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Time-to-exit was defined as the number of days at which a patient either met the switching criterion [a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study.


Secondary Outcome Measures:
  • Time-to-Exit Due to Lack of Efficacy [ Time Frame: Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation ] [ Designated as safety issue: No ]

    Time-to-exit due to lack of efficacy was defined as a patient that met the switching criterion (a 2-category change in Pain Relief Scale (PRS) in the worsening direction [increasing pain or decreasing pain relief] for 2 consecutive days) or was discontinued from the current period or study due to lack of efficacy. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief.

    No patients discontinued from the study due to lack of efficacy.


  • Exit Status From Current Study Treatment - Yes [ Time Frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation ] [ Designated as safety issue: No ]
    Exit status from a current study treatment was categorized as yes or no for patients who exited prior to the 4-week planned duration. This analysis supports the results of the primary analysis. The number of patients exiting (yes) is reported.

  • Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The Numerical Rating Scale (NRS) is an 11-point categorical rating scale to assess pain intensity (PI-NRS); 0= no pain and 10= worst possible pain. The scale is anchored on the left with "No Pain" and on the right with "Worst Possible Pain." Patients were to complete this assessment at approximately the same time each day during the double-blind treatment period in their e-diary. The overall treatment difference for the Lidoderm (lidocaine patch 5%) and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence.

  • Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The Pain Relief Scale (PRS) is a 9-point categorical rating scale to assess pain relief during the 24-hours since the last assessment; 0= completely worse and 8= complete pain relief. Patients completed this assessment each day during the run-in period and each day during the double-blind treatment phase in their e-diary.

  • Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores [ Time Frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) ] [ Designated as safety issue: No ]
    The PQAS measures individual pain qualities and the impact of treatment on those qualities. Items 1-19 are each rated on an 11-point scale ranging from 0 (lowest score - no pain of that type) to 10 (highest score - the highest level of that type of pain). Average surface pain = average of PQAS items: cold, sensitive, itchy, numb, and tingling. Average deep pain = average of PQAS items: dull, cramping, throbbing, aching, and heavy. Average paroxymal pain = average of PQAS items: sharp, shooting, electric, and radiating.

  • Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain [ Time Frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) ] [ Designated as safety issue: No ]
    Patients rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale indicating: "very much worse" (0); "much worse" (1); "minimally worse" (2); "no change" (3); "minimally improved" (4); "much improved" (5); and "very much improved" (6).

  • Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain [ Time Frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) ] [ Designated as safety issue: No ]
    Investigators rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale ranging from "very much worse" to "very much improved." A similar questionnaire was completed by the Investigator.

  • Patient Global Assessment of Treatment Satisfaction [ Time Frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) ] [ Designated as safety issue: No ]
    At the end of each period, patients rated their overall satisfaction with study treatment using a 5-point categorical scale indicating: 0 - very dissatisfied; 1 - dissatisfied; 2 - no preference; 3 - satisfied; and 4 - very satisfied.

  • Investigator Global Assessment of Treatment Satisfaction [ Time Frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) ] [ Designated as safety issue: No ]
    At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied).


Enrollment: 169
Study Start Date: March 2007
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidoderm (Lidocaine 5% Patch)
Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)
Drug: Lidoderm (Lidocaine 5% Patch)
Topical Patch
Other Name: Lidoderm
Placebo Comparator: Placebo Patch
Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)
Drug: Placebo Patch
Topical Patch
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   37 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589979

Locations
United States, Arizona
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, United States, 85253
HOPE Research Institute, LLC
Phoenix, Arizona, United States, 85050
NextCare Institute for Clinical Research
Phoenix, Arizona, United States, 85016
United States, Connecticut
Clinical Research Consulting
Milford, Connecticut, United States, 06460
New England Research Associates, LLC
Trumbull, Connecticut, United States, 06611
United States, Florida
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 33761
Delray Research Associates
Delray Beach, Florida, United States, 33484
CNS Clinical Trials
St. Petersburg, Florida, United States, 33702
Clinical Research of West Florida
Tampa, Florida, United States, 33606
United States, Maryland
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, United States, 21702
United States, Missouri
Midwest Pharmaceutical Research
St. Peters, Missouri, United States, 63376
United States, Nebraska
Arthritis Center of Nebraska
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
United States, Ohio
University Hospitals of Case Medical Center - Arthritis Translational Research Program
Beachwood, Ohio, United States, 44122
Community Research
Cincinnati, Ohio, United States, 45245
United States, Oklahoma
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Dakota
Health Concepts
Rapid City, South Dakota, United States, 57702
United States, Texas
Radiant Research
San Antonio, Texas, United States, 78217
United States, Virginia
Advanced Pain Management & Rehabilitation, Hilltop Medical
Virginia Beach, Virginia, United States, 23454
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Ernest A. Kopecky, PhD, MBA Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Dr. Ernest A. Kopecky, Sr. Director, Clinical Research and Development, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00589979     History of Changes
Other Study ID Numbers: EN3260-003
Study First Received: December 26, 2007
Results First Received: December 22, 2009
Last Updated: June 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Osteoarthritis
Knee
Lidoderm
Lidocaine
Topical patch
Adjunct therapy

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 29, 2014