Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee - Full Text View

Sponsored by:	Endo Pharmaceuticals
Information provided by:	Endo Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00589979

Purpose

Patients with knee pain due to 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
Osteoarthritis of the Knee	Drug: Lidocaine 5% Patch Drug: Placebo

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:

Time-to-loss of adequate pain control [ Time Frame: ≤ 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Time Frame: ≤ 28 days ] [ Designated as safety issue: No ]

Enrollment:	93
Study Start Date:	February 2007
Study Completion Date:	October 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lidocaine 5% Patch Topical Patch
2: Placebo Comparator	Drug: Placebo Topical Patch

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

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
New England Research Associates, LLC
Trumbull, Connecticut, United States, 06611
Clinical Research Consulting
Milford, Connecticut, United States, 06460
United States, Florida
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 33761
CNS Clinical Trials
St. Petersburg, Florida, United States, 33702
Clinical Research of West Florida
Tampa, Florida, United States, 33606
Delray Research Associates
Delray Beach, Florida, United States, 33484
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:	Endo Pharmaceuticals Inc. ( Dr. Ernest A. Kopecky, Sr. Director, Clinical Research and Development )
Study ID Numbers:	EN3260-003
Study First Received:	December 26, 2007
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00589979 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:

Osteoarthritis
Knee
Lidoderm

Lidocaine
Topical patch
Adjunct therapy

Study placed in the following topic categories:

Osteoarthritis
Joint Diseases
Lidocaine
Anesthetics
Central Nervous System Depressants
Pain
Cardiovascular Agents
Rheumatic Diseases

Anesthetics, Local
Osteoarthritis, Knee
Musculoskeletal Diseases
Arthritis
Anti-Arrhythmia Agents
Analgesics
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Physiological Effects of Drugs
Lidocaine
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Rheumatic Diseases
Anesthetics, Local

Pharmacologic Actions
Osteoarthritis, Knee
Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009