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Sponsored by: |
Endo Pharmaceuticals |
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Information provided by: | Endo Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00589979 |
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 |
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Osteoarthritis of the Knee |
Drug: Lidocaine 5% Patch Drug: Placebo |
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 |
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 |
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1: Experimental |
Drug: Lidocaine 5% Patch
Topical Patch
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2: Placebo Comparator |
Drug: Placebo
Topical Patch
|
Ages Eligible for Study: | 37 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion criteria:
Key Exclusion criteria:
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 |
Study Director: | Ernest A. Kopecky, PhD, MBA | Endo Pharmaceuticals |
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 |
Health Authority: | United States: Food and Drug Administration |
Osteoarthritis Knee Lidoderm |
Lidocaine Topical patch Adjunct therapy |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Lidocaine Pain Rheumatic Diseases |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Cardiovascular Agents |
Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |