Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Drug: Placebo Patch
- Registration Number
- NCT00589979
- Lead Sponsor
- Endo Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 169
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lidoderm (Lidocaine 5% Patch) 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) Placebo Patch Placebo Patch Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)
- Primary Outcome Measures
Name Time Method Time-to-Exit From Current Study Treatment 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 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
Name Time Method Exit Status From Current Study Treatment - Yes Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation 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.
Time-to-Exit Due to Lack of Efficacy Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation 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.Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS) 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) 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 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) 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 Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) 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 Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) 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 Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) 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 Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) 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 Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) 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).
Trial Locations
- Locations (20)
Tampa Bay Medical Research, Inc.
🇺🇸Clearwater, Florida, United States
Delray Research Associates
🇺🇸Delray Beach, Florida, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Arthritis Center of Nebraska
🇺🇸Lincoln, Nebraska, United States
Advanced Pain Management & Rehabilitation, Hilltop Medical
🇺🇸Virginia Beach, Virginia, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Health Research of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Health Concepts
🇺🇸Rapid City, South Dakota, United States
NextCare Institute for Clinical Research
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
CNS Clinical Trials
🇺🇸Saint Petersburg, Florida, United States
Arthritis & Osteoporosis Center of Maryland
🇺🇸Frederick, Maryland, United States
Midwest Pharmaceutical Research
🇺🇸Saint Peters, Missouri, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
University Hospitals of Case Medical Center - Arthritis Translational Research Program
🇺🇸Beachwood, Ohio, United States
New England Research Associates, LLC
🇺🇸Trumbull, Connecticut, United States
Arizona Arthritis Research, PLC
🇺🇸Paradise Valley, Arizona, United States
Radiant Research
🇺🇸San Antonio, Texas, United States