Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00589979
First received: December 26, 2007
Last updated: June 13, 2011
Last verified: June 2011
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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
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, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on October 17, 2012
