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

Primary Purpose

Osteoarthritis of the Knee

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lidoderm (Lidocaine 5% Patch)

Placebo Patch

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Knee, Lidoderm, Lidocaine, Topical patch, Adjunct therapy

Eligibility Criteria

37 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arizona Arthritis Research, PLC
NextCare Institute for Clinical Research
HOPE Research Institute, LLC
Clinical Research Consulting
New England Research Associates, LLC
Tampa Bay Medical Research, Inc.
Delray Research Associates
CNS Clinical Trials
Clinical Research of West Florida
Arthritis & Osteoporosis Center of Maryland
Midwest Pharmaceutical Research
Arthritis Center of Nebraska
Comprehensive Clinical Research
University Hospitals of Case Medical Center - Arthritis Translational Research Program
Community Research
Health Research of Oklahoma
Altoona Center for Clinical Research
Health Concepts
Radiant Research
Advanced Pain Management & Rehabilitation, Hilltop Medical

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidoderm (Lidocaine 5% Patch)

Placebo Patch

Arm Description

Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)

Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)

Outcomes

Primary Outcome Measures

Time-to-Exit From Current Study Treatment

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-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

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)

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

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

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

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

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

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

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).

Full Information

NCT ID

NCT00589979

First Posted

December 26, 2007

Last Updated

September 7, 2017

Sponsor

Endo Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00589979

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

Osteoarthritis, Knee, Lidoderm, Lidocaine, Topical patch, Adjunct therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

169 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidoderm (Lidocaine 5% Patch)

Arm Type

Experimental

Arm Description

Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)

Arm Title

Placebo Patch

Arm Type

Placebo Comparator

Arm Description

Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)

Intervention Type

Drug

Intervention Name(s)

Lidoderm (Lidocaine 5% Patch)

Other Intervention Name(s)

Lidoderm

Intervention Description

Topical Patch

Intervention Type

Drug

Intervention Name(s)

Placebo Patch

Other Intervention Name(s)

Placebo

Intervention Description

Topical Patch

Primary Outcome Measure Information:

Title

Time-to-Exit From Current Study Treatment

Description

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

Secondary Outcome Measure Information:

Title

Time-to-Exit Due to Lack of Efficacy

Description

Time Frame

Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation

Title

Exit Status From Current Study Treatment - Yes

Description

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation

Title

Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)

Description

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)

Title

Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores

Description

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)

Title

Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores

Description

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)

Title

Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain

Description

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)

Title

Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain

Description

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)

Title

Patient Global Assessment of Treatment Satisfaction

Description

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)

Title

Investigator Global Assessment of Treatment Satisfaction

Description

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).

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)

Other Pre-specified Outcome Measures:

Title

Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score

Description

The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.

Time Frame

Baseline and end of treatment period (up to 4 weeks)

Title

Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score

Description

Time Frame

Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)

Title

Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores

Description

Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline (Day 0) and at each clinic visit (at least every 4 weeks) or at premature discontinuation. Values of the EQ-5D index score range from -1 (worst) to 1 (best).

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation

Title

Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)

Description

Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Values of the continuous EQ-5D health state today (VAS) ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation

Title

Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months

Description

Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Categories included Better, Much the Same, and Worse.

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation

Title

Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale

Description

The VSH Sleep Scale is contained in a 15 item self-report instrument that measures the quality of a patient's sleep over the last 24 hours. Each item is scored on a 0-100 visual analog scale. The VSH is categorized into 3 sleep scales: disturbance (which measures delays and interruptions in sleep)[maximum score = 700], effectiveness (which measures how well sleep refreshed the individual) [maximum score = 600], and supplementation (which measures the need for napping) [maximum score = 400]. The higher the score the greater the value of the sleep characteristic for that patient.

Time Frame

Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ernest A. Kopecky, PhD, MBA

Organizational Affiliation

Endo Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Arthritis Research, PLC

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

Facility Name

NextCare Institute for Clinical Research

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

HOPE Research Institute, LLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85050

Country

United States

Facility Name

Clinical Research Consulting

City

Milford

State/Province

Connecticut

ZIP/Postal Code

06460

Country

United States

Facility Name

New England Research Associates, LLC

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Tampa Bay Medical Research, Inc.

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Delray Research Associates

City

Delray Beach

State/Province

Florida

ZIP/Postal Code

33484

Country

United States

Facility Name

CNS Clinical Trials

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33702

Country

United States

Facility Name

Clinical Research of West Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Arthritis & Osteoporosis Center of Maryland

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Midwest Pharmaceutical Research

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63376

Country

United States

Facility Name

Arthritis Center of Nebraska

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Comprehensive Clinical Research

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

University Hospitals of Case Medical Center - Arthritis Translational Research Program

City

Beachwood

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

Community Research

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Health Research of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Health Concepts

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Radiant Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

Advanced Pain Management & Rehabilitation, Hilltop Medical

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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