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

NCT00589979 | Completed Phase 2 Results

• 1 other identifier: EN3260-003
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 20

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.

Conditions

Osteoarthritis of the Knee

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (9)

• 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

• 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

• 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)

• 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)

• 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)

Other Outcomes (6)

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

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

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

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

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

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

Study Arms (2)

Lidoderm (Lidocaine 5% Patch)

EXPERIMENTAL

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)

Placebo Patch

PLACEBO COMPARATOR

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

Drug: Placebo Patch

Interventions

Lidoderm (Lidocaine 5% Patch) DRUG

Topical Patch

Also known as: Lidoderm

Lidoderm (Lidocaine 5% Patch)

Placebo Patch DRUG

Topical Patch

Also known as: Placebo

Placebo Patch

Eligibility Criteria

• Age: 37 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (20)

Arizona Arthritis Research, PLC

Paradise Valley, Arizona, 85253, United States

Location

NextCare Institute for Clinical Research

Phoenix, Arizona, 85016, United States

Location

HOPE Research Institute, LLC

Phoenix, Arizona, 85050, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

New England Research Associates, LLC

Trumbull, Connecticut, 06611, United States

Location

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

Delray Research Associates

Delray Beach, Florida, 33484, United States

Location

CNS Clinical Trials

St. Petersburg, Florida, 33702, United States

Location

Clinical Research of West Florida

Tampa, Florida, 33606, United States

Location

Arthritis & Osteoporosis Center of Maryland

Frederick, Maryland, 21702, United States

Location

Midwest Pharmaceutical Research

City of Saint Peters, Missouri, 63376, United States

Location

Arthritis Center of Nebraska

Lincoln, Nebraska, 68516, United States

Location

Comprehensive Clinical Research

Berlin, New Jersey, 08009, United States

Location

University Hospitals of Case Medical Center - Arthritis Translational Research Program

Beachwood, Ohio, 44122, United States

Location

Community Research

Cincinnati, Ohio, 45245, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Radiant Research

San Antonio, Texas, 78217, United States

Location

Advanced Pain Management & Rehabilitation, Hilltop Medical

Virginia Beach, Virginia, 23454, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Lidoderm; Lidocaine; Transdermal Patch

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies

Limitations and Caveats

Due to operational issues, the modified intent-to-treat (MITT) population, consisting of all intent-to-treat (ITT) patients randomized on or after January 22, 2008, was added to the analysis plan; all efficacy data are presented for this population.

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Use e-mail contact

Study Officials

• Ernest A. Kopecky, PhD, MBA

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: March 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 5, 2017
• Results First Posted: September 22, 2010

Record last verified: 2017-09

Locations

US (20)