Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee
A Randomized, Double-Blind, Pilot Study Comparing the Efficacy and Safety of Lidocaine 5% Patch With Placebo in Patients With Pain From Osteoarthritis of the Knee
1 other identifier
interventional
224
1 country
24
Brief Summary
Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the treatment of pain from OA of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 19, 2009
CompletedFebruary 10, 2010
February 1, 2010
1.1 years
May 15, 2009
February 9, 2010
Conditions
Outcome Measures
Primary Outcomes (5)
Western Ontario and McMaster Universities (WOMAC) OA Index
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Pain intensity and pain relief (BPI Questions 3, 4, 5, 6, and 8)
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Pain Quality Assessment Scale (PQAS)
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Patient-rated and Investigator-rated Global Impression of Change in OA pain (categorical scale)
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Patient-rated and Investigator-rated Global Assessment of Treatment Satisfaction (categorical scale)
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Secondary Outcomes (4)
QoL: Pain interference on activities of daily living using Question 9 of the BPI
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
QoL: Beck Depression Inventory (BDI)
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Quality of Sleep (QOS)
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Safety assessments included AEs, dermal assessments, clinical laboratory tests (including urinalysis), vital sign measurements, physical examination results, and plasma lidocaine concentrations
Visit: V2(Day 0), V3(Day 14), V4(Day 28), V5(Day 42), V6(Day 56), V7/EOS(Day 84)
Study Arms (2)
Lidocaine 5% patch
EXPERIMENTALLidocaine 5% patch (Lidoderm®, Endo Pharmaceuticals Inc.), 1⅓ patches applied on each affected knee once every 24 hours
Placebo patch
PLACEBO COMPARATORMatching placebo patch, 1â…“ patches applied on each affected knee once every 24 hours
Interventions
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Eligibility Criteria
You may qualify if:
- Had unilateral or bilateral OA of the knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (presence of osteophytes on x-ray and written evaluation) of OA
- Had functional capacity class rating of I, II, or III according to ACR classification
- Had normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
- Had discontinued use of all analgesic medications (including over-the-counter \[OTC\] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for non study pain
- At baseline visit, patients were randomized to double-blind treatment if they had an average pain intensity rating for the index joint of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 is defined as "no pain" and 10 is defined as "pain as bad as ever imagined" as measured by Question 5 of the BPI and recorded in a diary
- At baseline visit, patients were randomized to double-blind treatment if they had, at the baseline visit, an OA severity score for the index joint of 7 or greater on a composite scale of 0 to 24 as measured by the Index of Severity for Osteoarthrosis of the Knee
You may not qualify if:
- Had been diagnosed with inflammatory arthritis, gout, pseudo-gout or Paget's disease that in the investigator's opinion would have interfered with the assessment of pain and other symptoms of OA
- Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that could have confounded study results
- Had any other clinically significant joint disease or prior joint replacement surgery at the index joint
- Had severe renal insufficiency (creatinine clearance of \<30 mL/min)
- Had moderate or greater hepatic impairment
- Were taking analgesic medications, glucosamine, or chondroitin that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
- Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period.
- Were using lidocaine-containing product that could not be discontinued during the study
- Had previously failed treatment with Lidoderm analgesic patch for OA
- Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry
- Were unable to discontinue use of topical drugs applied to the knee
- Were taking class I anti-arrhythmic drugs (e.g. mexiletine, tocainide)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Hueytown, Alabama, United States
Unknown Facility
Tallassee, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Boulder, Colorado, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Largo, Florida, United States
Unknown Facility
Palm Harbor, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Wheaton, Maryland, United States
Unknown Facility
Peabody, Massachusetts, United States
Unknown Facility
Bingham Farms, Michigan, United States
Unknown Facility
Reno, Nevada, United States
Unknown Facility
Berlin, New Jersey, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Duncansville, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Bartlett, Tennessee, United States
Unknown Facility
Cordova, Tennessee, United States
Unknown Facility
Memphis, Tennessee, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Endo Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 19, 2009
Study Start
August 1, 2004
Primary Completion
September 1, 2005
Last Updated
February 10, 2010
Record last verified: 2010-02