Osteoarthritis of the KneePhase 2NCT00589979

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

A Phase 2 study testing Lidoderm (Lidocaine 5% Patch) in people with Osteoarthritis of the Knee, run by Endo USA Inc., a Keenova Therapeutics Company at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 37 years and older
Conditions the study is for: Osteoarthritis of the Knee
What is being tested?: Lidoderm (Lidocaine 5% Patch)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 169 participants
Where: 20 sitesUnited States
Study dates: Mar 2007to Oct 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 37 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

University Hospitals of Case Medical Center - Arthritis Translational Research Program
Beachwood, Ohio, 44122
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Community Research
Cincinnati, Ohio, 45245
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, 63376
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
Delray Research Associates
Delray Beach, Florida, 33484
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, 21702
Arthritis Center of Nebraska
Lincoln, Nebraska, 68516
Clinical Research Consulting
Milford, Connecticut, 06460
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, 85253
NextCare Institute for Clinical Research
Phoenix, Arizona, 85016
HOPE Research Institute, LLC
Phoenix, Arizona, 85050
Health Concepts
Rapid City, South Dakota, 57702
Radiant Research
San Antonio, Texas, 78217
CNS Clinical Trials
St. Petersburg, Florida, 33702
Clinical Research of West Florida
Tampa, Florida, 33606
New England Research Associates, LLC
Trumbull, Connecticut, 06611
Advanced Pain Management & Rehabilitation, Hilltop Medical
Virginia Beach, Virginia, 23454

Other trials in United States

About this study

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

Conditions: Osteoarthritis of the Knee
Being tested: Lidoderm (Lidocaine 5% Patch), Placebo Patch
Keywords: Osteoarthritis, Knee, Lidoderm, Lidocaine, Topical patch, Adjunct therapy
Medical subject headings: Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lidoderm (Lidocaine 5% Patch)Drug
Also called Lidoderm
Topical Patch
Placebo PatchDrug
Also called Placebo
Topical Patch

Study groups in NCT00589979
Study group	Role	What they receive
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) Receives: 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) Receives: Drug: Placebo Patch

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Oct 2008

First posted10 Jan 2008 (estimated)
Study startMar 2007
Primary completionJun 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00589979
Sponsor's protocol ID: EN3260-003
Status last verified: Sep 2017
First submitted: 26 Dec 2007
Last updated: 5 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00589979
Acronym / sponsor ID: EN3260-003
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, Knee, Lidoderm, Lidocaine, Topical patch, Adjunct therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jun 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 10 Jan 2008 (estimated)
Results: Posted 22 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Lidoderm (Lidocaine 5% Patch)	Experimental	Drug: 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 comparator	Drug: Placebo PatchPlacebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)

Who may qualify

Ages: 37 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lidoderm (Lidocaine 5% Patch)Also: LidodermTopical Patch	Drug	Lidoderm (Lidocaine 5% Patch)
Placebo PatchAlso: PlaceboTopical Patch	Drug	Placebo Patch

Primary outcome

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
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.

9 secondary outcomes

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
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
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)
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)
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)
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)
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)
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)
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)

Results and safety

Results posted to the registry on 22 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Run-in Period: Lidoderm	169	93
Treatment Sequence: Lidoderm - Placebo - Placebo	0	0
Treatment Sequence: Placebo - Lidoderm - Lidoderm	0	0

Primary outcome: 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. Median (95% Confidence Interval). Unit: Days

Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n = 21	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n = 21
Period 1 ( Sequence LPP, N=21; Sequence PLL, N=21)	31 (10 to 31)	20 (12 to 30)
Period 2 (Sequence LPP, N=19; Sequence PLL, N=20)	NA (NA to NA)	NA (NA to NA)
Period 3 (Sequence LPP, N=19; Sequence PLL, N=19)	NA (19 to NA)	NA (NA to NA)

Sequence: Lidoderm - Placebo - Placebo (LPP) vs Sequence: Placebo - Lidoderm - Lidoderm (PLL): Hazard Ratio (HR): 1.78 (95% CI 0.89 to 3.55), p = 0.1006, Cox frailty model

Population analysed: The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008. Note: Kaplan-Meier estimates for median time-to-exit from current study treatment could not be calculated for Period 2 or Period 3, because the survival distribution function did not fall below 0.5000.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events (AEs) were recorded from the beginning of the active Run-in Period through 30 days post-study completion/early termination; a period lasting up to 20 weeks in total.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-In Period With Lidoderm (Lidocaine 5% Patch)	1 of 169 (0.6%)	51 of 169 (30.2%)	Not reported
Double-Blind Treatment Period With Lidoderm	1 of 91 (1.1%)	24 of 91 (26.4%)	Not reported
Double-Blind Active Treatment Period With Placebo	1 of 91 (1.1%)	23 of 91 (25.3%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ernest A. Kopecky, PhD, MBA study director

Endo USA Inc., a Keenova Therapeutics Company

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidoderm (Lidocaine 5% Patch) in people with Osteoarthritis of the Knee, run by Endo USA Inc., a Keenova Therapeutics Company at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00589979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.