Trial Outcomes & Findings for Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee (NCT NCT00589979)

Last Updated: 2017-10-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

169 participants

Primary outcome timeframe

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

Results posted on

2017-10-05

Participant Flow

This exploratory, Phase IIb study was initiated on March 6, 2007 at 21 study centers in the United States and completed on June 24, 2008.

During the active Run-in Period, eligible patients applied Lidoderm patches every 24 hours for 28 days. During the 12-week Double-blind Treatment Period, patients were randomized to apply Lidoderm patches or matching placebo patches every 24 hours for 4 weeks and then crossed over to the other treatment for the next two 4-week treatment periods.

Participant milestones

Participant milestones
Measure	Run-in Period: Lidoderm Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks).	Treatment Sequence: Lidoderm - Placebo - Placebo Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Treatment Sequence: Placebo - Lidoderm - Lidoderm Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Run-In Period STARTED	169	0	0
Run-In Period COMPLETED	93	0	0
Run-In Period NOT COMPLETED	76	0	0
Double-Blind Treatment Period 1 STARTED	0	50	43
Double-Blind Treatment Period 1 COMPLETED	0	48	41
Double-Blind Treatment Period 1 NOT COMPLETED	0	2	2
Double-Blind Treatment Period 2 STARTED	0	48	41
Double-Blind Treatment Period 2 COMPLETED	0	47	39
Double-Blind Treatment Period 2 NOT COMPLETED	0	1	2
Double-Blind Treatment Period 3 STARTED	0	47	39
Double-Blind Treatment Period 3 COMPLETED	0	46	38
Double-Blind Treatment Period 3 NOT COMPLETED	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Run-in Period: Lidoderm Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks).	Treatment Sequence: Lidoderm - Placebo - Placebo Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Treatment Sequence: Placebo - Lidoderm - Lidoderm Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Run-In Period Adverse Event	5	0	0
Run-In Period Protocol Violation	3	0	0
Run-In Period Did not qualify for randomization	54	0	0
Run-In Period Withdrawal by Subject	10	0	0
Run-In Period Informed Consent Withdrawn	4	0	0
Double-Blind Treatment Period 1 Adverse Event	0	1	0
Double-Blind Treatment Period 1 Protocol Violation	0	1	1
Double-Blind Treatment Period 1 Withdrawal by Subject	0	0	1
Double-Blind Treatment Period 2 Adverse Event	0	1	0
Double-Blind Treatment Period 2 Withdrawal by Subject	0	0	1
Double-Blind Treatment Period 2 Other	0	0	1
Double-Blind Treatment Period 3 Protocol Violation	0	1	0
Double-Blind Treatment Period 3 Withdrawal by Subject	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence: Lidoderm - Placebo - Placebo n=50 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.	Sequence: Placebo - Lidoderm - Lidoderm n=43 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.	Total n=93 Participants Total of all reporting groups
Age, Continuous	61.1 years STANDARD_DEVIATION 10.0 • n=5 Participants	61.1 years STANDARD_DEVIATION 10.9 • n=7 Participants	61.1 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	43 participants n=7 Participants	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Time-to-Exit From Current Study Treatment Period 1 ( Sequence LPP, N=21; Sequence PLL, N=21)	31 Days Interval 10.0 to 31.0	20 Days Interval 12.0 to 30.0
Time-to-Exit From Current Study Treatment Period 2 (Sequence LPP, N=19; Sequence PLL, N=20)	NA Days Survival distribution function did not reach 0.5000; ie, patients within the study period did not reach exit criteria by the end of the 4-week period.	NA Days Survival distribution function did not reach 0.5000; ie, patients within the study period did not reach exit criteria by the end of the 4-week period.
Time-to-Exit From Current Study Treatment Period 3 (Sequence LPP, N=19; Sequence PLL, N=19)	NA Days Interval 19.0 to Survival distribution function did not reach 0.5000; ie, patients within the study period did not reach exit criteria by the end of the 4-week period.	NA Days Survival distribution function did not reach 0.5000; ie, patients within the study period did not reach exit criteria by the end of the 4-week period.

SECONDARY outcome

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

Population: 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: No patients exited a study period due to lack of efficacy, therefore median time-to-exit could not be calculated.

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Time-to-Exit Due to Lack of Efficacy Period 1 (Sequence LPP, N=21; Sequence PLL, N=21)	NA days No patients discontinued from this study period due to lack of efficacy.	NA days No patients discontinued from this study period due to lack of efficacy.
Time-to-Exit Due to Lack of Efficacy Period 2 (Sequence LPP, N=19; Sequence PLL, N=20)	NA days No patients discontinued from this study period due to lack of efficacy.	NA days No patients discontinued from this study period due to lack of efficacy.
Time-to-Exit Due to Lack of Efficacy Period 3 (Sequence LPP, N=19; Sequence PLL, N=19)	NA days No patients discontinued from this study period due to lack of efficacy.	NA days No patients discontinued from this study period due to lack of efficacy.

SECONDARY outcome

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

Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Exit Status From Current Study Treatment - Yes Period 1 (Sequence LPP, N=21; Sequence PLL, N=21)	10 Participants	12 Participants
Exit Status From Current Study Treatment - Yes Period 2 (Sequence LPP, N=19; Sequence PLL, N=20)	5 Participants	4 Participants
Exit Status From Current Study Treatment - Yes Period 3 (Sequence LPP, N=19; Sequence PLL, N=19)	6 Participants	2 Participants

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)	3.03 Units on a scale Standard Error 0.35	3.57 Units on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores	4.45 Units on a scale Standard Error 0.25	4.06 Units on a scale Standard Error 0.25

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Intense	3.31 Units on a scale Standard Error 0.32	3.53 Units on a scale Standard Error 0.32
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Sharp	2.50 Units on a scale Standard Error 0.34	3.00 Units on a scale Standard Error 0.34
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Hot	1.12 Units on a scale Standard Error 0.26	1.59 Units on a scale Standard Error 0.27
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Dull	3.04 Units on a scale Standard Error 0.33	3.28 Units on a scale Standard Error 0.33
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Cold	0.62 Units on a scale Standard Error 0.14	0.50 Units on a scale Standard Error 0.14
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Sensitive	0.88 Units on a scale Standard Error 0.20	0.96 Units on a scale Standard Error 0.21
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Tender	2.08 Units on a scale Standard Error 0.30	1.89 Units on a scale Standard Error 0.30
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Itchy	0.90 Units on a scale Standard Error 0.23	1.00 Units on a scale Standard Error 0.23
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Shocking	1.95 Units on a scale Standard Error 0.34	2.36 Units on a scale Standard Error 0.34
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Numb	1.31 Units on a scale Standard Error 0.28	1.52 Units on a scale Standard Error 0.28
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Electrical	1.32 Units on a scale Standard Error 0.29	1.26 Units on a scale Standard Error 0.30
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Tingling	1.24 Units on a scale Standard Error 0.26	1.24 Units on a scale Standard Error 0.26
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Cramping	1.78 Units on a scale Standard Error 0.33	2.03 Units on a scale Standard Error 0.33
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Radiating	2.03 Units on a scale Standard Error 0.35	2.10 Units on a scale Standard Error 0.35
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Throbbing	2.24 Units on a scale Standard Error 0.34	2.06 Units on a scale Standard Error 0.35
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Aching	2.78 Units on a scale Standard Error 0.36	3.22 Units on a scale Standard Error 0.37
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Heavy	2.12 Units on a scale Standard Error 0.34	2.26 Units on a scale Standard Error 0.34
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Overall unpleasantness	2.98 Units on a scale Standard Error 0.34	3.55 Units on a scale Standard Error 0.35
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Intense deep pain	3.33 Units on a scale Standard Error 0.37	3.77 Units on a scale Standard Error 0.37
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Intense surface pain	1.61 Units on a scale Standard Error 0.28	1.82 Units on a scale Standard Error 0.29
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Average surface pain	0.99 Units on a scale Standard Error 0.15	1.05 Units on a scale Standard Error 0.15
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Average deep pain	2.38 Units on a scale Standard Error 0.29	2.55 Units on a scale Standard Error 0.29
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores Average paroxysmal pain	1.78 Units on a scale Standard Error 0.25	2.06 Units on a scale Standard Error 0.25

SECONDARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21)	3 Participants	5 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 6-Very Much Impr., Period 2 (LPP, N=19; PLL, N=20)	3 Participants	2 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 6-Very Much Impr., Period 3 (LPP, N=19; PLL, N=19)	4 Participants	4 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 5-Much Improved, Period 1 (LPP, N=21; PLL, N=21)	6 Participants	8 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 5-Much Improved, Period 2 (LPP, N=19; PLL, N=20)	9 Participants	8 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 5-Much Improved, Period 3 (LPP, N=19; PLL, N=19)	8 Participants	10 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 4-Mini. Improved, Period 1 (LPP, N=21; PLL, N=21)	7 Participants	4 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 4-Mini. Improved, Period 2 (LPP, N=19; PLL, N=20)	3 Participants	6 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 4-Mini. Improved, Period 3 (LPP, N=19; PLL, N=19)	3 Participants	3 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 3-No Change, Period 1 (LPP, N=21; PLL, N=21)	5 Participants	1 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 3-No Change, Period 2 (LPP, N=19; PLL, N=20)	1 Participants	2 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 3-No Change, Period 3 (LPP, N=19; PLL, N=19)	4 Participants	2 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 2-Minimally Worse, Period 1 (LPP, N=21; PLL,N=19)	0 Participants	3 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20)	1 Participants	1 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19)	0 Participants	0 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 1-Much Worse, Period 1 (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 1-Much Worse, Period 2 (LPP, N=19; PLL, N=20)	2 Participants	0 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 1-Much Worse, Period 3 (LPP, N=19; PLL, N=19)	0 Participants	0 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 0-Very Much Worse, Period 1 (LPP,N=21; PLL, N=21)	0 Participants	0 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20)	0 Participants	1 Participants
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19)	0 Participants	0 Participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21)	3 Participants	4 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 6-Very Much Impr, Period 2 (LPP, N=19; PLL, N=20)	2 Participants	3 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 6-Very Much Impr, Period 3 (LPP, N=19; PLL, N=19)	5 Participants	4 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 5-Much Improved, Period 1 (LPP, N=21; PLL, N=21)	7 Participants	9 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 5-Much Improved, Period 2 (LPP, N=19; PLL, N=20)	10 Participants	8 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 5-Much Improved, Period 3 (LPP, N=19; PLL, N=19)	7 Participants	8 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 4-Min. Improved, Period 1 (LPP, N=21; PLL, N=21)	4 Participants	2 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 4-Min. Improved, Period 2 (LPP, N=19; PLL, N=20)	3 Participants	7 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 4-Min. Improved, Period 3 (LPP, N=19; PLL, N=19)	4 Participants	4 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 3-No Change, Period 1 (LPP, N=21; PLL, N=21)	3 Participants	2 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 3-No Change, Period 2 LPP, N=19; PLL, N=20)	0 Participants	1 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 3-No Change, Period 3 (LPP, N=19; PLL, N=19)	1 Participants	2 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 2-Minimally Worse, Period 1 (LPP, N=21; PLL, N=21)	3 Participants	3 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20)	1 Participants	0 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19)	0 Participants	1 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 1-Much Worse, Period 1 (LPP, N=21; PLL, N=21)	1 Participants	1 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 1-Much Worse, Period 2 (LPP, N=19; PLL, N=20)	3 Participants	0 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 1-Much Worse, Period 3 (LPP, N=19; PLL, N=19)	1 Participants	0 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 0-Very Much Worse, Period 1 (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20)	0 Participants	1 Participants
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain 0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19)	1 Participants	0 Participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Patient Global Assessment of Treatment Satisfaction 4-Very Satisfied, Period 1 (LPP, N=21; PLL, N=21)	12 Participants	9 Participants
Patient Global Assessment of Treatment Satisfaction 4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20)	8 Participants	10 Participants
Patient Global Assessment of Treatment Satisfaction 4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=20)	12 Participants	12 Participants
Patient Global Assessment of Treatment Satisfaction 3-Satisfied, Period 1 (LPP, N=21; PLL, N=21)	7 Participants	8 Participants
Patient Global Assessment of Treatment Satisfaction 3-Satisfied, Period 2 (LPP, N=19; PLL, N=20)	9 Participants	6 Participants
Patient Global Assessment of Treatment Satisfaction 3-Satisfied, Period 3 (LPP, N=19; PLL, N=20)	5 Participants	6 Participants
Patient Global Assessment of Treatment Satisfaction 2-No Preference, Period 1 (LPP, N=21; PLL, N=21)	1 Participants	3 Participants
Patient Global Assessment of Treatment Satisfaction 2-No Preference, Period 2 (LPP, N=19; PLL, N=20)	0 Participants	3 Participants
Patient Global Assessment of Treatment Satisfaction 2-No Preference, Period 3 (LPP, N=19; PLL, N=20)	1 Participants	1 Participants
Patient Global Assessment of Treatment Satisfaction 1-Dissatisfied, Period 1 (LPP, N=21; PLL, N=21)	1 Participants	1 Participants
Patient Global Assessment of Treatment Satisfaction 1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20)	2 Participants	0 Participants
Patient Global Assessment of Treatment Satisfaction 1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=20)	0 Participants	0 Participants
Patient Global Assessment of Treatment Satisfaction 0-Very Dissatisfied, Per. 1 (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Patient Global Assessment of Treatment Satisfaction 0-Very Dissatisfied, Per. 2 (LPP, N=19; PLL, N=20)	0 Participants	1 Participants
Patient Global Assessment of Treatment Satisfaction 0-Very Dissatisfied, Per. 3 (LPP, N=19; PLL, N=19)	1 Participants	0 Participants

SECONDARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Investigator Global Assessment of Treatment Satisfaction 4-Very Satisfied, Period 1 (LPP, N=21; PLL,N=21)	7 Participants	6 Participants
Investigator Global Assessment of Treatment Satisfaction 4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20)	5 Participants	8 Participants
Investigator Global Assessment of Treatment Satisfaction 4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=19)	8 Participants	11 Participants
Investigator Global Assessment of Treatment Satisfaction 3-Satisfied, Period 1 (LPP, N=21; PLL,N=21)	8 Participants	9 Participants
Investigator Global Assessment of Treatment Satisfaction 3-Satisfied, Period 2 (LPP, N=19; PLL, N=20)	11 Participants	10 Participants
Investigator Global Assessment of Treatment Satisfaction 3-Satisfied, Period 3 (LPP, N=19; PLL, N=19)	9 Participants	5 Participants
Investigator Global Assessment of Treatment Satisfaction 2-No Preference, Period 1 (LPP, N=21; PLL,N=21)	1 Participants	1 Participants
Investigator Global Assessment of Treatment Satisfaction 2-No Preference, Period 2 (LPP, N=19; PLL, N=20)	1 Participants	1 Participants
Investigator Global Assessment of Treatment Satisfaction 2-No Preference, Period 3 (LPP, N=19; PLL, N=19)	1 Participants	2 Participants
Investigator Global Assessment of Treatment Satisfaction 1-Dissatisfied, Period 1 (LPP, N=21; PLL,N=21)	4 Participants	5 Participants
Investigator Global Assessment of Treatment Satisfaction 1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20)	2 Participants	0 Participants
Investigator Global Assessment of Treatment Satisfaction 1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=19)	0 Participants	1 Participants
Investigator Global Assessment of Treatment Satisfaction 0-Very Dissatisfied, Period 1 (LPP,N=21; PLL,N=21)	1 Participants	0 Participants
Investigator Global Assessment of Treatment Satisfaction 0-Very Dissatisfied, Period 2 (LPP,N=19; PLL,N=20)	0 Participants	1 Participants
Investigator Global Assessment of Treatment Satisfaction 0-Very Dissatisfied, Period 3 (LPP,N=19; PLL,N=19)	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

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

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score	4.41 Units on a scale Standard Error 0.39	4.29 Units on a scale Standard Error 0.39

OTHER_PRE_SPECIFIED outcome

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

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Minimal at Screening (LPP, N=21; PLL, N=21)	21 Participants	20 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Minimal at Baseline (LPP, N=21; PLL, N=21)	21 Participants	20 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Minimal, end of Period 1 (LPP, N=21; PLL, N=21)	21 Participants	19 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Minimal, end of Period 2 (LPP, N=19; PLL, N=20)	19 Participants	20 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Minimal, end of Period 3 (LPP, N=19; PLL, N=19)	19 Participants	19 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Mild at Screening (LPP, N=21; PLL, N=21)	0 Participants	1 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Mild at Baseline (LPP, N=21; PLL, N=21)	0 Participants	1 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Mild, end of Period 1 (LPP, N=21; PLL, N=21)	0 Participants	1 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Mild, end of Period 2 (LPP, N=19; PLL, N=20)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Mild, end of Period 3 (LPP, N=19; PLL, N=19)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Moderate at Screening (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Moderate at Baseline (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Moderate, end of Period 1 (LPP, N=21; PLL, N=21)	0 Participants	1 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Moderate, end of Period 2 (LPP, N=19; PLL, N=20)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Moderate, end of Period 3 (LPP, N=19; PLL, N=19)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Severe at Screening (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Severe at Baseline (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Severe, end of Period 1 (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Severe, end of Period 2 (LPP, N=19; PLL, N=20)	0 Participants	0 Participants
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score Severe, end of Period 3 (LPP, N=19; PLL, N=19)	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

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

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).

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores	0.82 Units on a scale Standard Error 0.01	0.81 Units on a scale Standard Error 0.01

OTHER_PRE_SPECIFIED outcome

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

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).

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)	81.1 Units on a scale Standard Error 1.25	79.4 Units on a scale Standard Error 1.26

OTHER_PRE_SPECIFIED outcome

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

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Better Baseline (LPP, N=21; PLL, N=21)	11 Participants	4 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Better Period 1 (LPP, N=21; PLL, N=21)	7 Participants	5 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Better Period 2 (LPP, N=19; PLL, N=20)	8 Participants	4 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Better Period 3 (LPP, N=19; PLL, N=19)	9 Participants	6 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Much the Same Baseline (LPP, N=21; PLL, N=21)	10 Participants	17 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Much the Same Period 1 (LPP, N=21; PLL, N=21)	14 Participants	15 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Much the Same Period 2 (LPP, N=19; PLL, N=20)	10 Participants	16 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Much the Same Period 3 (LPP, N=19; PLL, N=19)	9 Participants	12 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Worse Baseline (LPP, N=21; PLL, N=21)	0 Participants	0 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Worse Period 1 (LPP, N=21; PLL, N=21)	0 Participants	1 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Worse Period 2 (LPP, N=19; PLL, N=20)	1 Participants	0 Participants
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months Worse Period 3 (LPP, N=19; PLL, N=19)	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

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

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.

Outcome measures

Outcome measures
Measure	Sequence: Lidoderm - Placebo - Placebo (LPP) n=21 Participants Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks	Sequence: Placebo - Lidoderm - Lidoderm (PLL) n=21 Participants Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale Disturbance	246 Units on a scale Standard Error 13.7	224 Units on a scale Standard Error 13.9
Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale Effectiveness	303 Units on a scale Standard Error 9.69	302 Units on a scale Standard Error 9.85
Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale Supplementation	49.7 Units on a scale Standard Error 7.62	41.4 Units on a scale Standard Error 7.76

Adverse Events

Run-In Period With Lidoderm (Lidocaine 5% Patch)

Serious events: 1 serious events

Other events: 51 other events

Deaths: 0 deaths

Double-Blind Treatment Period With Lidoderm

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Double-Blind Active Treatment Period With Placebo

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Run-In Period With Lidoderm (Lidocaine 5% Patch) n=169 participants at risk Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the active treatment Run-in Period. A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).	Double-Blind Treatment Period With Lidoderm n=91 participants at risk Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the Double-blind Treatment Period. A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated). \*NOTE: two subjects randomized to the treatment sequence Placebo - Lidoderm - Lidoderm (PLL) discontinued from the study during treatment with Placebo (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Lidoderm) is equal to 91.	Double-Blind Active Treatment Period With Placebo n=91 participants at risk Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Placebo during the Double-blind Treatment Period. A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated). \\NOTE: two subjects randomized to the treatment sequence Lidoderm - Placebo - Placebo (PLL) discontinued from the study during treatment with Lidoderm (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Placebo) is equal to 91.
Infections and infestations Pneumonia	0.59% 1/169 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.	0.00% 0/91 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.	1.1% 1/91 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/169 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.	1.1% 1/91 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.	0.00% 0/91 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/169 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.	0.00% 0/91 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.	1.1% 1/91 • 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. The safety population included all patients who received study medication during the study and did not return all study medication unopened.

Other adverse events

Additional Information

Clinical Trial Coordinator

Endo Pharmaceuticals, Inc.

Phone: Use e-mail contact

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Delay of 12-18 months from Completion Date to publish results from all sites, embargo of 60 to 180 days from the time communication is submitted to sponsor, and ability to redact confidential information (excluding results).
Publication restrictions are in place

Restriction type: OTHER