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Trial record 1 of 1 for:    NCT00589979
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Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00589979
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : September 22, 2010
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis of the Knee
Interventions Drug: Lidoderm (Lidocaine 5% Patch)
Drug: Placebo Patch
Enrollment 169
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Run-in Period: Lidoderm Treatment Sequence: Lidoderm - Placebo - Placebo Treatment Sequence: Placebo - Lidoderm - Lidoderm
Hide Arm/Group Description 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). 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 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
Period Title: Run-In Period
Started 169 0 0
Completed 93 0 0
Not Completed 76 0 0
Reason Not Completed
Adverse Event             5             0             0
Protocol Violation             3             0             0
Did not qualify for randomization             54             0             0
Withdrawal by Subject             10             0             0
Informed Consent Withdrawn             4             0             0
Period Title: Double-Blind Treatment Period 1
Started 0 [1] 50 [2] 43 [2]
Completed 0 48 41
Not Completed 0 2 2
Reason Not Completed
Adverse Event             0             1             0
Protocol Violation             0             1             1
Withdrawal by Subject             0             0             1
[1]
Participants completing the Run-in Period were then randomized to two different treatment sequences.
[2]
N=21 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
Period Title: Double-Blind Treatment Period 2
Started 0 48 [1] 41 [2]
Completed 0 47 39
Not Completed 0 1 2
Reason Not Completed
Adverse Event             0             1             0
Withdrawal by Subject             0             0             1
Other             0             0             1
[1]
N=19 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
[2]
N=20 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
Period Title: Double-Blind Treatment Period 3
Started 0 47 [1] 39 [1]
Completed 0 46 38
Not Completed 0 1 1
Reason Not Completed
Protocol Violation             0             1             0
Withdrawal by Subject             0             0             1
[1]
N=19 randomized on or after 22JAN2008; included in mod. intent-to-treat (MITT) analysis population.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo Sequence: Placebo - Lidoderm - Lidoderm Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 50 43 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 43 participants 93 participants
61.1  (10.0) 61.1  (10.9) 61.1  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 43 participants 93 participants
Female
32
  64.0%
28
  65.1%
60
  64.5%
Male
18
  36.0%
15
  34.9%
33
  35.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 43 participants 93 participants
50 43 93
1.Primary Outcome
Title Time-to-Exit From Current Study Treatment
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Median (95% Confidence Interval)
Unit of Measure: Days
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 [1] 
(NA to NA)
NA [1] 
(NA to NA)
Period 3 (Sequence LPP, N=19; Sequence PLL, N=19)
NA [1] 
(19 to NA)
NA [1] 
(NA to NA)
[1]
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.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sequence: Lidoderm - Placebo - Placebo (LPP), Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Comments The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1006
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Cox frailty model
Comments Model included treatment, sequence, period, and first-order carryover as fixed effects and frailty; patient nested within sequence was frailty.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.78
Confidence Interval 95%
0.89 to 3.55
Estimation Comments The Hazard Ratio (HR) provided is the ratio of Placebo to Lidoderm.
2.Secondary Outcome
Title Time-to-Exit Due to Lack of Efficacy
Hide Description

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.

Time Frame Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Median (95% Confidence Interval)
Unit of Measure: days
Period 1 (Sequence LPP, N=21; Sequence PLL, N=21)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Period 2 (Sequence LPP, N=19; Sequence PLL, N=20)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
Period 3 (Sequence LPP, N=19; Sequence PLL, N=19)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
No patients discontinued from this study period due to lack of efficacy.
3.Secondary Outcome
Title Exit Status From Current Study Treatment - Yes
Hide Description 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.
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
Period 1 (Sequence LPP, N=21; Sequence PLL, N=21) 10 12
Period 2 (Sequence LPP, N=19; Sequence PLL, N=20) 5 4
Period 3 (Sequence LPP, N=19; Sequence PLL, N=19) 6 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sequence: Lidoderm - Placebo - Placebo (LPP), Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Comments The proportion of patients who exited from the current treatment period prior to the 4-week planned duration was analyzed using a logistic regression model for repeated measures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1272
Comments The logistic regression model for repeated measures used for this analysis included treatment, sequence, period, and first-order carry-over as fixed effects and repeated measures taken on patients nested within sequence.
Method Regression, Logistic
Comments The results presented are reported in terms of odds ratios, corresponding 95% confidence intervals, and P-values for each fixed effect in the model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.86
Confidence Interval 95%
0.86 to 4.02
Estimation Comments The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.
4.Secondary Outcome
Title Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lidoderm (Lidocaine 5% Patch) Placebo Patch
Hide Arm/Group Description:
The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
The group represents the pooled data for all patients receiving Placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.03  (0.35) 3.57  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0224
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.54
Confidence Interval 95%
-1.01 to -0.08
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
5.Secondary Outcome
Title Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lidoderm (Lidocaine 5% Patch) Placebo Patch
Hide Arm/Group Description:
The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
4.45  (0.25) 4.06  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2747
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Confidence Interval 95%
-0.31 to 1.09
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
6.Secondary Outcome
Title Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores
Hide Description 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.
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lidoderm (Lidocaine 5% Patch) Placebo Patch
Hide Arm/Group Description:
The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Intense 3.31  (0.32) 3.53  (0.32)
Sharp 2.50  (0.34) 3.00  (0.34)
Hot 1.12  (0.26) 1.59  (0.27)
Dull 3.04  (0.33) 3.28  (0.33)
Cold 0.62  (0.14) 0.50  (0.14)
Sensitive 0.88  (0.20) 0.96  (0.21)
Tender 2.08  (0.30) 1.89  (0.30)
Itchy 0.90  (0.23) 1.00  (0.23)
Shocking 1.95  (0.34) 2.36  (0.34)
Numb 1.31  (0.28) 1.52  (0.28)
Electrical 1.32  (0.29) 1.26  (0.30)
Tingling 1.24  (0.26) 1.24  (0.26)
Cramping 1.78  (0.33) 2.03  (0.33)
Radiating 2.03  (0.35) 2.10  (0.35)
Throbbing 2.24  (0.34) 2.06  (0.35)
Aching 2.78  (0.36) 3.22  (0.37)
Heavy 2.12  (0.34) 2.26  (0.34)
Overall unpleasantness 2.98  (0.34) 3.55  (0.35)
Intense deep pain 3.33  (0.37) 3.77  (0.37)
Intense surface pain 1.61  (0.28) 1.82  (0.29)
Average surface pain 0.99  (0.15) 1.05  (0.15)
Average deep pain 2.38  (0.29) 2.55  (0.29)
Average paroxysmal pain 1.78  (0.25) 2.06  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Intense: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4498
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval 95%
-0.80 to 0.36
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Sharp: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1065
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effect models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.50
Confidence Interval 95%
-1.11 to 0.11
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch)
Comments Hot: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0484
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval 95%
-0.94 to -0.00
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch)
Comments Dull: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4973
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effect models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.24
Confidence Interval 95%
-0.93 to 0.46
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Cold: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3966
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effect models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.12
Confidence Interval 95%
-0.16 to 0.41
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Sensitive: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6941
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval 95%
-0.53 to 0.35
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Tender: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5664
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.18
Confidence Interval 95%
-0.45 to 0.82
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Itchy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6871
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval 95%
-0.55 to 0.37
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Shocking: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2318
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.41
Confidence Interval 95%
-1.08 to 0.27
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Numb: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3383
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.21
Confidence Interval 95%
-0.64 to 0.22
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Electrical: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8740
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.05
Confidence Interval 95%
-0.63 to 0.73
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Tingling: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9990
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.00
Confidence Interval 95%
-0.54 to 0.54
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Cramping: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4183
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.25
Confidence Interval 95%
-0.85 to 0.36
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Radiating: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8227
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval 95%
-0.71 to 0.57
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Throbbing: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5870
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.18
Confidence Interval 95%
-0.48 to 0.85
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Aching: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2181
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Confidence Interval 95%
-1.15 to 0.27
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Heavy: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6276
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.13
Confidence Interval 95%
-0.68 to 0.42
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Overall unpleasantness: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0917
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.57
Confidence Interval 95%
-1.23 to 0.09
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Intense deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2089
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Confidence Interval 95%
-1.13 to 0.25
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Intense surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4188
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.22
Confidence Interval 95%
-0.75 to 0.31
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Average surface pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6959
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.05
Confidence Interval 95%
-0.32 to 0.21
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Average deep pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4806
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.17
Confidence Interval 95%
-0.64 to 0.30
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Average paroxysmal pain: the difference between Lidoderm and placebo was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2291
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.28
Confidence Interval 95%
-0.74 to 0.18
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
7.Secondary Outcome
Title Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain
Hide Description 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).
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21) 3 5
6-Very Much Impr., Period 2 (LPP, N=19; PLL, N=20) 3 2
6-Very Much Impr., Period 3 (LPP, N=19; PLL, N=19) 4 4
5-Much Improved, Period 1 (LPP, N=21; PLL, N=21) 6 8
5-Much Improved, Period 2 (LPP, N=19; PLL, N=20) 9 8
5-Much Improved, Period 3 (LPP, N=19; PLL, N=19) 8 10
4-Mini. Improved, Period 1 (LPP, N=21; PLL, N=21) 7 4
4-Mini. Improved, Period 2 (LPP, N=19; PLL, N=20) 3 6
4-Mini. Improved, Period 3 (LPP, N=19; PLL, N=19) 3 3
3-No Change, Period 1 (LPP, N=21; PLL, N=21) 5 1
3-No Change, Period 2 (LPP, N=19; PLL, N=20) 1 2
3-No Change, Period 3 (LPP, N=19; PLL, N=19) 4 2
2-Minimally Worse, Period 1 (LPP, N=21; PLL,N=19) 0 3
2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20) 1 1
2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19) 0 0
1-Much Worse, Period 1 (LPP, N=21; PLL, N=21) 0 0
1-Much Worse, Period 2 (LPP, N=19; PLL, N=20) 2 0
1-Much Worse, Period 3 (LPP, N=19; PLL, N=19) 0 0
0-Very Much Worse, Period 1 (LPP,N=21; PLL, N=21) 0 0
0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20) 0 1
0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19) 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sequence: Lidoderm - Placebo - Placebo (LPP), Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Comments Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3185
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.32
Confidence Interval 95%
0.77 to 2.27
Estimation Comments The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.
8.Secondary Outcome
Title Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain
Hide Description 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.
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21) 3 4
6-Very Much Impr, Period 2 (LPP, N=19; PLL, N=20) 2 3
6-Very Much Impr, Period 3 (LPP, N=19; PLL, N=19) 5 4
5-Much Improved, Period 1 (LPP, N=21; PLL, N=21) 7 9
5-Much Improved, Period 2 (LPP, N=19; PLL, N=20) 10 8
5-Much Improved, Period 3 (LPP, N=19; PLL, N=19) 7 8
4-Min. Improved, Period 1 (LPP, N=21; PLL, N=21) 4 2
4-Min. Improved, Period 2 (LPP, N=19; PLL, N=20) 3 7
4-Min. Improved, Period 3 (LPP, N=19; PLL, N=19) 4 4
3-No Change, Period 1 (LPP, N=21; PLL, N=21) 3 2
3-No Change, Period 2 LPP, N=19; PLL, N=20) 0 1
3-No Change, Period 3 (LPP, N=19; PLL, N=19) 1 2
2-Minimally Worse, Period 1 (LPP, N=21; PLL, N=21) 3 3
2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20) 1 0
2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19) 0 1
1-Much Worse, Period 1 (LPP, N=21; PLL, N=21) 1 1
1-Much Worse, Period 2 (LPP, N=19; PLL, N=20) 3 0
1-Much Worse, Period 3 (LPP, N=19; PLL, N=19) 1 0
0-Very Much Worse, Period 1 (LPP, N=21; PLL, N=21) 0 0
0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20) 0 1
0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19) 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sequence: Lidoderm - Placebo - Placebo (LPP), Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Comments Global impression of change from baseline with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4748
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval 95%
0.72 to 2.06
Estimation Comments The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.
9.Secondary Outcome
Title Patient Global Assessment of Treatment Satisfaction
Hide Description 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.
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
4-Very Satisfied, Period 1 (LPP, N=21; PLL, N=21) 12 9
4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20) 8 10
4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=20) 12 12
3-Satisfied, Period 1 (LPP, N=21; PLL, N=21) 7 8
3-Satisfied, Period 2 (LPP, N=19; PLL, N=20) 9 6
3-Satisfied, Period 3 (LPP, N=19; PLL, N=20) 5 6
2-No Preference, Period 1 (LPP, N=21; PLL, N=21) 1 3
2-No Preference, Period 2 (LPP, N=19; PLL, N=20) 0 3
2-No Preference, Period 3 (LPP, N=19; PLL, N=20) 1 1
1-Dissatisfied, Period 1 (LPP, N=21; PLL, N=21) 1 1
1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20) 2 0
1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=20) 0 0
0-Very Dissatisfied, Per. 1 (LPP, N=21; PLL, N=21) 0 0
0-Very Dissatisfied, Per. 2 (LPP, N=19; PLL, N=20) 0 1
0-Very Dissatisfied, Per. 3 (LPP, N=19; PLL, N=19) 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sequence: Lidoderm - Placebo - Placebo (LPP), Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Comments Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2605
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.71
Confidence Interval 95%
0.38 to 1.30
Estimation Comments The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.
10.Secondary Outcome
Title Investigator Global Assessment of Treatment Satisfaction
Hide Description At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied).
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
4-Very Satisfied, Period 1 (LPP, N=21; PLL,N=21) 7 6
4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20) 5 8
4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=19) 8 11
3-Satisfied, Period 1 (LPP, N=21; PLL,N=21) 8 9
3-Satisfied, Period 2 (LPP, N=19; PLL, N=20) 11 10
3-Satisfied, Period 3 (LPP, N=19; PLL, N=19) 9 5
2-No Preference, Period 1 (LPP, N=21; PLL,N=21) 1 1
2-No Preference, Period 2 (LPP, N=19; PLL, N=20) 1 1
2-No Preference, Period 3 (LPP, N=19; PLL, N=19) 1 2
1-Dissatisfied, Period 1 (LPP, N=21; PLL,N=21) 4 5
1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20) 2 0
1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=19) 0 1
0-Very Dissatisfied, Period 1 (LPP,N=21; PLL,N=21) 1 0
0-Very Dissatisfied, Period 2 (LPP,N=19; PLL,N=20) 0 1
0-Very Dissatisfied, Period 3 (LPP,N=19; PLL,N=19) 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sequence: Lidoderm - Placebo - Placebo (LPP), Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Comments Treatment satisfaction with the lidocaine patch 5% and placebo patch were compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence. An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects, with repeated measures taken on patient within sequence.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3193
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.76
Confidence Interval 95%
0.44 to 1.30
Estimation Comments The odds ratio (OR) provided is the ratio of Lidoderm to Placebo.
11.Other Pre-specified Outcome
Title Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score
Hide Description The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.
Time Frame Baseline and end of treatment period (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lidoderm (Lidocaine 5% Patch) Placebo Patch
Hide Arm/Group Description:
The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
4.41  (0.39) 4.29  (0.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7839
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.12
Confidence Interval 95%
-0.74 to 0.98
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
12.Other Pre-specified Outcome
Title Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score
Hide Description The BDI-II is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression. Patients were to consider each item as it related to the way they felt for the previous 2 weeks. Each of the 21 items corresponding to a symptom of depression was summed to give a single score for the BDI-II, with a 4-point scale for each item ranging from 0-3. A total score of 0-13 is minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Values were based on measurements taken at Screening, at Baseline (Visit 3), and at the end of each period.
Time Frame Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
Minimal at Screening (LPP, N=21; PLL, N=21) 21 20
Minimal at Baseline (LPP, N=21; PLL, N=21) 21 20
Minimal, end of Period 1 (LPP, N=21; PLL, N=21) 21 19
Minimal, end of Period 2 (LPP, N=19; PLL, N=20) 19 20
Minimal, end of Period 3 (LPP, N=19; PLL, N=19) 19 19
Mild at Screening (LPP, N=21; PLL, N=21) 0 1
Mild at Baseline (LPP, N=21; PLL, N=21) 0 1
Mild, end of Period 1 (LPP, N=21; PLL, N=21) 0 1
Mild, end of Period 2 (LPP, N=19; PLL, N=20) 0 0
Mild, end of Period 3 (LPP, N=19; PLL, N=19) 0 0
Moderate at Screening (LPP, N=21; PLL, N=21) 0 0
Moderate at Baseline (LPP, N=21; PLL, N=21) 0 0
Moderate, end of Period 1 (LPP, N=21; PLL, N=21) 0 1
Moderate, end of Period 2 (LPP, N=19; PLL, N=20) 0 0
Moderate, end of Period 3 (LPP, N=19; PLL, N=19) 0 0
Severe at Screening (LPP, N=21; PLL, N=21) 0 0
Severe at Baseline (LPP, N=21; PLL, N=21) 0 0
Severe, end of Period 1 (LPP, N=21; PLL, N=21) 0 0
Severe, end of Period 2 (LPP, N=19; PLL, N=20) 0 0
Severe, end of Period 3 (LPP, N=19; PLL, N=19) 0 0
13.Other Pre-specified Outcome
Title Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores
Hide Description Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline (Day 0) and at each clinic visit (at least every 4 weeks) or at premature discontinuation. Values of the EQ-5D index score range from -1 (worst) to 1 (best).
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lidoderm (Lidocaine 5% Patch) Placebo Patch
Hide Arm/Group Description:
The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.82  (0.01) 0.81  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3773
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval 95%
-0.02 to 0.04
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
14.Other Pre-specified Outcome
Title Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)
Hide Description Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Values of the continuous EQ-5D health state today (VAS) ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lidoderm (Lidocaine 5% Patch) Placebo Patch
Hide Arm/Group Description:
The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
81.1  (1.25) 79.4  (1.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments The overall treatment difference for the lidocaine patch 5% and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1378
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.74
Confidence Interval 95%
-0.57 to 4.04
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
15.Other Pre-specified Outcome
Title Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months
Hide Description Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Categories included Better, Much the Same, and Worse.
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sequence: Lidoderm - Placebo - Placebo (LPP) Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 21 21
Measure Type: Number
Unit of Measure: Participants
Better Baseline (LPP, N=21; PLL, N=21) 11 4
Better Period 1 (LPP, N=21; PLL, N=21) 7 5
Better Period 2 (LPP, N=19; PLL, N=20) 8 4
Better Period 3 (LPP, N=19; PLL, N=19) 9 6
Much the Same Baseline (LPP, N=21; PLL, N=21) 10 17
Much the Same Period 1 (LPP, N=21; PLL, N=21) 14 15
Much the Same Period 2 (LPP, N=19; PLL, N=20) 10 16
Much the Same Period 3 (LPP, N=19; PLL, N=19) 9 12
Worse Baseline (LPP, N=21; PLL, N=21) 0 0
Worse Period 1 (LPP, N=21; PLL, N=21) 0 1
Worse Period 2 (LPP, N=19; PLL, N=20) 1 0
Worse Period 3 (LPP, N=19; PLL, N=19) 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sequence: Lidoderm - Placebo - Placebo (LPP), Sequence: Placebo - Lidoderm - Lidoderm (PLL)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6833
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Regression, Logistic
Comments An ordinal multinomial regression model was performed with sequence, period, treatment, carry over effect as fixed effects.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.88
Confidence Interval 95%
0.47 to 1.65
Estimation Comments The Odds Ratio (OR) provided is the ratio of Lidoderm to Placebo.
16.Other Pre-specified Outcome
Title Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale
Hide Description The VSH Sleep Scale is contained in a 15 item self-report instrument that measures the quality of a patient’s sleep over the last 24 hours. Each item is scored on a 0-100 visual analog scale. The VSH is categorized into 3 sleep scales: disturbance (which measures delays and interruptions in sleep)[maximum score = 700], effectiveness (which measures how well sleep refreshed the individual) [maximum score = 600], and supplementation (which measures the need for napping) [maximum score = 400]. The higher the score the greater the value of the sleep characteristic for that patient.
Time Frame Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Lidoderm (Lidocaine 5% Patch) Placebo Patch
Hide Arm/Group Description:
The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
Overall Number of Participants Analyzed 21 21
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Disturbance 246  (13.7) 224  (13.9)
Effectiveness 303  (9.69) 302  (9.85)
Supplementation 49.7  (7.62) 41.4  (7.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Disturbance: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1143
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 22.16
Confidence Interval 95%
-5.48 to 49.8
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Effectiveness: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9108
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.18
Confidence Interval 95%
-19.8 to 22.2
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Lidoderm (Lidocaine 5% Patch), Placebo Patch
Comments Supplementation: the overall treatment difference for Lidoderm and placebo patch was compared by combining data for patients receiving the respective treatment regardless of randomized study sequence. The endpoint was analyzed by linear mixed effects models incorporating treatment, period, sequence, and first-order carryover as fixed effects, and patient nested within sequence as a random effect. P-value for the random effect (s2) is from the Wald Z-test for the covariance parameter estimates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3769
Comments All statistical tests were 2-sided with a significance level of alpha=0.05.
Method Linear mixed effects models
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.31
Confidence Interval 95%
-10.3 to 27.0
Estimation Comments The results are reported as least squares means and their differences along with associated P-values, and 95% confidence intervals for each fixed effect in the model.
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.
Adverse Event Reporting Description The safety population included all patients who received study medication during the study and did not return all study medication unopened.
 
Arm/Group Title Run-In Period With Lidoderm (Lidocaine 5% Patch) Double-Blind Treatment Period With Lidoderm Double-Blind Active Treatment Period With Placebo
Hide Arm/Group Description

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).

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.

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.

All-Cause Mortality
Run-In Period With Lidoderm (Lidocaine 5% Patch) Double-Blind Treatment Period With Lidoderm Double-Blind Active Treatment Period With Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Run-In Period With Lidoderm (Lidocaine 5% Patch) Double-Blind Treatment Period With Lidoderm Double-Blind Active Treatment Period With Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/169 (0.59%)   1/91 (1.10%)   1/91 (1.10%) 
Cardiac disorders       
Supraventricular extrasystoles * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Infections and infestations       
Pneumonia * 1  1/169 (0.59%)  0/91 (0.00%)  1/91 (1.10%) 
Respiratory, thoracic and mediastinal disorders       
Respiratory failure * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Run-In Period With Lidoderm (Lidocaine 5% Patch) Double-Blind Treatment Period With Lidoderm Double-Blind Active Treatment Period With Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/169 (30.18%)   24/91 (26.37%)   23/91 (25.27%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Cardiac disorders       
Coronary artery disease * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Sinus bradycardia * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Bradycardia * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Palpitations * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Sinus tachycardia * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Ear and labyrinth disorders       
Eustachian tube dysfunction * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Vertigo * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Eye disorders       
Dry eye * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Gastrointestinal disorders       
Constipation * 1  2/169 (1.18%)  1/91 (1.10%)  0/91 (0.00%) 
Diarrhoea * 1  2/169 (1.18%)  0/91 (0.00%)  2/91 (2.20%) 
Gastritis * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Nausea * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Stomach discomfort * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Vomiting * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
General disorders       
Application site dermatitis * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Application site erythema * 1  2/169 (1.18%)  1/91 (1.10%)  2/91 (2.20%) 
Oedema peripheral * 1  2/169 (1.18%)  1/91 (1.10%)  0/91 (0.00%) 
Pain * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Pyrexia * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Application site reaction * 1  1/169 (0.59%)  4/91 (4.40%)  1/91 (1.10%) 
Application site oedema * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Application site swelling * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Application site vesicles * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Fatigue * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Immune system disorders       
Hypersensitivity * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Seasonal allergy * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Infections and infestations       
Nasopharyngitis * 1  3/169 (1.78%)  2/91 (2.20%)  3/91 (3.30%) 
Sinusitis * 1  2/169 (1.18%)  2/91 (2.20%)  3/91 (3.30%) 
Upper respiratory tract infection * 1  1/169 (0.59%)  2/91 (2.20%)  0/91 (0.00%) 
Bronchitis * 1  0/169 (0.00%)  1/91 (1.10%)  1/91 (1.10%) 
Pneumonia * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Cellulitis * 1  1/169 (0.59%)  1/91 (1.10%)  1/91 (1.10%) 
Ear infection * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Gastrointestinal infection * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Keratitis herpetic * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Otitis media * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Vaginal candidiasis * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Influenza * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Pharyngitis * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Urinary tract infection * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Injury, poisoning and procedural complications       
Contusion * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Arthropod sting * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Excoriation * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Hand fracture * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Joint dislocation * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Upper limb fracture * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Burns first degree * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Joint injury * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Investigations       
Blood potassium decreased * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Chest wall pain * 1  2/169 (1.18%)  1/91 (1.10%)  0/91 (0.00%) 
Neck pain * 1  0/169 (0.00%)  1/91 (1.10%)  1/91 (1.10%) 
Arthropathy * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Back pain * 1  1/169 (0.59%)  0/91 (0.00%)  1/91 (1.10%) 
Muscle spasms * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Musculoskeletal stiffness * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Shoulder pain * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Tendonitis * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neuroma * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Nervous system disorders       
Headache * 1  3/169 (1.78%)  1/91 (1.10%)  0/91 (0.00%) 
Dizziness * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Carpal tunnel syndrome * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Hypoaesthesia * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Paraesthesia * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Burning sensation * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Psychiatric disorders       
Agitation * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Anger * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Depression * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Renal and urinary disorders       
Renal cyst * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Renal failure * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Haematuria * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Dyspnoea * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Haemoptysis * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Productive cough * 1  1/169 (0.59%)  1/91 (1.10%)  0/91 (0.00%) 
Sinus congestion * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Cough * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Rales * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Respiratory tract congestion * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Skin and subcutaneous tissue disorders       
Erythema * 1  2/169 (1.18%)  1/91 (1.10%)  0/91 (0.00%) 
Pruritus * 1  2/169 (1.18%)  0/91 (0.00%)  0/91 (0.00%) 
Rash * 1  2/169 (1.18%)  0/91 (0.00%)  1/91 (1.10%) 
Pruritus generalised * 1  0/169 (0.00%)  1/91 (1.10%)  0/91 (0.00%) 
Skin irritation * 1  0/169 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Nail pigmentation * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Psoriasis * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
Vascular disorders       
Hypertension * 1  1/169 (0.59%)  1/91 (1.10%)  0/91 (0.00%) 
Peripheral coldness * 1  1/169 (0.59%)  0/91 (0.00%)  0/91 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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).
Results Point of Contact
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
Phone: Use e-mail contact
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00589979     History of Changes
Other Study ID Numbers: EN3260-003
First Submitted: December 26, 2007
First Posted: January 10, 2008
Results First Submitted: December 22, 2009
Results First Posted: September 22, 2010
Last Update Posted: October 5, 2017