Osteoarthritis of the Knee
Conditions
Keywords
Osteoarthritis, Knee, Lidoderm, Lidocaine, Topical patch, Adjunct therapy
Brief summary
Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.
Interventions
DRUGLidoderm (Lidocaine 5% Patch)
Topical Patch
DRUGPlacebo Patch
Topical Patch
Sponsors
Endo Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
37 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion criteria: * Male or female patients ≥37 years with moderate-to-severe OA related pain in one knee * Body mass index (BMI) ≤40 kg/m2 * Symptomatic OA of the index knee diagnosed with a functional capacity of II or III according to ACR criteria classification Note: Patients with symptomatic contralateral knee OA with persistent pain ≤2 cm on a 0-10 cm PI-NRS for ≥2 months will be allowed to participate. * Unchanged dose of analgesic medication for OA for at least 4 weeks prior to screening and for the duration of the study * Able and willing to complete all paper and e-diary assessments required by protocol Key
Exclusion criteria
* Pain in any joint other than the index joint that could interfere with the patient's assessment of pain in the index joint * Compromised integrity of the intact, superficial skin layer * A grade 1 or 4 Kellgren and Lawrence score on radiographic examination * Recent injury to either knee causing pain and interference with daily activities (eg. walking) * Recent surgery/procedure to either knee causing pain that could interfere with study assessments of pain, function, and QoL * Known hypersensitivity or allergy to lidocaine, local anesthetics of the amide type, or any component of the product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-Exit From Current Study Treatment | Baseline, Period 1 (up to 4 weeks ±2 days), Period 2 (up to 4 weeks ±2 days), Period 3 (up to 4 weeks ±2 days), or Premature Discontinuation | Time-to-exit was defined as the number of days at which a patient either met the switching criterion \[a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days\] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS) | Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks) | 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. |
| Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores | Baseline, End of Period 1 (up to 4 weeks), End of Period 2 (up to 4 weeks) and End of Period 3 (up to 4 weeks) | 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. |
| Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) | 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. |
| Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) | Patients rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale indicating: very much worse (0); much worse (1); minimally worse (2); no change (3); minimally improved (4); much improved (5); and very much improved (6). |
| Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) | Investigators rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale ranging from very much worse to very much improved. A similar questionnaire was completed by the Investigator. |
| Patient Global Assessment of Treatment Satisfaction | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) | At the end of each period, patients rated their overall satisfaction with study treatment using a 5-point categorical scale indicating: 0 - very dissatisfied; 1 - dissatisfied; 2 - no preference; 3 - satisfied; and 4 - very satisfied. |
| Investigator Global Assessment of Treatment Satisfaction | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) | At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied). |
| Time-to-Exit Due to Lack of Efficacy | Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation | 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. |
| Exit Status From Current Study Treatment - Yes | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation | 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). |
| Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS) | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation | Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Values of the continuous EQ-5D health state today (VAS) ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation | Health status was assessed using the EuroQol Quality of Life Instrument (EQ-5D). Patients completed the EQ-5D assessment at Baseline and at the end of each period or at premature discontinuation. Categories included Better, Much the Same, and Worse. |
| Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale | Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) | The VSH Sleep Scale is contained in a 15 item self-report instrument that measures the quality of a patient's sleep over the last 24 hours. Each item is scored on a 0-100 visual analog scale. The VSH is categorized into 3 sleep scales: disturbance (which measures delays and interruptions in sleep)\[maximum score = 700\], effectiveness (which measures how well sleep refreshed the individual) \[maximum score = 600\], and supplementation (which measures the need for napping) \[maximum score = 400\]. The higher the score the greater the value of the sleep characteristic for that patient. |
| Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score | Baseline and end of treatment period (up to 4 weeks) | 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. |
| Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Screening, Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks) | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Sequence: Lidoderm - Placebo - Placebo Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 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. | 50 |
| Sequence: Placebo - Lidoderm - Lidoderm 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. | 43 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-Blind Treatment Period 1 | Adverse Event | 0 | 1 | 0 |
| Double-Blind Treatment Period 1 | Protocol Violation | 0 | 1 | 1 |
| Double-Blind Treatment Period 1 | Withdrawal by Subject | 0 | 0 | 1 |
| Double-Blind Treatment Period 2 | Adverse Event | 0 | 1 | 0 |
| Double-Blind Treatment Period 2 | Other | 0 | 0 | 1 |
| Double-Blind Treatment Period 2 | Withdrawal by Subject | 0 | 0 | 1 |
| Double-Blind Treatment Period 3 | Protocol Violation | 0 | 1 | 0 |
| Double-Blind Treatment Period 3 | Withdrawal by Subject | 0 | 0 | 1 |
| Run-In Period | Adverse Event | 5 | 0 | 0 |
| Run-In Period | Did not qualify for randomization | 54 | 0 | 0 |
| Run-In Period | Informed Consent Withdrawn | 4 | 0 | 0 |
| Run-In Period | Protocol Violation | 3 | 0 | 0 |
| Run-In Period | Withdrawal by Subject | 10 | 0 | 0 |
Baseline characteristics
| Characteristic | Sequence: Lidoderm - Placebo - Placebo | Sequence: Placebo - Lidoderm - Lidoderm | Total |
|---|---|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 10 | 61.1 years STANDARD_DEVIATION 10.9 | 61.1 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 50 participants | 43 participants | 93 participants |
| Sex: Female, Male Female | 32 Participants | 28 Participants | 60 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 169 | 24 / 91 | 23 / 91 |
| serious Total, serious adverse events | 1 / 169 | 1 / 91 | 1 / 91 |
Outcome results
Primary
Time-to-Exit From Current Study Treatment
Time-to-exit was defined as the number of days at which a patient either met the switching criterion \[a 2-category change in the Pain Relief Scale (PRS) score in the worsening direction (increasing pain or decreasing pain relief) for 2 consecutive days\] or discontinued from the study. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. Traditional survival models that consider event times (e.g. median survival time) as independent and homogeneous across patients were not suitable for this study.
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
Population: The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: Kaplan-Meier estimates for median time-to-exit from current study treatment could not be calculated for Period 2 or Period 3, because the survival distribution function did not fall below 0.5000.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Time-to-Exit From Current Study Treatment | Period 1 ( Sequence LPP, N=21; Sequence PLL, N=21) | 31 Days |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Time-to-Exit From Current Study Treatment | Period 2 (Sequence LPP, N=19; Sequence PLL, N=20) | NA Days |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Time-to-Exit From Current Study Treatment | Period 3 (Sequence LPP, N=19; Sequence PLL, N=19) | NA Days |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Time-to-Exit From Current Study Treatment | Period 3 (Sequence LPP, N=19; Sequence PLL, N=19) | NA Days |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Time-to-Exit From Current Study Treatment | Period 1 ( Sequence LPP, N=21; Sequence PLL, N=21) | 20 Days |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Time-to-Exit From Current Study Treatment | Period 2 (Sequence LPP, N=19; Sequence PLL, N=20) | NA Days |
Comparison: The two treatments were compared by time-varying relative hazards, associated P values, and 95% confidence intervals. Appropriate survival or hazard functions were calculated.p-value: 0.100695% CI: [0.89, 3.55]Cox frailty model
Secondary
Exit Status From Current Study Treatment - Yes
Exit status from a current study treatment was categorized as yes or no for patients who exited prior to the 4-week planned duration. This analysis supports the results of the primary analysis. The number of patients exiting (yes) is reported.
Time frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Exit Status From Current Study Treatment - Yes | Period 1 (Sequence LPP, N=21; Sequence PLL, N=21) | 10 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Exit Status From Current Study Treatment - Yes | Period 2 (Sequence LPP, N=19; Sequence PLL, N=20) | 5 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Exit Status From Current Study Treatment - Yes | Period 3 (Sequence LPP, N=19; Sequence PLL, N=19) | 6 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Exit Status From Current Study Treatment - Yes | Period 1 (Sequence LPP, N=21; Sequence PLL, N=21) | 12 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Exit Status From Current Study Treatment - Yes | Period 2 (Sequence LPP, N=19; Sequence PLL, N=20) | 4 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Exit Status From Current Study Treatment - Yes | Period 3 (Sequence LPP, N=19; Sequence PLL, N=19) | 2 Participants |
Comparison: 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.p-value: 0.127295% CI: [0.86, 4.02]Regression, Logistic
Secondary
Investigator Global Assessment of Treatment Satisfaction
At the end of each period, investigators rated their overall satisfaction with study treatment using a 5-point categorical scale ranging from 0 (very dissatisfied) to 4 (very satisfied).
Time frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 2-No Preference, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 1 (LPP, N=21; PLL,N=21) | 7 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 2-No Preference, Period 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 11 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 1 (LPP, N=21; PLL,N=21) | 4 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=19) | 8 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20) | 2 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 3 (LPP, N=19; PLL, N=19) | 9 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Period 1 (LPP,N=21; PLL,N=21) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 5 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Period 2 (LPP,N=19; PLL,N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 2-No Preference, Period 1 (LPP, N=21; PLL,N=21) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Period 3 (LPP,N=19; PLL,N=19) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 1 (LPP, N=21; PLL,N=21) | 8 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Period 3 (LPP,N=19; PLL,N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 1 (LPP, N=21; PLL,N=21) | 6 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 8 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=19) | 11 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 1 (LPP, N=21; PLL,N=21) | 9 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 10 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 3 (LPP, N=19; PLL, N=19) | 5 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 2-No Preference, Period 1 (LPP, N=21; PLL,N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 2-No Preference, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 2-No Preference, Period 3 (LPP, N=19; PLL, N=19) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 1 (LPP, N=21; PLL,N=21) | 5 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Period 1 (LPP,N=21; PLL,N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Period 2 (LPP,N=19; PLL,N=20) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
Comparison: 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.p-value: 0.319395% CI: [0.44, 1.3]Regression, Linear
Secondary
Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain
Investigators rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale ranging from very much worse to very much improved. A similar questionnaire was completed by the Investigator.
Time frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 2 (LPP, N=19; PLL, N=20) | 2 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 3 (LPP, N=19; PLL, N=19) | 5 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 1 (LPP, N=21; PLL, N=21) | 7 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 2 (LPP, N=19; PLL, N=20) | 10 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 3 (LPP, N=19; PLL, N=19) | 7 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Min. Improved, Period 1 (LPP, N=21; PLL, N=21) | 4 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Min. Improved, Period 2 (LPP, N=19; PLL, N=20) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Min. Improved, Period 3 (LPP, N=19; PLL, N=19) | 4 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 1 (LPP, N=21; PLL, N=21) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 2 LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 1 (LPP, N=21; PLL, N=21) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 1 (LPP, N=21; PLL, N=21) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21) | 4 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 2 LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 2 (LPP, N=19; PLL, N=20) | 3 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 3 (LPP, N=19; PLL, N=19) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 3 (LPP, N=19; PLL, N=19) | 4 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 1 (LPP, N=21; PLL, N=21) | 9 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 1 (LPP, N=21; PLL, N=21) | 3 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 2 (LPP, N=19; PLL, N=20) | 8 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 3 (LPP, N=19; PLL, N=19) | 8 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Min. Improved, Period 1 (LPP, N=21; PLL, N=21) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Min. Improved, Period 2 (LPP, N=19; PLL, N=20) | 7 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Investigator Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Min. Improved, Period 3 (LPP, N=19; PLL, N=19) | 4 Participants |
Comparison: 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.p-value: 0.474895% CI: [0.72, 2.06]Regression, Linear
Secondary
Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS)
The Numerical Rating Scale (NRS) is an 11-point categorical rating scale to assess pain intensity (PI-NRS); 0= no pain and 10= worst possible pain. The scale is anchored on the left with No Pain and on the right with Worst Possible Pain. Patients were to complete this assessment at approximately the same time each day during the double-blind treatment period in their e-diary. The overall treatment difference for the Lidoderm (lidocaine patch 5%) and placebo patch was compared by combining data for patients receiving the respective treatment regardless of the randomized study sequence.
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)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS) | 3.03 Units on a scale | Standard Error 0.35 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Intensity Numerical Rating Scale (PI-NRS) | 3.57 Units on a scale | Standard Error 0.35 |
Comparison: 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.p-value: 0.022495% CI: [-1.01, -0.08]Linear mixed effects model
Secondary
Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores
The Pain Relief Scale (PRS) is a 9-point categorical rating scale to assess pain relief during the 24-hours since the last assessment; 0= completely worse and 8= complete pain relief. Patients completed this assessment each day during the run-in period and each day during the double-blind treatment phase in their e-diary.
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)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores | 4.45 Units on a scale | Standard Error 0.25 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in the LSMeans of the Average of the Last Two Daily Pain Relief Scale (PRS) Scores | 4.06 Units on a scale | Standard Error 0.25 |
Comparison: 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.p-value: 0.274795% CI: [-0.31, 1.09]Linear mixed effects regression
Secondary
Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores
The PQAS measures individual pain qualities and the impact of treatment on those qualities. Items 1-19 are each rated on an 11-point scale ranging from 0 (lowest score - no pain of that type) to 10 (highest score - the highest level of that type of pain). Average surface pain = average of PQAS items: cold, sensitive, itchy, numb, and tingling. Average deep pain = average of PQAS items: dull, cramping, throbbing, aching, and heavy. Average paroxymal pain = average of PQAS items: sharp, shooting, electric, and radiating.
Time frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Numb | 1.31 Units on a scale | Standard Error 0.28 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Dull | 3.04 Units on a scale | Standard Error 0.33 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Electrical | 1.32 Units on a scale | Standard Error 0.29 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Tingling | 1.24 Units on a scale | Standard Error 0.26 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Cold | 0.62 Units on a scale | Standard Error 0.14 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Radiating | 2.03 Units on a scale | Standard Error 0.35 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Intense | 3.31 Units on a scale | Standard Error 0.32 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Sensitive | 0.88 Units on a scale | Standard Error 0.2 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Aching | 2.78 Units on a scale | Standard Error 0.36 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Cramping | 1.78 Units on a scale | Standard Error 0.33 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Heavy | 2.12 Units on a scale | Standard Error 0.34 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Tender | 2.08 Units on a scale | Standard Error 0.3 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Overall unpleasantness | 2.98 Units on a scale | Standard Error 0.34 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Sharp | 2.50 Units on a scale | Standard Error 0.34 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Intense deep pain | 3.33 Units on a scale | Standard Error 0.37 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Itchy | 0.90 Units on a scale | Standard Error 0.23 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Intense surface pain | 1.61 Units on a scale | Standard Error 0.28 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Hot | 1.12 Units on a scale | Standard Error 0.26 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Average surface pain | 0.99 Units on a scale | Standard Error 0.15 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Shocking | 1.95 Units on a scale | Standard Error 0.34 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Average deep pain | 2.38 Units on a scale | Standard Error 0.29 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Average paroxysmal pain | 1.78 Units on a scale | Standard Error 0.25 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Throbbing | 2.24 Units on a scale | Standard Error 0.34 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Average paroxysmal pain | 2.06 Units on a scale | Standard Error 0.25 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Tingling | 1.24 Units on a scale | Standard Error 0.26 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Average deep pain | 2.55 Units on a scale | Standard Error 0.29 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Intense | 3.53 Units on a scale | Standard Error 0.32 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Hot | 1.59 Units on a scale | Standard Error 0.27 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Dull | 3.28 Units on a scale | Standard Error 0.33 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Cold | 0.50 Units on a scale | Standard Error 0.14 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Sensitive | 0.96 Units on a scale | Standard Error 0.21 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Tender | 1.89 Units on a scale | Standard Error 0.3 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Itchy | 1.00 Units on a scale | Standard Error 0.23 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Shocking | 2.36 Units on a scale | Standard Error 0.34 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Numb | 1.52 Units on a scale | Standard Error 0.28 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Electrical | 1.26 Units on a scale | Standard Error 0.3 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Cramping | 2.03 Units on a scale | Standard Error 0.33 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Radiating | 2.10 Units on a scale | Standard Error 0.35 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Throbbing | 2.06 Units on a scale | Standard Error 0.35 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Aching | 3.22 Units on a scale | Standard Error 0.37 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Heavy | 2.26 Units on a scale | Standard Error 0.34 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Overall unpleasantness | 3.55 Units on a scale | Standard Error 0.35 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Intense deep pain | 3.77 Units on a scale | Standard Error 0.37 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Intense surface pain | 1.82 Units on a scale | Standard Error 0.29 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Average surface pain | 1.05 Units on a scale | Standard Error 0.15 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference of the LSMeans of the Pain Quality Assessment Scale (PQAS) Scores | Sharp | 3.00 Units on a scale | Standard Error 0.34 |
Comparison: 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.p-value: 0.449895% CI: [-0.8, 0.36]Linear mixed effects model
Comparison: 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.p-value: 0.106595% CI: [-1.11, 0.11]Linear mixed effect models
Comparison: 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.p-value: 0.048495% CI: [-0.94, 0]Linear mixed effects models
Comparison: 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.p-value: 0.497395% CI: [-0.93, 0.46]Linear mixed effect models
Comparison: 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.p-value: 0.396695% CI: [-0.16, 0.41]Linear mixed effect models
Comparison: 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.p-value: 0.694195% CI: [-0.53, 0.35]Linear mixed effects model
Comparison: 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.p-value: 0.566495% CI: [-0.45, 0.82]Linear mixed effects models
Comparison: 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.p-value: 0.687195% CI: [-0.55, 0.37]Linear mixed effects models
Comparison: 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.p-value: 0.231895% CI: [-1.08, 0.27]Linear mixed effects models
Comparison: 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.p-value: 0.338395% CI: [-0.64, 0.22]Linear mixed effects models
Comparison: 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.p-value: 0.87495% CI: [-0.63, 0.73]Linear mixed effects models
Comparison: 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.p-value: 0.99995% CI: [-0.54, 0.54]Linear mixed effects models
Comparison: 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.p-value: 0.418395% CI: [-0.85, 0.36]Linear mixed effects models
Comparison: 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.p-value: 0.822795% CI: [-0.71, 0.57]Linear mixed effects models
Comparison: 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.p-value: 0.58795% CI: [-0.48, 0.85]Linear mixed effects models
Comparison: 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.p-value: 0.218195% CI: [-1.15, 0.27]Linear mixed effects models
Comparison: 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.p-value: 0.627695% CI: [-0.68, 0.42]Linear mixed effects models
Comparison: 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.p-value: 0.091795% CI: [-1.23, 0.09]Linear mixed effects models
Comparison: 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.p-value: 0.208995% CI: [-1.13, 0.25]Linear mixed effects models
Comparison: 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.p-value: 0.418895% CI: [-0.75, 0.31]Linear mixed effects models
Comparison: 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.p-value: 0.695995% CI: [-0.32, 0.21]Linear mixed effects models
Comparison: 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.p-value: 0.480695% CI: [-0.64, 0.3]Linear mixed effects models
Comparison: 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.p-value: 0.229195% CI: [-0.74, 0.18]Linear mixed effects models
Secondary
Patient Global Assessment of Treatment Satisfaction
At the end of each period, patients rated their overall satisfaction with study treatment using a 5-point categorical scale indicating: 0 - very dissatisfied; 1 - dissatisfied; 2 - no preference; 3 - satisfied; and 4 - very satisfied.
Time frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 9 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 2-No Preference, Period 3 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 8 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 3 (LPP, N=19; PLL, N=20) | 5 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20) | 2 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 1 (LPP, N=21; PLL, N=21) | 7 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 2-No Preference, Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Per. 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=20) | 12 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Per. 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 2-No Preference, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Per. 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 1 (LPP, N=21; PLL, N=21) | 12 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Per. 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 1 (LPP, N=21; PLL, N=21) | 9 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 10 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 4-Very Satisfied, Period 3 (LPP, N=19; PLL, N=20) | 12 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 1 (LPP, N=21; PLL, N=21) | 8 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 2 (LPP, N=19; PLL, N=20) | 6 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 3-Satisfied, Period 3 (LPP, N=19; PLL, N=20) | 6 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 2-No Preference, Period 1 (LPP, N=21; PLL, N=21) | 3 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 2-No Preference, Period 2 (LPP, N=19; PLL, N=20) | 3 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 2-No Preference, Period 3 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 1-Dissatisfied, Period 3 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Per. 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Assessment of Treatment Satisfaction | 0-Very Dissatisfied, Per. 2 (LPP, N=19; PLL, N=20) | 1 Participants |
Comparison: 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.p-value: 0.260595% CI: [0.38, 1.3]Regression, Linear
Secondary
Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain
Patients rated their overall impression of change from Baseline to the end of each period during the double-blind treatment period, including premature discontinuation. Change was rated using a categorical scale indicating: very much worse (0); much worse (1); minimally worse (2); no change (3); minimally improved (4); much improved (5); and very much improved (6).
Time frame: Baseline, Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 2 (LPP, N=19; PLL, N=20) | 9 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 3 (LPP, N=19; PLL, N=19) | 8 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Mini. Improved, Period 3 (LPP, N=19; PLL, N=19) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Mini. Improved, Period 2 (LPP, N=19; PLL, N=20) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 1 (LPP, N=21; PLL, N=21) | 5 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr., Period 2 (LPP, N=19; PLL, N=20) | 3 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 1 (LPP,N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 3 (LPP, N=19; PLL, N=19) | 4 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr., Period 3 (LPP, N=19; PLL, N=19) | 4 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Mini. Improved, Period 1 (LPP, N=21; PLL, N=21) | 7 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 1 (LPP, N=21; PLL, N=21) | 6 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 1 (LPP, N=21; PLL,N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Mini. Improved, Period 1 (LPP, N=21; PLL, N=21) | 4 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 1 (LPP,N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 0-Very Much Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr, Period 1 (LPP, N=21; PLL, N=21) | 5 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr., Period 2 (LPP, N=19; PLL, N=20) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 6-Very Much Impr., Period 3 (LPP, N=19; PLL, N=19) | 4 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 1 (LPP, N=21; PLL, N=21) | 8 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 2 (LPP, N=19; PLL, N=20) | 8 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 5-Much Improved, Period 3 (LPP, N=19; PLL, N=19) | 10 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Mini. Improved, Period 2 (LPP, N=19; PLL, N=20) | 6 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 4-Mini. Improved, Period 3 (LPP, N=19; PLL, N=19) | 3 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 2 (LPP, N=19; PLL, N=20) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 3-No Change, Period 3 (LPP, N=19; PLL, N=19) | 2 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 1 (LPP, N=21; PLL,N=19) | 3 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 2-Minimally Worse, Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Patient Global Impression of Change From Baseline in Osteoarthritis (OA) Pain | 1-Much Worse, Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
Comparison: 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.p-value: 0.318595% CI: [0.77, 2.27]Regression, Linear
Secondary
Time-to-Exit Due to Lack of Efficacy
Time-to-exit due to lack of efficacy was defined as a patient that met the switching criterion (a 2-category change in Pain Relief Scale (PRS) in the worsening direction \[increasing pain or decreasing pain relief\] for 2 consecutive days) or was discontinued from the current period or study due to lack of efficacy. The PRS is a 9-point categorical rating scale to assess pain relief in the last 24 hours in which 0 = completely worse and 8 = complete pain relief. No patients discontinued from the study due to lack of efficacy.
Time frame: Period 1 (up to 4 weeks), Period 2 (up to 4 weeks), Period 3 (up to 4 weeks), or Premature Discontinuation
Population: The modified intent-to treat (MITT) population consisted of all intent-to-treat (ITT) patients who were randomized on or after January 22, 2008.~Note: No patients exited a study period due to lack of efficacy, therefore median time-to-exit could not be calculated.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Time-to-Exit Due to Lack of Efficacy | Period 1 (Sequence LPP, N=21; Sequence PLL, N=21) | NA days |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Time-to-Exit Due to Lack of Efficacy | Period 2 (Sequence LPP, N=19; Sequence PLL, N=20) | NA days |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Time-to-Exit Due to Lack of Efficacy | Period 3 (Sequence LPP, N=19; Sequence PLL, N=19) | NA days |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Time-to-Exit Due to Lack of Efficacy | Period 1 (Sequence LPP, N=21; Sequence PLL, N=21) | NA days |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Time-to-Exit Due to Lack of Efficacy | Period 2 (Sequence LPP, N=19; Sequence PLL, N=20) | NA days |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Time-to-Exit Due to Lack of Efficacy | Period 3 (Sequence LPP, N=19; Sequence PLL, N=19) | NA days |
Other Pre-specified
Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS)
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
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS) | 81.1 Units on a scale | Standard Error 1.25 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Health Status Today Using a Visual Analog Scale (VAS) | 79.4 Units on a scale | Standard Error 1.26 |
Comparison: 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 estimatesp-value: 0.137895% CI: [-0.57, 4.04]Linear mixed effects model
Other Pre-specified
Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores
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
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores | 0.82 Units on a scale | Standard Error 0.01 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in LSMeans for Continuous EuroQol Quality of Life Instrument (EQ-5D) Index Scores | 0.81 Units on a scale | Standard Error 0.01 |
Comparison: 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.p-value: 0.377395% CI: [-0.02, 0.04]Linear mixed effects model
Other Pre-specified
Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale
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)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale | Disturbance | 246 Units on a scale | Standard Error 13.7 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale | Effectiveness | 303 Units on a scale | Standard Error 9.69 |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale | Supplementation | 49.7 Units on a scale | Standard Error 7.62 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale | Disturbance | 224 Units on a scale | Standard Error 13.9 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale | Effectiveness | 302 Units on a scale | Standard Error 9.85 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in LSMeans for Verran Snyder-Halpern (VSH) Sleep Scale | Supplementation | 41.4 Units on a scale | Standard Error 7.76 |
Comparison: 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.p-value: 0.114395% CI: [-5.48, 49.8]Linear mixed effects models
Comparison: 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.p-value: 0.910895% CI: [-19.8, 22.2]Linear mixed effects models
Comparison: 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.p-value: 0.376995% CI: [-10.3, 27]Linear mixed effects models
Other Pre-specified
Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score
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)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score | 4.41 Units on a scale | Standard Error 0.39 |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Overall Treatment Difference in LSMeans of Beck Depression Inventory Second Edition (BDI-II) Total Score | 4.29 Units on a scale | Standard Error 0.39 |
Comparison: 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.p-value: 0.783995% CI: [-0.74, 0.98]Linear mixed effects models
Other Pre-specified
Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score
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)
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal at Baseline (LPP, N=21; PLL, N=21) | 21 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal at Screening (LPP, N=21; PLL, N=21) | 21 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal, end of Period 1 (LPP, N=21; PLL, N=21) | 21 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal, end of Period 2 (LPP, N=19; PLL, N=20) | 19 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal, end of Period 3 (LPP, N=19; PLL, N=19) | 19 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild at Screening (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild at Baseline (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild, end of Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild, end of Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild, end of Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate at Screening (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate at Baseline (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate, end of Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate, end of Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate, end of Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe at Screening (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe at Baseline (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe, end of Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe, end of Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe, end of Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe, end of Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate at Screening (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal at Screening (LPP, N=21; PLL, N=21) | 20 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal at Baseline (LPP, N=21; PLL, N=21) | 20 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe at Screening (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal, end of Period 1 (LPP, N=21; PLL, N=21) | 19 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate at Baseline (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal, end of Period 2 (LPP, N=19; PLL, N=20) | 20 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe, end of Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Minimal, end of Period 3 (LPP, N=19; PLL, N=19) | 19 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate, end of Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild at Screening (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe at Baseline (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild at Baseline (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate, end of Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild, end of Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Severe, end of Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild, end of Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Moderate, end of Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Four Category Beck Depression Inventory Second Edition (BDI-II) Composite Score | Mild, end of Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
Other Pre-specified
Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months
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
Population: The modified intent-to-treat (MITT) population consisted of all intent-to-treat (ITT) patients defined as all patients who received study medication and provided run-in and baseline assessments and had at least 1 post-baseline efficacy assessment and who were randomized on or after January 22, 2008.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Baseline (LPP, N=21; PLL, N=21) | 11 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Period 1 (LPP, N=21; PLL, N=21) | 7 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Period 2 (LPP, N=19; PLL, N=20) | 8 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Period 3 (LPP, N=19; PLL, N=19) | 9 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Baseline (LPP, N=21; PLL, N=21) | 10 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Period 1 (LPP, N=21; PLL, N=21) | 14 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Period 2 (LPP, N=19; PLL, N=20) | 10 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Period 3 (LPP, N=19; PLL, N=19) | 9 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Baseline (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Period 1 (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Period 2 (LPP, N=19; PLL, N=20) | 1 Participants |
| Sequence: Lidoderm - Placebo - Placebo (LPP) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Period 3 (LPP, N=19; PLL, N=19) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Period 2 (LPP, N=19; PLL, N=20) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Baseline (LPP, N=21; PLL, N=21) | 4 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Period 2 (LPP, N=19; PLL, N=20) | 16 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Period 1 (LPP, N=21; PLL, N=21) | 5 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Period 1 (LPP, N=21; PLL, N=21) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Period 2 (LPP, N=19; PLL, N=20) | 4 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Period 3 (LPP, N=19; PLL, N=19) | 12 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Better Period 3 (LPP, N=19; PLL, N=19) | 6 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Period 3 (LPP, N=19; PLL, N=19) | 1 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Baseline (LPP, N=21; PLL, N=21) | 17 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Worse Baseline (LPP, N=21; PLL, N=21) | 0 Participants |
| Sequence: Placebo - Lidoderm - Lidoderm (PLL) | Quality of Life: Three-Category EuroQol Quality of Life Instrument (EQ-5D) General Health Today Compared to Last 12 Months | Much the Same Period 1 (LPP, N=21; PLL, N=21) | 15 Participants |
p-value: 0.683395% CI: [0.47, 1.65]Regression, Logistic