Neuralgia, Postherpetic
Conditions
Brief summary
The purpose of this study is to evaluate efficacy and safety of pregabalin in the treatment of postherpetic neuralgia in a dose-ranging manner.
Interventions
DRUGPlacebo
placebo, oral administration for 13 weeks (1 week titration and 12-week fixed dose).
DRUGPregabalin
Pregabalin 150mg/day (75mg BID), oral administration for 13 weeks (1-week titration and 12-week fixed dose).
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Visual Analogue Scale (VAS) of pain is higher than 40 mm. * Pain is sustained for more than 3 months after healing of herpes zoster skin rash.
Exclusion criteria
* Malignancy within the past 2 years. * Patients who have undergone neurolytic or neurosurgical therapy for postherpetic neuralgia. * Creatinine clearance \</= 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation, by omitting any decimal fractions). * Patients having other severe pain which may impair the self assessment of the pain due to postherpetic neuralgia. * Skin conditions in the affected dermatome that could alter sensation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Scores at Endpoint | Week13/discontinuation | Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain. |
| Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | Week13/discontinuation | Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain. |
| Number of Responders | Week13/discontinuation | A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint. |
| Mean Pain Scores at Week 1 | Week 1 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 2 | Week 2 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 3 | Week 3 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 4 | Week4 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 5 | Week 5 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 6 | Week 6 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 7 | Week 7 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 8 | Week 8 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 9 | Week 9 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 10 | Week 10 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 11 | Week 11 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 12 | Week 12 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
| Mean Pain Scores at Week 13 | Week 13 | Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Endpoint Short-Form 36-Item Health Survey Scores: Vitality | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Endpoint Short-Form 36-Item Health Survey Scores: Mental Health | Week13/discontinuation | Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Number of Patients Not Reporting Allodynia | Week13/discontinuation | Participants not reporting allodynia. |
| Number of Patients Not Reporting Hyperalgesia | Week13/discontinuation | Participants not reporting hyperalgesia. |
| Mean Sleep Interference Scores at Week 1 | week 1 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 2 | week 2 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 3 | week 3 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 4 | week 4 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 5 | week 5 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 6 | week 6 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 7 | week 7 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Sensory score range from 0-33. Higher scores indicate more severe pain. |
| Mean Sleep Interference Scores at Week 9 | week 9 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 10 | week 10 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 11 | week 11 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 12 | week 12 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 13 | week 13 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Mean Sleep Interference Scores at Week 8 | week 8 | Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. |
| Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Affective score range from 0-12. Higher scores indicate more severe pain. |
| Endpoint Total Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Total score range from 0-45. Higher scores indicate more severe pain. |
| Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain. |
| Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire | Week13/discontinuation | Present pain intensity score range from 0-5. Higher scores indicate more severe pain. |
| Mean Sleep Interference Scores at Endpoint | Week13/discontinuation | Scores range from 0-10. Higher scores indicate more severe interference with sleep. |
| Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance | Week13/discontinuation | Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute. |
| Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring | Week13/discontinuation | Score range for snoring is 0-100.Higher scores indicate more of the attribute. |
| Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache | Week13/discontinuation | Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute. |
| Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep | Week13/discontinuation | Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale. |
| Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy | Week13/discontinuation | Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute. |
| Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence | Week13/discontinuation | Score range for Somnolence is 0-100. Higher scores indicate more of the attribute. |
| Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index | Week13/discontinuation | Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute. |
| Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep | Week13/discontinuation | Number of participants who reported Optimal Sleep |
| Endpoint Patient Global Impression Change | Week13/discontinuation | Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse. |
| Endpoint Clinical Global Impression Change | Week13/discontinuation | Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse. |
Countries
Japan
Participant flow
Recruitment details
Fifty (50) centers in Japan
Pre-assignment details
After a 1-week baseline phase, subjects were stratified into 1 of 2 strata based on their creatinine clearance (CLcr) values (Low, 30 \<CLcr \<=60 mL/min or Normal, CLcr \> 60 mL/min) and then equally randomized into 1 of 4 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo During a 13-week double-blind phase, subjects received matching placebo. | 98 |
| Pregabalin 150 mg/Day During a 13-week double-blind phase, subjects received pregabalin 150 mg/day. | 87 |
| Pregabalin 300 mg/Day During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks. | 89 |
| Pregabalin 600 mg/Day During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks. | 97 |
| Total | 371 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Baseline Phase | Protocol Violation | 0 | 0 | 1 | 0 |
| Double-blind Phase | Adverse Event | 5 | 7 | 16 | 20 |
| Double-blind Phase | Death | 1 | 0 | 0 | 0 |
| Double-blind Phase | Entry into another study was found | 0 | 0 | 1 | 0 |
| Double-blind Phase | Found not to meet entrance criteria | 0 | 0 | 0 | 1 |
| Double-blind Phase | Lack of Compliance | 0 | 3 | 0 | 0 |
| Double-blind Phase | Lack of Efficacy | 6 | 4 | 1 | 3 |
| Double-blind Phase | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Double-blind Phase | Protocol Violation | 0 | 0 | 0 | 1 |
| Double-blind Phase | Subject's Personal Reason | 1 | 0 | 0 | 1 |
| Double-blind Phase | Withdrawal by Subject | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Pregabalin 150 mg/Day | Pregabalin 300 mg/Day | Pregabalin 600 mg/Day | Total |
|---|---|---|---|---|---|
| Age, Continuous | 71.1 years STANDARD_DEVIATION 8.6 | 70.2 years STANDARD_DEVIATION 9.2 | 70.9 years STANDARD_DEVIATION 9.8 | 68.4 years STANDARD_DEVIATION 12.5 | 70.1 years STANDARD_DEVIATION 10.2 |
| Age, Customized <18 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized >=65 years | 84 participants | 69 participants | 72 participants | 71 participants | 296 participants |
| Age, Customized Between 18 and 44 years | 2 participants | 1 participants | 2 participants | 6 participants | 11 participants |
| Age, Customized Between 45 and 64 years | 12 participants | 17 participants | 15 participants | 20 participants | 64 participants |
| Region of Enrollment Japan | 98 participants | 87 participants | 89 participants | 97 participants | 371 participants |
| Sex: Female, Male Female | 41 Participants | 44 Participants | 44 Participants | 44 Participants | 173 Participants |
| Sex: Female, Male Male | 57 Participants | 43 Participants | 45 Participants | 53 Participants | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 35 / 98 | 44 / 87 | 61 / 89 | 77 / 97 |
| serious Total, serious adverse events | 6 / 98 | 2 / 87 | 4 / 89 | 1 / 97 |
Outcome results
Primary
Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | 4.99 score on scale | Standard Error 0.18 |
| Pregabalin 150 mg/Day | Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | 4.35 score on scale | Standard Error 0.19 |
| Pregabalin 300 mg/Day | Mean Pain Score at Endpoint by Groups of Subjects With Expected Similar Plasma Concentrations | 4.34 score on scale | Standard Error 0.16 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01695% CI: [-1.16, -0.12]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00895% CI: [-1.14, -0.17]ANCOVA
Primary
Mean Pain Scores at Endpoint
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Endpoint | 5.12 score on scale | Standard Error 0.19 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Endpoint | 4.81 score on scale | Standard Error 0.2 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Endpoint | 4.26 score on scale | Standard Error 0.2 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Endpoint | 4.49 score on scale | Standard Error 0.19 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.26295% CI: [-0.85, 0.23]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00295% CI: [-1.39, -0.32]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01995% CI: [-1.15, -0.1]ANCOVA
Primary
Mean Pain Scores at Week 1
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 1
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 1 | 5.96 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 1 | 5.45 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 1 | 5.21 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 1 | 5.23 score on scale | Standard Error 0.17 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.03895% CI: [-0.99, -0.03]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00295% CI: [-1.22, -0.27]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00295% CI: [-1.19, -0.26]repeated measures analysis
Primary
Mean Pain Scores at Week 10
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 10
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 10 | 5.08 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 10 | 4.86 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 10 | 4.18 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 10 | 4.56 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.36495% CI: [-0.71, 0.26]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.39, -0.42]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.03195% CI: [-1, -0.05]repeated measures analysis
Primary
Mean Pain Scores at Week 11
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 11
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 11 | 5.12 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 11 | 4.88 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 11 | 4.18 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 11 | 4.47 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.32695% CI: [-0.73, 0.24]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.43, -0.46]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00795% CI: [-1.13, -0.18]repeated measures analysis
Primary
Mean Pain Scores at Week 12
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 12
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 12 | 5.00 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 12 | 4.71 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 12 | 4.15 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 12 | 4.37 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.24195% CI: [-0.78, 0.2]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00195% CI: [-1.34, -0.37]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0195% CI: [-1.1, -0.15]repeated measures analysis
Primary
Mean Pain Scores at Week 13
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 13
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 13 | 4.97 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 13 | 4.70 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 13 | 4.16 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 13 | 4.36 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.28195% CI: [-0.76, 0.22]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00195% CI: [-1.3, -0.33]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01295% CI: [-1.09, -0.14]repeated measures analysis
Primary
Mean Pain Scores at Week 2
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 2
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 2 | 5.75 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 2 | 5.27 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 2 | 4.76 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 2 | 4.73 score on scale | Standard Error 0.17 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.04895% CI: [-0.97, 0]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.47, -0.52]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.49, -0.56]repeated measures analysis
Primary
Mean Pain Scores at Week 3
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 3
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 3 | 5.59 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 3 | 5.18 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 3 | 4.63 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 3 | 4.60 score on scale | Standard Error 0.17 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.09695% CI: [-0.89, 0.07]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.44, -0.48]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.46, -0.52]repeated measures analysis
Primary
Mean Pain Scores at Week 4
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week4
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 4 | 5.43 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 4 | 5.14 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 4 | 4.57 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 4 | 4.50 score on scale | Standard Error 0.17 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.22795% CI: [-0.78, 0.18]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.34, -0.38]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.4, -0.46]repeated measures analysis
Primary
Mean Pain Scores at Week 5
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 5
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 5 | 5.29 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 5 | 5.15 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 5 | 4.42 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 5 | 4.55 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.57795% CI: [-0.62, 0.35]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.35, -0.39]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00295% CI: [-1.22, -0.27]repeated measures analysis
Primary
Mean Pain Scores at Week 6
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 6
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 6 | 5.29 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 6 | 5.02 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 6 | 4.31 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 6 | 4.54 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.27595% CI: [-0.75, 0.21]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.46, -0.5]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00295% CI: [-1.22, -0.28]repeated measures analysis
Primary
Mean Pain Scores at Week 7
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 7
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 7 | 5.14 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 7 | 4.90 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 7 | 4.24 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 7 | 4.48 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.33495% CI: [-0.72, 0.25]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.38, -0.42]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00695% CI: [-1.14, -0.19]repeated measures analysis
Primary
Mean Pain Scores at Week 8
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 8
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 8 | 5.04 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 8 | 4.89 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 8 | 4.23 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 8 | 4.47 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.5395% CI: [-0.64, 0.33]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00195% CI: [-1.3, -0.33]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01795% CI: [-1.05, -0.1]repeated measures analysis
Primary
Mean Pain Scores at Week 9
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain.
Time frame: Week 9
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Pain Scores at Week 9 | 5.08 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Pain Scores at Week 9 | 4.87 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Pain Scores at Week 9 | 4.22 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Mean Pain Scores at Week 9 | 4.50 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.39295% CI: [-0.7, 0.27]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.35, -0.38]repeated measures analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01695% CI: [-1.06, -0.11]repeated measures analysis
Primary
Number of Responders
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Responders | 15 participants |
| Pregabalin 150 mg/Day | Number of Responders | 21 participants |
| Pregabalin 300 mg/Day | Number of Responders | 32 participants |
| Pregabalin 600 mg/Day | Number of Responders | 30 participants |
Comparison: Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.116Cochran-Mantel-Haenszel
Comparison: Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0015Cochran-Mantel-Haenszel
Comparison: Proportion of responders were used for the statistical analyses. Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0107Cochran-Mantel-Haenszel
Secondary
Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire
Affective score range from 0-12. Higher scores indicate more severe pain.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire | 2.43 score on scale | Standard Error 0.22 |
| Pregabalin 150 mg/Day | Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire | 2.14 score on scale | Standard Error 0.23 |
| Pregabalin 300 mg/Day | Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire | 1.72 score on scale | Standard Error 0.23 |
| Pregabalin 600 mg/Day | Endpoint Affective Scores of the Short-Form McGill Pain Questionnaire | 1.82 score on scale | Standard Error 0.22 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.34995% CI: [-0.91, 0.32]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.02495% CI: [-1.32, -0.1]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.04595% CI: [-1.21, -0.01]ANCOVA
Secondary
Endpoint Clinical Global Impression Change
Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Clinical Global Impression Change | 3.3 score on scale | Standard Deviation 1.1 |
| Pregabalin 150 mg/Day | Endpoint Clinical Global Impression Change | 3.1 score on scale | Standard Deviation 1.2 |
| Pregabalin 300 mg/Day | Endpoint Clinical Global Impression Change | 2.7 score on scale | Standard Deviation 1.1 |
| Pregabalin 600 mg/Day | Endpoint Clinical Global Impression Change | 2.7 score on scale | Standard Deviation 1.1 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.344Cochran-Mantel-Haenszel
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep
Number of participants who reported Optimal Sleep
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep | 37 participants |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep | 26 participants |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep | 48 participants |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale: Number of Participants With Optimal Sleep | 44 participants |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.284295% CI: [0.34, 1.37]Regression, Logistic
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.057795% CI: [0.98, 3.66]Regression, Logistic
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.189395% CI: [0.81, 2.95]Regression, Logistic
Secondary
Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache
Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache | 5.99 score on scale | Standard Error 1.61 |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache | 6.70 score on scale | Standard Error 1.72 |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache | 6.70 score on scale | Standard Error 1.69 |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Awaken Short of Breath or With Headache | 4.95 score on scale | Standard Error 1.62 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.7695% CI: [-3.83, 5.24]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.75495% CI: [-3.75, 5.18]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.64195% CI: [-5.43, 3.35]ANCOVA
Secondary
Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index
Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index | 29.22 score on scale | Standard Error 1.5 |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index | 25.19 score on scale | Standard Error 1.59 |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index | 26.03 score on scale | Standard Error 1.58 |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Overall Sleep Problem Index | 26.78 score on scale | Standard Error 1.5 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.06195% CI: [-8.25, 0.18]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.13395% CI: [-7.37, 0.98]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.2495% CI: [-6.52, 1.64]ANCOVA
Secondary
Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep
Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep | 6.58 score on scale | Standard Error 0.11 |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep | 6.59 score on scale | Standard Error 0.12 |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep | 6.85 score on scale | Standard Error 0.12 |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Quantity of Sleep | 6.79 score on scale | Standard Error 0.11 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.95595% CI: [-0.3, 0.32]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.08495% CI: [-0.04, 0.58]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.1795% CI: [-0.09, 0.52]ANCOVA
Secondary
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy
Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy | 63.37 score on scale | Standard Error 2.67 |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy | 67.38 score on scale | Standard Error 2.85 |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy | 73.67 score on scale | Standard Error 2.82 |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Adequacy | 69.37 score on scale | Standard Error 2.69 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.29695% CI: [-3.52, 11.55]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00795% CI: [2.87, 17.73]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.10695% CI: [-1.29, 13.3]ANCOVA
Secondary
Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance
Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance | 31.99 score on scale | Standard Error 1.88 |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance | 23.09 score on scale | Standard Error 2 |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance | 23.75 score on scale | Standard Error 1.99 |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Sleep Disturbance | 20.65 score on scale | Standard Error 1.88 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00195% CI: [-14.2, -3.61]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00295% CI: [-13.5, -2.99]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-16.5, -6.22]ANCOVA
Secondary
Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring
Score range for snoring is 0-100.Higher scores indicate more of the attribute.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring | 22.28 score on scale | Standard Error 2.57 |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring | 26.58 score on scale | Standard Error 2.74 |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring | 25.24 score on scale | Standard Error 2.73 |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Snoring | 31.99 score on scale | Standard Error 2.59 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.24595% CI: [-2.95, 11.54]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.41795% CI: [-4.2, 10.11]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00795% CI: [2.67, 16.74]ANCOVA
Secondary
Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence
Score range for Somnolence is 0-100. Higher scores indicate more of the attribute.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence | 30.23 score on scale | Standard Error 2.09 |
| Pregabalin 150 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence | 34.16 score on scale | Standard Error 2.23 |
| Pregabalin 300 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence | 41.45 score on scale | Standard Error 2.19 |
| Pregabalin 600 mg/Day | Endpoint Medical Outcomes Study Sleep Scale Scores:Somnolence | 44.46 score on scale | Standard Error 2.1 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.19195% CI: [-1.97, 9.83]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [5.41, 17.02]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [8.5, 19.95]ANCOVA
Secondary
Endpoint Patient Global Impression Change
Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Patient Global Impression Change | 3.6 score on scale | Standard Deviation 1.2 |
| Pregabalin 150 mg/Day | Endpoint Patient Global Impression Change | 3.3 score on scale | Standard Deviation 1.2 |
| Pregabalin 300 mg/Day | Endpoint Patient Global Impression Change | 2.9 score on scale | Standard Deviation 1 |
| Pregabalin 600 mg/Day | Endpoint Patient Global Impression Change | 3.0 score on scale | Standard Deviation 1.2 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0466Cochran-Mantel-Haenszel
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire
Present pain intensity score range from 0-5. Higher scores indicate more severe pain.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire | 2.21 score on scale | Standard Error 0.1 |
| Pregabalin 150 mg/Day | Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire | 2.01 score on scale | Standard Error 0.11 |
| Pregabalin 300 mg/Day | Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire | 1.78 score on scale | Standard Error 0.11 |
| Pregabalin 600 mg/Day | Endpoint Present Pain Intensity Scores of the Short-Form McGill Pain Questionnaire | 1.90 score on scale | Standard Error 0.1 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.17895% CI: [-0.48, 0.09]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00395% CI: [-0.72, -0.15]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0395% CI: [-0.59, -0.03]ANCOVA
Secondary
Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire
Sensory score range from 0-33. Higher scores indicate more severe pain.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire | 8.97 score on scale | Standard Error 0.57 |
| Pregabalin 150 mg/Day | Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire | 8.42 score on scale | Standard Error 0.61 |
| Pregabalin 300 mg/Day | Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire | 7.11 score on scale | Standard Error 0.6 |
| Pregabalin 600 mg/Day | Endpoint Sensory Scores of the Short-Form McGill Pain Questionnaire | 6.97 score on scale | Standard Error 0.57 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.50595% CI: [-2.16, 1.06]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.02395% CI: [-3.46, -0.26]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01295% CI: [-3.56, -0.44]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain | 47.47 score on scale | Standard Error 1.82 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain | 48.09 score on scale | Standard Error 1.94 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain | 54.54 score on scale | Standard Error 1.91 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Bodily Pain | 52.50 score on scale | Standard Error 1.83 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.81195% CI: [-4.5, 5.75]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00695% CI: [2.03, 12.12]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.04795% CI: [0.06, 10]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception | 52.36 score on scale | Standard Error 1.49 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception | 57.66 score on scale | Standard Error 1.59 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception | 56.19 score on scale | Standard Error 1.57 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: General Health Perception | 56.30 score on scale | Standard Error 1.5 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01395% CI: [1.1, 9.5]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0795% CI: [-0.31, 7.96]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.05895% CI: [-0.13, 8]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: Mental Health
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: Mental Health | 61.91 score on scale | Standard Error 1.95 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Mental Health | 65.90 score on scale | Standard Error 2.08 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Mental Health | 68.90 score on scale | Standard Error 2.05 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Mental Health | 66.67 score on scale | Standard Error 1.96 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05p-value: 0.15495% CI: [-1.5, 9.49]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01295% CI: [1.58, 12.4]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.07995% CI: [-0.56, 10.08]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning | 76.16 score on scale | Standard Error 1.28 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning | 79.68 score on scale | Standard Error 1.37 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning | 76.93 score on scale | Standard Error 1.34 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Physical Functioning | 77.20 score on scale | Standard Error 1.28 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.05795% CI: [-0.1, 7.13]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.6795% CI: [-2.78, 4.32]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.55995% CI: [-2.45, 4.53]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional | 69.99 score on scale | Standard Error 2.4 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional | 76.14 score on scale | Standard Error 2.56 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional | 75.41 score on scale | Standard Error 2.52 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Emotional | 73.02 score on scale | Standard Error 2.41 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.07595% CI: [-0.63, 12.92]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.11195% CI: [-1.25, 12.08]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.36695% CI: [-3.55, 9.6]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical | 67.96 score on scale | Standard Error 2.26 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical | 77.35 score on scale | Standard Error 2.41 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical | 74.63 score on scale | Standard Error 2.38 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Role Limitations-Physical | 69.42 score on scale | Standard Error 2.28 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00495% CI: [3.01, 15.78]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.03795% CI: [0.39, 12.95]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.64395% CI: [-4.74, 7.66]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning | 75.28 score on scale | Standard Error 2.2 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning | 77.71 score on scale | Standard Error 2.35 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning | 82.69 score on scale | Standard Error 2.32 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Social Functioning | 77.11 score on scale | Standard Error 2.22 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.44395% CI: [-3.79, 8.65]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01895% CI: [1.28, 13.54]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.54995% CI: [-4.18, 7.85]ANCOVA
Secondary
Endpoint Short-Form 36-Item Health Survey Scores: Vitality
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Short-Form 36-Item Health Survey Scores: Vitality | 54.16 score on scale | Standard Error 1.9 |
| Pregabalin 150 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Vitality | 59.80 score on scale | Standard Error 2.02 |
| Pregabalin 300 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Vitality | 61.58 score on scale | Standard Error 2 |
| Pregabalin 600 mg/Day | Endpoint Short-Form 36-Item Health Survey Scores: Vitality | 58.31 score on scale | Standard Error 1.91 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.03995% CI: [0.29, 11]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00695% CI: [2.14, 12.69]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.11795% CI: [-1.05, 9.34]ANCOVA
Secondary
Endpoint Total Scores of the Short-Form McGill Pain Questionnaire
Total score range from 0-45. Higher scores indicate more severe pain.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Total Scores of the Short-Form McGill Pain Questionnaire | 11.39 score on scale | Standard Error 0.75 |
| Pregabalin 150 mg/Day | Endpoint Total Scores of the Short-Form McGill Pain Questionnaire | 10.56 score on scale | Standard Error 0.79 |
| Pregabalin 300 mg/Day | Endpoint Total Scores of the Short-Form McGill Pain Questionnaire | 8.84 score on scale | Standard Error 0.79 |
| Pregabalin 600 mg/Day | Endpoint Total Scores of the Short-Form McGill Pain Questionnaire | 8.78 score on scale | Standard Error 0.75 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.44195% CI: [-2.93, 1.28]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01795% CI: [-4.64, -0.46]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01295% CI: [-4.65, -0.56]ANCOVA
Secondary
Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire
Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire | 50.02 mm | Standard Error 2.15 |
| Pregabalin 150 mg/Day | Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire | 47.80 mm | Standard Error 2.28 |
| Pregabalin 300 mg/Day | Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire | 41.99 mm | Standard Error 2.25 |
| Pregabalin 600 mg/Day | Endpoint Visual Analogue Scale Scores of the Short-Form McGill Pain Questionnaire | 42.59 mm | Standard Error 2.14 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.4795% CI: [-8.28, 3.83]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00895% CI: [-14, -2.06]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.01395% CI: [-13.3, -1.59]ANCOVA
Secondary
Mean Sleep Interference Scores at Endpoint
Scores range from 0-10. Higher scores indicate more severe interference with sleep.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Endpoint | 3.20 score on scale | Standard Error 0.17 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Endpoint | 2.44 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Endpoint | 2.39 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Endpoint | 2.26 score on scale | Standard Error 0.17 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00195% CI: [-1.23, -0.3]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.00195% CI: [-1.27, -0.34]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.00195% CI: [-1.4, -0.49]ANCOVA
Secondary
Mean Sleep Interference Scores at Week 1
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 1
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 1 | 3.79 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 1 | 3.00 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 1 | 2.97 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 1 | 2.81 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 10
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 10
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 10 | 3.16 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 10 | 2.46 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 10 | 2.39 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 10 | 2.28 score on scale | Standard Error 0.16 |
Secondary
Mean Sleep Interference Scores at Week 11
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 11
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 11 | 3.16 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 11 | 2.43 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 11 | 2.37 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 11 | 2.27 score on scale | Standard Error 0.16 |
Secondary
Mean Sleep Interference Scores at Week 12
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 12
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 12 | 3.06 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 12 | 2.36 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 12 | 2.28 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 12 | 2.21 score on scale | Standard Error 0.16 |
Secondary
Mean Sleep Interference Scores at Week 13
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 13
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 13 | 3.08 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 13 | 2.33 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 13 | 2.27 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 13 | 2.19 score on scale | Standard Error 0.16 |
Secondary
Mean Sleep Interference Scores at Week 2
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 2
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 2 | 3.56 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 2 | 2.89 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 2 | 2.76 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 2 | 2.49 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 3
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 3
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 3 | 3.50 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 3 | 2.81 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 3 | 2.60 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 3 | 2.43 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 4
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 4
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 4 | 3.35 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 4 | 2.79 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 4 | 2.54 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 4 | 2.36 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 5
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 5
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 5 | 3.26 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 5 | 2.74 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 5 | 2.39 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 5 | 2.41 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 6
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 6
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 6 | 3.24 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 6 | 2.63 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 6 | 2.37 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 6 | 2.33 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 7
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 7
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 7 | 3.19 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 7 | 2.55 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 7 | 2.36 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 7 | 2.21 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 8
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 8
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 8 | 3.10 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 8 | 2.49 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 8 | 2.30 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 8 | 2.14 score on scale | Standard Error 0.15 |
Secondary
Mean Sleep Interference Scores at Week 9
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep.
Time frame: week 9
Population: Full analysis set. Observed case.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Sleep Interference Scores at Week 9 | 3.17 score on scale | Standard Error 0.15 |
| Pregabalin 150 mg/Day | Mean Sleep Interference Scores at Week 9 | 2.44 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Mean Sleep Interference Scores at Week 9 | 2.38 score on scale | Standard Error 0.16 |
| Pregabalin 600 mg/Day | Mean Sleep Interference Scores at Week 9 | 2.22 score on scale | Standard Error 0.16 |
Secondary
Number of Patients Not Reporting Allodynia
Participants not reporting allodynia.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Patients Not Reporting Allodynia | 65 participants |
| Pregabalin 150 mg/Day | Number of Patients Not Reporting Allodynia | 52 participants |
| Pregabalin 300 mg/Day | Number of Patients Not Reporting Allodynia | 63 participants |
| Pregabalin 600 mg/Day | Number of Patients Not Reporting Allodynia | 66 participants |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.645195% CI: [0.45, 3.59]Regression, Logistic
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.074595% CI: [0.91, 7.19]Regression, Logistic
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.178795% CI: [0.73, 5.58]Regression, Logistic
Secondary
Number of Patients Not Reporting Hyperalgesia
Participants not reporting hyperalgesia.
Time frame: Week13/discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Patients Not Reporting Hyperalgesia | 66 participants |
| Pregabalin 150 mg/Day | Number of Patients Not Reporting Hyperalgesia | 55 participants |
| Pregabalin 300 mg/Day | Number of Patients Not Reporting Hyperalgesia | 66 participants |
| Pregabalin 600 mg/Day | Number of Patients Not Reporting Hyperalgesia | 65 participants |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.073295% CI: [0.93, 5.52]Regression, Logistic
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.035395% CI: [1.07, 6.53]Regression, Logistic
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.039395% CI: [1.05, 5.96]Regression, Logistic