Neuropathic Pain
Conditions
Keywords
post-traumatic peripheral neuropathic pain
Brief summary
This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
Interventions
DRUGpregabalin
capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
DRUGplacebo
capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
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, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury. * Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms. * Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.
Exclusion criteria
* Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II). * Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain. * Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening. * Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction \[heart attack\] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism. * Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable. * Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment. * Use of prohibited medications in the absence of appropriate washout periods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Mean Pain Score | Baseline | This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. |
| Change From Baseline to Week 15 in Weekly Mean Pain Score | up to Week 15 | This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf]) | Week 15 | A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome. |
| Change From Baseline in Pain Interference Index (BPI-sf) | Week 15 | BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes). The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores. |
| Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Week 15 | A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale. |
| Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Baseline | MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours. |
| Patient Global Impression of Change (PGIC) at Week 15 | Week 15 | A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale. |
| Percentage of Participants in MOS-SS With Optimal Sleep Status. | Week 15 | MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable. |
| Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 15 | Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7\*(n-1) to Day 1+7\*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain. |
| Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 15 | Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7\*(n-1) to Day 1+7\*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain. |
| Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Week 15 | MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours. |
| Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | up to Week 15 | This is an 11-point NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep \[unable to sleep due to pain\]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context. Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7\*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings. Overall is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks. |
Countries
Bulgaria, Canada, Croatia, Denmark, Germany, Hungary, Poland, Puerto Rico, Romania, South Africa, South Korea, Sweden, United States
Participant flow
Recruitment details
A total of 187 centers participated in the study in 14 countries. During screening, with the exception of daily pain score data that was collected to determine participants eligibility, no participants were treated with active drug and no efficacy data were collected. Only safety and no efficacy data was collected during the taper period.
Pre-assignment details
Participants had clinic visits at screening, randomization, and during the treatment period, and a phone contact for follow-up after the last taper dose. All the eligible participants were randomly assigned (1:1) to 15 weeks of treatment with Pregabalin or Placebo.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase. | 274 |
| Placebo Participants randomized to receive placebo | 265 |
| Total | 539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse events not related to study drug | 1 | 6 |
| Overall Study | Adverse events related to study drug | 12 | 10 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Insufficient clinical response | 6 | 6 |
| Overall Study | Lost to Follow-up | 6 | 9 |
| Overall Study | No longer willing to participate | 8 | 14 |
| Overall Study | Protocol Violation | 5 | 3 |
| Overall Study | Randomized but not treated | 1 | 2 |
| Overall Study | Reasons other than those mentioned above | 3 | 5 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 52.8 Years STANDARD_DEVIATION 12.9 | 53.4 Years STANDARD_DEVIATION 12.7 | 53.1 Years STANDARD_DEVIATION 12.8 |
| Age, Customized 18 - 44 years | 59 Participants | 61 Participants | 120 Participants |
| Age, Customized 45 - 64 years | 163 Participants | 154 Participants | 317 Participants |
| Age, Customized >=65 years | 52 Participants | 50 Participants | 102 Participants |
| Sex: Female, Male Female | 132 Participants | 134 Participants | 266 Participants |
| Sex: Female, Male Male | 142 Participants | 131 Participants | 273 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 75 / 274 | 33 / 265 |
| serious Total, serious adverse events | 2 / 274 | 7 / 265 |
Outcome results
Primary
Baseline Mean Pain Score
This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Time frame: Baseline
Population: Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Baseline Mean Pain Score | 6.41 units on a scale | Standard Deviation 1.3 |
| Placebo | Baseline Mean Pain Score | 6.54 units on a scale | Standard Deviation 1.3 |
Primary
Change From Baseline to Week 15 in Weekly Mean Pain Score
This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Time frame: up to Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline to Week 15 in Weekly Mean Pain Score | -2.12 units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline to Week 15 in Weekly Mean Pain Score | -1.90 units on a scale | Standard Error 0.16 |
p-value: 0.182395% CI: [-0.54, 0.1]Mixed Model Repeated Measures Analysis
Secondary
Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.
Time frame: Baseline
Population: ITT population: all randomized participants who took at least one dose of study drug.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Disturbance Score (N = 274, 265) | 42.50 Units on a scale | Full Range 25.791 |
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Adequancy Score (N = 274, 265) | 40.0 Units on a scale | Full Range 28.153 |
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Snoring Score (N = 272, 263) | 20.0 Units on a scale | Full Range 33.482 |
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Awaken Short of Breath Score (N = 274, 265) | 0.0 Units on a scale | Full Range 25.647 |
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Quantity of Sleep Score (hours) (N = 273, 265) | 6.0 Units on a scale | Full Range 1.36 |
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Somnolence Score (N = 274, 265) | 26.67 Units on a scale | Full Range 21.618 |
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Problem Index (9) Score (N = 274, 265) | 40.56 Units on a scale | Full Range 20.282 |
| Pregabalin | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Optimal Sleep Score (N = 273, 265) | 0.0 Units on a scale | Full Range 0.476 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Optimal Sleep Score (N = 273, 265) | 0.0 Units on a scale | Full Range 0.487 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Disturbance Score (N = 274, 265) | 43.75 Units on a scale | Full Range 25.08 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Quantity of Sleep Score (hours) (N = 273, 265) | 6.0 Units on a scale | Full Range 1.411 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Adequancy Score (N = 274, 265) | 40.0 Units on a scale | Full Range 28.582 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Problem Index (9) Score (N = 274, 265) | 41.11 Units on a scale | Full Range 19.72 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Snoring Score (N = 272, 263) | 20.0 Units on a scale | Full Range 34.084 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Somnolence Score (N = 274, 265) | 26.67 Units on a scale | Full Range 19.884 |
| Placebo | Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Awaken Short of Breath Score (N = 274, 265) | 0.0 Units on a scale | Full Range 21.541 |
Secondary
Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)
This is an 11-point NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep \[unable to sleep due to pain\]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context. Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7\*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings. Overall is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.
Time frame: up to Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Baseline (raw scores) (N = 274, 265) | 4.97 units on a scale | Standard Deviation 2.3 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 1 (N = 260, 258) | -0.66 units on a scale | Standard Deviation 1.1 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 2 (N = 254, 244) | -1.15 units on a scale | Standard Deviation 1.51 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 4 (N = 245, 229) | -1.73 units on a scale | Standard Deviation 1.8 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 10 (N = 229, 212) | -2.04 units on a scale | Standard Deviation 2.11 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 5 (N = 241, 226) | -1.87 units on a scale | Standard Deviation 1.87 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 14 (N = 222, 208) | -2.19 units on a scale | Standard Deviation 2.16 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 8 (N = 236, 212) | -2.05 units on a scale | Standard Deviation 2 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 9 (N = 232, 214) | -2.09 units on a scale | Standard Deviation 1.99 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 6 (N = 244, 227) | -1.94 units on a scale | Standard Deviation 1.95 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 15 (N = 196, 186) | -2.13 units on a scale | Standard Deviation 2.17 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 11 (N = 230, 211) | -2.09 units on a scale | Standard Deviation 2.05 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Overall (N = 269, 262) | -1.83 units on a scale | Standard Deviation 1.93 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 12 (N = 227, 209) | -2.17 units on a scale | Standard Deviation 2.06 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 7 (N = 240, 216) | -2.01 units on a scale | Standard Deviation 1.99 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 13 (N = 225, 204) | -2.19 units on a scale | Standard Deviation 2.06 |
| Pregabalin | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 3 (N = 252, 245) | -1.55 units on a scale | Standard Deviation 1.73 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 13 (N = 225, 204) | -1.70 units on a scale | Standard Deviation 1.9 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 1 (N = 260, 258) | -0.28 units on a scale | Standard Deviation 0.91 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 2 (N = 254, 244) | -0.81 units on a scale | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 5 (N = 241, 226) | -1.40 units on a scale | Standard Deviation 1.68 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 7 (N = 240, 216) | -1.50 units on a scale | Standard Deviation 1.78 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 8 (N = 236, 212) | -1.52 units on a scale | Standard Deviation 1.76 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 14 (N = 222, 208) | -1.79 units on a scale | Standard Deviation 1.89 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 15 (N = 196, 186) | -1.83 units on a scale | Standard Deviation 1.87 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Overall (N = 269, 262) | -1.37 units on a scale | Standard Deviation 1.71 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 3 (N = 252, 245) | -1.14 units on a scale | Standard Deviation 1.45 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 4 (N = 245, 229) | -1.30 units on a scale | Standard Deviation 1.63 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 6 (N = 244, 227) | -1.46 units on a scale | Standard Deviation 1.79 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 9 (N = 232, 214) | -1.55 units on a scale | Standard Deviation 1.86 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 10 (N = 229, 212) | -1.55 units on a scale | Standard Deviation 1.83 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 11 (N = 230, 211) | -1.64 units on a scale | Standard Deviation 1.79 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Week 12 (N = 227, 209) | -1.68 units on a scale | Standard Deviation 1.89 |
| Placebo | Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS) | Baseline (raw scores) (N = 274, 265) | 4.99 units on a scale | Standard Deviation 2.27 |
Comparison: Week 1p-value: 0.011995% CI: [-0.62, -0.08]Mixed Model Repeated Measures Analysis
Comparison: Week 2p-value: 0.013595% CI: [-0.62, -0.07]Mixed Model Repeated Measures Analysis
Comparison: Week 3p-value: 0.002895% CI: [-0.69, -0.14]Mixed Model Repeated Measures Analysis
Comparison: Week 4p-value: 0.001695% CI: [-0.72, -0.17]Mixed Model Repeated Measures Analysis
Comparison: Week 5p-value: 0.000795% CI: [-0.75, -0.2]Mixed Model Repeated Measures Analysis
Comparison: Week 6p-value: 0.000695% CI: [-0.76, -0.21]Mixed Model Repeated Measures Analysis
Comparison: Week 7p-value: 0.000895% CI: [-0.75, -0.2]Mixed Model Repeated Measures Analysis
Comparison: Week 8p-value: 0.000395% CI: [-0.79, -0.24]Mixed Model Repeated Measures Analysis
Comparison: Week 9p-value: 0.000195% CI: [-0.82, -0.26]Mixed Model Repeated Measures Analysis
Comparison: Week 10p-value: 0.000595% CI: [-0.77, -0.22]Mixed Model Repeated Measures Analysis
Comparison: Week 11p-value: 0.000795% CI: [-0.76, -0.2]Mixed Model Repeated Measures Analysis
Comparison: Week 12p-value: 0.000195% CI: [-0.82, -0.27]Mixed Model Repeated Measures Analysis
Comparison: Week 13p-value: <0.000195% CI: [-0.84, -0.28]Mixed Model Repeated Measures Analysis
Comparison: Week 14p-value: 0.000595% CI: [-0.78, -0.22]Mixed Model Repeated Measures Analysis
Comparison: Week 15p-value: 0.003195% CI: [-0.71, -0.14]Mixed Model Repeated Measures Analysis
Comparison: Overallp-value: 0.000195% CI: [-0.71, -0.23]Mixed Model Repeated Measures Analysis
Secondary
Change From Baseline in Pain Interference Index (BPI-sf)
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes). The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.
Time frame: Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Pain Interference Index (BPI-sf) | -1.72 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Pain Interference Index (BPI-sf) | -1.33 units on a scale | Standard Error 0.13 |
p-value: 0.016895% CI: [-0.7, -0.07]ANCOVA
Secondary
Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])
A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.
Time frame: Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf]) | -2.40 units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf]) | -1.95 units on a scale | Standard Error 0.13 |
p-value: 0.00595% CI: [-0.77, -0.14]ANCOVA
Secondary
Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores
A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.
Time frame: Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Usual activities | -0.12 Units on a scale | Standard Error 0.03 |
| Pregabalin | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Dolan 2001 Index Score | -0.13 Units on a scale | Standard Error 0.02 |
| Pregabalin | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Self-care | -0.08 Units on a scale | Standard Error 0.02 |
| Pregabalin | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Pain/Discomfort | -0.35 Units on a scale | Standard Error 0.03 |
| Pregabalin | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Anxiety/Depression | 0.01 Units on a scale | Standard Error 0.03 |
| Pregabalin | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Dolan 1997 Index Score | 0.12 Units on a scale | Standard Error 0.01 |
| Pregabalin | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Mobility | -0.10 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Dolan 1997 Index Score | 0.11 Units on a scale | Standard Error 0.01 |
| Placebo | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Mobility | -0.09 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Self-care | -0.06 Units on a scale | Standard Error 0.02 |
| Placebo | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Usual activities | -0.13 Units on a scale | Standard Error 0.04 |
| Placebo | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Anxiety/Depression | -0.02 Units on a scale | Standard Error 0.03 |
| Placebo | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Dolan 2001 Index Score | -0.12 Units on a scale | Standard Error 0.02 |
| Placebo | Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores | Pain/Discomfort | -0.29 Units on a scale | Standard Error 0.04 |
Comparison: This statistical analysis is for mobilityp-value: 0.684195% CI: [-0.09, 0.06]ANCOVA
Comparison: This statistical analysis is for self-carep-value: 0.656495% CI: [-0.07, 0.04]ANCOVA
Comparison: This statistical analysis is for usual activitiesp-value: 0.85995% CI: [-0.08, 0.09]ANCOVA
Comparison: This statistical analysis is for pain/discomfortp-value: 0.162895% CI: [-0.14, 0.02]ANCOVA
Comparison: This statistical analysis is for anxiety/depressionp-value: 0.465495% CI: [-0.05, 0.1]ANCOVA
Comparison: This statistical analysis is for Dolan 1997 Index scorep-value: 0.595% CI: [-0.02, 0.04]ANCOVA
Comparison: This statistical analysis is for Dolan 2001 Index Scorep-value: 0.549395% CI: [-0.07, 0.04]ANCOVA
Secondary
Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores. Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement. Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement. Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.
Time frame: Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Disturbance Score (N = 257, 245) | -14.71 Units on a scale |
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Adequancy Score (N=257, 245) | 10.13 Units on a scale |
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Snoring Score (N = 257, 245) | -2.22 Units on a scale |
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Quantity of Sleep Score (hours) (N = 257, 245) | 0.42 Units on a scale |
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Somnolence Score (N = 257, 245) | -1.61 Units on a scale |
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Problem Index (9) Score (N = 257, 245) | -9.86 Units on a scale |
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Awaken Short of Breath Score (N = 257, 245) | -3.61 Units on a scale |
| Pregabalin | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Optimal Sleep Score (N = 256, 245) | 0.11 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Somnolence Score (N = 257, 245) | -3.74 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Disturbance Score (N = 257, 245) | -11.24 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Awaken Short of Breath Score (N = 257, 245) | -3.03 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Adequancy Score (N=257, 245) | 8.16 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Optimal Sleep Score (N = 256, 245) | 0.04 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Snoring Score (N = 257, 245) | -3.27 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Quantity of Sleep Score (hours) (N = 257, 245) | 0.26 Units on a scale |
| Placebo | Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score. | Sleep Problem Index (9) Score (N = 257, 245) | -8.19 Units on a scale |
Comparison: Statistical analysis for Sleep Disturbance Scorep-value: 0.054595% CI: [-0.07, 7]ANCOVA
Comparison: Statistical analysis for Sleep Adequancy Scorep-value: 0.391395% CI: [-6.47, 2.54]ANCOVA
Comparison: Statistical analysis for Snoring Scorep-value: 0.605995% CI: [-5.06, 2.96]ANCOVA
Comparison: Statistical analysis for Awaken Short of Breath Scorep-value: 0.731795% CI: [-2.76, 3.93]ANCOVA
Comparison: Statistical analysis for Quantity of Sleep Score (hours)p-value: 0.266395% CI: [-0.45, 0.12]ANCOVA
Comparison: Statistical analysis for Somnolence Scorep-value: 0.156295% CI: [-5.08, 0.82]ANCOVA
Comparison: Statistical analysis for Sleep Problem Index (9) Scorep-value: 0.24995% CI: [-1.18, 4.53]ANCOVA
Comparison: Statistical analysis for Optimal Sleep Scorep-value: 0.060995% CI: [-0.15, 0]ANCOVA
Secondary
Patient Global Impression of Change (PGIC) at Week 15
A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.
Time frame: Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient Global Impression of Change (PGIC) at Week 15 | Much worse | 0 Participants |
| Pregabalin | Patient Global Impression of Change (PGIC) at Week 15 | Minimally improved | 61 Participants |
| Pregabalin | Patient Global Impression of Change (PGIC) at Week 15 | Very much worse | 1 Participants |
| Pregabalin | Patient Global Impression of Change (PGIC) at Week 15 | No change | 34 Participants |
| Pregabalin | Patient Global Impression of Change (PGIC) at Week 15 | Much improved | 105 Participants |
| Pregabalin | Patient Global Impression of Change (PGIC) at Week 15 | Minimally worse | 5 Participants |
| Pregabalin | Patient Global Impression of Change (PGIC) at Week 15 | Very much improved | 52 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 15 | Minimally worse | 9 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 15 | Much worse | 4 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 15 | Very much worse | 0 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 15 | Very much improved | 41 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 15 | Much improved | 79 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 15 | Minimally improved | 62 Participants |
| Placebo | Patient Global Impression of Change (PGIC) at Week 15 | No change | 51 Participants |
p-value: 0.0012Cochran-Mantel-Haenszel
Secondary
Percentage of Participants in MOS-SS With Optimal Sleep Status.
MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.
Time frame: Week 15
Population: ITT population: all randomized subjects who took at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Percentage of Participants in MOS-SS With Optimal Sleep Status. | Any Improvements | 21.2 Percentage of participants |
| Pregabalin | Percentage of Participants in MOS-SS With Optimal Sleep Status. | No Change | 66.1 Percentage of participants |
| Pregabalin | Percentage of Participants in MOS-SS With Optimal Sleep Status. | Any Worsening | 6.2 Percentage of participants |
| Pregabalin | Percentage of Participants in MOS-SS With Optimal Sleep Status. | Not applicable | 6.6 Percentage of participants |
| Placebo | Percentage of Participants in MOS-SS With Optimal Sleep Status. | Not applicable | 7.5 Percentage of participants |
| Placebo | Percentage of Participants in MOS-SS With Optimal Sleep Status. | Any Improvements | 18.5 Percentage of participants |
| Placebo | Percentage of Participants in MOS-SS With Optimal Sleep Status. | Any Worsening | 13.2 Percentage of participants |
| Placebo | Percentage of Participants in MOS-SS With Optimal Sleep Status. | No Change | 60.8 Percentage of participants |
p-value: 0.7165Cochran-Mantel-Haenszel
Secondary
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.
Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7\*(n-1) to Day 1+7\*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
Time frame: Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 2 (N = 254, 244) | 27.17 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 15 (N = 196, 187) | 57.65 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 10 (N = 229, 212) | 52.84 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 7 (N = 240, 216) | 49.58 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 3 (N = 252, 245) | 38.89 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 12 (N = 227, 209) | 54.63 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 5 (N = 241, 226) | 45.64 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 4 (N = 246, 229) | 41.87 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 6 (N = 244, 227) | 48.77 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 13 (N = 226, 204) | 57.08 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 9 (N = 232, 214) | 50.86 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 8 (N = 236, 213) | 50.42 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 14 (N = 223, 208) | 57.40 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 11 (N = 231, 211) | 52.38 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 1 (N = 260, 258) | 11.92 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 11 (N = 231, 211) | 51.18 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 1 (N = 260, 258) | 5.04 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 2 (N = 254, 244) | 20.08 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 4 (N = 246, 229) | 34.50 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 8 (N = 236, 213) | 46.48 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 9 (N = 232, 214) | 47.66 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 12 (N = 227, 209) | 52.63 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 13 (N = 226, 204) | 54.41 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 14 (N = 223, 208) | 54.33 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 15 (N = 196, 187) | 58.29 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 3 (N = 252, 245) | 30.20 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 5 (N = 241, 226) | 38.05 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 6 (N = 244, 227) | 41.41 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 7 (N = 240, 216) | 43.06 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%. | Week 10 (N = 229, 212) | 47.17 Percentage of participants |
Comparison: Statistical analysis at Week 1p-value: 0.002895% CI: [1.5, 6.86]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 2p-value: 0.03695% CI: [1.03, 2.68]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 3p-value: 0.023595% CI: [1.07, 2.45]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 4p-value: 0.061995% CI: [0.98, 2.24]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 5p-value: 0.067795% CI: [0.97, 2.2]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 6p-value: 0.070795% CI: [0.97, 2.16]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 7p-value: 0.131395% CI: [0.91, 2.06]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 8p-value: 0.307295% CI: [0.82, 1.86]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 9p-value: 0.394795% CI: [0.79, 1.8]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 10p-value: 0.146295% CI: [0.9, 2.05]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 11p-value: 0.685495% CI: [0.72, 1.64]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 12p-value: 0.502595% CI: [0.76, 1.74]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 13p-value: 0.490895% CI: [0.76, 1.76]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 14p-value: 0.424595% CI: [0.78, 1.8]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 15p-value: 0.846495% CI: [0.61, 1.49]Gen linear model-logistic link function
Secondary
Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%
Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7\*(n-1) to Day 1+7\*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
Time frame: Week 15
Population: ITT population: all randomized participants who took at least one dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 1 (N = 260, 258) | 4.62 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 2 (N = 254, 244) | 11.42 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 3 (N = 252, 245) | 22.62 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 8 (N = 236, 213) | 33.05 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 9 (N = 232, 214) | 34.05 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 10 (N = 229, 212) | 32.75 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 12 (N = 227, 209) | 37.89 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 13 (N = 226, 204) | 35.84 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 14 (N = 223, 208) | 37.67 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 4 (N = 246, 229) | 25.20 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 5 (N = 241, 226) | 28.22 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 6 (N = 244, 227) | 29.51 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 7 (N= 240, 216) | 30.42 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 11 (N = 231, 211) | 34.20 Percentage of participants |
| Pregabalin | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 15 (N = 196, 187) | 39.80 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 5 (N = 241, 226) | 19.47 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 1 (N = 260, 258) | 2.33 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 13 (N = 226, 204) | 27.45 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 2 (N = 254, 244) | 6.97 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 9 (N = 232, 214) | 26.17 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 3 (N = 252, 245) | 13.47 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 7 (N= 240, 216) | 22.22 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 14 (N = 223, 208) | 29.81 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 8 (N = 236, 213) | 27.70 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 6 (N = 244, 227) | 22.91 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 4 (N = 246, 229) | 17.90 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 10 (N = 229, 212) | 26.42 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 11 (N = 231, 211) | 25.59 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 15 (N = 196, 187) | 34.22 Percentage of participants |
| Placebo | Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50% | Week 12 (N = 227, 209) | 26.79 Percentage of participants |
Comparison: Statistical analysis at Week 1p-value: 0.163395% CI: [0.74, 6]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 2p-value: 0.065295% CI: [0.96, 3.85]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 3p-value: 0.003995% CI: [1.29, 3.77]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 4p-value: 0.038295% CI: [1.03, 2.83]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 5p-value: 0.013795% CI: [1.14, 3.05]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 6p-value: 0.069395% CI: [0.97, 2.49]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 7p-value: 0.034995% CI: [1.04, 2.73]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 8p-value: 0.122795% CI: [0.91, 2.29]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 9p-value: 0.036495% CI: [1.03, 2.63]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 10p-value: 0.066795% CI: [0.97, 2.49]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 11p-value: 0.017695% CI: [1.1, 2.84]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 12p-value: 0.00395% CI: [1.27, 3.23]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 13p-value: 0.025695% CI: [1.07, 2.74]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 14p-value: 0.031495% CI: [1.05, 2.64]Gen linear model-logistic link function
Comparison: Statistical analysis at Week 15p-value: 0.188995% CI: [0.85, 2.21]Gen linear model-logistic link function