HIV Infections, Peripheral Neuropathy
Conditions
Brief summary
Study to determine if pregabalin is more effective than placebo in treating subjects with nerve pain associated with HIV neuropathy.
Interventions
DRUGpregabalin
75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4)
DRUGPlacebo
Placebo
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with confirmed diagnosis of HIV infection * HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study start * subjects with moderate to severe pain * subjects on stable HIV and pain medications (some medications are not allowed to be taken while participating in the study).
Exclusion criteria
* Pregnant or breast feeding females * subjects using street drugs or alcohol abusers during the study * subject's on anti-diabetic medications * use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior to study start and throughout the study * use of neurotoxic drugs (other than D-drugs) within a month prior to study start and throughout the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | Baseline, Week 14 | Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Baseline-Week 14 (Endpoint) | Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14). |
| Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) | Baseline, Week 14 | Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
| Gracely Pain Scale Score | Week 14 | The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment. |
| Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Baseline-Week 14 (Endpoint) | Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14) |
| Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Baseline, Week 14 | Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales sleep adequacy, quantity of sleep and optimal sleep low scores reflect impairment. |
| Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Baseline, Week 14 | Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21). |
| Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Baseline, Week 14 | Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from no pain (0) to pain as bad as you can imagine (10) |
| Change From Baseline for NRS-Sleep Interference Scores | Baseline, Week 14 | 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]) |
| Categorized Patient Global Impression of Change (PGIC) | Baseline, Week 14 | The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7). |
| Patient Global Impression of Change (PGIC) Rating | Baseline, Week 14, Endpoint-LOCF | PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). |
| Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Baseline, Week 14 | Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores |
| Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Baseline, Week 14 | Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable). |
| Change in NRS-Sleep Interference Scores | Baseline, Weeks 1-14 | Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week. |
| Shift in Hospital Anxiety and Depression (HADS) Subscales | Baseline, Week 14 | Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21. |
| Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Baseline, Weeks 1,2,6,10,14 and Endpoint | Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. |
| Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Baseline-Week 14 (Endpoint) | Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
| Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | Baseline-Week 14 (Endpoint) | Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
| Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) | Baseline, Week 14 | Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Weeks 1-14 endpoint BOCF | Number of subjects that experienced at least 30% decrease in mean weekly pain. |
| Duration Adjusted Average Change From Baseline in NRS Pain Scores | Weekly: Week 1 - Week 14 | Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation - mean at baseline)x(proportion of planned study duration that the subject completed). |
| Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Baseline, Weeks 1 - 14 and Endpoint-BOCF | Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR) |
| Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward) | Number of subjects that experienced at least a 50% decrease in mean weekly pain. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
43 centers in the United States; Study Initiation and Completion Dates: 6 October 2005 to 27 November 2007
Pre-assignment details
A total of 472 subjects were screened for the study, and 302 subjects were randomized to study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase. | 151 |
| Placebo Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio. | 151 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 9 | 4 |
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Other | 8 | 10 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 48.2 years STANDARD_DEVIATION 8.1 | 46.8 years STANDARD_DEVIATION 7.5 | 47.5 years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 26 Participants | 31 Participants | 57 Participants |
| Sex: Female, Male Male | 125 Participants | 120 Participants | 245 Participants |
Outcome results
Primary
Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, Week 14
Population: ITT population (ie, full analysis set)=all randomized participants who took at least 1 dose \& had at least 1 post-randomization efficacy assessment. The endpoint-LOCF mean value was computed from last 7 diary entries (Day 2 up to and including the day after the last dose w/n Dose-Adjustment or Maintenance phase (up to Day 99).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | -2.88 score on scale | Standard Error 0.21 |
| Placebo | Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline | -2.63 score on scale | Standard Error 0.21 |
Comparison: Primary hypotheses : null (H0): µA=µP vs alternative (HA): µA≠µP (µA and µP represent true means for primary endpoint in active treatment \& placebo groups respectively). Assumptions in power calculation: 2-sided test with type I error at α =0.05, type II error at β =0.10, \& a common s.d of 2.2 for primary endpoint (based on previous clinical trial data). With n=150 subjects/ group (300 subjects overall) at least 90% power to detect a treatment difference of at least 1.1 in primary endpointp-value: 0.391495% CI: [-0.83, 0.32]ANCOVA
Secondary
Categorized Patient Global Impression of Change (PGIC)
The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7).
Time frame: Baseline, Week 14
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Categorized Patient Global Impression of Change (PGIC) | Improved (scores 1-3) | 106 participants |
| Pregabalin | Categorized Patient Global Impression of Change (PGIC) | No Change (score 4) | 17 participants |
| Pregabalin | Categorized Patient Global Impression of Change (PGIC) | Worsened (scores 5-7) | 5 participants |
| Placebo | Categorized Patient Global Impression of Change (PGIC) | Improved (scores 1-3) | 84 participants |
| Placebo | Categorized Patient Global Impression of Change (PGIC) | No Change (score 4) | 32 participants |
| Placebo | Categorized Patient Global Impression of Change (PGIC) | Worsened (scores 5-7) | 10 participants |
p-value: 0.0077Cochran-Mantel-Haenszel
Secondary
Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales
Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21).
Time frame: Baseline, Week 14
Population: ITT population
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Anxiety | -1.33 score on scale | Standard Error 0.28 |
| Pregabalin | Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Depression | -1.10 score on scale | Standard Error 0.26 |
| Placebo | Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Anxiety | -1.59 score on scale | Standard Error 0.28 |
| Placebo | Change From Baseline for Hospital Anxiety and Depression Scale (HADS) Subscales | Depression | -1.52 score on scale | Standard Error 0.26 |
Comparison: Table above shows results of statistical analysis for Anxietyp-value: 0.510595% CI: [-0.51, 1.03]ANCOVA
Comparison: Table above shows results of statistical analysis for Depressionp-value: 0.251395% CI: [-0.3, 1.14]ANCOVA
Secondary
Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores
Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from no pain (0) to pain as bad as you can imagine (10)
Time frame: Baseline, Week 14
Population: ITT Population; n = number of participants with data for analysis reported (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Pain Severity Index (n=148,147) | -2.42 score on scale | Standard Error 0.19 |
| Pregabalin | Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Pain Interference Index (n=146,146) | -2.32 score on scale | Standard Error 0.18 |
| Placebo | Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Pain Severity Index (n=148,147) | -2.56 score on scale | Standard Error 0.19 |
| Placebo | Change From Baseline for Modified Brief Pain Inventory-Short Form (mBPI-sf) Scores | Pain Interference Index (n=146,146) | -2.39 score on scale | Standard Error 0.18 |
Comparison: Table above shows results of statistical analysis for Pain Severity Indexp-value: 0.583495% CI: [-0.38, 0.67]ANCOVA
Comparison: Table above shows results of statistical analysis for Pain Interference Indexp-value: 0.778395% CI: [-0.43, 0.57]ANCOVA
Secondary
Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices
Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales sleep adequacy, quantity of sleep and optimal sleep low scores reflect impairment.
Time frame: Baseline, Week 14
Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Disturbances (n=127,125) | -13.17 score on scale | Standard Error 1.82 |
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Somnolence (n=125,128) | -5.61 score on scale | Standard Error 1.81 |
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Snoring (n=122,126) | 4.34 score on scale | Standard Error 2.34 |
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Adequacy (n=126,128) | 10.04 score on scale | Standard Error 2.12 |
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Sleep problems Index I (n=122,127) | -10.11 score on scale | Standard Error 1.44 |
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Quantity (n=123,122) | 0.39 score on scale | Standard Error 0.18 |
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Sleep problems Index II (n=122,125) | -10.16 score on scale | Standard Error 1.37 |
| Pregabalin | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Awaken Short of Breath or w/Headache (n=125,128) | -6.52 score on scale | Standard Error 1.82 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Sleep problems Index II (n=122,125) | -11.59 score on scale | Standard Error 1.35 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Disturbances (n=127,125) | -14.71 score on scale | Standard Error 1.83 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Quantity (n=123,122) | 0.65 score on scale | Standard Error 0.19 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Adequacy (n=126,128) | 10.09 score on scale | Standard Error 2.11 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Awaken Short of Breath or w/Headache (n=125,128) | -7.93 score on scale | Standard Error 1.8 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Snoring (n=122,126) | -5.00 score on scale | Standard Error 2.29 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Sleep problems Index I (n=122,127) | -11.18 score on scale | Standard Error 1.41 |
| Placebo | Change From Baseline for MOS (Medical Outcomes Study)-Sleep Subscales and Sleep Problem Indices | Somnolence (n=125,128) | -7.01 score on scale | Standard Error 1.79 |
Comparison: Table above shows results of statistical analysis for Disturbance.p-value: 0.542595% CI: [-3.44, 6.52]ANCOVA
Comparison: Table above shows results of statistical analysis for Quantityp-value: 0.318495% CI: [-0.75, 0.25]ANCOVA
Comparison: Table above shows results of statistical analysis for Adequacyp-value: 0.988695% CI: [-5.81, 5.72]ANCOVA
Comparison: Table above shows results of statistical analysis for Awaken Short of Breath or with Headachep-value: 0.574295% CI: [-3.53, 6.35]ANCOVA
Comparison: Table above shows results of statistical analysis for Somnolencep-value: 0.577595% CI: [-3.54, 6.33]ANCOVA
Comparison: Table above shows results of statistical analysis for Snoringp-value: 0.00495% CI: [3.02, 15.66]ANCOVA
Comparison: Table above shows results of statistical analysis for Sleep Problems Index Ip-value: 0.588295% CI: [-2.83, 4.97]ANCOVA
Comparison: Table above shows results of statistical analysis for Sleep Problems Index IIp-value: 0.451695% CI: [-2.3, 5.14]ANCOVA
Secondary
Change From Baseline for NRS-Sleep Interference Scores
11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\])
Time frame: Baseline, Week 14
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline for NRS-Sleep Interference Scores | -2.53 score on scale | Standard Error 0.2 |
| Placebo | Change From Baseline for NRS-Sleep Interference Scores | -2.34 score on scale | Standard Error 0.2 |
p-value: 0.477695% CI: [-0.73, 0.34]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 1 (n=145,147) | -1.15 score on scale | Standard Error 0.16 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 2 (n=139,143) | -1.79 score on scale | Standard Error 0.17 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 6 (n=132,134) | -2.64 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 10 (n=126,128) | -2.86 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 14 (n=116,120) | -2.58 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Endpoint (n=148,147) | -2.37 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 14 (n=116,120) | -2.71 score on scale | Standard Error 0.22 |
| Placebo | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 1 (n=145,147) | -0.90 score on scale | Standard Error 0.16 |
| Placebo | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 10 (n=126,128) | -2.61 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 2 (n=139,143) | -1.77 score on scale | Standard Error 0.17 |
| Placebo | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Endpoint (n=148,147) | -2.60 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (Average Level of Pain in the Past 24 Hours) | Week 6 (n=132,134) | -2.55 score on scale | Standard Error 0.19 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.23995% CI: [-0.69, 0.17]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.944495% CI: [-0.49, 0.45]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.738695% CI: [-0.63, 0.45]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.349395% CI: [-0.79, 0.28]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.659695% CI: [-0.46, 0.73]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.407595% CI: [-0.31, 0.77]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 6 (n=132,131) | -2.69 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 1 (n=145,146) | -1.52 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 14 (n=116,119) | -2.78 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 10 (n=126,127) | -2.59 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Endpoint (n=148,146) | -2.64 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 2 (n=139,141) | -2.20 score on scale | Standard Error 0.24 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Endpoint (n=148,146) | -2.60 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 10 (n=126,127) | -2.45 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 1 (n=145,146) | -1.20 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 6 (n=132,131) | -2.64 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 14 (n=116,119) | -2.79 score on scale | Standard Error 0.22 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Enjoyment of Life) | Week 2 (n=139,141) | -2.13 score on scale | Standard Error 0.23 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.227795% CI: [-0.86, 0.21]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.840795% CI: [-0.71, 0.58]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.880995% CI: [-0.62, 0.53]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.628895% CI: [-0.72, 0.43]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.973995% CI: [-0.59, 0.61]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.892695% CI: [-0.61, 0.53]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Endpoint (n=148,147) | -2.15 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 2 (n=139,143) | -1.95 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 14 (n=116,120) | -2.16 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 6 (n=132,134) | -2.37 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 1 (n=145,147) | -1.35 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 10 (n=125,128) | -2.32 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 10 (n=125,128) | -2.26 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 14 (n=116,120) | -2.46 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Endpoint (n=148,147) | -2.23 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 1 (n=145,147) | -1.04 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 2 (n=139,143) | -1.87 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your General Activity) | Week 6 (n=132,134) | -2.25 score on scale | Standard Error 0.19 |
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.760795% CI: [-0.6, 0.44]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.235295% CI: [-0.82, 0.2]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.656395% CI: [-0.64, 0.4]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.831995% CI: [-0.58, 0.47]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.308695% CI: [-0.28, 0.89]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.797295% CI: [-0.48, 0.62]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 10 (n=125,128) | -2.52 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 1 (n=144,147) | -1.58 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 2 (n=138,143) | -2.23 score on scale | Standard Error 0.23 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 6 (n=131,134) | -2.60 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 14 (n=115,120) | -2.53 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Endpoint (n=147,147) | -2.31 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 14 (n=115,120) | -2.76 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 10 (n=125,128) | -2.37 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 6 (n=131,134) | -2.41 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 1 (n=144,147) | -1.20 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Endpoint (n=147,147) | -2.46 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Mood) | Week 2 (n=138,143) | -2.06 score on scale | Standard Error 0.22 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.186395% CI: [-0.94, 0.18]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.595395% CI: [-0.77, 0.44]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.50895% CI: [-0.73, 0.36]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.584295% CI: [-0.7, 0.39]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.428695% CI: [-0.35, 0.83]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.576695% CI: [-0.4, 0.71]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 1 (n=144,147) | -1.47 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 6 (n=130,134) | -2.54 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Endpoint (n=147,147) | -2.30 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 10 (n=125,128) | -2.49 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 2 (n=138,143) | -2.10 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 14 (n=114,120) | -2.21 score on scale | Standard Error 0.23 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 2 (n=138,143) | -1.99 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Endpoint (n=147,147) | -2.61 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 1 (n=144,147) | -1.42 score on scale | Standard Error 0.18 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 14 (n=114,120) | -2.70 score on scale | Standard Error 0.22 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 6 (n=130,134) | -2.45 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Normal Work Including Both Work Outside the Home and Housework) | Week 10 (n=125,128) | -2.36 score on scale | Standard Error 0.2 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.872795% CI: [-0.55, 0.46]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.689795% CI: [-0.65, 0.43]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.752795% CI: [-0.6, 0.44]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.639495% CI: [-0.67, 0.41]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.118895% CI: [-0.13, 1.11]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.268595% CI: [-0.24, 0.87]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 1 (n=145,147) | -1.06 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 2 (n=139,143) | -1.54 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 6 (n=132,134) | -1.91 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 10 (n=126,128) | -1.84 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 14 (n=115,120) | -2.08 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Endpoint (n=148,147) | -2.00 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 14 (n=115,120) | -2.10 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 1 (n=145,147) | -0.87 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 10 (n=126,128) | -1.91 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 2 (n=139,143) | -1.39 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Endpoint (n=148,147) | -1.99 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Relations With Other People) | Week 6 (n=132,134) | -1.67 score on scale | Standard Error 0.19 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.499195% CI: [-0.74, 0.36]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.609495% CI: [-0.73, 0.43]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.366995% CI: [-0.76, 0.28]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.764195% CI: [-0.43, 0.59]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.942895% CI: [-0.51, 0.55]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.950895% CI: [-0.52, 0.49]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 2 (n=139,142) | -2.22 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 6 (n=131,134) | -3.06 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 14 (n=116,120) | -2.65 score on scale | Standard Error 0.23 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 1 (n=145,147) | -1.80 score on scale | Standard Error 0.18 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Endpoint (n=148,147) | -2.51 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 10 (n=126,128) | -3.10 score on scale | Standard Error 0.22 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Endpoint (n=148,147) | -2.74 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 10 (n=126,128) | -2.71 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 1 (n=145,147) | -1.12 score on scale | Standard Error 0.18 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 6 (n=131,134) | -2.68 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 14 (n=116,120) | -2.90 score on scale | Standard Error 0.23 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Sleep) | Week 2 (n=139,142) | -1.86 score on scale | Standard Error 0.21 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.007395% CI: [-1.18, -0.19]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.220295% CI: [-0.96, 0.22]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.182495% CI: [-0.95, 0.18]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.187295% CI: [-0.98, 0.19]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.437495% CI: [-0.38, 0.88]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.440695% CI: [-0.36, 0.82]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 6 (n=132,134) | -2.44 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 1 (n=144,147) | -1.40 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 2 (n=139,142) | -1.84 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 10 (n=125,128) | -2.13 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 14 (n=115,120) | -2.09 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Endpoint (n=148,147) | -2.11 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 14 (n=115,120) | -2.54 score on scale | Standard Error 0.22 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 10 (n=125,128) | -2.33 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 1 (n=144,147) | -1.23 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Endpoint (n=148,147) | -2.42 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 2 (n=139,142) | -1.84 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (During the Past 24 Hours, How Pain Has Interfered With Your Walking Ability) | Week 6 (n=132,134) | -2.33 score on scale | Standard Error 0.2 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.549395% CI: [-0.73, 0.39]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.987595% CI: [-0.58, 0.59]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.693195% CI: [-0.68, 0.45]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.461495% CI: [-0.34, 0.75]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.146795% CI: [-0.16, 1.06]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.281995% CI: [-0.25, 0.87]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14 and Endpoint
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 1 (n=144,147) | -1.56 score on scale | Standard Error 0.17 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 2 (n=139,143) | -2.02 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 6 (n=132,134) | -2.66 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 10 (n=126,128) | -2.72 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 14 (n=116, 120) | -2.43 score on scale | Standard Error 0.23 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Endpoint (n=148,147) | -2.26 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 14 (n=116, 120) | -2.72 score on scale | Standard Error 0.22 |
| Placebo | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 1 (n=144,147) | -1.01 score on scale | Standard Error 0.17 |
| Placebo | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 10 (n=126,128) | -2.57 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 2 (n=139,143) | -1.98 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Endpoint (n=148,147) | -2.57 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-sf Scores (How Much Pain Are You Having Right Now) | Week 6 (n=132,134) | -2.66 score on scale | Standard Error 0.2 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.020295% CI: [-1.01, -0.09]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.886595% CI: [-0.55, 0.47]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.996495% CI: [-0.54, 0.54]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.599395% CI: [-0.7, 0.41]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.355395% CI: [-0.33, 0.9]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.277195% CI: [-0.25, 0.88]ANCOVA
Secondary
Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 10 (n=126,128) | -2.32 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 2 (n=139,143) | -1.49 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 14 (n=116,120) | -2.27 score on scale | Standard Error 0.2 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 6 (n=132,134) | -2.37 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Endpoint (n=148,147) | -2.07 score on scale | Standard Error 0.19 |
| Pregabalin | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 1 (n=145,147) | -0.84 score on scale | Standard Error 0.18 |
| Placebo | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Endpoint (n=148,147) | -2.20 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 2 (n=139,143) | -1.44 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 6 (n=132,134) | -2.05 score on scale | Standard Error 0.18 |
| Placebo | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 10 (n=126,128) | -2.13 score on scale | Standard Error 0.19 |
| Placebo | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 14 (n=116,120) | -2.41 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-sf Scores (The Least Pain in the Past 24 Hours) | Week 1 (n=145,147) | -0.80 score on scale | Standard Error 0.17 |
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.222795% CI: [-0.83, 0.19]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.475395% CI: [-0.73, 0.34]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.860595% CI: [-0.52, 0.44]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.834895% CI: [-0.58, 0.47]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.601795% CI: [-0.4, 0.68]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.615895% CI: [-0.38, 0.64]ANCOVA
Secondary
Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours)
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions.
Time frame: Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF
Population: ITT population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 6 (n=132,134) | -3.08 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 1 (n=145,147) | -1.52 score on scale | Standard Error 0.17 |
| Pregabalin | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 14 (n=116,120) | -2.97 score on scale | Standard Error 0.24 |
| Pregabalin | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 10 (n=126,128) | -3.02 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Endpoint -LOCF (n=148,147) | -2.82 score on scale | Standard Error 0.22 |
| Pregabalin | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 2 (n=139,143) | -2.18 score on scale | Standard Error 0.2 |
| Placebo | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Endpoint -LOCF (n=148,147) | -2.88 score on scale | Standard Error 0.22 |
| Placebo | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 6 (n=132,134) | -2.95 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 1 (n=145,147) | -1.09 score on scale | Standard Error 0.17 |
| Placebo | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 10 (n=126,128) | -3.03 score on scale | Standard Error 0.21 |
| Placebo | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 14 (n=116,120) | -3.01 score on scale | Standard Error 0.24 |
| Placebo | Change in Brief Pain Inventory-short Form (BPI-sf) Scores (The Worst Pain in the Past 24 Hours) | Week 2 (n=139,143) | -2.20 score on scale | Standard Error 0.2 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.068595% CI: [-0.89, 0.03]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.92895% CI: [-0.52, 0.57]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.667295% CI: [-0.71, 0.45]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.973195% CI: [-0.57, 0.59]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.904595% CI: [-0.61, 0.69]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.829895% CI: [-0.53, 0.66]ANCOVA
Secondary
Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores
Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores
Time frame: Baseline, Week 14
Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Burning (n=127,126) | -0.19 score on scale | Standard Error 0.02 |
| Pregabalin | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Pressing (n=125,126) | -0.17 score on scale | Standard Error 0.02 |
| Pregabalin | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Paroxysmal (n=127,127) | -0.16 score on scale | Standard Error 0.02 |
| Pregabalin | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Evoked (n=126,128) | -0.16 score on scale | Standard Error 0.02 |
| Pregabalin | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Paresthesia/dysesthesia (n=126,128) | -0.19 score on scale | Standard Error 0.02 |
| Pregabalin | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Total score (n=124,126) | -0.01 score on scale | Standard Error 0 |
| Placebo | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Paresthesia/dysesthesia (n=126,128) | -0.23 score on scale | Standard Error 0.02 |
| Placebo | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Burning (n=127,126) | -0.22 score on scale | Standard Error 0.02 |
| Placebo | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Evoked (n=126,128) | -0.15 score on scale | Standard Error 0.02 |
| Placebo | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Pressing (n=125,126) | -0.15 score on scale | Standard Error 0.02 |
| Placebo | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Total score (n=124,126) | -0.01 score on scale | Standard Error 0 |
| Placebo | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscores and Total Intensity Scores | Paroxysmal (n=127,127) | -0.17 score on scale | Standard Error 0.02 |
Comparison: Table above shows results of statistical analysis for Burningp-value: 0.309795% CI: [-0.03, 0.1]ANCOVA
Comparison: Table above shows results of statistical analysis for Pressingp-value: 0.614795% CI: [-0.07, 0.04]ANCOVA
Comparison: Table above shows results of statistical analysis for Paroxysmalp-value: 0.683895% CI: [-0.05, 0.07]ANCOVA
Comparison: Table above shows results of statistical analysis for Evokedp-value: 0.647995% CI: [-0.07, 0.04]ANCOVA
Comparison: Table above shows results of statistical analysis for Paresthesia/dysesthesiap-value: 0.184995% CI: [-0.02, 0.11]ANCOVA
Comparison: Table above shows results of statistical analysis for Total Scorep-value: 0.589895% CI: [0, 0]ANCOVA
Secondary
Change in NRS-Sleep Interference Scores
Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week.
Time frame: Baseline, Weeks 1-14
Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 2 (n=123,132) | -1.99 score on scale | Standard Error 0.17 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 1 (n=135, 133) | -1.04 score on scale | Standard Error 0.13 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 3 (n=117,121) | -2.26 score on scale | Standard Error 0.19 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 4 (n=117,124) | -2.34 score on scale | Standard Error 0.2 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 5 (n=115,121) | -2.57 score on scale | Standard Error 0.2 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 6 (n=110,119) | -2.73 score on scale | Standard Error 0.2 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 7 (n=110,111) | -2.89 score on scale | Standard Error 0.21 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 8 (n=109,111) | -2.98 score on scale | Standard Error 0.21 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 9 (n=105,111) | -2.73 score on scale | Standard Error 0.22 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 10 (n=104,114) | -2.79 score on scale | Standard Error 0.22 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 11 (n=100,106) | -2.76 score on scale | Standard Error 0.22 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 12 (n=94,105) | -2.83 score on scale | Standard Error 0.24 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 13 (n=94,105) | -2.95 score on scale | Standard Error 0.24 |
| Pregabalin | Change in NRS-Sleep Interference Scores | Week 14 (n=90,94) | -2.93 score on scale | Standard Error 0.25 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 11 (n=100,106) | -2.32 score on scale | Standard Error 0.21 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 2 (n=123,132) | -1.36 score on scale | Standard Error 0.16 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 7 (n=110,111) | -2.28 score on scale | Standard Error 0.21 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 8 (n=109,111) | -2.29 score on scale | Standard Error 0.21 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 1 (n=135, 133) | -0.68 score on scale | Standard Error 0.13 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 13 (n=94,105) | -2.28 score on scale | Standard Error 0.22 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 3 (n=117,121) | -1.68 score on scale | Standard Error 0.19 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 9 (n=105,111) | -2.25 score on scale | Standard Error 0.21 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 4 (n=117,124) | -2.01 score on scale | Standard Error 0.19 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 12 (n=94,105) | -2.29 score on scale | Standard Error 0.22 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 5 (n=115,121) | -2.22 score on scale | Standard Error 0.19 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 10 (n=104,114) | -2.32 score on scale | Standard Error 0.2 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 6 (n=110,119) | -2.18 score on scale | Standard Error 0.19 |
| Placebo | Change in NRS-Sleep Interference Scores | Week 14 (n=90,94) | -2.30 score on scale | Standard Error 0.25 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.046995% CI: [-0.71, 0]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.006795% CI: [-1.08, -0.18]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 3p-value: 0.03195% CI: [-1.1, -0.05]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 4p-value: 0.208895% CI: [-0.86, 0.19]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 5p-value: 0.184995% CI: [-0.87, 0.17]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.045295% CI: [-1.09, -0.01]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 7p-value: 0.035995% CI: [-1.18, -0.04]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 8p-value: 0.018495% CI: [-1.26, -0.12]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 9p-value: 0.104395% CI: [-1.06, 0.1]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.105395% CI: [-1.04, 0.1]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 11p-value: 0.14495% CI: [-1.03, 0.15]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 12p-value: 0.086695% CI: [-1.17, 0.08]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 13p-value: 0.035995% CI: [-1.3, -0.04]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.071195% CI: [-1.3, 0.05]ANCOVA
Secondary
Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory)
Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.
Time frame: Baseline, Week 14
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) | Improved from baseline to endpoint | 65 participants |
| Pregabalin | Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) | No change from baseline to endpoint | 35 participants |
| Pregabalin | Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) | Worsened from baseline to endpoint | 19 participants |
| Placebo | Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) | Improved from baseline to endpoint | 66 participants |
| Placebo | Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) | Worsened from baseline to endpoint | 21 participants |
| Placebo | Change in Number of Pain Attacks Compared to Baseline - NPSI (Neuropathic Pain Symptom Inventory) | No change from baseline to endpoint | 32 participants |
p-value: 0.7136Cochran-Mantel-Haenszel
Secondary
Change in Quantitative Assessment of Neuropathic Pain (QANeP)
Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable).
Time frame: Baseline, Week 14
Population: ITT Population; n = number of participants with data for analysis (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Static mechanical allodynia (n=120,119) | -1.11 score on scale | Standard Error 0.21 |
| Pregabalin | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Dynamic mechanical allodynia (n=120,119) | -0.99 score on scale | Standard Error 0.18 |
| Pregabalin | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Punctate hyperalgesia testing area (n=118,119) | -0.78 score on scale | Standard Error 0.25 |
| Pregabalin | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Temporal summation to tactile stimuli (n=120,118) | -1.21 score on scale | Standard Error 0.24 |
| Pregabalin | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Cold allodynia testing area (n=120,117) | -1.19 score on scale | Standard Error 0.23 |
| Pregabalin | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Cold hyperalgesia testing area (n=117,112) | -0.82 score on scale | Standard Error 0.27 |
| Placebo | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Cold allodynia testing area (n=120,117) | -0.90 score on scale | Standard Error 0.24 |
| Placebo | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Static mechanical allodynia (n=120,119) | -1.22 score on scale | Standard Error 0.21 |
| Placebo | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Temporal summation to tactile stimuli (n=120,118) | -1.04 score on scale | Standard Error 0.24 |
| Placebo | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Dynamic mechanical allodynia (n=120,119) | -0.77 score on scale | Standard Error 0.18 |
| Placebo | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Cold hyperalgesia testing area (n=117,112) | -0.93 score on scale | Standard Error 0.28 |
| Placebo | Change in Quantitative Assessment of Neuropathic Pain (QANeP) | Punctate hyperalgesia testing area (n=118,119) | -0.68 score on scale | Standard Error 0.26 |
Comparison: Table above shows results of statistical analysis for Static mechanical allodyniap-value: 0.686595% CI: [-0.45, 0.68]ANCOVA
Comparison: Table above shows results of statistical analysis for Dynamic mechanical allodyniap-value: 0.378795% CI: [-0.71, 0.27]ANCOVA
Comparison: Table above shows results of statistical analysis for Punctate hyperalgesia testing areap-value: 0.770495% CI: [-0.79, 0.59]ANCOVA
Comparison: Table above shows results of statistical analysis for Temporal summation to tactile stimulip-value: 0.608895% CI: [-0.82, 0.48]ANCOVA
Comparison: Table above shows results of statistical analysis for Cold allodynia testing areap-value: 0.376795% CI: [-0.93, 0.35]ANCOVA
Comparison: Table above shows results of statistical analysis for Cold hyperalgesia testing areap-value: 0.768995% CI: [-0.64, 0.86]ANCOVA
Secondary
Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory)
Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.
Time frame: Baseline, Week 14
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) | Improved from baseline to endpoint | 63 participants |
| Pregabalin | Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) | No change from baseline to endpoint | 46 participants |
| Pregabalin | Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) | Worsened from baseline to endpoint | 19 participants |
| Placebo | Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) | Improved from baseline to endpoint | 60 participants |
| Placebo | Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) | No change from baseline to endpoint | 40 participants |
| Placebo | Duration of Spontaneous Pain-NPSI (Neuropathic Pain Symptom Inventory) | Worsened from baseline to endpoint | 26 participants |
p-value: 0.6729Cochran-Mantel-Haenszel
Secondary
Gracely Pain Scale Score
The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment.
Time frame: Week 14
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Gracely Pain Scale Score | -2.70 score on scale | Standard Deviation 3.36 |
| Placebo | Gracely Pain Scale Score | -2.76 score on scale | Standard Deviation 3.19 |
Secondary
Patient Global Impression of Change (PGIC) Rating
PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).
Time frame: Baseline, Week 14, Endpoint-LOCF
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient Global Impression of Change (PGIC) Rating | Minimally improved (score 3) | 38 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) Rating | Minimally worse (score 5) | 2 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) Rating | Much improved (score 2) | 41 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) Rating | Much worse (score 6) | 3 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) Rating | No change (score 4) | 17 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) Rating | Very much worse (score 7) | 0 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) Rating | Very much improved (score 1) | 27 participants |
| Placebo | Patient Global Impression of Change (PGIC) Rating | Very much worse (score 7) | 0 participants |
| Placebo | Patient Global Impression of Change (PGIC) Rating | Very much improved (score 1) | 27 participants |
| Placebo | Patient Global Impression of Change (PGIC) Rating | Much improved (score 2) | 38 participants |
| Placebo | Patient Global Impression of Change (PGIC) Rating | Minimally improved (score 3) | 19 participants |
| Placebo | Patient Global Impression of Change (PGIC) Rating | No change (score 4) | 32 participants |
| Placebo | Patient Global Impression of Change (PGIC) Rating | Minimally worse (score 5) | 5 participants |
| Placebo | Patient Global Impression of Change (PGIC) Rating | Much worse (score 6) | 5 participants |
p-value: 0.3852Cochran-Mantel-Haenszel
Secondary
Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table
Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14)
Time frame: Baseline-Week 14 (Endpoint)
Population: ITT Population; Pregabalin weight range- 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived. Placebo weight range- 2.83, 3.61, 4.31, 4.56, 5.07, 6.65 and not perceived
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 2.83 Improved | 0 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 3.61 No Change | 3 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 3.61 Worsened | 9 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.31 Improved | 4 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.31 Worsened | 8 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.56 Improved | 5 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.56 No Change | 4 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.56 Worsened | 9 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 2.83 No Change | 0 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 2.83 Worsened | 0 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 3.61 Improved | 1 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.31 No Change | 17 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 5.07 Improved | 10 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 5.07 No Change | 8 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 6.65 Worsened | 2 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Not Perceived Improved | 3 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Not Perceived No Change | 8 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 5.07 Worsened | 10 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 6.65 Improved | 12 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 6.65 No Change | 7 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Not Perceived Worsened | 0 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Not Perceived Improved | 4 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 2.83 Improved | 0 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 3.61 Improved | 2 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 3.61 No Change | 2 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 6.65 Improved | 5 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 3.61 Worsened | 4 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.31 No Change | 13 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.31 Improved | 12 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 5.07 No Change | 3 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.31 Worsened | 18 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Not Perceived Worsened | 0 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.56 Improved | 6 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 6.65 No Change | 6 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.56 No Change | 7 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 5.07 Worsened | 5 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 4.56 Worsened | 8 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 5.07 Improved | 15 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 6.65 Worsened | 0 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 2.83 No Change | 1 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Not Perceived No Change | 5 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Maximum Sensory Thresholds : Shift Table | Weight 2.83 Worsened | 3 participants |
Secondary
Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table
Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14).
Time frame: Baseline-Week 14 (Endpoint)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 3.61 Worsened | 10 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.56 No Change | 6 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 2.83 Worsened | 5 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.56 Worsened | 5 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 6.65 Worsened | 0 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 5.07 Improved | 16 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 3.61 Improved | 0 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 5.07 No Change | 5 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.31 Improved | 12 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 5.07 Worsened | 6 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 2.83 Improved | 0 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 6.65 Improved | 10 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.31 No Change | 7 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 6.65 No Change | 2 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 3.61 No Change | 10 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Not Perceived Improved | 2 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.31 Worsened | 9 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Not Perceived No Change | 6 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 2.83 No Change | 1 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Not Perceived Worsened | 0 participants |
| Pregabalin | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.56 Improved | 8 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Not Perceived Worsened | 0 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 3.61 No Change | 9 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 3.61 Worsened | 13 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 6.65 No Change | 3 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 2.83 Improved | 0 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 2.83 No Change | 3 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 2.83 Worsened | 3 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.31 Improved | 11 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.31 No Change | 11 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.31 Worsened | 12 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.56 Improved | 7 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.56 No Change | 8 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 4.56 Worsened | 7 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 5.07 Improved | 11 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 5.07 No Change | 3 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 5.07 Worsened | 1 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 6.65 Improved | 8 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 6.65 Worsened | 0 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Not Perceived Improved | 3 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Not Perceived No Change | 4 participants |
| Placebo | Quantitative Assessments of Neuropathic Pain (QANeP) Median Sensory Thresholds : Shift Table | Weight 3.61 Improved | 2 participants |
Secondary
Shift in Hospital Anxiety and Depression (HADS) Subscales
Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21.
Time frame: Baseline, Week 14
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& severe(endpoint) | 2 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal (baseline&endpoint) | 47 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal (baseline)& mild (endpoint) | 7 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal (baseline)& moderate(endpoint) | 2 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal(baseline)&severe(endpoint) | 0 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& normal(endpoint) | 23 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& mild(endpoint) | 7 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& moderate(endpoint) | 2 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)& moderate(endpoint) | 7 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& normal(endpoint) | 11 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& mild(endpoint) | 6 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& moderate(endpoint) | 8 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& severe(endpoint) | 3 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)& normal(endpoint) | 0 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)& mild(endpoint) | 1 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)&severe(endpoint) | 2 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline&endpoint) | 75 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline)&mild (endpoint) | 8 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline)&moderate (endpoint) | 2 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline)&severe (endpoint) | 1 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&normal(endpoint) | 19 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&mild(endpoint) | 5 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&moderate(endpoint) | 3 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&severe(endpoint) | 0 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&normal(endpoint) | 5 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&mild(endpoint) | 6 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&moderate(endpoint) | 2 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&severe(endpoint) | 1 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&normal(endpoint) | 0 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&mild(endpoint) | 0 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&moderate(endpoint) | 0 participants |
| Pregabalin | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&severe(endpoint) | 1 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&severe(endpoint) | 1 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)& moderate(endpoint) | 6 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline&endpoint) | 69 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal (baseline&endpoint) | 55 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&normal(endpoint) | 11 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal (baseline)& mild (endpoint) | 6 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline)&mild (endpoint) | 7 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal (baseline)& moderate(endpoint) | 2 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&normal(endpoint) | 0 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-normal(baseline)&severe(endpoint) | 0 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline)&moderate (endpoint) | 2 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& normal(endpoint) | 19 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&mild(endpoint) | 7 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& mild(endpoint) | 6 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-normal (baseline)&severe (endpoint) | 0 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& moderate(endpoint) | 6 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&moderate(endpoint) | 0 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-mild(baseline)& severe(endpoint) | 0 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&normal(endpoint) | 21 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& normal(endpoint) | 8 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&moderate(endpoint) | 2 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& mild(endpoint) | 9 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&mild(endpoint) | 5 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& moderate(endpoint) | 5 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-severe (baseline)&mild(endpoint) | 0 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-moderate(baseline)& severe(endpoint) | 1 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&moderate(endpoint) | 2 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)& normal(endpoint) | 1 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-moderate (baseline)&severe(endpoint) | 1 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)& mild(endpoint) | 2 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Depression-mild (baseline)&severe(endpoint) | 0 participants |
| Placebo | Shift in Hospital Anxiety and Depression (HADS) Subscales | Anxiety-severe(baseline)&severe(endpoint) | 2 participants |
Secondary
Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks
Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.
Time frame: Baseline-Week 14 (Endpoint)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), no pain attacks (endpoint) | 3 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), 11-20 attacks (endpoint) | 2 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), 1-5 attacks (endpoint) | 14 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), >20 attacks (endpoint) | 1 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), >20 attacks (endpoint) | 3 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), 11-20 attacks (endpoint) | 3 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), >20 attacks (endpoint) | 0 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), no attacks (endpoint) | 10 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), 1-5 attacks (endpoint) | 1 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), no attacks (endpoint) | 6 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline & endpoint) | 4 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), 11-20 attacks (endpoint) | 0 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), 11-20 attacks (endpoint) | 2 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), 6-10 attacks (endpoint) | 5 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), 6-10 attacks (endpoint) | 1 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), 6-10 attacks (endpoint) | 0 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), 1-5 attacks (endpoint) | 3 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), 11-20 attacks (endpoint) | 2 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), >20 attacks (endpoint) | 2 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), no attacks (endpoint) | 3 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), 6-10 attacks (endpoint) | 7 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), 6-10 attacks (endpoint) | 7 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), 1-5 attacks (endpoint) | 10 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), 1-5 attacks (endpoint) | 21 participants |
| Pregabalin | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), no attacks (endpoint) | 9 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), 6-10 attacks (endpoint) | 3 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), >20 attacks (endpoint) | 7 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), 11-20 attacks (endpoint) | 2 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), 6-10 attacks (endpoint) | 8 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), 1-5 attacks (endpoint) | 17 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), >20 attacks (endpoint) | 1 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), 11-20 attacks (endpoint) | 2 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), 1-5 attacks (endpoint) | 15 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 1-5 attacks (baseline), no attacks (endpoint) | 11 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), >20 attacks (endpoint) | 2 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), 11-20 attacks (endpoint) | 0 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), 6-10 attacks (endpoint) | 1 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), no attacks (endpoint) | 1 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), 1-5 attacks (endpoint) | 3 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), 11-20 attacks (endpoint) | 2 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 6-10 attacks (baseline), no attacks (endpoint) | 4 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), no attacks (endpoint) | 5 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | no attacks (baseline), 1-5 attacks (endpoint) | 3 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline & endpoint) | 6 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), 11-20 attacks (endpoint) | 4 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), 6-10 attacks (endpoint) | 4 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | >20 attacks (baseline), no pain attacks (endpoint) | 2 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), >20 attacks (endpoint) | 0 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), 6-10 attacks (endpoint) | 8 participants |
| Placebo | Shift Table in NPSI (Neuropathic Pain Symptom Inventory)- Number of Pain Attacks | 11-20 attacks (baseline), 1-5 attacks (endpoint) | 8 participants |
Secondary
Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain
Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint.
Time frame: Baseline-Week 14 (Endpoint)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline&endpoint) | 15 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), 1-3 hrs (endpoint) | 3 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), 8-12 hrs (endpoint) | 10 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), < 1 hr (endpoint) | 7 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), 4-7 hours (endpoint) | 8 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), permanently (endpoint) | 1 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), 4-7 hrs (endpoint) | 5 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), 8-12 hrs (endpoint) | 2 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), 1-3 hours (endpoint) | 4 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), 4-7 hrs (endpoint) | 1 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), 8-12 hours (endpoint) | 11 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), 1-3 hrs (endpoint) | 6 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), <1 hr (endpoint) | 8 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), <1 hr (endpoint) | 9 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), 1-3 hours (endpoint) | 4 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), permanently (endpoint) | 0 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), permanently (endpoint) | 3 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), 8-12 hrs (endpoint) | 2 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hours (baseline), permanently (endpoint) | 2 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), 4-7 hrs (endpoint) | 0 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), 8-12 hrs (endpoint) | 7 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), 1-3 hrs (endpoint) | 1 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), < 1 hr (endpoint) | 4 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | <1 hr (baseline), <1 hr (endpoint) | 6 participants |
| Pregabalin | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), 4-7 hrs (endpoint) | 9 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | <1 hr (baseline), <1 hr (endpoint) | 0 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), 4-7 hours (endpoint) | 6 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hours (baseline), permanently (endpoint) | 7 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), 4-7 hrs (endpoint) | 9 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline&endpoint) | 21 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), 1-3 hours (endpoint) | 5 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), < 1 hr (endpoint) | 5 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), 8-12 hrs (endpoint) | 7 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), 1-3 hours (endpoint) | 4 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 8-12 hrs (baseline), <1 hr (endpoint) | 5 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), permanently (endpoint) | 3 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), 8-12 hrs (endpoint) | 6 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), 4-7 hrs (endpoint) | 9 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), 1-3 hrs (endpoint) | 8 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 4-7 hrs (baseline), < 1 hr (endpoint) | 8 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), permanently (endpoint) | 0 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), 8-12 hrs (endpoint) | 2 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), 4-7 hrs (endpoint) | 5 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), 1-3 hrs (endpoint) | 3 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | 1-3 hrs (baseline), <1 hr (endpoint) | 5 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), permanently (endpoint) | 1 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), 8-12 hrs (endpoint) | 0 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), 4-7 hrs (endpoint) | 0 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Less than 1 hr (baseline), 1-3 hrs (endpoint) | 2 participants |
| Placebo | Shift Table NPSI (Neuropathic Pain Symptom Inventory) - Duration of Spontaneous Pain | Permanently (baseline), 8-12 hours (endpoint) | 5 participants |
Other Pre-specified
Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward)
Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale \<(NRS)-Pain\> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR)
Time frame: Baseline, Weeks 1 - 14 and Endpoint-BOCF
Population: ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Endpoint BOCF (n=142,140) | -2.72 score on scale | Standard Error 0.21 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 1 (n=136,133) | -1.14 score on scale | Standard Error 0.13 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 2 (n=126,132) | -1.92 score on scale | Standard Error 0.17 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 3 (n=118,121) | -2.36 score on scale | Standard Error 0.2 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 4 (n=118,124) | -2.66 score on scale | Standard Error 0.21 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 5 (n=116,121) | -2.79 score on scale | Standard Error 0.22 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 6 (n=111,119) | -2.98 score on scale | Standard Error 0.23 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 7 (n=112,111) | -3.22 score on scale | Standard Error 0.23 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 8 (n=111,111) | -3.33 score on scale | Standard Error 0.22 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 9 (n=107,111) | -3.09 score on scale | Standard Error 0.23 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 10 (n=106,114) | -2.98 score on scale | Standard Error 0.23 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 11 (n=102,106) | -3.05 score on scale | Standard Error 0.24 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 12 (n=96,105) | -3.14 score on scale | Standard Error 0.25 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 13 (n=96, 105) | -3.21 score on scale | Standard Error 0.25 |
| Pregabalin | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 14 (n=92,94) | -3.19 score on scale | Standard Error 0.26 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Endpoint BOCF (n=142,140) | -2.64 score on scale | Standard Error 0.21 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 8 (n=111,111) | -2.58 score on scale | Standard Error 0.22 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 1 (n=136,133) | -0.69 score on scale | Standard Error 0.13 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 12 (n=96,105) | -2.59 score on scale | Standard Error 0.24 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 2 (n=126,132) | -1.43 score on scale | Standard Error 0.17 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 9 (n=107,111) | -2.56 score on scale | Standard Error 0.23 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 3 (n=118,121) | -1.83 score on scale | Standard Error 0.2 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 14 (n=92,94) | -2.70 score on scale | Standard Error 0.27 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 4 (n=118,124) | -2.24 score on scale | Standard Error 0.2 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 10 (n=106,114) | -2.66 score on scale | Standard Error 0.22 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 5 (n=116,121) | -2.50 score on scale | Standard Error 0.21 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 13 (n=96, 105) | -2.59 score on scale | Standard Error 0.24 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 6 (n=111,119) | -2.45 score on scale | Standard Error 0.22 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 11 (n=102,106) | -2.61 score on scale | Standard Error 0.24 |
| Placebo | Change in NRS-Pain Scores From Baseline to Endpoint-BOCF (Modified Baseline Observation Carried Forward) | Week 7 (n=112,111) | -2.53 score on scale | Standard Error 0.23 |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.013195% CI: [-0.81, -0.1]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.039395% CI: [-0.96, -0.02]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 3p-value: 0.055495% CI: [-1.08, 0.01]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 4p-value: 0.151395% CI: [-0.99, 0.15]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 5p-value: 0.334595% CI: [-0.89, 0.3]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.087995% CI: [-1.13, 0.08]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 7p-value: 0.030795% CI: [-1.32, -0.07]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 8p-value: 0.015695% CI: [-1.36, -0.14]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 9p-value: 0.098195% CI: [-1.15, 0.1]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.30695% CI: [-0.93, 0.29]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 11p-value: 0.187495% CI: [-1.08, 0.21]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 12p-value: 0.102595% CI: [-1.22, 0.11]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 13p-value: 0.066295% CI: [-1.3, 0.04]ANCOVA
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.185695% CI: [-1.21, 0.24]ANCOVA
Comparison: Table above shows results of statistical analysis for Endpointp-value: 0.792595% CI: [-0.66, 0.5]ANCOVA
Other Pre-specified
Duration Adjusted Average Change From Baseline in NRS Pain Scores
Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation - mean at baseline)x(proportion of planned study duration that the subject completed).
Time frame: Weekly: Week 1 - Week 14
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Duration Adjusted Average Change From Baseline in NRS Pain Scores | -2.45 score on scale | Standard Error 0.18 |
| Placebo | Duration Adjusted Average Change From Baseline in NRS Pain Scores | -2.07 score on scale | Standard Error 0.18 |
p-value: 0.127795% CI: [-0.86, 0.11]ANCOVA
Other Pre-specified
Responders - Decreases of at Least 30% in Mean Weekly Pain Score
Number of subjects that experienced at least 30% decrease in mean weekly pain.
Time frame: Weeks 1-14 endpoint BOCF
Population: ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo); BOCF = modified baseline observation carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 14 (n=101,108) | 58 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 4 (n=126,132) | 64 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Endpoint-BOCF (n=146,147) | 77 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 1 (n=140,141) | 33 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 2 (n=136,139) | 51 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 5 (n=124,131) | 65 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 6 (n=124,130) | 63 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 7 (n=125,124) | 69 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 8 (n=120,119) | 75 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 9 (n=116,121) | 68 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 10 (n=116,121) | 64 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 11 (n=113,117) | 67 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 12 (n=107,115) | 65 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 13 (n=103,111) | 62 participants |
| Pregabalin | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 3 (n=131,133) | 63 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 10 (n=116,121) | 69 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 3 (n=131,133) | 51 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 7 (n=125,124) | 64 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 14 (n=101,108) | 54 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 12 (n=107,115) | 57 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Endpoint-BOCF (n=146,147) | 81 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 8 (n=120,119) | 62 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 1 (n=140,141) | 21 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 11 (n=113,117) | 63 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 2 (n=136,139) | 46 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 4 (n=126,132) | 60 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 9 (n=116,121) | 65 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 5 (n=124,131) | 68 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 13 (n=103,111) | 62 participants |
| Placebo | Responders - Decreases of at Least 30% in Mean Weekly Pain Score | Week 6 (n=124,130) | 70 participants |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.113295% CI: [0.882, 2.969]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.468795% CI: [0.731, 1.978]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 3p-value: 0.154695% CI: [0.877, 2.375]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 4p-value: 0.421695% CI: [0.7444, 2.025]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 5p-value: 0.747995% CI: [0.556, 1.527]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.384295% CI: [0.481, 1.33]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 7p-value: 0.84595% CI: [0.627, 1.769]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 8p-value: 0.160295% CI: [0.864, 2.527]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 9p-value: 0.681595% CI: [0.66, 1.89]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.563595% CI: [0.486, 1.482]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 11p-value: 0.4995% CI: [0.699, 2.104]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 12p-value: 0.160295% CI: [0.856, 2.575]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 13p-value: 0.581995% CI: [0.663, 2.079]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.279695% CI: [0.768, 2.432]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Endpoint-BOCFp-value: 0.543795% CI: [0.534, 1.39]Cochran-Mantel-Haenszel
Other Pre-specified
Responders- Decreases of at Least 50% in Mean Weekly Pain Score
Number of subjects that experienced at least a 50% decrease in mean weekly pain.
Time frame: Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)
Population: ITT population; n = number of participants with data for analysis reported per week per treatment group (n=pregabalin, placebo), BOCF = modified baseline observation carried forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 11 (n=113,117) | 43 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 4 (n=126,132) | 45 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 13 (n=103,111) | 45 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 5 (n=124,131) | 48 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 10 (n=116,121) | 45 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 6 (n=124,130) | 49 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 14 (n=101,108) | 42 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 7 (n=125,124) | 53 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 2 (n=136,139) | 28 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 8 (n=120,119) | 54 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 12 (n=107,115) | 45 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 9 (n=116,121) | 50 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 3 (n=131,133) | 35 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Endpoint-BOCF (n=146,147) | 54 participants |
| Pregabalin | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 1 (n=140,141) | 13 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Endpoint-BOCF (n=146,147) | 62 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 1 (n=140,141) | 6 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 9 (n=116,121) | 45 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 10 (n=116,121) | 49 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 11 (n=113,117) | 46 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 12 (n=107,115) | 46 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 13 (n=103,111) | 47 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 2 (n=136,139) | 23 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 3 (n=131,133) | 33 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 4 (n=126,132) | 41 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 5 (n=124,131) | 47 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 6 (n=124,130) | 47 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 7 (n=125,124) | 38 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 8 (n=120,119) | 43 participants |
| Placebo | Responders- Decreases of at Least 50% in Mean Weekly Pain Score | Week 14 (n=101,108) | 44 participants |
Comparison: Table above shows results of statistical analysis for Week 1p-value: 0.119195% CI: [0.802, 5.935]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 2p-value: 0.504195% CI: [0.666, 2.301]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 3p-value: 0.685995% CI: [0.638, 1.985]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 4p-value: 0.41495% CI: [0.735, 2.116]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 5p-value: 0.785295% CI: [0.644, 1.794]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 6p-value: 0.739995% CI: [0.654, 1.817]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 7p-value: 0.105595% CI: [0.913, 2.701]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 8p-value: 0.210795% CI: [0.829, 2.401]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 9p-value: 0.52795% CI: [0.697, 2.046]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 10p-value: 0.684595% CI: [0.513, 1.546]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 11p-value: 0.773795% CI: [0.522, 1.619]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 12p-value: 0.885395% CI: [0.597, 1.818]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 13p-value: 0.771295% CI: [0.612, 1.946]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Week 14p-value: 0.958695% CI: [0.574, 1.796]Cochran-Mantel-Haenszel
Comparison: Table above shows results of statistical analysis for Endpoint-BOCFp-value: 0.348295% CI: [0.486, 1.283]Cochran-Mantel-Haenszel