Diabetic Neuropathy, Painful
Conditions
Keywords
Diabetic peripheral neuropathy, Lyrica, pregabalin, pain
Brief summary
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Interventions
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
DRUGPlacebo
Placebo is supplied as capsules and given 3 times daily.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
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
* Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.
Exclusion criteria
* Patients with other pain conditions cannot participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase | SB Baseline, Week 19 (DB Phase) | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase | SB Baseline, Week 6 (SB Phase) | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
| Weekly Mean Pain Scores (Single-Blind Phase) | Week 1, 2, 3, 4, 5, 6 | Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. |
| Weekly Mean Pain Scores (Double-Blind Phase) | DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 | Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1. |
| Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) | Week 6 | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
| Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) | Week 19 | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported. |
| Patient Global Impression of Change (PGIC) (Single-Blind Phase) | Week 6 | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. |
| Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Week 19 | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. |
| Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline, Week 6 | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. |
| Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Week 19 | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline, Week 6 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. |
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) | Week 19 | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. |
| Weekly Mean Sleep Interference Score (Single-Blind Phase) | SB Baseline, Week 1, 2, 3, 4, 5, 6 | Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
| Time to Loss of Pain Response (Double-Blind Phase) | SB Baseline up to Week 19 | Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (\<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
| Endpoint Mean Sleep Interference Score (Single-Blind Phase) | Week 6 | Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain). |
| Endpoint Mean Sleep Interference Score (Double-Blind Phase) | Week 19 | Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain). |
| Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | SB Baseline, Week 6 | QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL. |
| Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Week 19 | QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL. |
| Pain Visual Analog Scale (VAS) (Single-Blind Phase) | SB Baseline, Week 6 | Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain. |
| Pain Visual Analog Scale (VAS) (Double-Blind Phase) | Week 19 | Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain. |
| Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) | SB Baseline, Week 6 | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes). |
| Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) | Week 19 | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes). |
| Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) | SB Baseline, Week 6 | HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression. |
| Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) | Week 19 | HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression. |
| Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Week 6 | GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported. |
| Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Week 19 | GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported. |
| Weekly Mean Sleep Interference Score (Double-Blind Phase) | DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 | Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). |
Countries
Canada, Puerto Rico, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin SB Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced \>=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. | 665 |
| Total | 665 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Between Single-Blind and Double-Blind | Adverse Event | 5 | 0 | 0 |
| Between Single-Blind and Double-Blind | Lack of Efficacy | 247 | 0 | 0 |
| Between Single-Blind and Double-Blind | Lost to Follow-up | 1 | 0 | 0 |
| Between Single-Blind and Double-Blind | Other | 6 | 0 | 0 |
| Between Single-Blind and Double-Blind | Protocol Violation | 7 | 0 | 0 |
| Between Single-Blind and Double-Blind | Withdrawal by Subject | 4 | 0 | 0 |
| Double-Blind Phase (Week 7 to Week 19) | Adverse Event | 0 | 8 | 11 |
| Double-Blind Phase (Week 7 to Week 19) | Lack of Efficacy | 0 | 3 | 8 |
| Double-Blind Phase (Week 7 to Week 19) | Lost to Follow-up | 0 | 2 | 5 |
| Double-Blind Phase (Week 7 to Week 19) | Other | 0 | 1 | 0 |
| Double-Blind Phase (Week 7 to Week 19) | Protocol Violation | 0 | 0 | 4 |
| Double-Blind Phase (Week 7 to Week 19) | Randomized, Not Treated | 0 | 0 | 2 |
| Double-Blind Phase (Week 7 to Week 19) | Withdrawal by Subject | 0 | 8 | 6 |
| Single-Blind Phase (Up to Week 6) | Adverse Event | 45 | 0 | 0 |
| Single-Blind Phase (Up to Week 6) | Lack of Efficacy | 7 | 0 | 0 |
| Single-Blind Phase (Up to Week 6) | Lost to Follow-up | 14 | 0 | 0 |
| Single-Blind Phase (Up to Week 6) | Other | 2 | 0 | 0 |
| Single-Blind Phase (Up to Week 6) | Protocol Violation | 9 | 0 | 0 |
| Single-Blind Phase (Up to Week 6) | Withdrawal by Subject | 22 | 0 | 0 |
Baseline characteristics
| Characteristic | Pregabalin SB |
|---|---|
| Age, Customized 18 to 44 Years | 58 participants |
| Age, Customized 45 to 64 Years | 417 participants |
| Age, Customized >=65 Years | 190 participants |
| Sex: Female, Male Female | 302 Participants |
| Sex: Female, Male Male | 363 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 331 / 665 | 86 / 147 | 94 / 149 |
| serious Total, serious adverse events | 17 / 665 | 11 / 147 | 6 / 149 |
Outcome results
Primary
Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time frame: SB Baseline, Week 19 (DB Phase)
Population: Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase | Single-Blind Baseline | 6.8 units on a scale | Standard Deviation 1.24 |
| Pregabalin DB | Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase | Change at Week 19 (DB Phase) | -3.9 units on a scale | Standard Deviation 1.92 |
| Placebo | Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase | Single-Blind Baseline | 6.7 units on a scale | Standard Deviation 1.32 |
| Placebo | Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase | Change at Week 19 (DB Phase) | -3.5 units on a scale | Standard Deviation 2.1 |
Comparison: P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model.p-value: 0.122195% CI: [-0.74, 0.09]ANCOVA
Secondary
Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) | Pain Severity | 2.6 units on a scale | Standard Deviation 1.85 |
| Pregabalin DB | Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) | Pain Interference | 2.0 units on a scale | Standard Deviation 2.05 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) | Pain Interference | 2.4 units on a scale | Standard Deviation 2.1 |
| Placebo | Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) | Pain Severity | 3.0 units on a scale | Standard Deviation 2.03 |
Secondary
Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
Time frame: SB Baseline, Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here n signifies participants who were evaluable for specified time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) | SB Baseline: Pain Severity (n= 665) | 6.1 units on a scale | Standard Deviation 1.45 |
| Pregabalin DB | Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) | SB Baseline: Pain Interference (n= 665) | 5.2 units on a scale | Standard Deviation 2.09 |
| Pregabalin DB | Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) | Week 6: Pain Severity (n= 637) | 3.9 units on a scale | Standard Deviation 2.13 |
| Pregabalin DB | Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) | Week 6: Pain Interference (n= 637) | 3.1 units on a scale | Standard Deviation 2.31 |
Secondary
Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time frame: SB Baseline, Week 6 (SB Phase)
Population: Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. N (number of participants analyzed): participants who were evaluable for this measure and n: participants who were evaluable for specified time-point. Missing data were imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase | Change at Week 6 (SB Phase) (n= 658) | -2.2 units on a scale | Standard Deviation 2.03 |
| Pregabalin DB | Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase | SB Baseline (n= 663) | 6.7 units on a scale | Standard Deviation 1.27 |
Secondary
Endpoint Mean Sleep Interference Score (Double-Blind Phase)
Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin DB | Endpoint Mean Sleep Interference Score (Double-Blind Phase) | 2.4 units on a scale | Standard Deviation 2.1 |
| Placebo | Endpoint Mean Sleep Interference Score (Double-Blind Phase) | 2.4 units on a scale | Standard Deviation 2.05 |
Secondary
Endpoint Mean Sleep Interference Score (Single-Blind Phase)
Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
Time frame: Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin DB | Endpoint Mean Sleep Interference Score (Single-Blind Phase) | 3.8 units on a scale | Standard Deviation 2.42 |
Secondary
Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)
HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) | HADS-A | 3.8 units on a scale | Standard Deviation 2.94 |
| Pregabalin DB | Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) | HADS-D | 3.3 units on a scale | Standard Deviation 3.12 |
| Placebo | Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) | HADS-A | 4.3 units on a scale | Standard Deviation 3.56 |
| Placebo | Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) | HADS-D | 3.5 units on a scale | Standard Deviation 3.28 |
Secondary
Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)
HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
Time frame: SB Baseline, Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here N (number of participants) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) | SB Baseline: HADS-A (n= 663) | 5.8 units on a scale | Standard Deviation 3.95 |
| Pregabalin DB | Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) | SB Baseline: HADS-D (n= 663) | 5.3 units on a scale | Standard Deviation 3.7 |
| Pregabalin DB | Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) | Week 6: HADS-A (n= 616) | 4.6 units on a scale | Standard Deviation 3.54 |
| Pregabalin DB | Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) | Week 6: HADS-D (n= 616) | 4.0 units on a scale | Standard Deviation 3.52 |
Secondary
Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Sleep disturbance | 26.6 units on a scale | Standard Deviation 21.69 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Snoring | 41.9 units on a scale | Standard Deviation 36.24 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Sleep Adequacy | 59.2 units on a scale | Standard Deviation 28.67 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Somnolence | 29.7 units on a scale | Standard Deviation 24.39 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Sleep Problems Index | 28.5 units on a scale | Standard Deviation 17.86 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Awaken SOB or With Headache | 12.3 units on a scale | Standard Deviation 23.72 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Quantity of sleep | 6.7 units on a scale | Standard Deviation 1.34 |
| Placebo | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Awaken SOB or With Headache | 12.2 units on a scale | Standard Deviation 23.89 |
| Placebo | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Sleep disturbance | 30.9 units on a scale | Standard Deviation 23.05 |
| Placebo | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Sleep Problems Index | 30.9 units on a scale | Standard Deviation 18.59 |
| Placebo | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Snoring | 35.4 units on a scale | Standard Deviation 35.95 |
| Placebo | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Sleep Adequacy | 59.0 units on a scale | Standard Deviation 27.67 |
| Placebo | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Quantity of sleep | 6.5 units on a scale | Standard Deviation 1.47 |
| Placebo | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) | Somnolence | 30.6 units on a scale | Standard Deviation 22.98 |
Secondary
Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
Time frame: SB Baseline, Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here n signifies participants who were evaluable for specified time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline: Sleep disturbance (n= 665) | 53.6 units on a scale | Standard Deviation 24 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline: Snoring (n= 664) | 44.7 units on a scale | Standard Deviation 34.73 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline: Awaken SOB or With Headache (n=665) | 18.9 units on a scale | Standard Deviation 24.18 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline: Quantity of sleep (n=663) | 5.9 units on a scale | Standard Deviation 1.4 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline: Sleep Adequacy (n=665) | 39.2 units on a scale | Standard Deviation 23.22 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline: Somnolence (n=665) | 42.6 units on a scale | Standard Deviation 23.49 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline: Sleep Problems Index (n=665) | 49.2 units on a scale | Standard Deviation 18.17 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6: Sleep disturbance (n= 621) | 33.6 units on a scale | Standard Deviation 24.31 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6: Snoring (n= 621) | 39.9 units on a scale | Standard Deviation 34.83 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6: Awaken SOB or With Headache (n= 621) | 12.6 units on a scale | Standard Deviation 22.64 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6: Quantity of sleep (n= 615) | 6.6 units on a scale | Standard Deviation 1.64 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6: Sleep Adequacy (n= 621) | 52.6 units on a scale | Standard Deviation 25.55 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6: Somnolence (n= 621) | 34.2 units on a scale | Standard Deviation 24.11 |
| Pregabalin DB | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6: Sleep Problems Index (n= 621) | 34.4 units on a scale | Standard Deviation 18.82 |
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin DB | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) | 67 participants |
| Placebo | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) | 60 participants |
Secondary
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
Time frame: SB Baseline, Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin DB | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) | SB Baseline | 180 participants |
| Pregabalin DB | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) | Week 6 | 266 participants |
Secondary
Pain Visual Analog Scale (VAS) (Double-Blind Phase)
Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin DB | Pain Visual Analog Scale (VAS) (Double-Blind Phase) | 25.3 mm | Standard Deviation 20.98 |
| Placebo | Pain Visual Analog Scale (VAS) (Double-Blind Phase) | 30.1 mm | Standard Deviation 23.44 |
Secondary
Pain Visual Analog Scale (VAS) (Single-Blind Phase)
Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
Time frame: SB Baseline, Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here n signifies participants who were evaluable for specified time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Pain Visual Analog Scale (VAS) (Single-Blind Phase) | SB Baseline (n= 665) | 68.1 mm | Standard Deviation 13.79 |
| Pregabalin DB | Pain Visual Analog Scale (VAS) (Single-Blind Phase) | Week 6 (n= 621) | 39.8 mm | Standard Deviation 23.19 |
Secondary
Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)
GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Slightly Satisfied | 9 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Very Satisfied | 80 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Somewhat Dissatisfied | 1 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Somewhat Satisfied | 35 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Slightly Dissatisfied | 5 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Neither Satisfied Nor Dissatisfied | 6 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Very Dissatisfied | 2 participants |
| Placebo | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Neither Satisfied Nor Dissatisfied | 10 participants |
| Placebo | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Slightly Dissatisfied | 2 participants |
| Placebo | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Somewhat Dissatisfied | 6 participants |
| Placebo | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Very Dissatisfied | 2 participants |
| Placebo | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Very Satisfied | 64 participants |
| Placebo | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Slightly Satisfied | 14 participants |
| Placebo | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) | Somewhat Satisfied | 36 participants |
Secondary
Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)
GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
Time frame: Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Very Satisfied | 241 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Somewhat Satisfied | 181 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Slightly Satisfied | 66 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Neither Satisfied Nor Dissatisfied | 71 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Slightly Dissatisfied | 22 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Somewhat Dissatisfied | 21 participants |
| Pregabalin DB | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) | Very Dissatisfied | 19 participants |
Secondary
Patient Global Impression of Change (PGIC) (Double-Blind Phase)
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | No Change | 28 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Minimally Worse | 9 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Much Worse | 1 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Very Much Worse | 0 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Very Much Improved | 23 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Much Improved | 50 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Minimally Improved | 27 participants |
| Placebo | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | No Change | 20 participants |
| Placebo | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Very Much Improved | 23 participants |
| Placebo | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Minimally Worse | 6 participants |
| Placebo | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Minimally Improved | 28 participants |
| Placebo | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Much Worse | 8 participants |
| Placebo | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Much Improved | 46 participants |
| Placebo | Patient Global Impression of Change (PGIC) (Double-Blind Phase) | Very Much Worse | 3 participants |
Secondary
Patient Global Impression of Change (PGIC) (Single-Blind Phase)
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time frame: Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Single-Blind Phase) | No Change | 65 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Single-Blind Phase) | Minimally Worse | 29 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Single-Blind Phase) | Very Much Improved | 93 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Single-Blind Phase) | Much Improved | 221 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Single-Blind Phase) | Minimally Improved | 194 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Single-Blind Phase) | Much Worse | 15 participants |
| Pregabalin DB | Patient Global Impression of Change (PGIC) (Single-Blind Phase) | Very Much Worse | 3 participants |
Secondary
Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin DB | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) | >=30% Reduction | 82.99 percentage of participants |
| Pregabalin DB | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) | >=50% Reduction | 62.59 percentage of participants |
| Placebo | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) | >=30% Reduction | 79.19 percentage of participants |
| Placebo | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) | >=50% Reduction | 55.03 percentage of participants |
Secondary
Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time frame: Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin DB | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) | >=30 % Reduction | 49.92 percentage of participants |
| Pregabalin DB | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) | >=50 % Reduction | 27.22 percentage of participants |
Secondary
Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)
QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
Time frame: Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Total QOL Scores | 21.9 units on a scale | Standard Deviation 20.02 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Ph Fn/Large Fiber | 11.4 units on a scale | Standard Deviation 11.28 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Activities of Daily Living | 1.8 units on a scale | Standard Deviation 2.85 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Symptoms | 6.1 units on a scale | Standard Deviation 5.04 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Autonomic | 0.9 units on a scale | Standard Deviation 1.55 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Small Fiber | 1.8 units on a scale | Standard Deviation 3.38 |
| Placebo | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Autonomic | 1.1 units on a scale | Standard Deviation 1.53 |
| Placebo | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Total QOL Scores | 24.1 units on a scale | Standard Deviation 21.06 |
| Placebo | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Symptoms | 6.6 units on a scale | Standard Deviation 5.29 |
| Placebo | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Ph Fn/Large Fiber | 12.9 units on a scale | Standard Deviation 12.72 |
| Placebo | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Small Fiber | 1.7 units on a scale | Standard Deviation 2.5 |
| Placebo | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) | Activities of Daily Living | 1.8 units on a scale | Standard Deviation 2.79 |
Secondary
Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)
QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
Time frame: SB Baseline, Week 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here n signifies participants who were evaluable for specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | SB Baseline: Total QOL Scores (n= 665) | 42.6 units on a scale | Standard Deviation 22.22 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | SB Baseline: Ph Fn/Large Fiber (n= 665) | 23.9 units on a scale | Standard Deviation 13.07 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | SB Baseline: Activities of Daily Living (n= 665) | 3.2 units on a scale | Standard Deviation 3.69 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | SB Baseline: Symptoms (n= 665) | 10.8 units on a scale | Standard Deviation 5.55 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | SB Baseline: Small Fiber (n= 665) | 3.4 units on a scale | Standard Deviation 3.4 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | SB Baseline: Autonomic (n= 665) | 1.3 units on a scale | Standard Deviation 1.74 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | Week 6: Total QOL Scores (n= 618) | 29.3 units on a scale | Standard Deviation 21.76 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | Week 6: Ph Fn/Large Fiber (n= 618) | 15.8 units on a scale | Standard Deviation 12.62 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | Week 6: Activities of Daily Living (n= 618) | 2.2 units on a scale | Standard Deviation 3.08 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | Week 6: Symptoms (n= 618) | 7.8 units on a scale | Standard Deviation 5.72 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | Week 6: Small Fiber (n= 618) | 2.3 units on a scale | Standard Deviation 2.99 |
| Pregabalin DB | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) | Week 6: Autonomic (n= 618) | 1.1 units on a scale | Standard Deviation 1.69 |
Secondary
Time to Loss of Pain Response (Double-Blind Phase)
Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (\<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time frame: SB Baseline up to Week 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pregabalin DB | Time to Loss of Pain Response (Double-Blind Phase) | NA days |
| Placebo | Time to Loss of Pain Response (Double-Blind Phase) | NA days |
Secondary
Weekly Mean Pain Scores (Double-Blind Phase)
Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.
Time frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here n signifies participants who were evaluable for specified time-point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 9 (n= 140, 133) | 3.0 units on a scale | Standard Deviation 1.65 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 17 (n= 128, 115) | 2.7 units on a scale | Standard Deviation 1.61 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | DB Baseline (n= 147, 147) | 3.1 units on a scale | Standard Deviation 1.42 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 18 (n= 128, 115) | 2.8 units on a scale | Standard Deviation 1.66 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 10 (n= 138, 133) | 3.0 units on a scale | Standard Deviation 1.7 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 19 (n= 115, 104) | 2.7 units on a scale | Standard Deviation 1.57 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 8 (n= 143, 142) | 3.2 units on a scale | Standard Deviation 1.72 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 13 (n= 134, 122) | 2.9 units on a scale | Standard Deviation 1.68 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 11 (n= 138, 128) | 2.9 units on a scale | Standard Deviation 1.64 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 14 (n= 133, 122) | 2.9 units on a scale | Standard Deviation 1.64 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 7 (n= 144, 145) | 3.2 units on a scale | Standard Deviation 1.6 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 15 (n= 131, 118) | 2.9 units on a scale | Standard Deviation 1.63 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 12 (n= 135, 123) | 2.9 units on a scale | Standard Deviation 1.68 |
| Pregabalin DB | Weekly Mean Pain Scores (Double-Blind Phase) | Week 16 (n= 132, 118) | 2.8 units on a scale | Standard Deviation 1.65 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 12 (n= 135, 123) | 3.2 units on a scale | Standard Deviation 1.7 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | DB Baseline (n= 147, 147) | 3.0 units on a scale | Standard Deviation 1.4 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 7 (n= 144, 145) | 3.3 units on a scale | Standard Deviation 1.8 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 8 (n= 143, 142) | 3.6 units on a scale | Standard Deviation 1.79 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 9 (n= 140, 133) | 3.4 units on a scale | Standard Deviation 1.76 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 10 (n= 138, 133) | 3.4 units on a scale | Standard Deviation 1.77 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 11 (n= 138, 128) | 3.3 units on a scale | Standard Deviation 1.63 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 16 (n= 132, 118) | 3.0 units on a scale | Standard Deviation 1.58 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 17 (n= 128, 115) | 2.9 units on a scale | Standard Deviation 1.7 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 18 (n= 128, 115) | 2.9 units on a scale | Standard Deviation 1.73 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 19 (n= 115, 104) | 2.8 units on a scale | Standard Deviation 1.71 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 13 (n= 134, 122) | 3.1 units on a scale | Standard Deviation 1.69 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 14 (n= 133, 122) | 3.1 units on a scale | Standard Deviation 1.7 |
| Placebo | Weekly Mean Pain Scores (Double-Blind Phase) | Week 15 (n= 131, 118) | 3.0 units on a scale | Standard Deviation 1.64 |
Secondary
Weekly Mean Pain Scores (Single-Blind Phase)
Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.
Time frame: Week 1, 2, 3, 4, 5, 6
Population: SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for specified time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Weekly Mean Pain Scores (Single-Blind Phase) | Week 1 (n= 657) | 6.0 units on a scale | Standard Deviation 1.62 |
| Pregabalin DB | Weekly Mean Pain Scores (Single-Blind Phase) | Week 2 (n= 636) | 5.4 units on a scale | Standard Deviation 1.82 |
| Pregabalin DB | Weekly Mean Pain Scores (Single-Blind Phase) | Week 3 (n= 613) | 4.9 units on a scale | Standard Deviation 1.93 |
| Pregabalin DB | Weekly Mean Pain Scores (Single-Blind Phase) | Week 4 (n= 585) | 4.6 units on a scale | Standard Deviation 1.93 |
| Pregabalin DB | Weekly Mean Pain Scores (Single-Blind Phase) | Week 5 (n= 565) | 4.5 units on a scale | Standard Deviation 1.92 |
| Pregabalin DB | Weekly Mean Pain Scores (Single-Blind Phase) | Week 6 (n= 548) | 4.3 units on a scale | Standard Deviation 2.02 |
Secondary
Weekly Mean Sleep Interference Score (Double-Blind Phase)
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).
Time frame: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
Population: FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here n signifies participants who were evaluable for specified time-point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | DB Baseline (n= 147, 147) | 2.5 units on a scale | Standard Deviation 1.79 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 7 (n= 144, 145) | 2.6 units on a scale | Standard Deviation 1.92 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 8 (n= 143, 142) | 2.6 units on a scale | Standard Deviation 1.98 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 14 (n= 133, 122) | 2.3 units on a scale | Standard Deviation 1.93 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 15 (n= 132, 120) | 2.4 units on a scale | Standard Deviation 1.93 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 16 (n= 132, 120) | 2.3 units on a scale | Standard Deviation 1.9 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 9 (n= 140, 134) | 2.3 units on a scale | Standard Deviation 1.88 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 10 (n= 138, 133) | 2.3 units on a scale | Standard Deviation 1.9 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 11 (n= 138, 128) | 2.2 units on a scale | Standard Deviation 1.81 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 12 (n= 136, 123) | 2.3 units on a scale | Standard Deviation 1.9 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 13 (n= 134, 122) | 2.3 units on a scale | Standard Deviation 1.87 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 17 (n= 129, 116) | 2.2 units on a scale | Standard Deviation 1.88 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 18 (n= 128, 116) | 2.3 units on a scale | Standard Deviation 1.92 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 19 (n= 121, 111) | 2.3 units on a scale | Standard Deviation 2.05 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 13 (n= 134, 122) | 2.3 units on a scale | Standard Deviation 1.78 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | DB Baseline (n= 147, 147) | 2.3 units on a scale | Standard Deviation 1.66 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 10 (n= 138, 133) | 2.7 units on a scale | Standard Deviation 1.98 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 7 (n= 144, 145) | 2.7 units on a scale | Standard Deviation 1.99 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 18 (n= 128, 116) | 2.3 units on a scale | Standard Deviation 1.85 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 8 (n= 143, 142) | 3.0 units on a scale | Standard Deviation 1.98 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 11 (n= 138, 128) | 2.5 units on a scale | Standard Deviation 1.78 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 14 (n= 133, 122) | 2.3 units on a scale | Standard Deviation 1.8 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 17 (n= 129, 116) | 2.2 units on a scale | Standard Deviation 1.85 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 15 (n= 132, 120) | 2.3 units on a scale | Standard Deviation 1.8 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 12 (n= 136, 123) | 2.4 units on a scale | Standard Deviation 1.84 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 16 (n= 132, 120) | 2.3 units on a scale | Standard Deviation 1.77 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 19 (n= 121, 111) | 2.2 units on a scale | Standard Deviation 1.8 |
| Placebo | Weekly Mean Sleep Interference Score (Double-Blind Phase) | Week 9 (n= 140, 134) | 2.7 units on a scale | Standard Deviation 1.94 |
Secondary
Weekly Mean Sleep Interference Score (Single-Blind Phase)
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Time frame: SB Baseline, Week 1, 2, 3, 4, 5, 6
Population: SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin DB | Weekly Mean Sleep Interference Score (Single-Blind Phase) | SB Baseline (n= 663) | 5.9 units on a scale | Standard Deviation 2.09 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Single-Blind Phase) | Week 1 (n= 657) | 5.1 units on a scale | Standard Deviation 2.22 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Single-Blind Phase) | Week 2 (n= 636) | 4.5 units on a scale | Standard Deviation 2.29 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Single-Blind Phase) | Week 3 (n= 614) | 4.1 units on a scale | Standard Deviation 2.3 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Single-Blind Phase) | Week 4 (n= 589) | 3.8 units on a scale | Standard Deviation 2.3 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Single-Blind Phase) | Week 5 (n= 566) | 3.7 units on a scale | Standard Deviation 2.29 |
| Pregabalin DB | Weekly Mean Sleep Interference Score (Single-Blind Phase) | Week 6 (n= 548) | 3.6 units on a scale | Standard Deviation 2.35 |