A Phase 3 interventional study of pregabalin (Lyrica) and Placebo in Diabetic Neuropathy, Painful, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 172 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's enrollment of 633 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: pregabalin (Lyrica)
Drug: Placebo
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
Placebo is supplied as capsules and given 3 times daily.
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)
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Pregabalin SB | Pregabalin DB | Placebo |
|---|---|---|---|
| Started | 665 | 0 | 0 |
| Completed | 566 | 0 | 0 |
| Not completed | 99 | 0 | 0 |
| Withdrew: Adverse event | 45 | 0 | 0 |
| Withdrew: Lack of efficacy | 7 | 0 | 0 |
| Withdrew: Lost to follow-up | 14 | 0 | 0 |
| Withdrew: Protocol violation | 9 | 0 | 0 |
| Withdrew: Withdrawal by subject | 22 | 0 | 0 |
| Withdrew: Other | 2 | 0 | 0 |
| Milestone | Pregabalin SB | Pregabalin DB | Placebo |
|---|---|---|---|
| Started | 566 | 0 | 0 |
| Completed | 296 | 0 | 0 |
| Not completed | 270 | 0 | 0 |
| Withdrew: Adverse event | 5 | 0 | 0 |
| Withdrew: Lack of efficacy | 247 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
| Withdrew: Protocol violation | 7 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 | 0 |
| Withdrew: Other | 6 | 0 | 0 |
| Milestone | Pregabalin SB | Pregabalin DB | Placebo |
|---|---|---|---|
| Started | 0 | 147 | 149 |
| Treated | 0 | 147 | 147 |
| Completed | 0 | 125 | 113 |
| Not completed | 0 | 22 | 36 |
| Withdrew: Adverse event | 0 | 8 | 11 |
| Withdrew: Lack of efficacy | 0 | 3 | 8 |
| Withdrew: Lost to follow-up | 0 | 2 | 5 |
| Withdrew: Protocol violation | 0 | 0 | 4 |
| Withdrew: Withdrawal by subject | 0 | 8 | 6 |
| Withdrew: Other | 0 | 1 | 0 |
| Withdrew: Randomized, not treated | 0 | 0 | 2 |
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.
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| Single-Blind Baseline | 6.8 ± 1.24 | 6.7 ± 1.32 |
| Change at Week 19 (DB Phase) | -3.9 ± 1.92 | -3.5 ± 2.10 |
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.
| days | Pregabalin DB | Placebo |
|---|---|---|
| Time to Loss of Pain Response (Double-Blind Phase) | NA (NA to NA) | NA (NA to NA) |
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.
| units on a scale | Pregabalin SB |
|---|---|
| SB Baseline (n= 663) | 6.7 ± 1.27 |
| Change at Week 6 (SB Phase) (n= 658) | -2.2 ± 2.03 |
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.
| units on a scale | Pregabalin SB |
|---|---|
| Week 1 (n= 657) | 6.0 ± 1.62 |
| Week 2 (n= 636) | 5.4 ± 1.82 |
| Week 3 (n= 613) | 4.9 ± 1.93 |
| Week 4 (n= 585) | 4.6 ± 1.93 |
| Week 5 (n= 565) | 4.5 ± 1.92 |
| Week 6 (n= 548) | 4.3 ± 2.02 |
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.
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| DB Baseline (n= 147, 147) | 3.1 ± 1.42 | 3.0 ± 1.40 |
| Week 7 (n= 144, 145) | 3.2 ± 1.60 | 3.3 ± 1.80 |
| Week 8 (n= 143, 142) | 3.2 ± 1.72 | 3.6 ± 1.79 |
| Week 9 (n= 140, 133) | 3.0 ± 1.65 | 3.4 ± 1.76 |
| Week 10 (n= 138, 133) | 3.0 ± 1.70 | 3.4 ± 1.77 |
| Week 11 (n= 138, 128) | 2.9 ± 1.64 | 3.3 ± 1.63 |
| Week 12 (n= 135, 123) | 2.9 ± 1.68 | 3.2 ± 1.70 |
| Week 13 (n= 134, 122) | 2.9 ± 1.68 | 3.1 ± 1.69 |
| Week 14 (n= 133, 122) | 2.9 ± 1.64 | 3.1 ± 1.70 |
| Week 15 (n= 131, 118) | 2.9 ± 1.63 | 3.0 ± 1.64 |
| Week 16 (n= 132, 118) | 2.8 ± 1.65 | 3.0 ± 1.58 |
| Week 17 (n= 128, 115) | 2.7 ± 1.61 | 2.9 ± 1.70 |
| Week 18 (n= 128, 115) | 2.8 ± 1.66 | 2.9 ± 1.73 |
| Week 19 (n= 115, 104) | 2.7 ± 1.57 | 2.8 ± 1.71 |
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 | Pregabalin SB |
|---|---|
| >=30 % Reduction | 49.92 |
| >=50 % Reduction | 27.22 |
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.
| percentage of participants | Pregabalin DB | Placebo |
|---|---|---|
| >=30% Reduction | 82.99 | 79.19 |
| >=50% Reduction | 62.59 | 55.03 |
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.
| participants | Pregabalin SB |
|---|---|
| Very Much Improved | 93 |
| Much Improved | 221 |
| Minimally Improved | 194 |
| No Change | 65 |
| Minimally Worse | 29 |
| Much Worse | 15 |
| Very Much Worse | 3 |
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.
| participants | Pregabalin DB | Placebo |
|---|---|---|
| Very Much Improved | 23 | 23 |
| Much Improved | 50 | 46 |
| Minimally Improved | 27 | 28 |
| No Change | 28 | 20 |
| Minimally Worse | 9 | 6 |
| Much Worse | 1 | 8 |
| Very Much Worse | 0 | 3 |
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.
| units on a scale | Pregabalin SB |
|---|---|
| SB Baseline: Sleep disturbance (n= 665) | 53.6 ± 24.00 |
| SB Baseline: Snoring (n= 664) | 44.7 ± 34.73 |
| SB Baseline: Awaken SOB or With Headache (n=665) | 18.9 ± 24.18 |
| SB Baseline: Quantity of sleep (n=663) | 5.9 ± 1.40 |
| SB Baseline: Sleep Adequacy (n=665) | 39.2 ± 23.22 |
| SB Baseline: Somnolence (n=665) | 42.6 ± 23.49 |
| SB Baseline: Sleep Problems Index (n=665) | 49.2 ± 18.17 |
| Week 6: Sleep disturbance (n= 621) | 33.6 ± 24.31 |
| Week 6: Snoring (n= 621) | 39.9 ± 34.83 |
| Week 6: Awaken SOB or With Headache (n= 621) | 12.6 ± 22.64 |
| Week 6: Quantity of sleep (n= 615) | 6.6 ± 1.64 |
| Week 6: Sleep Adequacy (n= 621) | 52.6 ± 25.55 |
| Week 6: Somnolence (n= 621) | 34.2 ± 24.11 |
| Week 6: Sleep Problems Index (n= 621) | 34.4 ± 18.82 |
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.
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| Sleep disturbance | 26.6 ± 21.69 | 30.9 ± 23.05 |
| Snoring | 41.9 ± 36.24 | 35.4 ± 35.95 |
| Awaken SOB or With Headache | 12.3 ± 23.72 | 12.2 ± 23.89 |
| Quantity of sleep | 6.7 ± 1.34 | 6.5 ± 1.47 |
| Sleep Adequacy | 59.2 ± 28.67 | 59.0 ± 27.67 |
| Somnolence | 29.7 ± 24.39 | 30.6 ± 22.98 |
| Sleep Problems Index | 28.5 ± 17.86 | 30.9 ± 18.59 |
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.
| participants | Pregabalin SB |
|---|---|
| SB Baseline | 180 |
| Week 6 | 266 |
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.
| participants | Pregabalin DB | Placebo |
|---|---|---|
| Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) | 67 | 60 |
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.
| units on a scale | Pregabalin SB |
|---|---|
| SB Baseline (n= 663) | 5.9 ± 2.09 |
| Week 1 (n= 657) | 5.1 ± 2.22 |
| Week 2 (n= 636) | 4.5 ± 2.29 |
| Week 3 (n= 614) | 4.1 ± 2.30 |
| Week 4 (n= 589) | 3.8 ± 2.30 |
| Week 5 (n= 566) | 3.7 ± 2.29 |
| Week 6 (n= 548) | 3.6 ± 2.35 |
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).
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| DB Baseline (n= 147, 147) | 2.5 ± 1.79 | 2.3 ± 1.66 |
| Week 7 (n= 144, 145) | 2.6 ± 1.92 | 2.7 ± 1.99 |
| Week 8 (n= 143, 142) | 2.6 ± 1.98 | 3.0 ± 1.98 |
| Week 9 (n= 140, 134) | 2.3 ± 1.88 | 2.7 ± 1.94 |
| Week 10 (n= 138, 133) | 2.3 ± 1.90 | 2.7 ± 1.98 |
| Week 11 (n= 138, 128) | 2.2 ± 1.81 | 2.5 ± 1.78 |
| Week 12 (n= 136, 123) | 2.3 ± 1.90 | 2.4 ± 1.84 |
| Week 13 (n= 134, 122) | 2.3 ± 1.87 | 2.3 ± 1.78 |
| Week 14 (n= 133, 122) | 2.3 ± 1.93 | 2.3 ± 1.80 |
| Week 15 (n= 132, 120) | 2.4 ± 1.93 | 2.3 ± 1.80 |
| Week 16 (n= 132, 120) | 2.3 ± 1.90 | 2.3 ± 1.77 |
| Week 17 (n= 129, 116) | 2.2 ± 1.88 | 2.2 ± 1.85 |
| Week 18 (n= 128, 116) | 2.3 ± 1.92 | 2.3 ± 1.85 |
| Week 19 (n= 121, 111) | 2.3 ± 2.05 | 2.2 ± 1.80 |
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).
| units on a scale | Pregabalin SB |
|---|---|
| Endpoint Mean Sleep Interference Score (Single-Blind Phase) | 3.8 ± 2.42 |
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).
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| Endpoint Mean Sleep Interference Score (Double-Blind Phase) | 2.4 ± 2.10 | 2.4 ± 2.05 |
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.
| units on a scale | Pregabalin SB |
|---|---|
| SB Baseline: Total QOL Scores (n= 665) | 42.6 ± 22.22 |
| SB Baseline: Ph Fn/Large Fiber (n= 665) | 23.9 ± 13.07 |
| SB Baseline: Activities of Daily Living (n= 665) | 3.2 ± 3.69 |
| SB Baseline: Symptoms (n= 665) | 10.8 ± 5.55 |
| SB Baseline: Small Fiber (n= 665) | 3.4 ± 3.40 |
| SB Baseline: Autonomic (n= 665) | 1.3 ± 1.74 |
| Week 6: Total QOL Scores (n= 618) | 29.3 ± 21.76 |
| Week 6: Ph Fn/Large Fiber (n= 618) | 15.8 ± 12.62 |
| Week 6: Activities of Daily Living (n= 618) | 2.2 ± 3.08 |
| Week 6: Symptoms (n= 618) | 7.8 ± 5.72 |
| Week 6: Small Fiber (n= 618) | 2.3 ± 2.99 |
| Week 6: Autonomic (n= 618) | 1.1 ± 1.69 |
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.
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| Total QOL Scores | 21.9 ± 20.02 | 24.1 ± 21.06 |
| Ph Fn/Large Fiber | 11.4 ± 11.28 | 12.9 ± 12.72 |
| Activities of Daily Living | 1.8 ± 2.85 | 1.8 ± 2.79 |
| Symptoms | 6.1 ± 5.04 | 6.6 ± 5.29 |
| Small Fiber | 1.8 ± 3.38 | 1.7 ± 2.50 |
| Autonomic | 0.9 ± 1.55 | 1.1 ± 1.53 |
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.
| mm | Pregabalin SB |
|---|---|
| SB Baseline (n= 665) | 68.1 ± 13.79 |
| Week 6 (n= 621) | 39.8 ± 23.19 |
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.
| mm | Pregabalin DB | Placebo |
|---|---|---|
| Pain Visual Analog Scale (VAS) (Double-Blind Phase) | 25.3 ± 20.98 | 30.1 ± 23.44 |
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).
| units on a scale | Pregabalin SB |
|---|---|
| SB Baseline: Pain Severity (n= 665) | 6.1 ± 1.45 |
| SB Baseline: Pain Interference (n= 665) | 5.2 ± 2.09 |
| Week 6: Pain Severity (n= 637) | 3.9 ± 2.13 |
| Week 6: Pain Interference (n= 637) | 3.1 ± 2.31 |
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).
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| Pain Severity | 2.6 ± 1.85 | 3.0 ± 2.03 |
| Pain Interference | 2.0 ± 2.05 | 2.4 ± 2.10 |
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.
| units on a scale | Pregabalin SB |
|---|---|
| SB Baseline: HADS-A (n= 663) | 5.8 ± 3.95 |
| SB Baseline: HADS-D (n= 663) | 5.3 ± 3.70 |
| Week 6: HADS-A (n= 616) | 4.6 ± 3.54 |
| Week 6: HADS-D (n= 616) | 4.0 ± 3.52 |
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.
| units on a scale | Pregabalin DB | Placebo |
|---|---|---|
| HADS-A | 3.8 ± 2.94 | 4.3 ± 3.56 |
| HADS-D | 3.3 ± 3.12 | 3.5 ± 3.28 |
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.
| participants | Pregabalin SB |
|---|---|
| Very Satisfied | 241 |
| Somewhat Satisfied | 181 |
| Slightly Satisfied | 66 |
| Neither Satisfied Nor Dissatisfied | 71 |
| Slightly Dissatisfied | 22 |
| Somewhat Dissatisfied | 21 |
| Very Dissatisfied | 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.
| participants | Pregabalin DB | Placebo |
|---|---|---|
| Very Satisfied | 80 | 64 |
| Somewhat Satisfied | 35 | 36 |
| Slightly Satisfied | 9 | 14 |
| Neither Satisfied Nor Dissatisfied | 6 | 10 |
| Slightly Dissatisfied | 5 | 2 |
| Somewhat Dissatisfied | 1 | 6 |
| Very Dissatisfied | 2 | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin SB | — | 17/665 (2.6%) | 331/665 (49.8%) |
| Pregabalin DB | — | 11/147 (7.5%) | 86/147 (58.5%) |
| Placebo | — | 6/149 (4%) | 94/149 (63.1%) |
| Event | Pregabalin SB | Pregabalin DB | Placebo |
|---|---|---|---|
| Myocardial infarctionCardiac disorders | 0/665 | 2/147 | 0/149 |
| Acute coronary syndromeCardiac disorders | 0/665 | 1/147 | 0/149 |
| Angina pectorisCardiac disorders | 0/665 | 1/147 | 0/149 |
| Atrial fibrillationCardiac disorders | 0/665 | 1/147 | 0/149 |
| Chest painGeneral disorders | 1/665 | 1/147 | 0/149 |
| Non-cardiac chest painGeneral disorders | 0/665 | 1/147 | 0/149 |
| GangreneInfections and infestations | 0/665 | 1/147 | 0/149 |
| PneumoniaInfections and infestations | 3/665 | 1/147 | 0/149 |
| SepsisInfections and infestations | 0/665 | 1/147 | 0/149 |
| TracheitisInfections and infestations | 0/665 | 1/147 | 0/149 |
| Event | Pregabalin SB | Pregabalin DB | Placebo |
|---|---|---|---|
| Oedema peripheralGeneral disorders | 53/665 | 20/147 | 16/149 |
| DizzinessNervous system disorders | 45/665 | 4/147 | 2/149 |
| SomnolenceNervous system disorders | 38/665 | 6/147 | 5/149 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 19/665 | 3/147 | 8/149 |
| Upper respiratory tract infectionInfections and infestations | 11/665 | 7/147 | 7/149 |
| HeadacheNervous system disorders | 29/665 | 4/147 | 4/149 |
| OedemaGeneral disorders | 10/665 | 6/147 | 5/149 |
| Weight increasedInvestigations | 11/665 | 6/147 | 3/149 |
| DiarrhoeaGastrointestinal disorders | 15/665 | 5/147 | 6/149 |
| Dry mouthGastrointestinal disorders | 12/665 | 5/147 | 3/149 |
| Age, Customized(participants) | Pregabalin SB |
|---|---|
| 18 to 44 Years | 58 |
| 45 to 64 Years | 417 |
| >=65 Years | 190 |
| Sex: Female, Male(Participants) | Pregabalin SB |
|---|---|
| Female | 302 |
| Male | 363 |
Showing the first 100 of 172 sites across 4 countries.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Peripheral Nervous System Diseases→
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