A Phase 3 interventional study of pregabalin and Placebo in Diabetic Neuropathies and Neuralgia, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 10 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 3, Interventional, and Treatment
To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 241 is above the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia 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
Drug: Placebo
150-600mg/day, BID
Placebo
Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population)
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.
Time frame: Endpoint- Week 8 or Early Discontinuation
Daily Pain Rating Scale (DPRS)- Number of 30% Responders (With Respect to Pain Scores)
DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline
Time frame: Endpoint- Week 8 or Early Discontinuation
Daily Pain Rating Scale (DPRS)- Number of 50% Responders (With Respect to Pain Scores)
DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.
Time frame: Endpoint- Week 8 or Early Discontination
Daily Pain Rating Scale (DPRS)- Weekly Mean Pain Score
DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.
Time frame: Weeks 1 to 8
Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score
DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.
Time frame: Weeks 1 to 8
Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS).
DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.
Time frame: Endpoint- Week 8 or Early Discontinuation
Mean Sleep Score as Computed by DSIS.
DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.
Time frame: Weeks 1 to 8
Medical Outcome Study (MOS) Sleep Disturbance
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.
Time frame: Week 8
Medical Outcome Study (MOS) Snoring Score
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.
Time frame: Week 8
Medical Outcome Study (MOS) Awaken Short of Breath or Headache
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.
Time frame: Week 8
Medical Outcome Study (MOS) Sleep Quantity
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).
Time frame: Week 8
Medical Outcome Study (MOS) Optimal Sleep: Number of Participants With Optimal Sleep
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.
Time frame: Week 8
Medical Outcome Study (MOS) Sleep Adequacy
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.
Time frame: Week 8
Medical Outcome Study (MOS) Somnolence
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.
Time frame: Week 8
Medical Outcome Study (MOS) Overall Sleep Problems Index
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.
Time frame: Week 8
Euro Quality of Life (QOL) (EQ-5D) Utility Score
EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject's level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort \& anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).
Time frame: Week 8
Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS)
EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) \& Visual Analog Scale (VAS)). The VAS is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time frame: Week 8
Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score
HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety
Time frame: Week 8
Hospital Anxiety and Depression Scale- Depression (HADS-D) Score
HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response ("lowering of hedonic tone"). Score range = 0 to 21; higher scores indicate a greater intensity of depression
Time frame: Week 8
Patient Global Impression of Change (PGIC)
PGIC is a subject-rated instrument that measured change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.
Time frame: Week 8
Clinical Global Impression of Change (CGIC)
CGIC is a clinician-rated instrument that assesses the subject's overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.
Time frame: Week 8
Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score
DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.
Time frame: Weeks 1 to 8
Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population)
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.
Time frame: Endpoint- Week 8 or Early Discontinuation
Study Initiation and Completion Dates: 27 December 2005 to 28 December 2007; 10 study centers in Korea
| Milestone | Pregabalin | Placebo |
|---|---|---|
| Started | 162 | 78 |
| Completed | 138 | 62 |
| Not completed | 24 | 16 |
| Withdrew: Protocol violations | 5 | 4 |
| Withdrew: Adverse event | 8 | 6 |
| Withdrew: Lack of efficacy | 5 | 4 |
| Withdrew: Withdrawal by subject | 6 | 2 |
DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline
| participants | Pregabalin | Placebo |
|---|---|---|
| Yes | 68 | 27 |
| No | 93 | 50 |
DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline.
| participants | Pregabalin | Placebo |
|---|---|---|
| Yes | 42 | 11 |
| No | 119 | 66 |
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Daily Pain Rating Scale (DPRS)- Mean Pain Score (ITT Population) | 4.63 ± 0.15 | 5.13 ± 0.21 |
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Daily Pain Rating Scale (DPRS)- Mean Pain Scores (Evaluable Population) | 4.47 ± 0.156 | 4.94 ± 0.225 |
DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Overall Comparison (weeks 1 to 8) | 4.91 ± 0.110 | 5.29 ± 0.156 |
| Week 1 (n=161, 77) | 5.80 ± 0.124 | 6.18 ± 0.176 |
| Week 2 (n=156, 75) | 5.30 ± 0.125 | 5.61 ± 0.177 |
| Week 3 (n=154, 72) | 5.02 ± 0.125 | 5.42 ± 0.178 |
| Week 4 (n=151, 68) | 4.84 ± 0.125 | 5.27 ± 0.180 |
| Week 5 (n=146, 66) | 4.69 ± 0.126 | 5.11 ± 0.181 |
| Week 6 (n=145, 65) | 4.64 ± 0.126 | 4.93 ± 0.181 |
| Week 7 (n=142, 62) | 4.52 ± 0.126 | 4.87 ± 0.183 |
| Week 8 (n=138, 62) | 4.47 ± 0.127 | 4.92 ± 0.183 |
DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of (Adjusted) Mean Pain Score | -1.27 ± 0.110 | -0.89 ± 0.156 |
DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Mean Sleep Interference Score Based on Daily Sleep Interference Scale (DSIS). | 3.26 ± 0.162 | 3.91 ± 0.228 |
DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Overall Comparison (Weeks 1 to 8) | 3.46 ± 0.134 | 3.97 ± 0.189 |
| Week 1 (n= 161, 77) | 4.18 ± 0.145 | 4.56 ± 0.205 |
| Week 2 (n=156, 75) | 3.74 ± 0.145 | 4.24 ± 0.206 |
| Week 3 (n=154, 72) | 3.55 ± 0.146 | 4.13 ± 0.207 |
| Week 4 (n=151, 68) | 3.41 ± 0.146 | 3.95 ± 0.208 |
| Week 5 (n=146, 66) | 3.29 ± 0.146 | 3.73 ± 0.209 |
| Week 6 (n=145, 65) | 3.22 ± 0.147 | 3.74 ± 0.210 |
| Week 7 (n=142, 62) | 3.19 ± 0.147 | 3.71 ± 0.211 |
| Week 8 (n=138, 62) | 3.10 ± 0.147 | 3.72 ± 0.211 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Medical Outcome Study (MOS) Sleep Disturbance | 28.96 ± 1.550 | 34.58 ± 2.237 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Medical Outcome Study (MOS) Snoring Score | 34.21 ± 1.964 | 29.16 ± 2.788 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Medical Outcome Study (MOS) Awaken Short of Breath or Headache | 6.90 ± 1.116 | 9.98 ± 1.590 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Medical Outcome Study (MOS) Sleep Quantity | 6.46 ± 0.108 | 6.02 ± 0.154 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night.
| participants | Pregabalin | Placebo |
|---|---|---|
| No | 85 | 44 |
| Yes | 73 | 31 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Medical Outcome Study (MOS) Sleep Adequacy | 48.81 ± 2.244 | 46.65 ± 3.194 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Medical Outcome Study (MOS) Somnolence | 34.02 ± 1.394 | 29.31 ± 1.977 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Medical Outcome Study (MOS) Overall Sleep Problems Index | 32.27 ± 1.204 | 34.40 ± 1.730 |
EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject's level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort \& anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best).
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Euro Quality of Life (QOL) (EQ-5D) Utility Score | 0.651 ± 0.0192 | 0.626 ± 0.0274 |
EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) \& Visual Analog Scale (VAS)). The VAS is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) | 61.53 ± 1.406 | 58.03 ± 2.008 |
HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Hospital Anxiety and Depression Scale- Anxiety (HADS-A) Score | 6.01 ± 0.242 | 6.86 ± 0.345 |
HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response ("lowering of hedonic tone"). Score range = 0 to 21; higher scores indicate a greater intensity of depression
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Hospital Anxiety and Depression Scale- Depression (HADS-D) Score | 7.54 ± 0.259 | 7.73 ± 0.369 |
PGIC is a subject-rated instrument that measured change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.
| participants | Pregabalin | Placebo |
|---|---|---|
| Improved | 118 | 54 |
| No change | 29 | 12 |
| Worse | 11 | 9 |
CGIC is a clinician-rated instrument that assesses the subject's overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse.
| participants | Pregabalin | Placebo |
|---|---|---|
| Improved | 117 | 51 |
| No change | 37 | 16 |
| Worse | 6 | 10 |
DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed.
| score on scale | Pregabalin | Placebo |
|---|---|---|
| Duration Adjusted Average Change (DAAC) of (Unadjusted) Mean Pain Score | -1.24 ± 1.320 | -0.87 ± 1.488 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | 2/162 (1.2%) | 68/162 (42%) |
| Placebo | — | 1/78 (1.3%) | 23/78 (29.5%) |
| Event | Pregabalin | Placebo |
|---|---|---|
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 0/162 | 1/78 |
| ArthritisMusculoskeletal and connective tissue disorders | 1/162 | 0/78 |
| Gallbladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/162 | 0/78 |
| Event | Pregabalin | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 34/162 | 7/78 |
| SomnolenceNervous system disorders | 22/162 | 4/78 |
| Face oedemaGeneral disorders | 10/162 | 1/78 |
| Oedema peripheralGeneral disorders | 10/162 | 0/78 |
| Weight increasedInvestigations | 9/162 | 1/78 |
| Generalized oedemaGeneral disorders | 7/162 | 0/78 |
| HeadacheNervous system disorders | 4/162 | 3/78 |
| InsomniaPsychiatric disorders | 1/162 | 3/78 |
| NasopharyngitisInfections and infestations | 6/162 | 1/78 |
| Dry mouthGastrointestinal disorders | 3/162 | 2/78 |
| Age, Continuous(years) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Mean | 59.7 ± 10.8 | 61.3 ± 12.9 | 60.2 ± 11.5 |
| Sex: Female, Male(Participants) | Pregabalin | Placebo | Total |
|---|---|---|---|
| Female | 83 | 46 | 129 |
| Male | 79 | 32 | 111 |
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.