Chemotherapy Induced Neuropathic Pain, Diabetic Peripheral Neuropathic Pain (DPN), HIV-related Neuropathic Pain (HIV), Postherpetic Neuralgia (PHN)
Conditions
Brief summary
Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
Interventions
DRUGPregabalin
Pregabalin will be administered orally, twice a day for 12 weeks, including 4-week dose adjustment phase followed by 8-week maintenance phase. The minimum allowable pregabalin dose during the trial will be 75 mg BID (150 mg/day) and the maximum allowable dose will be 300 mg BID (600 mg/day).
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
Exclusion criteria
* Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain. * Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Baseline, End of Treatment | 11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Baseline, Week 8, Week 12, EOT/LOCF | Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline. |
| Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF) | Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean. |
| Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4. |
| Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Baseline, Week 8, Week 12, EOT/LOCF | Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4. |
| Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Week 4, Week 8, Week 12 | 11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline. |
| Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) | Baseline, Week 8, Week 12, EOT/LOCF | 100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline. |
| Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF | Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries. |
| Patient Global Impression of Change (PGIC) | End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) | 7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse) |
| Clinical Global Impression of Change (CGIC) | End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment) | 7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse). |
| Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF | 100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean. |
Countries
Colombia, Ecuador, Mexico, Peru, Venezuela
Participant flow
Recruitment details
Subjects were recruited at 13 medical centers in Latin America and participated between January 2007 and July 2008.
Pre-assignment details
160 subjects were screened and evaluated for inclusion/exclusion criteria; 121 were assigned to open-label treatment.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability. | 121 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Other | 5 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Customized >= 65 years | 30 participants |
| Age, Customized Between 18 to 44 years | 15 participants |
| Age, Customized Between 45 to 64 years | 76 participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 69 / — |
| serious Total, serious adverse events | 4 / — |
Outcome results
Primary
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.
Time frame: Baseline, End of Treatment
Population: Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pregabalin | Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS) | -3.8 scores on scale | Standard Deviation 2.5 |
Comparison: End of treatment/last observation carried forward (EOT/LOCF): value consists of the mean of the last 7 post-baseline visits scores. Mean change: the arithmetic mean change and p-value from the single sample t-test. If \< = 7 and \> = 4 post-baseline scores were available, the mean pain score was computed using the available scores. The mean was not calculated if there were less than 4 post-baseline scores prior to study termination.p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores
Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline.
Time frame: Baseline, Week 8, Week 12, EOT/LOCF
Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Week 8 (n=102) | -4.2 scores on scale | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | Week 12 (n=98) | -4.7 scores on scale | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores | EOT/LOCF (n=102) | -4.6 scores on scale | Standard Deviation 2.6 |
Comparison: Week 8, FAS. Week 8: subjects were only included if their visit fell within the computed week (49 to 63 days).p-value: <0.000195% CI: [-4.7, -3.7]Mixed Models Analysis
Comparison: Week 12: subjects were only included if their visit fell within the computed week (\>= 78 days).p-value: <0.000195% CI: [-5.1, -4.1]Mixed Models Analysis
Comparison: EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)
100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline.
Time frame: Baseline, Week 8, Week 12, EOT/LOCF
Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) | Week 8 (n=99) | -39.2 scores on scale | Standard Deviation 29.6 |
| Pregabalin | Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) | Week 12 (n=97) | -41.4 scores on scale | Standard Deviation 32.9 |
| Pregabalin | Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS) | EOT/LOCF (n=101) | -40.5 scores on scale | Standard Deviation 33.1 |
Comparison: Week 8: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 8 assessment only if their visit fell within Days 49 and 63.p-value: <0.000195% CI: [-43.4, -33.9]Mixed Models Analysis
Comparison: Week 12: LS mean, p-value, and confidence interval are based on a repeated measures effect model with baseline value, center, and week as fixed effects; subjects were included as a random effect. Subjects were included in the Week 12 assessment only if their visit fell \>=Day 78.p-value: <0.000195% CI: [-45.5, -35.9]Mixed Models Analysis
Comparison: EOT/LOCF: last post-baseline assessment. Mean change= arithmetic mean change; p-value is from a single-sample t-test.p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Mean Daily Sleep Interference Score (DSIS)
Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF
Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 8 (n=100) | -3.4 scores on scale | Standard Deviation 2.5 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 9 (n=97) | -3.5 scores on scale | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 10 (n=99) | -3.5 scores on scale | Standard Deviation 2.7 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 11 (n=98) | -3.5 scores on scale | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 12 (n=96) | -3.4 scores on scale | Standard Deviation 2.7 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | EOT/LOCF (n=120) | -3.1 scores on scale | Standard Deviation 2.7 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 1 (n=120) | -1.0 scores on scale | Standard Deviation 1.5 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 2 (n=118) | -1.8 scores on scale | Standard Deviation 2 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 3 (n=114) | -2.5 scores on scale | Standard Deviation 2.2 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 4 (n=110) | -2.8 scores on scale | Standard Deviation 2.3 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 5 (n=104 | -3.0 scores on scale | Standard Deviation 2.3 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 6 (n=103) | -3.1 scores on scale | Standard Deviation 2.5 |
| Pregabalin | Change From Baseline in Mean Daily Sleep Interference Score (DSIS) | Week 7 (n=100) | -3.3 scores on scale | Standard Deviation 2.5 |
Comparison: Week 1: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-1.4, -0.7]Mixed Models Analysis
Comparison: Week 2: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-2.2, -1.5]Mixed Models Analysis
Comparison: Week 3: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-2.9, -2.2]Mixed Models Analysis
Comparison: Week 4: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.2, -2.5]Mixed Models Analysis
Comparison: Week 5: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.3, -2.6]Mixed Models Analysis
Comparison: Week 6: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.4, -2.6]Mixed Models Analysis
Comparison: Week 7: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.5, -2.8]Mixed Models Analysis
Comparison: Week 8: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.6, -2.8]Mixed Models Analysis
Comparison: Week 9: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.7, -2.9]Mixed Models Analysis
Comparison: Week 10: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.7, -3]Mixed Models Analysis
Comparison: Visit 11: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.8, -3]Mixed Models Analysis
Comparison: Week 12: LS mean, p-value, and confidence interval are based on repeated measures mixed effect model with baseline value, pooled center, and weeks 1, 4, 8 and 12 as fixed effects; subjects were included as a random effect.p-value: <0.000195% CI: [-3.7, -3]Mixed Models Analysis
Comparison: EOT/LOCF value consists of the mean of the last 7 post-baseline sleep scores; mean change = arithmetic mean change; p-value: from single sample t-test.p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline.
Time frame: Week 4, Week 8, Week 12
Population: Full Analysis Set (FAS).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Week 4 (n=110) | -3.2 scores on scale | Standard Deviation 1.9 |
| Pregabalin | Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Week 8 (n=100) | -3.9 scores on scale | Standard Deviation 2.3 |
| Pregabalin | Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS) | Week 12 (n=96) | -4.2 scores on scale | Standard Deviation 2.4 |
Comparison: Week 4p-value: <0.000195% CI: [-3.6, -2.8]Mixed Models Analysis
Comparison: Week 8p-value: <0.000195% CI: [-4.3, -3.5]Mixed Models Analysis
Comparison: Week 12p-value: <0.000195% CI: [-4.5, -3.7]Mixed Models Analysis
Secondary
Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores
Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean.
Time frame: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)
Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Week 8 (n=102) | -3.8 scores on scale | Standard Deviation 2.7 |
| Pregabalin | Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | Week 12 (n=98) | -4.2 scores on scale | Standard Deviation 2.6 |
| Pregabalin | Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores | EOT/LOCF (n=102) | -4.0 scores on scale | Standard Deviation 2.6 |
Comparison: Week 8: subjects were only included if their visit fell within the computed week (Day 49 to 63).p-value: <0.000195% CI: [-4.2, -3.4]Mixed Models Analysis
Comparison: Week 12: subjects were only included if their visit fell within the computed week (\>= Day 78)p-value: <0.000195% CI: [-4.5, -3.7]Mixed Models Analysis
Comparison: EOT/LOCF: last post-baseline value; mean change from Baseline was the arthmetic mean change and the p-value was from the single-sample t-test.p-value: <0.0001t-test, 2 sided
Secondary
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)
100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean.
Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF
Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Week 12 (n = 98) | -49.0 scores on scale | Standard Deviation 26.6 |
| Pregabalin | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | EOT/LOCF (n = 120) | -45.9 scores on scale | Standard Deviation 28.8 |
| Pregabalin | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Week 1 (n = 120) | -18.8 scores on scale | Standard Deviation 21.9 |
| Pregabalin | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Week 2 (n = 116) | -28.5 scores on scale | Standard Deviation 24.1 |
| Pregabalin | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Week 3 (n = 116) | -34.9 scores on scale | Standard Deviation 25.8 |
| Pregabalin | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Week 4 (n = 109) | -41.0 scores on scale | Standard Deviation 24.6 |
| Pregabalin | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) | Week 8 (n = 102) | -46.6 scores on scale | Standard Deviation 26.2 |
Comparison: Week 1: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 1 assessment if their visit fell within Days 4 to 10.p-value: <0.000195% CI: [-22.3, -14]Mixed Models Analysis
Comparison: Week 2: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 2 assessment if their visit fell within Days 11 to 17.p-value: <0.000195% CI: [-32.4, -24]Mixed Models Analysis
Comparison: Week 3: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 3 assessment if their visit fell within Days 18 to 24.p-value: <0.000195% CI: [-38.5, -30]Mixed Models Analysis
Comparison: Week 4: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 4 assessment if their visit fell within days 25 to 35.p-value: <0.000195% CI: [-45.2, -36.7]Mixed Models Analysis
Comparison: Week 8: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 8 assessment if their visit fell within Days 49 to 63.p-value: <0.000195% CI: [-50.2, -41.4]Mixed Models Analysis
Comparison: Week 12: LS mean, p-value, and confidence interval are based on a repeated measures mixed effect model with baseline value, center, and week as fixed effects; subject was included as a random effect. Subjects were only included in the Week 12 assessment if their visit fell \>= Day 78.p-value: <0.000195% CI: [-52.8, -44]Mixed Models Analysis
Comparison: EOT/LOCF: last post-baseline assessment. Mean change is the arithmetic mean change; p-value is from a single-sample t-test.p-value: <0.0001t-test, 2 sided
Secondary
Clinical Global Impression of Change (CGIC)
7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse).
Time frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Clinical Global Impression of Change (CGIC) | Very much improved | 41 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | Much improved | 55 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | Minimally improved | 5 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | No change | 2 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | Minimally worse | 0 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | Much Worse | 0 participants |
| Pregabalin | Clinical Global Impression of Change (CGIC) | Very much worse | 0 participants |
Secondary
Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication
Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4.
Time frame: Baseline, Week 8, Week 12, EOT/LOCF
Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Baseline (n=78) | 62.34 scores on scale | Standard Deviation 29.99 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Week 8 (n=100) | 90.38 scores on scale | Standard Deviation 16.17 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | Week 12 (n=97) | 91.66 scores on scale | Standard Deviation 13.83 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication | EOT/LOCF (n=105) | 91.40 scores on scale | Standard Deviation 14.95 |
Secondary
Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication
Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=\[(5-mean of non-missing items)\*100\]/4.
Time frame: Baseline, Week 8, Week 12, EOT/LOCF
Population: Full Analysis Set (FAS); End of Treatment/Last Observation Carried Forward (EOT/LOCF): last post-baseline assessment. Subjects were only included in the Week 8 analysis if their visit fell between Days 49 and 63, and were only included in the Week 12 analysis if their visit was after Day 78.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Baseline (n=78) | 52.56 scores on scale | Standard Deviation 24.68 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Week 8 (n=100) | 85.92 scores on scale | Standard Deviation 16.96 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | Week 12 (n=97) | 88.56 scores on scale | Standard Deviation 13.87 |
| Pregabalin | Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication | EOT/LOCF (n=105) | 88.08 scores on scale | Standard Deviation 14.72 |
Secondary
Patient Global Impression of Change (PGIC)
7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse)
Time frame: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregabalin | Patient Global Impression of Change (PGIC) | Very much improved | 37 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | Much improved | 53 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | Minimally improved | 12 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | No change | 1 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | Minimally worse | 0 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | Much worse | 0 participants |
| Pregabalin | Patient Global Impression of Change (PGIC) | Very much worse | 0 participants |