Diabetic Neuropathy, Painful
Conditions
Brief summary
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.
Interventions
DRUGplacebo
Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
DRUGpregabalin
Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Visual Analogue Scale (VAS) of pain is higher than 40 mm. * Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year
Exclusion criteria
* Malignancy within the past 2 years. * Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Study Endpoint in Mean Weekly Pain Scores | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. |
| Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr). |
| Number of Responders | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint. |
| Change From Baseline at Week 1 in Mean Weekly Pain Scores | From baseline to Week 1 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1. Change from baseline: Score at Week 1 minus score at baseline |
| Change From Baseline at Week 2 in Mean Weekly Pain Scores | From baseline to Week 2 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2. Change from baseline: Score at Week 2 minus score at baseline |
| Change From Baseline at Week 3 in Mean Weekly Pain Scores | From baseline to Week 3 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3. Change from baseline: Score at Week 3 minus score at baseline |
| Change From Baseline at Week 4 in Mean Weekly Pain Scores | From baseline to Week 4 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4. Change from baseline: Score at Week 4 minus score at baseline |
| Change From Baseline at Week 5 in Mean Weekly Pain Scores | From baseline to Week 5 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5. Change from baseline: Score at Week 5 minus score at baseline |
| Change From Baseline at Week 6 in Mean Weekly Pain Scores | From baseline to Week 6 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6. Change from baseline: Score at Week 6 minus score at baseline |
| Change From Baseline at Week 7 in Mean Weekly Pain Scores | From baseline to Week 7 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7. Change from baseline: Score at Week 7 minus score at baseline |
| Change From Baseline at Week 8 in Mean Weekly Pain Scores | From baseline to Week 8 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8. Change from baseline: Score at Week 8 minus score at baseline |
| Change From Baseline at Week 9 in Mean Weekly Pain Scores | From baseline to Week 9 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9. Change from baseline: Score at Week 9 minus score at baseline |
| Change From Baseline at Week 10 in Mean Weekly Pain Scores | From baseline to Week 10 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10. Change from baseline: Score at Week 10 minus score at baseline |
| Change From Baseline at Week 11 in Mean Weekly Pain Scores | From baseline to Week 11 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11. Change from baseline: Score at Week 11 minus score at baseline |
| Change From Baseline at Week 12 in Mean Weekly Pain Scores | From baseline to Week 12 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12. Change from baseline: Score at Week 12 minus score at baseline |
| Change From Baseline at Week 13 in Mean Weekly Pain Scores | From baseline to Week 13 | The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13. Change from baseline: Score at Week 13 minus score at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute. |
| Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale. |
| Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute. |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. |
| Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute. |
| Clinical Global Impression of Change | Week 13 or up to discontinuation | Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). |
| Patient Global Impression of Change | Week 13 or up to discontinuation | The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). |
| Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. |
| Change From Baseline in Mean Sleep Interference Scores | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep. |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. |
| Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. |
| Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain. |
| Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring | From baseline to Week 13 or up to study discontinuation (Study Endpoint) | The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute. |
Countries
Japan
Participant flow
Pre-assignment details
After a 1-week baseline phase, subjects were classified into 2 strata based on creatinine clearance (CLcr) values (Low: 30 \<CLcr \<=60 mL/minute; Normal: CLcr \> 60 mL/minute) and were each randomly assigned to 1 of 3 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo During a 13-week double-blind phase, subjects received matching placebo. | 135 |
| Pregabalin 300 mg/Day During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks. | 134 |
| Pregabalin 600 mg/Day During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks. | 45 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 17 | 13 |
| Overall Study | Due to moving | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 7 | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Pregabalin 600 mg/Day | Pregabalin 300 mg/Day | Placebo |
|---|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 10 | 62.2 years STANDARD_DEVIATION 10.3 | 61.3 years STANDARD_DEVIATION 10.3 | 61.3 years STANDARD_DEVIATION 9.6 |
| Age, Customized 18 - 44 years | 16 participants | 1 participants | 8 participants | 7 participants |
| Age, Customized < 18 years | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized 45 - 64 years | 179 participants | 25 participants | 78 participants | 76 participants |
| Age, Customized >= 65 years | 119 participants | 19 participants | 48 participants | 52 participants |
| Region of Enrollment Japan | 314 participants | 45 participants | 134 participants | 135 participants |
| Sex: Female, Male Female | 77 Participants | 13 Participants | 32 Participants | 32 Participants |
| Sex: Female, Male Male | 237 Participants | 32 Participants | 102 Participants | 103 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 | 50 / 135 | 71 / 134 | 36 / 45 |
| serious Total, serious adverse events | 3 / 135 | 2 / 134 | 1 / 45 |
Outcome results
Primary
Change From Baseline at Week 10 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10. Change from baseline: Score at Week 10 minus score at baseline
Time frame: From baseline to Week 10
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 10 in Mean Weekly Pain Scores | -1.23 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 10 in Mean Weekly Pain Scores | -1.93 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 10 in Mean Weekly Pain Scores | -2.10 score on scale | Standard Error 0.28 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.000595% CI: [-1.1, -0.31]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.003495% CI: [-1.46, -0.29]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 11 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11. Change from baseline: Score at Week 11 minus score at baseline
Time frame: From baseline to Week 11
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 11 in Mean Weekly Pain Scores | -1.32 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 11 in Mean Weekly Pain Scores | -1.95 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 11 in Mean Weekly Pain Scores | -2.09 score on scale | Standard Error 0.28 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.002395% CI: [-1.02, -0.22]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.010595% CI: [-1.36, -0.18]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 12 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12. Change from baseline: Score at Week 12 minus score at baseline
Time frame: From baseline to Week 12
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 12 in Mean Weekly Pain Scores | -1.36 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 12 in Mean Weekly Pain Scores | -2.01 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 12 in Mean Weekly Pain Scores | -2.13 score on scale | Standard Error 0.29 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001695% CI: [-1.05, -0.25]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.011195% CI: [-1.37, -0.18]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 13 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13. Change from baseline: Score at Week 13 minus score at baseline
Time frame: From baseline to Week 13
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 13 in Mean Weekly Pain Scores | -1.38 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 13 in Mean Weekly Pain Scores | -2.04 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 13 in Mean Weekly Pain Scores | -2.12 score on scale | Standard Error 0.29 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001395% CI: [-1.07, -0.26]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.015295% CI: [-1.34, -0.14]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 1 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1. Change from baseline: Score at Week 1 minus score at baseline
Time frame: From baseline to Week 1
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 1 in Mean Weekly Pain Scores | -0.39 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 1 in Mean Weekly Pain Scores | -0.82 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 1 in Mean Weekly Pain Scores | -1.14 score on scale | Standard Error 0.26 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.028795% CI: [-0.82, -0.05]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.007395% CI: [-1.29, -0.2]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 2 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2. Change from baseline: Score at Week 2 minus score at baseline
Time frame: From baseline to Week 2
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 2 in Mean Weekly Pain Scores | -0.57 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 2 in Mean Weekly Pain Scores | -1.17 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 2 in Mean Weekly Pain Scores | -1.80 score on scale | Standard Error 0.26 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.002195% CI: [-1, -0.22]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.000195% CI: [-1.78, -0.69]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 3 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3. Change from baseline: Score at Week 3 minus score at baseline
Time frame: From baseline to Week 3
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 3 in Mean Weekly Pain Scores | -0.80 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 3 in Mean Weekly Pain Scores | -1.40 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 3 in Mean Weekly Pain Scores | -1.93 score on scale | Standard Error 0.26 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.002695% CI: [-0.99, -0.21]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.000195% CI: [-1.69, -0.58]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 4 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4. Change from baseline: Score at Week 4 minus score at baseline
Time frame: From baseline to Week 4
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 4 in Mean Weekly Pain Scores | -0.89 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 4 in Mean Weekly Pain Scores | -1.53 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 4 in Mean Weekly Pain Scores | -2.00 score on scale | Standard Error 0.26 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001295% CI: [-1.03, -0.25]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.000195% CI: [-1.67, -0.56]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 5 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5. Change from baseline: Score at Week 5 minus score at baseline
Time frame: From baseline to Week 5
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 5 in Mean Weekly Pain Scores | -0.91 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 5 in Mean Weekly Pain Scores | -1.57 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 5 in Mean Weekly Pain Scores | -2.07 score on scale | Standard Error 0.27 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001195% CI: [-1.04, -0.26]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.000195% CI: [-1.72, -0.6]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 6 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6. Change from baseline: Score at Week 6 minus score at baseline
Time frame: From baseline to Week 6
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 6 in Mean Weekly Pain Scores | -0.94 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 6 in Mean Weekly Pain Scores | -1.72 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 6 in Mean Weekly Pain Scores | -2.06 score on scale | Standard Error 0.27 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.000195% CI: [-1.18, -0.4]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.000195% CI: [-1.68, -0.56]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 7 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7. Change from baseline: Score at Week 7 minus score at baseline
Time frame: From baseline to Week 7
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 7 in Mean Weekly Pain Scores | -1.04 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 7 in Mean Weekly Pain Scores | -1.76 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 7 in Mean Weekly Pain Scores | -2.13 score on scale | Standard Error 0.27 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.000395% CI: [-1.12, -0.33]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.000295% CI: [-1.66, -0.52]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 8 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8. Change from baseline: Score at Week 8 minus score at baseline
Time frame: From baseline to Week 8
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 8 in Mean Weekly Pain Scores | -1.18 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 8 in Mean Weekly Pain Scores | -1.85 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 8 in Mean Weekly Pain Scores | -2.12 score on scale | Standard Error 0.27 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.000895% CI: [-1.07, -0.28]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001495% CI: [-1.51, -0.36]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline at Week 9 in Mean Weekly Pain Scores
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9. Change from baseline: Score at Week 9 minus score at baseline
Time frame: From baseline to Week 9
Population: Full analysis set. Observed case (No imputation).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline at Week 9 in Mean Weekly Pain Scores | -1.20 score on scale | Standard Error 0.17 |
| Pregabalin 300 mg/Day | Change From Baseline at Week 9 in Mean Weekly Pain Scores | -1.93 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline at Week 9 in Mean Weekly Pain Scores | -2.06 score on scale | Standard Error 0.28 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.000395% CI: [-1.12, -0.33]Mixed Model Repeated Measures Analysis
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.003695% CI: [-1.44, -0.28]Mixed Model Repeated Measures Analysis
Primary
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Study Endpoint in Mean Weekly Pain Scores | -1.20 score on scale | Standard Error 0.21 |
| Pregabalin 300 mg/Day | Change From Baseline to Study Endpoint in Mean Weekly Pain Scores | -1.82 score on scale | Standard Error 0.22 |
| Pregabalin 600 mg/Day | Change From Baseline to Study Endpoint in Mean Weekly Pain Scores | -1.94 score on scale | Standard Error 0.32 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.007595% CI: [-1.09, -0.17]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.025495% CI: [-1.39, -0.09]ANCOVA
Primary
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations | -1.27 score on scale | Standard Error 0.16 |
| Pregabalin 300 mg/Day | Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations | -1.93 score on scale | Standard Error 0.17 |
| Pregabalin 600 mg/Day | Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations | -1.90 score on scale | Standard Error 0.25 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.005895% CI: [-1.14, -0.19]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.033395% CI: [-1.23, -0.05]ANCOVA
Primary
Number of Responders
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Responders | 29 participants |
| Pregabalin 300 mg/Day | Number of Responders | 39 participants |
| Pregabalin 600 mg/Day | Number of Responders | 16 participants |
Comparison: Significance level of 0.05 was used.p-value: 0.153Cochran-Mantel-Haenszel
Comparison: Significance level of 0.05 was used.p-value: 0.059Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Mean Sleep Interference Scores
The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Sleep Interference Scores | -0.74 score on scale | Standard Error 0.18 |
| Pregabalin 300 mg/Day | Change From Baseline in Mean Sleep Interference Scores | -1.59 score on scale | Standard Error 0.18 |
| Pregabalin 600 mg/Day | Change From Baseline in Mean Sleep Interference Scores | -1.36 score on scale | Standard Error 0.27 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: <0.000195% CI: [-1.25, -0.46]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.027395% CI: [-1.19, -0.07]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index | -7.91 score on scale | Standard Error 1.45 |
| Pregabalin 300 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index | -11.45 score on scale | Standard Error 1.46 |
| Pregabalin 600 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index | -9.73 score on scale | Standard Error 2.16 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.026995% CI: [-6.67, -0.41]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.418395% CI: [-6.24, 2.6]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep | 0.37 score on scale | Standard Error 0.12 |
| Pregabalin 300 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep | 0.69 score on scale | Standard Error 0.12 |
| Pregabalin 600 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep | 0.54 score on scale | Standard Error 0.18 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.017795% CI: [0.06, 0.59]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.366195% CI: [-0.2, 0.55]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy | 12.08 score on scale | Standard Error 2.61 |
| Pregabalin 300 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy | 17.69 score on scale | Standard Error 2.64 |
| Pregabalin 600 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy | 21.73 score on scale | Standard Error 3.87 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.051195% CI: [-0.03, 11.26]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.017395% CI: [1.72, 17.59]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance | -9.03 score on scale | Standard Error 1.86 |
| Pregabalin 300 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance | -15.40 score on scale | Standard Error 1.88 |
| Pregabalin 600 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance | -12.81 score on scale | Standard Error 2.77 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001995% CI: [-10.38, -2.36]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.190795% CI: [-9.45, 1.89]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache | -1.63 score on scale | Standard Error 1.69 |
| Pregabalin 300 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache | -3.02 score on scale | Standard Error 1.71 |
| Pregabalin 600 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache | -4.47 score on scale | Standard Error 2.51 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.453895% CI: [-5.05, 2.26]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.278295% CI: [-7.97, 2.3]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring | -6.00 score on scale | Standard Error 2.51 |
| Pregabalin 300 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring | -5.96 score on scale | Standard Error 2.53 |
| Pregabalin 600 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring | -1.56 score on scale | Standard Error 3.71 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.990595% CI: [-5.37, 5.43]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.253295% CI: [-3.19, 12.08]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence | -2.96 score on scale | Standard Error 2.17 |
| Pregabalin 300 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence | 0.83 score on scale | Standard Error 2.19 |
| Pregabalin 600 mg/Day | Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence | 4.83 score on scale | Standard Error 3.2 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.112395% CI: [-0.89, 8.47]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.020695% CI: [1.2, 14.38]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain | 10.34 score on scale | Standard Error 1.97 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain | 11.84 score on scale | Standard Error 1.99 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain | 12.89 score on scale | Standard Error 2.91 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.487395% CI: [-2.75, 5.76]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.400895% CI: [-3.42, 8.53]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception | 2.31 score on scale | Standard Error 1.44 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception | 3.29 score on scale | Standard Error 1.45 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception | 4.40 score on scale | Standard Error 2.14 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.537295% CI: [-2.13, 4.09]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.34895% CI: [-2.29, 6.47]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health | 3.84 score on scale | Standard Error 1.83 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health | 5.33 score on scale | Standard Error 1.85 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health | 7.81 score on scale | Standard Error 2.72 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.460295% CI: [-2.47, 5.45]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.162595% CI: [-1.61, 9.54]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning | 2.70 score on scale | Standard Error 1.58 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning | 2.43 score on scale | Standard Error 1.59 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning | 3.86 score on scale | Standard Error 2.33 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.873195% CI: [-3.67, 3.12]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.633795% CI: [-3.62, 5.94]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional | 4.13 score on scale | Standard Error 2.52 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional | 5.05 score on scale | Standard Error 2.55 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional | 6.35 score on scale | Standard Error 3.77 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.739495% CI: [-4.52, 6.37]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.571295% CI: [-5.49, 9.93]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical | 4.38 score on scale | Standard Error 2.47 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical | 2.28 score on scale | Standard Error 2.5 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical | 3.97 score on scale | Standard Error 3.7 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.439895% CI: [-7.44, 3.24]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.915395% CI: [-7.96, 7.14]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning | 3.00 score on scale | Standard Error 2.39 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning | 8.06 score on scale | Standard Error 2.41 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning | 11.16 score on scale | Standard Error 3.54 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.054495% CI: [-0.1, 10.21]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.027895% CI: [0.89, 15.42]ANCOVA
Secondary
Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality | 5.28 score on scale | Standard Error 1.92 |
| Pregabalin 300 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality | 4.20 score on scale | Standard Error 1.94 |
| Pregabalin 600 mg/Day | Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality | 12.87 score on scale | Standard Error 2.84 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.611895% CI: [-5.23, 3.08]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.010995% CI: [1.76, 13.42]ANCOVA
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | -0.83 score on scale | Standard Error 0.2 |
| Pregabalin 300 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | -1.43 score on scale | Standard Error 0.2 |
| Pregabalin 600 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores | -1.39 score on scale | Standard Error 0.3 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.006895% CI: [-1.03, -0.17]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.070795% CI: [-1.17, 0.05]ANCOVA
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | -0.59 score on scale | Standard Error 0.09 |
| Pregabalin 300 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | -0.80 score on scale | Standard Error 0.09 |
| Pregabalin 600 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores | -0.96 score on scale | Standard Error 0.13 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.036595% CI: [-0.4, -0.01]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.007395% CI: [-0.65, -0.1]ANCOVA
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | -2.82 score on scale | Standard Error 0.5 |
| Pregabalin 300 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | -4.60 score on scale | Standard Error 0.5 |
| Pregabalin 600 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores | -4.95 score on scale | Standard Error 0.74 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001395% CI: [-2.87, -0.71]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.006295% CI: [-3.65, -0.61]ANCOVA
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | -3.68 score on scale | Standard Error 0.66 |
| Pregabalin 300 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | -6.03 score on scale | Standard Error 0.66 |
| Pregabalin 600 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores | -6.36 score on scale | Standard Error 0.97 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.001395% CI: [-3.76, -0.93]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.008795% CI: [-4.67, -0.68]ANCOVA
Secondary
Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain.
Time frame: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | -16.92 mm | Standard Error 2.38 |
| Pregabalin 300 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | -24.19 mm | Standard Error 2.4 |
| Pregabalin 600 mg/Day | Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores | -24.41 mm | Standard Error 3.53 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.005695% CI: [-12.4, -2.14]ANCOVA
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.042795% CI: [-14.74, -0.25]ANCOVA
Secondary
Clinical Global Impression of Change
Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 13 or up to discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Clinical Global Impression of Change | 3.3 score on scale | Standard Deviation 1.2 |
| Pregabalin 300 mg/Day | Clinical Global Impression of Change | 2.9 score on scale | Standard Deviation 1.1 |
| Pregabalin 600 mg/Day | Clinical Global Impression of Change | 2.7 score on scale | Standard Deviation 1.1 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0148Cochran-Mantel-Haenszel
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0063Cochran-Mantel-Haenszel
Secondary
Patient Global Impression of Change
The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 13 or up to discontinuation
Population: Full analysis set. Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Patient Global Impression of Change | 3.4 score on scale | Standard Deviation 1.3 |
| Pregabalin 300 mg/Day | Patient Global Impression of Change | 3.2 score on scale | Standard Deviation 1 |
| Pregabalin 600 mg/Day | Patient Global Impression of Change | 2.8 score on scale | Standard Deviation 1 |
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0818Cochran-Mantel-Haenszel
Comparison: Hypothesis testing was conducted using two-sided tests with significance level of 0.05.p-value: 0.0075Cochran-Mantel-Haenszel