Fibromyalgia
Conditions
Brief summary
This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.
Interventions
DRUGpregabalin
600mg/day
DRUGplacebo
placebo
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ACR criteria for fibromyalgia * A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries
Exclusion criteria
* Patients with other severe pain conditions * Patients with severe depression * Patients taking excluded medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | Baseline, Week 14 | Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication. |
| Patient Global Impression of Change (PGIC) | Week 14 | Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | Baseline, Week 14 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more disturbance. |
| Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Baseline, Week 14 | Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | Baseline, Week 14 | FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. |
| Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | Baseline, Week 14 | FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. |
| Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | Baseline, Week 14 | Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication. |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | Baseline, Week 14 | MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue). |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | Baseline, Week 14 | HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. |
| Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14 | Baseline, Week 14 | Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain. |
| Total Daily Acetaminophen Dose | Week 14 | Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days). |
| Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Baseline, Week 14 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. |
| Change From Baseline in Weekly Mean Sleep Quality Score | Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 | Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries. |
Countries
Australia, Canada, Denmark, France, Germany, India, Italy, Mexico, Netherlands, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom, Venezuela
Participant flow
Recruitment details
Recruitment from 73 centers in North America \[Canada (12) and Mexico (4)\], South America \[Venezuela (3)\], Europe \[Denmark (2), France (5), Germany (5), Italy (6), Netherlands (5), Portugal (4), Spain (4), Sweden (4), Switzerland (3) and United Kingdom(5)\] and Asia \[India (4) and Korea (3)\] and Australia (4).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to pregabalin capsules orally twice daily up to Week 14. | 184 |
| Pregabalin 300 mg Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14. | 184 |
| Pregabalin 450 mg Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14. | 182 |
| Pregabalin 600 mg Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14. | 186 |
| Total | 736 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 23 | 37 | 38 | 47 |
| Overall Study | Lack of Efficacy | 8 | 6 | 3 | 5 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 | 2 |
| Overall Study | Other | 3 | 2 | 2 | 2 |
| Overall Study | Randomized but not Treated | 5 | 3 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 14 | 4 | 9 |
Baseline characteristics
| Characteristic | Total | Placebo | Pregabalin 300 mg | Pregabalin 450 mg | Pregabalin 600 mg |
|---|---|---|---|---|---|
| 36-Item Short-Form Health Survey (SF-36) Bodily Pain | 28.74 Units on a scale STANDARD_DEVIATION 14.03 | 29.28 Units on a scale STANDARD_DEVIATION 15.61 | 28.67 Units on a scale STANDARD_DEVIATION 13.65 | 28.30 Units on a scale STANDARD_DEVIATION 13.62 | 28.70 Units on a scale STANDARD_DEVIATION 13.2 |
| 36-Item Short-Form Health Survey (SF-36) Emotional Role Limitations | 60.76 Units on a scale STANDARD_DEVIATION 29.25 | 59.61 Units on a scale STANDARD_DEVIATION 29.52 | 60.61 Units on a scale STANDARD_DEVIATION 29.23 | 61.54 Units on a scale STANDARD_DEVIATION 28.94 | 61.31 Units on a scale STANDARD_DEVIATION 29.5 |
| 36-Item Short-Form Health Survey (SF-36) General Health Perception | 43.47 Units on a scale STANDARD_DEVIATION 18.63 | 41.65 Units on a scale STANDARD_DEVIATION 18.35 | 42.12 Units on a scale STANDARD_DEVIATION 19.24 | 45.56 Units on a scale STANDARD_DEVIATION 18.56 | 44.58 Units on a scale STANDARD_DEVIATION 18.23 |
| 36-Item Short-Form Health Survey (SF-36) Mental Component Score | 40.43 Units on a scale STANDARD_DEVIATION 12.13 | 40.11 Units on a scale STANDARD_DEVIATION 11.57 | 40.45 Units on a scale STANDARD_DEVIATION 11.72 | 40.79 Units on a scale STANDARD_DEVIATION 13.15 | 40.37 Units on a scale STANDARD_DEVIATION 12.14 |
| 36-Item Short-Form Health Survey (SF-36) Mental Health | 56.78 Units on a scale STANDARD_DEVIATION 20.77 | 56.48 Units on a scale STANDARD_DEVIATION 20.68 | 56.41 Units on a scale STANDARD_DEVIATION 20.49 | 57.56 Units on a scale STANDARD_DEVIATION 21.7 | 56.71 Units on a scale STANDARD_DEVIATION 20.39 |
| 36-Item Short-Form Health Survey (SF-36) Physical Component Score | 32.35 Units on a scale STANDARD_DEVIATION 7.55 | 31.87 Units on a scale STANDARD_DEVIATION 7.59 | 32.60 Units on a scale STANDARD_DEVIATION 7.43 | 32.51 Units on a scale STANDARD_DEVIATION 8.16 | 32.42 Units on a scale STANDARD_DEVIATION 7.03 |
| 36-Item Short-Form Health Survey (SF-36) Physical Functioning | 43.43 Units on a scale STANDARD_DEVIATION 20.94 | 42.93 Units on a scale STANDARD_DEVIATION 21.04 | 44.71 Units on a scale STANDARD_DEVIATION 20.29 | 42.52 Units on a scale STANDARD_DEVIATION 22.17 | 43.54 Units on a scale STANDARD_DEVIATION 20.39 |
| 36-Item Short-Form Health Survey (SF-36) Physical Role Limitations | 39.69 Units on a scale STANDARD_DEVIATION 24.63 | 37.14 Units on a scale STANDARD_DEVIATION 22.75 | 40.79 Units on a scale STANDARD_DEVIATION 25.58 | 41.44 Units on a scale STANDARD_DEVIATION 25.39 | 39.46 Units on a scale STANDARD_DEVIATION 24.71 |
| 36-Item Short-Form Health Survey (SF-36) Social Functioning | 54.72 Units on a scale STANDARD_DEVIATION 26.24 | 54.44 Units on a scale STANDARD_DEVIATION 26.95 | 56.79 Units on a scale STANDARD_DEVIATION 26 | 53.93 Units on a scale STANDARD_DEVIATION 26.55 | 53.70 Units on a scale STANDARD_DEVIATION 25.55 |
| 36-Item Short-Form Health Survey (SF-36) Vitality | 27.63 Units on a scale STANDARD_DEVIATION 18.39 | 26.46 Units on a scale STANDARD_DEVIATION 16.76 | 27.88 Units on a scale STANDARD_DEVIATION 17.67 | 28.78 Units on a scale STANDARD_DEVIATION 19.94 | 27.42 Units on a scale STANDARD_DEVIATION 19.14 |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.2 | 48.1 years STANDARD_DEVIATION 11.3 | 48.4 years STANDARD_DEVIATION 10.8 | 48.0 years STANDARD_DEVIATION 11.3 | 49.6 years STANDARD_DEVIATION 11.3 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Anxiety | 5.34 Units on a scale STANDARD_DEVIATION 2.97 | 5.38 Units on a scale STANDARD_DEVIATION 3.09 | 5.27 Units on a scale STANDARD_DEVIATION 2.96 | 5.35 Units on a scale STANDARD_DEVIATION 2.86 | 5.35 Units on a scale STANDARD_DEVIATION 2.97 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Depression | 4.76 Units on a scale STANDARD_DEVIATION 3.01 | 4.85 Units on a scale STANDARD_DEVIATION 3.12 | 4.73 Units on a scale STANDARD_DEVIATION 2.93 | 4.79 Units on a scale STANDARD_DEVIATION 3.01 | 4.65 Units on a scale STANDARD_DEVIATION 3 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Do Work | 6.70 Units on a scale STANDARD_DEVIATION 2.12 | 6.96 Units on a scale STANDARD_DEVIATION 2.24 | 6.54 Units on a scale STANDARD_DEVIATION 2.23 | 6.68 Units on a scale STANDARD_DEVIATION 1.96 | 6.62 Units on a scale STANDARD_DEVIATION 2.01 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Fatigue | 7.55 Units on a scale STANDARD_DEVIATION 2.02 | 7.85 Units on a scale STANDARD_DEVIATION 1.84 | 7.45 Units on a scale STANDARD_DEVIATION 2.14 | 7.34 Units on a scale STANDARD_DEVIATION 2.02 | 7.56 Units on a scale STANDARD_DEVIATION 2.04 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Feel Good | 7.59 Units on a scale STANDARD_DEVIATION 2.64 | 7.50 Units on a scale STANDARD_DEVIATION 2.61 | 7.46 Units on a scale STANDARD_DEVIATION 2.77 | 7.63 Units on a scale STANDARD_DEVIATION 2.53 | 7.77 Units on a scale STANDARD_DEVIATION 2.65 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Pain | 7.21 Units on a scale STANDARD_DEVIATION 1.58 | 7.35 Units on a scale STANDARD_DEVIATION 1.63 | 7.24 Units on a scale STANDARD_DEVIATION 1.48 | 7.09 Units on a scale STANDARD_DEVIATION 1.62 | 7.15 Units on a scale STANDARD_DEVIATION 1.6 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Physical Impairment | 3.88 Units on a scale STANDARD_DEVIATION 2.14 | 4.04 Units on a scale STANDARD_DEVIATION 2.18 | 3.88 Units on a scale STANDARD_DEVIATION 2.13 | 3.87 Units on a scale STANDARD_DEVIATION 2.12 | 3.75 Units on a scale STANDARD_DEVIATION 2.15 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Rested | 7.58 Units on a scale STANDARD_DEVIATION 2.02 | 7.71 Units on a scale STANDARD_DEVIATION 2.03 | 7.61 Units on a scale STANDARD_DEVIATION 2.08 | 7.55 Units on a scale STANDARD_DEVIATION 1.96 | 7.44 Units on a scale STANDARD_DEVIATION 2.02 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Stiffness | 7.26 Units on a scale STANDARD_DEVIATION 2.12 | 7.52 Units on a scale STANDARD_DEVIATION 2.13 | 7.19 Units on a scale STANDARD_DEVIATION 2.07 | 7.03 Units on a scale STANDARD_DEVIATION 2.02 | 7.28 Units on a scale STANDARD_DEVIATION 2.24 |
| Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores FIQ Work Missed | 3.20 Units on a scale STANDARD_DEVIATION 3.22 | 3.38 Units on a scale STANDARD_DEVIATION 3.34 | 3.35 Units on a scale STANDARD_DEVIATION 3.18 | 3.22 Units on a scale STANDARD_DEVIATION 3.36 | 2.86 Units on a scale STANDARD_DEVIATION 2.99 |
| Fibromyalgia Impact Questionnaire (FIQ) Total Scores | 61.08 Units on a scale STANDARD_DEVIATION 14.52 | 62.58 Units on a scale STANDARD_DEVIATION 14.85 | 60.75 Units on a scale STANDARD_DEVIATION 14.77 | 60.59 Units on a scale STANDARD_DEVIATION 14.59 | 60.40 Units on a scale STANDARD_DEVIATION 13.87 |
| Hospital Anxiety and Depression Scale (HADS) HADS Anxiety (HADS-A) Total | 8.88 Units on a scale STANDARD_DEVIATION 4.51 | 8.95 Units on a scale STANDARD_DEVIATION 4.52 | 8.96 Units on a scale STANDARD_DEVIATION 4.5 | 8.75 Units on a scale STANDARD_DEVIATION 4.44 | 8.85 Units on a scale STANDARD_DEVIATION 4.58 |
| Hospital Anxiety and Depression Scale (HADS) HADS Depression (HADS-D) Total | 7.51 Units on a scale STANDARD_DEVIATION 4.2 | 7.83 Units on a scale STANDARD_DEVIATION 4.17 | 7.16 Units on a scale STANDARD_DEVIATION 4.03 | 7.66 Units on a scale STANDARD_DEVIATION 4.32 | 7.39 Units on a scale STANDARD_DEVIATION 4.28 |
| Mean Pain Score | 6.65 Units on a scale STANDARD_DEVIATION 1.36 | 6.68 Units on a scale STANDARD_DEVIATION 1.48 | 6.76 Units on a scale STANDARD_DEVIATION 1.29 | 6.57 Units on a scale STANDARD_DEVIATION 1.31 | 6.59 Units on a scale STANDARD_DEVIATION 1.37 |
| Mean Sleep Quality Score | 5.95 Units on a scale STANDARD_DEVIATION 1.77 | 6.01 Units on a scale STANDARD_DEVIATION 1.9 | 5.94 Units on a scale STANDARD_DEVIATION 1.7 | 5.94 Units on a scale STANDARD_DEVIATION 1.7 | 5.91 Units on a scale STANDARD_DEVIATION 1.8 |
| Medical Outcome Study Sleep Scale (MOS-SS) Overall Sleep Problem Index | 58.22 Units on a scale STANDARD_DEVIATION 18.38 | 57.46 Units on a scale STANDARD_DEVIATION 17.27 | 59.27 Units on a scale STANDARD_DEVIATION 19.24 | 58.11 Units on a scale STANDARD_DEVIATION 18.94 | 58.05 Units on a scale STANDARD_DEVIATION 18.12 |
| Medical Outcome Study Sleep Scale (MOS-SS) Quantity of Sleep | 5.53 Units on a scale STANDARD_DEVIATION 1.63 | 5.47 Units on a scale STANDARD_DEVIATION 1.54 | 5.59 Units on a scale STANDARD_DEVIATION 1.66 | 5.61 Units on a scale STANDARD_DEVIATION 1.68 | 5.45 Units on a scale STANDARD_DEVIATION 1.65 |
| Medical Outcome Study Sleep Scale (MOS-SS) Shortness of Breath, Headache | 36.55 Units on a scale STANDARD_DEVIATION 31.97 | 34.18 Units on a scale STANDARD_DEVIATION 32.96 | 36.70 Units on a scale STANDARD_DEVIATION 31.01 | 38.31 Units on a scale STANDARD_DEVIATION 32.46 | 37.07 Units on a scale STANDARD_DEVIATION 31.54 |
| Medical Outcome Study Sleep Scale (MOS-SS) Sleep Adequacy | 24.62 Units on a scale STANDARD_DEVIATION 23.79 | 24.70 Units on a scale STANDARD_DEVIATION 23.39 | 24.43 Units on a scale STANDARD_DEVIATION 24.8 | 24.30 Units on a scale STANDARD_DEVIATION 22.83 | 25.03 Units on a scale STANDARD_DEVIATION 24.25 |
| Medical Outcome Study Sleep Scale (MOS-SS) Sleep Disturbance | 60.47 Units on a scale STANDARD_DEVIATION 25.72 | 60.02 Units on a scale STANDARD_DEVIATION 25.6 | 61.86 Units on a scale STANDARD_DEVIATION 25.8 | 59.59 Units on a scale STANDARD_DEVIATION 26.55 | 60.37 Units on a scale STANDARD_DEVIATION 25.09 |
| Medical Outcome Study Sleep Scale (MOS-SS) Snoring | 31.36 Units on a scale STANDARD_DEVIATION 31.94 | 31.05 Units on a scale STANDARD_DEVIATION 32.39 | 32.53 Units on a scale STANDARD_DEVIATION 30.82 | 29.77 Units on a scale STANDARD_DEVIATION 32.52 | 32.09 Units on a scale STANDARD_DEVIATION 32.2 |
| Medical Outcome Study Sleep Scale (MOS-SS) Somnolence | 42.77 Units on a scale STANDARD_DEVIATION 23.09 | 41.68 Units on a scale STANDARD_DEVIATION 21.78 | 44.03 Units on a scale STANDARD_DEVIATION 22.8 | 42.37 Units on a scale STANDARD_DEVIATION 23.91 | 42.97 Units on a scale STANDARD_DEVIATION 23.92 |
| Multidimensional Assessment of Fatigue (MAF) | 34.68 Units on a scale STANDARD_DEVIATION 7.8 | 34.89 Units on a scale STANDARD_DEVIATION 7.52 | 34.97 Units on a scale STANDARD_DEVIATION 7.71 | 33.98 Units on a scale STANDARD_DEVIATION 8.29 | 34.87 Units on a scale STANDARD_DEVIATION 7.7 |
| Pain Visual Analogue Scale (VAS) Scores | 71.88 millimeter (mm) STANDARD_DEVIATION 13.72 | 72.72 millimeter (mm) STANDARD_DEVIATION 14.09 | 72.43 millimeter (mm) STANDARD_DEVIATION 13.61 | 70.92 millimeter (mm) STANDARD_DEVIATION 13.69 | 71.43 millimeter (mm) STANDARD_DEVIATION 13.51 |
| Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | 87.2 Percentage of Participants | 20.33 Percentage of Participants | 25.27 Percentage of Participants | 24.57 Percentage of Participants | 17.03 Percentage of Participants |
| Sex: Female, Male Female | 673 Participants | 168 Participants | 167 Participants | 169 Participants | 169 Participants |
| Sex: Female, Male Male | 63 Participants | 16 Participants | 17 Participants | 13 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 97 / 184 | 137 / 184 | 141 / 182 | 154 / 186 |
| serious Total, serious adverse events | 4 / 184 | 2 / 184 | 8 / 182 | 4 / 186 |
Outcome results
Primary
Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)
Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication.
Time frame: Baseline, Week 14
Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using last observation carried forward (LOCF) method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | -0.73 Units on a scale | Standard Error 0.14 |
| Pregabalin 300 mg | Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | -1.06 Units on a scale | Standard Error 0.14 |
| Pregabalin 450 mg | Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | -1.29 Units on a scale | Standard Error 0.14 |
| Pregabalin 600 mg | Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) | -0.96 Units on a scale | Standard Error 0.14 |
Comparison: P value was calculated using Analysis of Covariance (ANCOVA) with treatment and center in the model, and the baseline mean pain score as covariate.p-value: 0.236195% CI: [-0.61, 0.15]ANCOVA
Comparison: P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.p-value: 0.013295% CI: [-0.94, -0.17]ANCOVA
Comparison: P value was calculated using ANCOVA with treatment and center in the model, and the baseline mean pain score as covariate.p-value: 0.169495% CI: [-0.72, 0.05]ANCOVA
Primary
Patient Global Impression of Change (PGIC)
Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).
Time frame: Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression of Change (PGIC) | No change | 43 participants |
| Placebo | Patient Global Impression of Change (PGIC) | Minimally worse | 11 participants |
| Placebo | Patient Global Impression of Change (PGIC) | Very much worse | 3 participants |
| Placebo | Patient Global Impression of Change (PGIC) | Much improved | 43 participants |
| Placebo | Patient Global Impression of Change (PGIC) | Very much improved | 7 participants |
| Placebo | Patient Global Impression of Change (PGIC) | Much worse | 17 participants |
| Placebo | Patient Global Impression of Change (PGIC) | Minimally improved | 45 participants |
| Pregabalin 300 mg | Patient Global Impression of Change (PGIC) | No change | 28 participants |
| Pregabalin 300 mg | Patient Global Impression of Change (PGIC) | Minimally improved | 50 participants |
| Pregabalin 300 mg | Patient Global Impression of Change (PGIC) | Minimally worse | 9 participants |
| Pregabalin 300 mg | Patient Global Impression of Change (PGIC) | Very much improved | 13 participants |
| Pregabalin 300 mg | Patient Global Impression of Change (PGIC) | Very much worse | 5 participants |
| Pregabalin 300 mg | Patient Global Impression of Change (PGIC) | Much worse | 14 participants |
| Pregabalin 300 mg | Patient Global Impression of Change (PGIC) | Much improved | 45 participants |
| Pregabalin 450 mg | Patient Global Impression of Change (PGIC) | Minimally worse | 7 participants |
| Pregabalin 450 mg | Patient Global Impression of Change (PGIC) | Very much improved | 16 participants |
| Pregabalin 450 mg | Patient Global Impression of Change (PGIC) | Much improved | 50 participants |
| Pregabalin 450 mg | Patient Global Impression of Change (PGIC) | Minimally improved | 55 participants |
| Pregabalin 450 mg | Patient Global Impression of Change (PGIC) | No change | 27 participants |
| Pregabalin 450 mg | Patient Global Impression of Change (PGIC) | Much worse | 8 participants |
| Pregabalin 450 mg | Patient Global Impression of Change (PGIC) | Very much worse | 2 participants |
| Pregabalin 600 mg | Patient Global Impression of Change (PGIC) | Very much improved | 20 participants |
| Pregabalin 600 mg | Patient Global Impression of Change (PGIC) | Very much worse | 3 participants |
| Pregabalin 600 mg | Patient Global Impression of Change (PGIC) | Much worse | 10 participants |
| Pregabalin 600 mg | Patient Global Impression of Change (PGIC) | No change | 25 participants |
| Pregabalin 600 mg | Patient Global Impression of Change (PGIC) | Minimally improved | 41 participants |
| Pregabalin 600 mg | Patient Global Impression of Change (PGIC) | Much improved | 46 participants |
| Pregabalin 600 mg | Patient Global Impression of Change (PGIC) | Minimally worse | 10 participants |
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.p-value: 0.0227Cochran-Mantel-Haenszel
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.p-value: 0.0017Cochran-Mantel-Haenszel
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. P-values were calculated using a modified ridit transformation with the Cochran-Mantel-Haenszel procedure, adjusting for center.p-value: 0.0768Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Fatigue (n=183,184,179,184) | -0.81 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Rested (n=183,184,179,185) | -0.94 Units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Stiffness (n=183,184,179,185) | -1.06 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Anxiety (n=183,184,179,185) | -0.48 Units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Depression (n=181,184,179,184) | -0.22 Units on a scale | Standard Error 0.2 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Physical Impairment (n=183,184,179,186) | -0.09 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Feel Good (n=182,184,178,183) | -1.15 Units on a scale | Standard Error 0.22 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Work Missed (n=182,181,178,184) | -0.13 Units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Do Work (n=182,183,179,185) | -0.90 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Pain (n=183,184,179,185) | -0.97 Units on a scale | Standard Error 0.17 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Stiffness (n=183,184,179,185) | -1.02 Units on a scale | Standard Error 0.18 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Do Work (n=182,183,179,185) | -1.04 Units on a scale | Standard Error 0.18 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Anxiety (n=183,184,179,185) | -0.66 Units on a scale | Standard Error 0.2 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Depression (n=181,184,179,184) | -0.56 Units on a scale | Standard Error 0.2 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Physical Impairment (n=183,184,179,186) | -0.26 Units on a scale | Standard Error 0.14 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Feel Good (n=182,184,178,183) | -1.11 Units on a scale | Standard Error 0.22 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Pain (n=183,184,179,185) | -1.18 Units on a scale | Standard Error 0.17 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Work Missed (n=182,181,178,184) | -0.29 Units on a scale | Standard Error 0.18 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Fatigue (n=183,184,179,184) | -0.86 Units on a scale | Standard Error 0.18 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Rested (n=183,184,179,185) | -1.17 Units on a scale | Standard Error 0.19 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Work Missed (n=182,181,178,184) | -0.75 Units on a scale | Standard Error 0.19 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Feel Good (n=182,184,178,183) | -1.77 Units on a scale | Standard Error 0.22 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Pain (n=183,184,179,185) | -1.72 Units on a scale | Standard Error 0.17 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Fatigue (n=183,184,179,184) | -1.36 Units on a scale | Standard Error 0.18 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Anxiety (n=183,184,179,185) | -1.12 Units on a scale | Standard Error 0.2 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Physical Impairment (n=183,184,179,186) | -0.35 Units on a scale | Standard Error 0.14 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Do Work (n=182,183,179,185) | -1.60 Units on a scale | Standard Error 0.18 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Rested (n=183,184,179,185) | -1.47 Units on a scale | Standard Error 0.2 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Depression (n=181,184,179,184) | -1.19 Units on a scale | Standard Error 0.2 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Stiffness (n=183,184,179,185) | -1.28 Units on a scale | Standard Error 0.18 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Depression (n=181,184,179,184) | -0.43 Units on a scale | Standard Error 0.2 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Work Missed (n=182,181,178,184) | -0.27 Units on a scale | Standard Error 0.18 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Physical Impairment (n=183,184,179,186) | -0.26 Units on a scale | Standard Error 0.14 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Pain (n=183,184,179,185) | -1.10 Units on a scale | Standard Error 0.17 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Feel Good (n=182,184,178,183) | -1.26 Units on a scale | Standard Error 0.22 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Rested (n=183,184,179,185) | -1.40 Units on a scale | Standard Error 0.19 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Stiffness (n=183,184,179,185) | -0.94 Units on a scale | Standard Error 0.18 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Anxiety (n=183,184,179,185) | -0.68 Units on a scale | Standard Error 0.2 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Fatigue (n=183,184,179,184) | -1.05 Units on a scale | Standard Error 0.18 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14 | FIQ Do Work (n=182,183,179,185) | -0.98 Units on a scale | Standard Error 0.18 |
Comparison: FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.362795% CI: [-0.54, 0.2]ANCOVA
Comparison: FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.168695% CI: [-0.63, 0.11]ANCOVA
Comparison: FIQ Physical Impairment: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.346895% CI: [-0.55, 0.19]ANCOVA
Comparison: FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.714795% CI: [-0.71, 0.49]ANCOVA
Comparison: FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.040995% CI: [-1.23, -0.03]ANCOVA
Comparison: FIQ Feel Good: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.907795% CI: [-0.56, 0.63]ANCOVA
Comparison: FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.592395% CI: [-0.64, 0.37]ANCOVA
Comparison: FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.017495% CI: [-1.12, -0.11]ANCOVA
Comparison: FIQ Work Missed: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.540895% CI: [-0.66, 0.35]ANCOVA
Comparison: FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.723695% CI: [-0.57, 0.4]ANCOVA
Comparison: FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.004595% CI: [-1.19, -0.22]ANCOVA
Comparison: FIQ Do Work: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.561395% CI: [-0.63, 0.34]ANCOVA
Comparison: FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.560995% CI: [-0.6, 0.33]ANCOVA
Comparison: FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.001695% CI: [-1.22, -0.28]ANCOVA
Comparison: FIQ Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.369295% CI: [-0.68, 0.25]ANCOVA
Comparison: FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.329495% CI: [-0.73, 0.25]ANCOVA
Comparison: FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.02795% CI: [-1.05, -0.06]ANCOVA
Comparison: FIQ Fatigue: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.843295% CI: [-0.54, 0.44]ANCOVA
Comparison: FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.080695% CI: [-0.98, 0.06]ANCOVA
Comparison: FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.04795% CI: [-1.06, -0.01]ANCOVA
Comparison: FIQ Rested: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.384595% CI: [-0.75, 0.29]ANCOVA
Comparison: FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.632695% CI: [-0.37, 0.6]ANCOVA
Comparison: FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.37495% CI: [-0.71, 0.27]ANCOVA
Comparison: FIQ Stiffness: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.893695% CI: [-0.45, 0.52]ANCOVA
Comparison: FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.474395% CI: [-0.73, 0.34]ANCOVA
Comparison: FIQ Anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.019295% CI: [-1.18, -0.1]ANCOVA
Comparison: FIQ anxiety: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.510195% CI: [-0.71, 0.35]ANCOVA
Comparison: FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.461795% CI: [-0.75, 0.34]ANCOVA
Comparison: FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.000695% CI: [-1.51, -0.42]ANCOVA
Comparison: FIQ Depression: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.22995% CI: [-0.88, 0.21]ANCOVA
Secondary
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | -6.94 Units on a scale | Standard Error 1.3 |
| Pregabalin 300 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | -8.11 Units on a scale | Standard Error 1.29 |
| Pregabalin 450 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | -12.79 Units on a scale | Standard Error 1.32 |
| Pregabalin 600 mg | Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14 | -8.38 Units on a scale | Standard Error 1.29 |
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.4295% CI: [-4.95, 2.06]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.001295% CI: [-9.38, -2.31]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.512695% CI: [-4.68, 2.34]ANCOVA
Secondary
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Anxiety (HADS-A) Total | -0.31 Units on a scale | Standard Error 0.25 |
| Placebo | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Depression (HADS-D) Total | -0.11 Units on a scale | Standard Error 0.24 |
| Pregabalin 300 mg | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Depression (HADS-D) Total | -0.33 Units on a scale | Standard Error 0.24 |
| Pregabalin 300 mg | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Anxiety (HADS-A) Total | -0.42 Units on a scale | Standard Error 0.25 |
| Pregabalin 450 mg | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Anxiety (HADS-A) Total | -0.81 Units on a scale | Standard Error 0.26 |
| Pregabalin 450 mg | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Depression (HADS-D) Total | -0.70 Units on a scale | Standard Error 0.25 |
| Pregabalin 600 mg | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Anxiety (HADS-A) Total | -0.90 Units on a scale | Standard Error 0.25 |
| Pregabalin 600 mg | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14 | HADS Depression (HADS-D) Total | 0.04 Units on a scale | Standard Error 0.24 |
Comparison: HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.0995% CI: [-1.28, 0.09]ANCOVA
Comparison: HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.156495% CI: [-1.2, 0.19]ANCOVA
Comparison: HADS-Anxiety Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.751995% CI: [-0.8, 0.58]ANCOVA
Comparison: HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.641695% CI: [-0.5, 0.8]ANCOVA
Comparison: HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.077895% CI: [-1.25, 0.07]ANCOVA
Comparison: HADS-Depression Total: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.519195% CI: [-0.87, 0.44]ANCOVA
Secondary
Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | -0.94 Units on a scale | Standard Error 0.15 |
| Pregabalin 300 mg | Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | -1.42 Units on a scale | Standard Error 0.15 |
| Pregabalin 450 mg | Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | -1.72 Units on a scale | Standard Error 0.15 |
| Pregabalin 600 mg | Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14) | -1.95 Units on a scale | Standard Error 0.15 |
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.p-value: <0.000195% CI: [-1.42, -0.6]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.p-value: 0.000295% CI: [-1.2, -0.37]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline mean sleep score as covariate.p-value: 0.022295% CI: [-0.89, -0.07]ANCOVA
Secondary
Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable for specified category for each arm group.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Disturbance (n=183,183,177,185) | -5.99 Units on a scale | Standard Error 1.79 |
| Placebo | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Somnolence (n=182,182,177,184) | -0.10 Units on a scale | Standard Error 1.5 |
| Placebo | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Adequacy (n=183,183,179,185) | 7.62 Units on a scale | Standard Error 1.93 |
| Placebo | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Snoring (n=172,174,174,177) | -0.03 Units on a scale | Standard Error 1.75 |
| Placebo | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Overall Sleep Problem Index (n=181,181,174,184) | -4.83 Units on a scale | Standard Error 1.35 |
| Placebo | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Shortness of Breath, Headache (n=182,182,177,184) | -0.67 Units on a scale | Standard Error 1.92 |
| Placebo | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Quantity of Sleep (n=182,182,175,182) | 0.41 Units on a scale | Standard Error 0.1 |
| Pregabalin 300 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Somnolence (n=182,182,177,184) | 0.67 Units on a scale | Standard Error 1.49 |
| Pregabalin 300 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Quantity of Sleep (n=182,182,175,182) | 0.61 Units on a scale | Standard Error 0.1 |
| Pregabalin 300 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Shortness of Breath, Headache (n=182,182,177,184) | -9.62 Units on a scale | Standard Error 1.91 |
| Pregabalin 300 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Adequacy (n=183,183,179,185) | 10.19 Units on a scale | Standard Error 1.92 |
| Pregabalin 300 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Overall Sleep Problem Index (n=181,181,174,184) | -9.19 Units on a scale | Standard Error 1.34 |
| Pregabalin 300 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Snoring (n=172,174,174,177) | 1.17 Units on a scale | Standard Error 1.73 |
| Pregabalin 300 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Disturbance (n=183,183,177,185) | -13.18 Units on a scale | Standard Error 1.78 |
| Pregabalin 450 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Quantity of Sleep (n=182,182,175,182) | 0.91 Units on a scale | Standard Error 0.11 |
| Pregabalin 450 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Disturbance (n=183,183,177,185) | -19.26 Units on a scale | Standard Error 1.84 |
| Pregabalin 450 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Snoring (n=172,174,174,177) | 4.89 Units on a scale | Standard Error 1.75 |
| Pregabalin 450 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Shortness of Breath, Headache (n=182,182,177,184) | -12.59 Units on a scale | Standard Error 1.96 |
| Pregabalin 450 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Adequacy (n=183,183,179,185) | 16.76 Units on a scale | Standard Error 1.96 |
| Pregabalin 450 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Somnolence (n=182,182,177,184) | 0.61 Units on a scale | Standard Error 1.53 |
| Pregabalin 450 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Overall Sleep Problem Index (n=181,181,174,184) | -13.07 Units on a scale | Standard Error 1.39 |
| Pregabalin 600 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Shortness of Breath, Headache (n=182,182,177,184) | -9.91 Units on a scale | Standard Error 1.91 |
| Pregabalin 600 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Overall Sleep Problem Index (n=181,181,174,184) | -11.72 Units on a scale | Standard Error 1.34 |
| Pregabalin 600 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Somnolence (n=182,182,177,184) | 1.92 Units on a scale | Standard Error 1.49 |
| Pregabalin 600 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Snoring (n=172,174,174,177) | 5.87 Units on a scale | Standard Error 1.73 |
| Pregabalin 600 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Disturbance (n=183,183,177,185) | -18.70 Units on a scale | Standard Error 1.78 |
| Pregabalin 600 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Sleep Adequacy (n=183,183,179,185) | 11.97 Units on a scale | Standard Error 1.92 |
| Pregabalin 600 mg | Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14 | Quantity of Sleep (n=182,182,175,182) | 0.76 Units on a scale | Standard Error 0.1 |
Comparison: Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: <0.000195% CI: [-17.56, -7.86]ANCOVA
Comparison: Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: <0.000195% CI: [-18.18, -8.38]ANCOVA
Comparison: Sleep Disturbance: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.003895% CI: [-12.06, -2.33]ANCOVA
Comparison: Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.014295% CI: [1.19, 10.61]ANCOVA
Comparison: Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.041495% CI: [0.19, 9.66]ANCOVA
Comparison: Snoring: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.616595% CI: [-3.53, 5.95]ANCOVA
Comparison: Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.000595% CI: [-14.44, -4.05]ANCOVA
Comparison: Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: <0.000195% CI: [-17.17, -6.68]ANCOVA
Comparison: Shortness of Breath, Headache: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.000895% CI: [-14.16, -3.74]ANCOVA
Comparison: Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.012795% CI: [0.08, 0.64]ANCOVA
Comparison: Quantity of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.000595% CI: [0.22, 0.79]ANCOVA
Comparison: Quality of Sleep: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.145395% CI: [-0.07, 0.49]ANCOVA
Comparison: Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.103395% CI: [-0.88, 9.57]ANCOVA
Comparison: Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.000795% CI: [3.88, 14.41]ANCOVA
Comparison: Sleep Adequacy: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.33795% CI: [-2.68, 7.81]ANCOVA
Comparison: Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.330895% CI: [-2.05, 6.07]ANCOVA
Comparison: Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.736495% CI: [-3.39, 4.8]ANCOVA
Comparison: Somnolence: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.713295% CI: [-3.31, 4.84]ANCOVA
Comparison: Overall sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.000295% CI: [-10.54, -3.25]ANCOVA
Comparison: Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: <0.000195% CI: [-11.94, -4.55]ANCOVA
Comparison: Overall Sleep Problem Index: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.019795% CI: [-8.02, -0.7]ANCOVA
Secondary
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14
MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue).
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | -1.91 Units on a scale | Standard Error 0.62 |
| Pregabalin 300 mg | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | -2.78 Units on a scale | Standard Error 0.63 |
| Pregabalin 450 mg | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | -3.32 Units on a scale | Standard Error 0.64 |
| Pregabalin 600 mg | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14 | -2.19 Units on a scale | Standard Error 0.62 |
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.738495% CI: [-1.98, 1.4]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.104495% CI: [-3.12, 0.29]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.313795% CI: [-2.58, 0.83]ANCOVA
Secondary
Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14
Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14 | -10.30 mm | Standard Error 1.67 |
| Pregabalin 300 mg | Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14 | -12.86 mm | Standard Error 1.66 |
| Pregabalin 450 mg | Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14 | -17.75 mm | Standard Error 1.69 |
| Pregabalin 600 mg | Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14 | -11.74 mm | Standard Error 1.66 |
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.53495% CI: [-5.97, 3.09]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.001495% CI: [-12, -2.88]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.269495% CI: [-7.09, 1.98]ANCOVA
Secondary
Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Functioning (n=184,184,177,186) | 4.64 Units on a scale | Standard Error 1.32 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Role Limitations (n=183,183,177,185) | 4.01 Units on a scale | Standard Error 1.63 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Emotional Role Limitations (n=183,183,177,185) | -2.31 Units on a scale | Standard Error 1.94 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Social Functioning (n=183,184,178,186) | 0.75 Units on a scale | Standard Error 1.77 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Health (n=183,184,178,186) | -1.67 Units on a scale | Standard Error 1.35 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Bodily Pain (n=183,184,178,186) | 4.95 Units on a scale | Standard Error 1.31 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Vitality (n=183,184,178,186) | 4.15 Units on a scale | Standard Error 1.42 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | General Health Perception (n=183,184,177,186) | 0.94 Units on a scale | Standard Error 1.16 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Component Score (n=182,183,176,184) | -1.27 Units on a scale | Standard Error 0.81 |
| Placebo | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Component Score (n=182,183,176,184) | 2.47 Units on a scale | Standard Error 0.52 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Emotional Role Limitations (n=183,183,177,185) | 1.44 Units on a scale | Standard Error 1.93 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Component Score (n=182,183,176,184) | 0.87 Units on a scale | Standard Error 0.81 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Social Functioning (n=183,184,178,186) | 4.10 Units on a scale | Standard Error 1.76 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Health (n=183,184,178,186) | 1.65 Units on a scale | Standard Error 1.34 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Bodily Pain (n=183,184,178,186) | 7.77 Units on a scale | Standard Error 1.3 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Vitality (n=183,184,178,186) | 4.89 Units on a scale | Standard Error 1.41 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Component Score (n=182,183,176,184) | 2.60 Units on a scale | Standard Error 0.52 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | General Health Perception (n=183,184,177,186) | 2.76 Units on a scale | Standard Error 1.15 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Functioning (n=184,184,177,186) | 5.22 Units on a scale | Standard Error 1.31 |
| Pregabalin 300 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Role Limitations (n=183,183,177,185) | 4.40 Units on a scale | Standard Error 1.62 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | General Health Perception (n=183,184,177,186) | 3.67 Units on a scale | Standard Error 1.18 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Vitality (n=183,184,178,186) | 9.25 Units on a scale | Standard Error 1.45 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Component Score (n=182,183,176,184) | 3.01 Units on a scale | Standard Error 0.53 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Functioning (n=184,184,177,186) | 6.63 Units on a scale | Standard Error 1.35 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Social Functioning (n=183,184,178,186) | 5.76 Units on a scale | Standard Error 1.81 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Bodily Pain (n=183,184,178,186) | 10.32 Units on a scale | Standard Error 1.33 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Component Score (n=182,183,176,184) | 2.39 Units on a scale | Standard Error 0.83 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Role Limitations (n=183,183,177,185) | 5.50 Units on a scale | Standard Error 1.66 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Health (n=183,184,178,186) | 4.25 Units on a scale | Standard Error 1.38 |
| Pregabalin 450 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Emotional Role Limitations (n=183,183,177,185) | 3.93 Units on a scale | Standard Error 1.98 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Health (n=183,184,178,186) | 2.41 Units on a scale | Standard Error 1.34 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | General Health Perception (n=183,184,177,186) | 2.21 Units on a scale | Standard Error 1.14 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Bodily Pain (n=183,184,178,186) | 7.53 Units on a scale | Standard Error 1.3 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Component Score (n=182,183,176,184) | 2.34 Units on a scale | Standard Error 0.52 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Vitality (n=183,184,178,186) | 7.29 Units on a scale | Standard Error 1.41 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Role Limitations (n=183,183,177,185) | 5.03 Units on a scale | Standard Error 1.62 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Emotional Role Limitations (n=183,183,177,185) | 1.56 Units on a scale | Standard Error 1.93 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Social Functioning (n=183,184,178,186) | 3.60 Units on a scale | Standard Error 1.76 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Physical Functioning (n=184,184,177,186) | 4.13 Units on a scale | Standard Error 1.31 |
| Pregabalin 600 mg | Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14 | Mental Component Score (n=182,183,176,184) | 1.35 Units on a scale | Standard Error 0.81 |
Comparison: Physical functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.778195% CI: [-4.07, 3.05]ANCOVA
Comparison: Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.279295% CI: [-1.62, 5.59]ANCOVA
Comparison: Physical Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.751295% CI: [-3, 4.15]ANCOVA
Comparison: Physical role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.64995% CI: [-3.39, 5.43]ANCOVA
Comparison: Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.510595% CI: [-2.96, 5.96]ANCOVA
Comparison: Physical Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.862595% CI: [-4.04, 4.82]ANCOVA
Comparison: Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.148995% CI: [-1.39, 9.12]ANCOVA
Comparison: Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.021395% CI: [0.93, 11.54]ANCOVA
Comparison: Emotional Role Limitations: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.16295% CI: [-1.51, 9.02]ANCOVA
Comparison: Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.244695% CI: [-1.95, 7.65]ANCOVA
Comparison: Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.042995% CI: [0.16, 9.85]ANCOVA
Comparison: Social Functioning: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.172195% CI: [-1.46, 8.16]ANCOVA
Comparison: Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.029195% CI: [0.42, 7.74]ANCOVA
Comparison: Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.001795% CI: [2.23, 9.62]ANCOVA
Comparison: Mental Health: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.076395% CI: [-0.35, 6.99]ANCOVA
Comparison: Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.152495% CI: [-0.95, 6.11]ANCOVA
Comparison: Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.003295% CI: [1.8, 8.93]ANCOVA
Comparison: Bodily Pain: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.11895% CI: [-0.72, 6.36]ANCOVA
Comparison: Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.108195% CI: [-0.69, 6.99]ANCOVA
Comparison: Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.010195% CI: [1.22, 8.99]ANCOVA
Comparison: Vitality: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.703195% CI: [-3.1, 4.6]ANCOVA
Comparison: General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.425395% CI: [-1.86, 4.39]ANCOVA
Comparison: General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.09195% CI: [-0.44, 5.89]ANCOVA
Comparison: General Health Perception: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.252695% CI: [-1.3, 4.95]ANCOVA
Comparison: Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.019595% CI: [0.42, 4.82]ANCOVA
Comparison: Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.001395% CI: [1.44, 5.88]ANCOVA
Comparison: Mental Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.056895% CI: [-0.06, 4.34]ANCOVA
Comparison: Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.852995% CI: [-1.54, 1.27]ANCOVA
Comparison: Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.456495% CI: [-0.88, 1.96]ANCOVA
Comparison: Physical Component Score: P-values less than 0.05 (2-sided) considered statistically significant. ANCOVA method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.857695% CI: [-1.28, 1.54]ANCOVA
Secondary
Change From Baseline in Weekly Mean Sleep Quality Score
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries.
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. 'N' (number of participants analyzed) signifies participants evaluable for this measure. 'n' participants evaluable at given time point for each group, respectively.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 1 (n=183,179,174,178) | -0.38 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 12 (n=141,121,135,119) | -1.22 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 9 (n=146,128,141,126) | -1.11 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 3 (n=174, 164, 159,163) | -0.75 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 10 (n=144,125,139,126) | -1.14 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 11 (n=143,123,137,121) | -1.09 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 4 (n=165,157,155,156) | -0.73 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 2 (n=180,172,168,174) | -0.62 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 14 (n=134,115,128,111) | -1.08 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 5 (n=163, 150, 152,148) | -0.82 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 6 (n=159,145,148,144) | -0.84 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 13 (n=140,120,133,118) | -1.05 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 7 (n=155,140,144,133) | -0.91 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Overall (n=183,179,174,178) | -0.91 Units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Weekly Mean Sleep Quality Score | Week 8 (n=149,133,142,127) | -0.99 Units on a scale | Standard Error 0.15 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 8 (n=149,133,142,127) | -1.60 Units on a scale | Standard Error 0.16 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 12 (n=141,121,135,119) | -1.62 Units on a scale | Standard Error 0.17 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 5 (n=163, 150, 152,148) | -1.67 Units on a scale | Standard Error 0.15 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 9 (n=146,128,141,126) | -1.64 Units on a scale | Standard Error 0.16 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 2 (n=180,172,168,174) | -1.48 Units on a scale | Standard Error 0.15 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 11 (n=143,123,137,121) | -1.65 Units on a scale | Standard Error 0.17 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 13 (n=140,120,133,118) | -1.66 Units on a scale | Standard Error 0.17 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 10 (n=144,125,139,126) | -1.75 Units on a scale | Standard Error 0.16 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 3 (n=174, 164, 159,163) | -1.42 Units on a scale | Standard Error 0.15 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 7 (n=155,140,144,133) | -1.50 Units on a scale | Standard Error 0.16 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Overall (n=183,179,174,178) | -1.57 Units on a scale | Standard Error 0.12 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 14 (n=134,115,128,111) | -1.73 Units on a scale | Standard Error 0.17 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 6 (n=159,145,148,144) | -1.56 Units on a scale | Standard Error 0.15 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 4 (n=165,157,155,156) | -1.52 Units on a scale | Standard Error 0.15 |
| Pregabalin 300 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 1 (n=183,179,174,178) | -1.20 Units on a scale | Standard Error 0.15 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 8 (n=149,133,142,127) | -1.95 Units on a scale | Standard Error 0.16 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 1 (n=183,179,174,178) | -1.08 Units on a scale | Standard Error 0.15 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 2 (n=180,172,168,174) | -1.43 Units on a scale | Standard Error 0.15 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 3 (n=174, 164, 159,163) | -1.56 Units on a scale | Standard Error 0.15 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 4 (n=165,157,155,156) | -1.67 Units on a scale | Standard Error 0.15 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 5 (n=163, 150, 152,148) | -1.69 Units on a scale | Standard Error 0.15 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 6 (n=159,145,148,144) | -1.76 Units on a scale | Standard Error 0.16 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 7 (n=155,140,144,133) | -1.83 Units on a scale | Standard Error 0.16 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 9 (n=146,128,141,126) | -1.94 Units on a scale | Standard Error 0.16 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 10 (n=144,125,139,126) | -2.03 Units on a scale | Standard Error 0.16 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 11 (n=143,123,137,121) | -1.92 Units on a scale | Standard Error 0.16 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 12 (n=141,121,135,119) | -1.95 Units on a scale | Standard Error 0.16 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 13 (n=140,120,133,118) | -1.93 Units on a scale | Standard Error 0.17 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 14 (n=134,115,128,111) | -1.95 Units on a scale | Standard Error 0.17 |
| Pregabalin 450 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Overall (n=183,179,174,178) | -1.76 Units on a scale | Standard Error 0.12 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 7 (n=155,140,144,133) | -2.20 Units on a scale | Standard Error 0.16 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 2 (n=180,172,168,174) | -1.59 Units on a scale | Standard Error 0.15 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 12 (n=141,121,135,119) | -2.29 Units on a scale | Standard Error 0.17 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 6 (n=159,145,148,144) | -2.15 Units on a scale | Standard Error 0.16 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 5 (n=163, 150, 152,148) | -1.99 Units on a scale | Standard Error 0.15 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 1 (n=183,179,174,178) | -1.23 Units on a scale | Standard Error 0.15 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 13 (n=140,120,133,118) | -2.26 Units on a scale | Standard Error 0.17 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 4 (n=165,157,155,156) | -2.01 Units on a scale | Standard Error 0.15 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 3 (n=174, 164, 159,163) | -1.90 Units on a scale | Standard Error 0.15 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Overall (n=183,179,174,178) | -2.07 Units on a scale | Standard Error 0.12 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 10 (n=144,125,139,126) | -2.34 Units on a scale | Standard Error 0.17 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 9 (n=146,128,141,126) | -2.24 Units on a scale | Standard Error 0.16 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 14 (n=134,115,128,111) | -2.29 Units on a scale | Standard Error 0.18 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 11 (n=143,123,137,121) | -2.24 Units on a scale | Standard Error 0.17 |
| Pregabalin 600 mg | Change From Baseline in Weekly Mean Sleep Quality Score | Week 8 (n=149,133,142,127) | -2.25 Units on a scale | Standard Error 0.16 |
Comparison: Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.000395% CI: [-1.1, -0.3]Mixed Model Repeated Measures ANCOVA
Comparison: Week 1: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.4]Mixed Model Repeated Measures ANCOVA
Comparison: Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.6]Mixed Model Repeated Measures ANCOVA
Comparison: Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.4]Mixed Model Repeated Measures ANCOVA
Comparison: Week 2: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.5, -0.8]Mixed Model Repeated Measures ANCOVA
Comparison: Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.4]Mixed Model Repeated Measures ANCOVA
Comparison: Week 3: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.000595% CI: [-1, -0.3]Mixed Model Repeated Measures ANCOVA
Comparison: Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.7, -0.9]Mixed Model Repeated Measures ANCOVA
Comparison: Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.6]Mixed Model Repeated Measures ANCOVA
Comparison: Week 4: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.4]Mixed Model Repeated Measures ANCOVA
Comparison: Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.6, -0.8]Mixed Model Repeated Measures ANCOVA
Comparison: Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 5: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.7, -0.9]Mixed Model Repeated Measures ANCOVA
Comparison: Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 6: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.000395% CI: [-1.1, -0.3]Mixed Model Repeated Measures ANCOVA
Comparison: Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.7, -0.9]Mixed Model Repeated Measures ANCOVA
Comparison: Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 7: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.003795% CI: [-1, -0.2]Mixed Model Repeated Measures ANCOVA
Comparison: Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.7, -0.9]Mixed Model Repeated Measures ANCOVA
Comparison: Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.4, -0.6]Mixed Model Repeated Measures ANCOVA
Comparison: Week 8: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.003195% CI: [-1, -0.2]Mixed Model Repeated Measures ANCOVA
Comparison: Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.5, -0.7]Mixed Model Repeated Measures ANCOVA
Comparison: Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.4]Mixed Model Repeated Measures ANCOVA
Comparison: Week 9: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.011795% CI: [-0.9, -0.1]Mixed Model Repeated Measures ANCOVA
Comparison: Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.6, -0.8]Mixed Model Repeated Measures ANCOVA
Comparison: Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 10: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.00495% CI: [-1, -0.2]Mixed Model Repeated Measures ANCOVA
Comparison: Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.6, -0.7]Mixed Model Repeated Measures ANCOVA
Comparison: Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.2, -0.4]Mixed Model Repeated Measures ANCOVA
Comparison: Week 11: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.0195% CI: [-1, -0.1]Mixed Model Repeated Measures ANCOVA
Comparison: Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.5, -0.6]Mixed Model Repeated Measures ANCOVA
Comparison: Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.000695% CI: [-1.2, -0.3]Mixed Model Repeated Measures ANCOVA
Comparison: Week 12: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.06995% CI: [-0.8, 0]Mixed Model Repeated Measures ANCOVA
Comparison: Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.6, -0.8]Mixed Model Repeated Measures ANCOVA
Comparison: Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.5]Mixed Model Repeated Measures ANCOVA
Comparison: Week 13: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.005495% CI: [-1, -0.2]Mixed Model Repeated Measures ANCOVA
Comparison: Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.6, -0.8]Mixed Model Repeated Measures ANCOVA
Comparison: Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.3, -0.4]Mixed Model Repeated Measures ANCOVA
Comparison: Week 14: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: 0.003695% CI: [-1.1, -0.2]Mixed Model Repeated Measures ANCOVA
Comparison: Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.5, -0.9]Mixed Model Repeated Measures ANCOVA
Comparison: Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1.1, -0.6]Mixed Model Repeated Measures ANCOVA
Comparison: Overall: P-values less than 0.05 (2-sided) considered statistically significant. A mixed model repeated measures ANCOVA using treatment, center, week, and treatment-by-week interaction in the model and baseline mean sleep score as the covariate.p-value: <0.000195% CI: [-1, -0.4]Mixed Model Repeated Measures ANCOVA
Secondary
Percentage of Participants With Optimal Sleep Assessed Using MOS-SS
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more disturbance.
Time frame: Baseline, Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were handled using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | 30.8 Percentage of participants |
| Pregabalin 300 mg | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | 33.5 Percentage of participants |
| Pregabalin 450 mg | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | 44.0 Percentage of participants |
| Pregabalin 600 mg | Percentage of Participants With Optimal Sleep Assessed Using MOS-SS | 32.4 Percentage of participants |
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.53795% CI: [0.71, 1.95]Regression, Logistic
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.010995% CI: [1.16, 3.18]Regression, Logistic
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. Logistic regression method was used with treatment and center in the model, and the baseline score as covariate.p-value: 0.961395% CI: [0.61, 1.68]Regression, Logistic
Secondary
Total Daily Acetaminophen Dose
Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days).
Time frame: Week 14
Population: FAS included all randomized participants who received at least 1 dose of study medication, regardless of medication compliance. Missing data were imputed using LOCF method. 'N' (number of participants analyzed) signifies participants evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Daily Acetaminophen Dose | 460.65 mg/day | Standard Error 125.43 |
| Pregabalin 300 mg | Total Daily Acetaminophen Dose | 449.14 mg/day | Standard Error 124.79 |
| Pregabalin 450 mg | Total Daily Acetaminophen Dose | 508.53 mg/day | Standard Error 126.71 |
| Pregabalin 600 mg | Total Daily Acetaminophen Dose | 724.42 mg/day | Standard Error 124.72 |
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.p-value: 0.782995% CI: [-293.2, 389.02]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using analysis of variance (ANOVA), with treatment and center in the model.p-value: 0.127795% CI: [-75.78, 603.33]ANCOVA
Comparison: P-values less than 0.05 (2-sided) considered statistically significant. P value was calculated using ANOVA, with treatment and center in the model.p-value: 0.947195% CI: [-351.9, 328.86]ANCOVA